Helicobacter pylori eradication with either quadruple regimen with lactoferrin or levofloxacin-based triple therapy: a multicentre study.

BACKGROUND: Helicobacter pylori eradication rate following standard triple therapy is decreasing worldwide. A quadruple therapy with lactoferrin and a levofloxacin-based triple therapy has been found to achieve a very high (>90%) cure rate. This study aimed to confirm these encouraging results. METHODS: This was a prospective, open-label, randomised, multicentre, Italian study enrolling consecutive H. pylori infected patients. The infection at entry was assessed by endoscopy and biopsies (histology plus rapid urease test) in all patients, whilst bacterial eradication was assessed by 13C-urea breath test 4-6 weeks after therapy ended. Patients were randomised to receive either a 7-day, triple therapy with rabeprazole 20mg o.d., levofloxacin 500 mg o.d., and amoxycillin 1g b.i.d. (4 tablets/day) or a 7-day quadruple therapy comprising of rabeprazole 20mg, clarithromycin 500 mg, tinidazole 500 mg plus bovine lactoferrin 200mg, all given twice daily (10 tablets/day). RESULTS: Overall, 144 consecutive patients were enrolled in the study. Following the triple therapy, H. pylori infection was cured in 49 out of 72 (68.1%; 95% CI=57-79) patients and in 49 out of 71 (69.1%; 95% CI=58-80) at intention-to-treat and per protocol analyses, respectively. Following the quadruple regimen, the infection was cured in 52 out of 72 (72.2%; 95% CI=62-83) and in 52 out of 68 (76.5; 95% CI=66-87) patients at intention-to-treat and per protocol analyses, respectively. No statistically significant difference emerged between the two therapy regimens. CONCLUSIONS: H. pylori eradication rate following both quadruple therapy with lactoferrin and a low-dose PPI, triple therapy with levofloxacin is disappointingly low.

Has desmoplastic response extent protective action against tumor aggressiveness in gastric carcinoma?

A clinical assessment of protective action of desmoplastic response by limiting tumor aggressiveness has been carried out in 171 patients with gastric carcinoma, surgically treated at the First Surgical Clinic of the University of Rome "La Sapienza" between 1988-1999. A univariate statistical analysis was performed using Kaplan-Meier method for: desmoplastic reaction, age, sex, histologic type, tumor size, stage, lymphonodal status and metastases. To determine the influence of these factors on prognosis, the Cox regression was applied. We found a significant association between desmoplastic reaction extent and presence or absence of metastases (p= 0.026), lymphonodal involvement (p = 0.05), stage (p = 0.036). In the univariate analysis, survival was significantly related to sex (p = 0.012), tumor size (p = 0.009), lymphonodal involvement (p = 0.000), metastases (p = 0.000), stage (p = 0.000), desmoplastic reaction extent (p = 0.05); age and histologic type showed no relationship (p = n.s.). The desmoplastic response extent is not a protective factor against tumor invasiveness in gastric carcinoma, on the contrary it may be considered a negative prognostic factor.