美沙拉嗪肠溶片治疗激素抵抗型重症溃疡性结肠炎的临床研究  

Clinical trial of mesalazine enteric-coated tablets on patients with steroid-refractory severe ulcerative colitis

作　　者：牟海军[1] 陈幸幸[1] 周光群 刘黔[1] 

机构地区：[1]遵义医学院附属医院消化内科,贵州遵义563099

出　　处：《中国临床药理学杂志》2016年第21期1950-1952,1963,共4页The Chinese Journal of Clinical Pharmacology

摘　　要：目的观察美沙拉嗪肠溶片与硫唑嘌呤治疗激素抵抗型重症溃疡性结肠炎的临床疗效。方法 80例激素抵抗型重症溃疡性结肠炎随机分为对照组和试验组,每组40例。对照组口服硫唑嘌呤,每次100 mg,每天3次;试验组口服美沙拉嗪肠溶片,每次1 g,每天3次。2组疗程均为1个月。比较2组患者的临床疗效、临床应答情况、内镜下肠黏膜愈合情况、Mayo评分和实验室检查结果等。结果试验组总有效率为87.50%(35/40例),对照组总有效率为57.50%(23/40例),差异有统计学意义(P<0.05)。治疗后,试验组Mayo评分为(3.62±1.21)分,对照组为(3.92±1.53)分,差异无统计学意义(P>0.05);试验组平均腹泻次数为(2.52±1.34)次,对照组为(5.63±1.51)次,差异有统计学意义(P<0.05)。治疗后,试验组C-反应蛋白为(10.45±2.15)mg·L^(-1),红细胞沉降率(ESR)为(23.62±6.25)mm·h-1,对照组C-反应蛋白为(15.57±3.45)mg·L^(-1),ESR为(32.54±5.83)mm·h-1(P<0.05)。试验组出现白细胞计数减少2例,脱发1例,肝功能损伤1例,药物不良反应发生率为10.00%(4/40例);对照组出现白细胞计数减少4例,脱发2例,肝功能损伤3例,药物不良反应发生率为22.50%(9/40例),差异无统计学意义(P>0.05)。结论美沙拉嗪治疗激素抵抗型重症溃疡性结肠炎临床疗效较好,能有效控制炎症,极大提高患者的生存质量。Objective To evaluate the clinical effect of mesalazine and azathioprine in patients with steroid resistant severe ulcerative colitis. Methods Eighty patients with steroid resistant severe ulcerative colitis were randomly divided into control group and treatment group, 40 cases in each group. Control group was treated with azathioprine 100 mg, rid. Treatment group was orally given mesalazine enteric coated tablets 1.0 g, rid. All patients were treated for 1 month. The clinical effect, clinical re： sponse, endoscopic mueosal healing, Mayo score, and laboratory test re- sults were observed in two groups. Results Total efficacy in treatment group was 87.50% （35/40） , which had significant difference with that in control group [57.50% （23/40）, P〈0.05]. The Mayo score in treatment group was 3.62 ± 1.21, without significant difference to that in control group （3.92 ± 1.53, P 〉 0.05）. The average number of diarrhea in treatment and control group were 2.52 ±1.34, 5.63 ± 1.51 significant difference（ P 〈 0.05 ）. After treatment, in treatment group were （10. 45 ±2. 15） mg L-1 control group, which were （ 15.57 ± 3.45 ） mg the C - reactive protein and erythrocyte sedimentation rate （ESR） 1, （23.62 ± 6. 25 ） mm h- 1, with significant difference to those in , （32. 54 ± 5.83 ） mm L-1 （ P 〈 0.05 ）. In treatment group, there were 2 cases of white blood cell reduction, 1 case of alopecia and 1 case of liver function injury, with the inci- dence of 10. 00% （4/40）. In control group, there were 4 cases of white blood cell reduction, 2 cases of hair loss, 3 cases of liver function injury, with the incidence of 22. 50% （9/40, P 〉 0. 05 ）. Conclusion Mesalazine has good clinical efficacy in the treatment of steroid resistant severe ulcerative colitis, which also could effectively control the in- flammation and improve the quality of life.

关 键 词：激素抵抗型 溃疡性结肠炎 美沙拉嗪 硫唑嘌呤 C-反应蛋白 

分 类 号：R982[医药卫生—药品]