益气开郁中药治疗抑郁障碍的多队列临床疗效观察研究

A Cohort Study of Invigorating Qi and Dissipating Depression Herbs on DepressiveDisorders in the Clinical Efficacy

目的评价队列研究下益气开郁中药治疗抑郁障碍的动态疗效及对复发率、自杀观念的影响。方法采用前瞻性队列研究的方法,根据暴露因素(治疗方案)的不同将患者分为3个队列:西药组、中西医结合组、益气开郁中药组,进行2年随访,分别观察服药0.5年、1年、1.5年、2年时各队列的治疗效果,评价指标有蒙哥马利抑郁量表(Montgomery-Asberg Depression Rating Scale,MADRS)、汉密尔顿焦虑量表(Hamilton Anxiety Scale,HAMA)及社会功能缺陷筛选量表(Social Disability Screening Schedule,SDSS)减分率,并观测2年内终点事件(复发、自杀观念)发生率;通过对比3个队列的疗效及终点事件发生率以评价益气开郁法所代表的中医药治疗方案改善抑郁障碍的效果。结果共纳入患者409例(西药组67例、中西医结合组131例、益气开郁中药组211例),随着服药时间的延长,各队列MADRS、HAMA、SDSS治疗后较治疗前减分率均有提高。益气开郁中药组在服药0.5年时MADRS、SDSS减分率及服药1年时SDSS减分率,与西药组相比差异有统计学意义,且与中西医结合组相比差异无统计学意义;在服药1.5年和2年时,中西医结合组相较益气开郁中药组在MADRS减分率上更有优势。西药组、中西医结合组、益气开郁中药组三组患者2年内抑郁复发率分别为20.9%、30.5%、36.0%,差异无统计学意义,经logistic回归分析服药时长为保护因素;自杀观念发生率分别为44.8%、19.1%、17.5%,差异具有统计学意义,经logistic回归分析暴露因素和收入水平为保护因素。结论益气开郁中药可以显著改善患者抑郁状态,促进社会功能的恢复,减少患者远期自杀观念的发生,并且适当延长服药时间可增加远期疗效、减少复发。

Objective To evaluate the dynamic efficacy of Invigorating Qi and Dissipating Depression Herbs in the treatment of depressive disorders and its effect on recurrence rate and suicidal thoughts.Methods The prospective cohort study was used to divide the patients into three cohorts according to the different exposure factors(treatment regimens):Western medicine group,integrated traditional Chinese and Western medicine group,and Invigorating Qi and Dissipating Depression Herbs group,and followed up for 2 years,and the treatment effects of each cohort at half a year,one year,one and a half years,and two years were observed respectively,and the evaluation indicators were Montgomery Depression Scale(MADRS),Hamilton Anxiety Scale(HAMA)and Social Deficit Screening Scale(SDSS)reduction rates,and endpoint events(relapse,suicidal ideation)incidence;By comparing the efficacy and endpoint event rate of the three cohorts,the effect of Invigorating Qi and Dissipating Depression Herbs on improving depressive disorders was evaluated.Results A total of 409 patients(67 in the Western medicine group,131 in the integrated traditional Chinese and Western medicine group,and 211 cases in the Invigorating Qi and Dissipating Depression Herbs group)were enrolled,and the rate of score reduction after treatment with MADRS,HAMA and SDSS increased compared with the pretreatment treatment with the extension of the drug taking time.The difference between the MADRS and SDSS reduction rates in the Invigorating Qi and Dissipating Depression Herbs group on taking the drug for half a year and the SDSSreduction rate on one year of taking the drug were statistically significant compared with the Western medicine group,and there was no significant difference compared with the integrated Chinese and Western medicine group. On one and ahalf years and two years of medication, the integrated Chinese and Western medicine group had more advantages inMADRS reduction rate than the Invigorating Qi and Dissipating Depression Herbs group. The recurrence rates ofdepression in the three groups within 2 years were 20.9%, 30.5% and 36.0%, and the difference was not statisticallysignificant, and the length of taking medication was used as a protective factor by logistic regression analysis. Theincidence rates of suicidal thoughts were 44.8%, 19.1% and 17.5%, and the differences were statistically significant, andthe exposure factors and income level were the protective factors by logistic regression analysis. Conclusion Invigorating Qi and Dissipating Depression Herbs can significantly improve the depressive state of patients, promote therecovery of social function, reduce the occurrence of long-term suicidal ideation, and appropriately extend the time oftaking medicine can increase the long-term efficacy and reduce recurrence.