益肾消癥颗粒治疗子宫内膜异位症所致肾虚血瘀证痛经的双盲随机对照研究

Efficacy of Yishen Xiaozheng granules on dysmenorrhea with syndrome of kidney deficiency and blood stasis caused by endometriosis:A double-blind randomized controlled study

目的 探究益肾消癥颗粒治疗盆腔子宫内膜异位症所致痛经的临床疗效。方法 将2019年12月—2021年9月在北京中医药大学东方医院妇科门诊就诊的62例子宫内膜异位症所致痛经患者按照随机数字表法分成试验组32例及对照组30例。试验组予益肾消癥颗粒口服,自月经来潮的第1天起,连服3个月经周期;对照组予无治疗作用的安慰剂口服,服用方法同试验组。记录2组患者治疗前及治疗1,2,3个月经周期后NRS评分、中医证候评分、痛经症状评分、COX痛经症状量表(CMSS)评分及布洛芬胶囊使用情况。结果 治疗1,2,3个月经周期后试验组NRS评分、中医证候评分、痛经症状评分、CMSS评分均明显低于治疗前及同期对照组(P均<0.05),对照组治疗1,2,3个月经周期后NRS评分、中医证候评分、痛经症状评分、CMSS评分与治疗前比较差异均无统计学意义(P均>0.05)。治疗1,2,3个月经周期后,试验组服布洛芬时间、服布洛芬粒数明显减少(P均<0.05);对照组治疗1,2,3个月经周期后服布洛芬时间、服布洛芬粒数与治疗前比较差异均无统计学意义(P均>0.05);治疗后,2组间各时点服布洛芬时间、粒数比较差异均无统计学意义(P均>0.05)。2组受试者均未出现严重药物不良事件。结论 益肾消癥颗粒能明显改善子宫内膜异位症所致痛经患者的临床症状,且安全性高。

Objective It is to explore the clinical efficacy of Yishen Xiaozheng granule in the treatment of dysmenorrhea caused by pelvic endometriosis.Methods A total of 62 patients with dysmenorrhea caused by endometriosis who were treated at the Obstetrics and Gynecology Clinic of Dongfang Hospital,Beijing University of Traditional Chinese Medicine from December 2019 to September 2021 were randomly divided into an experimental group of 32 cases and a control group of 30 cases by a random number table.The experimental group was treated with Yishen Xiaozheng granule orally,starting from the first day of menstruation,continuously treated for 3 menstrual cycles;The control group was treated with a placebo with no therapeutic effect orally,the administration was the same as the experimental group.The NRS scores,traditional Chinese medical syndrome scores,dysmenorrhea symptom scores,the Cox Menstrual Symptom Scale(CMSS)scores and the use of ibuprofen capsule were recorded before treatment and after 1,2 and 3 menstrual cycles of treatment.Results After treatment for 1,2,and 3 menstrual cycles,the NRS scores,traditional Chinese medical syndrome scores,dysmenorrhea symptom scores,CMSS scores of the experimental group were significantly lower than those before treatment and in the control group at the same period(all P<0.05),there was no statistically significant difference in NRS scores,traditional Chinese medical syndrome scores,dysmenorrhea symptom scores,CMSS scores compared with before treatment in the control group(all P>0.05).After the treatment of 1,2 and 3 menstrual cycles,the administration duration and dosage of ibuprofen pills in the experimental group were significantly reduced(all P<0.05);there was no significant difference in the administration duration and dosage of ibuprofen pills compared with before treatment in the control group(all P>0.05).After treatment,there was no statistically significant difference in the administration duration and dosage of ibuprofen pills at each time point between the two groups(all P>0.05).The subjects of both groups did not experience any serious adverse drug events.Conclusion Yishen Xiaozheng granule can significantly improve the clinical symptoms of dysmenorrhea patients caused by endometriosis with high safety.