黄连素等四联疗法根除幽门螺杆菌感染的临床观察

Clinical Observation of Quadruple Therapy to Eradicate Helicobacter pylori Infection

摘要: 背景：由于抗H. pylori感染抗生素耐药率的逐渐升高，探索高效的H. pylori根除方案已成为临床工作者的当务之急。目的：探讨黄连素联合阿莫西林、雷贝拉唑、果胶铋四联治疗Hp感染的临床疗效。方法：选取¹⁴C呼气试验确诊为HP感染的120名患者为研究对象，随机分为黄连素组和呋喃唑酮组。黄连素组由盐酸小檗碱片、阿莫西林、胶体果胶铋、雷贝拉唑组成；呋喃唑酮组由呋喃唑酮、阿莫西林、胶体果胶铋、雷贝拉唑组成。两组疗程均为14天。用药结束后1月复查碳-14，碳-14为阴性为H. pylori根除成功，并计算根除率。根除率分别用意愿分析(ITT)和按方案分析(PP)进行评估。结果：60例呋喃唑酮组中有57例完成复查，其中53例成功根除H. pylori。60例黄连素组全部完成复查，其中53例成功根除H. pylori。按ITT分析，呋喃唑酮组和黄连素组的H. pylori根除率分别为92.9% (53/57)和88.3% (53/60)，差异无统计学意义(χ² =0.000, P = 1.000, P > 0.05)。按PP分析，呋喃唑酮组和黄连素组的H. pylori根除率分别为93.0% (53/57)和88.3% (53/60)，差异无统计学意义(χ² = 0.742, P = 0.389, P > 0.05)。黄连素组和呋响唑酮组不良反应总体发生率分别是11.7%和7.0%，差异无统计学意义(P > 0.05)。结论：黄连素组与呋喃唑酮组均能获得理想的根除效果，两组不良反应低，经济成本低。

Abstract: Background: Due to the gradually increasing rate of antibiotic resistance against H. pylori infection, the exploration of highly efficient Helicobacter pylori (HP) eradication programs has become a top priority for clinical workers. Objective: To explore the clinical efficacy of berberine combined with amoxicillin, rabeprazole and pectin bismuth quadruple therapy for Hp infection. Methods: A total of 120 patients with the ¹⁴C breath test were selected and randomized into berberine and furazolidone. The berberine group consists of berberine hydrochloride tablets, amoxicillin, colloidal pectin bismuth, and rabeprazole, and the furazolidone group consists of furazolidone, amoxicillin, colloidal pectin bismuth, and rabeprazole. Both sessions were 14 days. ¹⁴C breath test was reviewed at 1 month after medication, and ¹⁴C breath test was negative for H. pylori eradication, and the eradication rate was calculated. The eradication rates were assessed by intention analysis (ITT) and per protocol analysis (PP). Results: 57 of the 60 patients in the furazolidone group completed review, and 53 had successful eradication of H. pylori. All 60 cases in the berberine group completed review, and 53 had successful eradication of H. pylori. By ITT analysis, H. pylori eradication rates were 92.9% (53/57) and 88.3% (53/60) in the furazolidone and berberine groups, respectively, without a statistically significant difference (χ² = 0.000, P = 1.000, P > 0.05). By PP analysis, the H. pylori eradication rate was 93.0% (53/57) and 88.3% (53/60), respectively, with no statistically significant difference (χ² = 0.742, P = 0.389, P > 0.05). The overall incidence of adverse reactions in the berberine and furazazolone groups was 11.7% and 7.0%, respectively, which was not statistically significant. Conclusion: Both the berberine and furazolidone groups achieved an ideal eradication effect, with low adverse effects and low economic cost in both groups.