The Efficacy Observation Of Different Regimens For Helicobacter Pylori Eradication

Background and aimsHelicobacter pylori (Hp) eradication treatment is becoming an emergent and difficult problem in clinical practice in recent years. Although there are various regimens for Hp eradication but few meet the need of high efficacy and compliance, safe and cheap at the same time. The regimen of standard dose proton pump inhibitors with amoxicillin, clarithromycin is presently regarded as a first alternative fist-line triple therapy. High efficacy and low drug resistance of this therapy has been proved. With more and more antibiotics are abused, the eradication rate is declining, even if accept a normal regimen, at most 20% of patients failed. Those failed patients need to access to second-line treatment. Usually PPI and bismuth salts + tetracycline + metronidazole / furazolidone quadruple therapy has been recommended as a rescue therapy. But its efficacy is dissatisfactory; there are problems of high side-effect events and lacking of tetracycline. Therefore, it is necessary to find new therapies for Helicobacter pylori eradication.This study was designed to assess the efficacy and security of a low-dose (0.5g/d) clarithromycin-based first-line triple regimen for Hp eradication and two different levofloxacin-based or doxycycline-based second-line quadruple regimens as well to analyze the cost-effectiveness ration of them.Patients and methods1. A total of 250 H.pylori-positive initial patients with peptic ulcer or chronic gastritis were randomly divided into two groups. The treatment group (low-dose clarithromycin group) received clarithromycin 0.25g, esomeprazole 20mg, amoxicillin 1.0g, twice a day for 7 days. The control group (standard group) received 7-day twice-daily treatment with clarithromycin 0.5g in combination with esomeprazole 20mg, amoxicillin 1.0g.2. Seventy H.pylori-positive patients who have failed eradication once or more previous treatments were enrolled and randomly divided into two groups. The LFBL group and the DFBL group were respective administered levofloxacin (0.5g Qd) or doxycycline (0.1g Bid) with furazolidone (0.1g Bid), bismuth potassium citrate (220 mg Bid), and lansoprazole (30 mg Bid) for 7 days.3. Follow-up ¹⁴C-UBT was performed at least 4 weeks after the end of treatment and at least 2 weeks after taking PPIs to assess the treatment response. ¹⁴C-UBT showed negative means Hp was eradicated, otherwise, means failed.4. Registered the status of gastric symptoms relief, side-effectiveness events and observed patients' compliance and tolerance.5. Cost was the whole drug expenses of a patient during eradication therapy in this study.6. Statistical method all the parameters were analyzed by the SPSS14.0.The eradication rate of Hp was analyzed by intention-to-treat(ITT) and per-protocol(PP).Enumeration data was analyzed by Chi-square test or Fisher's exact test. The significant standard was P<0.05.Results1. The results of first-line therapies for Hp eradication(1) On ITT and PP analysis, the eradication rates of Hp in the treatment group were 68.25% (95%confidence interval [CI]: 61.83-77.85%) and 74.78%(95%CI: 68.77-84.27%), in the control groupwere70.96%and 79.28%(95%CI:71.74-86.82%), respectively. There was no significant difference by statistics (P>0.05).(2) The eradication rate of patients with peptic ulcer was higher than that of patients with chronic gastritis in the two groups (P<0.01).The eradication rate of patients with chronic gastritis were especially low, 58% in treatment group and 65.22% in control group. But the eradication rate of patients with peptic ulcer or chronic gastritis was similar between the two groups (P>0.05).(3) Side effects were observed generally minor and were comparable between groups (13.04% vs. 15.32%, P>0.05). The main symptoms were nausea, light in the head or fatigue.(4) The remission rates of gastric symptoms in the two groups were 92.17%and 94.59%, respectively, difference between the two groups was not significant by statistics (P>0.05).(5) Costs of treatment group and control group were RMB 306.15 and RMB352.99. The cost-effectiveness rations of two groups were 4.09 and 4.45. The incremental cost-effectiveness ration of control group was 10.41 as against treatment group.2. The results of second-line therapies:(1) On ITT and PP analysis, the eradication rates in LFBL group were 84.21% and 88.89% (95%CI: 78.62-99.15%), DFBL group were 61.76% and 65.63% (95%CI: 49.17-82.08%), the difference was significant by statistics (P<0.05).(2) The eradication rate of patients with peptic ulcer was similar between the two groups (P>0.05), but the eradication rate of patients with chronic gastritis in LFBL group was higher than that of DFBL group (P<0.05).(3) Incidences of ADR were generally minor, respectively. No patient had to interrupt the treatment due to the presence of side effects. The occurrence of ADR were 11.11% (4/36) and 34.34% (11/32), the difference was significant by statistics (P<0.05).(4) The remission rates of gastric symptoms in the two groups were 94.44% and 81.25%, respectively. The rates of gastric symptoms relief in LFBL group was higher than that of DFBL group, but the difference was not significant by statistics (P>0.05).(5) Costs of two groups were RMB324.24 and RMB248.34, respectively. The cost-effectiveness rations of them were 3.65 and 3.78. The incremental cost-effectiveness ration of LFBL quadruple therapy as against DFBL regimen was 3.26.Conclusions1. Compared with standard triple therapy, low-dose clarithromycin triple therapy has similar therapeutic effect, side effects and lower health care costs, which is proper for low income patients.2. The eradication rate of patients with peptic ulcer is higher than that of patients with chronic gastritis in the low dose clarithromycin-based and standard triple regimens.3. Comparing with the doxycycline-based quadruple rescue regimen, the 7-days levofloxacin-based second-line quadruple therapy with levofloxacin, furazolidone, bismuth potassium citrate, and lansoprazole has higher eradication rate and fewer side effects. It's an effective, safe and economical second-line regimen for Hp eradication.