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首页> 美国卫生研究院文献>Neuropsychiatric Disease and Treatment >Amisulpride plus valproate vs haloperidol plus valproate in the treatment of acute mania of bipolar I patients: a multicenter open-label randomized comparative trial
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Amisulpride plus valproate vs haloperidol plus valproate in the treatment of acute mania of bipolar I patients: a multicenter open-label randomized comparative trial

机译：氨磺必利联合丙戊酸盐vs氟哌啶醇联合丙戊酸盐治疗双相I型患者的急性躁狂症：一项多中心开放标签随机比较试验

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The primary objective of this study was to compare the effectiveness of combination treatment of valproate and amisulpride with that of valproate and haloperidol in bipolar I disorder. Adult inpatients with a current manic episode fulfilling DSM-IV-TR diagnostic criteria for bipolar type I disorder were included. Patients were randomized to amisulpride (400–800 mg/day) or haloperidol (5–15 mg/day) for 3 months and all received valproate. The primary effectiveness criterion was the percentage of responders (defined by a decrease of ≥50% of the Y-MRS) in patients completing the study. Safety was evaluated by adverse event reporting, determination of extrapyramidal function and clinical examination. Sixty-two patients were randomized to receive valproate-amisulpride, and 61 to receive valproate-haloperidol. At study end, responder rates were 72.6% in the amisulpride group and 65.5% in the haloperidol group. Remission rates were 83.9% and 89.7%, respectively. At study end, neither response rates nor remission rates differed significantly between groups. Treatment-emergent adverse events occurred significantly (p = 0.009) more frequently in the haloperidol group (86.4%) than in the amisulpride group (66.1%). In conclusion, the valproate–amisulpride combination was as effective as the valproate – haloperidol combination in bipolar I patients, with a better safety profile.
机译：这项研究的主要目的是比较丙戊酸和氨磺必利与丙戊酸和氟哌啶醇联合治疗双相性I型障碍的有效性。包括目前躁狂发作的成人住院患者，该患者符合双相I型障碍的DSM-IV-TR诊断标准。患者随机接受氨磺必利（400-800 mg /天）或氟哌啶醇（5-15 mg /天）治疗3个月，均接受丙戊酸盐治疗。主要有效性标准是完成研究的患者中应答者的百分比（定义为Y-MRS降低≥50％）。通过不良事件报告，锥体外系功能测定和临床检查评估安全性。 62例患者被随机分配接受丙戊酸阿米普利，61例接受丙戊酸氟哌啶醇。在研究结束时，氨磺必利组和氟哌啶醇组的缓解率分别为72.6％和65.5％。缓解率分别为83.9％和89.7％。在研究结束时，两组之间的缓解率和缓解率均无显着差异。氟哌啶醇组（86.4％）比氨磺必利组（66.1％）更频繁地出现治疗发生的不良事件（p = 0.009）。总之，在双相I型患者中，丙戊酸-氨磺必利联合用药与丙戊酸-氟哌啶醇联合用药有效，安全性更高。

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