정신분열병, 정신분열형장애 및 분열정동장애환자에서 아리피프라졸 장기 투여에 따른 유효성 및 안전성 연구：52주 전향적 개방 연구 = Efficacy and Safety of Long-term Aripiprazole Therapy in Patients with Schizophrenia, Schizophreniform Disorder, and Schizoaffective Disorder： A 52-week, Prospective, Open-label Study

다국어 초록 (Multilingual Abstract)

Objective：We investigated the long-term efficacy, safety, and tolerability of aripiprazole in a large number of
patients with schizophrenia, schizophreniform disorder, and schizoaffective disorder in Korea. Methods：This was an open-label, multi-center, single-arm, 52-week study of patients with schizophrenia, schizophreniform
disorder, and schizoaffective disorder. Korean patients (N=300) experiencing either a first episode or recurrence
participated in this study. The primary efficacy measure was the Positive and Negative Syndrome Scale (PANSS)
total score. Secondary efficacy measures included the PANSS positive and negative subscales, and the Clinical
Global Impression-Severity of Illness (CGI-S). Safety was evaluated prospectively by recording treatmentemergent
adverse events；measuring extrapyramidal symptoms (EPS), vital signs, and body weight；and performing
laboratory tests. Results：Overall, 55 (18.33%) of the patients completed the entire 52-week study. Treatment
with aripiprazole provided rapid and significant improvement in all of the efficacy measures. Comparing
PANSS total scores, PANSS positive subscale scores, and CGI-S scores, first-episode patients showed significant
improvement than the patients who had experienced at least one recurrence. There were no significant differences
in the mean change of EPS during the study, except for akathisia at week 8 and a significant decrease in serum
prolactin level in patients experiencing first and recurrent episodes. At the end of the study, the mean weight gain
was 2.40 kg. Conclusion：Aripiprazole is effective and safe for patients with schizophrenia, schizophreniform
disorder, and schizoaffective disorder during a long-term, 52-week treatment. The result may be associated with
the unique mechanism of aripiprazole. We have extended the findings of previous studies in the United States and
other countries and demonstrated a similar effectiveness of aripiprazole for Korean patients.

국문 초록 (Abstract)

본 연구는 장기간 아리피프라졸을 투여 받은 우리나라
의 정신분열병, 정신분열형 장애 및 분열정동장애 환자
들에 대한 약물 치료 효과와 안전성 등을 평가하였다.
이번 연구는 52주, 전향적, 개방형, 다기관 임상시험이
었으며, 총 300명의 초발 및 재발 환자들이 참여하였다.
연구등록 시점과 각 평가 시점간의 PANSS 전체 점수의
평균변화를 비교하여 아리피프라졸에 의한 치료효과를
평가하였고, 아울러 PANSS의 양성증상과 음성증상 척
도 점수 및 CGI-S도 함께 평가하였다. 이와 함께 부작
용 평가를 위해 SAS, AIMS 및 BAS 등을 시행하였으
며, 활력징후와 체중, 이학적 검사와 혈액학적 검사 및
소변 검사, 심전도 검사도 함께 시행하였다.
연구에 참여한 300명의 환자 가운데 55명(18.33%)이
연구를 완료하였으며, 모든 유효성 평가 척도에서 치료
초기부터 유의한 증상의 호전을 보였고, 초발 환자들이
재발 환자들에 비해 PANSS 전체점수와 양성증상 척도
점수, 그리고 CGI-S 점수에서 유의한 호전을 보였다. 치
료 초기인 8주에서만 정좌불능증이 증가되었으나 이후
연구 기간 동안에는 유의미한 정좌불능증의 증가는 보이
지 않았으며, 연구기간 내내 의미 있는 추체외로 증상이
나 지연성 운동장애 등의 악화는 보이지 않았다. 혈청 프
로락틴은 초발과 재발 환자 모두에서 의미 있는 감소를
보이고 있었고, 한편으로 경도의 체중 증가를 보였다.
결론적으로 장기적인 아리피프라졸의 투여는 우리나라
의 정신분열병, 정신분열형 장애 및 분열정동장애 환자
들에서 효과적이었으며 비교적 안전하였고, 다른 나라에
서 실시된 기존의 연구 결과도 유사하였으며, 이러한 효
과는 아리피프라졸이 가지고 있는 독특한 작용기전과도
연관이 있을 것이다.

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