Objective: To investigate the Helicobacter pylori (H. pylori) eradication rate and improvement of dyspepsia in patients who were newly diagnosed with H. pylori infection and dyspepsia and treated by bismuth-containing quadruple therapy followed by Jing-Hua-Wei-Kang(JHWK). Methods: Patients who were newly diagnosed with dyspepsia and H. pylori infection and treated in 16 medical centers in China between December 1, 2017 and September 30, 2019 were randomly divided into two groups. The experimental group received bismuth-containing quadruple therapy (esomeprazole+amoxicillin+furazolidone+colloidal bismuth pectin capsule, 14 days), followed by JHWK (30 days), and the course of treatment was 44 days in total. In the control group, the administration regimen was bismuth-containing quadruple therapy (esomeprazole+amoxicillin+furazolidone+colloidal bismuth pectin capsule, 14 days). The main outcome measure was H. pylori eradication rate, while the secondary outcome measures were dyspepsia symptom changes and adverse events during the treatment and the 1st month after treatment. Results: A total of 1 054 patients were included in the study. There were 522 cases enrolled in the experimental group, including 224(42.91%) men and 298(57.09%) women, and the age was 53(26, 73) years old; 532 cases enrolled in the control group, including 221(41.54%) men and 311(58.46%) women, and the age was 46(22, 71) years old. Based on PP analysis, it was found that the H. pylori eradication rate in the experimental group was significantly higher than those in the control group (93.85% vs 87.88%, P=0.001). In the group of all enrolled patients, the symptom dyspepsia after H. pylori eradication was significantly improved compared with that before treatment [4(4, 7) vs 15(10, 22), P<0.001], so was the superior and middle abdominal pain [1(1, 4) vs 4(1, 8), P<0.001], the postprandial fullness [1(1, 4) vs 4(4, 9), P<0.001], the early satiety [1(1, 1) vs 4(1, 4), P<0.001], and the heartburn [1(1, 1) vs 1(1, 4), P<0.001]. The symptom dyspepsia after treatment was significantly improved compared with that before treatment in the experimental, the control groups, the successful and the unsuccessful H. pylori eradication groups. The superior and middle abdominal pain after treatment was signifcantly improved than that before treatment [1(1, 2) vs 1(1, 4), P<0.001], so were the postprandial fullness [1(1, 3) vs 1(1, 4), P=0.002] and the dyspepsia[4(4, 7) VS 7(4, 10), P<0.001]. There was no statistically significant difference in the incidence of adverse events between the experimental group and the control group (1.34% vs 0.38%, P=0.09). Conclusions: Compared with bismuth-containing quadruple therapy, bismuth-containing quadruple therapy followed by JHWK significantly improves the H. pylori eradication rate without increasing the incidence of adverse events. H. pylori eradication therapy can improve symptoms of patients with H. pylori infection and dyspepsia.
目的： 探讨铋剂四联疗法序贯荆花胃康胶丸对伴有消化不良症状的幽门螺杆菌（H. pylori）感染初治患者的H. pylori根除率和症状改善作用。 方法： 纳入2017年12月1日至2019年9月30日就诊于全国16家医疗中心的伴有消化不良症状的H. pylori感染初治患者，随机分为两组。试验组给药方案为传统铋剂四联疗法（埃索美拉唑+阿莫西林+呋喃唑酮+果胶铋胶囊，疗程14 d）序贯荆花胃康胶丸（疗程30 d），疗程共44 d。对照组给药方案为铋剂四联疗法（埃索美拉唑+阿莫西林+呋喃唑酮+果胶铋胶囊，疗程14 d）。主要观察指标为H. pylori根除率，次要观察指标为治疗后1个月消化不良症状变化情况以及不良事件的发生情况。 结果： 共纳入患者1 054例，其中试验组522例，年龄53（26，73）岁，男224例（42.91%），女298例（57.09%）；对照组532例，年龄46（22，71）岁，男221例（41.54%），女311例（58.46%）。基于PP分析发现，试验组H. pylori根除率高于对照组（93.85%比87.88%， P=0.001）。分析1 054例患者发现，H. pylori根除治疗后相较于治疗前消化不良总分［4（4，7）比15（10，22），P<0.001］、中上腹痛［1（1，4）比4（1，8），P<0.001］、餐后饱胀不适感［1（1，4）比4（4，9），P<0.001］、早饱［1（1，1）比4（1，4），P<0.001］、中上腹烧灼感［1（1，1）比1（1，4），P<0.001］均降低。同样地，试验组、对照组、根除成功组、根除失败组中消化不良在治疗后均得到改善（P<0.001）。此外H. pylori根除成功组消化不良总分［4（4，7）比7（4，10），P<0.001］、中上腹痛［1（1，2）比1（1，4），P<0.001］和餐后饱胀不适感［1（1，3）比1（1，4），P=0.002］相较于根除失败组均降低。试验组和对照组的不良反应事件发生率差异无统计学意义（1.34%比0.38%，P=0.09）。 结论： 相较于传统铋剂四联疗法，铋剂四联疗法序贯荆花胃康胶丸可提高H. pylori根除率，且不会增加不良反应事件的发生。H. pylori根除治疗可以缓解H. pylori阳性消化不良患者的症状。.