發(fā)布時間：2018-05-05 02:23

  本文選題：開郁寧 + 氟西汀��； 參考：《中國新藥雜志》2015年13期

【摘要】：目的:評價開郁寧片治療輕中度抑郁癥的療效及安全性。方法:采用多中心、隨機(jī)、雙盲雙模擬、平行對照的實(shí)驗(yàn)設(shè)計。共納入228例患者,隨機(jī)分為開郁寧組114例、氟西汀組114例;療程6周。以漢密爾頓抑郁量表(Hamilton Depression Scale,HAMD)、漢密爾頓焦慮量表(Hamilton Anxiety Scale,HAMA)和臨床大體印象量表(Clinical Global Impression,CGI)進(jìn)行療效評估。以不良事件發(fā)生率,血常規(guī)、尿常規(guī)、血生化、心電圖檢查及生命體征等進(jìn)行安全性評估。結(jié)果:開郁寧組113例和氟西汀組111例納入療效統(tǒng)計分析。開郁寧組和氟西汀組治療第6周末HAMD減分值的結(jié)轉(zhuǎn)值分別為(12.4±4.2)分和(11.0±4.6)分,開郁寧組優(yōu)于氟西汀組,差異有統(tǒng)計學(xué)意義(F=5.36,P=0.022);但兩組符合方案的實(shí)測值分別為(12.7±3.7)分和(12.0±3.5)分,兩組比較差異無統(tǒng)計學(xué)意義(F=2.06,P=0.153)。開郁寧組和氟西汀組有效率分別為81.4%(92/113)和70.3%(78/111),兩組比較差異無統(tǒng)計學(xué)意義(P0.05)。開郁寧組和氟西汀組不良事件發(fā)生率分別為14.2%和18.7%,兩組比較差異無統(tǒng)計學(xué)意義(P0.05)。開郁寧組與藥物相關(guān)的不良事件主要表現(xiàn)為惡心(1.8%)。結(jié)論:開郁寧片治療輕中度抑郁癥安全有效。
[Abstract]:Objective: to evaluate the efficacy and safety of Kaiyuning tablet in the treatment of mild to moderate depression. Methods: a multi-center, randomized, double-blind and double-simulated, parallel-controlled design was used. A total of 228 patients were randomly divided into Kaiyuning group (114 cases) and fluoxetine group (114 cases) for 6 weeks. The efficacy was evaluated by Hamilton Depression scale, Hamilton Anxiety scale and Clinical General impression scale. Safety was evaluated by adverse events, blood routine, urine routine, blood biochemistry, electrocardiogram and vital signs. Results: 113 cases in Kaiyuning group and 111 cases in fluoxetine group were included in the statistical analysis of curative effect. At the end of the 6th week of treatment, the carryover values of HAMD in the Kaiyuning group and fluoxetine group were 12.4 鹵4.2 and 11.0 鹵4.6, respectively, which were better than those in the fluoxetine group, the difference was statistically significant, but the actual values of the two groups were 12.7 鹵3.7 and 12.0 鹵3.5, respectively. There was no statistical difference between the two groups. The effective rates of Kaiyuning group and fluoxetine group were 81.4 / 92 / 113) and 70.33 / 78 / 111 respectively. There was no significant difference between the two groups (P 0.05). The incidence of adverse events in Kaiyuning group and fluoxetine group were 14.2% and 18.7%, respectively. There was no significant difference between the two groups (P 0.05). The main adverse events related to drugs in Kaiyuning group were nausea 1.8%. Conclusion: Kaiyuning tablet is safe and effective in the treatment of mild and moderate depression.
【作者單位】： 首都醫(yī)科大學(xué)附屬北京安定醫(yī)院 精神疾病診斷與治療北京市重點(diǎn)實(shí)驗(yàn)室 北京腦重大疾病研究院精神分裂癥研究所;健民藥業(yè)集團(tuán)股份有限公司;第四軍醫(yī)大學(xué)西京醫(yī)院;昆明醫(yī)科大學(xué)第一附屬醫(yī)院;河北省第六人民醫(yī)院;武漢市精神衛(wèi)生中心;
【分類號】：R749.4

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本文編號：1845763