1、Management of Helicobacter pylori infection the Maastricht IV/ Florence Consensus Report 幽门螺杆菌感染的处理 马斯特里赫特 IV/ 佛罗伦萨共识报告 Malfertheiner P, et al. Gut 2012; 61: 646-664 （ 上海 交通大 学医 学院附 属仁 济医院 消化 科 刘 文忠 教授 译） WORKSHOP 1 工作小组 1 (Indications and contraindications for diagnosis and treatment) ( 诊断、治疗指证和反指证
2、) Statement 1: A test-and-treat strategy is appropriate for uninvestigated dyspepsia in populations where the H. pylori prevalence is high (20%). This approach is subject to local cost-benefit considerations and is not applicable to patients with alarm symptoms, or older patients (age to be determin
3、ed locally according to cancer risk) Evidence level:1a, Grade of recommendation: A 检测和治疗 策略对 幽 门 螺杆菌感染 率高于 20%人群 中 未 经 调 查的消 化不良 者 是合适的。这一方法 应考虑当地的费用- 效益 比，不适用于有报警 症状患者或 老年患者（年龄应根据当地癌症风险确定） 证据水平:1a, 推荐级别: A Statement 2: The main non-invasive tests that can be used for the test-and-treat strategy are
4、 the UBT and monoclonal stool antigen tests. Certain validated serological tests can also be used.2a,B 用于检测和治疗策略的主要非侵入性试验是尿素呼气试验 （UBT ） 和单克隆 粪便抗原试验。也可用某些已经过验证的血清学试验。2a ，B Statement 3: H. pylori eradication produces long-term relief of dyspepsia in one of 12 patients with H.pylori and functional dysp
5、epsia; this is better than any other treatment.1a,A 根除幽门螺杆菌可使 1/12 幽门螺杆菌阳性功 能性消化不良患者有长期的症 状缓解，这一疗效优于其他任何治疗。1a,A Statement 4: H. pylori can increase or decrease acid secretion depending on the intragastric distribution of inflammation.2b,B 幽门螺杆菌感染可以增加或降低胃酸分泌，这取决于胃内炎症的分布。 2b,B Statement 5: On average,
6、 H.pylori status has no effect on symptom severity, symptom recurrence and treatment efficacy in GORD. H. pylori eradication does not exacerbate pre-existing GORD or affect treatment efficacy.1a,A 平均而言， 幽门螺杆菌状态对胃食管反流病 （GERD ） 症状的严重性、 症状复 发和治疗效果无影响。根除幽门螺杆菌不会加重原本已存在的 GERD ，不会影响 治疗效果。1a,A Statement 6:
7、Epidemiological studies show a negative association between the prevalence of H.pylori and the severity of GORD and incidence of esophageal adenocarcinoma.2a,B 流行病学研究表明， 幽门螺杆菌感染率与 GERD 严重性和食道腺癌发病率呈 负相关。2a,B Statement 7: H. pylori infection is associated with an increased risk of uncomplicated and co
8、mplicated gastroduodenal ulcers in NSAID and low-dose aspirin (acetosalicylic acid (ASA) users. 2a,B Eradication reduces the risk of complicated and uncomplicated gastroduodenal ulcers associated with either NSAID or low-dose ASA use.1b,A 幽门螺杆菌感 染与服用 非甾体类抗炎 药（NSAID ）和低剂量阿司 匹林 者发生 胃十二指肠溃疡 （无或有并发症） 的风
9、险增加相关。2a,B 根除幽门 螺杆菌可降 低服用 NSAID 或低剂量 阿司匹林者发生胃十二指肠溃疡 （无或有并发症） 的风险。 1b,A Statement 8: H. pylori eradication is beneficial before starting NSAID treatment. It is mandatory in patients with a peptic ulcer history 1b,A. However, H pylori eradication alone does not reduce the incidence of gastroduodenal u
10、lcers in patients already receiving long-term NSAID treatment. They require continued PPI treatment as well as eradication treatment.1b,A 在 NSAID 治疗开始前根 除幽门螺杆菌是有益的。 有消化性溃疡病史者 必须进 行根除。 然而单单根除 幽门螺杆菌不能降低已在接受长期 NSAID 治疗 患者胃十二 指肠溃疡的发生率。 他们除需要根除幽门螺杆菌外， 还要持续质子泵抑制剂 （PPI ） 治疗。1b,A Statement 9: Testing for H.
11、 pylori should be performed in ASA users with a history of gastroduodenal ulcer. The long-term incidence of peptic ulcer bleeding is low in these patients after receiving eradication even in the absence of gastroprotective treatment.2b,B 有胃十二指肠溃疡病史的阿司匹林服用者必须检测幽门螺杆菌。 接受根除治 疗后，即使无胃保护治疗，这些患者中消化性溃疡出血的长期
12、发生率低。2b,B Statement 10a: Long-term treatment with PPIs in H.pylori-positive patients is associated with the development of a corpus-predominant gastritis. This accelerates the process of loss of specialised glands, leading to atrophic gastritis.1c,A 幽门螺杆菌阳性患者长期 PPI 治疗与发生胃体为主胃炎相关。这可加速特 殊腺体的丢失，从而导致萎缩性
13、胃炎。1c,A Statement 10b: Eradication of H. pylori in patients receiving long-term PPIs heals gastritis and prevents the progression to atrophic gastritis. However, there is no evidence that this reduces the risk of gastric cancer.1b,A 接受长期 PPI 治疗的患者根除幽门螺杆菌可愈合胃炎， 预防萎缩性胃炎发生。 但尚无证据表明，这可降低胃癌发生的风险。1b,A Sta
14、tement 11a: There is accumulating evidence that after H.pylori eradication, corpus function may improve. However, whether this is associated with regression of atrophic gastritis remains equivocal.2a,B 越来越多的证据表明， 幽门螺杆菌根除后， 胃体功能改善。 然而， 这一相关 性是否由于萎缩性胃炎逆转尚不明确。2a,B Statement 11b: There is no evidence th
15、at H. pylori eradication can lead to regression of intestinal metaplasia.2a,B 尚无证据表明，根除幽门螺杆菌能逆转肠化生。2a,B Statement 12: H. pylori eradication is the first-line treatment for low-grade gastric marginal zone (MALT) lymphoma.1a,A 根除幽门螺杆菌是低级别胃 MALT 淋巴瘤的一 线治疗。1a,A Statement 13: There is evidence linking H.
16、 pylori to the aetiology of otherwise unexplained iron-deficiency anemia, idiopathic thrombocytopenic purpura (ITP) and vitamin B12 deficiency. In these disorders, H pylori should be sought and eradicated. 1. Iron-deficiency anaemia1a,A 2. ITP 1b,A 3. Vitamin B12 deficiency 3b, B The evidence availa
17、ble shows no unequivocal causative association between H pylori and other extragastric disorders, including cardiovascular and neurological disorders. 有证据表 明，幽 门螺杆 菌与不明 原因缺 铁性贫 血、特发 性血小 板减少 性紫癜 （ITP ）和维生素 B12 缺乏的发病相关。对这些疾病，应该检测和根除幽门螺杆 菌。 1. 缺铁性贫血1a,A 2. ITP 患者1b,A 3. 维生素 B12 缺乏3b,B 现有证据尚未能明确幽门螺杆菌和其他
18、胃外疾病( 包括心血管系统和神经系 统疾病) 之间的因果关系。 Statement 14: The evidence available shows no definite causative protective effect of H. pylori against the following disorders nor that its eradication causes or worsens them. However, further research is needed. 1. Asthma and atopy 2. Obesity and related illnesses 现
19、有的证据尚未能明确幽门螺杆菌对下列疾病的发病起保护性作用，也 不 明 确根除治疗是否可引起或加重这些疾病。然而，还需要进一步研究。 1. 哮喘和过敏性疾病 2. 肥胖及其相关疾病 Statement 15: In H. pylori-positive patients eradication treatment improves the bioavailability of thyroxine and l-dopa.2b,B 幽门螺杆菌阳性患者根除治疗可改善甲状腺素和左旋多巴的生物利用度。 2b,B Statement 16: Certain H.pylori virulence factor
20、s and certain host genetic polymorphisms are known to affect the risk of any specific individual developing H. pylori-associated disease. However, there is no evidence that strategies based on testing for these factors are useful for an individual patient. 幽门螺杆菌的某些毒力因子和宿主的某些遗传多态性被认为影响特异个体 发生幽门螺杆菌相关疾
21、病的风险。 然而， 无证 据表明基于这些因子检测的策略对 个体患者有用。 WORKSHOP 2 工 作小组 2 (Diagnostic tests and treatment of infection) （感染的诊断试验和治疗） Statement 1: The diagnostic accuracy of the stool antigen test (SAT) is equivalent to the UBT if a validated laboratory-based monoclonal test is used.1a,A 如果使 用经 过验 证 的在实 验室 检测 的单克 隆试验
22、，粪 便抗 原试验 （SAT ）的 诊断准确率与尿素呼气试验相当。1a,A Statement 2: The serological tests are not all equivalent. Only validated IgG serology tests should be used owing to variability in the accuracy of different commercial tests.1b,B 血清学试验并不都相同。 不同的商业试验准确性存在差异， 只有经过验证的 IgG 血清学试验才可以应用。1b,B Statement 3: A validated I
23、gG serology may be used in the setting of recent use of antimicrobial 5,D and antisecretory drugs, or ulcer bleeding, atrophy and gastric malignancies.1b,B 验证的 IgG 血清学试验可用于最近使用抗菌素5,D和抑酸药物，或溃 疡出 血、萎缩及胃恶性肿瘤等情况。1b,B Statement 4: In patients treated with PPIs: (1) if possible, PPI should be stopped for
24、2 weeks before testing by culture, histology, rapid urease test, UBT or stool test.1b,A (2) if it is not possible, validated IgG serology can be performed.2b,B 用 PPI 治疗的患者： （1 ）如果可能，在用培养、组织学、快速尿素酶试验、 尿素呼气 试验或 粪便试验 检测幽 门螺杆 菌前， 应停用 2 周。1b,A （2 ）如果不 可能，可用经过验证的 IgG 血清试验。2b,B Statement 5: (1) It is impor
25、tant to perform culture and standard susceptibility testing to antimicrobial agents in a region or population of high clarithromycin resistance before prescription of the first-line treatment if the standard clarithromycin- containing triple therapy is being considered. Furthermore, culture and stan
26、dard susceptibility testing should be considered in all regions before second-line treatment if endoscopy is carried out for another reason and generally when a second-line treatment has failed.5,D (2) If standard susceptibility testing is not possible, molecular tests can be used to detect H pylori
27、 and clarithromycin and/or fluoroquinolone resistance directly on gastric biopsies.1b,A (1) 在克拉霉素高耐药率地区，如果考虑用含克拉霉素的标准三联方案作为 一线疗法， 那么重要的是进行培养和标准药敏试验。 此外， 当因其他原因进行内 镜检查时的第 2 次治疗和第 2 次治疗失败时， 所有地区都应该考虑进行培养和标 准药敏试验。5,D (2) 如果标准药敏试验不可能进行， 就直接在活检标本上用分 子试验方法检测幽门螺杆菌以及克拉霉素和/ 或氟喹诺酮的耐药。1b,A Statement 6: (1) If
28、H. pylori is cultured from gastric biopsy specimens, antibiotic susceptibility testing should include metronidazole. 1b,A(2) If susceptibility for clarithromycin is assessed by molecular tests, the addition of culture for the assessment of metronidazole resistance is not justified.5,D (1) 如果幽 门螺杆菌是
29、从胃活检标本 中培养， 药敏试验应包 括甲硝唑 。(2) 如 果对克拉霉素的敏感性是从分子试验评估， 另加培养来评估甲硝唑耐药性就不合 适。5,D Statement 7: PPI-clarithromycin-containing triple therapy without prior susceptibility testing should be abandoned when the clarithromycin resistance rate in the region is more than 15-20%.5,D 当该地区克拉霉素耐药率大于 15-20时，不 预先进行药敏试验就应
30、该放弃 含 PPI - 克拉霉素的三联 疗法。5,D Statement 8: In areas of low clarithromycin resistance, clarithromycin-containing treatments are recommended for first-line empirical treatment. Bismuth-containing quadruple therapy is also an alternative.1a,A 克拉霉素 低耐药 地区， 含克拉霉 素的方案 被推 荐作为一 线经验 治疗。 含铋剂 的四联疗法也是一种替代方案。1a,A S
31、tatement 9: The use of high-dose (twice a day) PPI increases the efficacy of triple therapy.1b,A 应用高剂量（1 日 2 次）PPI 可增加三 联疗法的疗效。1b,A Statement 10: Extending the duration of PPI-clarithromycin-containing triple therapies from 7 to 10-14 days improves the eradication success by about 5% and may be cons
32、idered.1a,A 将含 PPI- 克拉霉素三联 方案的疗程从 7 天延长至 10-14 天， 可使根除 率提高 约 5% ，可予考虑。1a,A Statement 11: PPI-clarithromycin-metronidazole (PCM) and PPI-clarithromycin- amoxicillin (PCA) regimens are equivalent.1a,A PPI- 克拉霉素- 甲硝唑方案 与 PPI- 克拉霉素- 阿莫 西林方案等效。1a,A Statement 12: Certain probiotics and prebiotics show pro
33、mising results as an adjuvant treatment in reducing side effects.5,D 某些益生菌和益生元作为辅助治疗在减少副作用方面显示有益。5,D Statement 13: PPI-clarithromycin-containing treatments do not need to be adapted to patient factors except for dosing.5,D 含 PPI- 克拉霉素的治疗 方案， 除剂量外， 并不 需要根据患者的因素进行调整。 5,D Statement 14: (1) After failur
34、e of a PPI-clarithromycin-containing treatment, either a bismuth-containing quadruple therapy or levofloxacin-containing triple therapy is recommended.1a,A (2) Rising rates of levofloxacin resistance should be taken into account.2b,B (1) 含 PPI- 克拉霉素的方案治疗失败后，推荐应用含铋剂的四联疗法或含左 氧氟沙星的三联疗法。1a,A (2) 应考虑到左氧氟
35、沙星的耐药率在上升。2b,B Statement 15: After failure of second-line treatment, treatment should be guided by antimicrobial susceptibility testing whenever possible.4,A 二线方案治疗失败后，应尽可能根据药敏试验指导治疗。4,A Statement 16: In areas of high clarithromycin resistance, bismuth-containing quadruple therapies are recommended
36、for first-line empirical treatment. If this regimen is not available, sequential treatment or a non-bismuth quadruple therapy is recommended.1a,A 在克拉霉素高耐药地区， 含铋剂的四联疗法被推荐作为一线经验治疗。 如果 不能获得这一方案，推荐序贯疗法或不含铋剂的四联疗法。1a,A Statement 17: (1) In areas of high clarithromycin resistance after failure of bismuth-
37、containing quadruple therapy, levofloxacin containing triple therapy is recommended.5,D (2) Rising rates of levofloxacin resistance should be taken into account.2b,B (1) 在克拉霉素高耐药地区，含铋剂的四联疗法失败后，推荐含左氧氟沙 星的三联疗方案5,D。(2) 应考虑到左氧氟沙星的耐药率在上升。2b,B Statement 18: After failure of second-line therapy, treatment
38、should be guided by antimicrobial susceptibility testing, whenever possible.4,A 二线方案治疗失败后，应尽可能根据药敏试验指导治疗。4,A Statement 19: In patients with penicillin allergy, in areas of low clarithromycin resistance, for a first-line treatment, a PPI-clarithromycin-metronidazole combination may be prescribed and
39、in areas of high clarithromycin resistance, the bismuth- containing quadruple therapy should be preferred. As a rescue regimen, in areas of low fluoroquinolone resistance, a levofloxacin- containing regimen (together with a PPI and clarithromycin) represents a second-line alternative in the presence
40、 of penicillin allergy.2c,B 对 青霉素 过敏患者 ， 在克拉霉素 低 耐药地 区， 可用 PPI- 克拉 霉素- 甲 硝唑作 为一线方案； 在克拉霉素高耐药地区， 优先用含铋剂的四联疗法。 作为补救方案， 在氟喹诺酮低耐药地区，含左氧氟沙星的方案( 合用 PPI 和克拉霉素) 可作为二线替代。2c,B Statement 20: The UBT or a laboratory-based validated monoclonal stool test are both recommended as non-invasive tests for determining
41、 the success of eradication treatment. There is no role for serology.1a,A 尿素呼气试验或实验室检测的经过验证的单克隆粪便试验都推荐作为确定 幽门螺杆菌是否根除成功的非侵入性测试。血清学试验无作用。1a,A Statement 21: The time for testing the success of H. pylori eradication after the end of treatment should be at least 4 weeks.2b,B 检测幽门螺杆菌是否成功根除的试验时间为治疗结束后至少 4
42、周。2b,B Statement 22: (1) In uncomplicated duodenal ulcer (DU), prolonging acid inhibition with PPI is not recommended after H. pylori treatment.1a,A (2) In gastric ulcers (GUs) and complicated DUs, prolonging PPI is recommended.1b,A 根除幽门螺杆菌治疗后， 无并发症的十二指肠溃疡(DU)， 不推荐延长 PPI 抑 酸治疗；1a,A 胃溃疡 和有并发症的十二指肠溃疡，
43、推荐延长 PPI 治疗。1b,A Statement 23: H. pylori eradication treatment should be started at reintroduction of oral feeding in cases of bleeding ulcer.1b,A 幽门螺杆菌根除治疗应在出血性溃疡患者重新进食时就开始。1b,A WORKSHOP 3 工 作小组 3 (Prevention of gastric cancer and other complications) ( 预防胃癌和其他并发症) Statement 1: H. pylori infection
44、is the most consistent risk factor for gastric cancer. Its elimination is therefore the most promising strategy to reduce the incidence of gastric cancer.1a,A 幽门螺杆菌感染是胃癌最一致的危险因素。 因此， 其根除是降低胃癌发病率 最有前途的策略。1a,A Statement 2: There is strong evidence that H. pylori infection exerts direct mutagenic effec
45、ts in animal models and cell lines.?,C 有强力的 证据表 明，幽 门螺杆菌 感染在 动物模 型和细胞 株上有 直接的 致突变 作用。?,C Statement 3: The risk for gastric cancer development is influenced by bacterial virulence factors, but no specific bacterial virulence markers can be recommended for clinical practice.1a,A 胃癌发生的风险受细菌毒力因素影响， 但无具体
46、的细菌毒力标志物可推荐用 于临床实践。1a,A Statement 4: The risk of gastric cancer is influenced by host genetic factors but in clinical practice no specific marker can be recommended for genetic testing at present.1b,A 胃癌发生的风险受宿主遗传因素影响， 但目前在临床实践中没有具体的指标 可推荐用于遗传检测。1b,A Statement 5: The influence of environmental facto
47、rs is subordinate to the effect of H pylori infection.1a,A 环境因素的影响次于幽门螺杆菌感染的作用。1a,A Statement 6: Histopathological changes at the morphological level indicate that: 1. gastric cancer is rare in the absence of chronic active gastritis; 2. the extent and severity of the gastritis together with atrophy
48、 and IM is positively associated with cancer.2b,A 形态学水平的组织病理学变化表明： 1. 在无慢性活动性胃炎的情况下罕有胃 癌发生;2. 胃炎的范围、严重性与萎缩和肠化一起与胃癌呈正相关。2b,A Statement 7: Mechanisms at the functional level indicate: 1. atrophic corpus gastritis causes hypochlorhydria; 2.hypochlorhydria allows the overgrowth of non-H. pylori organism
49、s that are capable of producing metabolites with a carcinogenic potential.2c,A 在功能水平的机制表明：1. 萎缩性胃体炎引起低胃酸; 2. 低胃酸使得 非幽门 螺杆菌性细菌在胃内过度生长，后者能生产具有致癌潜能的代谢物。2c,A Statement 8: H. pylori eradication abolishes the inflammatory response and slows or may arrest the progression of atrophy. In some cases it may reverse atrophy.1a,A 根除幽门 螺杆 菌消除 了 炎症反应 ，使 萎缩发 展 减慢或停 止。在 一些 情 况下 可能会逆转
