Arunpongpaisal Suwanna, Srisurapanont Manit, Kongsakon Ronnachai, Kitiwattanagul Khanogwan, Samanwongthai Umpaikanit
Department of Psychiatry, Khon Kaen University, Khon Kaen, Thailand.
J Med Assoc Thai. 2010 Mar;93(3):343-50.
Although oral atypical antipsychotics have improved the outcomes in schizophrenia, the patient medication adherence plays role as the important factor to clinical potential of the drugs. Therefore, the long-acting formulations of antipsychotics have been developed to improve the treatment compliance in patient with schizophrenia and risperidone long-acting injection (RLAI) is the first long-acting injectable drug since then.
To evaluate the efficacy and tolerability of long-acting risperidone injection in Thai patients with chronic schizophrenia for 12 weeks treatment.
This was a non-randomized, open-label, single-arm study, performed at 5 centers in Thailand. The eligible patients with schizophrenia diagnosed by DSM-IV criteria were enrolled. Patients received long-acting risperidone injection 25, 37.5 or 50 mg every 2 weeks. Efficacy assessments were measured by Manchester Psychiatric Rating Scale (MPS), CGI-S and SF-36 at baseline, week 6 and week 12 or endpoint visit. Tolerability assessments were measured by Yale Extrapyramidal Symptoms Rating Scale (YESS), Visual analogue scale 10-cm for pain at injection site, body weight (BW) and incidence of adverse events.
Of 184 patients recruited, 160 patients (87%) completed the study. RLAI produced a significant improvement (p < 0.001) in MPS positive score from baseline to endpoint, 4.4 +/- 3.7 to 1.6 +/- 2.6. There was also significant reduction in MPS negative score, from 3.06 +/- 2.68 to 0.93 +/- 1.61 at endpoint (p < 0.001). The CGI-S score improved significantly from baseline to endpoint (p < 0.001), as reflected by the increase the proportion of patients rated as "not ill" or "borderline ill" from 5.9% at baseline to 53.2% at endpoint. Quality of life measured on the SF-36 scale was improved in all domains except bodily pain. Movement disorders, measured by YESS, were significantly reduced following RLAI introduction. Treatment with this drug was well tolerated and no significant weight gain occurred during the study.
This study suggests that RLAI produces symptomatic improvement in chronic schizophrenia patients, along with improvement of movement disorders and had a good tolerability and adherence to treatment.
尽管口服非典型抗精神病药物改善了精神分裂症的治疗效果，但患者的药物依从性是影响这些药物临床潜力的重要因素。因此，已开发出抗精神病药物的长效制剂以提高精神分裂症患者的治疗依从性，利培酮长效注射剂（RLAI）是此后的首个长效注射药物。
评估长效利培酮注射剂治疗泰国慢性精神分裂症患者12周的疗效和耐受性。
这是一项在泰国5个中心进行的非随机、开放标签、单臂研究。纳入符合DSM-IV标准诊断的精神分裂症患者。患者每2周接受25、37.5或50mg的长效利培酮注射。在基线、第6周、第12周或终点访视时，通过曼彻斯特精神病评定量表（MPS）、临床总体印象量表-严重程度（CGI-S）和健康调查简表（SF-36）进行疗效评估。通过耶鲁锥体外系症状评定量表（YESS）、注射部位疼痛的10厘米视觉模拟量表、体重（BW）和不良事件发生率进行耐受性评估。
在招募的184例患者中，160例（87%）完成了研究。从基线到终点，RLAI使MPS阳性评分显著改善（p<0.001），从4.4±3.7降至1.6±2.6。终点时MPS阴性评分也显著降低，从3.06±2.68降至0.93±1.61（p<0.001）。CGI-S评分从基线到终点显著改善（p<0.001），表现为评为“无病”或“边缘性疾病”的患者比例从基线时的5.9%增至终点时的53.2%。除身体疼痛外，SF-36量表测量的生活质量在所有领域均有所改善。引入RLAI后，通过YESS测量的运动障碍显著减少。该药物治疗耐受性良好，研究期间未出现显著体重增加。
本研究表明，RLAI可使慢性精神分裂症患者症状改善，同时改善运动障碍，且耐受性良好，治疗依从性高。
