青白灌肠液治疗急性期溃疡性结肠炎的多中心随机对照研究

A Multicenter Randomized Controlled Study of Qingbai Enema Decoction on Acute Ulcerative Colitis

目的观察青白灌肠液对湿热蕴结型活动急性期左半结肠型溃疡性结肠炎的临床疗效。方法按照多中心随机对照研究的方法,按照1∶1的比例将180例符合标准的患者随机分为对照组和治疗组。对照组给予美沙拉嗪灌肠液治疗,治疗组在对照组的基础上给予青白灌肠液治疗。两组疗程均为4周。比较两组患者治疗前后Mayo疾病活动指数、Boran肠镜积分及血清血沉(ESR)、D二聚体(D-D)、C反应蛋白(CRP)、超氧化物歧化酶(SOD)、丙二醛(MDA)水平,并评价两组患者的临床疗效。结果治疗组总有效率明显高于对照组(P<0.01);两组治疗后Mayo疾病活动指数及Boran肠镜积分均较本组治疗前显著降低(P<0.01),且治疗组均明显优于对照组(P<0.01);两组治疗后血清ESR、D-D、CRP及SOD、MDA较本组治疗前均显著降低(P<0.01),且治疗组均明显优于对照组(P<0.01)。治疗组不良反应发生率为4.44%,明显优于对照组的16.67%(P<0.01)。结论青白灌肠液不仅能够明显缓解湿热蕴结型急性期左半结肠型溃疡性结肠炎患者的临床症状,降低疾病活动指数和肠镜积分,且能显著降低血清ESR、D-D、CRP及SOD、MDA水平,临床疗效显著。

Objective： To observe the clinical effect of Qingbai Enema Decoction on acute ulcerative colitis of left hemicolon type with damp-heat accumulation. Methods： According to the multieenter randomized controlled study, 180 patients, meeting the diagnostic criteria and inclusion criteria,were divided into the control group and the treatment group randomly according to the proportion of 1 ：1. The control group was treated with Mesalazine enema and the treatment group was treated with Qingbai Enema Decoction on the basis of the control group. Both groups were treated for 8 weeks. The changes of Mayo disease activity index, Boran enteroscopy score and the lev- els of serum Erythrocyte sedimentation rate, D-Dimer, C reactive protein, Superoxide dismutase, Malondialdehyde were observed before and after treatment,and to evaluate the clinical efficacy of the two groups after treatment. Results： The total effective rate in the treatment group was 88.89% ,and the treatment group was significantly better than the control group （P〈 0.01）. Mayo disease activity index and Boran enteroscopy scores were reduced significantly compared with before treatment in both groups （P〈 0.01 ）,and the treatment group was significantly lower than that of the control group（P〈 0.01）. Serum ESR,D-D, CRP, SOD and MDA were decreased significant- ly, compared with before treatment in both groups （P〈 0.01 ）, and the treatment group was significantly lower than the control group （P〈 0.01 ）. Adverse reaction rate was 4.44% in the treatment group. The treatment group was significantly better than the control group （P〈 0.01 ）. Conclusion： Qingbai Enema Decoction can not only relieve clinical symptoms of patients with acute ulcerative colitis of left hemicolon type with damp-heat accumulation,but also can reduce disease activity index,enteroscopy score and the levels of serum Erythrocyte sedimentation rate, D-Dimer, C reactive protein, Superoxide dismutase, Malondialdehyde,with an obvious curative effect.