针刺结合香附汤加减治疗围绝经期失眠肝郁气滞证的临床研究

评价针刺联合香附汤加减治疗围绝经期失眠肝郁气滞证的疗效及安全性。将120例患者随机分为对照组和治疗组,各60例,分别给予艾司唑仑片、针刺结合香附汤加减,疗程均为16周。比较2组患者治疗前后爱泼沃斯嗜睡量表(ESS),匹兹堡睡眠质量指数(PSQI),汉密尔顿焦虑量表(HAMA)和中医症状评分;采用多导睡眠监测仪监测睡眠进程和睡眠结构;检测血清黄体生成素(LH)、卵泡激素(FSH)和雌二醇(E2)的含量;观察2组临床疗效和不良反应发生率。研究期间脱落4例。治疗组总有效率91.5%,高于对照组的75.4%(P<0.05)。治疗后,治疗组临床症状(ESS、PSQI、HAMA和中医症状)评分均明显降低(P<0.05),且较对照组降低更为明显(P<0.05);治疗组睡眠总时间(TST)和睡眠维持率(SE)升高(P<0.05);觉醒时间(AWT),睡眠潜伏期(SL),觉醒次数(AT)降低(P<0.05),且较对照组改善更为明显(P<0.05);治疗组S1降低(P<0.05),S2,S3+4和快速眼动睡眠期(REM)升高(P<0.05),且较对照组改善更为明显(P<0.05);治疗组LH和FSH含量明显降低(P<0.05),E2含量明显升高(P<0.05),且较对照组改变更为明显(P<0.05)。对照组总不良反应发生率8.8%,明显高于治疗组的1.7%(P<0.05)。结果表明针刺联合香附汤加减可明显改善围绝经期失眠肝郁气滞证患者的睡眠状况,不良反应发生率低。

Clinical efficacy of acupuncture combined with modified Xiangfu Decoction in treatment of menopausal insomnia cause by liver Qi stagnation

To evaluate the efficacy and safety of acupuncture combined with modified Xiangfu Decoction in the treatment of menopausal insomnia case by liver Qi stagnation.Totally 120 cases were randomly divided into the control group(60 cases)and the treatment group(60 cases).Estazolam and acupuncture combined with modified Xiangfu Decoction were given for 16 weeks.Before and after treatment,Epworth sleepiness scale(ESS),Pittsburgh sleep quality index(PSQI),Hamilton anxiety scale(HAMA)and traditional Chinese medicine(TCM)syndrome score were compared between the two groups.Polysomnography monitor was used to monitor sleep progress and sleep structure.Serum LH,FSH and E2 were determined.The clinical efficacy and incidence of adverse reactions were observed.Four cases were lost during the study.The total effective rate in the treatment group was 91.5%,which was higher than that in the control group 75.4%(P<0.05).After treatment,the scores of clinical symptoms(ESS,PSQI,HAMA,TCM symptoms)in the treatment group were significantly reduced(P<0.05),and lower than that in the control group(P<0.05).TST,SE in the treatment group were increased(P<0.05),while AWT,SL,AT in the treatment group were decreased(P<0.05),and the improvement was more significant than that in the control group(P<0.05).S1 in the treatment group was decreased(P<0.05),whereas S2,S3+4,REM in the treatment group were increased(P<0.05),and the improvement was more significant than that in the control group(P<0.05).The contents of LH and FSH in the treatment group were significantly reduced(P<0.05),while the content of E2 was significantly increased(P<0.05),and the changes were more significant than those in the control group(P<0.05).The incidence of adverse reactions in the control group was 8.8%,which was higher than 1.7%in the treatment group(P<0.05).Acupuncture combined with modified Xiangfu Decoction could significantly improve the sleep status of menopausal insomnia cases caused by liver Qi stagnation,with a lower incidence of adverse reactions,and so is worthy of clinical promotion and application.