幽门螺杆菌最新共识及刘文忠教授解读（Maastricht IV，载于2012年5月GUT）

第一部分什么样的病人需要接受除菌治疗？

意见1. A test-and-treat strategy is appropriate for uninvestigateddyspepsia in popul ations where the H pylori prevalence is high ($ 20%). Thisapproach is subject to loc al cost e benefit considerations and is notapplicable to patient s with alarm symptoms , or older patients (age to bedetermined locally according to cancer risk)中国中医科学院西苑医院肝病科张引强

证据级别：1a

幽门螺杆菌高感染率地区（感染率≥20%）的消化不良患者，可选用“检查-治疗“方案，即选择非侵入性检查检测幽门螺杆菌，并对阳性患者进行杀菌治疗。是否选择“检查-治疗”方案取决于当地的费效比，具报警症状及高龄（高龄的界定取决于当地肿瘤风险）患者不适用“检查-治疗”方案。

意见2. Statement 2: The main non-invasive tests that can be used for thetest-and-treat strategy are the UBT and monoclonal stool antigen tests. Certainvalidated serological tests can also be used.

证据级别：2a

主流的非侵入性幽门螺杆菌检查方法包括UBT检测、大便抗原单克隆抗体检测及部分被证明可信度高的血清学检查。

意见3. H pylori eradication produces long-term relief of dyspepsia inone of 12 patients with H pylori and functional dyspepsia; this is better thanany other treatment.

证据级别：1a

根除幽门螺杆菌可使1/12的幽门螺杆菌阳性的功能性消化不良患者症状得到长期缓解，效果优于其他任何治疗方法。

意见4. H pylori can increase or decrease acid secretion depending on theintragastric distributio n of inflammation.

证据级别：2b

幽门螺杆菌抑制或增加胃酸分泌取决于胃内炎症的分布。

意见5. On average, H pylori status has no effect on symptom severity,symptom recurrence and treatment efficacy in GORD. H pylori eradication doesnot exacerbate pre-existing GORD or affect treatment efficacy.

证据级别：1a

整体来说，幽门螺杆菌与胃食管反流疾病的症状严重程度、复发及疗效无显著关联。根除幽门螺杆菌不会加重既有胃食管反流疾病症状，也不会影响其疗效。

意见6. Epidemiological studies show a negative association between the prevalenceof H pylori and the severity of GORD and incidence of esophageal adenocarcinoma.

证据级别：2a

流行病学证据表明幽门螺杆菌感染率与胃食管反流病严重程度及食管腺癌的发病率呈负相关。

意见7. H pylori infection is associated with an increased risk ofuncomplicated and complicated gastroduodenal ulcers in NSAID and low-doseaspirin (acetosalicylic acid (ASA)) users. Eradication reduces the risk ofcomplicated and uncomplicated gastroduodenal ulcers associated with eitherNSAID or low-dose ASA use.

证据级别：2a、1b

使用非甾体类抗炎药及低剂量阿司匹林的患者发生伴或不伴并发症的胃十二指肠溃疡与幽门螺杆菌感染相关。上述患者根除幽门螺杆菌有助减少胃十二指肠溃疡病发生。

意见8. H pylori eradication is beneficial before starting NSAIDtreatment. It is mandatory in patients with a peptic ulcer history. However, Hpylori eradication alone does not reduce the incidence of gastroduodenal ulcersin patients already receiving long-term NSAID treatment. They require continuedPPI treatment as well as eradication treatment.

证据级别：1b、1b

只有在开始非甾体类抗炎药之前根除幽门螺杆菌才能使上述患者获益。既往有消化性溃疡史的病人必需在开始非甾体类抗炎药之前根除幽门螺杆菌。对于已经开始长期非甾体类抗炎药治疗的患者，仅根除幽门螺杆菌不能降低其胃十二指肠溃疡发病率，该群患者需在除菌的基础上长期服用质子泵抑制剂。

意见9. Testing for H pylori should be performed in ASA users with ahistory of gastroduodenal ulcer. The long-term incidence of peptic ulcerbleeding is low in these patients after receiving eradication even in the absenceof gastroprotective treatment.

证据级别：2b

对于长期使用低剂量阿司匹林并胃十二指肠溃疡病史的患者推荐幽门螺杆菌检查。除菌治疗之后，即使不使用胃黏膜保护剂，患者也可长期维持较低的消化性溃疡出血发生率。

意见10. Long-term treatment with PPIs in H pylori-positive patients is associatedwith the development of a corpus-predominant gastritis. This accelerates theprocess of loss of specialised glands, leading to atrophic gastritis.Eradication of H pylori in patients receiving long-term PPIs heals gastritisand prevents the progres ion to atrophic gastritis . However, there is no evidencethat this reduces the risk of gastric cancer.

证据级别：1c、1b

幽门螺杆菌阳性患者长期接受PPI治疗与胃体为主胃炎的发生相关，可加剧特定腺体丢失，导致萎缩性胃炎。长期接受PPI治疗的患者在除菌之后有助于胃炎痊愈并防止疾病向萎缩性胃炎进展，目前尚无证据表明可降低胃癌发生率。

意见11. There is accumulating evidence that after H pylori eradication,corpus function may improve. However, whether this is associated withregression of atrophic gastritis remains equivocal. There is no evidence that Hpylori eradication can lead to regression of intestinal metaplasia.

证据级别：2a、2a

不断有证据表明除菌治疗或可使胃体功能恢复，但能否缓解胃体萎缩尚不明确。尚无证据表明除菌治疗可逆转肠上皮化生。

意见12. H pylori eradication is the first-line treatment for low-gradegastric marginal zone (MALT) lymphoma

证据级别：1a

根除幽门杆菌为低级别MALT淋巴瘤的一线治疗。

意见13. There is evidence linking H pylori to the aetiology of otherwiseunexplained iron-deficiency anaemia, idiopathic thrombocytopenic purpura (ITP)and vitamin B12 deficiency. In these disorder s, H pylori should be sought anderadicated. The evidence available shows no unequivocal causative associationbetween H pylori and other extragastric disorders, including cardiovasc ularand neurological disorders.

证据级别：1a、1b、3b

有证据表明幽门螺杆菌与病因不明的缺铁性贫血、原发性血小板减少性紫癜及维生素B12缺乏症相关。上述患者应检测幽门螺杆菌及采取相应治疗。现有证据不能证明幽门螺杆菌与其他系统疾病相关，如心血管疾病或神经系统疾病。

意见14. The evidence available shows no definite causative protectiveeffect of H pylori against the following disorders nor that its eradicationcauses or worsens them. However, further resea rch is needed.

1. Asthma and atopy

2. Obesity and related illnesses

现有证据不能表明幽门螺杆菌是下列疾病的病因或保护因素，除菌治疗对下列疾病利弊亦不明确。

1.哮喘及特异质反应

2.肥胖及相关疾病

意见15. In H pylori-positive patients eradication treatment improves thebioavailability of thyroxine and l-dopa.

证据级别：2b

除菌治疗有助提高甲状腺素及左旋多巴的生物利用率

意见16. Certain H pylori virulence factors and certain host genetic polymorphismsare known to affect the risk of any specific individual developing H. pylori-associateddisease. However, there is no evidence that strategies based on testing forthese factors are useful for an individual patient

个体感染后是否发生幽门螺杆菌相关疾病受某些幽门螺杆菌毒力因子与宿主基因多态性的影响。检测上述因素是否可使病人获利尚无确凿证据。

第二部分除菌治疗

意见1. The diagnostic accuracy of the stool antigen test (SAT) isequivalent to the UBT if a validated laboratory-based monoclonal test is used.

证据级别：1a

大便抗原单抗检测与UBT试验的可信度相当

意见2. The serological tests are not all equivalent. Only validated IgGserology tests should be used owing to variability in the accuracy of differentcommercial tests.

证据级别：1b

商品化的血清学试验结果变异度较大，仅经证实的IgG血清学结果可供临床参考。

意见3. A validated IgG serology may be used in the setting of recent useof antimicrobial* and anti secretory drugs, or ulcer bleeding, atrophy andgastric malignancies

证据级别：5d、1b

当患者近期有使用抗生素、抑酸药物或存在溃疡出血、萎缩及胃癌的情况时，临床可参考经证实的IgG血清学试验结果。

意见4. In patients treated with PPIs: (1) if possible, PPI should bestopped for 2 weeks before testing by culture, histology, rapid urease test,UBT or stool test. (2) if it is not possible, validated IgG serology can beperformed.

证据级别：1b、2b

使用PPI的患者需在停药至少2周后再行幽门螺杆菌的培养、组织学、快速尿素酶测试、UBT或大便抗原检测。若无停药条件，可参考IgG血清学试验结果。

意见5. (1) It is important to perform culture and standard susceptibilitytesting to antimicrobial agents in a region or population of highclarithromycin resistance before prescription of the first-line treatment ifthe standard clarithromycin-containing triple therapy is being considered.Furthermore, culture and standard susceptibility testing should be consideredin all regions before second-line treatment if endoscopy is carried out foranother reason and generally when a second-line treatment has failed. (2) Ifstandard susceptibility testing is not possible, molecular tests can be used todetect H pylori and clarithromycin and/or fluoroquinolone resistance directlyon gastric biopsies.

证据级别：5、1b

在高克拉霉素耐药区域，如考虑使用包含克拉霉素的三联疗法作为一线治疗，杀菌治疗前行细菌培养及药敏测试是十分重要的。如在二线治疗之前开始前因其他原因进行内镜检查，或二线治疗除菌失败，应进行细菌培养及药敏测试。如无条件进行标准药敏测试，可检测胃活检标本的克拉霉素和/或氟喹诺酮药物耐药的分子标志物。

意见6. (1) If H pylori is cultured from gastric biopsy specimens,antibiotic susceptibility testing should include metronidazole. (2) Ifsusceptibility for clarithromycin is assessed by molecular tests, the additionof culture for the assessment of metronidazole resistance is not justified .

证据级别：1b、5

如幽门螺杆菌培养自胃活检标本，药敏测试应包含甲硝唑。若克拉霉素的敏感度是通过分子检测确定的，则无需在培养中检测甲硝唑的耐药性。

意见7. PPI-clarithromycin-containing triple therapy without priorsusceptibility testing should be abandoned when the clarithromycin resistancerate in the region is more than 15-20%.

证据级别：5

若无药敏结果支持，包含PPI及克拉霉素的三联疗法在克拉霉素耐药率高于15-20%的地区应予废止。

意见8. In areas of low clarithromycin resistance, clarithromycin-containingtreatments are recommended for first-line empirical treatment.Bismuth-containing quadruple thera py is also an alternative.

证据级别：1a

在克拉霉素低耐药区域，包含克拉霉素的疗法及包含铋剂的四联疗法可作为经验性的一线治疗。

意见9. The use of high-dose (twice a day) PPI increases the efficacy oftriple therapy.

证据级别：1b

大剂量PPI（一日两次）可增加三联疗法疗效。

意见10. Extending the duration of PPI-clarithromycin-containing tripletherapies from 7 to 10-14 days improves the eradication success by about 5% andmay be considered.

证据级别：1a

包含PPI及克拉霉素的三联疗法疗程由7天延长至10-14天可提高约5%的除菌率，可酌情选用。

意见11. PPI-clarithromycin-metronidazole(PCM) and PPI-clarithromycin-amoxicillin(PCA) regimens are equivalent.

证据级别：1a

PPI-克拉霉素-甲硝唑疗法与PPI-克拉霉素-阿莫西林疗法疗效相当

意见12. Certain probiotics and prebiotics show promising results as anadjuvant treatment in reducing side effects

证据级别：5

某些益生菌及益生元制剂可降低除菌治疗的副作用，并作为辅助治疗。

意见13. PPI-clarithromycin-containing treatments do not need to beadapted to patient factors excep t for dosing.

证据级别：5

除剂量外，包含PPI-克拉霉素的疗法无需个体化治疗。

意见14. (1) After failure of a PPI-clarithromycin-containing treatment,either a bismuth-containing quadruple therapy or levofloxacin-containing tripletherapy is recommended. (2) Rising rates of levofloxacin resistance should betaken into account.

证据级别：1a、2b

若PPI-克拉霉素疗法失败，推荐包含铋剂的四联疗法或包含左氧氟沙星的三联疗法。但需注意左氧氟沙星的耐药率正在上升。

意见15. After failure of second-line treatment, treatment should beguided by antimicrobial susceptibility testing whenever possible.

证据级别：4

二线治疗失败后，需用药敏试验指导下一步治疗方案

意见16. In areas of high clarithromycin resistance, bismuth-containingquadruple therapies are recommended for first-line empirical treatment. If thisregimen is not available, sequential treatment or a non-bismuth quadrupletherapy is recommended.

证据级别：1a

在高克拉霉素耐药的区域，推荐含铋剂的四联疗法作为一线治疗。无铋剂区域推荐使用序贯疗法或无铋剂四联疗法。

意见17. (1) In areas of high clarithromycin resistance after failure ofbismuth-containing quadruple therapy, levofloxacin containing triple therapy isrecommended. (2) Rising rates of levofloxacin resistance should be taken intoaccount.

证据级别：5、2b

在高克拉霉素耐药的区域，含铋剂的四联疗法失败后，推荐使用含左氧氟沙星三联疗法。但但需注意左氧氟沙星的耐药率正在上升。

意见18：After failure of second-line therapy, treatment should be guided by antimicrobialsusceptibility testing, whenever possible

证据级别：4

二线治疗失败后，需用药敏试验指导下一步治疗方案

意见19. In patients with penicillin allergy, in areas of low clarithromycinresistance, for a first-line treatment, a PPI-clarithromycin-metronidazolecombination may be prescribed and in areas of high clarithromycin resistance,the bismuth-containing quadruple therapy should be preferred. As a rescueregimen, in areas of low fluoroquinolone resistance, a levofloxacin-containingregimen (together with a PPI and clarithromycin) represents a second-line alternativein the presence of penicillin allergy .

证据级别：2c

对于青霉素过敏患者，低克拉霉素耐药区域可考虑PPI-克拉霉素-甲硝唑作为一线疗法，高耐药区域推荐铋剂四联疗法。低氟喹诺酮耐药区域推荐PPI-克拉霉素-左氧氟沙星作为青霉素过敏患者的补救治疗。

意见20. The UBT or a laboratory-based validated monoclonal stool testare both recommended as non-invasive tests for determining the success oferadication treatment. There is no role for serology.

证据级别：1a

根除治疗后可采用UBT或大便抗原单抗检测等非侵入性方法随访。血清学检测作为除菌随访手段毫无意义。

意见21. The time for testing the success of H pylori eradication afterthe end of treatment should be at least 4 weeks.

证据级别：2b

复查时间需在停药至少4周后。

意见22. (1) In uncomplicated duodenal ulcer (DU), prolonging acid inhibitionwith PPI is not recommended after H pylori treatment.(2) In gastric ulcers(GUs) and complicated DUs, prolonging PPI is recommended.

证据级别：1a、1b

无并发症的十二指肠溃疡在根除幽门螺杆菌后无需延用PPI，存在并发症的十二指肠溃疡及胃溃疡推荐长期使用PPI。

意见23. H pylori eradication treatment should be started atreintroduction of oral feeding in cases of bleeding ulcer.

证据级别：1b

溃疡出血的患者在恢复进食后应立即开始除菌治疗。

 

转自丁香园：http://www.dxy.cn/bbs/topic/22892661