美沙拉秦栓每日1次与每日2次给药治疗轻中度活动期溃疡性直肠炎的临床疗效比较

Comparison of Clinical Effect of Mesalazine Suppositories in the Treatment of Mild to Moderate Active Stage Ulcerative Proctitis Between Once Daily and Twice Daily

目的观察美沙拉秦栓1次/d与2次/d给药治疗轻中度活动期溃疡性直肠炎的疗效及安全性。方法本试验为随机、非劣效性研究。选取2013年10月—2015年6月济南军区总医院符合纳入与排除标准的轻中度活动期溃疡性直肠炎患者82例,采用随机数字表将其分为A组(n=41)和B组(n=41)。A组给予美沙拉秦栓1.0g/次,晚睡前便后纳肛,1次/d;B组给予美沙拉秦栓0.5 g/次,便后纳肛,早、晚各1次。两组均给药8周。采用疾病活动指数(DAI)评价疾病活动程度。以治疗第8周时DAI评分作为主要疗效指标;以治疗第8周时DAI各分项评分(大便次数、大便带血、黏膜炎症、总体评价)及临床缓解率作为次要疗效指标,并记录两组不良反应发生情况。结果患者均完成8周治疗。两组治疗前后DAI评分比较,差异均有统计学意义(P<0.001);两组间治疗前及治疗第8周DAI评分比较,差异均无统计学意义(P>0.05)。A组治疗第8周时DAI评分-B组治疗第8周时DAI评分(U1-U2)双侧95%可信区间(-0.33,0.87)的下限>-1.00,拒绝无效假设,认为A组的疗效不差于B组。两组治疗8周后大便次数、大便带血、黏膜炎症、整体评价评分均低于治疗前,差异有统计学意义(P<0.05)。治疗前和治疗第8周,两组间大便次数、大便带血、黏膜炎症、整体评价评分比较,差异均无统计学意义(P>0.05)。经过8周治疗后,A、B两组临床缓解率分别为95.1%(39/41)、90.2%(37/41),差异无统计学意义(χ2=0.719,P=0.396)。A组不良反应发生率为48.8%(20/41),B组不良反应发生率为61.0%(25/41),差异无统计学意义(χ2=1.231,P=0.267)。结论在8周的临床试验中,美沙拉秦栓1.0 g 1次/d给药与0.5 g 2次/d给药治疗轻中度活动期溃疡性直肠炎疗效一致,且安全。

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（χ^2 = 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（χ^2 = 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.