조현병 환자에서 Paliperidone Extended Release의 약물만족도와 치료반응을 조사하기 위한 개방형 다기관 전향적 관찰연구

An Open Label Multi-Center Prospective Observational Study of Paliperidone Extended Release to Assess the Medication Satisfaction and Treatment Response in Patients with Schizophrenia

본 연구는 기존의 항정신병 약물에서 paliperidone ER으로 교체한 조현병 환자를 8주간 전향적으로 관찰하여 환자의 만족도의 변화 및 임상척도와의 연관성을 조사한 개방형 다기관 공동연구이다. 총 374명의 환자를 모집하였으며 이 중 탈락을 제외한 본 연구의 조사대상은 320명을 조사한 결과, paliperidone ER으로 교체 후 환자의 만족도는 상승하였으며, 임상적 변화와 환자의 만족도 간의 상관성을 알 수 있었다. 추후 환자의 치료평가에 환자의 만족도를 이용한 다양하고 체계화된 연구들을 통해 조현병의 치료에서 환자 만족도의 유용성을 입증할 수 있을 것이다.

Objective : The aim of this study was to demonstrate changes of subjective medication satisfaction and clinical benefit after once-daily paliperidone extended release (ER) in treatment of schizophrenia. Methods : In an open-label, observational, and multicenter study, 374 patients with schizophrenia who switched to paliperidone ER due to any reason were recruited. Medication Satisfaction Questionnaire (MSQ), Clinical Global Impression-Severity (CGI-S), Clinical Global Impression-Improvement and visual analogue scale for sleep (VAS) were assessed at baseline, 4 weeks and 8 weeks after treatment. We also examined the type, frequency, and severity of adverse events newly formed. Results : Among 374 patients, 320 patients (76.5%) were included in the intent-to-treat analysis set. The mean dose of paliperidone ER was 5.33±2.31 mg/day at the initiation. At the endpoint, the mean dose of paliperidone ER was 6.68±3.13 mg/day. The percentages of patients satisfied with medication were changed from 40.9% at baseline to 67.8% at endpoint (p<0.001). Both CGI-S scores and VAS for daytime drowsiness were significantly decreased after 8 weeks (both p<0.0001) and mean scores of MSQ and VAS for sleep quality were improved after 8 weeks (both p<0.0001). Conclusion : After switching to paliperidone ER, 67.8% of patients with schizophrenia who had any reason to switch medication showed subjective satisfaction for medication and clinical improvement without significant adverse events. Regarding that medication satisfaction was associated with changes of clinical states, medication satisfaction can be used for measures for clinical scales in the treatment of schizophrenia.