【摘要】 目的 观察利胆清微丸治疗慢性胆囊炎湿热蕴结兼血瘀证患者的疗效及安全性，进一步为临床研究提供依据。 方法 2001年4—7月，采用双盲、双模拟、随机平行对照临床试验，将40例患者随机分为试验组（20例）及对照组（20例）。试验组服用利胆清微丸3.5 g/次，3次/d，同时服用胆宁片模拟剂；对照组服用胆宁片3片/次，3次/d，同时服用利胆清微丸模拟剂。 结果 试验组痊愈1例，显效12例，有效5例，无效2例，显效率65%，有效率90%；对照组痊愈2例，显效10例，有效7例，无效1例，显效率60%，有效率95%，两组疗效比较差异无统计学意义（Pgt;0.05）。试验过程中未发现明显不良反应。 结论 利胆清微丸对于治疗慢性胆囊炎湿热蕴结兼血瘀证有良好效果，是一种安全有效的药物。【Abstract】 Objective To observe the safety and efficacy of Lidanqing pellet on chronic cholecystitis with damp and hot accumulate knot including blood stasis, and to provide a basis for further clinical trials. Methods A double-blind, double dummy, randomized, and controlled clinic trial was undertaken between April and July 2001. A total of 40 patients were randomly divided into trail group and control group. The trial group was given Lidanqin pellet 3.5 g per time, and three times per day; simultaneously taking Danning tablet simulation agent. The control group was given 3 tablets of Danning tablet per time and three times per day; simultaneously taking taking Lidanqing pellets simulation agent. Results In the trail group, one patient was cured, the therapeutic effect was obvious in 12, basically effective in five and invalid in two (with the rate of obvious effect of 65.00% and rate of basic effect of 90.00%). In the control group, two patients was cured, the therapeutic effect was obvious in 12, basically effective in 10, effective in seven and invalid in one (with the rate of basic effect of 60.00% and the rate of obvious effect of 95.00%). The difference between the two groups was significant (Pgt;0.05). Adverse reaction was not found in the trial group. Conclusion Lidanqing pellet, a safe medication, is effective on chronic cholecystitis with damp and hot accumulate knot including blood stasis.