Randomised controlled trial: susceptibility-guided therapy versus empiric bismuth quadruple therapy for first-line Helicobacter pylori treatment

被引：103

作者：

Chen, Qi ^{[1
]}

Long, Xiaohua ^{[1
]}

Ji, Yingjie ^{[1
]}

Liang, Xiao ^{[1
]}

Li, Dongping ^{[2
]}

Gao, Hong ^{[2
]}

Xu, Beili ^{[2
]}

Liu, Ming ^{[2
]}

Chen, Ying ^{[3
]}

Sun, Yunwei ^{[3
]}

Zhao, Yan ^{[4
]}

Xu, Gang ^{[5
]}

Song, Yanyan ^{[6
]}

Yu, Lou ^{[1
]}

Zhang, Wei ^{[1
]}

Liu, Wenzhong ^{[1
]}

Graham, David Y. ^{[7
,8
]}

Lu, Hong ^{[9
]}

机构：

[1] Shanghai Jiao Tong Univ, Key Lab Gastroenterol & Hepatol, Div Gastroenterol & Hepatol, Minist Hlth,Shanghai Inst Digest Dis,Renji Hosp,S, Shanghai, Peoples R China

[2] Fudan Univ, Zhongshan Hosp, Dept Gastroenterol, Shanghai, Peoples R China

[3] Shanghai Jiao Tong Univ, Ruijin Hosp, Dept Gastroenterol, Sch Med, Shanghai, Peoples R China

[4] Tongji Univ, Shanghai Peoples Hosp 10, Dept Gastroenterol, Sch Med, Shanghai, Peoples R China

[5] Shanghai Jiao Tong Univ, Shanghai Gen Hosp, Dept Gastroenterol & Hepatol, Sch Med, Shanghai, Peoples R China

[6] Shanghai Jiao Tong Univ, Inst Med Sci, Dept Biostat, Sch Med, Shanghai, Peoples R China

[7] Michael E DeBakey VA Med Ctr, Dept Med, Houston, TX USA

[8] Baylor Coll Med, Houston, TX 77030 USA

[9] Shanghai Jiao Tong Univ, Clin Res Ctr, Sch Med, Shanghai, Peoples R China

来源：

ALIMENTARY PHARMACOLOGY & THERAPEUTICS | 2019年 / 49卷 / 11期

关键词：

14-DAY TRIPLE THERAPY; ERADICATION THERAPY; ANTIBIOTIC-RESISTANCE; CONCOMITANT THERAPY; CLARITHROMYCIN; AMOXICILLIN; TETRACYCLINE; AZITHROMYCIN; DOXYCYCLINE; BENZATHINE;

D O I：

10.1111/apt.15273

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

100201 [内科学];

摘要：

Background Increasing Helicobacter pylori resistance has led to decreases in treatment effectiveness. Aim To test the effectiveness of susceptibility-guided therapy vs a locally highly effective empiric modified bismuth quadruple therapy for first-line H pylori treatment in a region with high antimicrobial resistance. Methods We compared 14-day susceptibility-guided with empiric therapy using a multicentre superiority-design trial, which randomised H pylori infected subjects 3:1 to (a) susceptibility-guided therapies contained esomeprazole 20 mg and amoxicillin 1 g b.d. plus clarithromycin 500 mg, metronidazole 400 mg b.d., or levofloxacin 500 mg daily for susceptible infections or bismuth 220 mg b.d. and metronidazole 400 mg q.d.s. for triple-resistant infections; (b) Empiric therapy contained esomeprazole 20 mg, bismuth 220 mg b.d., amoxicillin 1 g and metronidazole 400 mg t.d.s. Primary outcome was H pylori eradication. Results Between February 2017 and March 2018, 491 subjects were screened and 382 were randomised. Both the susceptibility-guided and the empiric regimens were highly successful with per-protocol eradication rates of 97.7% (250/256) vs 97.6% (81/83, P = 1.00) and intent-to-treat eradication rates of 91.6% (262/286) vs 85.4% (82/96, P = 0.12). Overall, susceptibility-guided therapy was not superior to empiric therapy with 0.1% per-protocol (95% CI -3.1% to 3.2%) and 6.2% intent-to-treat (-0.3% to 12.7%) eradication difference. Both approaches had high adherence and low adverse event rates. Conclusions Both susceptibility-guided and empiric therapies provided excellent eradication rates. Clinically, the choice would hinge on availability of susceptibility testing and/or a locally highly effective empiric therapy.

引用

页码：1385 / 1394

页数：10

共 49 条

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Rescue Therapy for Helicobacter pylori Eradication: A Randomized Non-Inferiority Trial of Amoxicillin or Tetracycline in Bismuth Quadruple Therapy [J].