國(guó)產(chǎn)布南色林片與利培酮片治療精神分裂癥的多中心隨機(jī)雙盲雙模擬平行對(duì)照臨床試驗(yàn)
發(fā)布時(shí)間:2018-04-01 04:46
本文選題:布南色林 切入點(diǎn):利培酮 出處:《中國(guó)新藥雜志》2016年07期
【摘要】:目的:評(píng)價(jià)國(guó)產(chǎn)布南色林治療急性精神分裂癥的療效及安全性。方法:采用隨機(jī)雙盲多中心活性藥對(duì)照研究方法。將298例18~65歲急性精神分裂癥患者隨機(jī)分為布南色林組(n=148,8~24 mg·d-1)和利培酮組(n=150,2~6 mg·d-1),療程8周。以陽(yáng)性和陰性癥狀量表(PANSS)總分變化為療效指標(biāo)。結(jié)果:布南色林組PANSS總分從基線的93.99分降至62.24分,利培酮組從基線的92.09分降至58.67分,平均減分分別為31.74和33.43分。布南色林組和利培酮組的有效率分別為58.11%和64.67%,不良事件發(fā)生率分別為78.38%和86.67%。布南色林組對(duì)體質(zhì)量和血清泌乳素的影響較小。結(jié)論:國(guó)產(chǎn)布南色林治療急性精神分裂癥的療效非劣于利培酮,不良反應(yīng)相似。但是,布南色林較少引起患者體質(zhì)量增加,對(duì)血清泌乳素水平影響較小。
[Abstract]:Objective: to evaluate the efficacy and safety of domestic bunanserin in the treatment of acute schizophrenia. Methods: 298 patients with acute schizophrenia aged 1865 were randomly divided into Bunam by randomized double-blind multicenter active drug control study. Results: the total score of PANSS was decreased from 93.99 to 62.24 in the penicillin group and in the risperidone group for 8 weeks. The total score of the positive and negative symptom scale was used as the index of curative effect, and the results showed that the total score of PANSS decreased from 93.99 to 62.24 in the Bunanserin group, and the results showed that the total score of PANSS was decreased from 93.99 to 62.24 in the penicillin group and in the risperidone group for 8 weeks. The risperidone group decreased from 92.09 at baseline to 58.67 at baseline. The effective rate of Bunanserin group and risperidone group were 58.11% and 64.677.The incidence of adverse events were 78.38% and 86.67%, respectively. The effect of Bunanserin group on body mass and serum prolactin was small. Conclusion:. The efficacy of bugenserin in the treatment of acute schizophrenia is not inferior to that of risperidone. The adverse reactions were similar. However, less Bunanserin caused an increase in body mass and had little effect on serum prolactin levels.
【作者單位】: 北京大學(xué)第六醫(yī)院北京大學(xué)精神衛(wèi)生研究所衛(wèi)生部精神衛(wèi)生學(xué)重點(diǎn)實(shí)驗(yàn)室(北京大學(xué));北京回龍觀醫(yī)院;首都醫(yī)科大學(xué)附屬北京安定醫(yī)院;天津市安定醫(yī)院;河北省精神衛(wèi)生中心;廣州市精神病醫(yī)院;無錫市精神衛(wèi)生中心;昆明醫(yī)學(xué)院第一附屬醫(yī)院;四川大學(xué)華西醫(yī)院;第四軍醫(yī)大學(xué)衛(wèi)生統(tǒng)計(jì)學(xué)教研室;
【分類號(hào)】:R749.3
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