Lindenmayer Jean-Pierre, Jarboe Kathleen, Bossie Cynthia A, Zhu Young, Mehnert Angelika, Lasser Robert
New York University Medical Center, New York, USA.
Int Clin Psychopharmacol. 2005 Jul;20(4):213-21. doi: 10.1097/00004850-200507000-00004.
Long-acting injectable antipsychotic formulations of conventional antipsychotics were developed to address the problem of partial adherence among patients with schizophrenia. Injection site pain, other skin reactions and patient satisfaction with treatment were assessed in two large, multicentre studies of long-acting injectable risperidone (Risperdal CONSTA, Janssen Pharmaceutica Products, Titusville, New Jersey, USA), the first available long-acting atypical antipsychotic agent. Patients rated injection site pain using a 100-mm Visual Analogue Scale (VAS), and investigators rated injection site pain, redness, swelling and induration. Patient satisfaction with treatment was assessed with the Drug Attitude Inventory (DAI). VAS pain ratings were low at all visits across all doses in both studies, and decreased from first to final injection. In the 12-week, double-blind study, mean +/- SD VAS scores at the first and final injections were 15.6 +/- 20.7 and 12.5 +/- 18.3 for placebo-treated patients, and 11.8 +/- 14.4 (first) and 10.0 +/- 12.4 (final) for 25 mg; 16.3+/-21.9 (first) and 13.6 +/- 21.7 (final) for 50 mg; and 16.0 +/- 17.9 (first) and 9.6 +/- 16.0 (final, P<0.01) for 75 mg of long-acting risperidone. Mean VAS scores in the 50-week, open-label study at the first and final injection were: 17.9 +/- 22.2 (first) and 9.5 +/- 16.7 (final, P<0.0001) for 25 mg; 18.1 +/- 19.7 (first) and 10.4 +/- 14.8 (final, P<0.0001) for 50 mg; and 18.5 +/- 21.6 (first) and 13.6 +/- 19.9 (final, P = 0.0001) for 75 mg of long-acting risperidone. Overall, there was no or minimal injection site pain and skin reactions were rare. Mean DAI ratings were available for the 50-week study and indicated high patient satisfaction throughout the trial (baseline = 7.30; endpoint = 7.70; P<0.0001 versus baseline). These findings may positively affect patient and clinician attitudes towards long-term therapy with long-acting injectable risperidone.
为解决精神分裂症患者部分依从性问题，开发了传统抗精神病药物的长效注射制剂。在两项关于长效注射用利培酮（Risperdal CONSTA，杨森制药产品公司，美国新泽西州蒂特斯维尔）的大型多中心研究中，评估了注射部位疼痛、其他皮肤反应以及患者对治疗的满意度。利培酮是首个可用的长效非典型抗精神病药物。患者使用100毫米视觉模拟量表（VAS）对注射部位疼痛进行评分，研究人员对注射部位疼痛、发红、肿胀和硬结进行评分。使用药物态度量表（DAI）评估患者对治疗的满意度。在两项研究中，所有剂量的所有访视中VAS疼痛评分均较低，且从首次注射到最后一次注射呈下降趋势。在为期12周的双盲研究中，安慰剂治疗患者首次和最后一次注射时的平均±标准差VAS评分分别为15.6±20.7和12.5±18.3，25毫克长效利培酮组分别为11.8±14.4（首次）和10.0±12.4（最后）；50毫克组分别为16.3±21.9（首次）和13.6±21.7（最后）；75毫克组分别为16.0±17.9（首次）和9.6±16.0（最后，P<0.01）。在为期50周的开放标签研究中，25毫克长效利培酮首次和最后一次注射时的平均VAS评分分别为：17.9±22.2（首次）和9.5±16.7（最后，P<0.0001）；50毫克组分别为18.1±19.7（首次）和10.4±14.8（最后，P<0.0001）；75毫克组分别为18.5±21.6（首次）和13.6±19.9（最后，P = 0.0001）。总体而言，注射部位疼痛不存在或很轻微，皮肤反应很少见。可获得为期50周研究的平均DAI评分，表明在整个试验过程中患者满意度较高（基线=7.30；终点=7.70；与基线相比P<0.0001）。这些发现可能会对患者和临床医生对长效注射用利培酮长期治疗的态度产生积极影响。
