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【摘要】：目的評價不同劑量舒肝解郁膠囊治療輕、中度抑郁癥的有效性和安全性。方法采用多中心、隨機(jī)、開放、平行對照的研究方法�；颊唠S機(jī)分為研究組和對照組。研究組每日2次舒肝解郁膠囊(每粒0.36 g)強(qiáng)化治療:第1周每次4粒,第2周每次3粒,第3~6周每次2粒。對照組為常規(guī)治療組,舒肝解郁膠囊每日2次、每次2粒。兩組均連續(xù)口服用藥6周。以漢密爾頓抑郁量表17項(HAMD-17)總分、總分減分率為主要評價指標(biāo)。安全性評價采用研究者經(jīng)驗效度、患者自評和實驗室檢查。結(jié)果實際納入研究組70例,對照組86例。經(jīng)過6周治療,研究組和對照組總有效率分別為90%和84%,痊愈率分別為79%和64%,組間比較均無顯著差異(P0.05)。研究組抑郁癥狀改善(HAMD-17總分變化差異)趨勢優(yōu)于對照組(P0.01)。治療1周末研究組HAMD-17減分率優(yōu)于對照組[(17.98±15.63)%vs.(12.21±12.62)%,P0.05],治療2、4、6周末組間有非常顯著差異(P0.01)。兩組不良反應(yīng)發(fā)生率無顯著差異(P0.05)。結(jié)論舒肝解郁膠囊治療輕、中度抑郁癥的抑郁癥狀和伴隨的焦慮癥狀安全、有效,首周劑量加倍能顯著加快抑郁癥狀緩解速度,提高最終改善程度。
[Abstract]:Objective to evaluate the efficacy and safety of Shugan Jieyu capsule in the treatment of mild and moderate depression. Methods A multicenter, randomized, open and parallel controlled study was used. The patients were randomly divided into study group and control group. In the study group, Shugan jiayu capsule (0.36 g per capsule) was treated twice daily: 4 capsules per week 1, 3 capsules per second week, 2 capsules at the 6th week of 3th week. The control group was treated with 2 capsules of Shugan Jieyu capsule twice a day. Both groups were treated orally for 6 weeks. The total score of 17 items of Hamilton Depression scale (HAMD-17) and the rate of total score reduction were taken as the main evaluation index. The safety assessment was conducted with the researcher's empirical validity, patient self-assessment and laboratory examination. Results 70 cases were included in the study group and 86 cases in the control group. After 6 weeks of treatment, the total effective rate of the study group and the control group were 90% and 84%, the cure rate was 79% and 64%, respectively. There was no significant difference between the two groups (P0.05). The improvement of depressive symptoms (the difference of total score of HAMD-17) was better in the study group than in the control group (P0.01). At the end of 1 week, the HAMD-17 reduction rate of the study group was better than that of the control group [(17.98 鹵15.63)% vs. (12.21 鹵12.62)%, P0.05]. There was a very significant difference between the two groups at the end of 6 weeks (P0.01). There was no significant difference in the incidence of adverse reactions between the two groups (P0.05). Conclusion Shugan Jieyu capsule is safe and effective in the treatment of depressive symptoms and associated anxiety symptoms in mild and moderate depression. Doubling the first week dose can significantly accelerate the relief rate of depressive symptoms and improve the degree of final improvement.
【作者單位】： 同濟(jì)大學(xué)附屬同濟(jì)醫(yī)院;上海交通大學(xué)醫(yī)學(xué)院附屬精神衛(wèi)生中心;復(fù)旦大學(xué)附屬中山醫(yī)院;浙江省同德醫(yī)院;
【分類號】：R749.4

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