Abstract: Objective　To evaluate the effectiveness and safety of modified Chaihu Guizhi Ganjiang decoction for insomnia (stagnation of liver-qi and phlegm). Methods　Sixty cases of insomnia patients diagnosed as stagnation of liver-qi and phlegm treated at Department of Traditional Chinese Medicine, Jieyang People's Hospital from August 2021 to June 2022 were selected, and were divided into an observation group and a control group by the random number table method, with 30 cases in each group. There were 10 males and 20 females in the observation group, and they were (50.40±16.30) year old. There were 8 males and 22 females in the control group, and they were (50.17±14.80) year old. The observation group were treated with modified Chaihu Guizhi Ganjiang decoction, and the control group with hypnotics (zolpidem tartrate), for 2 weeks. The scores of Athens Insomnia Scale (AIS) and traditional Chinese medicine (TCM) syndromes, effectiveness, and safety in the two groups were observed and compared. t and χ² tests were applied. Results　The AIS scores before and after the treatment were (11.77±1.83) and (6.63±1.30) in the control group, and were (10.90±1.88) and (4.80±1.50) in the observation group; the AIS scores of the two groups after the treatment were significantly lower than those before the treatment, with statistical differences (both P<0.05); the AIS score of the observation group after the treatment was much better than that of the control group, with a statistical difference (P<0.05). The TCM syndrome scores before and after the treatment were (9.50±1.61) and (9.27±2.32) in the control group, and were (9.60±1.81) and (4.17±1.86) in observation group; the TCM syndrome score of the observation group after the treatment was significantly lower than that before the treatment, with a statistical difference (P<0.05). The effective rate was 73.33% (22/30) in the control group, and was 93.33% (28/30) in the observation group, with a statistical difference (P<0.05). The incidence of adverse reactions was 33.33% (10/30) in the control group, and was 10.00% (3/30) in the observation group, with a statistical difference (P<0.05). Conclusion　The modified Chaihu Guizhi Ganjiang decoction has definite curative effect on insomnia (stagnation of liver-qi and phlegm) and fewer adverse reactions, and can improve the patients' sleep quality and symptoms.

Key words: Insomnia, Modified Chaihu Guizhi Ganjiang decoction, Stagnation of liver-qi and phlegm

摘要： 目的　探讨柴胡桂枝干姜汤加味治疗不寐（肝郁痰凝证）的效果和安全性。方法　选取2021年8月至2022年6月在揭阳市人民医院中医科门诊诊断为不寐（肝郁痰凝证）的患者60例，采用随机数字表法将患者分为观察组和对照组，各30例。观察组男10例，女20例，年龄（50.40±16.30）岁。对照组男8例，女22例，年龄（50.17±14.80）岁。观察组采用中药汤剂柴胡桂枝干姜汤加味治疗，对照组给予催眠药酒石酸唑吡坦片治疗，疗程2周。比较两组治疗前后阿森斯失眠量表（AIS）、中医证候评分和疗效及安全性。采用t检验和χ²检验。结果　对照组治疗前AIS评分（11.77±1.83）分，治疗后（6.63±1.30）分；观察组治疗前AIS评分（10.90±1.88）分，治疗后（4.80±1.50）分；两组治疗后AIS评分分别与治疗前比较，均明显减少，差异均有统计学意义（均P<0.05）；治疗后，观察组AIS评分优于对照组，差异有统计学意义（P<0.05）。对照组治疗前中医证候积分为（9.50±1.61）分，治疗后（9.27±2.32）分；观察组治疗前中医证候积分（9.60±1.81）分，治疗后（4.17±1.86）分；观察组治疗后中医证候积分与治疗前对比，分值明显降低，差异有统计学意义（P<0.05）。对照组的有效率为73.33%（22/30），观察组的有效率为93.33%（28/30），两组疗效比较，观察组优于对照组，差异有统计学意义（P<0.05）。对照组不良反应发生率为33.33%（10/30），观察组为10.00%（3/30），差异有统计学意义（P<0.05）。结论　柴胡桂枝干姜汤加味治疗不寐（肝郁痰凝证）疗效确切，能改善患者的睡眠质量，减轻患者伴随的不适症状，不良反应少。

关键词: 不寐, 柴胡桂枝干姜汤加味, 肝郁痰凝