莉芙敏与利维爱治疗围绝经期综合征的临床疗效观察

Comparison on the efficacy and safety of Remifemin and Livial in the treatment of perimenopausal symptoms

目的比较莉芙敏与利维爱用于改善女性围绝经期症的效果及安全性。方法选择120例在我院妇科门诊就诊的有临床症状的围绝经期女性,随机分为莉芙敏组与利维爱组各60例,以Kupperman总值(KIM)为主要疗效评价标准,各单项为次要疗效评价标准,分别于治疗前及治疗后4、12周进行疗效评定,以肝肾功能、性激素水平、血脂、药物不良反应评价安全性,对两组患者用药前后的各项指标进行比较。结果两组患者KMI值治疗后均有明显下降,与治疗前比较差异有统计学意义(P<0.05),而两组疗效比较差异无统计学意义(P>0.05);两组患者的ALT、BUN、TC、TG治疗前后变化不明显,莉芙敏组HDL治疗后上升,LDL治疗后下降,与利维爱组治疗后比较差异有统计学意义(P<0.05);莉芙敏组不良反应以乳房胀痛、胃肠道反应多见,利维爱组不良反应以阴道出血、乳房胀痛、子宫内膜增厚多见。结论莉芙敏与利维爱都能有效地改善女性围绝经期症状,且安全性及耐受性好,但莉芙敏的不良反应少于利维爱。

Objective To investigate the efficacy and safety ofRemifemin （isopropanolie extract ofeimieifu- ga racemosa） and Livial in the treatment of perimenopansal syndromes. Methods One hundred and twenty women treated in our hospital were enrolled and equally divided into group A （treated with Remifemin） and group B （treated with Livial）, with 60 patients in each group. With total score of Kupperman menopause index （KMI） as the major eval- uating index, the observation and comparison were made before treatment, after 4 weeks and 12 weeks of treatment both within and between the two groups. The safety of treatment was evaluated in terms of liver and kidney function, sex hormone levels, blood lipids, and adverse drug reactions. Results Compared with before treatment, total score of KMI was declined in both two groups after 4 weeks and 12 weeks of treatment. There was no statistically significant difference in the respect of clinical effect, ALT, BUN, TC, TG levels of the two groups before and after treatment. Af- ter treatment, the index of HDL of group A was significantly increased, and the LDL was significantly declined, show- ing statistically significant difference with that of group B （P〈0.05）. The main adverse reactions in group A contained breast swelling and gastrointestinal reactions, while those in group B were vaginal bleeding, breast swelling, thickness of endometrium. Conclusion Remifemin is an effective and safe agent to manage climacteric symptoms. It displays similar therapeutic effects and lower incidence of adverse reactions, compared with Livial.