中医药治疗高脂血症临床随机对照试验的质量评价

Quality Assessment for Clinical Randomized Controlled Trials of Traditional Chinese Medicine for Hyperlipidemia

目的:评价中医药治疗高脂血症的临床随机对照试验的质量及中医药治疗高脂血症的证型和治则。方法:通过计算机和手工检索获得2002—2007年发表的有关中医药治疗高脂血症的临床随机对照试验(RCTs)文献,按照中医药临床随机对照试验报告规范对文献的质量进行评价及中医药治疗高脂血症的证型和治则进行统计。结果:共检出中医药治疗高脂血症RCTs文献181篇,其中,仅2篇文献题目体现随机内容,无一篇提及随机隐藏和样本量估算,21篇提及随机分配方法,16篇采用盲法,88篇提供完整的干预措施描述,145篇有基线资料统计分析,157篇提供疗效评价标准,98篇有统计方法描述,4篇提及失访、脱落、退出,1篇进行了意向性治疗分析。66篇含有中医证型分类,各证型中以痰瘀互结型、痰浊阻遏型较多,痰湿证与血瘀证最为常见;治则以活血化瘀法最常用,化痰降浊法与益气健脾法的应用率亦半数左右,高脂血症与脾虚、肾虚、肝郁关系密切,痰浊血瘀为其最终病理产物,活血化痰法应推广应用。结论:近几年来,中医药治疗高脂血症的RCTs文献数量不少,但质量有待进一步提高。

Objective： Assess quality of literatures for RCTs of TCM for hyperlipidemia and analyze the TCM syndromes and therapeutic principles. Methods ： Search information in literatures on RCTs of TCM for hyperlipidemia between 2002 and 2007. According to CONSORT for TCM, assess quality of these literatures and analyze the TCM syndromes and therapeutic principles. Results ：181 documents are involved into statistical. Among these,2 state randomization in titile, no one explains allocation concealment and the rationale of sample size determined. 21 mention the method used to generate the random allocation sequence. 16 implement blinding. 88 have precise details of the interventions intended for each group. 145 provide baseline data. 157 have the standard of curative effect evaluation. 98 explain the statistical methods. 4 mention the excluded and the ones lost to follow up. Only one has the analysis by ＂intention - to - treat＂. 66 refer to TCM syndrome classification and the most syndrome types are phlegm and blood statis type and turbid phlegm type. Phlegm damp syndrome and blood statis syndrome are most common. In theapeutic principles,promoting blood circulation therapy is used most frequently, while the methods of resolving phlegm and replenishing spleen qi occupy nearly a half. Hyperlipi- demia is closely related to spleen deficiency, kidney deficiency and liver depression. As the phlegm and blood statis are the final products, the method of promoting blood circulation and resolving phlegm should be extended. Conclusion：Although there are a large numberthe of literatures on RCTs of TCM for hyperlipidemia recent years, the overall quality is urged to be improved.