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落花安神口服液治疗失眠症疗效的随机双盲安慰剂对照临床试验

Efficacy of Luohua Anshen Oral Liquid on insomnia: A randomized, double-blind, placeb-controlled clinical trial

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【作者】 张雯静王国华王翘楚

【Author】 ZHANG Wen-jing;WANG Guo-hua;WANG Qiao-chu;Shanghai Municipal Hospital of Traditional Chinese Medicine;

【机构】 上海市中医医院(上海中医药大学附属市中医医院)

【摘要】 目的:为观察落花安神口服液对失眠症的临床疗效和安全性。方法:64例失眠症患者随机分为安慰剂(A)组33例,落花安神口服液(B)组31例。通过治疗前后测Spiegel量表及失眠症中医症状症候量表检测有效性。安全性检测包括不良事件报道及Tess量表检查。结果:与治疗前相比,治疗后A组和B组Spiegel量表及中医症状症候量表评分均有所下降(P<0.05,P<0.01)。A组总有效率33.3%,B组总有效率77.4%,差异显著(P<0.05);未发现明显不良反应。结论:落花安神合剂治疗失眠症安全、有效。

【Abstract】 Objective: To evaluate the efficacy and safety of Luohua Anshen Oral Liquid on insomnia. Methods: Sixtyfour patients with insomnia were randomly divided into the placebo group(A) and the Luohua Anshen Oral Liquid group(B), 33 and 31 patients per each group respectively. Efficacy was assessed by Spiegel scale and insomnia TCM syndrome scale. Safety assessments included emergent adverse events reports and Tess scale. Results: After the treatment, total scores of Spiegel scale and insomnia TCM syndrome scale decreased and significant differences between two groups were found(P<0.05, P<0.01).The total effective rate were 33.3% and 77.4% in group A and B respectively with significant differences(P<0.05). No obvious adverse reaction was found. Conclusion: Luohua Anshen Oral Liquid could be seen as an effective and safe treatment method for insomnia.

【基金】 上海市卫生局科研基金项目(No.034y23);上海市进一步加快中医药事业发展三年行动计划项目(No.ZY3-RCPY-3-1052,No.ZY3-LCPT-1-1010)~~
  • 【文献出处】 中华中医药杂志 ,China Journal of Traditional Chinese Medicine and Pharmacy , 编辑部邮箱 ,2017年06期
  • 【分类号】R256.23
  • 【被引频次】12
  • 【下载频次】527
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