坤宝丸对围绝经期睡眠障碍的改善作用

Improvement Effect of Kunbao Pill on Perimenopausal Sleep Disorder

目的探讨坤宝丸对围绝经期妇女睡眠障碍的改善作用。方法将118例围绝经期睡眠障碍患者随机分为对照组和观察组,各59例。对照组患者采用戊酸雌二醇片联合谷维素片治疗,观察组患者采用坤宝丸治疗,两组疗程均为3个月。观察并比较两组患者总有效率、匹兹堡睡眠质量指数(PQSI)评分改善程度,雌二醇(E2)、促黄体生成素(LH)、卵泡刺激素(FSH)水平的变化情况,以及患者治疗过程中药品不良反应发生情况。结果观察组与对照组患者的总有效率差异不明显(72.88%比77.97%,P>0.05);两组患者治疗后PQSI评分均较治疗前显著下降(P<0.05),且观察组下降更明显(P<0.05);两组患者治疗后的E2,LH,FSH等相关激素水平均较治疗前显著改善(P<0.05),但组间比较,差异不明显(P>0.05);对照组不良反应发生率显著高于观察组(10.17%比3.39%,P<0.05)。结论坤宝丸改善围绝经期睡眠障碍的疗效明确,且较传统激素替代治疗安全性更好。

Objective To investigate the effect of Kunbao Pills for improving sleep disorder in perimenopausal women. Methods Totally 118 patients with perimenopausal sleep disorder were randomly divided into the control group and the observation group,59 cases in each group. The control group was treated by Oryzanol Tablets combined with Estradiol Valerate Tablets,while the observation group was treated by Kunbao Pill. The treatment course for both groups lasted for 3 months. The total effective rate,improvement degree of Pitts-burph sleep quality index（PSQI）score and the changes of estradiol（E2）,luteinizing hormone（LH）and follicle stimulating hormone（FSH） were observed and compared between the two groups. At the same time the occurrence rates of adverse drug reactions during the treat-ment process were also compared. Results The total effective rate had no statistically significant difference between the two groups （72. 88% vs 77. 97%,P ﹥ 0. 05）. The PSQI scores after treatment in the two groups were decreased significantly compared with before treatment（ P ﹤ 0. 05）,but the descend degree in the observation group was more obvious than that in the control group（ P ﹤ 0. 05）. The related hormone levels of E2,LH and FSH after treatment in the two groups were significantly improved compared with before treatment（ P ﹤ 00. 05）,but the differences after treatment between the two groups had no statistical significance（ P ﹥ 0. 05）. The occur-rence rate of adverse reactions in control group was significantly higher than that in the observation group（10. 17% vs 3. 39%,P ﹤0. 05）. Conclusion Kunbao Pills has definite effect for improving perimenopausal sleep disorder,moreover has better safety than the traditional hormone replacement therapy.