二仙汤治疗围绝经期综合征的疗效观察

Effect Observation of the Erxian Decoction in Treating Perimenopausal Syndrome

目的观察二仙汤加减治疗妇女围绝经期综合征的疗效及安全性。方法将70例患者随机分为观察组和对照组各35例,观察组采用二仙汤加减治疗,对照组采用激素替代治疗,治疗3个月后,观察两组治疗前后的改良Kupperman评分,从而分析两种疗法对患者Kupperman指数变化的影响及其临床疗效与安全性。结果两组治疗后Kupperman指数均较治疗前明显降低,差异有统计学意义(P<0.05),但两组治疗前后Kupperman指数差值无明显差异(P>0.05);观察组总有效率(94.29%)与对照组总有效率(91.43%)无显著差异(P>0.05)。治疗期间对照组在第一个月出现阴道点滴出血2例,乳房胀痛3例,经继续治疗后症状可缓解,2例患者在用药期间体重显著增加(10 kg);观察组未出现明显不良反应。结论二仙汤加减治疗围绝经期综合征可达到与激素替代治疗相当的疗效,并具有适用人群广、不良反应少的特点,值得临床推广和应用。

Objective To observe the clinical effect and safety of the modified Erxian decoction（ EXD） in perimenopausal syndrome.Methods Seventy patients were randomly devided into 2 groups： the observation group（n=35） received the EXD, and the control group（ n =35） was treated by hormone replacement therapy（ HRT）. The modified Kupperman index（ MI） was examined before and after treatment. The variation of MI, the effect and safety of HRT and TCM therapy were evaluated. Results After 3 months of treatment, MI decreased in both groups compared with before treatment, and there was statistically significant difference（ P〈0.05）. There was no significant difference（P〉0.05） in the variation of MI between the observation group and control group. The total effective rate of the obser-vation group and the control group was 94.29% and 91.43%, respectively, and there was no significant difference（P〉0.05）. During therapy, in the control group, 2 cases had small amount of vaginal bleeding, 3 cases had breast pain at first month, which were relieved with continued treatment, and 2 cases occured weight gain. There were no obvious adverse reactions in the observation group. Conclusion The modified EXD has equivalent effect to HRT（ P 〉0.05） in the treatment of perimenopasual syndrome, but with less adverse effects and wider application, which is worthy promotion and application.