Zhongguo cuzhong zazhi (May 2022)
盐酸舍曲林预防性治疗卒中后抑郁的多中心研究Efficacy of Sertraline Hydrochloride for Post-stroke Depression: A Multicenter Study
Abstract
Objective To investigate the effect of early application of sertraline on post-stroke depression (PSD) and cognitive dysfunction after ischemic stroke. Methods Patients with first acute ischemic stroke who were hospitalized in neurology department of 6 hospitals in Suzhou from February 2016 to August 2017 were randomly divided into 3 groups: the control group was given conventional treatment, the low-dose treatment group was given sertraline hydrochloride 50 mg/d on the basis of conventional treatment, and the high-dose treatment group was given sertraline hydrochloride 100 mg/d on the basis of conventional treatment, with the treatment course for 3 months. At 1 month, 3 months, 6 months and 1 year after stroke, the patients were evaluated by Hamilton depression scale (HAMD), MMSE and mRS. The incidence of PSD, cognitive function and prognosis at the above point-in-time and ischemic stroke recurrence within one year were compared among the 3 groups. Results A total of 404 patients were included in the final analysis, including 136 in control group, 140 in the low-dose treatment group, and 128 in the high-dose treatment group. (1) There were no statistical difference in the incidence of 1-year ischemic stroke among the 3 groups; (2) The incidence of PSD in the low-dose (22.9% vs . 44.1%, P <0.001) and high-dose treatment groups (18.8% vs . 44.1%, P <0.001) were lower than that in the control group at 3 months, and the incidence of PSD in the low-dose (5.7% vs . 44.1%, P <0.001) and high-dose treatment groups (4.7% vs . 44.1%, P <0.001) were lower than that in the control group at 6 months,all with statistical differences; (3) The HAMD scores of the low-dose and high-dose treatment groups were lower than those of the control group at 3, 6 months and 1 year, all with statistical differences; (4) The MMSE score of the high-dose treatment group was higher than that of the control group at 3 months, and the MMSE scores of the low-dose and the high-dose treatment groups were higher than that of the control group at 6 and 12 months, all with statistical differences. Conclusions Early application of sertraline hydrochloride after acute ischemic stroke can reduce the incidence of post-stroke depression, improve cognitive function of patients at 1 year after stroke, while had no influence on recurrent stroke and functional prognosis. 目的 探讨缺血性卒中后早期应用盐酸舍曲林对卒中后抑郁（post-stroke depression，PSD）和认知功 能障碍的影响。方法 前瞻性连续入组2016年2月-2017年8月苏州市6家三级医院神经内科住院的首发急性缺血性卒中患者。将其随机分为3组，对照组给予常规治疗，低剂量治疗组在常规治疗基础上加用盐酸舍曲林50 mg/d，高剂量治疗组在常规治疗基础上加用盐酸舍曲林100 mg/d，疗程均为3个月。分别 于卒中后1个月、3个月、6个月和1年对患者进行汉密尔顿抑郁量表（Hamilton depression scale HAMD）、MMSE、mRS评定，比较3组上述随访时间点的PSD发生率、认知功能和预后情况，以及1年缺血性卒中的复发率。结果 最终完成随访的患者为404例，其中对照组136例，低剂量治疗组140例，高剂量治疗组128例。①3组间1年缺血性卒中复发率差异无统计学意义，不同随访时间mRS差异均无统计学意义；②卒中后3个月时低剂量治疗组（22.9% vs. 44.1%，P <0.001）和高剂量治疗组（18.8% vs. 44.1%，P <0.001）的PSD发生率均低于对照组；卒中后6个月时低剂量治疗组（5.7% vs. 44.1%，P<0.001）和高剂量治疗组（4.7% vs. 44.1%，P <0.001）的PSD发生率均显著低于对照组；③卒中后3个月、6个月和1年时低剂量治疗组和高剂量治疗组的HAMD评分均低于对照组，差异有统计学意义；④卒中后3个月时高剂量治疗组的MMSE评分高于对照组，6个月与12个月时低剂量治疗组和高剂量治疗组的MMSE评分均高于对照组，差异有统计学意义。结论 盐酸舍曲林早期干预急性缺血性卒中患者可降低3个月和6个月时PSD的发生率，改善患者发病1年的认知功能，但对缺血性卒中的复发率和功能预后无影响。PSD的药物治疗是目前卒中诊疗中有争议的领域，缺乏大样本、统一标准的研究，本研究尝试在多中心联合开展不同剂量盐酸舍曲林预防性治疗PSD的安全性和有效性研究，结果显示卒中后早期使用盐酸舍曲林可以改善患者抑郁状态和认知功能，具有一定的临床价值。
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