注射用利培酮微球治疗精神分裂症的长期疗效初步观察

A clinical observation of long-acting injectable risperidone in patients with schizophrenia

目的:考察自然观察过程中注射用利培酮微球(恒德)治疗精神分裂症的长期疗效与安全性。方法:自然观察法对使用注射用利培酮微球的34例精神分裂症患者观察12个月,用自身对照法比较治疗前后的疗效变化。应用阳性症状与阴性症状量表(PANSS)、PANSS总分减分率、临床总体病情严重程度印象量表(CGI-S)和临床总体疗效总评印象量表(CGI-I)评定疗效;用药物不良反应量表(TESS)评定安全性。所有患者在治疗前与治疗后的1,2,3,6,9与12月应用上述量表评定患者的疗效与安全性。结果:PANSS总分及各项因子分、CGI-S平均分在治疗后的2,3,6,9,12月的各个时点与治疗后的1个月比较其差异均有非常显著性(P<0.01),有效率从32%增加到97%,CGI-I被评为显著进步的患者从18%增加到94%。锥体外系反应(EPS)的发生率低,不良反应少见。结论:注射用利培酮微球治疗34例精神分裂症患者经过12个月的临床观察,病情持续稳定且耐受性好,在12个月的维持治疗中无1例复发。

Objective： To assess the efficacy and safety of long-acting injectable risperidone （LAIR） for the maintenance treatment of patients with schizophrenia. Methods： A 12 month naturalistic observation for LAIR was conducted in 34 patients. The Positive and Negative Symptom Scale （PANSS） , the reduction rate of PANSS score, Clinical Global Impressions-Severity （CGI-S） , and Clinical Global Impressions-Improvement （CGI-I） were used to assess the efficacy of LAIR. Treatment Emergent Symptoms Scale （TESS） was used for the evaluation of the safety of LAIR. The assessments were performed at baseline and at the end of 1, 2, 3, 6, 9 and 12 months by using self-control method. Results： Mean PANSS total scores, positive symptoms, negative symptoms, general symptoms and mean CGI-S scores were significantly improved （P〈 0.01 ） at 2, 3, 6, 9 and 12 months as compared with Month 1. The effective rate increased from 32% to 97%. The proportion of patients rated as ＂significant improvement＂ increased significantly from 18% to 94%. The incidence of EPS was low. The adverse events were scarcely observed. Conclusion： LAIR is safe, and maintains the stable efficacy in one-year study in 34 patients with schizophrenia. LAIR is appropriate for the long-term maintenance treatment of schizophrenia without relapse.