Tan Bei, Luo Han-Qing, Xu Hong, Lv Nong-Hua, Shi Rui-Hua, Luo He-Sheng, Li Jian-Sheng, Ren Jian-Lin, Zou Yi-You, Li Yan-Qing, Ji Feng, Fang Jing-Yuan, Qian Jia-Ming
Department of Gastroenterology, Peking Union Medical College Hospital, Chinese Academy of Medical Science & Peking Union Medical College, Beijing, China.
Department of Gastroenterology, the First Bethune Hospital of Jilin University, Jilin, China.
PLoS One. 2017 Apr 13;12(4):e0175625. doi: 10.1371/journal.pone.0175625. eCollection 2017.
The efficacy and safety of polaprezinc combined with triple therapy was compared with triple therapy alone in the eradication of Helicobacter pylori. A randomized, parallel-group, open-label, controlled, prospective multicenter study was conducted in 11 cities in China. Treatment-naive patients with H. pylori-associated gastritis were randomly assigned to one of three arms for a 14-day treatment: Arm A triple therapy (omeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily) plus polaprezinc 75 mg twice daily; Arm B triple therapy plus polaprezinc 150 mg twice daily, or Arm C triple therapy alone. The rate of H. pylori eradication was the primary endpoint. Secondary endpoints were symptom improvement and lower incidence of adverse events. 303 patients completed the study- 106, 96, and 101 patients in Arms A, B, and C, respectively. Intention-to-treat (ITT) analysis showed that the rate of H. pylori eradication was significantly higher for Arms A (77.0%) and B (75.9%) compared to Arm C (58.6%) (P < 0.01), whereas there was no difference between Arms A and B (P = 0.90). Per-protocol (PP) analysis showed that the rate of H. pylori eradication was significantly higher for Arms A (81.1%) and B (83.3%) compared to Arm C (61.4%) (P < 0.01), whereas there was no significant difference between Arms A and B (P = 0.62). All three groups reported significant symptom improvement at 7, 14, and 28 days after treatment, compared to baseline (P < 0.0001). The adverse event rate for Arm B (5.1%) was higher than for Arms A (2.8%) (P = 0.04) and C (1.9%) (P = 0.02). There were no serious adverse events in any group. It appears that standard dose polaprezinc combined with triple therapy can significantly improve the H. pylori eradication rate, without an increase in toxicity.
在根除幽门螺杆菌方面，比较了聚普瑞锌联合三联疗法与单纯三联疗法的疗效和安全性。在中国11个城市进行了一项随机、平行组、开放标签、对照、前瞻性多中心研究。未接受过治疗的幽门螺杆菌相关性胃炎患者被随机分配到三个治疗组之一，进行为期14天的治疗：A组为三联疗法（奥美拉唑20毫克、阿莫西林1克和克拉霉素500毫克，均每日两次）加聚普瑞锌75毫克，每日两次；B组为三联疗法加聚普瑞锌150毫克，每日两次；C组为单纯三联疗法。幽门螺杆菌根除率是主要终点。次要终点是症状改善和不良事件发生率降低。303例患者完成了研究，A组、B组和C组分别有106例、96例和101例患者。意向性分析（ITT）显示，A组（77.0%）和B组（75.9%）的幽门螺杆菌根除率显著高于C组（58.6%）（P<0.01），而A组和B组之间无差异（P=0.90）。符合方案分析（PP）显示，A组（81.1%）和B组（83.3%）的幽门螺杆菌根除率显著高于C组（61.4%）（P<0.01），而A组和B组之间无显著差异（P=0.62）。与基线相比，所有三组在治疗后7天、14天和28天均报告症状有显著改善（P<0.0001）。B组的不良事件发生率（5.1%）高于A组（2.8%）（P=0.04）和C组（1.9%）（P=0.02）。任何组均未发生严重不良事件。似乎标准剂量的聚普瑞锌联合三联疗法可显著提高幽门螺杆菌根除率，且不增加毒性。
