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含铋剂的七天钾竞争性酸阻滞剂一线方案根除治疗的疗效。

Efficacy of Seven-Day Potassium-Competitive Acid Blocker-Based First-Line Eradication Therapy Administered with Bismuth.

机构信息

Department of Internal Medicine, Konkuk University School of Medicine, Seoul, Korea.

Department of Pathology, Konkuk University School of Medicine, Seoul, Korea.

出版信息

Yonsei Med J. 2021 Aug;62(8):708-716. doi: 10.3349/ymj.2021.62.8.708.

Abstract

PURPOSE

To determine the efficacy of a potassium-competitive acid blocker (P-CAB)-based first-line eradication therapy with bismuth compared with that of proton pump inhibitor-based first-line therapy with bismuth.

MATERIALS AND METHODS

Eradication-naive -infected patients were consecutively enrolled from January to November 2020. Before approval of the P-CAB-based eradication therapy, twice daily administration of a regimen containing lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and bismuth potassium citrate 300 mg was prescribed for 7 days. After approval, lansoprazole was replaced with tegoprazan (50 mg). Clarithromycin resistance was examined in patients who underwent gastroscopic biopsy at our center. Efficacy was assessed via the C-urea breath test.

RESULTS

Of the 381 eradication-naive patients, eradication was successful in 88.3% (151/171) treated with tegoprazan and 82.8% (140/169) treated with lansoprazole in per-protocol analysis (=0.151). In intention-to-treat analysis, eradication rates were 78.8% (152/193) in the tegoprazan and 74.5% (140/188) in the lansoprazole group (=0.323). Clarithromycin resistance was observed in 30 (20.1%) of the 148 patients (74 from each group), and only four of the 16 clarithromycin-resistant patients in the tegoprazan group achieved successful eradication. Clarithromycin resistance [odds ratio (OR)=42.1, 95% confidence intervals (CIs)=12.6-141.0] and poor patient compliance (OR=17.1, 95% CIs=1.6-189.1) were independent risk factors for eradication failure.

CONCLUSION

In eradication-naive patients, eradication success rates for 7-day first-line triple therapy regimen exceeded 82% with bismuth administration. In clarithromycin-resistant patients, neither tegoprazan 50 mg nor lansoprazole 30 mg achieved acceptable eradication rates when administered twice daily for 7 days.

摘要

目的

比较基于钾竞争性酸阻滞剂(P-CAB)的铋一线根除疗法与质子泵抑制剂(PPI)联合铋的一线治疗方案的疗效。

材料和方法

2020 年 1 月至 11 月连续招募初治感染患者。在批准基于 P-CAB 的根除疗法之前,每日两次给予包含兰索拉唑 30mg、阿莫西林 1g、克拉霉素 500mg 和枸橼酸铋钾 300mg 的方案治疗 7 天。批准后,兰索拉唑被替戈拉赞(50mg)取代。在我们中心进行胃镜活检的患者中检查克拉霉素耐药性。通过 C-尿素呼气试验评估疗效。

结果

在 381 名初治患者中,替戈拉赞组 171 例(151/171)和兰索拉唑组 169 例(140/169)按方案分析的根除成功率分别为 88.3%(151/171)和 82.8%(140/169)(=0.151)。意向治疗分析中,替戈拉赞组 193 例(152/193)和兰索拉唑组 188 例(140/188)的根除率分别为 78.8%和 74.5%(=0.323)。在 148 例接受克拉霉素耐药检测的患者中(每组 74 例),有 30 例(20.1%)患者检测到克拉霉素耐药,而替戈拉赞组的 16 例克拉霉素耐药患者中,仅有 4 例达到了成功根除。克拉霉素耐药(比值比[OR]=42.1,95%置信区间[CI]为 12.6-141.0)和患者用药依从性差(OR=17.1,95%CI 为 1.6-189.1)是根除失败的独立危险因素。

结论

在初治患者中,含铋的 7 天一线三联疗法根除率超过 82%。在克拉霉素耐药患者中,替戈拉赞 50mg 或兰索拉唑 30mg 每日两次连续给药 7 天,均不能达到可接受的根除率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ffbc/8298865/41c96aee108e/ymj-62-708-g001.jpg

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