甘露聚糖肽注射液干预治疗溃疡性结肠炎的前瞻性、随机、开放性对照临床研究

目的:评价甘露聚糖肽注射液治疗溃疡性结肠炎治疗中的有效性及安全性。方法:采用前瞻性,开放,随机平行对照试验方法,纳入符合诊断标准的溃疡性结肠炎患者240例,其中治疗组(n=120)采用柳氮磺吡啶片(4g/d)和甘露聚糖肽注射液(10mg/d);对照组(n=120)则给予柳氮磺吡啶片(4g/d)及生理盐水滴注,疗程4周,治疗前后评价症状体征评分变化及肠黏膜病变情况,并评价疗效。结果:①治疗组总有效率(82.2%vs 56.9%)及显效率(42.37%vs 25%)均优于对照组,具有显著差异(P<0.05);②治疗组在脓血便,腹痛,肠黏膜充血水肿、糜烂、溃疡改善方面优于对照组,具有显著差异(P<0.05);③甘露聚糖肽治疗过程中有发热病例14例,均为轻微,可自行缓解。结论:甘露聚糖肽治疗溃疡性结肠炎,可显著提高临床疗效,缓解腹痛,便血等临床症状及减少肠黏膜病变,无明显不良反应。

Randomized Controlled Prospective Clinical Trial of Mannatide Injecta in the Treatment with Ulcerative Colitis

Objective:To study the efficacy and safety of Mannatide injecta in the treatment with Ulcerative Colitis.Methods:Pros pective,randomized,open and paralleled controlled trial was conducted on 240 patients with Ulcerative Colitis,the treatment group(n=120) were given Mannatide injecta(10mg/d)and SASP tablets(4g/d),and the control group(n=120) were only given SASP tablets(4g/d) and normal saline for 4 weeks.Observing the clinical symptoms,signs and intestinal lesions to evaluate clinical effect before and after treatment.Results:①The total Clinical efficacy(82.2% vs 56.9%)and Significant efficiency(42.37% vs 25%) of the treatment group were superior to the control group.②Treatment group has more significant improvement than the control group in Pus and blood stool,Intestinal mucosa congestion and edema,erosion,ulcer(P<0.05).③There are 14 patients get slight fever in the treatment with Mannatide.Conclusion:Mannatide can effectively improve the clinical symptoms of patients with ulcerative colitis and intestinal mucosal lesion.Besides there is no obvious adverse effect.