美沙拉秦栓治疗轻、中度远端溃疡性结肠炎的疗效评价

摘要

Objective:To evaluate the efifcacy and safety of Mesalazine Suppositories on the treatment of active mild or moderate ulcerative colitis(UC).Methods: 64 patients who were diagnosed as mild or moderate UC based on (the Consensus of cooperation of Chinese and western medicine diagnosis on treatment of ulcerative colitis in 2010) were enrolled in this randomized, multicenter, double blind, double dummy, andparallel controlled study. Among of them, 32 patients were assigned to receive 1.5 g mesalazine suppositories daily for 8 weeks(Group A) , another 32 to orally receive 3 g Sulfasalazine tablets daily for 8 weeks (Group B).Results: The total effective rates of Group A and B were 90.625% and 71.875%, respectively. There was signiifcant statistical difference between the two groups(P < 0.05). The endoscopic index of Group A and B had signiifcant statistical differences between before and 2,4, and 8 weeks after administration(P <0.05). The endoscopic index of Group A was much lower than that of Group B(P < 0.05). The incidence of adverse reaction for group A and Group B was 3.125% and 31.25% during the treatment, with signiifcant statistical difference between the two groups(P<0.05).Conclusion:Clinical curative effect of Mesalazine Suppositories on treating mild or moderate ulcerative colitis was more remarkable and safe.%目的：评价美沙拉秦栓治疗轻、中度溃疡性结肠炎的疗效及安全性。方法：符合《溃疡性结肠炎中西医结合诊疗共识（2010）》确诊的轻、中度溃疡性结肠炎作为研究对象，进行双盲双模拟，平行对照研究：A 组：美沙拉秦栓(32例)每日1.5 g；B组：柳氮磺吡啶片(32例)每日3 g。疗程均为8周。结果：用药8周后A组与B组总有效率分别为90.625%，71.875%，两组比较差异有统计学意义（P＜0.05）；治疗前和治疗2周、4周、8周后A， B组内镜指数均有显著差异（P＜0.05）；两组比较发现，美沙拉秦组的内镜指数下降更低（P＜0.05）。治疗期间， A组不良反应发生率3.125%，B组为31.25%，2组比较差异有统计学意义（P＜0.05）。两组血、尿、粪常规及心、肝、肾功能检查，均无统计差异（P＞0.05）。结论：美沙拉秦栓治疗轻、中度溃疡性结肠炎临床疗效显著，临床用药更安全。