Gastroenterologist at Damascus Hospital, Almujtahed street, Damascus, Syria.
BMC Infect Dis. 2021 Jul 4;21(1):642. doi: 10.1186/s12879-021-06356-5.
Antibiotic-resistance reduces the efficacy of conventional triple therapy for Helicobacter Pylori infections worldwide, which necessitates using various treatment protocols. We used two protocols, doxycycline-based quadruple regimen and concomitant levofloxacin regimen. The aim was to assess the effectiveness of doxycycline-based quadruple regimen for treating Helicobacter Pylori infections compared with levofloxacin concomitant regimen as empirical first-line therapy based on intention-to-treat (ITT) and per-protocol analyses (PPA) in Syrian population.
An open-label, randomised, parallel, superiority clinical trial.
We randomly assigned 78 naïve patients who tested positive for Helicobacter Pylori gastric infection, with a 1:1 ratio to (D-group) which received (bismuth subsalicylate 524 mg four times daily, doxycycline 100 mg, tinidazole 500 mg, and esomeprazole 20 mg, each twice per day for 2 weeks), or (L-group) which received (levofloxacin 500 mg daily, tinidazole 500 mg, amoxicillin 1000 mg, and esomeprazole 20 mg each twice per day for two weeks). We confirmed Helicobacter Pylori eradication by stool antigen test 8 weeks after completing the treatment.
Thirty-nine patients were allocated in each group. In the D-group, 38 patients completed the follow-up, 30 patients were cured. While in the L-group, 39 completed the follow-up, 32patients were cured. According to ITT, the eradication rates were 76.92%, and 82.05%, for the D-group and L-group respectively. Odds ratio with 95% confidence interval was 1.371 [0.454-4.146]. According to PPA, the eradication rates were 78.9%, and 82.05% for the D-group and L-group respectively. The odds ratio with 95% confidence interval was 1.219 [0.394-3.774]. We didn't report serious adverse effects.
Levofloxacin concomitant therapy wasn't superior to doxycycline based quadruple therapy. Further researches are required to identify the optimal first-line treatment for Helicobacter-Pylori Infection in the Syrian population.
We registered this study as a standard randomized clinical trial ( Clinicaltrial.gov , identifier- NCT04348786 , date:29-January-2020).
抗生素耐药性降低了全球范围内幽门螺杆菌感染的常规三联疗法的疗效，这需要使用各种治疗方案。我们使用了两种方案，基于多西环素的四联疗法和同时使用左氧氟沙星的方案。目的是根据意向治疗（ITT）和符合方案分析（PPA）评估基于多西环素的四联疗法治疗幽门螺杆菌感染的有效性，与左氧氟沙星同时使用作为经验性一线治疗方案在叙利亚人群中的疗效。
一项开放标签、随机、平行、优效性临床试验。
我们随机分配了 78 名未经治疗的幽门螺杆菌胃感染阳性患者，比例为 1:1，分为（D 组），接受（次水杨酸铋 524mg，每日 4 次；多西环素 100mg；替硝唑 500mg；埃索美拉唑 20mg，每日 2 次，持续 2 周）或（L 组），接受（左氧氟沙星 500mg，每日 1 次；替硝唑 500mg；阿莫西林 1000mg；埃索美拉唑 20mg，每日 2 次，持续 2 周）。我们在完成治疗后 8 周通过粪便抗原检测确认幽门螺杆菌的根除情况。
每组 39 名患者被分配。在 D 组中，38 名患者完成了随访，30 名患者治愈。而在 L 组中，39 名患者完成了随访，32 名患者治愈。根据 ITT，D 组和 L 组的根除率分别为 76.92%和 82.05%。95%置信区间的优势比为 1.371[0.454-4.146]。根据 PPA，D 组和 L 组的根除率分别为 78.9%和 82.05%。95%置信区间的优势比为 1.219[0.394-3.774]。我们没有报告严重的不良反应。
左氧氟沙星同时使用的方案并不优于基于多西环素的四联疗法。需要进一步研究以确定在叙利亚人群中幽门螺杆菌感染的最佳一线治疗方案。
我们将这项研究作为一项标准的随机临床试验（Clinicaltrial.gov，标识符-NCT04348786，日期：2020 年 1 月 29 日）进行了注册。
