基于云数据的中医药方案降低抑郁障碍远期复发率的大样本、多中心、前瞻性队列研究

Cloud data-based TCM regimen reduces the long-term recurrence rate of major depressive disorder:a large-scale,multi-centered,prospective cohort study

目的评价中医药治疗方案对抑郁障碍(MDD)2年复发率的疗效。方法运用大样本、多中心、前瞻性的队列研究方法,基于博识医疗云数据管理平台,2017年1月—2018年4月在全国13个分中心招募MDD患者,分别运用中医治疗、中西医结合治疗、西医治疗方案进行干预,形成中医治疗队列、中西医结合治疗队列和西医治疗队列,比较3个队列的复发率。并根据中医药方案干预的时间,将中医治疗队列和中西医结合治疗队列分为低、中、高3个暴露水平,比较低、中、高3个暴露水平的复发率,以评价中医药治疗方案降低MDD远期复发率的疗效。结果共纳入4440例MDD患者,其中中医治疗队列1484例,西医治疗队列1412例,中西医结合治疗队列1544例。中医治疗队列2年复发率25.5%(379/1484),西医治疗队列2年复发率35.4%(500/1412),中西医结合治疗队列2年复发率19.3%(298/1544)。其中中医治疗队列中水平暴露组比低水平暴露组复发风险低41.6%[HR=0.584,95%CI(0.467~0.731),P<0.001],高水平暴露组比低水平暴露组复发风险低71.3%[HR=0.287,95%CI(0.214~0.384),P<0.001],中西医结合治疗队列中水平暴露组比低水平暴露组复发风险低54.3%[HR=0.457,95%CI(0.352~0.692),P<0.001],高水平暴露组比低水平暴露组复发风险低75.2%[HR=0.248,95%CI(0.182~0.337),P<0.001]。结论中医药治疗方案能够降低MDD的远期复发率。中医药干预的暴露水平与复发率之间具有密切的关系,较长的暴露水平可以获得较低的患者复发率。

Objective To evaluate the efficacy of a comprehensive TCM regimen on reducing the 2-year recurrence rate of major depressive disorder(MDD).Methods This large-scale multi-centered,prospective cohort study was conducted by recruiting MDD patients from 13 sub-centers nationwide from January 2017 to April 2018 with assistance of the Boshi Medical Cloud Data Management Platform.A comprehensive TCM regimen was used in the intervention of MDD patients.Three cohorts(TCM cohort,integrated Chinese and western medicine cohort,and western medicine cohort)were formed to observe the differences in the recurrence rate of MDD.According to the exposure time of the comprehensive TCM regimen intervention,the TCM cohort and the integrated Chinese and western medicine cohort were further divided into three groups with low,medium and high exposure levels respectively,and difference in the recurrence rate among those groups of different exposure levels was observed,so as to evaluate the long-term efficacy of the comprehensive TCM regimen in reducing the recurrence rate of MDD.Results A total of 4440 patients with MDD were included in the TCM cohort(1484 patients),western medicine cohort(1412 patients)and integrated Chinese and Western medicine cohort(1544 patients).The two-year recurrence rate was 25.5%in the TCM cohort,35.4%in the western medicine cohort,and 19.3%in the integrated Chinese and western medicine cohort.Compared with the recurrence risk of the low-level exposure group in the Chinese medicine cohort,it was 41.6%lower in the medium-level exposure group(HR=0.584,95%CI(0.467~0.731),P<0.001),and 71.3%lower in the high-level exposure group(HR=0.287,95%CI(0.214~0.384),P<0.001).Compared with the recurrence risk of the low-level exposure group in the integrated Chinese and western medicine cohort,it was 54.3%lower in the medium-level exposure group(HR=0.457,95%CI(0.352~0.692),P<0.001)and 75.2%lower in the high-level exposure group(HR=0.248,95%CI(0.182~0.337),P<0.001).Conclusion The comprehensive TCM regimen seems to reduce the 2-year recurrence rate of MDD.There is probably a close correlation between the exposure level of TCM intervention and the recurrence rate,and a longer exposure duration could possibly lead to a lower recurrence rate.