糖尿病及其并发症临床治疗试验10年文献评价

目的：评价国内医学文献中有关糖尿病及其并发症（以下简称糖尿病）临床治疗试验的质量，为改变和提高临床治疗试验水平提供依据。方法：选择7种中华系列杂志，用手工检索1990－1999年间发表的有关糖尿病临床治疗试验，共查69卷536期。各杂志文献分布为：中华内分泌杂志57篇（1994年缺）、中华内科杂志10篇、中华肾脏病杂志10篇、中华老年医学杂志7篇、中华眼科杂志4篇、中华儿科杂志4篇、中华医学杂志3篇。文献年度分布为：7、10、20、8、4、11、14、6、16、9。调查内容包括：治疗试验的设计类型、诊断标准、对象选择、疗效评定标准、随访情况、药物不良反应观察等。结果：7种杂志10年间共有95篇糖尿病临床治疗试验发表。治疗试验的设计类型分为：随机对照试验37篇占38．9％，非随机的对照试验16篇占16．8％，无试验对象选择有诊断标准的占50．6％，有明确纳入标准的占62．1％；盲法试验9篇，其中双盲试验5篇。试验对象选择有诊断标准的占50．6％，有明确纳入标准的占62．1％，有排除标准的占8．4％。55．8％（53／95）的治疗试验设立对照组，其中药物对照占37．7％，空白对照占30．2％，安慰剂对照占24．5％；23．2％有组间可比性。疗效评价标准多为自定标准96．8％。15．8％的试验有随访观察；44．2％报告了不良反应或作用。结论：从10年来有关糖尿病及其并发症的治疗试验来看，试验设计总体有待提高，高论证强度的RCT较少。只有采用论证强度高的RCT设计，才能客观、科学地评价药物及治疗措施的疗效。

Evaluation of Clinical Trials for Diabetes Mellitus in Past 10 Years to Chinese Medical Literatures

Objective:To assess the qualit y of clinical trials relevant to Diabetes Mellitus and its complications publish ed in Chinese Medical Journal to provide scientific basis in the benefit of impr ovement of clinical works.Methods:Seven Chinese Key Medical Journal in the years of 1990－1999 were hand-searched and 95 clinical trails for Diabetes Mellitus a nd its complications were identified from 536 issues of 56 volumes.The journal i ncluded:Chinese Journal of Endocrinology and Metabolism;Chinese Journal of Inter nal Medicine;Chinese Journal of Nephrology;Chinese Journal of Geriatrics;Chinese Journal of Ophthalmology;Chinese Journal of Pediatrics;National Medical Journal of China.The numbers of the literature of each year distribution are:1990(7),19 91(10),1992(10),1993(8),1994(4),1995(11),1996(14),1997(6),1998(16),1999(9).The i nvestigation content:Design type of clinical trials;Diagnosis criteria;Therapeut ic effectively criteria;Follow-up;Drug adverse reaction.Results:In the recently 10 years,95 issues of clinical trials of Diabetes mellitus have published in sev en keys Chinese Medical Journal.Among the 95 trials were 38.9% RCT(Randomized C ontrolled Trial)and 16.8% Non-RCT,and 16.8% No-controlled-trial.Among the RCT there were only 4 issues described the method for randomized allocation;Blindnes s and Double blindness were 9 and 5 issues respectively.50.6% have diagnosis cr iteria,62.1% were with explicit inclusion criteria for subject selection and 8 .4% with exclusion criteria.55.8% clinical trials set up the controlled group. Among there were with 37.7% drug controlled group and 24.5% with placebo.Almos t 96.8% evaluation criteria for therapeutic effect were not used National or WH O criteria.There were 44.2% trials reported drug adverse reaction or drug side effect.and 15.8% did follow-up.Conclusion:The quality of clinical trials especi al RCTs is not high as placebo controlled and blindness were seldom used and ade quate randomization and its concealment were not used correctly and rigorously.T herefore,clinicians should be used correctly RCTs method in order to improve the quality of clinical trials,after that we can make the evaluation for drug and m edical apply on the right way.