Dai Ning, Li Yuanyuan, Sun Jing, Li Feng, Xiong Hang
College of Traditional Chinese Medicine, Beijing University of Traditional Chinese Medicine (TCM), Beijing, China.
Department of Acupuncture and Moxibustion, Dongfang Hospital, Beijing University of Traditional Chinese Medicine (TCM), Beijing, China.
Front Neurol. 2020 Nov 9;11:537402. doi: 10.3389/fneur.2020.537402. eCollection 2020.
This study aimed to assess the efficacy and safety of self-designed Ningxin Anshen (NXAS) Formula for post-ischemic stroke insomnia of blood-deficient and liver-heat syndrome. Ninety patients were randomized into NXAS group, Placebo group and Zopiclone group. Patients in the NXAS group, Placebo group and Zopiclone group were treated with Ningxin Anshen Formula, placebo and zopiclone for 4 weeks, respectively. The scores of the Pittsburgh Sleep Quality Index (PSQI), Insomnia Severity Index (ISI) and traditional Chinese Medicine (TCM) Syndromes of self-designed scale and the number of adverse events (AEs) were determined. Results showed that the overall effective rate in the NXAS group and Placebo group was 76.67 and 30.00%, respectively, showing significant difference ( < 0.01). There was no marked difference between Zopiclone group (80.00%) and NXAS group. In both NXAS group and Zopiclone group, the scores of PSQI, ISI, and TCM Syndromes of self-designed scale after 4-week treatment were significantly different from those before treatment ( < 0.01). After 4-week treatment, the scores of PSQI, ISI, and TCM Syndromes of self-designed score were comparable between NXAS group and Zopiclone group ( > 0.05). Only one patient in the NXAS group developed gastrointestinal discomfort, which resolved without treatment discontinuation. In conclusion, self-designed NXAS Formula is effective and safe and has little adverse effect in treating post-stroke insomnia of blood-deficient and liver-heat syndrome.
本研究旨在评估自行设计的宁心安神方治疗缺血性中风后血虚肝热证失眠的有效性和安全性。90例患者随机分为宁心安神方组、安慰剂组和佐匹克隆组。宁心安神方组、安慰剂组和佐匹克隆组患者分别接受宁心安神方、安慰剂和佐匹克隆治疗4周。测定匹兹堡睡眠质量指数（PSQI）、失眠严重程度指数（ISI）、自行设计量表的中医证候评分及不良事件（AE）数量。结果显示，宁心安神方组和安慰剂组的总有效率分别为76.67%和30.00%，差异有统计学意义（<0.01）。佐匹克隆组（80.00%）与宁心安神方组之间无显著差异。宁心安神方组和佐匹克隆组治疗4周后PSQI、ISI及自行设计量表的中医证候评分与治疗前相比均有显著差异（<0.01）。治疗4周后，宁心安神方组与佐匹克隆组的PSQI、ISI及自行设计量表评分相当（>0.05）。宁心安神方组仅1例患者出现胃肠道不适，未停药自行缓解。综上所述，自行设计的宁心安神方治疗中风后血虚肝热证失眠有效、安全，不良反应少。
