溃疡性结肠炎缓解期单独服用益生菌制剂维持治疗的评价

目的评价益生菌制剂用于静止期溃疡性结肠炎（UC）维持缓解治疗的疗效。方法以益生菌及其近义词、溃疡性结肠炎等主题词检索Cochrane国际协作网随机对照试验（RCT）注册数据库、PubMed、Embase数据库和中国期刊网等数据库,所选文献符合缓解期UC的诊断标准,以美沙拉嗪为对照的平行设计的随机、对照和双盲的临床试验并经过Jadad评分。资料分析采用Cochrane协作网提供的RevMan4．2软件,同时进行敏感性和安全性分析。结果（1）共有5项RCT、病例数总计624例的文献分析显示,益生菌制剂单独应用于UC缓解期维持治疗3-12个月,患者维持缓解的比率与单独使用美沙拉嗪比较,无显著性差异（OR=0．97,95％CI：0．68,1．39,P=0．88）;（2）使用益生菌制剂不良事件的发生率低于美沙拉嗪组,但两者安全性分析结果相近（OR：1．13;95％CI：0．77,167;P=0．52）。结论单独使用益生菌制剂或美沙拉嗪对于UC缓解期维持治疗的疗效和安全性相近,上述RCT研究的Meta分析结论支持单独服用益生菌制剂应用于静止期UC的维持缓解治序;     

益生菌联合标准三联疗法根除幽门螺杆菌的荟萃分析

标准三联疗法根除幽门螺杆菌（H．prlori）的根除率常低于80％，且胃肠道不良反应较明显。目的：系统性评价益生菌联合标准三联疗法能否提高H．prlori根除率，减少根除过程中的不良反应。方法：从常用电子数据库检索标准三联疗法联合与未联合益生菌根除H．prlori的随机临床试验，荟萃分析各项研究的根除率和不良反应发生率的合并OR值；行亚组分析和敏感性分析；以漏斗图检测发表偏倚。结果：共11项随机临床试验（1335例）符合纳入标准。三联疗法联合与未联合益生菌按意向治疗（ITT）分析的H．prlori根除率分别为81，8％（95％CI：80．9％-87．5％）和72，4％（95％CI：71．1％-79.3％），合并OR值为1．82（95％CI：1．31-2．51）；总不良反应发生率分别为24．6％（95％CI：20．4％-29．2％）和38．7％（95％CI：32．4％-43．8％），合并OR值为0．44（95％CI：0．30-0．66）。结论：联合益生菌可有效提高标准三联疗法的H．prlori根除率．降低根除过程中的不良反应发生率。     

表皮生长因子受体单克隆抗体在结直肠癌治疗中作用的系统评价

背景：研究表明表皮生长因子受体（EGFR）信号通路可调节细胞的分化、增殖、迁移、凋亡以及血管发生。近年来,靶向EGFR的单克隆抗体拓宽了结直肠癌治疗的选择范围。目的：系统评价EGFR单抗联合结直肠癌治疗方案在结直肠癌治疗中的疗效和安全性。方法：从常用电子数据库中检索结直肠癌治疗方案联合与未联合EGFR单抗治疗结直肠癌的随机对照试验,分析反应率和不良反应发生率的合并比值比（OR）,行亚组分析和敏感性分析,以漏斗图检测出版偏倚。结果：共7项随机对照试验（n=4186）纳入分析。联合与未联合EGFR单抗（治疗组和对照组）的反应率按意向治疗（ITT）分析分别为25．4％和17．6％（OR3．36,95％CI：1．42～7．95）,按方案（PP）分析分别为25．6％和18．0％（OR3．32,95％CI：1．40～7．88）．治疗组反应率明显优于对照组;两组3级以上不良反应总体发生率按ITT分析分别为71．2％和54.3％（OR2．23．95％CI：1．74～2．86）．治疗组3级以上不良反应总体发生率和皮肤损害、腹泻、低镁血症发生率均高于对照组。结论：EGFR单抗可明显提高结直肠癌,尤其是转移性或进展期结直肠癌患者对治疗的反应率,伴3级以上不良反应发生率增高。     

益生菌制剂VSL#3对溃疡性结肠炎诱导缓解作用的系统评价

循证医学证据提示益生菌对溃疡性结肠炎（UC）的诱导缓解无效,但对维持缓解有效,然而2009年发表的两项临床试验结果显示益生菌合剂VSL#3对UC的诱导缓解有效。目的：系统评价益生菌尤其是VSL#3诱导UC缓解的有效性和安全性。方法：联机检索MEDLINE、EMBASE、CochraneLibrary和中国生物医学文献数据、万方数据库,由两名分析人员独立选取与UC诱导缓解相关、比较益生菌治疗组与对照组（安慰剂或阳性对照）的随机对照试验（不限语种）并提取数据。应用RevMan5．2．10软件行meta分析,同时行亚组分析和敏感性分析。结果：共纳入9项随机对照试验,共557例UC患者,其中4项治疗组使用VSL#3。Meta分析显示益生菌组总体诱导缓解率显著优于对照组（OR=2．05,95％CI：1．14～3．70,P=0．02）,亚组分析显示VSL#3亚组诱导缓解率显著优于对照组（OR：2．35,95％CI：1．45—3．80,P=0．0005）,其他菌种与对照组间诱导缓解率无明显差异。益生菌组、VSL#3亚组与对照组间不良反应发生率均无明显差异。敏感性分析显示meta分析结果稳定。结论：VSL#3对UC的诱导缓解作用优于对照组且安全性高。     

云南白药治疗溃疡性结肠炎的meta分析

[目的]系统评价云南白药治疗溃疡性结肠炎（UC）的有效性。[方法]计算机检索PubMed（1966-2013）、CBM（1978-2013）、CNKI（1979-2013）、WangfangData（1990-2013）、VIP（1989-2013）等数据库,收集采用云南白药治疗溃疡性结肠炎的随机对照试验（RCT）,并追溯纳入研究的参考文献,由2位评价者按照纳入与排除标准独立筛选文献、提取资料和评价质量后,采用RevMan5．1软件进行Meta分析。[结果]共纳入20个RCT,1463例患者。Meta分析结果显示：云南白药组在治疗溃疡性结肠炎的总有效率[0R=4．05,95％CI（2．98,5．50）,P〈0．01]、治愈率[0R=3．24,95％CI（2．57,4．09）,P〈O．01]均高于对照组,不良反应发生率则低于对照组[OR=O．27,95％CI（0．12,0．58）,P〈0．01]。漏斗图分析显示存在发表性偏倚。[结论]现有证据显示,云南白药组治疗溃疡性结肠炎的疗效优于对照组,但尚需更多高质量的前瞻性多中心随机对照研究为临床提供更可靠的证据。     

稳心颗粒抗心律失常的Meta分析

目的评价稳心颗粒治疗心律失常的有效性及安全性。方法计算机检索至2010年12月Co-chrane图书馆临床对照试验资料库（CCRCT）、Pubmed、Embase、万方数据库、中国学术期刊全文数据库（CNKI）、中国生物医学文献数据库（CBMdisc）、维普数据库（VIP）,收集稳心颗粒治疗心律失常的随机对照试验（RCT）,按纳入和排除标准由2名评价者独立选择试验、提取资料,交叉核对并进行方法学质量评估,使用RevMan5.0软件进行Meta分析。结果共纳入24项研究的2564例患者。①稳心颗粒抗心律失常疗效优于美西律（OR=2.46;95CI：1.49～4.07;P〈0.01）、普罗帕酮（OR=1.98;95CI：1.53～2.58;P〈0.01）;与胺碘酮无显著性差异（OR=1.34;95CI：0.81～2.23;P=0.26）;总体抗心律失常疗效优于西药对照组（OR=1.93;95CI：1.57～2.38;P〈0.01）。②心电图改善方面优于美西律（OR=2.24：95CI：1.08～4.65;P〈0.05）、普罗帕酮（OR=2.05;95CI：1.56～2.70;P〈0.01）;与胺碘酮无显著性差异（OR=1.13;95CI：0.52～2.45;P〉0.05）,总体心电图改善优于西药对照组（OR=1.95;95CI：1.53～2.49;P〈0.01）。③安全性方面：致胃肠道不良反应率低于普罗帕酮（OR=0.24;95CI：0.12～0.45;P〈0.01）;与胺碘酮无显著性差异（OR=0.58;95CI：0.28～1.22;P〉0.05）;总体致胃肠道不良反应率低于西药对照组（OR=0.34;95CI：0.21～0.54;P〈0.01）。稳心颗粒致心律失常不良反应率低于普罗帕酮（OR=0.15;95CI：0.05～0.47;P〈0.01）;低于胺碘酮（OR=0.06;95CI：0.01～0.24;P〈0.01）,总体致心律失常不良反应发生率低于西药对照组（OR=0.10;95CI：0.04～0.23;P〈0.01）。结论稳心颗粒抗心律失常方面不差于目前临床常用的西药,且不良反应发生率较低。受纳入文献质量的限制,其抗心律失常疗效与安全性的评价期待更多高质量的随机对照双盲试验,以做进一步评价。     

大量放腹水后输注人体白蛋白疗效的 Meta 分析

目的：评估肝硬化合并腹水患者经腹腔大量穿刺放液后（LVP）输注人体白蛋白的疗效。方法检索Cochrane 图书馆、PubMed、Embase、High Wire Press、web of Science、中国生物医学文献数据库、中国知网、维普数据库和万方数据库，收集用人体白蛋白治疗肝硬化腹水的随机对照试验的论文。根据纳入标准对文献进行筛选和评估，采用RevMan 5．2软件进行统计分析，计算相对危险度（RR）和95％置信区间（CI ），试验组静脉输注人体白蛋白，对照组静脉滴注人工胶体或者血管加压素，比较试验组与对照组 LVP 后 PCD、低钠血症、肾损伤、住院病死率的情况。结果最终纳入文献13篇，均为英文文献。Meta 分析结果显示，试验组穿刺后循环障碍（PCD）发生率为14．76％，低于对照组的31．98％，差异有统计学意义（RR ＝0．48，95％ CI ：0．364～0．63，P ＜0．01）。试验组低钠血症发生率（8．12％）低于对照组（15．28％），差异有统计学意义（RR＝0．57，95％CI ：0．37～0．87，P ＝0．009）。试验组肾损伤发生率（5．62％）低于对照组（7．03％），差异无统计学意义（RR ＝0．88，95％CI ：0．53～1．44，P ＝0．61）。试验组住院病死率（9．56％）低于对照组（12．55％），差异有统计学意义（RR＝0．58，95％CI ：0．364～0．93，P ＝0．02）。结论输注人体白蛋白在预防肝硬化腹水患者 LVP 后 PCD、低钠血症方面有优势，且住院病死率降低。     

白细胞介素-1β基因多态性与慢性阻塞性肺疾病易感性的系统评价

目的通过Meta分析探讨IL-1β基因多态性与慢性阻塞性肺疾病（COPD）易感性的关系。方法计算机及手工检索1980年1月至2013年1月发表的关于IL-1β基因多态性和COPD易感性关系的文献资料。根据纳入及排除标准筛选文献并提取数据。Meta分析采用RevMan5．0．25和Stata11．0软件进行。合并效应采用比值比（OR）和95％可信区间（95％CI）进行评价。发表偏倚通过漏斗图直观判断和Egger回归法、Begg秩相关法定量检测。敏感性分析为剔除不符合H—W平衡的文献后重新进行Meta分析。5篇文献（6项研究）被纳入Meta分析,共有749例COPD患者及923例对照纳入研究。结果Meta分析结果表明,IL-1β-511C／T基因多态性与COPD易感性无关联（TvsC：OR=0．97,95％CI=0．76～1．24：TTvsCC：OR：0．93,95％CI=0．55—1．59;CT＋TYvsCC：OR=1．25,95％CI=0．98～1．58;TTvsCT＋CC：OR=0．82,95％CI：0．64—1．05）,IL-1β-31T／C基因多态性与COPD易感性亦无明显联系（CUST：OR=0．99,95％CI=0．86～1．15;CCvsTF：OR=0．99,95％CI=0．72～1．35;CT＋TTvsCC：OR=1．21．95％CI=0．94—1．55;TTvsCT＋CC：OR=0．80,95％CI=0．63～1．03）。结论IL-1β-511C／T、-31T／C基因多态性与COPD易感性无关。     

阿达木单抗对克罗恩病的疗效和安全性评估

背景：国外一系列随机对照试验（RCT）比较了阿达木单抗和安慰剂治疗成人中重度克罗恩病（CD）的疗效和安全性,但目前尚无统一结论。目的：对阿达木单抗治疗成人CD的疗效和安全性行荟萃分析。方法：联机检索PubMed、EMBASE和CochraneLbrary．纳入比较阿达木单抗与安慰剂治疗成人中重度CD的RCT和相关文献．应用RevMan4．2软件行荟萃分析。结果：共4篇文献纳入本荟萃分析。阿达木单抗对成人CD的诱导缓解率（OR=2．98,95％CI：1．78-4．99,P〈0．0001）和维持缓解率（0R=4．79,95％CI：2．96-7．73,P〈0．00001）均明显高于安慰剂组,差异有统计学意义;诱导治疗的整体不良反应发生率低于安慰剂组,差异有统计学意义（OR=0．60,95％CI：0．42～0．87,P=0．007）：维持治疗的整体不良反应发生率与安慰剂组相比无明显差异（OR=1．09,95％CI：0．72-1．65,P=0．68）,严重不良反应发生率低于安慰剂组。差异有统计学意义（OR=0．51,95％CI：0．33-0．80,P=0．003）。结论：阿达木单抗治疗成人CD有效且安全性较高．可作为英夫利昔单抗治疗无效或不耐受者的选择．但仍需进一步行大样本临床试验加以验证。     

抗TNF—α制剂治疗克罗恩病的系统评价

背景：克罗恩病（CD）目前尚无有效治愈方法,抗肿瘤坏死因子-α（TNF-α）制剂的出现给CD的治疗带来了新的选择。目的：系统评价抗TNF—α制剂治疗CD的疗效和安全性。方法：计算机检索MEDLINE／PubMed、OVID、E1sevier ScienceDirect、ISI Web of Knowledge、Cochrane Central Register of Controlled Trials以及国内的CBM、CNKI、VIP数据库,手工检索所获文献的参考文献以及重要会议摘要,纳入关于抗TNF-α制剂治疗CD的随机对照试验（RCT）。使用Jadad量表评价纳入文献质量,以RevMan4．2软件行荟萃分析。结果：共纳入15项RCT,均为高质量研究（Jadad评分≥3分）。治疗组总体临床反应率（44．9％对30．0％,RR=1．39,95％CI：1．16～1．67,P=0．0004）和缓解率（2913％对18．7％,RR=1．63,95％CI：1．26—2．09,P=0．0001）均高于安慰剂组,瘘管愈合率亦较高（40．6％对25.2％,RR=1．74,95％CI：1．23～2．45,P=0．002）。亚组分析显示治疗组诱导治疗和维持治疗阶段临床反应率和缓解率均高于安慰剂组。两组不良事件（77．0％对75．5％,RR=1．01,95％CI：0．96—1．07,P=0．57）和严重不良事件发生率（11．6％对12．6％,RR=0．87,95％CI：0．73～1．04,P=0．13）差异均无统计学意义。结论：抗TNF-α制剂治疗CD疗效优于安慰剂,不良事件和严重不良事件发生情况与安慰剂相似,但其安全性和耐受性尚需更多大样本试验长期观察加以验证。     

Infliximab is superior to other biological agents for treatment of active ulcerative colitis:A meta-analysis

AIM: To compare the efficacy and safety of biological agents for the treatment of active ulcerative colitis(UC).METHODS: PubMed, MEDLINE, EMBASE and the Cochrane library were searched to screen relevant articles from January 1996 to August 2014. The mixedtreatment comparison meta-analysis within a Bayesian framework was performed using WinBUGS14 software.The proportions of patients reaching clinical response,clinical remission and mucosal healing in induction and maintenance phases were analyzed as efficacy indicators. Serious adverse events in maintenance phase were analyzed as safety indicators.RESULTS: The meta-analysis results showed that biological agents achieved better clinical response,clinical remission and mucosal healing than placebo.Indirect comparison indicated that in induction phase,infliximab was more effective than adalimumab in inducing clinical response(OR = 0.41, 95%CI:0.29-0.57), clinical remission(OR = 0.33, 95%CI:0.19-0.56) and mucosal healing(OR = 0.33, 95%CI:0.19-0.56), and golimumab in inducing clinical response(OR = 0.66, 95%CI: 0.39-2.33) and mucosal healing(OR = 2.15, 95%CI: 1.18-4.22). No significant difference was found between placebo and biological agents regarding their safety.CONCLUSION: All biological agents were superior to placebo for UC treatment in both induction and maintenance phases with a similar safety profile, and infliximab had a better clinical effect than the other biological agents.     

布地奈德治疗胶原性结肠炎疗效和安全性的荟萃分析

背景:胶原性结肠炎以慢性水样腹泻和结肠黏膜上皮下胶原带增厚为特征,目前尚无标准治疗方案。目的:系统评价口服布地奈德治疗胶原性结肠炎的疗效和安全性。方法:计算机检索Cochrane Central Register of Controlled Trials(1995～2008.1)、MEDLINE/PubMed(1978～2009.12)、Ovid(1978～2009.12)、EMBASE(1978～2009.12)、中国期刊全文数据库(1980～2009.12)和万方数据资源系统(1980～2009.12),纳入所有口服布地奈德治疗胶原性结肠炎的随机对照试验(RCT),按Cochrane协作网推荐的方法进行荟萃分析。结果:共纳入5项RCT,包括179例患者,3项研究评价了诱导缓解治疗,2项评价了维持治疗。在诱导缓解方面,布地奈德的临床和组织学缓解率均优于安慰剂(OR=15.04,95% CI:5.47～41.33,P0.000 01;OR=34.02,95% CI:5.90～196.20,P0.0001)。在维持治疗方面,布地奈德的临床复发率和组织学缓解维持率亦优于安慰剂(OR=0.11.95% CI:0.04～0.31,P0.0001;0R=5.88,95% CI:1.90～18.17,P=-0.002)。布地奈德不良反应轻微,耐受性良好。结论:口服布地奈德能有效诱导并维持胶原性结肠炎的临床和组织学缓解,耐受性良好。由于本荟萃分析纳入研究的样本量较小,故应谨慎对待上述结论,并设计、开展大样本、高质量的RCT作进一步验证。     

Meta-analysis of the efficacy of probiotics in Helicobacter pylori eradication therapy

AIM: To evaluate the role of probiotics in the standard triple Helicobacter pylori therapy.METHODS: In this meta-analysis, we investigated the efficacy of probiotics in a standard triple H. pylori therapy in adults. Searches were mainly conducted in MEDLINE/PubMed, EMBASE, and the Cochrane Central Register of Controlled Trials. Fourteen studies met our criteria, and the quality of these studies was assessed using the Jadad scale. We used STATA version 12.0 to extract data and to calculate the odds ratios (ORs), which are presented with the corresponding 95% confidence intervals (CIs). The data are presented as forest plots.RESULTS: The pooled ORs for the eradication rates calculated by intention-to-treat analysis and per-protocol analysis in the probiotic group vs the control group were 1.67 (95%CI: 1.38-2.02) and 1.68 (95%CI: 1.35-2.08), respectively, using the fixed-effects model. The sensitivity of the Asian studies was greater than that of the Caucasian studies (Asian: OR = 1.78, 95%CI: 1.40-2.26; Caucasian: OR = 1.48, 95%CI: 1.06-2.05). The pooled OR for the incidence of total adverse effects was significantly lower in the probiotic group (OR = 0.49, 95%CI: 0.26-0.94), using the random effects model, with significant heterogeneity (I² = 85.7%). The incidence of diarrhea was significantly reduced in the probiotic group (OR = 0.21, 95%CI: 0.06-0.74), whereas the incidence of taste disorders, metallic taste, vomiting, nausea, and epigastric pain did not differ significantly between the probiotic group and the control group.CONCLUSION: Supplementary probiotic preparations during standard triple H. pylori therapy may improve the eradication rate, particularly in Asian patients, and the incidence of total adverse effects.     

Effect of clopidogrel on 1-year mortality in hospital survivors of acute ST-segment elevation myocardial infarction in clinical practice.

AIMS: We sought to assess the effect of clopidogrel on clinical events 1 year after discharge in survivors of ST-elevation myocardial infarction (STEMI) in clinical practice. METHODS AND RESULTS: We analysed data of consecutive survivors of acute STEMI and either concomitant therapy with aspirin or aspirin plus clopidogrel at discharge, who were prospectively enrolled in the Acute Coronary Syndromes (ACOS) registry between July 2000 and November 2002. A total of 5886 (3795 with and 2091 without clopidogrel) patients were included into this analysis. Patients were divided into three groups according to the initial reperfusion therapy: no reperfusion therapy (n=1445), fibrinolysis (n=1734), or primary PCI (n=2707). The multivariable analysis for 12+2 month mortality after discharge using the propenstiy score with adjustment for baseline characteristics and treatments (age, sex, diabetes mellitus, hypertension, prior MI, hyperlipidaemia, renal insufficiency, cardiogenic shock, heart rate, systolic blood pressure, anterior infarct location, reduced left ventricular function, elective revascularization, beta-blockers, statins, ACE-inhibitors) showed that mortality was significantly lower in the aspirin plus clopidogrel group compared with the aspirin group in the total group and patients with reperfusion therapy [total group odds ratio (OR) 0.48, 95% confidence interval (CI) 0.48-0.61; no reperfusion therapy OR 0.96, 95% CI 0.65-1.45; fibrinolysis OR 0.53, 95% CI 0.32-0.87; primary percutaneous coronary intervention OR 0.38, 95% CI 0.23-0.62]. CONCLUSION: In clinical practice, adjunctive therapy with clopidogrel, in addition to aspirin, in survivors after STEMI is associated with a reduction in 1-year mortality in patients treated with early reperfusion therapy.     

Effects of corticosteroids in patients with sickle cell disease and acute complications: a systematic review and meta-analysis

Whether corticosteroids improve outcome in patients with acute complications of sickle cell disease (SCD) is still debated. We performed a systematic review of the literature with the aim of estimating effects of corticosteroids on the clinical course of vaso-occlusive crisis (VOC) or acute chest syndrome (ACS) in patients with SCD. The primary outcome was transfusion requirement during hospitalization. Studies were identified by search of MEDLINE and CENTRAL database. Three randomized clinical trials (RCT) and three retrospective cohort studies (RCS) were included, involving 3,304 participants and 5,562 VOC or ACS episodes. There was no difference between corticosteroids and standard treatment regarding transfusion requirement overall (odds ratio [OR]=0.98, 95% confidence interval [CI]: 0.38-2.53) but there was a significant interaction of the study type (P<0.0001): corticosteroid therapy was associated with a lower risk of transfusion in RCT (OR=0.13, 95% CI: 0.04-0.45) and a higher risk of transfusion in RCS (OR=2.12, 95% CI: 1.33-3.40. In RCT, the length of hospital stay was lower with corticosteroids as compared with standard treatment: mean difference - 24 hours (95% CI: -35 to -14). Corticosteroids were associated with an increased risk of hospital readmission as compared with standard treatment, in RCT, RCS, and the entire cohort: OR=5.91, 95% CI: 1.40-24.83; OR=3.28, 95% CI: 1.46-7.36 and OR=3.21, 95% CI: 1.97-5.24, respectively. Corticosteroids were associated with reduced number of transfusions and length of stay in RCT but not in RCS, with more rehospitalizations overall. Additional RCT should be conducted while minimizing the risk of re-hospitalizations.     

抗肿瘤坏死因子α制剂治疗溃疡性结肠炎的荟萃分析

目的 根据现有临床研究评价抗TNFα制剂治疗溃疡性结肠炎(UC)的疗效与安全性.方法 检索Cochrane图书馆、EMBASE、PubMed、OVID数据库和中国知网、万方数据库、维普数据库中有关抗TNFa制剂[英夫利西单抗、阿达木单抗、塞妥珠单抗、依那西普、奥那西普、CDP571、CNI-1493、沙利度胺]治疗UC的RCT文献,采用Revman 5.0软件进行分析,并绘制漏斗图评定有无发表偏倚.结果 共9项RCT研究符合纳入标准,共包括1226例UC患者,其中806例接受抗TNFα制剂治疗,420例接受安慰剂或其他对照药物治疗.荟萃分析显示,在短期应答、短期缓解、长期应答、长期缓解方面,抗TNFα制剂明显优于对照组,OR值分别为2.36(95%CI 1.34～4.15)、2.42(95%CI 1.22～4.81)、3.22(95%CI 2.28～4.55)、2.82(95%CI 1.91～4.16).与对照组相比,抗TNFα制剂可以降低结肠切除率,OR值为0.31(95%CI 0.20～0.48);但在结肠黏膜愈合方面[OR值为1.59(95%CI 0.91～2.78)]及生活质量方面[炎症性肠病问卷(IBDQ)评分的加权均数差(WMD)为24.00(95%CI为-0.95～48.95)],两组的差异均无统计学意义.在安全性方面,两组不良反应发生率相似,OR值为1.07(95%CI0.55～2.09,P=0.84),但抗TNFα制剂的重度不良反应发生率明显低于对照组,OR值为0.65(95%CI 0.48～0.89).各计数资料观察指标的漏斗图均基本呈现下宽上窄、左右对称的图形,提示无发表偏倚.结论 抗TNFα制剂对于常规药物治疗无效的中、重度UC有较好的疗效,可以诱导UC短期应答,降低结肠切除率,并可维持长期的临床应答与临床缓解,严重不良反应的发生率较低,但抗TNFα制剂未能提高UC患者的生活质量与黏膜愈合率.

Abstract：

Objective To pool the data of studies and evaluate the efficacy and safety of TNFα blocking agents in the treatment of ulcerative colitis(UC).Methods The randomized clinical trials(RCT)that compared the efficacy or safety of TNFα in the treatment of UC were researched from Pubmed. OVID. EMBASE. Cochrane library, CNKI, Wanfang data and VIP Chinese Scientific and Technologic Periodical Database. Statistical heterogeneity between trials was evaluated by Revman 5.0 and was considered to exist when P＜0.1.Heterogeneity of the included articles was tested. which was used to select proper effect model to calculate. Publication bias was investigated through visual inspection of funnel plots. Results Nine RCT including 1226 cases were analyzed. Eight hundred and six cases had received TNFα treatment and 420cases had received placebo or glucocorticoid treatment. Compared with placebo or glucocorticoid groups, TNFα group achieved significantly higher rates of short-term clinical response, short-term clinical remission, long-term clinical response.10ng-term clinical remission and the total OR were 2.36(95%C,1.34-4.15),2.42(95%CI 1.22-4.81).3.22(95%CI2.28-4.55)and 2.82(95%CI1.91-4.16)respectively. TNFα group was less likely to undergo colectomy than placebo group and the total OR was 0.31(95%CI0.20-0.48).TNFα could not improve the mucosal healing and quality of lire. No significant difference was found in adverse effect between TNFα group and placebo or glueoeortieoid group(OR=1.07(95%CI0.55-2.09,P=0.84)).The rate of serious adverse effect in TNFα group was less than placebo or glueoeorticoid groups (OR=0.65,95%CI0.48-0.89,P=0.007).Inspection of the funnel plots for all dichotomous data measures had not revealed evidence of publication bias. Conclusions Patients with moderately to severely active UC treated with TNFαhave effective clinical response and clinical remission and are less likely to undergo colectomy than those receiving placebo or glucocorticoid. TNFα treatment is safe for UC but can not improve the mucosal healing and quality of life. Large-scale, high-quality RCTs ale needed to confirm or refuse the available evidence.     

Continuous infusion versus bolus administration of steroids in severe attacks of ulcerative colitis: a randomized, double-blind trial

BACKGROUND: In patients with severe attacks of ulcerative colitis (UC), IV steroids represent the first-line treatment, leading to clinical improvement in approximately 50-60% of patients. AIM: The aim of this study was to prospectively compare the efficacy and safety of different modalities of steroid administration, and to evaluate predictors of failure to therapy. MATERIALS AND METHODS: In a single-center, double-blind trial, consecutive patients with a severe attack of UC received 1 mg/kg/day of 6-methyl-prednisolone administered randomly by either a bolus injection (group A) or continuous infusion (group B). RESULTS: Sixty-six patients were enrolled (35 men, mean age 38 +/- 15, range 18-75 yr), 15 of them at their first attack of UC; in the remaining cases, the mean duration of disease was 4.5 +/- 5 yr. At inclusion, forty patients (60%) had pancolitis and the remainder had left-sided colitis. Overall, thirty-three patients (50%) underwent clinical remission after 7 days of treatment: 16 of 32 in group A and 17 of 34 in group B. Thirty-one patients eventually underwent total colectomy (12 in group A and 9 in group B), which was carried out by the first month in 10 patients (5 in each group). Twenty-eight patients (15 in group A and 13 in group B) experienced steroid-related adverse reactions. All differences between groups were not statistically significant. Previous use of steroids (OR 13.6, CI 2-86) and active smoking (OR 11.6, CI 1.4-107) were independent predictors of nonresponse. CONCLUSIONS: In severe attacks of UC, methyl-prednisolone given as a continuous infusion was no better than bolus administration in terms of efficacy and safety.     

Meta-analysis of the effectiveness and safety of vedolizumab for ulcerative colitis

AIM: To conduct a meta-analysis examining the effectiveness and safety of vedolizumab for the treatment of ulcerative colitis (UC).METHODS: A search was conducted of MEDLINE, Cochrane, EMBASE, and Google Scholar on July 31, 2013. Inclusion criteria were: (1) Randomized controlled trial (RCT); (2) Patients treated for UC; and (3) Intervention was vedolizumab. The following information/data were extracted from studies that met the inclusion criteria: the name of the first author, year of publication, study design, patient demographic information, response rate, remission rate, and adverse events. The primary outcome was clinical response rate, and the secondary outcomes were clinical remission rate and serious adverse events. Odds ratio (OR) with 95%CI were calculated for each outcome.RESULTS: Of 224 studies initially identified, three RCTs examining the use of vedolizumab meeting the inclusion criteria were included in the meta-analysis. All studies examined the use of vedolizumab at dosages ranging from 0.5 to 10 mg/kg body weight (one study used a standard dose of 300 mg). The follow-up periods were approximately 6 wk. The total number of patients in the intervention groups was 901, and in the control groups was 221. The mean age of the patients was approximately 41 years, and approximately half were males. The follow-up periods ranged from 43 d to 6 wk. The clinical response and remission rates were significantly higher for patients who received vedolizumab as compared to control patients (clinical response: OR = 2.69; 95%CI: 1.94-3.74, P < 0.001 and remission rate: OR = 2.72; 95%CI: 1.76-4.19, P < 0.001). Serious adverse events were not higher in patients that received vedolizumab.CONCLUSION: This analysis supports the use of vedolizumab for the treatment of UC.     

The economics of mesalazine in active ulcerative colitis and maintenance in the Netherlands

Background: In this study we investigate the costs and benefits of topical mesalazine combined with oral mesalazine therapy for active ulcerative colitis (UC), and once daily (OD ) mesalazine 2 grams versus twice daily (BID ) for maintaining UC remission. Methods: Two decision analytic models were constructed to evaluate treatment costs and quality-adjusted life years (QALYs) associated with mesalazine. The first model explored 4 g oral mesalazine in combination with 1 g topical mesalazine during active UC compared with 4 g oral mesalazine monotherapy for achieving clinical remission. The second model compared remission rates at one year for OD 2 g oral mesalazine compared with BID 1 g adjusted for compliance. All direct costs were obtained from established treatment costs in the Netherlands. Results: The average cost of treatment to transition an active UC patient into remission using oral plus topical mesalazine or oral mesalazine monotherapy was v2207 (95% CI: v1402 to v3332) and v2945 (95% CI: v1717 to v4592), respectively. The annual average cost-saving of adding topical mesalazine delivered for four weeks during active UC was v738. The average annual costs of maintenance of remission with OD and BID therapy were v1293 (95% CI: v1062 to v1496) and v1502 (95% CI: v1262 to 1708), respectively with an annual average per person savings of v209. Conclusion: Topical mesalazine during acute UC flares results in lower costs due to reduced healthcare consumption attributed to faster symptom resolution. Furthermore, as a result of lower costs and modest QALY gains, maintenance therapy using OD mesalazine is the dominant treatment option if compared with BID mesalazine.