目的: 探讨基于病证结合的中药复方临床拆方疗效, 以期进一步阐明复方作用机理与证的病理机制。方法: 123例冠心病心绞痛病人随机分为血府逐瘀汤原方组、精制血府逐瘀组、药对配伍组、安慰剂组四组进行干预治疗。结果: (1) 四组心绞痛疗效经秩和检验依次为血府逐瘀组, 精制血府逐瘀组, 药对组, 安慰剂组(P < 0. 01);(2)四组血瘀气滞证证候疗效经秩和检验依次为血府逐瘀组, 精制血府逐瘀组, 药对组, 安慰剂组(P < 0. 01); (3)四组治疗后血脂及氧化低密度脂蛋白变化均无显著性差异(P > 0. 05)。(4)炎症指标: 血府逐瘀组、精制血府逐瘀组、药对组治疗后IL - 6均降低, 安慰剂组治疗后IL- 6升高, 经t检验有显著性差异( P < 0. 05)。四组间比较有显著性差异(P < 0. 05)。结论:(1)理法拆方可在一定范围内保持原方病证疗效, 随着复方配伍的改变, 复方功能靶向出现差异; (2)临床拆方研究对于明晰复方作用的物质基础, 研究#证?病理机制, 观察证% 方、方% 证的相互关系以及进一步加强中药复方的针对性, 提高中医药临床疗效有着切实意义。

This study investigates the therapeutic effects of separated TCM compound recipes of Xuefu Zhuyu Decoction in a clinical environment, based on the combined consideration of both disease and syndrome, in an attempt to expound the relationship between TCM recipe formulation and syndromes. In this study, a randomized design of double blind placebo control is used for the clinical trials, where 131 cases were randomly divided into four groups for Xuefu Zhuyu, refined Xuefu Zhuyu, drug-pair, and placebo. Each case was administered with 10ml of the medicine each time, three times a day, 4 weeks for a therapeutic session. Our findings suggest that 1) the medicine produces an therapeutic effect on coronary angina pectoris patients in the following order: Xuefu Zhuyu group, refined Xuefu Zhuyu group, drug-pair group, and placebo group (P< 0. 01); 2) for blood stasis and qi stagnation patients, the therapeutic effectwo rks in the follow ing order: Xuefu Zhuyu group, refined Xuefu Zhuyu group, drug-pair group, and placebo group (P< 0. 01). 3) there are no differences between the levels of blood lipoprotein and ox-LDL in all four groups, before and after treatment (P > 0. 05); 4) the level of IL-6 comes down in the Xuefu Zhuyu group, re fined group and drug- pair group, though goes up in the placebo group, showing a statistically significant difference, before and after treatment (P< 0. 05) . It is concluded that the therapeutic effect of separated recipes based on the TCM principle may retain its originally desired strength to some extent. Such effect, however, will be changed, when the medicine is differentiated in applications. Clinical study of separated complex prescriptions makes a useful tool for clarifying the syndromes, screening the targets for TCM compound prescriptions, and expounding the principles under which TCM recipes are formulated.

国家973 重点基础发展计划项目( 2003CB517103): 证候规范及其与疾病、方剂的基础研究,负责人: 王?? 阶。