| 张盛杰,沈仲夏.百乐眠胶囊治疗非器质性失眠症的对照研究[J].浙江中西医结合杂志,2017,27(6): |
| 百乐眠胶囊治疗非器质性失眠症的对照研究 |
| The control research of Bai Lemian Capsule on the treatment of insomnia |
| 投稿时间：2016-12-04 修订日期：2017-01-29 |
| DOI： |
| 中文关键词: 百乐眠胶囊 乌灵胶囊 奥沙西泮 失眠症 |
| 英文关键词:Bai Lemian Capsule Wuling Capsule,Oxazepam,Insomnia |
| 基金项目:湖州市科技技术项目 项目编号(2012C33080) |
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| 中文摘要: |
| 目的：观察百乐眠胶囊治疗失眠症的疗效和安全性。方法：将120例非器质性失眠症患者随机分成百乐眠胶囊治疗组(n=44),乌灵胶囊治疗组(n=39)以及奥沙西泮治疗组(n=41),其中百乐眠胶囊组服用百乐眠胶囊2粒每日二次治疗,乌灵胶囊组治疗剂量服用乌灵胶囊3粒每日三次,奥沙西泮组服用奥沙西泮15-30mg/日治疗,治疗持续4周,治疗前及治疗第4周末用匹兹堡睡眠质量指数(PSQI)和失眠严重程度指数(ISI)评定患者的失眠严重程度及疗效,同时用副反应量表(TESS)和实验室检查评估治疗安全性。结果：治疗后百乐眠胶囊组,乌灵胶囊组,奥沙西泮组的PSQI分数分别为(6.14±2.11),(7.45±2.42),(6.10±1.90),均较治疗前显著下降,三组间存在差异(F=5.12,P<0.01),百乐眠组PSQI分数显著低于乌灵胶囊组(Q=3.9213,P<0.01),但是与奥沙西泮组相比没有显著差异(Q=0.1213,P>0.05)。同时治疗后三组的ISI分数分别为(12.30±3.55),(14.42±4.18),(11.93±3.19),均较治疗前显著下降,(F=10.19,P<0.01),百乐眠胶囊组ISI分数显著低于乌灵胶囊组(Q=5.1262,P<0.01),但是与奥沙西泮组相比没有显著差异(Q=0.9065,P>0.05)。奥沙西泮组不良反应显著高于百乐眠胶囊组。结论：百乐眠胶囊治疗非器质性失眠症疗效良好,不良反应少,患者依从性较好。 |
| 英文摘要: |
| Objective: To observe the efficacy and safety of Bai Lemian Capsule in the treatment of insomnia. Methods: 120 insomnia patients were treated with Bai Lemian Capsule(n=44),Bai Wuling Capsule (n=39) and Oxazepam (n=41) randomly. The trial lasted 4 weeks. The insomnia severity and efficacy were evaluated with PSQI (Pittsburgh Sleep Quality Index) and ISI(Insomnia Severity Index) before and after the treatment respectively and the safety was evaluated by TESS and laboratory examination. Results: The PSQI scores of all three groups declined significantly after the treatment(6.14±2.11)(7.45±2.42)(6.10±1.90)which had significant difference(F=5.12,P<0.01), the scores of Bai Lemian Capsule group is lower than that in Wuling Capsule group(Q=3.9213,P<0.01),while there are no difference between Bai Lemian Capsule group and Oxazepam group(Q=0.1213,P>0.05), and the ISI scores of all three groups declined significantly after the treatment(12.30±3.55)(14.42±4.18)(11.93±3.19)which had significant difference(F=10.19,P<0.01), the scores of Bai Lemian Capsule group is lower than that in Wuling Capsule group(Q=5.1262,P<0.01), while there are no difference between Bai Lemian Capsule group and Oxazepam group(Q=0.9065,P>0.05).The incidence of side effects in Bai Lemian Capsule group is much lower than that in Oxazepam group. Conclusion: Bai Lemian Capsule demonstrated to be effective and safe in the treatment of insomnia. |
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