Equivalent switching dose from oral risperidone to risperidone long-acting injection: A 48-week randomized, prospective, single-blind pharmacokinetic study
Equivalent switching dose from oral risperidone to risperidone long-acting injection: A 48-week randomized, prospective, single-blind pharmacokinetic study
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DOI：
10.4088/jcp.v68n0808
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发表时间：
2007-08-01
影响因子：
5.3
通讯作者：
Lin, Wen Kuo
中科院分区：
文献类型：
--
作者：
Bai, Ya Mei;Chen, Tzu Ting;Lin, Wen Kuo
目的：利培酮长效注射液治疗精神分裂症的临床疗效已有研究。然而，从口服利培酮到长效注射剂的等效转换剂量仍存在争议。本研究在住院患者中进行，包括一个足够长的研究期和药物依从性的最佳控制，以测试等效转换dose.Method：50例有症状的，稳定的住院精神分裂症患者被随机分配到每天口服利培酮或利培酮长效注射剂每2周。最初口服利培酮剂量为4 mg/天或更少的患者接受25 mg利培酮长效注射剂，口服剂量超过4 mg/天但6 mg/天或更少的患者接受37.5 mg利培酮长效注射剂，口服剂量超过6 mg/天的患者接受50 mg利培酮长效注射剂。反复评估临床疗效、副作用、代谢安全性、药物耐受性和利培酮代谢物的血清浓度。研究时间为2004年3月至2005年5月。两组之间的阳性和阴性症状量表（PANSS）评分无显著差异，但利培酮长效注射液组显示UKU副作用评定量表总分（p = 0.048）、E-G量表评分（p = 0.028）、催乳素水平（p = 0.046）和利培酮代谢物血清浓度（p = 0.028）降低。利培酮长效注射剂组中，接受利培酮25 mg q2 wk或37.5 mg q2 wk的患者的PANSS评分增加（p = .058），血清代谢物浓度降低（p = 0.028），且复发倾向增加。结论：结果支持利培酮长效注射剂耐受性良好，但建议将等效转换剂量调整如下：最初口服利培酮剂量为3 mg/天或更少的患者应接受25 mg利培酮长效注射剂，口服剂量超过3 mg/天但为5 mg/天或更少的患者应接受37.5 mg，口服剂量超过5 mg/天者，应给予利培酮长效注射液50 mg。
Objective: Previous studies showed clinical benefit of risperidone long-acting injection in the treatment of schizophrenia. However, the equivalent switching dose from oral risperidone to risperidone long-acting injection was still in debate. This study, conducted among hospitalized patients, included a long-enough study period and optimal control of drug compliance to test the equivalent switching dose.Method: Fifty symptomatic, stable hospitalized patients with DSM-IV schizophrenia were randomly assigned to receive either daily oral risperidone or risperidone long-acting injection every 2 weeks. Those originally receiving an oral risperidone dose of 4 mg/day or less received 25 mg of risperidone long-acting injection, those taking an oral dose of more than 4 mg/day but of 6 mg/day or less received 37.5 mg of risperidone long-acting injection, and those taking more than 6 mg/day received 50 mg of risperidone long-acting injection. Assessments of clinical efficacy, side effects, metabolic safety, drug tolerance, and serum concentration of risperidone metabolites were performed repeatedly. The study was conducted from March 2004 to May 2005.Result: Forty-five patients (90%) completed the study. There were no significant differences in Positive and Negative Syndrome Scale (PANSS) scores between the 2 groups, but the risperidone long-acting injection group showed reduced UKU Side Effect Rating Scale total scores (p = .048), Simpson-Angus Scale scores (p = .028), prolactin levels (p = .046), and serum concentrations of risperidone metabolites (p = .028). Among the risperidone long-acting injection group, patients who received either 25 mg q 2 weeks or 37.5 mg q 2 weeks of risperidone long-acting injection showed increased PANSS scores (p = .058), decreased serum metabolite concentrations (p = .028), and an increased tendency to relapse.Conclusions: The results support good tolerability of risperidone long-acting injection, but it is suggested that the equivalent switching dose be adjusted as follows: those originally on an oral risperidone dose of 3 mg/day or less should receive 25 mg of risperidone long-acting injection, those taking an oral dose of more than 3 mg/day but of 5 mg/day or less should receive 37.5 mg, and those taking an oral dose of more than 5 mg/day should receive 50 mg of risperidone long-acting injection.