复方柴金解郁片治疗肝郁脾虚型抑郁症的临床观察

Clinical Observation on Compound Chaijin Jieyu Tablets(复方柴金解郁片)in Treating Depression of Liver Depression and Spleen Deficiency

目的:观察复方柴金解郁片治疗肝郁脾虚型抑郁症的临床疗效及安全性。方法:采用随机、对照原则,将80例肝郁脾虚型抑郁症患者按照随机数字表法分为治疗组和对照组各40例。治疗组予复方柴金解郁片治疗,对照组予盐酸舍曲林治疗。分别于治疗前和治疗后第4周、第8周对两组汉密尔顿抑郁量表(HAMD-17)、匹兹堡睡眠质量指数量表(PSQI)、中医证候积分、中医证候疗效、疾病疗效及睡眠效率进行记录对比。结果:在治疗中,两组患者HAMD-17评分、PSQI评分及中医证候评分均从第4周开始出现下降趋势,直至第8周结束。睡眠效率从第4周开始得到改善,直至第8周结束,两组组内治疗前后比较,差异均有统计学意义(P<0.05)。治疗组与对照组疾病疗效评价总有效率分别为86.49%(32/37)、84.21%(32/38),两组比较,差异无统计学意义(P>0.05),但治疗组治疗后第4周、第8周中医证候疗效总有效率均显著高于对照组,且在治疗8周后差异均有统计学意义(P<0.05)。两组不良反应发生率比较,治疗组低于对照组,差异有统计学意义(P<0.05)。结论:复方柴金解郁片治疗肝郁脾虚型抑郁症疗效肯定,与西药盐酸舍曲林疗效相当,能够显著改善患者的抑郁行为和睡眠质量,提高患者生活质量,不良反应少,安全性较高。

Objective: To observe the clinical efficacy and safety of Compound Chaijin Jieyu Tablet in treating depression of liver stagnation and spleen deficiency. Methods: Using the principle of randomization and control, all cases were divided into the observation group of Compound Chaijin Jieyu Tablets and the control group of sertraline hydrochloride according to the random number table method, 40 cases in each group. The Hamilton Depression Scale(HAMD-17), Pittsburgh sleep quality index(PSQI), TCM syndrome score, TCM syndrome efficacy, disease efficacy and sleep efficiency were recorded and compared before treatment, 4 weeks after treatment and 8 weeks. Results: In the treatment, HAMD-17 score, PSQI score and TCM syndrome score of the two groups showed a downward trend from the fourth week to the end of the eighth week. The sleep efficiency was improved from the fourth week to the end of the eighth week. The differences between the two groups before and after treatment were statistically significant(P<0.05). The total effective rates of the treatment group and the control group were 86.49%(32/37) and 84.21%(32/38), respectively. There was no significant difference between the two groups(P >0.05). However, the total effective rate of TCM syndrome efficacy in the treatment group was significantly higher than that in the control group at fourth weeks and eighth weeks after treatment,and the differences were statistically significant after 8 weeks of treatment(P<0.05). The incidence of adverse reactions in the treatment group was lower than that in the control group(P<0.05). Conclusion: Compound Chaijin Jieyu Tablets has a positive effect on depression of liver depression and spleen deficiency type, which is equivalent to that of sertraline hydrochloride. It can significantly improve the depressive behavior and sleep quality of patients, and improve the quality of life of patients with less adverse reactions and higher safety.