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一项关于沃诺拉赞联合阿莫西林双联方案根除幽门螺杆菌疗效的随机临床研究。

A randomized clinical study on the efficacy of vonoprazan combined with amoxicillin duo regimen for the eradication of Helicobacter pylori.

机构信息

Department of Gastroenterology, Taixing Clinical College of Bengbu Medical College, Taixing, China.

Department of Neurology, Taixing Clinical College of Bengbu Medical College, Taixing, China.

出版信息

Medicine (Baltimore). 2023 Oct 13;102(41):e35610. doi: 10.1097/MD.0000000000035610.

Abstract

BACKGROUND

Helicobacter pylori (H pylori) can cause gastritis, peptic ulcers, gastric cancer, and many other gastrointestinal diseases. The 14-day neo-dual therapy for H pylori is considered by most countries to have good eradication rates, while the 7- and 10-day studies have been more widely explored, however, we find that their results are different. The applicability of the shorter and less expensive 10-day neo-dual therapy to our country has not yet been confirmed.

METHODS

The patients were divided into 3 groups of 200 each by randomization method. Group A: patients received vonoprazan 20 mg, bid + amoxicillin(1 g), tid, for 14 days. Group B: vonoprazan (20 mg) bid + amoxicillin (1 g) tid, duration of treatment is 10 days, group C: rabeprazole (20 mg) bid + bismuth potassium citrate tablets/tinidazole tablets/clarithromycin tablets, combined package (4.2 g), bid, duration of treatment 14 days. The main comparisons were H pylori eradication rate, adverse drug reaction profile and cost-effect ratio in each group.

RESULTS

The eradication rates of groups A, B, and C were 92.5%, 91.6%, and 80.1%, respectively. There was no significant difference in the eradication rates of groups A and B (P > .05), groups A and B had statistically significantly better eradication rates than group C (P < .05). The incidence of adverse reactions in groups A, B, and C was 9.5%, 8.5%, and 17.0%, respectively. There was no difference in the incidence of adverse reactions between A and B: (P > .05), The incidence of adverse reactions was statistically significantly lower in groups A and B than in group C (P < .05). Logistic regression analysis showed nonsmokers had a higher eradication rate (OR 2.587, 95% CI: 1.377-4.859, P = .003), and taller patients were more likely to have successful eradication (OR 1.052, 95% CI: 1.008-1.097, P = .020). Group B had the lowest cost-benefit analysis results.

CONCLUSION

Group B had an acceptable eradication rate, the lowest incidence of adverse effects, and the lowest cost analysis. Eradication is more likely to be successful in patients who do not smoke and in those who are taller.

摘要

背景

幽门螺杆菌(H pylori)可引起胃炎、消化性溃疡、胃癌等多种胃肠道疾病。14 天的新型双重疗法被大多数国家认为具有良好的根除率,而 7 天和 10 天的研究则更为广泛,但我们发现其结果不同。较短、较便宜的 10 天新型双重疗法在我国的适用性尚未得到证实。

方法

采用随机分组方法将患者分为 3 组,每组 200 例。A 组:患者接受沃诺拉赞 20mg,bid+阿莫西林(1g),tid,疗程 14 天。B 组:沃诺拉赞(20mg)bid+阿莫西林(1g)tid,疗程 10 天,C 组:雷贝拉唑(20mg)bid+枸橼酸铋钾片/替硝唑片/克拉霉素片复方制剂(4.2g),bid,疗程 14 天。主要比较各组的 H 螺杆菌根除率、药物不良反应谱和成本效益比。

结果

A、B、C 组的根除率分别为 92.5%、91.6%和 80.1%。A、B 两组的根除率无统计学差异(P>0.05),A、B 两组的根除率均明显高于 C 组(P<0.05)。A、B、C 组不良反应发生率分别为 9.5%、8.5%和 17.0%。A、B 两组不良反应发生率无差异(P>0.05),A、B 两组不良反应发生率明显低于 C 组(P<0.05)。Logistic 回归分析显示,不吸烟者根除率较高(OR 2.587,95%CI:1.377-4.859,P=0.003),身高较高的患者更有可能成功根除(OR 1.052,95%CI:1.008-1.097,P=0.020)。B 组成本效益分析结果最低。

结论

B 组根除率可接受,不良反应发生率最低,成本分析最低。不吸烟者和身高较高的患者根除成功率更高。

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