Journal of digestive diseases · 2016
Standard-dose versus low-dose azathioprine in the treatment of Crohn's disease: A prospective randomized study.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Zhang Yu, Xia Jing Jing, Xiao Peng, Zhao Yuan, Ye Ling Na, Li Xiao Lin, Lin Zi Wen, Xu Zhen Jie, Huang Yi Biao, Wang Meng Yu, Qian Jia Ming, Hu Pin Jin, Cao Qian
Аннотация
OBJECTIVE: Azathioprine (AZA) is widely used to treat Crohn's disease (CD) with a recommended dose of 2-2.5 mg/kg per day for Westerners. Asian patients are suggested to take a lower dose. However, many clinicians reported poor efficacy with a reduced dose. This study aimed to explore a efficient and safe dose of AZA providing the best efficacy for Chinese CD patients.
METHODS: Fifty patients with active CD were enrolled and randomized into two groups (n = 25 each). All other treatments were the same except that group A received 1 mg/kg per day and group B took 2 mg/kg per day of AZA. Complete remission (CR) rate and response rate at weeks 12, 24 and 48 were assessed by using intent-to-treat (ITT) and per-protocol (PP) analyses. Adverse events and recurrence rate were also evaluated.
RESULTS: At week 48, CR rate and response rate in group B (ITT: 50.0% and 59.1%; PP: 57.9% and 68.4%) were significantly higher than those in group A (ITT: 13.0% and 17.4%; PP: 16.7% and 22.2%) (P < 0.05). Nine adverse events occurred, including pancreatitis (n = 1), arthritis (n = 2) and myelosuppression (n = 6). There was no significant difference in adverse events between the two groups. However, recurrence rate was significantly higher in group A than in group B (P = 0.042).
CONCLUSION: AZA 2 mg/kg per day is more appropriate than 1 mg/kg per day for Chinese CD patients with a high efficacy, a low recurrence rate and not increased adverse events.
METHODS: Fifty patients with active CD were enrolled and randomized into two groups (n = 25 each). All other treatments were the same except that group A received 1 mg/kg per day and group B took 2 mg/kg per day of AZA. Complete remission (CR) rate and response rate at weeks 12, 24 and 48 were assessed by using intent-to-treat (ITT) and per-protocol (PP) analyses. Adverse events and recurrence rate were also evaluated.
RESULTS: At week 48, CR rate and response rate in group B (ITT: 50.0% and 59.1%; PP: 57.9% and 68.4%) were significantly higher than those in group A (ITT: 13.0% and 17.4%; PP: 16.7% and 22.2%) (P < 0.05). Nine adverse events occurred, including pancreatitis (n = 1), arthritis (n = 2) and myelosuppression (n = 6). There was no significant difference in adverse events between the two groups. However, recurrence rate was significantly higher in group A than in group B (P = 0.042).
CONCLUSION: AZA 2 mg/kg per day is more appropriate than 1 mg/kg per day for Chinese CD patients with a high efficacy, a low recurrence rate and not increased adverse events.