果胶铋四联方案补救治疗幽门螺杆菌根除失败患者的有效性和安全性评价

Efficacy and safety of pectin bismuth-based quadruple therapy as a remedy for patients in whom eradication of Helicobacter pylori initially failed

目的评价果胶铋四联疗法作为幽门螺杆菌(HP)初次根除失败后补救方案的有效性和安全性。方法选取2015年9月至2017年3月就诊于本院消化内科的HP感染患者100例,随机分为对照组(采用序贯疗法)和观察组(采用胶体果胶铋四联疗法),每组各50例,根据两组患者HP根除率,临床症状改善,溃疡愈合程度,再生黏膜组织成熟度,血清EGF含量和不良反应等评价该疗法的有效性和安全性。结果ITT分析对照组治疗后HP根除率为76.00%(38/50),观察组为84.00%(42/50),差异有统计学意义(χ~2=9.003,P<0.05);PP分析对照组治疗后HP根除率为79.17%(38/48),观察组为85.71%(42/49),差异有统计学意义(χ~2=5.198,P<0.05)。观察组和对照组患者溃疡愈合有效率分别为95.92%和85.42%,差异有统计学意义(χ~2=7.816,P<0.05);再生粘膜组织成熟度优良率分别为93.88%和83.33%,差异有统计学意义(χ~2=5.338,P<0.05);血清EGF分别为(0.98±0.14)μg/L和(0.67±0.18)μg/L,差异有统计学意义(t=7.904,P<0.05);不良反应发生率分别为10.20%(5/49)和10.41%(5/48),差异无统计学意义(χ~2=0.892,P>0.05)。两组患者临床不适症状评分与治疗前比较差异均有统计学意义(t=15.964,P<0.01);观察组临床症状缓解程度与对照组比较差异有统计学意义(t=12.017,P<0.01)。结论胶体果胶铋四联疗法可作为HP根除失败后的治疗首选,其安全性和有效性均高于10d序贯疗法。

Objective To evaluate the efficacy and safety of pectin bismuth-based quadruple therapy as a remedy for patients in whom eradication of Helicobacter pylori initially failed. Methods Subjects were 100 patients who were diagnosed with an H.pylori infection by Gastroenterology at this Hospital from September 2015 to March 2017.Patients were randomly divided into a control group（receiving sequential therapy）and an observation group（receiving colloidal pectin bismuth-based quadruple therapy）,with 50 patients in each group.The rate of H.pylori eradication,clinical symptoms,the degree of ulcer healing,maturation of regenerated mucosa,the serum level of EGF,and adverse reactions were compared between the 2 groups to evaluate the efficacy and safety of the therapy. Results ITT analysis indicated that the rate of H.pylori eradication was 76.00%（38/50）in the control group after treatment and 84.00%（42/50）in the observation group,and the rate of H.pylori eradication differed significantly（χ-2=9.003,P〈0.05）.According to PP analysis,the rate of H.pylori eradication was 79.17%（38/48）in the control group after treatment and 85.71%（42/49）in the observation group,and the rate of H.pylori eradication differed significantly（χ-2=5.198,Pvalue〈0.05）.The effective rate of ulcer healing was 95.92%in the observation group and 85.42%in the control group,and the effective rate of ulcer healing differed significantly（χ-2=7.816,P〈0.05）.Ninety-three-point-eight-eight percent of regenerated mucosa was acceptably mature in the observation group and 83.33% was acceptably mature in the control group,and the percentage of acceptably mature mucosa differed significantly（χ-2=5.338,P〈0.05）.The serum level of EGF was 0.98 ± 0.14μg/L in the observation group and 0.67± 0.18μg/L in the control group,and the level differed significantly（t=7.904,P〈0.05）.The incidence of adverse reactions was 10.20%（5/49）in the observation group and10.41%（5/48）in the control group,and the incidence of adverse reactions did not differ significantly（χ-2=0.892,P〉0.05）.The 2 groups’ clinical scores for discomfort after treatment differed significantly from their scores before treatment（t=15.964,P〈0.01）.Clinical symptoms in the observation group and the control group differed significantly（t=12.017,P〈0.01）. Conclusion Colloid pectin bismuth-based quadruple therapy can be used as the treatment of choice when eradication of H.pylori initially fails,and it is safer and more efficacious than sequential therapy.