国产氨磺必利与丙咪嗪治疗迟滞性抑郁症的临床对照研究

Controlled Clinical Studies of Domestic Amisulpride and Imipramine in the Treatment of Hysteresis Depression

目的探讨国产氨磺必利治疗迟滞性抑郁症的疗效和安全性。方法将162例迟滞性抑郁患者随机分为观察组(国产氨磺必利)和对照组(丙咪嗪),治疗12周后对疗效、不良反应发生率、治疗依从性及随访1年复发率等数据进行组间比较及统计学分析。结果观察组研究对象的痊愈率和总有效率分别为39.0%和91.4%与对照组的38.3%和88.9%进行组间比较,观察组具有一定优势,但差异无统计学意义(P>0.05);随访1年复发率的比较中,观察组优于对照组,且差异有统计学意义(P<0.05);观察组研究对象的不良发应率为14.8%,低于对照组的23.5%,且差异有统计学意义(P<0.05);在治疗依从性的比较中,观察组显著高于对照组,且差异有统计学意义(P<0.05)。结论国产氨磺必利在迟滞性抑郁症的治疗中具有疗效显著,安全性高,复发率低,治疗依从性高等优势,具有重要的临床价值,适于临床推广使用。

Objective To investigate the curative effect and safety of domestic amisulpride in treating of hysteresis depression. Methods 162 patients with hysteresis depression were randomly divided into an observation group （treated with domestic amisulpride） and a control group （treated with imipramine）. After 12 weeks of treatment, the curative effect, incidence of adverse reactions, and treatment compliance were comparatively analysed between the two groups. And recurrence rate in the 1-year follow-up were compared. Results The cure rate and the total effective rate in the observation group were 39.0% and 91.4%. Compared to the 38.3% and 88.9% in the control group, the difference between the two groups was not statistically significant （P 〉0.05）. The recurrence rate in the 1-year follow-up in the observation group was significantly higher than that of the control group （P 〈0.05）. The incidence of adverse reactions in the observation group was 14.8%, significantly lower than the 23.5% in the control group （P〈0.05）. Besides, the treatment compliance in the observation group was significantly better than that of the control group （P 〈0.05）. Conclusions Domestic amisulpride is highly effective in treating hysteresis depression, with higher security, lower recurrence rate and better treatment compliance. It has important clinical value and is suitable for clinical application.