异痛舒丸治疗卵巢子宫内膜异位囊肿的临床研究

Clinical Study on Yitong Shu Pill in the Treatment of Ovarian Endometriosis Cysts

目的:探讨异痛舒丸治疗卵巢子宫内膜异位囊肿(OEC)的临床疗效,并评估其安全性。方法:选择符合纳入标准的OEC患者60例,依据随机数字表随机分为对照组和观察组,每组各30例。对照组口服地诺孕素,观察组给予地诺孕素联合异痛舒丸治疗,1个月经周期为1个疗程,连续治疗3个疗程。观察两组患者治疗前后中医证候积分、异位囊肿最大径线、CA125、FSH、LH、E_(2)水平的变化情况,比较临床疗效、中医证候疗效及不良反应发生情况。结果:治疗后,两组患者中医证候疗效比较,观察组总有效率96.67%(29/30),对照组总有效率76.67%(23/30),差异具有统计学意义(P<0.05);两组患者临床疗效比较,观察组临床总有效率93.33%(28/30),对照组临床总有效率73.33%(22/30),差异具有统计学意义(P<0.05)。治疗后,两组患者中医证候积分均下降(P<0.05),且观察组较对照组下降更显著(P<0.05);两组患者异位囊肿最大径线均下降(P<0.05),观察组较对照组下降更显著(P<0.05);两组患者血清CA125、FSH、LH及E_(2)水平均下降(P<0.05),观察组较对照组下降更显著(P<0.05);治疗过程中两组患者未出现不良反应。结论:异痛舒丸治疗OEC疗效显著,可有效改善OEC患者临床症状与体征,降低中医证候积分,调节血清CA125、FSH、LH及E_(2)水平,缩小异位囊肿,不良反应发生率低。

Objective:To explore the clinical efficacy and safety of Yitong Shu Pill(YSP)in the treatment of ovarian endometrial cysts(OEC).Methods:Sixty OEC patients who met the inclusion criteria were selected and randomly divided into a control group and an observation group based on a random number table,with 30 cases in each group.The control group received oral administration of denorgestrel,while the observation group received the same in addition to YSP.One menstrual cycle was considered as a course of treatment,and the treatment lasted for three consecutive courses.Changes in traditional Chinese medicine syndrome scores,maximum diameter of ectopic cysts,CA125,FSH,LH,and E_(2)levels before and after treatment in the two groups of patients were observed,and the clinical efficacy,traditional Chinese medicine syndrome efficacy,and adverse reactions in the two groups were compared.Results:After treatment,the total effective rate of traditional Chinese medicine syndromes in the observation group was 96.67%(29/30),while that of the control group was 76.67%(23/30),with a statistically significant difference(P<0.05).Total clinical effective rate was 93.33%(28/30)in the observation group and 73.33%(22/30)in the control group,and the difference was statistically significant(P<0.05).The traditional Chinese medicine syndrome scores of both groups decreased(P<0.05),and they decreased more in observation group than in the control group(P<0.05).The maximum diameter of ectopic cysts in both groups of patients decreased(P<0.05),and the diameter decreased more in the observation group than in the control group(P<0.05).The serum CA125 levels in both groups of patients decreased(P<0.05),and the observation group showed more significant compared to the control group(P<0.05).The serum levels of CA125,FSH,LH,and E_(2)in both groups of patients decreased,and the observation group was obvious compared with the control group(P<0.05).During the treatment process,there were no adverse reactions observed in both groups of patients.Conclusion:Yitong Shu Pill has a significant therapeutic effect on OEC,which can effectively improve clinical symptoms and signs of OEC patients,reduce traditional Chinese medicine syndrome scores,regulate serum levels of CA125,FSH,LH,and E_(2),reduce the size of ectopic cysts,and have a low incidence of adverse reactions.