摘要
Abstract
Objective To observe the efficacy and safety of mesalazine suppositories on mild to moderate active stage ulcerative proctitis between once daily and twice daily. Methods The trial was random research with non - inferiority. A total of 82 patients who met including and excluding criteria of mild and moderate active stage ulcerative proctitis in Ji'nan Military District General Hospital from October 2013 to June 2015 were divided into group A(n = 41)and group B(n = 41)by random number table. Group A was administrated mesalazine suppositories 1. 0 g once and returned anus once daily before sleeping and after defecating in the evening;group B was administrated mesalazine suppositories 0. 5 g once and returned anus after defecating once in the morning and once in the evening. The two groups were both administrated mesalazine suppositories for 8 weeks. The degree of disease activity was evaluated using disease activity index(DAI). The DAI score after 8 - week treatment was the main index of curative effect,and the scores of each item of DAI(defection times,excrement with blood,mucosal inflammation and comprehensive evaluation)and clinical remission rate after 8 - week treatment were secondary indexes. The adverse reactions of the two groups were recorded. Results The patients all received treatment for 8 weeks. The difference of DAI scores of the two groups between before and after treatment was significant( P < 0. 001);before and after 8 - week treatment,the two groups were not significantly different in DAI scores(P > 0. 05). The lower limit of bilateral 95% credibility interval( - 0. 33,0. 87) of(U1-U2)(the DAI scores of group A after 8 - week treatment - the DAI scores of group B after 8 - week treatment of)was greater than - 1. 00 and null hypothesis was rejected,and the treatment effect of group A was the same as the treatment effect of group B. The scores of defection times,excrement with blood,mucosal inflammation and comprehensive evaluation after 8 - week treatment of the two groups were lower than those before treatment(P < 0. 05). The scores of defection times,excrement with blood,mucosal inflammation and comprehensive evaluation of two groups between before treatment and after 8 - week treatment were not significantly different(P > 0. 05). After 8 - week treatment,the clinical remission rates of the two groups were 95. 1%(39 / 41)and 90. 2% (37 / 41)without significant difference between them(χ2 = 0. 719,P = 0. 396). The occurrence rate of adverse actions of group A was 48. 8% (20 / 41) and that of B group was 61. 0% ( 25 / 41 ). The two groups were not significantly different in the occurrence rate of adverse actions(χ2 = 1. 231,P = 0. 267). Conclusion In the 8 - week clinical trial,the curative effects of mesalazine suppositories 1 g once daily and 0. 5 g twice daily on mild and moderate active stage ulcerative proctitis are unanimous and safe.关键词
直肠炎/氨水杨酸/栓剂/疾病活动指数Key words
Proctitis/Mesalamine/Suppositories/Disease activity index分类
医药卫生
