發(fā)布時(shí)間：2018-06-26 20:11

  本文選題：幽門螺桿菌 + 鉍劑四聯(lián)療法�。� 參考：《第三軍醫(yī)大學(xué)》2017年碩士論文

【摘要】：研究背景及目的幽門螺桿菌(Helicobacter pylori,H.pylori)是一種重要的人類病原菌,是許多消化道疾病及胃腸外疾病的常見致病因素,根除其可減少傳染源、緩解或治愈相關(guān)疾病,減少其并發(fā)癥的發(fā)生,因此有效根除H.pylori是非常必要的。然而抗生素耐藥率的急劇增加、抑酸作用不足、根除方案的不合理使用使得H.pylori根除治療面臨新的困境,為評(píng)價(jià)鉍劑四聯(lián)療法H.pylori的根除療效,本研究含有中國(guó)10天或14天鉍劑四聯(lián)療法與其他常見根除方案根除幽門螺桿菌的療效進(jìn)行了Meta分析。方法首先充分通過計(jì)算機(jī)檢索以下數(shù)據(jù)庫:Pubmed,EMBASE,the Cochrane Central Register of Controlled Trials、中國(guó)知網(wǎng)、中國(guó)生物醫(yī)學(xué)文獻(xiàn)數(shù)據(jù)庫、維普等數(shù)據(jù)庫,收集中國(guó)2005年至2016年11月期間所有包含10d或14d鉍劑四聯(lián)療法根除幽門螺桿菌感染的隨機(jī)對(duì)照試驗(yàn),依照納入排除標(biāo)準(zhǔn),兩位研究者獨(dú)立行文獻(xiàn)篩選、提取受試者的基本資料、觀察指標(biāo)(根除率及不良反應(yīng)發(fā)生率)等相關(guān)數(shù)據(jù)、采用Jadad評(píng)分評(píng)價(jià)納入研究質(zhì)量,使用Rev Man5.3軟件分析相關(guān)指標(biāo),計(jì)算RR及95%CI,使用漏斗圖行發(fā)表偏倚評(píng)價(jià)。結(jié)果43項(xiàng)研究(共7686例患者)符合納入標(biāo)準(zhǔn)。通過意向性分析(Intention-toTreat analysis,ITT分析),10天或14天鉍劑四聯(lián)療法和三聯(lián)療法H.pylori根除率分別是88.96%(95%CI:87.73%~90.19%)和74.11%(95%CI:72.53%~75.69%),差異有統(tǒng)計(jì)學(xué)意義(RR=1.20,95%CI:1.16%~1.25%);10d或14d鉍劑四聯(lián)療法和7d鉍劑四聯(lián)療法H.pylori根除率分別是87.34%(95%CI:84.87%~89.80%)、81.65%(95%CI:78.76%~84.54%)(意向性分析),差異有統(tǒng)計(jì)學(xué)意義(RR=1.07,95%CI:1.02%~1.12%);10d或14d鉍劑四聯(lián)聯(lián)療法與序貫療(RR=1.02,95%CI:0.97%~1.07%)、及與伴隨療法(RR=1.01,95%CI:0.95%~1.07%)差異無統(tǒng)計(jì)學(xué)意義。結(jié)論10d或14d鉍劑四聯(lián)療法與序貫療法及伴隨療法療效相當(dāng),三聯(lián)療法及7d鉍劑四聯(lián)療法不作為首選治療方案。背景及目的與克拉霉素不同的是,幽門螺桿菌對(duì)阿莫西林的耐藥率無論是原發(fā)性或繼發(fā)性均很低。有研究報(bào)道表明根據(jù)阿莫西林的時(shí)間依賴性及PH值依賴性等特點(diǎn)結(jié)合大劑量的質(zhì)子泵抑制劑組成的大劑量二聯(lián)療法可取得滿意療效。因此本研究探討大劑量二聯(lián)療法在幽門螺桿菌(Helicobacter Pylori,Hp)根除治療中的效果并與含鉍劑的四聯(lián)療法療效進(jìn)行比較。方法收集263例幽門螺桿菌陽性初次治療的患者(13C尿素呼氣試驗(yàn)或14C尿素呼氣試驗(yàn)或快速尿素酶法或幽門螺桿菌培養(yǎng)證實(shí)),按Excel設(shè)計(jì)的隨機(jī)對(duì)照數(shù)字表分組,進(jìn)行對(duì)應(yīng)的治療方案。A組:雷貝拉唑10mg及阿莫西林750 mg,均4次/日;B組:雷貝拉唑20mg及阿莫西林750mg,均4次/日;C組:雷貝拉唑20mg、枸櫞酸鉍鉀220mg、阿莫西林1 000mg及克拉霉素500mg,均2次/日。上述方案療程均14d。治療結(jié)束4周后行13C或14C尿素呼氣試驗(yàn)復(fù)查,呼氣試驗(yàn)陽性表明根除失敗,反之則成功。每位受試者在治療前均應(yīng)進(jìn)行Hp的相關(guān)教育:根除Hp的必要性、正規(guī)治療的重要性、治療過程中可能出現(xiàn)的不良反應(yīng)及必要時(shí)停藥并告知醫(yī)生、及時(shí)復(fù)查呼氣試驗(yàn)等,正確填寫病例報(bào)告調(diào)查表。結(jié)果據(jù)ITT分析及PP分析,A組的幽門螺桿菌的根除率分別是78.1%(95%CI,68.4%~86.8%)和79.1%(95%CI,70.5%~87.7%),B組的根除率是81.6%(95%CI,73.5%~89.7%)和83.5(95%CI,75.6%~91.4%),C組的根除率是84.3%(95%CI,76.7%~91.9%)和86.2%(95%CI,75.6%~91.4%),差異無統(tǒng)計(jì)學(xué)意義(P0.05)。3組總不良反應(yīng)發(fā)生率分別是3.4%、5.7%、11.2%(P值:0.109),差異無統(tǒng)計(jì)學(xué)意義(P0.05)),但C組味覺異常(P=0.002)及牙齦發(fā)黑(P=0.002)等不良反應(yīng)均較AB兩組高,具有統(tǒng)計(jì)學(xué)差異。結(jié)論大劑量二聯(lián)療法在Hp根除治療方面并不優(yōu)于含鉍劑的四聯(lián)療法。
[Abstract]:Background and objective Helicobacter pylori (H.pylori) is an important human pathogen, which is a common pathogenic factor of many digestive and gastrointestinal diseases. It is essential to eradicate H.pylori effectively by eradicating the source of infection, alleviating or curing the related diseases and reducing the incidence of its complications. The rapid increase of antibiotic resistance rate, insufficient acid suppressor effect and irrational use of the eradication regimen make H.pylori eradication treatment face new difficulties and to evaluate the eradication effect of bismuth quadruple therapy H.pylori. This study contains the efficacy of bismuth quadruple therapy with other common eradication regimens for eradicating Helicobacter pylori in 10 or 14 days of China. TA analysis. The method first fully retrieves the following database through the computer: Pubmed, EMBASE, the Cochrane Central Register of Controlled Trials, Chinese knowledge network, Chinese biomedical literature database, VP and other databases, all containing 10d or 14d bismuth therapy in the eradication of Helicobacter pylori from 2005 to November 2016. According to the exclusion criteria, two researchers were screened independently, the basic data of the subjects were extracted, the related data were extracted from the subjects, the indexes (the rate of eradication and the incidence of adverse reactions) were observed, the quality of the study was included by the Jadad score, and the related indexes were analyzed with the Rev Man5.3 software, the RR and 95%CI were calculated and the funnel plot was used. Results 43 studies (7686 patients) were in conformity with the inclusion criteria. Through intentional analysis (Intention-toTreat analysis, ITT analysis), 10 or 14 days of bismuth quadruple therapy and triple therapy H.pylori eradication rates were 88.96% (95%CI:87.73%~90.19%) and 74.11% (95%CI:72.53%~75.69%), respectively, and the difference was statistically significant (RR=1.20,95% CI:1.16%~1.25%); the rate of H.pylori eradication was 87.34% (95%CI:84.87%~89.80%) and 81.65% (95%CI:78.76%~84.54%) (intentionality analysis) in the quadruple therapy of 10d or 14d bismuth and 7d bismuth, respectively. The difference was statistically significant (RR=1.07,95%CI:1.02%~1.12%); 10d or 14d bismuth combined therapy and sequential therapy (RR=1.02,95%CI:0.97%~1.07%), and associated with it. The treatment (RR=1.01,95%CI:0.95%~1.07%) difference was not statistically significant. Conclusion 10d or 14d Bi agent quadruple therapy is equivalent to sequential therapy and concomitant therapy. Triple therapy and 7d bismuth quadruple therapy are not the first choice. A large dose of two couplet therapy based on the time dependence of amoxicillin and the pH dependence of amoxicillin combined with large doses of proton pump inhibitors can achieve satisfactory results. Therefore, this study explored the treatment of Helicobacter Pylori (Hp) eradication with large dose of two couplet therapy. The effect was compared with the quadruple therapy with bismuth. Methods 263 patients with HP positive initial treatment (13C urea breath test or 14C urea breath test or rapid urease or Helicobacter pylori culture) were collected and grouped according to the random control digital table designed by Excel, and the corresponding treatment scheme.A group: rebebe 10mg and amoxicillin 750 mg were all 4 times per day; group B: 4 times / day for 20mg and amoxicillin 750mg; group C: Ray 20mg, bismuth potassium citrate 220mg, amoxicillin 1 000mg and clarithromycin 500mg, all 2 times / day. The course of treatment was 4 weeks after the end of 14D. treatment. The eradication failure and vice versa are successful. Every subject should have Hp related education before treatment: eradicating the necessity of Hp, the importance of regular treatment, the possible adverse reactions in the course of treatment and the necessary stopping of the drug when necessary and telling the doctor, rechecking the exhalation test in time, and correctly filling out the case report questionnaire. Results according to ITT analysis and PP analysis The eradication rates of Helicobacter pylori in group A were 78.1% (95%CI, 68.4%~86.8%) and 79.1% (95%CI, 70.5%~87.7%). The eradication rate of group B was 81.6% (95%CI, 73.5%~89.7%) and 83.5 (95%CI, 75.6%~91.4%). The eradication rate of C group was 84.3% (95%CI, 86.2%) and 86.2%. The difference was 3.4%, 5.7%, 11.2% (P value: 0.109), the difference was not statistically significant (P0.05), but the adverse reactions of C group (P=0.002) and gingival blackening (P=0.002) were higher than those of the AB two group, and there were statistical differences. Conclusion the high-dose two combination therapy in the eradication treatment of Hp is not better than the quadruplex therapy with bismuth.
【學(xué)位授予單位】：第三軍醫(yī)大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2017
【分類號(hào)】：R57

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