A Systematic Review of Animal and Clinical Studies on the Use of Scaffolds for Urethral Repair

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.

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.

Effect of Jianpi Shengxue Tablet on Iron Metabolism and Nutritional Status in Patients with Renal Anemia:A Prospective,Randomized,Open,Parallel Controlled and Multicenter Clinical Study

Objective This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia.Methods A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled and randomly divided into two groups.Patients in the control group were treated with polysaccharide-iron complex,and those in the experimental group were administered Jianpi Shengxue tablet.After 8 weeks of continuous treatment,the therapeutic outcomes regarding anemia were compared between the two groups.Results After treatment,the red blood cell(RBC)count,hematocrit(HCT),reticulocyte percentage(RET),ferritin(SF),serum iron(SI),transferrin saturation(TSAT),and serum albumin(ALB)all increased(P<0.01),and the clinical symptom score and total iron binding capacity decreased(P<0.01)in the experimental group.Moreover,the improvements in RBC,HCT,RET,SF,SI,TAST,ALB,and clinical symptoms(fatigue,anorexia,dull skin complexion,numbness of hands and feet)in the experimental group were significantly greater than those in the control group(P<0.05).The total effective rate for treating renal anemia was significantly higher in the experimental group than in the control group(P<0.01).Conclusion The Jianpi Shengxue tablet demonstrates efficacy in treating renal anemia,leading to significant improvements in the laboratory examination results and clinical symptoms of patients with renal anemia.

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.

Clinical comprehensive treatment protocol for managing diabetic foot ulcers:A retrospective cohort study

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.

Clinical study of chemotherapy-related cognitive impairment in patients with non-Hodgkin lymphoma

BACKGROUND Chemotherapy for malignant tumors can cause brain changes and cognitive impairment,leading to chemotherapy-induced cognitive impairment(CICI).Current research on CICI has focused on breast cancer and Hodgkin’s lymphoma.Whether patients with non-Hodgkin’s lymphoma(NHL)undergoing chemo-therapy have cognitive impairment has not been fully investigated.therapy have cognitive impairment has not been fully investigated.AIM To investigate whether NHL patients undergoing chemotherapy had cognitive impairments.METHODS The study included 100 NHL patients who were required to complete a compre-hensive psychological scale including the Brief Psychiatric Examination Scale(MMSE)at two time points:before chemotherapy and within 2 wk of two chemo-therapy courses.A language proficiency test(VFT),Symbol Number Pattern Test(SDMT),Clock Drawing Test(CDT),Abbreviated Daily Cognition Scale(ECog-12),Prospective and Retrospective Memory Questionnaire,and Karnofsky Perfor-mance Status were used to assess cognitive changes before and after chemo-therapy.RESULTS The VFT scores for before treatment(BT)and after treatment(AT)groups were 45.20±15.62,and 42.30±17.53,respectively(t-2.16,P<0.05).The CDT scores were 8(3.5-9.25)for BT and 7(2.5-9)for AT groups(Z-2.1,P<0.05).Retrospective memory scores were 13.5(9-17)for BT and 15(13-18)for AT(Z-3.7,P<0.01).The prospective memory scores were 12.63±3.61 for BT and 14.43±4.32 for AT groups(t-4.97,P<0.01).The ECog-12 scores were 1.71(1.25-2.08)for BT and 1.79(1.42-2.08)for AT groups(Z-2.84,P<0.01).The SDMT and MMSE values did not show a significant difference between BT and AT groups.CONCLUSION Compared to the AT group,the BT group showed impaired language,memory,and subjective cognition,but objec-tive cognition and execution were not significantly affected.

Clinical Study of Tianji Robotic-Assisted Surgery for Upper Cervical Spine Fractures

Object: To compare the safety, clinical efficacy, and complication rate of “Tianji” robot-assisted surgery with traditional open surgery in the treatment of cervical vertebrae fracture. Methods: 60 patients with upper cervical vertebrae fracture admitted to Baise People’s Hospital between November 2018 and April 2024 were retrospectively analyzed. Among these patients, 29 underwent “Tianji” robot-assisted surgery (Robot group), and 31 underwent traditional C-arm fluoroscopy-assisted open surgery (Open group). Statistical analysis of the data was performed using SPSS 27.0 software to compare general data (gender, age, BMI), preoperative and postoperative visual analogue scale (VAS) scores, neck disability index (NDI), intraoperative blood loss, accuracy of screw placement on imaging, and the number of complications in both groups for comprehensive evaluation. A P value < 0.05 was deemed to have achieved statistical significance. Results: There was no significant difference in preoperative VAS scores between the two groups (Robot group: 8.34 ± 0.61;Open group: 8.26 ± 0.68, P = 0.317). There was also no significant difference in VAS scores at 1 week postoperatively (Robot group: 6.90 ± 0.31;Open group: 6.94 ± 0.36, P = 0.3237). Preoperative NDI scores showed no significant difference between the two groups (Robot group: 43.31 ± 2.67;Open group: 43.84 ± 2.67, P = 0.2227), and the difference in NDI scores at 1 week postoperatively was also not significant (Robot group: 35.69 ± 4.24;Open group: 37.35 ± 3.48, P = 0.0509). Intraoperative blood loss in the Robot group was significantly lower than in the Open group (246.21 ± 209 ml vs 380.65 ± 328.04 ml, P = 0.0308), with a statistically significant difference. The operation time was longer in the Robot group (3.75 ± 0.74 h) compared to the Open group (2.74 ± 0.86 h). In terms of screw placement accuracy, the Robot group had a higher accuracy rate for Class A screws compared to the Open group (102 screws vs 94 screws, P = 0.0487), and the accuracy rate for Class B screws was also higher in the Robot group (13 screws vs 29 screws, P = 0.0333), with both differences being statistically significant. There was no significant difference in the number of complications between the two groups (Robot group: 8 cases;Open group: 10 cases, P = 0.6931). Conclusion: Patients treated with “Tianji” robot-assisted surgery for upper cervical vertebrae fracture had lower intraoperative blood loss and higher screw placement accuracy compared to those undergoing traditional C-arm fluoroscopy-assisted open surgery, indicating that this robot-assisted surgery can effectively reduce intraoperative blood loss and improve screw placement accuracy.

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.

Oral Herbal Medicines for Psoriasis:A Review of Clinical Studies

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.

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.

Magnesium sulfate and fetal neuroprotection: overview of clinical evidence

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.

Clinical significance of TOAST typing of ischemic stroke in young adults

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.

Pharmacological intervention for chronic phase of spinal cord injury

Spinal cord injury is an intractable traumatic injury. The most common hurdles faced during spinal cord injury are failure of axonal regrowth and reconnection to target sites. These also tend to be the most challenging issues in spinal cord injury. As spinal cord injury progresses to the chronic phase, lost motor and sensory functions are not recovered. Several reasons may be attributed to the failure of recovery from chronic spinal cord injury. These include factors that inhibit axonal growth such as activated astrocytes, chondroitin sulfate proteoglycan, myelin-associated proteins, inflammatory microglia, and fibroblasts that accumulate at lesion sites. Skeletal muscle atrophy due to denervation is another chronic and detrimental spinal cord injury–specific condition. Although several intervention strategies based on multiple outlooks have been attempted for treating spinal cord injury, few approaches have been successful. To treat chronic spinal cord injury, neural cells or tissue substitutes may need to be supplied in the cavity area to enable possible axonal growth. Additionally, stimulating axonal growth activity by extrinsic factors is extremely important and essential for maintaining the remaining host neurons and transplanted neurons. This review focuses on pharmacotherapeutic approaches using small compounds and proteins to enable axonal growth in chronic spinal cord injury. This review presents some of these candidates that have shown promising outcomes in basic research(in vivo animal studies) and clinical trials: AA-NgR(310)ecto-Fc(AXER-204), fasudil, phosphatase and tensin homolog protein antagonist peptide 4, chondroitinase ABC, intracellular sigma peptide,(-)-epigallocatechin gallate, matrine, acteoside, pyrvate kinase M2, diosgenin, granulocyte-colony stimulating factor, and fampridine-sustained release. Although the current situation suggests that drug-based therapies to recover function in chronic spinal cord injury are limited, potential candidates have been identified through basic research, and these candidates may be subjects of clinical studies in the future. Moreover, cocktail therapy comprising drugs with varied underlying mechanisms may be effective in treating the refractory status of chronic spinal cord injury.

ADRs and Children： Knowledge and Methodological Standard in PASS （Post Authorization Safety Studies）

PhV （pharmacovigilance） knowledge has the outcome of being inadequate in particular due to the lack of instruction. Pediatricians have to face the realization that over-the-counter medicines increments the peril of ADRs （adverse drug reactions） has become a public health concern. The purpose of this article is to disseminate knowledge of the PhV and to highlight the cultural and organizational difficulties for its implementation. The objectives of promoting the organization of specific training courses and research projects aimed at： （1） to foster the culture of iatrogenic disease in pediatrics; （2） to improve the appropriateness of prescribing drugs in children; （3） to enco.urage spontaneous reporting of ADRs in children; （4） to involve Pediatricians in PASS （post-authorization safety studies） according to GCP, GVP and ENCEPP Code of Conduct. An up to date proposal of PhV, a procedure of preparation improves the productivity of creating novel informative reports which can be utilized for a benefit/risk scrutiny making strides in medicine prescription. In this context, FP-MCRN （family paediatficians-medicines for children research network） established with the aim of developing competence, infrastructure and education for paediatric clinical trials, plays a crucial role in paediatric PhV, through an improvement of PhV training, a correct research methodology and very strong relationship with the families. The initial necessity is cultural, implementing culture of iatrogenic illnesses and a watchful evaluation of the importance of PASS by FPs （family pediatricians）. Participation in clinical trials that generates a precise database administered by FPs together with follow-up outcomes becomes relevant and vital for a scrupulous and accurate assessment of ADRs. PASS can foresee on one hand training and information regarding the proper use of drugs in children and possible iatrogenic pathologies caused by their improper use, the other to constitute a territorial survey in the prescriptive appropriateness and safety of pediatric drugs aimed at evaluating the risk-benefit balance on usage.

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.