摘要
目的 探讨中医药方案治疗心胆气虚证抑郁障碍的疗效及对远期复发率的影响.方法 根据干预方法,将2017 年1 月—2020 年12 月在全国13 个分中心招募的心胆气虚证抑郁障碍患者分为西医治疗队列、中医治疗队列、中西医结合治疗队列,所有患者随访6~24 个月,以随访过程中临床诊断抑郁障碍为复发,评估不同队列的抑郁障碍复发风险及中医治疗队列、中西医结合治疗队列中不同暴露水平亚组的抑郁障碍复发风险.结果 共纳入患者503 例,西医治疗队列、中医治疗队列、中西医结合治疗队列的 24 个月复发率分别为 39.6%(63/159)、28.2%(49/174)、18.8%(32/170),中医治疗队列比西医治疗队列的复发风险低 45.70%(HR = 0.543,95%CI:0.355~0.830,P =0.005),中西医结合治疗队列比西医治疗队列的复发风险低 66.90%(HR =0.331,95%CI:0.206~0.531,P<0.001).在中医治疗队列中,高水平暴露亚组比低水平暴露亚组的复发风险低63.1%(HR =0.349,95%CI:0.174~0.701,P =0.003).在中西医结合治疗队列中,高水平暴露亚组比低水平暴露亚组的复发风险低 88.8%(HR =0.112,95%CI:0.044~0.286,P<0.001).结论 中医药治疗方案能够有效降低心胆气虚证抑郁障碍的复发率,合用西药后效果更明显,且服药时间越长复发率越低.
Abstract
Objective It is to investigate the therapeutic effect of traditional Chinese medicine(TCM)on depression disorder of heart-gallbladder Qi deficiency syndrome,especially its effect on recurrence rate.Methods According to the in-tervention factors,the patients with depression disorder of heart-gallbladder Qi deficiency syndrome recruited at 13 sub-cen-ters nationwide from January 2017-December 2020 were divided into a TCM treatment cohort,a western medicine treatment cohort,and a combined Chinese and western medicine treatment cohort.All patients were followed up for 6-24 months.The risk of recurrence of depressive disorders in different cohorts and the risk of recurrence of depressive disorders in subgroups with different exposure levels in the TCM treatment cohort and the combined TCM and western medicine treatment cohort were assessed using the clinical diagnosis of depressive disorders as recurrence during the follow-up.Results A total of 503 patients were included,and the 24-month recurrence rates of the western medicine treatment cohort,Chinese medicine treatment cohort,and combined Chinese and western medicine treatment cohort were 39.6%(63/159),28.2%(49/174),and18.8%(32/170),respectively,the risk of recurrence was 45.70%lower in the TCM treatment cohort than that in the western medicine treatment cohort(HR =0.543,95%CI:0.355-0.830,P =0.005),and the risk of recur-rence was 66.90%lower in the combined TCM and western medicine treatment cohort than that in the western medicine treatment cohort(HR =0.331,95%CI:0.206-0.531,P<0.001).In the TCM cohort,the risk of recurrence was re-duced by 63.1%in the TCM group treated with high exposure duration compared with low exposure duration(HR =0.349,95%CI 0.174-0.701,P =0.003).In the traditional Chinese and western cohort,the risk of recurrence was reduced by 88.8%by high exposure time compared with low exposure time(HR =0.112,95%CI 0.044-0.286,P<0.001).Con-clusion Traditional Chinese medicine treatment can effectively reduce the recurrence rate of depression disorder of heart-gallbladder Qi deficiency syndrome,and the effect is more obvious after the combination of western medicine,and the lon-ger the duration of medication,the lower the recurrence rate.
基金项目
国家中医药行业专项(201507001)
国家中医药局岐黄学者项目(10400633210001)
江苏省中医药科技发展计划面上项目(MS2023093)
南京中医药大学自然科学基金重点项目(XZR2023023)
苏州市姑苏卫生人才计划(GSWS2022077)
苏州市科技发展项目(SKY2023215)
苏州市吴门医派名老中医药专家传承工作室建设项目(第三批)(苏卫健中医[2023]32号)