益肾调气法治疗肾虚肝郁型抑郁障碍远期复发率的多中心前瞻性队列研究

Long-term Recurrence Rate of Depressive Disorder with Kidney Deficiency and Liver Depression Syndrome by Kidney-tonifying and Qi-regulating Therapy:A Multi-centered,Prospective Cohort Study

目的:评价益肾调气法对肾虚肝郁型抑郁障碍2年复发率的影响。方法:选取2017年1月至2018年4月在全国13个分中心招募肾虚肝郁型抑郁障碍患者,按照接受的治疗方案自然形成中医组、中西医组和西医组,比较3组的复发率。并根据干预的时间,将中医组和中西医组分为低、中、高3个暴露水平,比较不同水平的复发率,评价益肾调气法降低肾虚肝郁型抑郁障碍的远期复发率的效果。结果:共纳入肾虚肝郁型抑郁障碍1314例,其中中医组385例,西医组453例,中西医组476例。中医组、西医组、中西医组的两年复发率分别是23.61%,34.97%、18.14%。中医组比西医组使复发风险降低29.2%(P<0.05),中西医组比西医组使复发风险降低45.5%(P<0.001)。中医组以低中药水平暴露时间(TCM-ET)为参照,高TCM-ET较于低TCM-ET复发风险降低81.4%(P<0.01);中西医组以低TCM-ET为参照,中TCM-ET比低TCM-ET复发风险降低46.9%(P<0.05),高TCM-ET比低TCM-ET复发风险降低65.3%(P<0.01)。结论:益肾调气法治疗肾虚肝郁型抑郁障碍能够降低远期复发率,且中医药干预的暴露水平与复发率之间具有密切的关系,较长的暴露水平显著降低了患者的复发率。

Objective:To evaluate the effect of kidney-tonifying and qi-regulating therapy on the 2-year recurrence rate of depressive disorder with kidney deficiency and liver depression syndrome.Methods:Patients with depressive disorder characterized by kidney deficiency and liver depression syndrome were recruited from 13 sub-centers in China between January 2017 and April 2018.According to the treatment they received,patients were naturally divided into a traditional Chinese medicine(TCM)group,an integrated TCM and Western medicine group,and a Western Medicine group.The recurrence rates of the three groups were compared.Additionally,based on the duration of intervention,the TCM and integrated groups were divided into low,medium,and high exposure levels,and the recurrence rates at different levels were compared to evaluate the long-term effect of the kidney-tonifying and qi-regulating therapy in reducing the recurrence rate of depressive disorder with kidney deficiency and liver depression syndrome.Results:A total of 1314 patients with depressive disorder characterized by kidney deficiency and liver depression syndrome were included,with 385 in the TCM group,453 in the Western medicine group,and 476 in the integrated group.The 2-year recurrence rates for the TCM,Western medicine,and integrated groups were 23.61%,34.97%,and 18.14%,respectively.The TCM group had a 29.2%lower risk of recurrence compared to the Western medicine group(P<0.05),and the integrated group had a 45.5%lower risk of recurrence compared to the Western medicine group(P<0.001).Using low TCM exposure time(TCM-ET)as a reference in the TCM group,high TCM-ET significantly reduced the risk of recurrence by 81.4%(P<0.01).In the integrated group,compared to low TCM-ET,medium TCM-ET reduced the risk of recurrence by 46.9%(P<0.05),and high TCM-ET reduced the risk by 65.3%(P<0.01).Conclusion:Kidney-tonifying and qi-regulating therapy can reduce the long-term recurrence rate of depressive disorder with kidney deficiency and liver depression syndrome.There is a close relationship between the level of TCM intervention exposure and the recurrence rate,with longer exposure levels significantly reducing the recurrence rate.