益坤抑痛平治疗子宫腺肌病痛经的疗效及安全性评价

The protective effect and safety evaluation of "Yi Kun Yi Tong Ping" in the treatment of dysmenorrhea caused by adenomyosis

目的:前瞻性随机对照研究益坤抑痛平治疗子宫腺肌病痛经的临床疗效及安全性评价。方法:选取2013年7月~2014年12月我院门诊子宫腺肌病痛经患者68例,将其按照随机数字表法分为益坤抑痛平治疗组34例和安慰剂对照组34例,每组自月经干净开始服"益坤抑痛平"颗粒,1袋/次,3次/d,经期停止服药。2组均治疗3个月经周期。观察治疗前后痛经VAS评分和中医证候、子宫体积大小及血清CA125含量的变化。结果:治疗后2组经过COX量表评分,与对照组相比,治疗组能显著缩短经行时下腹疼痛持续时间及其伴随症状发作的时间(P<0.05),治疗组能显著缓解经行下腹疼痛程度及伴随症状程度(P<0.05);且治疗组疗后的中医证候积分显著低于对照组;治疗组与对照组治疗前后子宫大小、血清CA125值均无显著变化(均P>0.05)。治疗组在用药期间未发现明显不良反应,治疗前后血常规、尿常规、肝肾功检查均未见异常。结论:"益坤抑痛平"颗粒可明显缓解子宫腺肌病患者痛经的程度及持续时间,改善其中医证候;对改善子宫腺肌病患者的子宫大小及降低血清CA125值无明显作用;治疗过程中无明显不良反应。

Objective：To observe the protective effect and safety of ＂Yi Kun Yi Tong Ping＂in the treatment of dysmenorrhea caused by adenomyosis （AM,andkidney deficiency and blood stasis syndrome as the traditional Chinese Medical diagnosis）by a prospective ease control study.Methods：Sixty-eight patients of dysmenorrhea caused by AM were selected from our clinic during July 2013-Dec.2014.They were divided into treatment group （TG,taking Yi Kun Yi Tong Ping orally after menstration and stop during menstraion for 3 menstrual cycles）and control group （CG,taking placebo instead）,aeeording to the random number table method.There were 34 cases in each group.The VAS scores for dysmenorrhea,the symptoms and signs according to traditional Chinese Medicine Theory,the changes of volumes of uterine size and levels of serum CA125 were observed and analyzed.Results：The VAS scores,the COX scores,the syndrome integral of the TG after treatment was significantly lower than those of the CG （P〈0.05）.There were no differences between the two groups on the changes of uterine size,and the levels of serum CA125 （P〉0.05）.No obvious adverse effects were found during the treatment in both groups.Conclusion： ＂Yi Kun Yi Tong Ping＂Granule can obviously relieve dysmenorrhea by its degree and duration,and also can significantly improve the symptoms of patients with AM. There is no obvious adverse effects of ＂Yi Kun Yi Tong Ping＂ during the treatment process.