目的 探讨知柏地黄丸联合坤泰胶囊治疗更年期综合征的临床疗效。方法 选取2013年1月-2015年5月在抚顺市中医院就诊的更年期综合征患者148例，根据患者自愿原则分为对照组（70例）和治疗组（78例）。对照组患者口服坤泰胶囊，4粒/次，3次/d。治疗组患者在对照组的基础上口服知柏地黄丸，8丸/次，3次/d。两组患者均连续治疗4周。观察两组患者临床疗效，同时比较两组患者治疗前后黄体生成素（LH）、雌二醇（E₂）和卵泡刺激素（FSH）水平以及Kupperman评分和ALS评分变化，记录治疗期间不良反应的发生情况。结果 治疗后，对照组和治疗组的总有效率分别为87.1%和96.2%，两组总有效率比较差异具有统计学意义（P<0.05）。治疗后，两组患者E₂水平增高，LH、FSH水平降低，同组治疗前后差异具有统计学意义（P<0.05）；与对照组相比，治疗后治疗组FSH、E₂和LH激素水平改善更显著，两组比较差异具有统计学意义（P<0.05）。治疗后，两组Kupperman和ALS评分均显著降低，同组治疗前后差异具有统计学意义（P<0.05）；且治疗后治疗组的Kupperman和ALS评分优于对照组，两组比较差异具有统计学意义（P<0.05）。结论 知柏地黄丸联合坤泰胶囊治疗更年期综合征可提高临床疗效，有效的改善患者临床潮热汗出和失眠的症状，具有一定的临床推广应用价值。

Objective To explore the clinical efficacy of Zhibai Dihuang Pills combined with Kuntai Capsules in treatment of menopausal syndrome. Methods Patients (148 cases) with menopausal syndrome in Fushun Hospital of TCM from January 2013 to May 2015 were divided into the control (70 cases) and treatment (78 cases) groups according to the voluntary principles. Patients in the control group were po administered with Kuntai Capsules, 4 grains/time, three times daily. Patients in the treatment group were po administered with Zhibai Dihuang Pills on the basis of the control group, 8 pills/time, three times daily. Patients in two groups were treated for 4 weeks. After treatment, the clinical efficacy was evaluated, and the level of LH, E₂, and FSH, at the same time, Kupperman and ALS scores before and after treatment in two groups was compared. Results After treatment, the clinical efficacy in the control and treatment group was 87.1% and 96.2%, respectively, and there were differences between two groups (P<0.05). After treatment, E₂ level in two groups was significantly increased, LH and FSH levels were significantly decreased, and the difference was statistically significant in the same group (P<0.05). And compared with the control group, the changes of FSH, E₂, and LH levels in the treatment group were more significantly than those in the control group, with significant difference between two groups (P<0.05). After treatment, Kupperman and ALS scores in two groups were significantly decreased, and there were differences between two groups (P<0.05). And the Kupperman and ALS scores in the treatment group were better than those in the control group, with significant difference between two groups (P<0.05). Conclusion Zhibai Dihuang Pills combined with Kuntai Capsules can improve the clinical effect in treatment of menopausal syndrome, and also effectively improve the symptoms of hectic fever with sweating and insomnia, which has a certain clinical application value..