宁神合剂治疗失眠症临床观察  

Clinical Observation of Ningshen Heji for Anhypnia

作　　者：叶玉妹[1] 张晓丹[1] 刘大庆[1] 张建勋[1] 刁枢[1] 王秀玲[1] 张丽葳[1] 王庆国[1] 俞惠琴[1] 周磐石[1] 林研[1] 赵滨[1] 纪树武[1] 柳洲[1] 徐国懿[1] 

机构地区：[1]上海市第七人民医院,上海200137

出　　处：《辽宁中医杂志》2013年第7期1396-1398,共3页Liaoning Journal of Traditional Chinese Medicine

摘　　要：目的:探索宁神合剂治疗阴虚内热型失眠症有效性的临床观察。方法:采用随机、阳性药对照试验设计方法。宁神合剂试验组100例、对照组复方五味子糖浆100例;每4周为1个疗程。分别在治疗前后综合参照《中药新药临床研究指导原则》相关诊断标准和《中医病证诊断标准》中不寐的诊断标准和SPIEGEL量表评分。安全性评价:按4级标准在治疗期进行评定。结果:治疗组治疗2周、4周各分项分值及总分均显著低于本组治疗前(P<0.01),其中睡眠时间、醒后感觉两个分项,治疗4周分值显著低于治疗2周(P<0.01),治疗4周总分亦显著低于治疗2周(P<0.01)。对照组治疗2周后入睡时间、睡眠时间、醒后感觉分项及总分分值均显著低于本组治疗前(P<0.01),对照组治疗4周后各分项分值及总分均显著低于本组治疗前(P<0.01)。在睡眠深度、醒后感觉两个分项,治疗组治疗4周后分值显著低于对照组(P<0.01)。结论:宁神合剂组和对照组复方五味子糖浆提示,宁神合剂与复方五味子糖浆比较,宁神合剂治愈率优于复方五味子糖浆,提示宁神合剂对失眠症更有效。Objective：To observe the efficacy of Ningshen Heji for anhypnia of internal heat due to Yin deficiency.Methods：The design method of randomized controlled trials was used.The cases of Ningshen Heji group were 100,and cases of Compound Wuweizi Syrup group were 100,4 weeks was as one course.Guiding Principle of Study on New Drugs of Traditional Chinese Medicine and SPIEGEL Scale in Guiding Principle of Disease and Syndrome of TCM were used.Safety Evaluation：Ⅳ grade standard was used for assessing during treatment period.Results：The subentry scores and total scores of treatment group after treating 2 weeks and 4 weeks were significantly lower than that before treatment（P0.01）,the scores of sleep time and feeling after waking up after treating 4 weeks were significantly lower than that treating 2 weeks（P0.01）,the total scores after treating 4 weeks were also lower than treating 2 weeks（P0.01）.The scores of time for falling asleep,sleep time,and feeling after waking up,and total scores of control group after treating 2 weeks were significantly lower than that before the treatment（P0.01）,the subentry scores and total scores of treatment group after treating 4 weeks were significantly lower than that before the treatment（P0.01）.Compared the scores of sleeping depth and feeling after waking up,the treatment group were lower than the control group（P0.01）.Conclusion：The cure rate of treatment group was better than control group,indicating Ningshen Heji was more effective for anhypnia.

关 键 词：宁神合剂 复方五味子糖浆 阴虚内热型失眠 SPIEGEL量表 

分 类 号：R256.23[医药卫生—中医内科学]