Insomnia with <italic style="font-style: italic">Qi</italic> Deficiency Syndrome group Treated with <italic style="font-style: italic">Qiye Shen'an Drop Pill </italic>（七叶神安滴丸）：A Randomized， Double-blind， Parallel-Controlled， Multicenter Clinical Trial

CHEN Wenjie; HE Chunying; CHEN Zhiyan; ZHAN Min; DU Yida; HAN Fuhua; SUN Linjuan; ZHANG Yunling; ZHANG Yunsheng; SHI Yunlong; ZHANG Kai; HE Zhaoyou

doi:10.13288/j.11-2166/r.2022.24.008

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Insomnia with Qi Deficiency Syndrome group Treated with Qiye Shen'an Drop Pill （七叶神安滴丸）：A Randomized， Double-blind， Parallel-Controlled， Multicenter Clinical Trial

更新时间：2022-12-13

- Insomnia with Qi Deficiency Syndrome group Treated with Qiye Shen'an Drop Pill （七叶神安滴丸）：A Randomized， Double-blind， Parallel-Controlled， Multicenter Clinical Trial
- Journal of Traditional Chinese Medicine Vol. 63, Issue 24, Pages: 2339-2345(2022)
- 作者机构：
  
  1.中国中医科学院西苑医院，北京市海淀区西苑操场路1号，100091
  2.云南金七制药有限公司
- 作者简介：
- 基金信息：
- DOI：10.13288/j.11-2166/r.2022.24.008
  CLC：
- Received：16 June 2022，
  
  Revised：2022-09-20，
  
  Published：17 December 2022
- 稿件说明：
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陈文洁,何春颖,陈芷妍等.七叶神安滴丸治疗失眠症气虚证的随机、双盲、平行对照、多中心临床研究[J].中医杂志,2022,63(24):2339-2345.

CHEN Wenjie,HE Chunying,CHEN Zhiyan,et al.Insomnia with Qi Deficiency Syndrome group Treated with Qiye Shen'an Drop Pill （七叶神安滴丸）：A Randomized， Double-blind， Parallel-Controlled， Multicenter Clinical Trial[J].Journal of Traditional Chinese Medicine,2022,63(24):2339-2345.
陈文洁,何春颖,陈芷妍等.七叶神安滴丸治疗失眠症气虚证的随机、双盲、平行对照、多中心临床研究[J].中医杂志,2022,63(24):2339-2345. DOI： 10.13288/j.11-2166/r.2022.24.008.

CHEN Wenjie,HE Chunying,CHEN Zhiyan,et al.Insomnia with Qi Deficiency Syndrome group Treated with Qiye Shen'an Drop Pill （七叶神安滴丸）：A Randomized， Double-blind， Parallel-Controlled， Multicenter Clinical Trial[J].Journal of Traditional Chinese Medicine,2022,63(24):2339-2345. DOI： 10.13288/j.11-2166/r.2022.24.008.

摘要

目的

探讨七叶神安滴丸干预失眠症气虚证的有效性及安全性。

方法

采用多中心、随机、双盲、平行对照试验方法，收集9家医院失眠症气虚证患者288例，按照3∶1比例随机分为治疗组216例，对照组72例。两组均给予基础治疗。治疗组再给予七叶神安滴丸，对照组再给予七叶神安滴丸模拟剂，两组均每日3次，每次300 mg，饭后口服，疗程4周。治疗前后采用匹兹堡睡眠质量量表（PSQI）评价睡眠质量，疲劳严重度量表（FSS）评价疲劳程度；记录实验期间不良事件发生情况评价安全性；治疗后判定临床疗效。结果有效性评价分析采用全分析（FAS）集及符合方案（PPS）集分析；安全性指标以安全性（SS）集进行分析。

结果

288例患者均进入SS集，284例均进入FAS集（治疗组212例，对照组72例），247例进入PPS集（治疗组185例，对照组62例）。FAS集：治疗组临床总有效率（76.89%）明显高于对照组（27.78%）（

＜0.0001）；PPS集：治疗组临床总有效率（84.86%）明显高于对照组（30.65%）（

＜0.0001）。PPS集与FAS集结果均显示，两组患者治疗后PSQI评分及FSS评分均较本组治疗前下降（

＜0.0001），且治疗后治疗组较对照组明显降低（

＜0.0001）；治疗组PSQI评分及FSS评分治疗前后差值较对照组明显增加（

＜0.0001）。治疗组不良事件发生率为6.94%（15/216），对照组为4.17%（3/72），均与试验无相关性。

结论

七叶神安滴丸治疗失眠症气虚证疗效较好，安全性较高。

Abstract

Objective

To investigate the efficacy and safety of

Qiye Shen'an Drop Pill

（七叶神安滴丸） in the treatment of insomnia with

deficiency syndrome.

Methods

A multicenter randomized double-blind parallel trial was designed to include 288 insomnia subjects with

deficiency syndrome from 9 hospitals. The subjects were randomly allocated into intervention group （216 cases） and control group （72 cases） at a ratio of 3∶1. Routine treatment was given to all the subjects. Besides， the intervention group was orally administered with

Qiye Shen'an Drop Pill，

while the control group was given the corresponding placebo， both for 300mg each time， taken after meals， three times a day， four weeks totally. Pittsburgh Sleep Quality Inventory （PSQI） and Fatigue Severity Scale （FSS） were used to evaluate the sleep quality and fatigue severity before and after treatment， respectively. The occurrence of adverse events were recorded to evaluate the safety. The clinical effect was judged after treatment. Full analysis set （FAS） and per protocol set （PPS） were used for effectiveness analysis， while safety set （SS） was used for safety analysis.

Results

All 288 subjects were included in the SS， and there were 284 subjects in the FAS （212 in the intervention group and 72 in the control group）， and 247 subjects in the PPS （185 in the intervention group and 62 in the control group）. FAS analysis： the total clinical effective rate in the intervention group was 76.89%， significantly higher than 27.78% in the control group （

＜0.0001）. PPS analysis： the total effective rate in the intervention group （84.86%） was significantly higher than that in the control group （30.65%）（

＜0.0001）. PPS and FAS analyses both showed that PSQI and FSS scores significantly decreased after treatment （

＜0.0001）， and more decreases were found in the intervention group than in the control group （

＜0.0001）； and the differences of PSQI scores and FSS scores were significantly higher in the intervention group than those in the control group （

＜0.0001）. The incidence of adverse events was 6.94% in the intervention group （15/216） and 4.17% in the control group （3/72）. All adverse events were judged to be not relevant to the trial.

Conclusion

Qiye Shen'an Drop Pill

has high efficacy and safety in treating insomnia with

deficiency syndrome.

关键词

Keywords

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Insomnia with Qi Deficiency Syndrome group Treated with Qiye Shen'an Drop Pill （七叶神安滴丸）：A Randomized， Double-blind， Parallel-Controlled， Multicenter Clinical Trial

DOI：10.13288/j.11-2166/r.2022.24.008

摘要

Abstract

关键词

Keywords

references