WANG Xiao-Zhong, LI Bin and LIN Gu-Zhen 世界华人消化杂志 1998 0 0 2
关键词：Subject headings Helicobacter pylori; helicobacter infections/drug therapy; peptic ulcer/drug therapy; famotidine/therapeutic use; amoxicillin/therapeutic use; omeprazole/analogs and derivatives 期刊 sjhrxhzz 0 Original Articles fur -->
Abstract
AIM Tomake a comparative study of a triple therapy with lansoprazole or famotidine for H.pylori-associated duodenal ulcer.
METHODS Sixty patients with activeDU were randomly allocated to two groups: the first group received lansoprazole (30mg, qd)for 4 weeks plus amoxycillin (500mg, qid) and gentamycine (40mg, tid) for 2 weeks; thesecond group received famotidine (20mg, bid) for 4 weeks, plus amoxycillin (500mg, qid)and gentamycine (40mg, tid) for 2 weeks. Clinical, endoscopic and bacteriologicalevaluations were made 1 month after the treatment.
RESULTS After the treatment, theulcer healing rates were 93.3% and 90% in the lansoprazole and famotidine groups. Theeradication rate of H. pylori in lansoprazole group was significantly higher (P<0.05) than that of famotidine group (93.3% vs 70%). Although theoccurrence rate of side-effects was higher in the lansoprazole group than in thefamotidine group (10% vs 7%, P>0.05), all drugs werewell tolerated.
CONCLUSION Triple therapy withlansoprazole (4 weeks) plus amoxycillin and gentamycine (2 weeks) seems to be an effectiveand economic treatment not only for the eradication of H.pylori but also for the healingof DU.INTRODUCTION
The development of effective therapies for the treatment of Helicobacter pylori (H.pylori) infection has been a long and arduous process. After a number of false starts,Borody in Australia formulated a therapy of three antimicrobial drugs which was successfulin curing the infection in most patients. This combination therapy was called tripletherapy and consisted of bismuth, metronidazole and tetracycline. A number of therapeuticregimes have subsequently been developed since then and multiple trials revealed thattriple therapy not only eradicated H. pylori, but also improved symptoms, healed ulcers,and diminished or eliminated recurrences[1] . This study was conducted to evaluate the efficacy of tripletherapy with lansoprazole or famotidine in patients with H. pylori-associated duodenal ulcer(DU).
MATERIALS AND METHODS
Clinical materials
After a clinical examination and bioptic confirmation of H. pylori infection, 60 patients(12 females and 48 males; age range 21-58 years, mean age 43 years) with active DU werestudied. Patients with known nonsteroidal anti-inflammatory drug consumption wereexcluded. The H. pylori status was based on a commercially available,rapid urease test andhistological examination (Giemsa).
Treatment
The patients were randomly allocated to two groups: the first group received lansoprazole (Takepron, 1×30mg) in the morning for 4 weeks, amoxycillin (4×500mg) daily before mealsand at bed time, and gentamycine (3×40mg) before meals for the first 2 weeks; the secondgroup received famotidine (Gaster, 2×20mg) in the morning and bed time for 4 weeks,amoxycillin (4×500mg) daily before meals and at bed time and gentamycine (3×40mg) beforemeals for the first 2 weeks. No additional medication was given. One month aftertermination of the treatment, a control endoscopy, a rapid urease test and histologicalexamination (Giemsa) of H. pylori were performed. After the treatment, the patients wereasked whether experienced any of the following side-effects: nausea or vomiting, metallictaste, dry mouth, malaise, dysuria, headache, diarrhea, skin rash, or constipation.
The ulcer was regarded as being healed if complete epithelialization or scar formation hadoccurred. Eradication of H. pylori was suggested if both urease test and histologicalexamination gave negative results.
Statistics
Statistical analyses were made using χ2 test.
RESULTS
All 60 patients were studied without withdrawl. Drug acceptance and compliance of thepatients was 100% as judged by the interview. In the study, the DU healing rate of thelansoprazole triple therapy group was similar to that of famotidine triple therapy group(P>0.05); theeradication rate of H. pylori in the lansoprazole group was higher than that in thefamotidine group (P<0.05, Table 1).
Table 1 Results of the triple therapy with lansoprazole or famotidine
| | n | H. pylori eradication | Ulcer healing |
| n | % | n | % |
| Lansoprazole group | 30 | 28 | 93.3a | 28 | 93.3a |
| Famotidine group | 30 | 21 | 70.0 | 27 | 90.0 |
a P<0.05，vs famotidine group.
Although theoccurrence rate of side-effects was higher in the lansoprazole group (10%, tiredness andheadache in two, constipation in one patient) than in the famotidine group (about 7%, milddiarrhea in two), all drugs were well tolerated.
DISCUSSION
Since H. pylori infection is considered as the major cause of acid peptic disease, thenumber of regimens suggested for its eradication has been increasing, and H. pylorieradication appears to be positively correlated with a significant fall in relapse ratesduring prospective surveillance. Multiple clinical trials suggest thatantibiotic-associated treatment, especially when applied together with a proton pumpinhibitor, is one of the best alternatives to eradicate H. pylori and cure duodenal ulcer.Therapeutic effects of antibiotics are improved when an anti-secretory drug is added,possibly because the latter may enhance antimicrobial activity by raising the pH toapproximate neutral to slightly alkaline[2] . The combination therapy of omeprazole, metronidazole and clarithromycin, originally introduced by Bazzoli[3] , has been effectively used worldwide. But this therapy isexpensive and caused serious side-effects. The side-effects of this triple therapyappeared to be related in part to metronidazole. Ongoing researches aimed at designingsimpler, cheaper and more effective regimens to treat such patients and to change thenatural history of duodenal ulcer disease.
This study was a one-center open study on an intention-to-treat basis. The study was notconducted in a double-blind manner because the major endpoints of ulcer healing and cureof H. pylori infection are objective. According to the results, ulcer healing rates were93.3% and 90%, and the H. pylori eradication rates were 93.3% and 70% respectively in thelansoprazole group and famotidine group. Although famotidine was cheaper than lansoprazole, the triple therapy with lansoprazole had a higher H. pylori eradication ratethan famotidine group (P<0.05). The treatment strategy of maintenance therapy with H2 blocker or protonpump inhibitor for 4 weeks was used in this study, although some recent studies reportedthat a low-dose and short-term triple therapy (1-week course of omeprazole, clarythromycinand tinidazole) was highly effective both for cure of H. pylori infection and healing ofpeptic ulcer[3,4] . The viewpoint that pepticulcers may heal spontaneously after H. pylori eradication should be further studied.
Multiple epidemiological trials revealed that triple therapy could cure H. pyloriinfection and heal peptic ulcer. Results of large clinical trials are needed to provideaccurate estimation concerning the effectiveness of the different treatment regimens usingdifferent dosages, dosing intervals, and duration of therapy. We now have a number ofeffective therapies, but we still need to better understand why they work, why they donot, and in what situations one is superior to another[5] . Much work still should be done in this area.Department of Microbiology and Immunology, ShandongMedical University, Jinan 250012, China
MA Chun-Hong, female, was born on Jan. 31,1970 in Zibo City, Shandong Province, andgraduated from Department of Biology, Huazhong Normal University as a postgraduate in1994, lecturer of Department of Microbiology and Immunology, having 6 papers published.
Tel. +86*531*2952424-651
* Project supported by the Shandong Natural Science Foundation, No.931237222.
Correspondence to Dr. MA Chun-Hong, Department of Microbiology and Immunology,Shandong Medical University, Jinan 250012, China
Received 1997-07-10 Revised 1997-09-03
Department of Gastroenterology, Union Hospital,Fujian Medical University, Fuzhou 350001, China
WANG Xiao-Zhong, male, born on 1962-08-13 in Fuzhou City, Fujian Province, graduated fromHubei Medical University, master degree of gastroenterology, associate professor, having56 papers published.
Tel. +86*591*3357896-8482
Correspondence to Dr. WANG Xiao-Zhong, Department of Gastroenterology,Union Hospital, Fujian Medical University, 29 Xinquan Road, Fuzhou 350001, FujianProvince, China
Received 1997-07-10
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