康妇炎胶囊联合抗生素治疗盆腔炎性疾病随机对照研究

A randomized case- control study of Kangfuyan capsule plus antibiotics in treating pelvic inflammatory disease

目的评价康妇炎胶囊联合抗生素治疗盆腔炎性疾病的有效性及安全性。方法 2014年6月至2016年6月在复旦大学附属妇产科医院门诊募集盆腔炎性疾病(pelvic inflammation disease,PID)患者,随机分为研究组(康妇炎联合抗生素治疗)、对照组(抗生素治疗),分别在治疗前及治疗开始后第3天、第4周、第8周和12周进行PID症状、体征量化评分;在治疗前及治疗开始后第4周、12周超声测盆腔积液情况。在治疗前与治疗后第12周进行血常规、血生化、心电图、不良反应等安全性评估。结果两组患者PID症状量化评分明显下降,从治疗第3天开始研究组的PID量化评分显著低于对照组,直到治疗后第12周。研究组在治疗第12周左附件触痛显著好于对照组,治疗第8周、12周子宫触痛显著好于对照组。研究组在治疗第4、12周盆腔积液显著少于对照组。研究组在治疗第4、8、12周疗效显著优于对照组。研究组在治疗第12周复发率显著低于对照组。两组治疗前后安全性评价差异均无统计学意义。结论康妇炎胶囊联合抗生素能显著改善PID症状,降低复发,减少盆腔积液,使用安全,确切机制有待深入探讨。

Objective To evaluate the efficiency and the safety of Kangfuyan capsule plus antibiotics in treating pelvic inflammatory disease（PID）. Methods The women with PID were recruited in the clinic of the Obstetrics and Gynecology Hospital of Fudan University from June 2014 to June 2016,then they were randomly divided into the experimental group（treated by Kangfuyan capsule plus antibiotics）and the control group（treated by antibiotics）. The score of PID was evaluated before treatment and after treatment（3days,4 weeks,8weeks and 12weeks）. Pelvic effusion was detected by ultrasound before treatment and after treatment（4 weeks,12weeks）. The safety evaluation,including blood test,biochemical indicators,electrocardiogram and adverse effect,was performed before and 12 weeks after treatment.Results Both groups showed that the score of PID decreased significantly. The score of PID of the experimental group was statistically lower than the control group from 3 days to 12 weeks after treatment. The tenderness over the left adnexa in the experimental group was obviously better than the control group 12 weeks after treatment. The tenderness over the uterus in the experimental group was obviously better than the control group 8 and 12 weeks after treatment. The experimental group had less pelvic effusion than the control group 4 and 12 weeks after treatment. The efficiency of treatment was better in the experimental group compared with the control group（4,8 and 12 weeks after treatment）. The experimental group had lower recurrent rate than the control group 12 weeks after treatment. Both groups had similar safety evaluation before and after treatment.Conclusion Kangfuyan capsule plus antibiotics can obviously improve the symptom of PID,decrease recurrence and the pelvic effusion. It＇s safe in clinical use and its concrete mechanism needs further study.