注射用长效利培酮微球治疗41例精神分裂症患者临床观察

Clinical observation of long-acting injectable risperidone treatment on 41 schizophrenia patients

目的:评估注射用长效利培酮微球(LAIR)在长期治疗精神分裂症的临床痊愈率和复发率。方法:采用回顾性与前瞻性研究相结合的方法,对本院LAIR治疗3个月且符合入组标准的精神分裂症患者进行前瞻性观察,每隔3个月随访1次,直至患者复发或脱落;对患者入组前3个月的情况进行回顾性调查。疗效指标为临床痊愈率和复发率、CGI-S和PSP。前瞻性观察中患者接受门诊常规治疗,研究者不干预患者治疗。结果:共纳入41例精神分裂症患者,其中5例(12.20%)因经济困难中断治疗,其他36例在治疗9个月时全部(100%)符合临床痊愈标准。治疗期间0例患者复发,复发率为0%。有10人发生了不良事件,总的不良事件发生率为24.49%。绝大多数不良事件为轻度(90.00%)。所有不良事件的发生均未影响继续使用LAIR。结论:注射用长效利培酮微球治疗9个月时获得较高临床痊愈率和较低复发率。

Objective： To investigate the remission and relapse of long-acting injectable risperidone （RLAI） long-term treatment on schizophrenia patients. Methods：This study integrated retrospective investigation and prospective observation. Schizophrenia patients who had been treated with RLAI for 3 months and meet the inclusion criteria were enrolled into the observation phase. Patients were followed up every three months until relapse or dropout occurred. Retrospective investigation was performed the data of patients in the prior to three months treatment. The efficacy endpoints were remission rate, relapse rate, CGI-S and PSP. In the observation phase, patients were treated in natural clinical setting and there was no interference from investigators. Results：At present, 41 schizophrenia patients were enrolled. 5 （ 12.20% ） patients discontinued due to economic difficulty, other 36 patients（ 100% ） meet the remission criteria after 9-month treatment . No relapse occurred during treatment period in 41 patients and the relapse rate was 0%. Adverse events occurred in 10 patients （24.49%）, and majority （90.00%） of them were mild. The LAIR treatment was not interrupted by the adverse events. Conclusion ： Patients achieved a high remission rate and a low relapse rate after 9-month RLAI treatment.