长效利培酮微球治疗精神分裂症的远期疗效研究

Analysis of long-term efficacy of long-acting injectable risperidone in patients with schizophrenia

目的探讨长效利培酮微球对精神分裂症的远期临床疗效和安全性,以及对血清催乳素的影响。方法于2007年至2009年间入选56例精神分裂症患者,随机分入长效利培酮微球(RLAI)研究组和利培酮口服液(ROS)对照组进行为期1年的治疗,分别以痊愈率、缓解率、停药率、复发率和再住院率进行评价,评定两组的临床总体印象-严重度(CGI-S)与个人和社会功能评分(PSP)量表,并测定血清催乳素水平,以χ2检验和t检验进行统计分析。结果至研究终点时,RLAI组的临床治愈率和缓解率均高于ROS组,无停药、复发或再次住院发生,临床总体印象与个人和社会功能评分改善均优于ROS组。RLAI组血清催乳素水平及总体不良反应发生率均明显低于ROS组(P<0.05)。与ROS组相比,RLAI组无1例发生不依从(P<0.05)。结论长效利培酮微球的远期疗效、安全性及治疗依从性均优于利培酮口服液,适用于维持治疗。

OBJECTIVE To explore the efficacy and safety of risperidone long-acting injection（RLAI）,and.changes of serum prolactin.METHODS Fifty six symptomatic,hospitalized patients with CCMD-3 schizophrenia were randomly assigned to receive either RLAI every 2 weeks or daily risperidone oral solution（ROS）.The cure rate,remission rate,relapse rate,dropout rate and rehospitalized rate were evalued.Also the clinical global impression-severety（CGI-S）and person and society performance scale（PSP）were measured,and serum concentrations of prolactin were tested Periodly.The study was conducted from Jan 2007 to Jan 2009.RESULTS At the endpoint,The cure rate and remission rate in the RLAI group were higher than which in the ROS group,so did the CGI-S and PSP scale.There was no dropout,relapse or rehospitalization is the RLAT group.The level of prolactin and adverse envents happened in the RLAI group were much lower than those of ROS group（P0.05）.Incompliance wasn＇t seen in the RLAI group（P 0.05）.CONCLUSION RLAI is more effective,safer and better-tolerated than ROS,and could be recommanded for maintain threrapy.