抑郁症中医疾病管理多中心随机对照研究

Disease of TCM management for depression: A multi-center randomized controlled clinical trial

目的:通过应用中医疾病管理模式干预抑郁症患者,探索疾病管理的理论和技术在抑郁症治疗中的作用。方法:采用前瞻性、多中心随机对照的研究方法,将2012年7月至2014年2月就诊的符合病例入选标准的180例患者作为观察对象,采用SAS软件获得随机编号,将入组患者随机分为管理组和对照组,每组90例。除均给予相同的中、西药综合常规治疗外,管理组患者接受中医疾病管理,包括综合抗抑郁治疗、抑郁症中医特色教育、定期复诊、评估等;对照组患者以常规诊疗模式接受治疗,疗程均为52周,选用汉密尔顿抑郁量表(HAMD-17)及其因子分析、生活质量量表(SF-36)作为评价指标。结果:1两组在干预8、12、24、36、52周末HAMD-17量表组内评分与干预前比较,差异有统计学意义(P<0.05,P<0.01),说明两组干预均有效;管理组在干预8、12、24、36、52周末HAMD-17量表评分明显低于对照组(P<0.05,P<0.01);2两组在干预4、8周末开始SF-36量表组内评分差异有统计学意义(P<0.05,P<0.01),说明两组干预均有效;管理组在干预4、8、12、24、36、52周末SF-36量表评分明显低于对照组(P<0.05,P<0.01)。结论:中医疾病管理模式干预抑郁症的近、远期疗效均优于常规治疗模式。

Objective： To explore the efficacy of TCM disease management theory and technique for depression intervention by applying the TCM disease management pattern to treat depressive patients. Methods： In this prospective, mulicenter, randomized controlled clinical trail, 180 patients who met the inclusion criteria form July 2012 to February 2014 were randomly divided in two groups（management group and control group） by SAS software. In the management group, the patients accepted the TCM disease management, including integrative anti-depressive treatment, depression TCM education, regular consultation and assessment etc. In the control group, the patients received the regular treatment pattern. The session for both group lasted for 52 weeks totally. The clinical efficacy was evaluated by HAMD-17 scale, HAMD-17 factor analysis and SF-36 at different time points. Results： 1 In the evaluation of the HAMD-17 scale, the score of both management group and control group was lower than the score before intervention at end of 8th week, 12 th week, 24 th week, 36 th week, 52 th week, and the difference was significant（P〈0.05, P〈0.01）; the efficacy of the management group was better than control group at the end of 8th week, 12 th week, 24 th week, 36 th week and 52 th week（P〈0.05, P〈0.01）. 2 In the evaluation of the SF-36 scale, the score of bothmanagement group and control group was lower than the score before intervention at end of 4th week and 8th week, the difference was significant（P〈0.05, P〈0.01）; the efficacy of the management group was better than control group at the end of 4th week, 8th week, 12 th week, 24 th week, 36 th week and 52 th week（P〈0.05, P〈0.01）. Conclusion： This study shows that both the short-term efficacy and long-term efficacy of TCM disease management pattern is better than the regular treatment pattern.