Objective To review the efficacy and safety of interventions for preventing infections in nephrotic syndrome using evidence-based principles for clinicians to practice easily. Methods We searched Cochrane controlled trials register database, MEDLINE, EMBASE and Chinese Biologic Medical database. Results Total 11 articles were obtained including RCTs, non-controlled clinical studies and traditional narrative reviews. No systematic review or meta-analysis was identified. Prophylactic interventions for reducing risks of infection in nephrotic syndrome included intravenous immunoglobulin, thymosin, traditional Chinese herb, lamivudine, pneumococcal vaccination and chemoprophylaxis. Conclusion At present, the studies about interventions for preventing infection in nephrotic syndrome were limited in quantity and poor in the quality of methodology, therefore, the promising conclusions were unavailable. Rigid randomized placebo-controlled clinical trials with blinding or systematic review or meta-analysis would be very necessary for further assessing the efficacy and safety of the prophylactic interventions for preventing infections in nephrotic syndrome
Intensive discussions and debates concerning whether we should and how to apply evidence-based medicine (EBM) research in traditional Chinese medicine (TCM) have arisen worldwide. We always hold the opinion: TCM needs EBM; the evidence from EBM is not limited to randomized controlled trials and systematic reviews; innovative methodological studies are urged based on the characteristics of TCM theoretically and clinically. Based on the methodological training and studies in this area, the authors discussed how to promote the evidence based TCM from five aspects including completing clinical trial procedure, reporting clinical trials according to international standards, reviewing the current clinical studies on TCM systematically, promoting the methodological research and academic exchange and better evidence (knowledge) management.
OBJECTIVE To assess the effect of sodium hyaluronate (HA) for degenerative disorders of the temporomandibular joint (TMJ). METHODS A prospective randomized controlled clinical trial was conducted. The experimental group received injections in the upper compartments of the involved TMJs with 1% HA 6 mg, whereas the control group received prednisolone (PS) 12.5 mg once a week. Three to four injections were as one course. Before and one week after the treatment courses, clinical symptoms, amount of interleukin-6 (IL-6) and total protein of synovial fluid were measured and compared. RESULTS Sixty-seven patients were included and 4 out of them were dropped out. There were 12 males and 51 females, among them, 14 cases with synovitis, 21 with anterior disc displacement without reduction and 28 with osteoarthritis of the TMJ. Thirty-five patients allocated in HA group and 28 in PS group. Both drugs could relieve the clinical symptoms of TMJ degenerative disorders. In HA group, marked improvement rate was 51.43% and failure rate was 2.86%, whereas marked improvement rate 39.29% and failure rate 17.86% in PS group. The declined levels of IL-6 in synovial fluid was notably greater in HA group than those in PS group. CONCLUSIONIntra-articular injection of HA is effective and safe to treat TMJ degenerative disorders with mild adverse reactions, better in terms of effective rate and declined level of IL-6 than PS.
Objective To analyze the adverse drug reactions (ADR) of Ciwujia injection and the relative influence factors. Methods We searched all clinical studies and ADR reports of Ciwujia injection from the China National Knowledge Infrastructure (CNKI) database. The relevant information such as the diseases for treatment; menstruum, dosage and compatibility of Ciwujia injection; the age, gender and allergic history of patients; and the category, treatment and prognosis of ADR were collected and analyzed. Results In the 800 clinical studies, only 97 (12.1%) reported 285 ADR cases, 144 ADR reports including 236 ADR cases. Of the ADR cases, the male to female ratio was 1׃1.34, mainly in 40 to 69 years group; The ADR cases mainly including anaphylactic shock and local pain in ADR reports and clinical studies, respectively; 72.3 percent ADR cases were Ⅲ to Ⅳ class, 4 anaphylactic shock cases died; the diseases for treatment of ADR cases mainly were coronary artery heart disease and cerebral infarction; 27 (11.4%) ADR cases had allergic history; The menstruum of Ciwujia injection mainly were 5% glucose, 0.9% NaCl and 10% glucose, drug incompatibility in 36 ADR cases; The usual dosage of Ciwujia injection was 20-60 ml; 196 (83.0%) ADR cases occurred in first time medication, mainly in the early 30 minutes of medication used. Conclusion (1) In both ADR reports and clinical studies of Ciwujia injection, there are some problems of ADR and adverse drug events (AE) were not easily distinguishable, key information of total prescriptions divided by drug persons were lacking, so we can’t calculate the ADR rate, the reporting quality remained to be improved. (2) To support the rational drug use, the basic researches of Ciwujia injection remains to be further studied, especially the dose-finding studies. (3) As one of the most frequently reported ADR of traditional Chinese medicine (TCM) injection, high quality ADR monitoring, normative ADR reporting and timely analyzing the ADR reason of Ciwujia injection is extremely urgent.
ObjectiveTo assess the feasibility and clinical value of lumbar elastic fixation through the clinical research of elastic fixation for lumbar intervertebral fusion. MethodsAccording to the criteria, we selected 12 patients with lumbar degenerative disease diagnosed between September 2011 and March 2013 as our study subjects. Among them, 8 were females, and 4 were males, aged between 40 and 62 years old, averaging 52.9 years. Elastic fixation was adopted in the lumbar fusion. Evaluation indicators included visual analogue scale (VAS) scores, Oswestry disability index (ODI) score and its rate of improvement, intervertebral height changes, the rate of intervertebral fusion, intervertebral bone callus formation, patient satisfaction and clinical success rate. ResultsAll patients were followed up. During various postoperative follow-up points, VAS score and ODI score improved significantly (P<0.05). A large amount of callus formation was shown in lumbar CT. No fracture, loosened or shifted internal fixation occurred. ConclusionElastic fixation for lumbar intervertebral fusion provides another choice for the treatment of lumbar degenerative disease.
ObjectiveTo observe and assess the therapeutic effect of posterior amputation of internal sphincter and partial external sphincter in the treatment of old anal fissure. MethodsEighty patients with old anal fissure treated between August 2012 and June 2014 were randomly divided into study group and control group with 40 in each. The study group received posterior amputation of internal sphincter and partial external sphincter, while the control group underwent single amputation of internal sphincter. Then we observed the cure rate, wound healing days, pain at defecation after operation, defecation control after operation, and long-term recurrence rate. ResultsAll the 40 patients in study group were healed with a recovery rate of 100%, while 38 in control group were healed with a recovery rate of 95%; the difference between the two groups were not significant (P>0.05). The wound healing time in study group[(17.0±3.5) days] was much longer than that in the control group[(10.5±3.8) days] (P<0.05). The pain extents of fundament during defecating on the first day and 3, 7, and 15 days later in study group were more alleviated than those in the control group (P<0.05). In the six-month follow-up period, one patient in study group had liquid stools out of control 3 months after the surgery, and the others had no similar symptoms (P>0.05). ConclusionPosterior amputation of internal sphincter and partial external sphincter is a reasonable method for the treatment of old anal fissure. It can not only cure old anal fissure but also alleviate pain at defecation after operation and facilitate defecation.
Objective To evaluate the efficacy and safety of different site injection of compound betamethasone injection, ropivacaine and sodium hyaluronate for treatment of frozen shoulder at early stage. Methods A Total of 68 participants were included from May 2015 to May 2017 and randomly assigned to the glenohumeral joint and subacromial space group (IA+SA group, n=34) and glenohumeral joint group (IA group, n=34). In the IA+SA group, a solution of 1 mL corticosteroid, 6 mL ropivacaine, 2 mL sodium hyaluronate, and 8 mL normal saline were prepared and injected to glenohumeral joint, and a solution of 1 mL corticosteroid, 2 mL ropivacaine, 2 mL sodium hyaluronate, and 2 mL normal saline were injected to subacromial space. In the IA group, participants were given the same dose of drugs to the glenohumeral joint. The Visual Analogue Scale (VAS) score and Constant-Murley score were used to assess pain and function of shoulder respectively. The change of VAS score and Constant-Murley score after treatment were used to evaluate pain relief and shoulder function improvement. Results Of the 68 participants, two in each group were lost to follow up and one in the IA+SA group dropped out. There was significant effect on pain relief and shoulder function improvement on all measurement in both groups (P<0.001) during the 12 weeks after treatment. In the IA group, group- by-time interaction were significant for pain relief at 6 and 12 weeks comparing with that at 3 weeks (P<0.001), while no significant difference at 6 weeks comparing with 12 weeks. In the IA+SA group, group-by-time interaction were significant for pain relief at all endpoints (3 weeksvs. 6 weeks: P<0.001; 3 weeksvs. 12 weeks: P<0.001; 3 weeksvs. 6 weeks: P=0.034). In both groups, there was significant effect on shoulder function improvement when compared at each endpoint within group (P<0.001). Between-group comparison revealed no significant effect on pain relief (P=0.386) or shoulder function improvement (P=0.685). There was also no significant effect on pain relief (3 weeks: P=0.898; 6 weeks: P=0.448; 12 weeks: P=0.216) and shoulder function improvement (3 weeks: P=0.120; 6 weeks: P=0.152; 12 weeks: P=0.868) at each same endpoint. Conclusions Different site injection can effectively release pain and improve shoulder function for the patients with frozen shoulder at early stage and be well tolerated. However, it is not found that two site injection is inferior to single site injection.
ObjectivesTo explore the characteristics of the international clinical studies using objective performance criteria (OPC) and provide a reference to design clinical trials and determine external controls.MethodsPubMed, The Cochrane Library and EMbase databases were searched for all clinical studies which used OPC. Two reviewers independently screened literature, extracted data and descriptive analysis was then performed.ResultsA total of 51 English language articles were included. Merely one was published in 2001, and others were published between 2010 and 2018. Twenty-seven articles (27/51, 52.9%) were published between 2017 and 2018, with accumulated impact factors of 411. In the article referring to the reasons for using the objective performance criteria, reasons for using OPC study was primarily the difficulties of randomization and comparison (8/11, 72.7%). Articles with cardiovascular disease and peripheral vascular disease accounted for 86%, and articles on the effectiveness or safety of medical devices accounted for 76.5%. Single-arm trial (40), randomized controlled trials (2), case-control studies (2), case series (5) and diagnostic tests (2) were included. OPCs were mostly derived from the data of clinical trials of other similar products, national standards, specialist association standard and meta-analysis of multiple clinical studies. A total of 27 articles (27/51, 52.9%) used hypothesis testing to compare research results with objective performance goal, and 24 articles (24/51, 47.1%) used the confidence interval method.ConclusionsOPC studies are primarily used for safety intervention and effect evaluation. OPC studies are developing very rapidly, especially in the field of cardiovascular studies. Methodological details are reported reasonably sufficient. Reasons for using OPC study are primarily the difficulties of randomization and comparison. Factors such as source of the OPC, sample size, and comparison method should be taken into account. The application of the OPC can not only solve the difficulties of the implementation of numerous clinical research, but also provide new insights for solving the practical difficulties of clinical research in the real-world.
ObjectivesTo establish an appropriate data governance mode in according with the database status of clinical study.MethodsForty-six doctors of different seniority with clinical research experience from six hospitals in Beijing were selected by stratified purposeful sampling and semi-structured interview and were used to understand the status and shortcomings of data acquisition and storage in clinical research. The data resource of current clinical studies were summarized and the main target of data governance and the characteristics of clinical study data were explored to establish the domains of clinical study data governance to construct the framework of clinical research data governance.ResultsCurrently, the data sources of clinical studies were diverse, including real-world data from various medical and health records, data collected independently for clinical studies and numerous other sources. However, since collecting the data from electronic medical records was difficult for numerous reasons, a large number of researchers still collected research data by hand writing and stored it insecurely. In addition, the combination of electronic information from multiple sources was difficult. Building ALCOA+CCEA standard clinical research data management system based on clinical research data governance was urgent. Data governance includes data architecture, data model, data standards, data quality, master data, timeliness management, metadata and data security, while life cycle management and data insight were not essential parts.ConclusionsBased on the real-world data resources, domains of data governance in clinical study should include data architecture, data model, data standards, data quality, master data, timeliness management, metadata and data security.
ObjectiveTo investigate the clinical efficacy, side effects, influence on viral nucleic acid conversion and prognosis of glucocorticoid used in patients with coronavirus disease 2019.MethodsEighty-seven patients with severe and critical coronavirus disease 2019 were included to observe respiratory symptoms, blood oxygen saturation, pulmonary imaging absorption, weaning status, complicated bacterial infection and double infection, and prognosis after glucocorticoid use. Whether glucocorticoid use affects the patient's viral nucleic acid was analyzed.ResultsOf the 87 patients included, 55 were severe, 32 were critical, and 38 died, which included 30 critical patients. Seventy-seven patients accepted short-term glucocorticoid, and 10 patients accepted long-term glucocorticoid due to diffuse lung lesions and poor absorption. Eleven patients had bacterial infection and 4 cases had double infection. In 10 patients with long-term use of glucocorticoids, the lung lesions relieved, no double infection was found, but 1 patient maintained nucleic acid positive even after 5 weeks’ treatment.ConclusionsThe use of appropriate glucocorticoids is beneficial to the improvement of disease status and disease absorption in patients with coronavirus disease 2019. Long-term oral administration of glucocorticoids in patients with diffuse lung lesions may be beneficial to disease absorption.