Levofloxacin-containing triple and sequential therapy or standard sequential therapy as the first line treatment for Helicobacter pylori eradication in China.
OBJECTIVE
To compare the efficacy and the adverse effects of levofloxacin-containing triple therapy, standard sequential therapy, and levofloxacin-containing sequential therapy as first-line treatment for Helicobacter pylori eradication.


METHODS
Three hundred and forty-five naive H. pylori-positive patients were randomized to receive levofloxacin-containing 7-day triple therapy (Levo triple, i.e., esomeprazole, 20 mg, twice daily, amoxicillin, 1 g, twice daily, and levofloxacin, 500 mg, once daily for 7 days, n = 114), standard sequential therapy (SST-10, 5-day esomeprazole, 20 mg, twice daily and amoxicillin, 1 g, twice daily followed by 5-day esomeprazole, 20 mg, twice daily, clarithromycin, 500 mg, twice daily and tinidazole, 500 mg, twice daily for 5 days, n = 115) or levofloxacin-containing sequential therapy (Levo-ST-10, 5-day esomeprazole, 20 mg, twice daily and amoxicillin, 1 g, twice daily for 5 days followed by 5-day esomeprazole, 20 mg, twice daily, levofloxacin, 500 mg, once daily and tinidazole, 500 mg, twice daily, n = 116). Eradication was confirmed by a (13) C-urea breath test 4 weeks after completion of treatment.


RESULTS
Intention to treat (ITT) eradication rates were 78.1% (95% CI: 69.4, 85.3%), 78.3% (95% CI: 69.6, 85.4%), and 82.8% (95% CI: 74.6, 89.1%) for Levo triple, SST-10, Levo-ST-10, respectively (p = .599). Per protocol (PP) eradication rates were 80.9% (95% CI: 72.3, 87.8%), 82.6% (95% CI: 74.1, 89.2%), and 86.5% (95% CI: 78.7, 92.2%), respectively, for the three therapies (p = .513). Overall, 3.8% experienced mild to moderate adverse events; the rates were 1.75, 4.35, and 5.17%, respectively, in the three groups (p = .325).


CONCLUSIONS
Standard sequential therapy and 7-day levofloxacin triple therapy produced unacceptably therapeutic efficacy in China. Only levofloxacin-containing sequential therapy achieved borderline acceptable result. None of the regimens tested reliably achieved 90% or greater therapeutic efficacy in China.
Department of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing, 210029, China.
Juan
J
Qian
Feng
F
Ye
Jun
J
Zhang
Yan-Mei
YM
Yang
Hui-Ming
HM
Tu
Qi
Q
Jiang
Li
L
Shang
Xiao-Lin
XL
Pan
Rui-Hua
RH
Shi
Guo-Xin
GX
Zhang
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001944:Breath Tests; D002681:China; D004359:Drug Therapy, Combination / Q000009:adverse effects / Q000379:methods; D005260:Female; D016481:Helicobacter Infections / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D064704:Levofloxacin; D008297:Male; D008875:Middle Aged; D015242:Ofloxacin / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome; D014508:Urea / Q000032:analysis; D055815:Young Adult
D000900:Anti-Bacterial Agents; D064704:Levofloxacin; D014508:Urea; D015242:Ofloxacin