乳铁蛋白联合三联疗法治疗小儿幽门螺杆菌相关性胃病的疗效及安全性评价

Efficacy and safety of lactoferrin combined with triple therapy in the treatment of Helicobacter pylori-associated gastropathy in children

目的研究乳铁蛋白与三联疗法联合运用对小儿幽门螺杆菌(Hp)相关性胃病的疗效和安全性。方法选择2014年1月—2016年12月于宁波大学医学院附属医院进行治疗的100例小儿HP感染患儿作为研究对象;根据双盲随机分组方法将其分成2组,即观察组与对照组,各50例。所有患儿均采用标准三联疗法:奥美拉唑肠溶胶囊(浙江金华康恩贝生物制药有限公司生产,国药准字I-19991118)20 mg空腹服用,2次/d,克拉霉素(浙江贝得药业有限公司,国药准字H20064143)500 mg餐后服用,2次/d,阿莫灵胶囊(澳美制药厂,国药准字C20130015)1 g餐后服用,每天1次;观察组患儿在对照组的基础之上加用乳铁蛋白胶囊4粒(每粒含0.024 g乳铁蛋白,四环生物,国食健字G20060117)顿服,每天1次。2组疗程均为2周;对2组患儿的不良反应发生率、症状改善、Hp根除率还有半年复发率实行密切观察,检验指标资料的数据运用SPSS 13.0统计学软件进行分析,计数资料运用χ~2检验。结果观察组患儿治疗1周、2周后临床疗效的总有效率分别是90.0%、94.0%,对照组患儿治疗1周、2周之后的总有效率分别是72.0%、78.0%;观察组患儿治疗后Hp根除率为92.0%,明显优于对照组的72.0%(P<0.05);观察组患儿不良反应的总发生率为8.0%,较对照组的30.0%显著降低(P<0.05);观察组半年后复发率为22.0%,对照组明显较高,为42.0%(P<0.05)。结论乳铁蛋白联合三联疗法治疗Hp感染相关性胃病患儿临床疗效优于三联疗法,可提高Hp转阴率,有效根除幽门螺杆菌,将复发率降至最低,安全性较高。

Objective To study the efficacy and safety of the combination of lactoferrin and triple therapy in the treat- ment of Helicobacter pylori （ H. pylori） -associated gastropathy in children. Methods Total 100 children with H. pylori infection in our hospital between January, 2014 and December, 2016 were enrolled in this study and divided into observation group and control group according to the double-blind randomized method with 50 cases in each group. A standard triple therapy （ taking 20 mg omeprazole enteric on an empty stomach, b. i. d ; taking 500 mg clarithromycin after a meal, b. i. d; taking aromoline 1 g after a meal, q. d） was performed in both groups. The observation group was additionally given 0.024 g lactoferrin, taking at a draft, q.d. The course was 2 weeks in both groups. The incidence of adverse reac- tions, symptoms improvement, HP eradication rate and recurrence rate with six months were observed. Chisquare test was performed by SPSS. Results The total curative rate in the observation group after one and two weeks treatment was 90.0% and 94.0%, in the control group was 72.0% and 78.0%. HP eradication rate after the treatment in the observa- tion group was 92.0%, which was significantly higher than 72.0% in the control group （ P 〈 0.05 ）. The incidence of adverse reactions in the observation group was 8%, which was significantly lower than 33.3% in the control group （P 〈 0.05）. The recurrence rate within six months was 22.0% in the observation group and 42.0% in the control group （P 〈 0.05）. Conclusion The clinical efficacy of Lactoferrin combined with triple therapy in the treatment of HP infection-related stomach disease in children is better than triple therapy alone, which can decrease HP positive rate and eradicate Helicobacter pylori effectively, with a lower recurrence rate and higher safety.