赛乐特（Sertindole）与利培酮治疗精神分裂症的安全性比较：赛乐特队列前瞻性研究（SCoP）的主要结果。
Safety of sertindole versus risperidone in schizophrenia: principal results of the sertindole cohort prospective study (SCoP).
机构信息
Institute of Cellular Medicine, Wolfson Unit of Clinical Pharmacology, Newcastle University, Newcastle, UK.
出版信息
Acta Psychiatr Scand. 2010 Nov;122(5):345-55. doi: 10.1111/j.1600-0447.2010.01563.x.
OBJECTIVE
To explore whether sertindole increases all-cause mortality or cardiac events requiring hospitalization, compared with risperidone.
METHOD
Multinational randomized, open-label, parallel-group study, with blinded classification of outcomes, in 9858 patients with schizophrenia.
RESULTS
After 14147 person-years, there was no effect of treatment on overall mortality (sertindole 64, risperidone 61 deaths, Hazard Ratio (HR) = 1.12 (90% CI: 0.83, 1.50)) or cardiac events requiring hospitalization [sertindole 10, risperidone 6, HR = 1.73 (95% CI: 0.63, 4.78)]: Of these, four were considered arrhythmia-related (three sertindole, one risperidone). Cardiac mortality was higher with sertindole (Independent Safety Committee (ISC): 31 vs. 12, HR=2.84 (95% CI: 1.45, 5.55), P = 0.0022; Investigators 17 vs. 8, HR=2.13 (95% CI: 0.91, 4.98), P = 0.081). There was no significant difference in completed suicide, but fewer sertindole recipients attempted suicide (ISC: 68 vs. 78, HR=0.93 (95% CI: 0.66, 1.29), P = 0.65; Investigators: 43 vs. 65, HR=0.67 (95% CI: 0.45, 0.99), P = 0.044).
CONCLUSION
Sertindole did not increase all-cause mortality, but cardiac mortality was higher and suicide attempts may be lower with sertindole.
目的
与利培酮相比，探讨索他洛尔是否会增加全因死亡率或需要住院治疗的心脏事件。
方法
一项多中心、随机、开放标签、平行组研究，对 9858 例精神分裂症患者进行盲法结局分类。
结果
在 14147 人年的随访中，治疗对总死亡率（索他洛尔 64 例死亡，利培酮 61 例死亡，风险比（HR）=1.12（90%可信区间：0.83，1.50））或需要住院治疗的心脏事件无影响[索他洛尔 10 例，利培酮 6 例，HR=1.73（95%可信区间：0.63，4.78）]：其中 4 例被认为与心律失常相关（3 例索他洛尔，1 例利培酮）。索他洛尔的心脏死亡率更高（独立安全委员会（ISC）：31 比 12，HR=2.84（95%可信区间：1.45，5.55），P=0.0022；研究者 17 比 8，HR=2.13（95%可信区间：0.91，4.98），P=0.081）。自杀完成率无显著差异，但索他洛尔组自杀未遂者较少（ISC：68 比 78，HR=0.93（95%可信区间：0.66，1.29），P=0.65；研究者：43 比 65，HR=0.67（95%可信区间：0.45，0.99），P=0.044）。
结论
索他洛尔不会增加全因死亡率，但心脏死亡率较高，且自杀未遂率可能较低。
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