Bai Ya Mei, Ting Chen Tzu, Chen Jen-Yeu, Chang Wen-Ho, Wu Bojian, Hung Chih Hung, Kuo Lin Wen
Department of Psychiatry, Taipei Veterans General Hospital, Taipei, Taiwan.
J Clin Psychiatry. 2007 Aug;68(8):1218-25. doi: 10.4088/jcp.v68n0808.
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.
Fifty symptomatic, stable hospitalized patients with DSM-IV schizophrenia were randomly assigned to receive either daily oral risperidone or risperi-done 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 risperi-done metabolites were performed repeatedly. The study was conducted from March 2004 to May 2005.
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.
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.
既往研究显示利培酮长效注射剂治疗精神分裂症有临床益处。然而，从口服利培酮转换为利培酮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，纳入了足够长的研究期并对药物依从性进行了优化控制，以测试等效转换剂量。
50例符合DSM-IV标准的有症状、病情稳定的住院精神分裂症患者被随机分配，分别接受每日口服利培酮或每2周注射一次利培酮长效注射剂。最初口服利培酮剂量为4mg/天或更低的患者接受25mg利培酮长效注射剂，口服剂量超过4mg/天但为6mg/天或更低的患者接受37.5mg利培酮长效注射剂，口服剂量超过6mg/天的患者接受50mg利培酮长效注射剂。反复进行临床疗效、副作用、代谢安全性、药物耐受性以及利培酮代谢物血清浓度的评估。研究于2004年3月至2005年5月进行。
45例患者（90%）完成了研究。两组间阳性与阴性症状量表（PANSS）评分无显著差异，但利培酮长效注射剂组的UKU副作用评定量表总分（p = 0.048）、辛普森-安格斯量表评分（p = 0.028）、催乳素水平（p = 0.046）以及利培酮代谢物血清浓度（p = 0.028）均降低。在利培酮长效注射剂组中，每2周接受25mg或37.5mg利培酮长效注射剂的患者PANSS评分升高（p = 0.058），血清代谢物浓度降低（p = 0.028），复发倾向增加。
结果支持利培酮长效注射剂具有良好耐受性，但建议等效转换剂量调整如下：最初口服利培酮剂量为3mg/天或更低的患者应接受25mg利培酮长效注射剂，口服剂量超过3mg/天但为5mg/天或更低的患者应接受37.5mg，口服剂量超过5mg/天的患者应接受50mg利培酮长效注射剂。
