龙凤宝片治疗围绝经期综合征的再评价研究

目的:对龙凤宝片治疗围绝经期综合征(肾阳虚证)的临床疗效与安全性进行评价。方法:84例患者随机分为治疗组和对照组各42例。对照组口服利维爱,2.5 mg/次,1次/d;治疗组口服龙凤宝片,1.2 g/次,3次/d。两组疗程均为12周。观察患者Kupperman评分,测定血清雌二醇(E2)、卵泡刺激素(FSH)及黄体生成素(LH)水平,测定子宫内膜厚度及中医临床症状积分。结果:治疗后两组Kupperman评分及肾阳虚证积分均明显降低(P<0.01),治疗组肾阳虚证积分低于对照组(P<0.01);治疗后两组血清E2水平明显升高(P<0.01);治疗组总有效率88.09%,对照组为92.85%,两组疗效相当;两组治疗后子宫内膜厚度变化不明显。治疗组未见明显不良反应。结论:龙凤宝片能明显改善围绝经期综合征(肾阳虚证)的临床症状,降低Kupperman评分,升高血清E2水平,不增加子宫内膜厚度,临床使用安全有效。

Re-evaluation of Longfengbao Tablets for Treatment of Perimenopausal Syndrome

Objective:To re-evaluate the clinical efficacy and safety of Longfengbao tablets for the treatment of perimenopausal syndrome. Method: Eighty-four patients were randomly divided into treatment group and control group (n=42 each). The control group was treated with livial 2.5 mg daily; the treatment group was orally given Longfengbao tablets 1.2 g tid. The treatment lasted for 12 weeks. Kupperman score, serum estradiol (E₂), follicle stimulating hormone (FSH), luteinizing hormone (LH) l, endometrial thickness were measured and traditional Chinese medicine clinical symptom score were compared between the two groups. Result: After the treatment, the two sets of the Kupperman ratings and deficiency syndrome integral were significantly lowered than before (P<0.01), the deficiency syndrome points of the treatment group was lower than that of the control group(P<0.01). Serum E₂ level in two groups was significantly increased after treatment (P<0.01). The effective rate of the treatment group was 88.09% while the control group was 92.85%; the endometrial thickness did not change significantly after the treatment in both groups. The treatment group showed no adverse reactions. Conclusion: Longfengbao tablets can significantly improve the clinical symptoms of perimenopause syndrome, reduce the Kupperman score, elevated serum E₂ levels without increasing endometrial thickness, and it is safe and effective.