疏肝解郁胶囊治疗恶劣心境的临床对照研究

Clinical control study of Shuganjieyu capsule in the treatment of dysthymia

目的探讨疏肝解郁胶囊治疗恶劣心境的疗效及安全性。方法将60例恶劣心境患者随机分为观察组和对照组各30例,观察组给予疏肝解郁胶囊治疗,对照组给予帕罗西汀治疗,6周为1疗程。于治疗前及治疗6周末采用汉密尔顿抑郁量表(HAMD)、临床总体印象量表(CGI)和中医证候量化评分(STCM)评定临床疗效,副反应量表(TESS)评定不良反应。结果两组治疗后HAMD、CGI、中医证候量化评分均较治疗前有显著下降(P<0.01),治疗后两组间HAMD评分无显著性差异(P>0.05),但CGI及STCM评分分别有显著性差异(P<0.05)和极显著性差异(P<0.01),两组治疗后TESS评分有显著性差异(P<0.05)。结论疏肝解郁胶囊治疗恶劣心境与帕罗西汀整体疗效相当,不良反应较少。

Objective To explore the effect and safety of Shuganjieyu capsule in the treatment of dysthymia. Methods A total of 60 patients with dysthymia were randomly divided into the stduy group （30 cases） treated with Shuganjieyu capsule for 6 weeks and the control group （30 cases） treated with Paroxetine for 6 weeks. All patients were assessed with Hamilton Depression Scale （HAMD）, Clinical Global Impression Scale （CGI） and Symptom of Traditional Chinese Medicine （STCM） at the baseline and the 6th weekend of the treatment to evaluate the clinical efficacy. Treatment Emergent Symptom Scale （TESS） was used to evaluate the adverse reactions. Results Scores of HAMD, CGI and STCM in the two groups decreased significantly at the end of the treatment when compared with the baseline （P 〈 0.01 ）. At the 6th weekend of the treatment, there was no significant difference in score of HAMD （P 〉 0.05 ） between the two groups, however, there were significant differences in scores of CGI and STCM between the two groups （ P 〈 0.05 or P 〈 0.01 ）. Score of TESS after the treatment showed significant difference between the two groups （P 〈 0.05 ）. Conclusion Shuganjieyu capsule is similar to Paroxetine in efficacy but has fewer adverse effects in the treatment of dysthymia.