枫蓼肠胃康冲剂联合美沙拉秦缓释片对反复发作型溃疡性结肠炎的临床疗效及安全性研究

Efficacy and safety of fengliao stomach granules combined with mesalazine in the treatment of recurrent ulcerative colitis

目的观察枫蓼肠胃康冲剂联合美沙拉秦缓释片治疗反复发作型溃疡性结肠炎患者的疗效及安全性。方法将52例反复发作型溃疡性结肠炎患者随机分为2组,每组26例。对照组患者给予美沙拉秦缓释片1 g/次口服,4次/d,共治疗4周。观察组患者在对照组的基础上,加服枫蓼肠胃康冲剂3.0 g(1包)/次,3次/d。两组患者均配合口服补液盐或补液、补钾等辅助治疗。治疗前后均进行结肠镜检查,比较两组患者临床疗效及治疗后结肠镜检结果。治疗前后均进行血压检查,密切观察两组患者治疗期间不良反应发生情况。随访半年,观察比较两组患者结肠炎复发情况。结果观察组、对照组总有效率分别为92.31%、69.23%,观察组疗效明显优于对照组(P<0.05)。观察组结肠镜检查0级12例,1级8例;对照组0级7例,1级5例,两组比较差异有统计学意义(P<0.05)。两组患者治疗前血压比较差异无统计学意义,观察组治疗后SBP、DBP均明显高于对照组(P<0.05)。两组患者均未出现肝肾功能异常及血常规异常。观察组、对照组分别有3例、2例发生不良反应,两组不良反应比较差异无统计学意义。随访半年期间,对照组、观察组分别有1例(3.85%)、6例(23.08%)复发,观察组复发率明显低于对照组(P<0.05)。结论枫蓼肠胃康冲剂联合美沙拉秦缓释片治疗反复发作型溃疡性结肠炎,疗效确切,不良反应少,可明显降低疾病复发率。

Objective To observe the efficacy and safety of fengliao stomach granules combined with mesalazinc in the treatment of recurrent episodes of ulcerative colitis. Methods 52 cases of recurrent ulcerative colitis patients were randomly divided into 2 groups. Control group （ n = 26 ） was treated with mesalazine 1 g per time orally, 4 times daily, the treatment lasted for 4 weeks. Patients in observation group （ n = 26 ） were added with fengliao stomach granules 3.0 g（ a pack）per time,3 times daily. All the patients received oral rehydration salts ,potassium and other adjuvant therapy. The clinical symptoms and colonoscopy results before and after treatment were observed. The blood pressure was checked, and the adverse events during treatment were observed. The colitis relapse was observed during the 6 months of follow-up. Results The total effective rate of control group and observation group were 69. 23 % and 92. 31%, there was significant difference between the two groups （P 〈 0. 05 ）. There were 12 cases of colonoscopy 0 level and 8 cases of 1 level in observation group, 7 cases of of colonoscopy 0 level and 5 cases of 1 level in control group,there were significant differences between the two groups （ P 〈 0.05 ）. There was no significant difference in blood pressure between the two groups before treatment, and the SBP and DBP in observation group were higher than those of control group after treatment（ P 〈 0. 05 ）. No abnormal liver and kidney function and blood abnormalities was observed in the patients,there were 3 cases and 2 cases of adverse reactions in observation group and control group respectively, there was no significant difference between the two groups （ P 〉 0. 05 ）. During the six months follow-up, there were 1 case（ 3.85 % ）and 6 cases （23.08%）of recurrence in control group and observation group, there was significant difference between the two groups（ P 〈 0.05 ）. Conclusion Fengliao stomach granules combined with mesalazinc has good efficacy in the treatment of recurrent ulcerative colitis, with fewer adverse reactions, it can significantly reduce the recurrence rate.