中医药随机对照试验与我国疾病负担的关系

Relation between Randomized Clinical Trials of Traditional Chinese Medicine and Local Burden of Disease in China

目的评估中医药临床研究是否与我国主要疾病负担相关。方法首先从1999年-2004年出版的13种中医、中西医结合杂志中手工检索出随机对照试验(RCT),并提取出杂志名称、出版年限、治疗的疾病类别及样本含量等数据。然后采用死亡率和伤残调整寿命年(DALY)作为衡量标准,统计2002年我国疾病负担前30位病因的RCT数量,采用秩相关分析这些疾病负担与发表的中医药RCT及其受试者数量的关系。结果最终确认7 422个RCT,约38%的RCT来自于3种国家级杂志。这些RCT覆盖了我国疾病负担中的主要病种,其中4 280个RCT(57.7%)研究前30位病因合并产生的42个病种,只有3个病种(7%)没有任何RCT研究。采用DALY得到的相关系数分别是0.108(P=0.569)、0.092(P=0.628),通过死亡率产生的相关系数分别是0.453(P=0.012)、0.536(P=0.002)。结论中医药RCT与采用死亡率衡量的疾病负担明显相关,但采用DALY分析却未发现二者存在相关性。中医药临床研究可能更注重死亡率高的病种,一定程度上忽略了DALY衡量的疾病负担。

Objective To evaluate whether clinical trials of traditional Chinese medicine（TCM） is related to the burden of disease in China.Methods Randomized controlled trials（RCTs） were manually searched from 13 journals of TCM or integrated medicine published between 1999 and 2004,and the information including name of the journal,year of publication,disease（s） targeted and number of samples was extracted.Then the number of RCTs of the 30 leading causes in local burden of disease taxonomy [measured by mortality and disability adjusted life years（DALYs） respectively] at year 2002 was summarized,and rank correlation analysis was used to evaluate whether the number of trials or participants correlated with mortality or DALYs attributed to each health problem.Results A total of 7422 RCTs were identified finally,and about 38% of them were published in state journals of TCM.These RCTs covered most of the local burden of diseases,among which,4280 trials（57.7%） studied the combined list of 42 leading causes,and only 3 causes（7%） were not studied by any RCTs.The coefficient of correlation was 0.108（P=0.569） and 0.092（P=0.628） for the number of TCM trials performed and the number of participants randomized respectively,when measured by mortality;and the coefficient was 0.453（P=0.012） and 0.536（P=0.002） when measured by DALYs.Conclusions There is a good correlation between the estimated local burden of disease at year 2002 measured by mortality and the number of TCM trials performed and the number of participants randomized,but the correlation is poor when measured by DALYs.More attention may have been paid to the diseases with high mortality by the clinical study of TCM,and the burden of disease measured by DALYs is somehow neglected.