Objective To know about the baseline and quality of clinical prophylaxis and treatment study on communicable diseases in China, by identifying and assessing the clinical studies published in Chinese Journal of Infectious Diseases for 18 years. Method Handsearching page by page to identify and register the clinical studies from the journal, the definition of randomized controlled trial (RCT) and controlled clinical trial (CCT) strictly according to the Cochrane Collaboration Handbook (1997). Results There were totally 214 clinical studies during the 18 years, including 67 RCTs, 67 CCTs and 80 Non-CCTs. The average sample size of the RCTs was 103.0±70.2 (range from 17 to 296). Counted by every 5 years period (3 years period from 1998 to 2000), the proportion of RCTs in clinical studies was increasing steadily. The proportion were 22.9% from 1983 to 1987 (11/48), 29.2% from 1988 to 1992 (14/48), 41.9% from 1993 to 1997 (26/62), 28.6% from 1998 to 2000 (16/56) respectively. The main diseases studied in 214 clinical studies include: virus hepatitis (65 studies), hemorrhagic fever with renal syndrome (19 studies), typhoid fever (11 studies), bacterial infection (13 studies), bacillary dysentery (5 studies), epidemic encephalitis B (3 studies) and parasitosis (9 studies). Conclusion RCT study design should be applied as much as possible. The quality of clinical studies on communicable diseases in China remains to be improved. Multi-center and large-scale collaborative study is worthy to advocate.
Objective To evaluate the efficacy and safety of amoxicillin/sulbactam (AMX/SBT) in the treatment of acute bacterial infections. Method A multicentre randomized controlled clinical trial was conducted. Ampicillin/sulbactam (AMP/SBT) was chosen as the control drug. 113 patients were enrolled in the study (58 cases in test group and 55 cases in control group). AMX/SUL and AMP/SUL were administered 4.5-6.0 g and 4.5-12.0 g every day respectively. Both drugs were given intravenously for 7-14 days. Results The cure rates and the efficacy rates of the two groups were 75.86%, 80.0% and 94.83%, 98.18% respectively. The β-lactamase producing rates were 67.35% , 69.57% and the bacterial clearance rates were 93.88%, 95.65%.There were no significant differences of the above results between the two groups (Pgt;0.05). There was no serious adverse drug reaction in AMX/SBT groups. Conclusion This study suggests that AMX/SBT is an effective and safe drug for treating acute bacterial infections.
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
Objective We searched and reviewed medical evidence to find the guide of treatment for local advanced nasopharyngeal carcinoma. Methods Firstly, we put forward clinical questions. Secondly, we searched medical evidence from Medline (1985-2002), Embase (1984-2000), Cochrane library (2002.1) and ACP. And then we reviewed the results. The key words we used were "nasopharyngeal carcinoma, chemotherapy and radiotherapy randomized" and "meta analysis or randomized control trial". Results Through searching, we got 17 papers including 1 systematic review and 16 randomized control trials, in which there were 8 prospective randomized phase Ⅲ trials. Most of these trials concluded that combination chemo-radiotherapy were better than radiotherapy alone. We think these results were suitable for our patient’treatment decision. Conclusion To treat our patients,we choosed the method of the mutimodality of squeitial neoadjuvant chemotherapy, concurrent chemo-radiotherapy and adjuvant chemotherapy with the drug doses down-adjusted.
The research background, way of thinking, research contents and methods of a united research project - "The Clinical Research on the Treatment of SARS with Integrated Traditional and Western Medicine" were reviewed. The latest research achievements on the treatment of SARS with integrated traditional and western medicine and the difficult points in the research were discussed. Furthermore, some tentative ideas were put forward to further the research. The conclusion was drawn that the principles of evidence-based medicine and the research scheme of multi-centered, prospective and randomized controlled trials, as well as the standard statistical and analyzing methods are the best way to assess the effectiveness and safety of treating SARS with integrated traditional and western medicine.
Based on the conclusion of recent clinical research conducted by foreign countries, there is no statistical difference in outcomes between real and placebo acupuncture. This paper analyzes the weaknesses of methods currently being used by foreign countries to compare the effects of real and placebo acupuncture, striving for a new way to test for the placebo effect; a way that is more scientific, more suitable for the current conditions of China, while at the same time capable of being recognized internationally. This paper describes a new acupuncture placebo-controlled method. Under the condition of complete patient trust, we may ensure an ideal placebo effect to the greatest extent by minimizing the potential curative effects in the placebo group. From the actual clinical practice, by randomized controlled trial comparing acupuncture and medicine, using the concept as the double-dummy clinical trail, this paper explores the “double-dummy – non-specific sites – random sampling” method in the clinical setting as a way to form a new acupuncture clinical research model of comparison between acupuncture and medicine.
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.
目的 观察盐酸氨基葡萄糖治疗膝骨关节炎（KOA）的临床疗效。 方法 2010年5月－2012年7月将130例经膝关节镜清理术后的KOA患者随机分成A、B两组，每组65例。A组联合口服盐酸氨基葡萄糖胶囊750 mg，2次/d，6周为1个疗程，治疗3个疗程；B组联合口服尼美舒利胶囊0.1 g，2次/d，服用12周。采用Lequesne指数作为疗效评定指标，观察治疗前后膝关节体征及症状变化，休息痛、运动痛、压痛、肿胀、晨僵和行走能力的改善情况。 结果 B组患者在治疗早期症状改善优于同期A组，且在第3个月有统计学意义（P＜0.05），随着治疗时间的延长，A组患者总有效率在1、3、6个月分别为70.8%、76.9%和92.3%，均呈逐渐上升趋势，且第6个月疗效较前2个时间点差异有统计学意义（P＜0.05）。分别停药后继续随访至1年，两组患者总有效率均有所下降，但A组疗效仍优于B组，且有统计学意义（P＜0.05）。A组出现不良反应2例，B组4例，均较轻微，无严重不良事件发生。 结论 盐酸氨基葡萄糖在改善OA患者膝关节症状等方面效果肯定，且疗效较稳定，安全性良好；但远期疗效仍需随访观察。