黑升麻制剂治疗围绝经期综合征的初步探讨

Efficacy and safety of black cohosh preparation on peri-menopausal symptoms

目的探讨黑升麻制剂治疗围绝经期综合征患者的临床疗效及安全性。方法选择2010年7月至2014年3月在大庆龙南康复医院及苏州大学附属第三医院妇科门诊就诊的51例绝经早期围绝经期综合征患者为研究对象,随机分为两组,其中黑升麻组26例,给予黑升麻制剂口服,0.28 g,Bid,连续用药12周;替勃龙组25例,给予替勃龙片口服,2.5 mg,Qd,连续用药12周。以Kupperman绝经指数(Kupperman menopause index,KMI)总分以及潮热出汗评分为主要疗效指标,在治疗前、治疗第4、8、12周时进行观察比较;同时检测两组患者用药12周前后肝肾功能、血脂4项、子宫内膜厚度及血清性激素水平变化,记录两组不良反应发生情况。结果①治疗前两组患者KMI总分、潮热出汗评分、肝肾功能、血脂4项、血清性激素水平及子宫内膜厚度比较,差异无统计学意义(P>0.05)。②两组患者治疗第4、8、12周时,KMI总分及潮热出汗评分较治疗前均明显下降(P<0.05),但两组之间比较,差异无统计学意义(P>0.05)。③两组肝肾功能、血脂水平治疗前后比较,差异无统计学意义(P>0.05)。④两组子宫内膜厚度治疗前后比较,差异无统计学意义(P>0.05)。⑤性激素变化:两组治疗前血清雌二醇(estradiol,E2)及卵泡刺激素(follicle stimulating hormone,FSH)比较,差异无统计学意义(P>0.05);黑升麻组E2及FSH治疗前后比较,差异无统计学意义(P>0.05);替勃龙组治疗后E2水平高于治疗前和黑生麻组,FSH水平低于治疗前,也低于黑生麻组(P<0.05)。⑥不良反应:黑升麻组阴道出血、乳房胀痛等发生率明显低于替勃龙组(P<0.05)。结论黑升麻制剂治疗绝经早期妇女围绝经期综合征的效果与替勃龙相似,短期内使用对患者肝肾功能、血脂、血清性激素水平、子宫内膜厚度无明显影响;黑升麻制剂导致的阴道出血、乳房胀痛等不良事件的发生率更低。

Objective To investigate the clinical efficacy and safety of black cohosh preparation on peri-menopausal symptoms. Methods 51 early postmenopausal women with peri-menopausal symptoms in Daqing Longnan Rehabilitation Hospital and The Third Affiliated Hospital of Soochow University from July 2010 to March 2014 were enrolled. They were divided into 2 groups randomly. The therapeutic strategy in black cohosh group(26 cases) was to take black cohosh 0.28 g,bid for 12 weeks, while tibolone 2.5 mg qd for 12 weeks in the tibolone group(25 cases). Kupperman menopause index(KMI) total score and hot flash/sweating scores were the main curative indicators, and were compared before treatment and at 4, 8, and 12 weeks of treatment. At the same time, the changes of liver and kidney function, blood lipids, endometrial thickness and serum sex hormone levels were measured before and 12 weeks after treatment. The incidence of adverse reactions in the two groups was recorded. Results ① There were no significant differences in KMI score, hot flash/sweating scores, liver and kidney function, blood lipids, serum sex hormone levels and endometrial thickness between the two groups before treatment(P>0.05);② At the 4 th, 8 th, and 12 th week of treatment, the scores of KMI and hot flash/sweating scores were significantly lower than those before treatment(P<0.05), but there was no significant difference between the two groups(P>0.05).③ There were no significant differences in liver and kidney function and blood lipid levels between the two groups before and after treatment(P>0.05).④ There was no significant difference in the endometrial thickness between the two groups before and after treatment(P>0.05).⑤ The post-therapeutic serum FSH and E2 level had no significant change in comparison of the initial level in black cohosh group(P>0.05), while in tibolone group, the level of E2 was higher than that pre-therapeutic and black cohosh group, and the FSH level was lower than that before treatment and also lower than that in the black cohosh group(P<0.05).⑥ The incidence of vaginal bleeding, breast distending pain in black cohosh group is remarkably lower than tibolone group(P<0.05). Conclusion Compared with tibolone, black cohosh had similar clinical efficacy for peri-menopausal symptoms in early postmenopausal women, and under short-term administration it had no obvious influence on liver and renal functions, blood lipid profile, serum sex hormone levels, and endometrial thickness,and had lower incidence of the adverse events such as vaginal bleeding and breast distending pain.