Abstract:

본 연구는 3,391명의 환자에서 ziprasidone의 시판 후 조사를 통해 실제 임상 상황에서의 정신분열병, 양극성 장애와 관련된 급성 조증 혹은 혼재 삽화 치료에 대한 유효성과 안전성을 관찰하였다. 한 번 이상 연구 약물을 복용한 모든 환자에서 82.2%의 임상적 호전이 관찰되었다. 평균 75.8일의 복용기간 동안 평균 0.9 kg의 유의한 체중 감소가 나타났으며, 이 외 가장 흔한 유해사례는 정좌불능, 졸림, 추체외로 증상과 불면증이었다. 중대한 유해사례는 2명의 환자에서 발생하였는데, 그 중 1명에서 정신증적 증상과 자살 시도가 있었다.

결론적으로 국내에서 ziprasidone은 실제의 일반적인 임상 상황에서 정신분열병, 양극성 장애와 관련된 급성 조증 혹은 혼재 삽화 치료에 안전하고 효과적으로 사용될 수 있다고 판단된다.

Objective:

The aim of this study was to observe the safety and efficacy of ziprasidone in the usual care setting in patients with schizophrenia or acute manic or mixed episodes associated with bipolar disorder.

Methods:

A total of 3,391 patients who were treated with ziprasidone were enrolled from 108 centers in Korea. Differences in the clinical global impression of severity and clinical global impression of improvement (CGI-I) were measured after 8±1 weeks administration of ziprasidone. Adverse events were observed in all subjects who were administered ziprasidone at least once. In 330 patients, the change of weight was evaluated.

Results:

Ziprasidone was effective for most of schizophrenia and acute manic or mixed episodes associated with bipolar disorder patients. CGI-I score was improved in 84.8% of PP subjects. Of the subjects who did not complete the study, sixty-four (1.9%) subjects discontinued treatment due to adverse events. The most common adverse events were akathisia, somnolence,extrapyramidal symptoms and insomnia. In total, 6 serious adverse events were reported in 2 subjects, including psychotic disorder and suicidal attempt. Mean 0.9 kg of weight loss was observed.

Conclusion:

ziprasidone was effective, safe and generally well tolerated for schizophrenia or acute manic or mixed episodes associated with bipolar disorder patients in Korea.