逍遥胶囊对新型冠状病毒肺炎恢复期患者睡眠障碍及情绪障碍的有效性：一项随机对照试验。
Effectiveness of Xiaoyao capsule on sleep disorders and mood disturbance in patients in recovery from coronavirus disease 2019: a randomized controlled trial.
机构信息
Department of Endocrinology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing 100053, China.
Department of Gastroenterology, Xiaogan Hospital of Traditional Chinese Medicine, Xiaogan 432100, China.
出版信息
J Tradit Chin Med. 2023 Apr;43(2):343-351. doi: 10.19852/j.cnki.jtcm.2023.02.005.
OBJECTIVE
To study the efficacy of Xiaoyao capsule in improving the clinical symptoms of sleep and mood disorders during recovery from coronavirus disease 2019 (COVID-19).
METHODS
The study cohort comprised 200 patients with sleep and mood disorders during recovery from COVID-19. Patients were randomized into the control group and the experimental group in a 1:1 ratio by blocked randomization. The patients received either Xiaoyao capsule (experimental group) or a placebo Xiaoyao capsule (control group) for 2 weeks. The improvements in the Traditional Chinese Medicine (TCM) syndrome scales, total effective rates, and disappearance rates of irritability, anxiety, and poor sleep were compared between the two groups.
RESULTS
The TCM syndrome pattern scales, total effective rates, and disappearance rates of irritability, anxiety, and poor sleep did not significantly differ between the experimental group versus the control group in the full analysis set and the per protocol set after 1 and 2 weeks of treatment ( > 0.05).
CONCLUSIONS
Xiaoyao capsule do not significantly improve the clinical symptoms of sleep and mood disorders in patients in recovery from COVID-19.
目的
研究逍遥胶囊改善新型冠状病毒肺炎（COVID-19）恢复期睡眠和情绪障碍的临床症状的疗效。
方法
本研究纳入了 200 例 COVID-19 恢复期睡眠和情绪障碍患者。患者按照 1:1 的比例通过区组随机化分为对照组和实验组。患者分别接受逍遥胶囊（实验组）或安慰剂逍遥胶囊（对照组）治疗 2 周。比较两组患者中医证候量表、总有效率及烦躁、焦虑、睡眠不良消失率的改善情况。
结果
在全分析集和治疗 1、2 周后的意向性治疗集，实验组与对照组的中医证候量表、总有效率以及烦躁、焦虑、睡眠不良消失率差异均无统计学意义（>0.05）。
结论
逍遥胶囊对 COVID-19 恢复期患者睡眠和情绪障碍的临床症状无明显改善作用。
Zotero 插件