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據(jù)近日在線發(fā)表在《柳葉刀》雜志上的一研究文章介紹,我國**幽門螺桿菌聯(lián)盟公布的一項(xiàng)多中心、開放標(biāo)簽、隨機(jī)研究顯示,與標(biāo)準(zhǔn)三聯(lián)抗幽門螺桿菌(Hp)治療相比,序貫治療的Hp根除率更高。因此,研究者認(rèn)為,序貫療法應(yīng)成為Hp感染的標(biāo)準(zhǔn)一線治療方案。
該研究從**6個(gè)醫(yī)療中心納入900例Hp感染患者,隨機(jī)分入序貫療法10 d(S-10,頭5 d應(yīng)用蘭索拉唑30 mg、阿莫西林1 g;后5 d應(yīng)用蘭索拉唑30 mg、克拉霉素500 mg和甲硝唑500 mg;按照2次/d給藥)組、序貫療法14 d(S-14,頭7 d應(yīng)用蘭索拉唑30 mg、阿莫西林1 g;后7 d應(yīng)用蘭索拉唑30 mg、克拉霉素500 mg和甲硝唑500 mg;按照2次/d給藥)組以及三聯(lián)療法14 d(T-14,全程應(yīng)用蘭索拉唑30 mg、阿莫西林1 g和克拉霉素500 mg,所有藥物2次/d)組。
結(jié)果顯示,S-14組、S-10組和T-14組的Hp根除率依次為90.7%、87.0%和82.3%。在意向治療(ITT)分析(需治療例數(shù)12.0,P=0.003)和實(shí)際完成治療(PP)分析(需治療例數(shù)13.7,P=0.003)中,S-14組的療效均優(yōu)于T-14組。三組的不良反應(yīng)或并發(fā)癥發(fā)生率無顯著差異。
研究者指出,在研究涉及的地區(qū),克拉霉素耐藥率和甲硝唑耐藥率分別為10%和24%。克拉霉素耐藥可降低所有Hp根除方案療效,而甲硝唑耐藥僅影響序貫療法療效。在該研究中,不論10 d還是14 d序貫療法,療效均優(yōu)于三聯(lián)療法。此外,在序貫療法和三聯(lián)療法治療失敗的患者中,包含左氧氟沙星的改良序貫療法也有效。因此,序貫療法可取代三聯(lián)療法,成為Hp感染的一線標(biāo)準(zhǔn)治療方案。研究者強(qiáng)調(diào),最佳Hp根除方案應(yīng)根據(jù)當(dāng)?shù)豀p的抗生素耐藥情況來選擇。
Sequential versus t**le therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial.
Lancet 2012 Nov 15;[Epub ahead of print] PMID:23158886
Department of Internal Medicine, National Taiwan University Hospital, National Taiwan University College of Medicine, Taipei, Taiwan; Graduate Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan.
BACKGROUND: Whether sequential treatment can replace t**le therapy as the standard treatment for Helicobacter pylori infection is unknown. We compared the efficacy of sequential treatment for 10 days and 14 days with t**le therapy for 14 days in first-line treatment. METHODS: For this multicentre, open-label, randomised trial, we recruited patients (≥20 years of age) with H pylori infection from six centres in Taiwan. Using a computer-generated randomisation sequence, we randomly allocated patients (1:1:1; block sizes of six) to either sequential treatment (lansoprazole 30 mg and amoxicillin 1 g for the first 7 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg for another 7 days; with all drugs given twice daily) for either 10 days (S-10) or 14 days (S-14), of 14 days of t**le therapy (T-14; lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg for 14 days; with all drugs given twice daily). Investigators were masked to treatment allocation. Our primary outcome was the eradication rate in first-line treatment by intention-to-treat (ITT) and per-protocol (PP) analyses. This trial is registered with ClinicalTrials.gov, number NCT01042184. FINDINGS: Between Dec 28, 2009, and Sept 24, 2011, we enrolled 900 patients: 300 to each group. The eradication rate was 90·7% (95% CI 87·4-94·0; 272 of 300 patients) in the S-14 group, 87·0% (83·2-90·8; 261 of 300 patients) in the S-10 group, and 82·3% (78·0-86·6; 247 of 300 patients) in the T-14 group. Treatment efficacy was better in the S-14 group than it was in the T-14 group in both the ITT analysis (number needed to treat of 12·0 [95% CI 7·2-34·5]; p=0·003) and PP analyses (13·7 [8·3-40], p=0·003). We recorded no significant difference in the occurrence of adverse effects or in compliance between the three groups. INTERPRETATION: Our findings lend support to the use of sequential treatment as the standard first-line treatment for H pylori infection. FUNDING: National Taiwan University Hospital and National Science Council.
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