Replacing urethral tissue with functional scaffolds has been one of the challenging problems in the field of urethra reconstruction or repair over the last several decades. Various scaffold materials have been used in...Replacing urethral tissue with functional scaffolds has been one of the challenging problems in the field of urethra reconstruction or repair over the last several decades. Various scaffold materials have been used in animal studies, but clinical studies on use of scaffolds for urethral repair are scarce. The aim of this study was to review recent animal and clinical studies on the use of different scaffolds for urethral repair, and to evaluate these scaffolds based on the evidence from these studies. Pub Med and OVID databases were searched to identify relevant studies, in conjunction with further manual search. Studies that met the inclusion criteria were systematically evaluated. Of 555 identified studies, 38 were included for analysis. It was found that in both animal and clinical studies, scaffolds seeded with cells were used for repair of large segmental defects of the urethra, such as in tubular urethroplasty. When the defect area was small, cell-free scaffolds were more likely to be applied. A lot of pre-clinical and limited clinical evidence showed that natural or artificial materials could be used as scaffolds for urethral repair. Urinary tissue engineering is still in the immature stage, and the safety, efficacy, cost-effectiveness of the scaffolds are needed for further study.展开更多
Background:Eye-acupuncture(EA)is a fine-needle acupuncture therapy for systemic diseases.This bibliometric analysis aims to provide a comprehensive review of the characteristics of EA for ischemic or hemorrhagic apopl...Background:Eye-acupuncture(EA)is a fine-needle acupuncture therapy for systemic diseases.This bibliometric analysis aims to provide a comprehensive review of the characteristics of EA for ischemic or hemorrhagic apoplexy based on clinical studies.Methods:A total of 195 clinical studies from six databases such as CNKI,VIP,Wanfang Data,SinoMed,PubMed and the Cochrane Library from inception to December 31,2017 were included.Bibliometric information mainly including study type,participant characteristics,intervention and comparison details,and outcomes were extracted.Data was analyzed descriptively using SPSSsoftware to determine their distribution(range,interquartile range)and central tendency(median).Results:The studies covered 108 RCTs,36 controlled clinical trials,45 case series and 6 case reports on EA for treatment of ischemic or hemorrhagic apoplexy,involved 15466 stroke patients.EA was used at different stages of ischemic or hemorrhagic apoplexy:acute stage(n Z 38),recovery(n Z 32),sequela(n Z 13)and unclear(n Z 112).The most frequently used EA acupoints were in the upper-jiao and lower-jiao regions.The commonly used comparisons were EA alone versus traditional acupuncture,or EA plus traditional acupuncture versus traditional acupuncture.Neurological deficit scale,Modified Barthel Index,and activities of daily living were the most frequently used outcome measures.Conclusion:EA as an adjuvant therapy is effective and safe in treating stroke at acute and recovery stages,but high-quality RCTs are lacking.展开更多
Dental pulp stem/stromal cells(DPSCs)are fibroblast-like,neural crest-derived,and multipotent cells that can differentiate into several lineages.They are relatively easy to isolate from healthy and inflamed pulps,with...Dental pulp stem/stromal cells(DPSCs)are fibroblast-like,neural crest-derived,and multipotent cells that can differentiate into several lineages.They are relatively easy to isolate from healthy and inflamed pulps,with little ethical concerns and can be successfully cryopreserved and thawed.The therapeutic effects of DPSCs derived from animal or human sources have been extensively studied through in-vitro and in-vivo animal experiments and the findings indicated that DPSCs are effective not only for dental diseases but also for systemic diseases.Understanding that translational research is a critical step through which the fundamental scientific discoveries could be translated into applicable diagnostics and therapeutics that directly benefit humans,several clinical studies were carried out to generate evidence for the efficacy and safety of autogenous or allogeneic human DPSCs(hDPSCs)as a treatment modality for use in cell-based therapy,regenerative medicine/dentistry and tissue engineering.In clinical medicine,hDPSCs were effective for treating acute ischemic stroke and human exfoliated deciduous teeth-conditioned medium(SHED-CM)repaired vascular damage of the corpus cavernous,which is the main cause of erectile dysfunction.Whereas in clinical dentistry,autologous SHED was able to rege-nerate necrotic dental pulp after implantation into injured teeth,and micrografts enriched with autologous hDPSCs and collagen sponge were considered a treatment option for human intrabony defects.In contrast,hDPSCs did not add a significant regenerative effect when they were used for the treatment of post-extraction sockets.Large-scale clinical studies across diverse populations are still lacking to provide robust evidence on the safety and efficacy of hDPSCs as a new treatment option for various human diseases including dental-related problems.展开更多
Ganoderma lucidum,one of the most well-known edible fungi,is believed to be very beneficial for longevity and vitality.A long usage history suggests that G.lucidum has various clinical therapeutic effects.And experime...Ganoderma lucidum,one of the most well-known edible fungi,is believed to be very beneficial for longevity and vitality.A long usage history suggests that G.lucidum has various clinical therapeutic effects.And experimental studies have confirmed that G.lucidum has multiple pharmacological effects,including antitumor,anti-microbial,anti-HIV protease,and antidiabetic activity and so on.With the deepening of research,more than 300 compounds have been isolated from G.lucidum.There is an increasing population of G.lucidum-based products,and its international development is expanding.Currently,G.lucidum has drawn much attention to its chemical composition,therapeutic effect,clinical value,and safety.This paper provides a comprehensive review of these aspects to enhance the global promotion of G.lucidum.展开更多
BACKGROUND Diabetic foot ulcers(DFUs)are a common complication of diabetes,often leading to severe infections,amputations,and reduced quality of life.The current standard treatment protocols for DFUs have limitations ...BACKGROUND Diabetic foot ulcers(DFUs)are a common complication of diabetes,often leading to severe infections,amputations,and reduced quality of life.The current standard treatment protocols for DFUs have limitations in promoting efficient wound healing and preventing complications.A comprehensive treatment approach targeting multiple aspects of wound care may offer improved outcomes for patients with DFUs.The hypothesis of this study is that a comprehensive treatment protocol for DFUs will result in faster wound healing,reduced amputation rates,and improved overall patient outcomes compared to standard treatment protocols.AIM To compare the efficacy and safety of a comprehensive treatment protocol for DFUs with those of the standard treatment protocol.METHODS This retrospective study included 62 patients with DFUs,enrolled between January 2022 and January 2024,randomly assigned to the experimental(n=32)or control(n=30)group.The experimental group received a comprehensive treatment comprising blood circulation improvement,debridement,vacuum sealing drainage,recombinant human epidermal growth factor and anti-inflammatory dressing,and skin grafting.The control group received standard treatment,which included wound cleaning and dressing,antibiotics administration,and surgical debridement or amputation,if necessary.Time taken to reduce the white blood cell count,number of dressing changes,wound healing rate and time,and amputation rate were assessed.RESULTS The experimental group exhibited significantly better outcomes than those of the control group in terms of the wound healing rate,wound healing time,and amputation rate.Additionally,the comprehensive treatment protocol was safe and well tolerated by the patients.CONCLUSION Comprehensive treatment for DFUs is more effective than standard treatment,promoting granulation tissue growth,shortening hospitalization time,reducing pain and amputation rate,improving wound healing,and enhancing quality of life.展开更多
Use of gold nanoparticles(GNPs)in medicine is an emerging field of translational research with vast clinical implications and exciting therapeutic potential.However,the safety of using GNPs in human subjects is an imp...Use of gold nanoparticles(GNPs)in medicine is an emerging field of translational research with vast clinical implications and exciting therapeutic potential.However,the safety of using GNPs in human subjects is an important question that remains unanswered.This study reviews over 20 clinical trials focused on GNP safety and aims to summarize all the clinical studies,completed and ongoing,to identify whether GNPs are safe to use in humans as a therapeutic platform.In these studies,GNPs were implemented as drug delivery devices,for photothermal therapy,and utilized for their intrinsic therapeutic effects by various routes of delivery.These studies revealed no major safety concerns with the use of GNPs;however,the number of trials and total patient number remains limited.Multi-dose,multicenter blinded trials are required to deepen our understanding of the use of GNPs in clinical settings to facilitate translation of this novel,multifaceted therapeutic device.Expanding clinical trials will require collaboration between clinicians,scientists,and biotechnology companies.展开更多
Various forms of complementary and alternative medicine are used in psoriasis.Among these,herbal medicines are frequently used as systemic and/or topical interventions either as a replacement for or in conjunction wit...Various forms of complementary and alternative medicine are used in psoriasis.Among these,herbal medicines are frequently used as systemic and/or topical interventions either as a replacement for or in conjunction with conventional methods.The benefit of such use is unclear.This review is to provide an up-to-date review and discussion of the clinical evidence for the main kinds of herbal therapies for psoriasis.Searches of the biomedical databases PubMed(including MEDLINE), EMBASE and CINAHL were conducted in December 2011 which identified 32 clinical studies,all published in English.Twenty of these primarily tested topical herbal medicines and were thus excluded.The 12 studies that evaluated systemic use of herbal medicines were included in the review.Four were case series studies and the other 8 were controlled trials.In terms of interventions,4 studies tested the systemic use of plant oils combined with marine oils and 8 studies tested multi-ingredient herbal formulations.The clinical evidence for plant and animal derived fatty acids is inconclusive and any benefit appears to be small.For the multi-herb formulations,benefits of oral herbal medicines were shown in several studies,however,a number of these studies are not controlled trials,a diversity of interventions are tested and there are methodological issues in the controlled studies.In conclusion,there is promising evidence in a number of the studies of multi-herb formulations.However,well-designed,adequately powered studies with proper control interventions are needed to further determine the benefits of these formulations.In addition,syndrome differentiation should be incorporated into trial design to ensure effective translation of findings from these studies into Chinese medicine clinical practice.展开更多
Trigonella foenum-graecum(fenugreek)belonging to the family Fabaceae,is widely used for both culinary as well as clinical purposes since antiquity.Folkloric medicines across globe particularly use this plant for boost...Trigonella foenum-graecum(fenugreek)belonging to the family Fabaceae,is widely used for both culinary as well as clinical purposes since antiquity.Folkloric medicines across globe particularly use this plant for boosting immunity and combating digestive and reproductive impairments.The plant is rich reservoir of different phytoconstituents attributed to their diverse pharmacological effects.Therefore,the present article is planned on its ethnomedicinal uses,botanical description,phytochemistry,pharmacology,toxicology,clinical efficacy,mechanism of action and nanoparticle synthesis.In all pharmacological studies,the dose,major bioactive,type of extract and possible outcomes is also discussed,to establish its specific role against a particular ailment.It was hypothesized that the nanoparticle synthesis will lead to the enhanced pharmacology.Results showed that ethnomedicinal data well supports the different pharmacological aspects of Trigonella formulations in different countries.Trigonelline(phytoestrogen)renders most of therapeutic potential of Trigonella.The reported therapeutics can also be accounted as the synergistic pharmacology of different bioactives.Nanoparticle synthesis significantly improves its pharmacological efficacy.Clinical studies well validated its antidiabetic and reproductive health improving efficacies.Though no serious toxic effects were observed with the use of this plant but further well-designed placebo trials are still needed to demonstrate its full therapeutic potential.展开更多
The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European countries.It is estimated that on the average 50 to 100 million dollars and 10 or more years ...The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European countries.It is estimated that on the average 50 to 100 million dollars and 10 or more years from the time of patenting are required to make a new drug available for general prescription. Every new drug needs to be charac-展开更多
Scrub typhus is an acute febrile vector-borne zoonotic disease caused by the obligate intracellular growth bacterium Orientia tsutsugamushi(Ot).Mites are the primary vectors and rodents play a pivotal role in the tran...Scrub typhus is an acute febrile vector-borne zoonotic disease caused by the obligate intracellular growth bacterium Orientia tsutsugamushi(Ot).Mites are the primary vectors and rodents play a pivotal role in the transmission of scrub typhus.Due to the climate warming,increased human activity and other factors,cases of scrub typhus have been increased sharply during the past decade in China,especially in the northern China.To understand the incidence trend,epidemic pattern,clinical sign,diagnosis and therapy of this diseases as well as genotype evolution of Orientia tsutsugamushi,we summarized and analyzed the current knowledge of scrub typhus in China from 2010 to 2020.The data indicated that the dominate genotypes of scrub typhus in China were Karp,Kato and Gilliam.Although the disease was distributed national wide,Yunnan,Guangzhou and Fujian showed the highest incidence rate.The main vector of scrub typhus in southwest,middle east and southeast of China appeared a geographic preference respectively.Seasonal timing,age and occupation were the key factors that relate to the peak incidence of scrub typhus.Notably,farmer was the occupation with the highest risk of Ot infection.Further study on the epidemic characteristics,risk factors,diagnosis and treatments of scrub typhus will be of benefit to a comprehensive guideline for prevention and control of this ancient disease.展开更多
Background: Since the appearance of the COVID-19 pandemic, several drugs have also been proposed for the treatment of the COVID-19, but the therapeutic effectiveness of those drugs is not satisfactory. This situation ...Background: Since the appearance of the COVID-19 pandemic, several drugs have also been proposed for the treatment of the COVID-19, but the therapeutic effectiveness of those drugs is not satisfactory. This situation has led to the search for therapeutic solutions based on recipes from traditional medicine. Aims: This study aimed to evaluate the clinical safety, efficacy and tolerability of the phytomedicine APIVIRINE in patients with non-severe COVID-19. Methods: Patients were included following defined criteria and followed on an outpatient basis until recovery in accordance with national guidelines for the management of single cases of COVID-19 in Burkina Faso. Vital signs, anthropometric parameters as well as electrocardiographic, hematological and biochemical examinations were measured on D4, D7, D14 and D21. Adverse events were recorded during maintenance. Results: The present study included 45 patients. The clinical signs present at inclusion were mostly cough (44.44%), asthenia (42.22%), headache (40%), and anosmia (35.55%). Dyspnoea and chest pain were less represented in 05 (11.11%) and 06 (13.33%) patients. Cough, dyspnoea, chest pain, fever, sore throat, headache, and nasal obstruction present at inclusion disappeared before Day 4 of treatment. Anosmia and asthenia disappeared before Day 7. At the inclusion visit (Day 1), CRP, WBC, and blood glucose were abnormal in 15 (33.33%), 13 (28.89%), and 11 (24.44%) patients respectively. In addition, 3 (6.66%) patients had elevated creatinine levels. Transaminases Alanine aminotransferase (ALAT) were elevated in 05 (11.11%) patients while Aspartate aminotransferase (ASAT) was elevated in 04 (8.89%) patients. After 4 days of treatment, the cure rate was 33.33% of patients and 48.89% after 7 days. The cumulative cure rate was 86.67% after 14 days of treatment. Conclusion: No serious side effects or allergic reactions were observed during treatment. No clinical complications were observed and all symptoms present resolved on the 7th day of treatment.展开更多
Antenatal administration of magnesium sulfate is an important part of the neuroprotective strategy for preterm infants. Strong evidence from five randomized controlled trials and five meta-analyses has demonstrated th...Antenatal administration of magnesium sulfate is an important part of the neuroprotective strategy for preterm infants. Strong evidence from five randomized controlled trials and five meta-analyses has demonstrated that magnesium sulfate, when administered before preterm delivery, significantly reduces the risk of cerebral palsy at two years. Through secondary analyses of randomized controlled trials and other original clinical studies, this state-of-the-art review highlights the absence of serious adverse effects in both pregnant women and neonates, as well as the impact of maternal body mass index and preeclamptic status on the maternal and neonatal magnesium levels, which could influence the magnitude of the neuroprotective effect. Although antenatal magnesium sulfate is a cost-effective strategy, some practice surveys have demonstrated that the use of magnesium sulfate is not sufficient and that its use is heterogeneous, differing among different maternity wards. Since 2010, an increasing number of obstetrical societies have recommended its use to improve the neurological outcomes of preterm infants, especially the International Federation of Gynecology and Obstetrics and World Health Organization in 2015, and France in 2017. Considering the neuroprotective impact of magnesium sulfate when administered before delivery, postnatal administration should be considered, and its effects should be assessed using randomized controlled trials.展开更多
BACKGROUND: Ischemic stroke in young adults brings extremely hurts for their families and society, and the etiological factors and risk factors are different in the world.OBJECTIVE: To analyze and evaluate clinical ...BACKGROUND: Ischemic stroke in young adults brings extremely hurts for their families and society, and the etiological factors and risk factors are different in the world.OBJECTIVE: To analyze and evaluate clinical significance of ischemic stroke in young adults by using TOAST typing.DESIGN: Case analysis.SETTING: Department of Neurology, the First Affiliated Hospital, Guangxi Medical University.PARTICIPANTS: A total of 64 young adults with acute ischemic stroke were selected from the Department of Neurology, the First Affiliated Hospital, Guangxi Medical University from September 2005 to June 2006.There were 44 males and 20 females and their age ranged from 15 to 45 years. All patients met with the diagnostic criteria of the Fourth National Cerebrovarscular Academic Meeting and certainly diagnosed with CT or MRI examination. In addition, all patients provided the confirmed consent.METHODS: ① TOAST typing: Based on X-ray of thoracic part, electrocardiography, blood routine, blood glucose, electrolure, lipid, blood coagulation test, anticardiolipin antibody, antinuclear antibody, anti-double chain DNA, antineutrophil cytoplasmic antibody, crook agglutination test, syphilis antibody and human immunodeficiency virus (HIV) antibody test, patients received TOAST typing, including large-artery atherosclerotic stroke (LA), small-artery occlusion lacunar (SA), cardioembolism (CE), stroke of other demonstrated etiology (SOE), and stroke of other undemonstrated etiology (SUE). ② Risk factors: Stages of hypertension, diabetes mellitus, hyperlipemia, smoking and drinking of patients were observed. Blood pressure was measured twice after onset of acute stroke, and values of total cholesterol (TC) and/or triacylglycerol (TG) were measured more than twice to finally diagnose hyperlipemia. Diagnostic criteria of diabetes mellitus: fasting≥7.0 mmol/L; 2 hours after administrating glucose ≥ 11.1 mmol/L. Risk factor of smoking defined as more than 10 smokes every day in the last year or last several years. Wile, drinking defined as more than twice every weak. Hyperlipemia was measured for twice at least.MAIN OUTCOME MEASURES: TOAST typing and risk factors.RESULTS: All 64 accepted patients were involved in the final analysis. ①TOAST typing: CA counted for 22%, SA for 33%, CE for 19%, SOE for 16%, and SUE for 11%. Among them, percentage of SA was the highest, and there was statistically significance (P〈0.01). ② Analysis of risk factors: Numbers of smoking and drinking were 19 (43%) and 15 (34%) respectively in the males, which was more than those in the females (0, 0, P〈0.01). In addition, numbers of hypertension was more in the females than those in the males [15 (75%), 20 (45%), P 〈 0.05].CONCLUSION: There are different clinical meanings for different ages in young parients according to TOAST subtypes and risk factors.展开更多
Collagen has been a component of skin care formulations for many years, and over this time, there have been numerous claims of its efficiency. Collagen protein is responsible for firm strong skin, but since collagen f...Collagen has been a component of skin care formulations for many years, and over this time, there have been numerous claims of its efficiency. Collagen protein is responsible for firm strong skin, but since collagen fibers are too large to penetrate the stratum corneum (SC), topical creams containing collagen fibers remain on the skin surface without affecting skin quality. To overcome the poor penetration of collagen fibers, we prepared in the past micronized collagen fibers that were proven to reach the epidermis layer while inserted in a cream. In the present paper, we have performed a clinical study that analyzes the effect of the micronized fibrillar collagen containing cream on skin. Fifty five healthy female volunteers were enrolled and completed the study. The anti-ageing, firming, elasticity and moisturization efficacy of the cream were measured using Profilometer, Cutometer and Corneometer respectively. The results showed a significant improvement in skin hydration firmness and elasticity, a significant reduction in fine lines and wrinkles was also observed.展开更多
Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promisin...Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.展开更多
Objective: To explore the safety of ultrasound and microbubbles for enhancing the chemotherapeutic sensitivity of malignant tumors in the digestive system in a clinical trial, as well as its efficacy.Methods: From O...Objective: To explore the safety of ultrasound and microbubbles for enhancing the chemotherapeutic sensitivity of malignant tumors in the digestive system in a clinical trial, as well as its efficacy.Methods: From October 2014 to June 2016, twelve patients volunteered to participate in this study. Eleven patients had hepatic metastases from tumors of the digestive system, and one patient had pancreatic carcinoma. According to the mechanical index (MI) in the ultrasound field, patients were classified into four groups with MIs of 0.4, 0.6, 0.8 and 1.0. Within half an hour after chemotherapy, patients underwent ultrasound scanning with ultrasound microbubbles (SonoVue) to enhance the efficacy of chemotherapy. All adverse reactions were recorded and were classified in 4 grades according to the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03). Tumor responses were evaluated by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria. All the patients were followed up until progression.Results: All the adverse reactions recorded were level 1 or level 2. No local pain occurred in any of the patients. Among all the adverse reactions, fever might be related to the treatment with ultrasound combined with microbubbles. Six patients had stable disease (SD), and one patient had a partial response (PR) after the first cycle of treatment. At the end of follow-up, tumor progression was restricted to the original sites, and no new lesions had appeared.Conclusions: Our preliminary data showed the potential role of a combined treatment with ultrasound and microbubbles in enhancing the chemotherapeutic sensitivity of malignant tumors of the digestive system. This technique is safe when the MI is no greater than 1.0.展开更多
Objective: In comparison with chemotherapy, to evaluate therapeutic effects on advanced pancreatic cancer treated by integrative Chinese and western medicine (ICWM) therapies. Methods: Based on the retrospective study...Objective: In comparison with chemotherapy, to evaluate therapeutic effects on advanced pancreatic cancer treated by integrative Chinese and western medicine (ICWM) therapies. Methods: Based on the retrospective study of 56 patients with advanced pancreatic cancer, life table was applied to the analysis of patients' survival rate and Xz test to the comparison of therapeutic response between ICWM and chemotherapy groups. Results: The results showed that 1-year survival rate in the ICWM group was 55. 37%±3.24%; 2-year survival rate 34. 61%±16. 31%; 3-year survival rate 25. 96%±24. 64%; 5-year survival rate 25. 96%±24.64%; and median survival period 16. 3 months. However 1-year survival rate in the chemotherapy group was 21. 95%±27. 54% ; 2-year survival rate 7. 31%±27. 54% ; 3-year survival rate 0 % ; and median survival period 7. 5 months. The therapeutic effects between two groups were significantly different (P=0. 004). Further analysis suggested that the reduction of cancer mass in the ICWM group was more than that in chemotherapy group (P=0.049) and the improvement of advanced pancreatic cancer related-symptoms better than that of chemotherapy group (P = 0. 002). Conclusion: The ICWM comprehensive therapy is of important value in the treatment of advanced pancreatic cancer.展开更多
Objective: To evaluate the efficacy of integrative Chinese and western medicine (ICWM) in treating severe acute respiratory syndrome (SARS) patients. Methods: Through parallel control design, 49 SARS patients were obs...Objective: To evaluate the efficacy of integrative Chinese and western medicine (ICWM) in treating severe acute respiratory syndrome (SARS) patients. Methods: Through parallel control design, 49 SARS patients were observed. Used as control, there were in the western medicine (WM) group 29 patients, who were treated with Ribavirin, Levofloxacin, Thymopentin, Azithromycin, methylprednisolone, etc. , on the basis of 'Recommended Protocol for Infectious Atypical Pneumonia' (abbreviated as 'Recommended Protocol') issueed by Ministry of Health. As the treated group, there were in the ICWM 20 cases. The protocol for treatment of SARS in 'Special Science and Technological Action to Prevent and Treat SARS' (abbreviated as 'Special S-T Action'), issued by Ministry of Science and Technology, together with the same WM as those for the control group. Results: (1) Time from the disease onset to the symptom improvement were 5.10±2. 83 days and 7. 62±2. 27 days in ICWM and WM group respectively, P<0.05; (2) As to corticosteroid (CS) amount and days before reducing dosage, 2 groups showed no significant difference, P>0. 05;(3) There was no significant difference in the time from disease onset to the body temperature normalization and the total amount of CS and the duration of using CS before reducing it to 80 mg between the ICWM group and the WM group; (4) The days and amounts for use CS after reducing between the ICWM group and the WM group were significantly different (P<0. 05). Conclusion: There were obvious advantages in ICWM to treat SARS, compared with that of WM alone, especially in improving the clinical symptoms, promoting the recovery of immune function, promoting the absorption of pulmonary inflammation and reducing the dosage and duration of CS treatment.展开更多
文摘Replacing urethral tissue with functional scaffolds has been one of the challenging problems in the field of urethra reconstruction or repair over the last several decades. Various scaffold materials have been used in animal studies, but clinical studies on use of scaffolds for urethral repair are scarce. The aim of this study was to review recent animal and clinical studies on the use of different scaffolds for urethral repair, and to evaluate these scaffolds based on the evidence from these studies. Pub Med and OVID databases were searched to identify relevant studies, in conjunction with further manual search. Studies that met the inclusion criteria were systematically evaluated. Of 555 identified studies, 38 were included for analysis. It was found that in both animal and clinical studies, scaffolds seeded with cells were used for repair of large segmental defects of the urethra, such as in tubular urethroplasty. When the defect area was small, cell-free scaffolds were more likely to be applied. A lot of pre-clinical and limited clinical evidence showed that natural or artificial materials could be used as scaffolds for urethral repair. Urinary tissue engineering is still in the immature stage, and the safety, efficacy, cost-effectiveness of the scaffolds are needed for further study.
基金y the Special Research Project for Traditional Chinese Medicine Sector,State Administration of Traditional Chinese Medicine:clinical trial of post-stroke shoulder-hand syndrome treated by eyeacupuncture therapy with warm external application of Chinese herbs(201407001-7)Liaoning Peng-Style Eye Acupuncture Academic Thought Transmission Project,State Administration of Traditional Chinese Medicine(LPGZS2012-09).
文摘Background:Eye-acupuncture(EA)is a fine-needle acupuncture therapy for systemic diseases.This bibliometric analysis aims to provide a comprehensive review of the characteristics of EA for ischemic or hemorrhagic apoplexy based on clinical studies.Methods:A total of 195 clinical studies from six databases such as CNKI,VIP,Wanfang Data,SinoMed,PubMed and the Cochrane Library from inception to December 31,2017 were included.Bibliometric information mainly including study type,participant characteristics,intervention and comparison details,and outcomes were extracted.Data was analyzed descriptively using SPSSsoftware to determine their distribution(range,interquartile range)and central tendency(median).Results:The studies covered 108 RCTs,36 controlled clinical trials,45 case series and 6 case reports on EA for treatment of ischemic or hemorrhagic apoplexy,involved 15466 stroke patients.EA was used at different stages of ischemic or hemorrhagic apoplexy:acute stage(n Z 38),recovery(n Z 32),sequela(n Z 13)and unclear(n Z 112).The most frequently used EA acupoints were in the upper-jiao and lower-jiao regions.The commonly used comparisons were EA alone versus traditional acupuncture,or EA plus traditional acupuncture versus traditional acupuncture.Neurological deficit scale,Modified Barthel Index,and activities of daily living were the most frequently used outcome measures.Conclusion:EA as an adjuvant therapy is effective and safe in treating stroke at acute and recovery stages,but high-quality RCTs are lacking.
文摘Dental pulp stem/stromal cells(DPSCs)are fibroblast-like,neural crest-derived,and multipotent cells that can differentiate into several lineages.They are relatively easy to isolate from healthy and inflamed pulps,with little ethical concerns and can be successfully cryopreserved and thawed.The therapeutic effects of DPSCs derived from animal or human sources have been extensively studied through in-vitro and in-vivo animal experiments and the findings indicated that DPSCs are effective not only for dental diseases but also for systemic diseases.Understanding that translational research is a critical step through which the fundamental scientific discoveries could be translated into applicable diagnostics and therapeutics that directly benefit humans,several clinical studies were carried out to generate evidence for the efficacy and safety of autogenous or allogeneic human DPSCs(hDPSCs)as a treatment modality for use in cell-based therapy,regenerative medicine/dentistry and tissue engineering.In clinical medicine,hDPSCs were effective for treating acute ischemic stroke and human exfoliated deciduous teeth-conditioned medium(SHED-CM)repaired vascular damage of the corpus cavernous,which is the main cause of erectile dysfunction.Whereas in clinical dentistry,autologous SHED was able to rege-nerate necrotic dental pulp after implantation into injured teeth,and micrografts enriched with autologous hDPSCs and collagen sponge were considered a treatment option for human intrabony defects.In contrast,hDPSCs did not add a significant regenerative effect when they were used for the treatment of post-extraction sockets.Large-scale clinical studies across diverse populations are still lacking to provide robust evidence on the safety and efficacy of hDPSCs as a new treatment option for various human diseases including dental-related problems.
基金supported by Macao Science and Technology Development Fund(001/2023/ALC and 0006/2020/AKP)the Research Fund of University of Macao(CPG2023-00028-ICMS)+1 种基金the Guangxi Science and Technology Major Project(GUIKEAA22096029)Macao Young Scholars Program(AM2022022)。
文摘Ganoderma lucidum,one of the most well-known edible fungi,is believed to be very beneficial for longevity and vitality.A long usage history suggests that G.lucidum has various clinical therapeutic effects.And experimental studies have confirmed that G.lucidum has multiple pharmacological effects,including antitumor,anti-microbial,anti-HIV protease,and antidiabetic activity and so on.With the deepening of research,more than 300 compounds have been isolated from G.lucidum.There is an increasing population of G.lucidum-based products,and its international development is expanding.Currently,G.lucidum has drawn much attention to its chemical composition,therapeutic effect,clinical value,and safety.This paper provides a comprehensive review of these aspects to enhance the global promotion of G.lucidum.
基金Supported by General Medical Research Fund Project,No.TYYLKYJJ-2022-021.
文摘BACKGROUND Diabetic foot ulcers(DFUs)are a common complication of diabetes,often leading to severe infections,amputations,and reduced quality of life.The current standard treatment protocols for DFUs have limitations in promoting efficient wound healing and preventing complications.A comprehensive treatment approach targeting multiple aspects of wound care may offer improved outcomes for patients with DFUs.The hypothesis of this study is that a comprehensive treatment protocol for DFUs will result in faster wound healing,reduced amputation rates,and improved overall patient outcomes compared to standard treatment protocols.AIM To compare the efficacy and safety of a comprehensive treatment protocol for DFUs with those of the standard treatment protocol.METHODS This retrospective study included 62 patients with DFUs,enrolled between January 2022 and January 2024,randomly assigned to the experimental(n=32)or control(n=30)group.The experimental group received a comprehensive treatment comprising blood circulation improvement,debridement,vacuum sealing drainage,recombinant human epidermal growth factor and anti-inflammatory dressing,and skin grafting.The control group received standard treatment,which included wound cleaning and dressing,antibiotics administration,and surgical debridement or amputation,if necessary.Time taken to reduce the white blood cell count,number of dressing changes,wound healing rate and time,and amputation rate were assessed.RESULTS The experimental group exhibited significantly better outcomes than those of the control group in terms of the wound healing rate,wound healing time,and amputation rate.Additionally,the comprehensive treatment protocol was safe and well tolerated by the patients.CONCLUSION Comprehensive treatment for DFUs is more effective than standard treatment,promoting granulation tissue growth,shortening hospitalization time,reducing pain and amputation rate,improving wound healing,and enhancing quality of life.
基金supported by grants from Canadian Institutes of Health Research(Grant Nos.:MOP-42546,MOP-119514,PJT148847).
文摘Use of gold nanoparticles(GNPs)in medicine is an emerging field of translational research with vast clinical implications and exciting therapeutic potential.However,the safety of using GNPs in human subjects is an important question that remains unanswered.This study reviews over 20 clinical trials focused on GNP safety and aims to summarize all the clinical studies,completed and ongoing,to identify whether GNPs are safe to use in humans as a therapeutic platform.In these studies,GNPs were implemented as drug delivery devices,for photothermal therapy,and utilized for their intrinsic therapeutic effects by various routes of delivery.These studies revealed no major safety concerns with the use of GNPs;however,the number of trials and total patient number remains limited.Multi-dose,multicenter blinded trials are required to deepen our understanding of the use of GNPs in clinical settings to facilitate translation of this novel,multifaceted therapeutic device.Expanding clinical trials will require collaboration between clinicians,scientists,and biotechnology companies.
文摘Various forms of complementary and alternative medicine are used in psoriasis.Among these,herbal medicines are frequently used as systemic and/or topical interventions either as a replacement for or in conjunction with conventional methods.The benefit of such use is unclear.This review is to provide an up-to-date review and discussion of the clinical evidence for the main kinds of herbal therapies for psoriasis.Searches of the biomedical databases PubMed(including MEDLINE), EMBASE and CINAHL were conducted in December 2011 which identified 32 clinical studies,all published in English.Twenty of these primarily tested topical herbal medicines and were thus excluded.The 12 studies that evaluated systemic use of herbal medicines were included in the review.Four were case series studies and the other 8 were controlled trials.In terms of interventions,4 studies tested the systemic use of plant oils combined with marine oils and 8 studies tested multi-ingredient herbal formulations.The clinical evidence for plant and animal derived fatty acids is inconclusive and any benefit appears to be small.For the multi-herb formulations,benefits of oral herbal medicines were shown in several studies,however,a number of these studies are not controlled trials,a diversity of interventions are tested and there are methodological issues in the controlled studies.In conclusion,there is promising evidence in a number of the studies of multi-herb formulations.However,well-designed,adequately powered studies with proper control interventions are needed to further determine the benefits of these formulations.In addition,syndrome differentiation should be incorporated into trial design to ensure effective translation of findings from these studies into Chinese medicine clinical practice.
基金The financial assistance from Haryana State Council for Science and Technology(HSCST)and Council for Scientific and Industrial Research(CSIR),New Delhi and DST-FIST,New Delhi is thankfully acknowledged.
文摘Trigonella foenum-graecum(fenugreek)belonging to the family Fabaceae,is widely used for both culinary as well as clinical purposes since antiquity.Folkloric medicines across globe particularly use this plant for boosting immunity and combating digestive and reproductive impairments.The plant is rich reservoir of different phytoconstituents attributed to their diverse pharmacological effects.Therefore,the present article is planned on its ethnomedicinal uses,botanical description,phytochemistry,pharmacology,toxicology,clinical efficacy,mechanism of action and nanoparticle synthesis.In all pharmacological studies,the dose,major bioactive,type of extract and possible outcomes is also discussed,to establish its specific role against a particular ailment.It was hypothesized that the nanoparticle synthesis will lead to the enhanced pharmacology.Results showed that ethnomedicinal data well supports the different pharmacological aspects of Trigonella formulations in different countries.Trigonelline(phytoestrogen)renders most of therapeutic potential of Trigonella.The reported therapeutics can also be accounted as the synergistic pharmacology of different bioactives.Nanoparticle synthesis significantly improves its pharmacological efficacy.Clinical studies well validated its antidiabetic and reproductive health improving efficacies.Though no serious toxic effects were observed with the use of this plant but further well-designed placebo trials are still needed to demonstrate its full therapeutic potential.
文摘The development of new drugs for therapeutic purposes has become very expensive and time-consuming in American and European countries.It is estimated that on the average 50 to 100 million dollars and 10 or more years from the time of patenting are required to make a new drug available for general prescription. Every new drug needs to be charac-
基金High-level Talent Project of the Hainan Province (No.820RC628)National Natural Science Foundation of China (No.82060378,81860367)+1 种基金Natural Science Foundation Youth Project of Hainan Province (No.820QN267)Cultivation Fund of Hainan Medical College (No.HYPY201919)。
文摘Scrub typhus is an acute febrile vector-borne zoonotic disease caused by the obligate intracellular growth bacterium Orientia tsutsugamushi(Ot).Mites are the primary vectors and rodents play a pivotal role in the transmission of scrub typhus.Due to the climate warming,increased human activity and other factors,cases of scrub typhus have been increased sharply during the past decade in China,especially in the northern China.To understand the incidence trend,epidemic pattern,clinical sign,diagnosis and therapy of this diseases as well as genotype evolution of Orientia tsutsugamushi,we summarized and analyzed the current knowledge of scrub typhus in China from 2010 to 2020.The data indicated that the dominate genotypes of scrub typhus in China were Karp,Kato and Gilliam.Although the disease was distributed national wide,Yunnan,Guangzhou and Fujian showed the highest incidence rate.The main vector of scrub typhus in southwest,middle east and southeast of China appeared a geographic preference respectively.Seasonal timing,age and occupation were the key factors that relate to the peak incidence of scrub typhus.Notably,farmer was the occupation with the highest risk of Ot infection.Further study on the epidemic characteristics,risk factors,diagnosis and treatments of scrub typhus will be of benefit to a comprehensive guideline for prevention and control of this ancient disease.
文摘Background: Since the appearance of the COVID-19 pandemic, several drugs have also been proposed for the treatment of the COVID-19, but the therapeutic effectiveness of those drugs is not satisfactory. This situation has led to the search for therapeutic solutions based on recipes from traditional medicine. Aims: This study aimed to evaluate the clinical safety, efficacy and tolerability of the phytomedicine APIVIRINE in patients with non-severe COVID-19. Methods: Patients were included following defined criteria and followed on an outpatient basis until recovery in accordance with national guidelines for the management of single cases of COVID-19 in Burkina Faso. Vital signs, anthropometric parameters as well as electrocardiographic, hematological and biochemical examinations were measured on D4, D7, D14 and D21. Adverse events were recorded during maintenance. Results: The present study included 45 patients. The clinical signs present at inclusion were mostly cough (44.44%), asthenia (42.22%), headache (40%), and anosmia (35.55%). Dyspnoea and chest pain were less represented in 05 (11.11%) and 06 (13.33%) patients. Cough, dyspnoea, chest pain, fever, sore throat, headache, and nasal obstruction present at inclusion disappeared before Day 4 of treatment. Anosmia and asthenia disappeared before Day 7. At the inclusion visit (Day 1), CRP, WBC, and blood glucose were abnormal in 15 (33.33%), 13 (28.89%), and 11 (24.44%) patients respectively. In addition, 3 (6.66%) patients had elevated creatinine levels. Transaminases Alanine aminotransferase (ALAT) were elevated in 05 (11.11%) patients while Aspartate aminotransferase (ASAT) was elevated in 04 (8.89%) patients. After 4 days of treatment, the cure rate was 33.33% of patients and 48.89% after 7 days. The cumulative cure rate was 86.67% after 14 days of treatment. Conclusion: No serious side effects or allergic reactions were observed during treatment. No clinical complications were observed and all symptoms present resolved on the 7th day of treatment.
文摘Antenatal administration of magnesium sulfate is an important part of the neuroprotective strategy for preterm infants. Strong evidence from five randomized controlled trials and five meta-analyses has demonstrated that magnesium sulfate, when administered before preterm delivery, significantly reduces the risk of cerebral palsy at two years. Through secondary analyses of randomized controlled trials and other original clinical studies, this state-of-the-art review highlights the absence of serious adverse effects in both pregnant women and neonates, as well as the impact of maternal body mass index and preeclamptic status on the maternal and neonatal magnesium levels, which could influence the magnitude of the neuroprotective effect. Although antenatal magnesium sulfate is a cost-effective strategy, some practice surveys have demonstrated that the use of magnesium sulfate is not sufficient and that its use is heterogeneous, differing among different maternity wards. Since 2010, an increasing number of obstetrical societies have recommended its use to improve the neurological outcomes of preterm infants, especially the International Federation of Gynecology and Obstetrics and World Health Organization in 2015, and France in 2017. Considering the neuroprotective impact of magnesium sulfate when administered before delivery, postnatal administration should be considered, and its effects should be assessed using randomized controlled trials.
基金the NaturalScience Foundation of Guangxi Zhuang Autonomous Region, No.0542048
文摘BACKGROUND: Ischemic stroke in young adults brings extremely hurts for their families and society, and the etiological factors and risk factors are different in the world.OBJECTIVE: To analyze and evaluate clinical significance of ischemic stroke in young adults by using TOAST typing.DESIGN: Case analysis.SETTING: Department of Neurology, the First Affiliated Hospital, Guangxi Medical University.PARTICIPANTS: A total of 64 young adults with acute ischemic stroke were selected from the Department of Neurology, the First Affiliated Hospital, Guangxi Medical University from September 2005 to June 2006.There were 44 males and 20 females and their age ranged from 15 to 45 years. All patients met with the diagnostic criteria of the Fourth National Cerebrovarscular Academic Meeting and certainly diagnosed with CT or MRI examination. In addition, all patients provided the confirmed consent.METHODS: ① TOAST typing: Based on X-ray of thoracic part, electrocardiography, blood routine, blood glucose, electrolure, lipid, blood coagulation test, anticardiolipin antibody, antinuclear antibody, anti-double chain DNA, antineutrophil cytoplasmic antibody, crook agglutination test, syphilis antibody and human immunodeficiency virus (HIV) antibody test, patients received TOAST typing, including large-artery atherosclerotic stroke (LA), small-artery occlusion lacunar (SA), cardioembolism (CE), stroke of other demonstrated etiology (SOE), and stroke of other undemonstrated etiology (SUE). ② Risk factors: Stages of hypertension, diabetes mellitus, hyperlipemia, smoking and drinking of patients were observed. Blood pressure was measured twice after onset of acute stroke, and values of total cholesterol (TC) and/or triacylglycerol (TG) were measured more than twice to finally diagnose hyperlipemia. Diagnostic criteria of diabetes mellitus: fasting≥7.0 mmol/L; 2 hours after administrating glucose ≥ 11.1 mmol/L. Risk factor of smoking defined as more than 10 smokes every day in the last year or last several years. Wile, drinking defined as more than twice every weak. Hyperlipemia was measured for twice at least.MAIN OUTCOME MEASURES: TOAST typing and risk factors.RESULTS: All 64 accepted patients were involved in the final analysis. ①TOAST typing: CA counted for 22%, SA for 33%, CE for 19%, SOE for 16%, and SUE for 11%. Among them, percentage of SA was the highest, and there was statistically significance (P〈0.01). ② Analysis of risk factors: Numbers of smoking and drinking were 19 (43%) and 15 (34%) respectively in the males, which was more than those in the females (0, 0, P〈0.01). In addition, numbers of hypertension was more in the females than those in the males [15 (75%), 20 (45%), P 〈 0.05].CONCLUSION: There are different clinical meanings for different ages in young parients according to TOAST subtypes and risk factors.
文摘Collagen has been a component of skin care formulations for many years, and over this time, there have been numerous claims of its efficiency. Collagen protein is responsible for firm strong skin, but since collagen fibers are too large to penetrate the stratum corneum (SC), topical creams containing collagen fibers remain on the skin surface without affecting skin quality. To overcome the poor penetration of collagen fibers, we prepared in the past micronized collagen fibers that were proven to reach the epidermis layer while inserted in a cream. In the present paper, we have performed a clinical study that analyzes the effect of the micronized fibrillar collagen containing cream on skin. Fifty five healthy female volunteers were enrolled and completed the study. The anti-ageing, firming, elasticity and moisturization efficacy of the cream were measured using Profilometer, Cutometer and Corneometer respectively. The results showed a significant improvement in skin hydration firmness and elasticity, a significant reduction in fine lines and wrinkles was also observed.
基金Supported by the key project of the 8th Five Year Plan of Scientific Committee of Guizhou Province(1993 No.2037)the key project of the"9th Five Year Plan”of Scientific Committee of Guizhou Province.(1996 No.1028)
基金supported by the National Key Research and Development Program of China,No.2017YFA0105403(to LMR)the Key Research and Development Program of Guangdong Province of China,No.2019B020236002(to LMR)+4 种基金The Clinical Innovation Research Program of Guangzhou Regenerative Medicine and Health Guangdong Laboratory of China,No.2018GZR0201006(to LMR)the National Natural Science Foundation of China,Nos.81772349(to BL),31470949(to BL)the Guangzhou Science and Technology Project of China,Nos.201704020221(to LMR),201707010115(to BL)the Natural Science Foundation of Guangdong Province of China,No.2017A030313594(to BL)the Medical Scientific Research Foundation of Guangdong Province of China,No.A2018547(to MP)
文摘Human umbilical cord mesenchymal stem cells(hUC-MSCs)support revascularization,inhibition of inflammation,regulation of apoptosis,and promotion of the release of beneficial factors.Thus,they are regarded as a promising candidate for the treatment of intractable spinal cord injury(SCI).Clinical studies on patients with early chronic SCI(from 2 months to 1 year post-injury),which is clinically common,are rare;therefore,we will conduct a prospective,multicenter,randomized,placebo-controlled,single-blinded clinical trial at the Third Affiliated Hospital of Sun Yat-sen University,West China Hospital of Sichuan University,and Shanghai East Hospital,Tongji University School of Medicine,China.The trial plans to recruit 66 early chronic SCI patients.Eligible patients will undergo randomization at a 2:1 ratio to two arms:the observation group and the control group.Subjects in the observation group will receive four intrathecal transplantations of stem cells,with a dosage of 1×106/kg,at one calendar month intervals.Subjects in the control group will receive intrathecal administrations of 10 mL sterile normal saline in place of the stem cell transplantations.Clinical safety will be assessed by the analysis of adverse events and laboratory tests.The American Spinal Injury Association(ASIA)total score will be the primary efficacy endpoint,and the secondary efficacy outcomes will be the following:ASIA impairment scale,International Association of Neural Restoration-Spinal Cord Injury Functional Rating Scale,muscle tension,electromyogram,cortical motor and cortical sensory evoked potentials,residual urine volume,magnetic resonance imaging–diffusion tensor imaging,T cell subtypes in serum,neurotrophic factors and inflammatory factors in both serum and cerebrospinal fluid.All evaluations will be performed at 1,3,6,and 12 months following the final intrathecal administration.During the entire study procedure,all adverse events will be reported as soon as they are noted.This trial is designed to evaluate the clinical safety and efficacy of subarachnoid transplantation of hUC-MSCs to treat early chronic SCI.Moreover,it will establish whether cytotherapy can ameliorate local hostile microenvironments,promote tracking fiber regeneration,and strengthen spinal conduction ability,thus improving overall motor,sensory,and micturition/defecation function in patients with early chronic SCI.This study was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2018]-02)on March 30,2018,and was registered with ClinicalTrials.gov(registration No.NCT03521323)on April 12,2018.The revised trial protocol(protocol version 4.0)was approved by the Stem Cell Research Ethics Committee of the Third Affiliated Hospital of Sun Yat-sen University,China(approval No.[2019]-10)on February 25,2019,and released on ClinicalTrials.gov on April 29,2019.
基金sponsored by National Key Research and Development Plan(No.2017YFC0107300 and No.2017YFC0107303)
文摘Objective: To explore the safety of ultrasound and microbubbles for enhancing the chemotherapeutic sensitivity of malignant tumors in the digestive system in a clinical trial, as well as its efficacy.Methods: From October 2014 to June 2016, twelve patients volunteered to participate in this study. Eleven patients had hepatic metastases from tumors of the digestive system, and one patient had pancreatic carcinoma. According to the mechanical index (MI) in the ultrasound field, patients were classified into four groups with MIs of 0.4, 0.6, 0.8 and 1.0. Within half an hour after chemotherapy, patients underwent ultrasound scanning with ultrasound microbubbles (SonoVue) to enhance the efficacy of chemotherapy. All adverse reactions were recorded and were classified in 4 grades according to the Common Terminology Criteria for Adverse Events version 4.03 (CTCAE V4.03). Tumor responses were evaluated by the Response Evaluation Criteria in Solid Tumors version 1.1 criteria. All the patients were followed up until progression.Results: All the adverse reactions recorded were level 1 or level 2. No local pain occurred in any of the patients. Among all the adverse reactions, fever might be related to the treatment with ultrasound combined with microbubbles. Six patients had stable disease (SD), and one patient had a partial response (PR) after the first cycle of treatment. At the end of follow-up, tumor progression was restricted to the original sites, and no new lesions had appeared.Conclusions: Our preliminary data showed the potential role of a combined treatment with ultrasound and microbubbles in enhancing the chemotherapeutic sensitivity of malignant tumors of the digestive system. This technique is safe when the MI is no greater than 1.0.
文摘Objective: In comparison with chemotherapy, to evaluate therapeutic effects on advanced pancreatic cancer treated by integrative Chinese and western medicine (ICWM) therapies. Methods: Based on the retrospective study of 56 patients with advanced pancreatic cancer, life table was applied to the analysis of patients' survival rate and Xz test to the comparison of therapeutic response between ICWM and chemotherapy groups. Results: The results showed that 1-year survival rate in the ICWM group was 55. 37%±3.24%; 2-year survival rate 34. 61%±16. 31%; 3-year survival rate 25. 96%±24. 64%; 5-year survival rate 25. 96%±24.64%; and median survival period 16. 3 months. However 1-year survival rate in the chemotherapy group was 21. 95%±27. 54% ; 2-year survival rate 7. 31%±27. 54% ; 3-year survival rate 0 % ; and median survival period 7. 5 months. The therapeutic effects between two groups were significantly different (P=0. 004). Further analysis suggested that the reduction of cancer mass in the ICWM group was more than that in chemotherapy group (P=0.049) and the improvement of advanced pancreatic cancer related-symptoms better than that of chemotherapy group (P = 0. 002). Conclusion: The ICWM comprehensive therapy is of important value in the treatment of advanced pancreatic cancer.
基金The study is supporded by The Ministry of Science Technology of 863 Programme "The Developing the Key of Technique and Products for Preventing SARS" (No.2003AA208101)
文摘Objective: To evaluate the efficacy of integrative Chinese and western medicine (ICWM) in treating severe acute respiratory syndrome (SARS) patients. Methods: Through parallel control design, 49 SARS patients were observed. Used as control, there were in the western medicine (WM) group 29 patients, who were treated with Ribavirin, Levofloxacin, Thymopentin, Azithromycin, methylprednisolone, etc. , on the basis of 'Recommended Protocol for Infectious Atypical Pneumonia' (abbreviated as 'Recommended Protocol') issueed by Ministry of Health. As the treated group, there were in the ICWM 20 cases. The protocol for treatment of SARS in 'Special Science and Technological Action to Prevent and Treat SARS' (abbreviated as 'Special S-T Action'), issued by Ministry of Science and Technology, together with the same WM as those for the control group. Results: (1) Time from the disease onset to the symptom improvement were 5.10±2. 83 days and 7. 62±2. 27 days in ICWM and WM group respectively, P<0.05; (2) As to corticosteroid (CS) amount and days before reducing dosage, 2 groups showed no significant difference, P>0. 05;(3) There was no significant difference in the time from disease onset to the body temperature normalization and the total amount of CS and the duration of using CS before reducing it to 80 mg between the ICWM group and the WM group; (4) The days and amounts for use CS after reducing between the ICWM group and the WM group were significantly different (P<0. 05). Conclusion: There were obvious advantages in ICWM to treat SARS, compared with that of WM alone, especially in improving the clinical symptoms, promoting the recovery of immune function, promoting the absorption of pulmonary inflammation and reducing the dosage and duration of CS treatment.