Eye-acupuncture as adjuvant therapy for stroke:A bibliometric analysis of clinical studies

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 SPSS
software 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.

Human dental pulp stem/stromal cells in clinical practice

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.

Ganoderma lucidum:a comprehensive review of phytochemistry,efficacy,safety and clinical study

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.

Applications and safety of gold nanoparticles as therapeutic devices in clinical trials

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.

Ethnopharmacological,phytochemical and clinical studies on Fenugreek(Trigonella foenum-graecum L.)

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.

PREDICTION OF THE THERAPEUTIC EFFECTIVENESS OF NEW DRUGS FROM CLINICAL PHARMACOLOGY STUDIES

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-

A review of the epidemic and clinical study on scrub typhus in China(2010-2020)

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.

Clinical Evaluation of the Safety and Efficacy of the Phytomedicine APIVIRINE Based on Aqueous Extracts of Dichrostachys glomerata (Forssk.). Chiov. (D. cinerea) in COVID-19 Patients without Signs of Severity

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.

Immediate and Long Term Clinical Benefits of a Novel Topical Micronized Collagen Face Cream

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.

Human umbilical cord mesenchymal stem cells to treat spinal cord injury in the early chronic phase: study protocol for a prospective, multicenter, randomized, placebo-controlled, single-blinded clinical trial

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.

Clinical study of recombinant human brain natriuretic peptide in patients with acute myocardial infarction complicating congestive heart failure

Objectives To observe the efficacy and safety of recombinant human brain natriuretic peptide(rh-BNP) on patients with acute myocardial infarction complicating congestive heart failure.Methods 40 patients with acute myocardial infarction complicated by congestive heart failure were randomly divided into control group and treatment group of 20 cases.The control group,15 cases of acute anterior myocardial infarction,5 cases of acute inferior wall myocardial infarction, 15 males and 5 females,aged 55-70 years,mean age 58±12 years;treated 16 cases of acute anterior myocardial infarction,4 cases of acute myocardial infarction,16 males and 4 females,aged 56-70 years,mean age 59±11 years;two groups of age,gender,severity of disease and vascular lesions no significant difference and comparable(P】0.05).Conventional group were given aspirin,clopidogrel, statins,Inotropic,diuretic and vasodilator therapy.In the con- ventional treatment group based on the use of recombinant human brain natriuretic peptide(new bios,Tibet Pharmaceutical Co.,Ltd.Chengdu Nuodikang biopharmaceutical production, usage:1.5μg/Kg intravenous injection(impact), then 0.0075μg-0.01μg/(kg·min)infusion rate).Continuous medication 72 h.The clinical symptoms observed for 3 days in patients before treatment and after treatment,heart rate,blood pressure and left ventricular ejection fraction (LVEF) and tumor necrosis factor(TNF-α),brain natriuretic peptide(BNP) levels were measured.Results In control group,8 cases markedly effect,5 cases effect and 7 cases no effect,the total effective rate was 65%;In treatment group,13 cases markedly effect,6 cases effect and 1 cases no effect,the total effective rate was 95%,compared with two groups P New bios treatment group significantly increased cardiac index(CI) in patients with heart failure and left ventricular ejection fraction(LVEF) than the control group(all P【0.05),further reduce the levels of tumor necrosis (TNF-α) and brain natriuretic peptide(BNP).Conclusions rh-BNP can improve symptoms and heart function,reduced plasma tumor necrosis factor(TNF-α) and BNP levels of acute myocardial infarction patients with congestive heart failure,the treatment safe and reliable.As small sample size observed,larger sample to be accumulated to further evaluate its efficacy and safety.

Multicenter Randomized Double-Blind Controlled Clinical Study of Huoxue Tongluo Recipe(活血通络方)External Washing in the Treatment of Chemotherapy-Induced Peripheral Neuropathy

Objective: To objectively evaluate the efficacy of Huoxue Tongluo Recipe(活血通络方) in the treatment of chemotherapy-induced peripheral neuropathy(CIPN).Methods: A multicenter, randomized, double-blind, block, and parallel-controlled study was conducted in which 184 subjects who met the inclusion criteria were randomized into a trial group(92 cases), a control group(46 cases), a placebo group(46 cases) at a 2:1:1 ratio, respectively.Huoxue Tongluo Recipe(活血通络方) granules, Huangqi Guizhi Wuwu Decoction(黄芪桂枝五物汤) instant granules, placebo instant granules were given for hand and foot soaking, with water temperature 38 ℃-45 ℃, soaking for 20 minutes and the intervention time was 14 days.Results:(1) The total effective test drug was 41.30%, the control group was 32.61%, and the placebo group was 32.61%.There was no significant difference in the efficiency of the 3 groups by CMH chi-square test(P>0.05);(2) In the statistics of previous chemotherapy regimens including oxaliplatin or paclitaxel as stratification factors, the overall efficiency of the trial group was significantly different from the other 2 groups.Conclusion: Huoxue Tongluo Recipe(活血通络方) external washing can improve the peripheral nerve injury caused by chemotherapy to some extent, especially in patients with previous chemotherapy regimen including oxaliplatin and paclitaxel.

Update on the preclinical and clinical assessment of Withania somnifera: from ancient Rasayana to modern perspectives

The Rasayana plant Withania somnifera(W.somnifera)Dunal,also known as“Ashwagandha”,has been mentioned in various classical Ayurvedic texts,such as Charaka Samhita,Sushruta Samhita,and Nighantus.This Ayurvedic drug has been referred to as a tonic that renews the body,provides physical and mental vigor in weakened states,and promotes endurance and longevity.W.somnifera possesses notable biological activity in many ailments,such as diabetes,conjunctivitis,insomnia,senile dementia,Parkinson’s disease,nervous system disorders,rheumatism,and arthritis.These pharmacological activities are due to the presence of diverse active components and their derivatives.Some lead compounds are found to be effective against anxiety and other central nervous system disorders.W.somnifera has been proven to be effective and safe for a wide range of ailments from ancient to modern times.Its reported properties represent the traditional use of W.somnifera as indicated in the literature;furthermore,W.somnifera is one of the most important prescribed drugs in Ayurveda for its multimodal effects.This current review highlights the bioactive present and provides an overview of the toxicological and pharmacological studies on W.somnifera,including preclinical and clinical studies.From its earliest utilization to its current application,W.somnifera has been recognized to be effective at clinical levels for human health and welfare.Greater attention to the safety and efficacy of W.somnifera would provide more scientific evidence,promoting global acceptance of the Ayurvedic plant.

Influence of pontic design of anterior fixed dental prosthesis on speech: A clinical case study

BACKGROUND The pontic design of fixed dental prostheses(FDPs)is strongly associated with the phonetic function,and the phonetic function of anterior FDPs with different pontic designs remains understudied.AIM To investigate the immediate and short-term influence of pontic design of anterior FDPs on Chinese speech in a clinical case using objective acoustic analysis.METHODS Two FDPs with two types of pontic design(saddle pontic and modified ridge lap pontic)were fabricated for one patient with maxillary anterior teeth missing.The acoustic analysis of patient’s articulation was conducted immediately after wearing the FDPs and 1 wk after wearing these FDPs.RESULTS The effect of FDP on Chinese vowels(/a/,/o/,/e/,/i/,/u/,and/ü/)was insignificant,because the recovery of vowel distortion occurred within 1 wk for both FDPs.Three(/f/,/s/,and/sh/)of eight Chinese fricative consonants were found to have obvious distortions,and the/s/sound distortion last for more than 1 wk for the patient wearing FDP with modified ridge lap pontic design.CONCLUSION The influence of anterior FDP on articulation of Chinese vowels is insignificant,while the articulation of Chinese fricative consonants is more susceptible.When fabricating anterior FDPs for patients with speech related professions,saddle pontic design can be an alternative option compared with modified ridge lap pontic design.

Clinical study of Qiming granule combined with compound anisodine injection in the treatment of diabetic retinopathy

Objective:To investigate the clinical study of Qiming granule combined with compound anisodine injection in the treatment of diabetic retinopathy.Methods:104 patients with nonproliferative diabetic retinopathy admitted to department of ophthalmology in Xishui Hospital Affiliated to Hubei University of science and technology from September 2016 to May 2018 were selected as the study subjects.According to the principle of treatment,they were divided into 52 cases in the control group and 52 cases in the treatment group,the clinical efficacy,blood sugar and lipid levels,hemorheological changes and adverse reactions were compared between the two groups.Results:The total effective rate difference between the treatment group(92.31%)and the control group(71.15%)was statistically significant(χ^(2)=7.792,P=0.005).After treatment,the two groups of fasting plasma glucose(FPG),hemoglobin A1c(HbA1c),total cholesterol(TC),low density lipoprotein-cholesterol(LDL-C),whole blood high-viscosity,whole blood cut viscosity,whole blood low-cut viscosity,plasma viscosity,number of microangioma and area of the hemorrhage were significantly lower than before treatment(P<0.05),and the levels of FPG,HbA1c,TC,LDL-C,whole blood highviscosity,whole blood cut viscosity,whole blood low-cut viscosity,plasma viscosity,number of microangioma and area of the hemorrhage in the treatment group were significantly lower than those in the control group(χ^(2)=0.122,P=0.727).Conclusions:Qiming granule combined with compound anisodine injection can effectively improve the clinical efficacy of patients with non-proliferative DR,and its mechanism may be related to improve blood sugar and blood lipid levels and correct blood rheology disorder,reduce microangioma and hemorrhage.It has clinical promotion significance.

A Clinical Study on Diabetes, Cholesteremia and Hyperlipemia

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Clinical Experience with the Fifth-Generation of a Breast Implant with a Smooth, Fine Surface from a Korean Manufacturer in Asian Women

Background: In this study, we describe our clinical experience with the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer (BellaGel® SmoothFine;HansBiomed Co. Ltd., Seoul, Korea) in Asian women. Methods: We analyzed 223 women (mean age = 35.28 ± 9.45 years and mean follow-up period = 12.03 ± 2.48 months), comprising 118 bilateral cases and 109 unilateral ones, who received breast augmentation using the BellaGel® SmoothFine at our hospital between June 4, 2018 and February 28, 2019. For safety assessment, we analyzed frequencies of postoperative complications and overall survival of the BellaGel® SmoothFine. Results: Postoperatively, complications (12 cases, 5.38%) include asymmetry (3 cases, 1.35%), hematoma (2 cases, 0.90%), hypertrophic scars (2 cases, 0.90%), wound disruption (2 cases, 0.90%), rippling (1 case, 0.45%), capsular contracture (1 case, 0.45%), stretch deformities with skin excess (1 case, 0.45%). In addition, time-to-events were calculated as 10.94 ± 0.64 months (95% CI 9.69 - 12.19) and the survival rate reached 0.290 ± 0.168 (95% CI 0.094 - 0.901) at 12 months postoperatively. Conclusions: Here, we describe our clinical experience with the BellaGel® SmoothFine. Our results are of significance in that this is the first report about the fifth-generation of a breast implant with a smooth, fine surface from a Korean manufacturer for Asian women.