中国药业
中國藥業
중국약업
CHINA PHARMACEUTICALS
2015年
10期
21-22,23
,共3页
坤宝丸%围绝经期%睡眠障碍%临床疗效%药品不良反应
坤寶汍%圍絕經期%睡眠障礙%臨床療效%藥品不良反應
곤보환%위절경기%수면장애%림상료효%약품불량반응
Kunbao Pill%perimenopause%sleep disorder%curative effect%adverse drug reaction
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。
目的：探討坤寶汍對圍絕經期婦女睡眠障礙的改善作用。方法將118例圍絕經期睡眠障礙患者隨機分為對照組和觀察組，各59例。對照組患者採用戊痠雌二醇片聯閤穀維素片治療，觀察組患者採用坤寶汍治療，兩組療程均為3箇月。觀察併比較兩組患者總有效率、匹玆堡睡眠質量指數（PQSI）評分改善程度，雌二醇（E2）、促黃體生成素（LH）、卵泡刺激素（FSH）水平的變化情況，以及患者治療過程中藥品不良反應髮生情況。結果觀察組與對照組患者的總有效率差異不明顯（72.88%比77.97%，P﹥0.05）；兩組患者治療後PQSI評分均較治療前顯著下降（ P ﹤0.05），且觀察組下降更明顯（ P ﹤0.05）；兩組患者治療後的E2，LH，FSH等相關激素水平均較治療前顯著改善（ P﹤0.05），但組間比較，差異不明顯（ P﹥0.05）；對照組不良反應髮生率顯著高于觀察組（10.17%比3.39%，P﹤0.05）。結論坤寶汍改善圍絕經期睡眠障礙的療效明確，且較傳統激素替代治療安全性更好。
목적：탐토곤보환대위절경기부녀수면장애적개선작용。방법장118례위절경기수면장애환자수궤분위대조조화관찰조，각59례。대조조환자채용무산자이순편연합곡유소편치료，관찰조환자채용곤보환치료，량조료정균위3개월。관찰병비교량조환자총유효솔、필자보수면질량지수（PQSI）평분개선정도，자이순（E2）、촉황체생성소（LH）、란포자격소（FSH）수평적변화정황，이급환자치료과정중약품불량반응발생정황。결과관찰조여대조조환자적총유효솔차이불명현（72.88%비77.97%，P﹥0.05）；량조환자치료후PQSI평분균교치료전현저하강（ P ﹤0.05），차관찰조하강경명현（ P ﹤0.05）；량조환자치료후적E2，LH，FSH등상관격소수평균교치료전현저개선（ P﹤0.05），단조간비교，차이불명현（ P﹥0.05）；대조조불량반응발생솔현저고우관찰조（10.17%비3.39%，P﹤0.05）。결론곤보환개선위절경기수면장애적료효명학，차교전통격소체대치료안전성경호。
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.
