散结镇痛胶囊联合促性腺激素释放激素激动剂和腹腔镜手术治疗子宫内膜异位症合并代谢综合征患者的有效性和安全性评价

Observation of clinical efficacy of Sanjie- zhentong capsule combined with gonadotrophin releasing hormone agonists and laparoscopic surgery on endometriosis patients complicated with metabolic syndrome and its safety evaluation

目的观察散结镇痛胶囊联合促性腺激素释放激素激动剂和腹腔镜手术治疗子宫内膜异位症合并代谢综合征的有效性和安全性。方法将124例子宫内膜异位症合并代谢综合征患者随机分为2组。对照组62例予促性腺激素释放激素激动剂,疗程为6个月,然后采用腹腔镜进行治疗。治疗组62例在对照组治疗基础上加用散结镇痛胶囊1.6 g,每日3次口服,3个月为1个疗程,连用6个月。观察2组治疗前和治疗后3、6个月kupperman评分[外阴和(或)阴道不适,潮热出汗和kupperman总分],痛经、盆腔痛视觉模拟评分(VAS),并采用彩色多普勒超声评价2组子宫内膜厚度及盆腔肿块大小,观察治疗结束后2组围绝经期症状(潮热出汗、乏力、情绪波动、失眠)发生率。结果 2组治疗3、6个月外阴和(或)阴道不适评分、潮热出汗评分及kupperman总分与本组治疗前比较差异均有统计学意义(P<0.05),且治疗组与对照组同期比较差异均有统计学意义(P<0.05);2组治疗6个月外阴和(或)阴道不适评分、潮热出汗评分及kupperman总分与本组治疗3个月比较差异均有统计学意义(P<0.05)。2组治疗3、6个月痛经、盆腔痛VAS评分与本组治疗前比较差异均有统计学意义(P<0.05),且治疗组与对照组同期比较差异均有统计学意义(P<0.05);2组治疗3、6个月子宫内膜厚度和盆腔肿块直径与本组治疗前比较差异有统计学意义(P<0.05)。治疗组潮热出汗、乏力发生率与对照组比较差异有统计学意义(P<0.05)。结论散结镇痛胶囊联合促性腺激素释放激素激动剂和腹腔镜手术治疗子宫内膜异位症合并代谢综合征可降低外阴和(或)阴道不适、潮热出汗、乏力等围绝经期症状,减少患者痛经和盆腔痛的疼痛感,降低子宫内膜厚度和盆腔肿块大小,疗效可靠,用药安全。

Objective To observe clinical efficacy and safety of Sanjie- zhentong capsule combined with gonadotrophin releasing hormone agonists（ GnRH- a） and laparoscopic surgery on endometriosis patients complicated with metabolic syndrome. Methods 124 endometriosis patients complicated with metabolic syndrome were randomly divided into two groups. 62 subjects in control group were received adult injection implant of GnRH- a for 6 months,and then the subjects treated with laparoscope. 62 subjects in treatment group were treated by Sanjie- zheentong capsule（ each 1. 6 g） on the basis of control group treatment,daily administration. The course in treatment group was three months continuous for 6 months. The Kupperman scores including vulva and（ or） vaginal uncomfortable,tidal fever and sweatiness,and total Kupperman score before and 3,6months after treatment were observed in two groups,as well as the visual analogue scale（ VAS）. The endometrial thickness and pelvic mass size were measured by color Doppler ultrasound. The occurrence rates of perimenopause syndromes including hectic fever and sweating, lacking in strength,mood swings and insomnia after treatment was observed in two groups. Results There were statistical differences on vulva and（ or） vaginal uncomfortable,hectic fever and sweating,and total Kupperman score between before and 3,6 months after treatment in two groups（ P〈0. 05）,and there were statistical differences between the same period of treatment and control group（ P〈0. 05）. There were statistical differences on the score of vulva and（ or） vaginal uncomfortable,hectic fever and sweating,and total Kupperman score between 3 and 6 months after treatment in two groups（ P〈0. 05）. There were statistical differences on the VAS scores of dysmenorrheal and pelvic pain between before and 3,6 months after treatment in two groups（ P〈0. 05）,and there were statistical differences between the same period of treatment and control group（ P〈0. 05）. There were statistical differences on endometrial thickness and pelvic mass size between before and 3,6 months after treatment in two groups（ P〈0. 05）. There were statistical differences on the occurrence rates of hectic fever,sweating and lacking in strength between two groups（ P〈0. 05）. Conclusion Combined therapy of Sanjie- zhentong capsule,GnRH- a and laparoscopic surgery on the treatment of endometriosis complicated with metabolic syndrome can alleviate perimenopause syndromes including vulva and（ or） vaginal uncomfortable,hectic fever,sweating and lacking in strength,relieve dysmenorrheal and pelvic pain,decreased the endometrial thickness and pelvic mass size.