独一味胶囊治疗69例原发性痛经临床研究

Clinic study on treatment of 69 cases of primary dysmenorrhea with lamiophlomis rotata capsule

目的:客观评价独一味胶囊治疗痛经的有效性和安全性。方法:采用随机、单盲、阳性药平行对照临床研究方法。从2006年4月至2006年8月共纳入病例数108例,其中试验组(独一味胶囊)69例,对照组(田七痛经胶囊)34例。月经前4天始服,7天为1个疗程,共治疗3个月经周期。进行原发性痛经症状评分。结果:试验组临床治愈20例(28.99%),显效14例(20.29%),有效28例(40.58%),无效7例(10.14%),总有效率89.86%;对照组临床治愈7例(20.59%),显效6例(17.65%),有效17例(50.00%),无效4例(11.76%),总有效率88.24%,两组间比较差异无统计学意义(P>0.05)。结论:独一味胶囊与田七痛经胶囊对痛经具有类似临床疗效和安全性。

Objective： To evaluate the effectivity and security of lamiophlomis rotata capsule on treating dysmenorrhea objectively. Methods： This is a randomized, single-blind and positive parallel controlled clinic study. From April 2006 to August, 108 subjects were included in the study, 69 in test group （lamiophlomis rotata capsule group） and 34 in control group （Radix Notoginseng capsule group）. One course of treatment was seven days in the study. The symptom of primary dysmenorrhea was graded before and after being treating by physician. Results： In test group, Lamiophlomis rotata capsule showed cure efficacy on 20（28.99% ） patients, significant efficacy on 14 （20.29%） patients, efficacy on 28（40.58% ） patients and no efficacy on 7（ 10.14% ） patients. In control group, Radix Notoginseng capsule showed cure efficacy on 7 （20.59 % ） patients, significant efficacy on 6 （ 17.65 %） patients, efficacy on 17（50.00%） patients and no efficacy on 4（11.76%） patients. The total efficacy rate was 89. 86% in test group and 88.24% in control group. But, there was no significant difference between the two groups （ P 〉 0.05）. Conclusion： Lamiophlomis rotata capsule showed the similar curative effect and safety as Radix Notoginseng capsule did on dysmenorrhea.