妇乐胶囊治疗慢性盆腔痛瘀热蕴结证330例

Fule Capsule for Treating 330 Cases of Chronic Pelvic Pain with Yureyunjie Syndrome

目的观察妇乐胶囊治疗慢性盆腔痛(瘀热蕴结证)的有效性及安全性。方法将多中心慢性盆腔痛(瘀热蕴结证)患者440例按照3:1比例分为试验组330例和对照组110例。试验组口服妇乐胶囊,每次6粒,每日2次;对照组口服金鸡胶囊,每次4粒,每日3次。两组疗程均为28 d,疗程结束后评价其有效性及安全性。结果试验组局部体征疗效的总有效率为99.39%,明显高于对照组的83.64%(P<0.05);试验组中医证候疗效的总有效率为99.70%,明显高于对照组的82.73%(P<0.05);试验组阴道清洁度的改善率为93.01%,明显高于对照组的76.36%(P<0.05);两组患者均未见不良事件和不良反应发生。结论妇乐胶囊治疗慢性盆腔痛(瘀热蕴结证)安全有效,疗效确切,值得临床推广。

Objective To observe the efficacy and safety of Fule Capsule in treating chronic pelvic pain （Yureyunjie syndrome）. Meth- ods Totally 440 cases of chronic pelvic pain（Yureyunjie syndrome） were divided into the experimental group（330 cases） and the control group（ll0 cases）according to the ratio of 3 ： 1. The experimental group was orally treated with Fule Capsule,6 capsules each time,twice daily,while the control group was given oral Jinji Capsule,4 capsules each time, three times a day. The course of treatment was 28 d for both groups. The efficacy and safety were evaluated after therapy. Results The total effective rate of local signs in the exper- imental group was 99.39% ,which was significantly higher than 83.64% in the control group（P 〈 O. 05）. The total effective rate of tradi- tional Chinese medicine syndrome was 99.70% in the experimental group,which was significantly higher than 82.73% in the control group（ P 〈 0.05）. The improvement rate of the vagina cleaness was 93.01% in the experimental group,which was significantly higher than 76. 36% in the control group（ P 〈 0. 05）. No adverse events and adverse reactions occurred in the two groups. Conclusion Fule Capsule has proved to be effective and safe in treating chronic pelvic pain （Yureyunjie syndrome）,and is worthy of clinical promotion.