复方酸枣仁安神胶囊治疗失眠症的疗效观察及药理研究

Observation on Efficacy and Experimental Study with Compound Suanzaoren Ansen(酸枣仁安神)Capsules for Insomnia

对374例失眠患者随机分为复方酸枣仁安神胶囊、朱砂安神丸及安眠酮3组治疗。总有效率分别为84.15%,67.06%及81.61%。结果表明,复方酸枣仁安神胶囊疗效优于朱砂安神丸(P<0.005),而与安眠酮相仿(P>0.05)。睡眠脑电图及动物实验表明,复方酸枣仁安神胶囊疗效可靠,作用迅速,安全无毒。

374 patients suffering from insomnia were divided into three groups by random:202 cases in group Ⅰ were treated with compound Suanzaoren Ansen capsules(SAC);85 cases in group Ⅱ were treated with Zhusha Ansen(硃砂安神)pills(ZAP)as control;87 cases in group Ⅲ were treated with Methaqualone(Hyminal)also as control.The therapeutic results were as follows:Groups Ⅰ,Ⅱ and Ⅲ snowed significant effective rates of 49.50%,18.82% and 32.18% respectively;moderate effective rates of 34.65%,48.24% and 49.43% respectively;and total rates of effectiveness of 84.15,67.06% and 81.61% respectively.The authors found significant statistical difference between group Ⅰ and Ⅱ(P< 0.005)and of no statistical difference between group Ⅰ and Ⅲ(P>0.05).The results showed that the effects of compound SAC were better than ZAP,and similar to that of methaqualone.EEG analysis carried out while sleeping confirmed the effects mentioned above.Low toxicity(LD_(50)10.7 g/kg)of compound SAC was found through animal experimentations.No towards reactions were revealed in clinical trials except nausea in 3 cases.Heart rate and blood pressure changed lightly in a few cases.