氟哌噻吨美利曲辛联合PPI治疗上腹痛综合征的meta分析

发布时间：2018-07-09 23:25

本文选题：氟哌噻吨美利曲辛 + 质子泵抑制剂　；参考：《山东大学》2016年硕士论文

【摘要】：研究背景：功能性消化不良(Functional Dyspepsia, FD)是指发生于胃和十二指肠区域的临床症候群,包括上腹痛或不适、餐后饱胀早饱等,但是缺乏系统性或器质性疾病可解释上述症状。FD的人群患病率较高,严重影响患者生活质量,造成沉重的经济和社会负担。根据功能性胃肠病罗马III诊断标准,将FD分为餐后不适综合征(post-prandial distress syndrome, PDS)和上腹痛综合征(epigastric pain syndrome, EPS)两个亚型。根据临床治疗经验,对于EPS患者常常优先使用PPI治疗,但是效果并不理想。相关研究指出,相比于PDS, EPS患者当中伴有焦虑抑郁情绪的比例更高且更严重,因此对于EPS的治疗在使用PPI的同时也应当关注患者精神心理因素对治疗的影响。近年来,新型抗抑郁药氟哌噻吨美利曲辛片(商品名：黛力新)开始逐渐应用于临床辅助治疗FD,国内已有氟哌噻吨美利曲辛片联合PPI治疗EPS的相关报道。为系统评价其疗效,本研究整合相关联合治疗的研究结果进行meta分析,以期得出合理结论,提供更加严谨的循证医学证据研究目的：系统评价氟哌噻吨美利曲辛(商品名：黛力新,丹麦灵北制药)联合应用质子泵抑制剂(proton pump inhibitor,PPI)治疗上腹痛综合征(epigastric pain syndrome, EPS)患者的疗效与不良反应。方法：检索Pubmed、Embase、Web of Science、Google scholor及The Cochrane Library数据库及相关期刊论文、维普数据库、万方医学数据库中发表于2015年12月31日之前的关于氟哌噻吨美利曲辛联合PPI治疗EPS的临床随机对照试验进行meta分析。评价的主要终点事件包括EPS患者治疗后全身症状改善有效率、焦虑抑郁情绪改善情况以及治疗过程中和随访期间的不良反应发生率。结果：总共纳入12个符合入选条件的研究,文献发表年限从2010年至2015年之间,10篇文献质量评估为B级,2篇为C级,纳入文献质量中等。相比于单用质子泵抑制剂,氟哌噻吨美利曲辛联合质子泵抑制剂能明显提高EPS患者的治疗有效率(RR=1.31,95% CI[1.23,1.41], P0.00001);并且减轻患者的焦虑(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)情绪。但是同时,联合用药也增加了药物不良反应的发生率(RR=2.00,95% CI [1.13,3.53], P=0.02).亚组分析显示,联用奥美拉唑或埃索美拉唑均提高了治疗有效率(RR=1.33,95% CI[1.21,1.46]; RR=1.27,95% CI[[1.14,1.42], P0.0001).在治疗4周时治疗有效率已显著提高(RR=1.23,95% CI [1.05,1.44], P=0.009),但相比于治疗8周,治疗4周的有效率有效率显著较低(RR=0.50,95% CI [0.40,0.62], P0.00001).结论：相比于单用PPI治疗EPS,氟哌噻吨美利曲辛联合应用PPI治疗能显著提升治疗有效率,并且减轻EPS患病者的焦虑抑郁症状。治疗4周时有效率较单用PPI就已显著提高,但联合治疗8周时有效率更高。联合用药虽然提高了不良反应发生率,但都为轻微不良反应症状,表明联合用药仍然安全有效。
[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 卤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 卤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 卤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.
【学位授予单位】：山东大学
【学位级别】：硕士
【学位授予年份】：2016
【分类号】：R57

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