本文選題：氟哌噻噸美利曲辛 + 質(zhì)子泵抑制劑��； 參考：《山東大學(xué)》2016年碩士論文

【摘要】：研究背景：功能性消化不良(Functional Dyspepsia, FD)是指發(fā)生于胃和十二指腸區(qū)域的臨床癥候群,包括上腹痛或不適、餐后飽脹早飽等,但是缺乏系統(tǒng)性或器質(zhì)性疾病可解釋上述癥狀。FD的人群患病率較高,嚴(yán)重影響患者生活質(zhì)量,造成沉重的經(jīng)濟(jì)和社會(huì)負(fù)擔(dān)。根據(jù)功能性胃腸病羅馬III診斷標(biāo)準(zhǔn),將FD分為餐后不適綜合征(post-prandial distress syndrome, PDS)和上腹痛綜合征(epigastric pain syndrome, EPS)兩個(gè)亞型。根據(jù)臨床治療經(jīng)驗(yàn),對(duì)于EPS患者常常優(yōu)先使用PPI治療,但是效果并不理想。相關(guān)研究指出,相比于PDS, EPS患者當(dāng)中伴有焦慮抑郁情緒的比例更高且更嚴(yán)重,因此對(duì)于EPS的治療在使用PPI的同時(shí)也應(yīng)當(dāng)關(guān)注患者精神心理因素對(duì)治療的影響。近年來,新型抗抑郁藥氟哌噻噸美利曲辛片(商品名：黛力新)開始逐漸應(yīng)用于臨床輔助治療FD,國(guó)內(nèi)已有氟哌噻噸美利曲辛片聯(lián)合PPI治療EPS的相關(guān)報(bào)道。為系統(tǒng)評(píng)價(jià)其療效,本研究整合相關(guān)聯(lián)合治療的研究結(jié)果進(jìn)行meta分析,以期得出合理結(jié)論,提供更加嚴(yán)謹(jǐn)?shù)难C醫(yī)學(xué)證據(jù)研究目的：系統(tǒng)評(píng)價(jià)氟哌噻噸美利曲辛(商品名：黛力新,丹麥靈北制藥)聯(lián)合應(yīng)用質(zhì)子泵抑制劑(proton pump inhibitor,PPI)治療上腹痛綜合征(epigastric pain syndrome, EPS)患者的療效與不良反應(yīng)。方法：檢索Pubmed、Embase、Web of Science、Google scholor及The Cochrane Library數(shù)據(jù)庫(kù)及相關(guān)期刊論文、維普數(shù)據(jù)庫(kù)、萬(wàn)方醫(yī)學(xué)數(shù)據(jù)庫(kù)中發(fā)表于2015年12月31日之前的關(guān)于氟哌噻噸美利曲辛聯(lián)合PPI治療EPS的臨床隨機(jī)對(duì)照試驗(yàn)進(jìn)行meta分析。評(píng)價(jià)的主要終點(diǎn)事件包括EPS患者治療后全身癥狀改善有效率、焦慮抑郁情緒改善情況以及治療過程中和隨訪期間的不良反應(yīng)發(fā)生率。結(jié)果：總共納入12個(gè)符合入選條件的研究,文獻(xiàn)發(fā)表年限從2010年至2015年之間,10篇文獻(xiàn)質(zhì)量評(píng)估為B級(jí),2篇為C級(jí),納入文獻(xiàn)質(zhì)量中等。相比于單用質(zhì)子泵抑制劑,氟哌噻噸美利曲辛聯(lián)合質(zhì)子泵抑制劑能明顯提高EPS患者的治療有效率(RR=1.31,95% CI[1.23,1.41], P0.00001);并且減輕患者的焦慮(SMD =-0.97,95% CI [-1.22,-0.72], P0.00001)及抑郁(SMD=-0.71,95% CI[-0.96,-0.46], P0.00001)情緒。但是同時(shí),聯(lián)合用藥也增加了藥物不良反應(yīng)的發(fā)生率(RR=2.00,95% CI [1.13,3.53], P=0.02).亞組分析顯示,聯(lián)用奧美拉唑或埃索美拉唑均提高了治療有效率(RR=1.33,95% CI[1.21,1.46]; RR=1.27,95% CI[[1.14,1.42], P0.0001).在治療4周時(shí)治療有效率已顯著提高(RR=1.23,95% CI [1.05,1.44], P=0.009),但相比于治療8周,治療4周的有效率有效率顯著較低(RR=0.50,95% CI [0.40,0.62], P0.00001).結(jié)論：相比于單用PPI治療EPS,氟哌噻噸美利曲辛聯(lián)合應(yīng)用PPI治療能顯著提升治療有效率,并且減輕EPS患病者的焦慮抑郁癥狀。治療4周時(shí)有效率較單用PPI就已顯著提高,但聯(lián)合治療8周時(shí)有效率更高。聯(lián)合用藥雖然提高了不良反應(yīng)發(fā)生率,但都為輕微不良反應(yīng)癥狀,表明聯(lián)合用藥仍然安全有效。
[Abstract]:Background: functional dyspepsia (FD) is a clinical syndrome occurring in the stomach and duodenum, including epigastric pain or discomfort, postprandial fullness and early satiety. However, the lack of systemic or organic diseases can explain the high prevalence of the above symptoms. FD has a serious impact on the quality of life of patients, resulting in a heavy economic and social burden. According to the Rome III diagnostic criteria of functional gastrointestinal disease, FD was divided into two subtypes: post-prandial distress syndrome (PDS) and epigastric pain syndrome (epigastric pain syndrome, EPS). According to clinical experience, PPI is often preferred in EPS patients, but the effect is not satisfactory. The related research indicates that the proportion of EPS patients with anxiety and depression is higher and more serious than that of PDS.Therefore, the treatment of EPS should pay attention to the influence of psycho-psychological factors on the treatment while using PPI. In recent years, a new antidepressant, droperthiothioate melitracin tablets (trade name: Delyxin) began to be gradually used in clinical adjuvant treatment FD-FD.There have been reports on the combination of droperthiothioate melitaxine tablets and PPI for the treatment of EPS in China. In order to evaluate its efficacy systematically, meta analysis was carried out in order to draw a reasonable conclusion. Objective: to provide more rigorous evidence-based medical evidence research objective: to systematically evaluate droperthiothione metriaxine (trade name: Delyxin). The efficacy and adverse effects of proton pump inhibitor (proton pump inhibitor PPI in patients with epigastric pain syndrome (epigastric pain syndrome,). Methods: the database of scholor and the Cochrane Library and the full text database of Chinese periodicals were searched. The clinical randomized controlled trial of droperthiothione combined with melitaxine in the treatment of EPS published before December 31, 2015 in the Wanfang Medical Database was analyzed by meta. The main endpoint events evaluated included the effective rate of improvement of systemic symptoms after treatment, the improvement of anxiety and depression, and the incidence of adverse reactions during and during the course of treatment and follow-up in EPS patients. Results: a total of 12 eligible studies were included in this study. The published years from 2010 to 2015 showed that 10 articles were evaluated as B grade and 2 articles as C grade, and the quality of the literature included was moderate. Compared with proton pump inhibitor alone, droperazothioate metriaxine combined with proton pump inhibitor could significantly improve the effective rate of treatment in EPS patients (RRX 1.31 鹵95% CI [1.231.41, P 0.00001], P0.00001), and relieve anxiety (SMD -0.97N 95% CI [-1.22-0.72], P0.00001) and depression (SMD-0.7195% CI [-0.96U -0.46], P0.00001). But at the same time, the incidence of adverse drug reaction was increased by combined use of RRX 2.00% 95% CI [1.133.53, P < 0.02]. Subgroup analysis showed that combination of omeprazole and esomeprazole increased the effective rate (RRN 1.33 / 95% CI [1.21 鹵1.46], RRN 1.27595% CI [1.141.42], P 0.0001). After 4 weeks of treatment, the effective rate was significantly improved (RRN 1.2395% CI [1.05 鹵1.44], P < 0.009), but the effective rate was significantly lower than that in the 8th week (RRRN 0.50 95% CI [0.400.62], P 0.00001). Conclusion: compared with PPI alone, the combination of droperidol and metroxine can significantly improve the effective rate of treatment and alleviate the anxiety and depression symptoms of EPS patients. The effective rate at 4 weeks was significantly higher than that of PPI alone, but the effective rate was higher at 8 weeks after combined therapy. Although combined use increased the incidence of adverse reactions, they were mild adverse reaction symptoms, indicating that combination therapy is still safe and effective.
【學(xué)位授予單位】：山東大學(xué)
【學(xué)位級(jí)別】：碩士
【學(xué)位授予年份】：2016
【分類號(hào)】：R57

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