目的 評價七葉神安滴丸治療氣虛型失眠癥的有效性和安全性。方法 采用區(qū)組隨機、雙盲單模擬、安慰劑平行對照、多中心、優(yōu)效性試驗設(shè)計方法。將288例失眠患者以3∶1的比例隨機分為試驗組（216例）和對照組（72例）。試驗組口服七葉神安滴丸，對照組口服安慰劑，6丸/次，3次/d。完成4周治療后，通過失眠嚴重指數(shù)量表（ISI）治療前后變化評價其有效性，通過生命體征、不良事件、實驗室檢查及體格檢查評價藥物安全性。結(jié)果 治療4周后，治療后全分析集（FAS）中試驗組的ISI評分顯著低于對照組分（P<0.0001）。符合方案集（PPS）中試驗組的ISI評分同樣顯著低于對照組（P<0.0001），PPS與FAS結(jié)果分析一致。治療后試驗組FAS集總有效率是85.64%，對照組是38.24%，兩組比較差異有統(tǒng)計學(xué)意義（P<0.05）。試驗組PPS集總有效率為88.11%，對照組是38.71%，兩組比較差異有統(tǒng)計學(xué)意義（P<0.05），PPS與FAS結(jié)果分析一致。試驗組共發(fā)生17例次不良事件，對照組共發(fā)生3例次不良事件，經(jīng)評定與藥物無關(guān)。結(jié)論 七葉神安滴丸治療氣虛型失眠癥療效確切，能夠改善失眠患者的失眠嚴重程度，且安全性良好。

Objective To evaluate the efficacy and safety of Qiye Shen’an Dropping Pills in treatment of insomnia with Qi deficiency. Methods A block randomized, double-blind, single simulation, placebo-controlled, multicenter, superiority trial design method was used. A total of 288 patients with insomnia were randomly divided into experimental group (216 cases) and control group (72 cases) with a ratio of 3∶1. Patients in the experimental group were po administered with Qiye Shenan Dropping Pills, while patients in the control group were po administered with placebo, 6 pills/time, 3 times daily. After 4 weeks of treatment, the efficacy was evaluated by insomnia Severity index (ISI) before and after treatment, and the safety was evaluated by vital signs, adverse events, laboratory tests and physical examination. Results After 4 weeks of treatment, ISI score in the full analysis set (FAS) of the experimental group was significantly lower than that of the control group (P< 0.000 1). The ISI score of the experimental group was also significantly lower than that of the control group (P < 0.000 1). The results of PPS and FAS were consistent. After treatment, the total effective rate of FAS was 85.64% in the experimental group and 38.24% in the control group, and the difference between the two groups was statistically significant (P < 0.05). The total effective rate of PPS in the experimental group was 88.11%, and that in the control group was 38.71%. The difference between the two groups was statistically significant (P < 0.05). The results of PPS and FAS were consistent. A total of 17 adverse events occurred in the experimental group and 3 adverse events occurred in the control group, which were assessed to be unrelated to drugs. Conclusion Qiye Shen’an Dropping Pills is effective in treatment of Qi deficiency insomnia, and can improve the severity of insomnia in patients with insomnia, which has good safety.

R971

國家自然科學(xué)基金面上項目（81873168）