Sequential Therapy Versus 10-day Triple-drug Therapy For Helicobacter Pylori Eradication

Objective: Helicobacter pylori-related (Helicobacter pylori,H.pylori) disease is a major global problem, China is one of the countries with a high H.pylori infection rate.In different countries,regions or different ethnic groups,H.pylori detection rate in natural crowd is 40 %-90 %,which has great difference. Because H.pylori infection is closely related to the diseases such as chronic gastritis,peptic ulcer,gastric cancer and gastric mucosa–associated lymphoid tissue lymphoma,eradication of H.pylori has been widely used in clinical treatment.There are two main Eradication treatment of triple therapy commonly used:PPI plus two antibiotics or bismuth plus two antibiotics. But in recent years with the rise of antibiotic resistance of H.pylori,Helicobacter pylori eradication rate of standard triple therapy have a declined tendency,which declined to 60-76% in many regions.Therefore,in order to improve the eradication rate,and to avoid the secondary drug resistance,it comes to be a hot spot at home and abroad looking for a new treatment option to improve the eradication rate for the first time.In recent years,it was suggested that a new treatment option - 10d sequential therapy,the domestic Foreign studies have shown that higher eradication rate for the first time.The objective of this study is to to determine whether sequential therapy eradicating H.pylori infection is better than standard triple-drug therapy.Methods:1 Materials:the time was from March 2009, to December 2009 a total of 198 adults were collected for eradication sequentially in shijiazhang from the patients having upper abdominal pain, heartburn,acid reflux and other upper gastrointestinal symptoms. 3 patients lost to follow,and 1 patient can not complete the full course of treatment,the actual completion is 194 cases.These patients ranged in age from 18 to 70 years with a average age of 46.19±11.43 years,including 98 males,and 96 females,whose illnesses were diagnosed with gastroduodenal diseaserom from Third Hospital of Hebei Medical University.2 Selection criteria: the following two terms must be met:(1)Patients with chronic active gastritis, peptic ulcer,first-degree relatives of the patients with gastric cancer, gastroesophageal reflux disease who need long-term acid-suppressing drugs, functional dyspepsia by conventional therapy is poor, willing to cooperate and can be follow-up of persons aged 18-75 years old; (2) H.pylori-positive: H. pylori infection at entry was assessed by rapid urease test from the antrum .And the following conditions must be met:①4 weeks without the use of proton pump inhibitor (PPI), H2 receptor antagonists, bismuth agents and antibiotics;②No relevant history of drug allergy;③No gastrointestinal bleeding, pyloric obstruction, perforation, cancer ulcer, etc.;④No history of gastrointestinal disease, surgery;⑤Without serious heart, lung, liver, renal insufficiency;⑥Non-pregnant and lactating women;⑦Drugs used in this study no allergic history. All patients were treated through eradication of H.pylori for the first time. 3Methods: Patients were randomly divided into two groups (according to random number tables, odd for the treatment group, even as the control group) for H.pylori eradication therapy, respectively, as follows: the treatment group (EACF group, n = 99): Esomeprazole 20 mg bid (Wuxi, AstraZeneca) plus Amoxycillin 1g bid (Commonwealth Pharmaceutical Co., Ltd. production) for the first 5 days,followed by Esomeprazole 20 mg bid., Clarithromycin 500 mg bid(Yangtze River Pharmaceutical Group production). and Furazolidone 100 mg bid. (Tianjin Lisheng Pharmaceutical Co., Ltd. production), for the remaining 5 days; the control group (EAC group, n = 95): Esomeprazole 20mg; Amoxicillin 1000mg, Clarithromycin tablet 500mg; are for the twice daily treatment for 10 days.4 Judgments of the effect of H.pylori eradication:Bacterial eradication was assessed by 14C-urea breath test when it is 4 weeks after therapy had ended. And the major side-effects were recorded accurately.SAS V8 data statistical software was used for statistical analysis. The differences of rates were analyzed byχ2 test. P value of <0.05 was regarded as statistically significant.Results:General information: Treatment group:101 cases were enrolled, 1 case lost to follow,1was removed from the 101 patients because they can not tolerate clarithromycin the first 3 days instead of the full 5 days, more than 99 cases have compl -eted the whole course of treatment,The treatment group contains 99 patients, ranged in age from 18 to 68 years with a average age of 46.72±6.19years; The control group contains 95 patients, ranged in age from 20 to 70 years with a average age of 45.81±7.03years; the difference between the two groups was of no statistical significance on age,sex and disease classification (P >0.05). (Table 1and 2)Comparison of eradication rate:99 complete the treatment in treatment group,92cases succeded in eradication, the eradication rate of 10-day sequential therapy was 91.92%, 95 complete the treatment in control group, among the total, of which 77 cases of successful eradication,and the eradication rate of control group was 81.05%. The difference between two groups was significant (P<0.05).(Table3)Adverse drug reactions:Adverse reactions take place in 8 cases of the treatment group,and 6 cases in the control group.The adverse effect rates of the 2 groups were 8.08% and 6.31%,respectively.The difference was of statistical significance between the 2 groups (P >0.05).(Table 4)The capital adverse effect are oral odor,some abdominal pain,diarrhea, nausea,vomiting and other gastrointestinal reactions,headaches,allergies.The adverse effectsare mild,and do not need the special treatmen.The symptom can disappear after the course of treatment.The adverse effects were considered to be concerned with Medication.The two groups all completed the whole course of treatment. (Table5)The cost comparison: 10-day sequential therapy cost 478.74 yuan,10-day triple therapy cost 629.14 yuan.The former reduces the patients economic burden in larger extent.(Table 6)Conclusion: 1.The eradication rate of 10-day sequential therapy was 91.92%,and the eradication rate of control group was 81.05%.10-day sequential therapy achieves a higher eradication rate than 10-day triple therapy for the first time in adults;2.10-day sequential therapy was well tolerated, high compliance and fewer adverse reactions;3.10-day sequential therapy has a higher cost-effective than the traditional 10-day triple therapy, with economic, affordable, effective and so on.