益生菌对炎症性肠病诱导缓解、维持治疗和贮袋炎作用系统评价

目的 评价益生菌对炎症性肠病缓解、维持治疗和贮袋炎的作用。方法 检索MEDLINE，EMBASE，the Cochrane Con—trolled Trials Register，OVID，BIOSIS和中国生物科技数据库，两位作者独立选取和炎症性肠病缓解率、复发率以及副作用相关的，对比益生菌治疗和非益生菌治疗的随机对照试验，使用Rev Man4．2．10软件统计分析，同时做亚组分析和敏感性分析。结果21项随机对照试验中共有1515例患者符合入选标准：4项研究评估了缓解率，14项研究评估了复发率，3项研究同时评估了缓解率和复发率。通过荟萃分析，炎症性肠病的总体缓解率相对危险度（relativerisk，RR）为1．05（95％CI=0．84—1．31），克罗恩病的缓解率RR0．85（95％CI=0．64—1．13），溃疡性结肠炎的缓解率RR1．18（95％CI=0．87—1．58）；贮袋炎临床复发率RR0．24（95％CI=0．12—0．48），克罗恩病临床复发率RR1．11（95％CI=0．69—1．80）；内镜复发率的RR1．08（95％CI=0．67—1．74）；益生菌与安慰剂比较，炎症性肠病的复发率RR0．51（95％CI=0．29—0．92）；益生菌与5-氨基水杨酸比较，溃疡性结肠炎的复发率RR0．96（95％CI=0．76—1．19）。结论 溃疡性结肠炎患者使用益生菌作为缓解治疗具有和5-氨基水杨酸相同的效果并优于安慰剂，但在炎症性肠病的诱导缓解中无额外益处。     

治疗功能性消化不良常用药物的有效性及安全性:Meta分析

目的评估根除幽门螺杆菌(Helicobacter pylori,H.pylori)及其他常用药物治疗功能性消化不良(functional dyspepsia,FD)的有效性及安全性。方法检索中国知网、万方数据库、PubMed数据库、Cochrane数据库、Embass数据库,检索随机对照、高质量前瞻性队列或交叉实验的相关文献,检索时间建库至2019年3月15日。采用Stata 12.0软件分析患者的总体症状改善率、不良反应发生率,计算RR及95%CI,并进行灵敏性分析和发表偏倚检验(包括绘制漏斗图及Egger法和Begg法检验)。同时,通过Meta回归的方式实现网状Meta分析。结果共纳入31篇文献,包括8 950例患者。其中4 435例接受试验组药物治疗,4 265例接受安慰剂治疗(因数据通过意向性分析选取,且根除H.pylori组只选取成功根除的病例)。结果显示:促动力药物(RR=1.14,95%CI:1.06～1.23,P=0.00)、抑酸药(RR=1.40,95%CI:1.09～1.79,P=0.01)、根除H.pylori(RR=1.65, 95%CI:1.43～1.91,P=0.00)、三环类抗抑郁药(TCAs)(RR=1.38,95%CI:1.17～1.63,P=0.000)的总体疗效优于安慰剂,而胃黏膜保护剂(RR=1.09,95%CI:0.91～1.30,P=0.35)及选择性5-羟色胺再摄取抑制剂(SSRIs)(RR=0.96,95%CI:0.77～1.20,P=0.70)与安慰剂的疗效差异无统计学意义。抗焦虑抑郁药物组不良反应发生率高于安慰剂组(RR=1.42,95%CI:1.07～1.89,P=0.02),而其他药物的不良反应率类似于安慰剂。结论促动力药物、PPIs、TCAs、根除H.pylori能明显改善FD总体症状,而SSRIs和胃黏膜保护剂的疗效欠佳。抗焦虑抑郁药物不良反应发生率较高,但无严重不良反应。     

维多珠单抗治疗活动性炎症性肠病疗效和安全性的评价

背景:炎症性肠病(IBD)是一种反复复发的胃肠道非特异性炎症性疾病。选择性阻断白细胞与肠道血管内皮细胞黏附的维多珠单抗(VDZ)对活动性IBD有较好疗效。目的:系统评价VDZ对活动性IBD的疗效和安全性。方法:计算机检索Pub Med、Embase、Cochrane Library、Google Scholar 2018年8月前发表的VDZ治疗IBD的随机安慰剂对照试验,检索语言仅限英文。应用Rev Man 5. 30软件进行meta分析。结果:8项涉及3 159例活动性IBD患者的随机对照试验纳入研究。Meta分析显示,对于活动期UC,VDZ组临床反应率、临床缓解率、内镜缓解率均优于安慰剂组(RR=1. 62,95%CI:1. 33～1. 97,P 0. 000 01; RR=2. 45,95%CI:1. 56～3. 83,P 0. 000 1; RR=1. 75,95%CI:1. 29～2. 37,P=0. 000 3),缓解期临床缓解率亦优于安慰剂组(RR=2. 43,95%CI:1. 73～3. 41,P 0. 000 01)。对于活动期CD,VDZ组临床反应率、临床缓解率同样优于安慰剂组(RR=1. 47,95%CI:1. 21～1. 79,P=0. 000 1; RR=1. 87,95%CI:1. 37～2. 56,P 0. 000 1),但亚组分析显示VDZ仅在未经抗肿瘤坏死因子-α(TNF-α)治疗者中具有诱导缓解作用。仅1篇文献描述了VDZ对缓解期CD的维持缓解情况,结果显示VDZ疗效优于安慰剂。除鼻咽炎外,VDZ引发的不良事件并不多于安慰剂。结论:VDZ用于活动性IBD的诱导和维持缓解安全、有效,但对抗TNF-α治疗失败的CD患者可能无效。     

中药补脾益肠丸辅助治疗溃疡性结肠炎的Meta分析

目的:评价补脾益肠丸治疗溃疡性结肠炎(ulcerative colitis,UC)的疗效和安全性.方法:用关键词或主题词检索Medline数据库、EMbase数据库、Cochrane图书馆、ISI数据库、中国期刊全文数据库、中文科技期刊数据库、万方数据库以获得相关随机对照试验,检索时间从建库至2012-05.根据纳入和排除标准由两名研究者独立进行文献质量评价,应用Review Manager 4.2.10统计软件分析疗效和安全性.效应量为相对危险度(relative risks,RR).结果:根据纳入标准纳入6个比较补脾益肠丸与氨基水杨酸制剂的随机对照试验.补脾益肠丸联合氨基水杨酸制剂的中西医结合治疗组的疗效优于氨基水杨酸制剂组(RR=1.16;95%CI:1.07-1.25;P<0.05),中西医结合治疗组的复发率低于氨基水杨酸制剂组(RR=0.26;95%CI:0.14-0.48;P<0.05),中西医结合治疗组不良反应发生率低于氨基水杨酸制剂组(RR=0.24;95%CI:0.10-0.58;P<0.05).结论:联用补脾益肠丸稍优于单独的氨基水杨酸制剂治疗.中药补脾益肠丸辅助治疗为UC治疗提供新的选择.     

华法林基因型指导临床用药疗效的Meta分析

目的:系统评价华法林基因型指导临床用药的有效性及安全性。方法:检索建库至2018年10月Pubmed、Embase、Cochrane图书馆、万方数据库和中国知网的随机对照试验,同时采用Revman5.3软件对纳入的随机对照试验进行荟萃分析。根据随访时间不同对TTR、INR4、大出血事件、血栓栓塞事件变量行亚组分析,评估华法林基因型指导临床用药的有效性及安全性。绘制漏斗图评价发表偏倚。结果:纳入11项研究共4 475例患者。随访时间1个月内的亚组分析显示,试验组与对照组TTR无显著统计学差异(WMD=1.30%,95%CI:-0.27～2.87,P=0.11),INR4事件无显著统计学差异(RR=0.88,95%CI:0.6～1.3,P=0.52),试验组大出血事件显著降低(RR=0.41,95%CI:0.18～0.94,P=0.03)。在随访时间大于1个月的亚组分析中,试验组TTR显著优于对照组(WMD=5.37%,95%CI:3.24～7.50,P0.000 01),两组INR4事件无显著统计学差异(RR=1.01,95%CI:0.83～1.23,P=0.93),试验组大出血事件显著降低(RR=0.5,95%CI:0.28～0.9,P=0.02),两组栓塞事件无显著统计学差异(RR=0.73,95%CI:0.48～1.1,P=0.14)。结论:对于需长期抗凝、高出血风险的患者,华法林基因型指导临床用药显示出其优越性。     

利那洛肽对便秘型肠易激综合征有效并改善患者生活质量的Meta分析

目的:评价利那洛肽与安慰剂对比在便秘型肠易激综合征(irritable bowel syndrome with constipation,IBS-C)患者中的疗效及安全性.方法:中国期刊全文数据库(China National Knowledge Internet,CNKI),中国生物医学文献数据库(China Biology Medicine,CBM)、中国万方数据库、中国维普数据库、PubMed、Embase、Web of science、Cochrane library和clinical trials.gov等数据库中关于利那洛肤应用于成人IBS-C的与安慰剂对照的随机对照试验.结果用RevMan v5.2版本统计了相对危险因素(relative risk,RR)和95%可信区间(confidence intervals,CI)等二分类资料.结果:检索出符合要求的关于利那洛肽用于IBS-C的3个随机对照试验的4篇公开发表的文章,主要观察指标为:腹痛的效果(RR=1.58,95%CI:1.02-2.46);对完全性自发排便(complete spontaneous bowel movements,CSBMs)的改善(RR=3.19,95%CI:2.40-4.25);患者生活质量的改善(RR=1.38,95%CI:1.09-1.74).利那洛肽还在改善大便性状、减少腹痛、腹胀和所有严重症状方面发挥作用.与安慰剂相比,腹泻是利那洛肤最常发生的不良反应.结论:通过本研究比较得知,利那洛肽与安慰剂相比,能改善肠道功能,减轻腹痛症状和改善IBS-C患者的生活质量.     

水飞蓟制剂预防性治疗抗结核药物性肝损伤效果的Meta分析

目的评估水飞蓟制剂在预防抗结核药物性肝损伤(ATB-DILI)中的作用。方法检索MEDLINE、PubMed、Embase和Cochrane对照试验中心注册库(CENTRAL)截至2018年11月30日,水飞蓟制剂与安慰剂相比预防ATB-DILI的随机对照试验研究。所有统计分析均使用STATA12. 0软件进行。使用具有95%可信区间(95%CI)的标准化均值差(SMD)和相对危险度(RR)来评估水飞蓟制剂的作用。纳入研究的质量根据Cochrane手册进行评估。使用漏斗图和Egger’s测试评估发生偏倚。采用敏感性分析以评估每项研究对整体效应大小的影响。结果共纳入5项随机对照试验的1198例患者(585例使用水飞蓟制剂,613例使用安慰剂)。水飞蓟制剂在第4周显著降低了ATB-DILI的发生风险(RR=0. 33,95%CI:0. 15～0. 75,P=0. 008)。此外,水飞蓟制剂对接受抗结核药物治疗的患者肝功能有保护作用(ALT:SMD=-0. 15,95%CI:-0. 24～-0. 07,P 0. 001; AST:SMD=-0. 14,95%CI:-0. 23～-0. 06,P=0. 001; ALP:SMD=-0. 12,95%CI:-0. 20～-0. 03,P=0. 008)。水飞蓟制剂和安慰剂不良反应发生风险相当(RR=1. 09,95%CI:0. 86～1. 39,P=0. 47)。结论水飞蓟制剂的预防性治疗有助于结核病患者开始治疗后4周显著降低ATB-DILI的发生风险。此外,水飞蓟制剂还能显著改善抗结核药物治疗患者的肝功能。     

肝细胞癌根治性治疗后口服维生素K2类似物的Meta分析

目的:评价肝细胞癌(hepatocellular carcinoma,HCC)根治性治疗后口服维生素K2(vitamin K2,VK2)类似物预防肿瘤复发及提高总生存率的疗效.方法:计算机检索中国知网、Medline、Embase和Cochrane图书馆数据库中的相关文献.检索所有关于HCC根治性术后VK2类似物治疗的研究.对纳入文献进行资料提取及质量评价.采用相对危险度(risk ratio,RR)及其95%可信区间(confidence interval,CI)表示统计效应量.结果:共纳入6个随机对照试验和1个队列研究,合计930例患者.Meta分析结果显示:(1)HCC根治性术后口服VK2类似物不能降低术后1年复发率(RR=0.67,95%CI:0.39-1.13,P=0.13),但术后2年及3年复发率显著降低(RR=0.65,95%CI:0.51-0.83,P<0.001;RR=0.70,95%CI:0.58-0.85,P<0.001);(2)1、2、3年总生存率:口服VK2类似物治疗组与单纯手术治疗组比较,2组差异有统计学意义(RR=1.03,95%CI:1.01-1.05,P=0.02;RR=1.11,95%CI:1.03-1.19,P=0.005;RR=1.14,95%CI:1.02-1.28,P=0.02);(3)口服VK2类似物安全,无不良反应报道.结论:目前证据显示辅助VK2类似物治疗对降低HCC患者根治性术后复发率及提高总生存率有一定的疗效.由于纳入研究的随访时间较短和存在的局限性,有必要开展多中心大样本的随机对照试验长期随访观察进一步证实其疗效.     

益生菌单独用药和联合用药对比安慰剂治疗溃疡性结肠炎的疗效分析

背景临床工作中,常加用益生菌来治疗溃疡性结肠炎(ulcerative colitis,UC),但其在UC的治疗中到底发挥多大的作用、在哪一阶段起作用,目前尚无定论.目的采用Meta分析的方法比较益生菌与安慰剂在成人UC中的疗效及安全性.方法检索Pub Med, EMBASE, Cochrane Library,万方数据库,中国知网数据库中有关益生菌与安慰剂在UC治疗中的随机对照试验研究(randomized controlled trials,RCTs).结果 14项RCTs共计869例患者纳入本研究.其中,关于UC诱导缓解的研究有9项RCTs,关于维持治疗的有5项RCTs.比较其在UC诱导缓解中的作用,发现益生菌对比安慰剂的缓解率分别为45.5%、34.7%, RR=1.36,95%CI:1.11-1.66),二者有统计学意义(P=0.002),各研究之间不存在异质性(χ~2=11.81, P=0.16, I~2=32%);比较其在UC维持治疗中的作用,发现各研究间存在异质性(P=0.09, I~2=72%),进一步亚组分析发现,单独应用益生菌较单独应用安慰剂有效(P=0.004),而益生菌联合应用其他药物(5-ASA、美沙拉嗪、激素和硫唑嘌呤)与安慰剂联合其他药物相比,无统计学意义(P=0.95);比较益生菌与安慰剂在UC治疗中的安全性,发现二者副作用相近,分别为23.1%、15.3%,二者比较无统计学意义(P=0.86).结论在UC诱导缓解中,无论单独应用益生菌还是益生菌联合其他药物的作用比安慰剂效果好;在UC维持治疗中,单用益生菌的作用比安慰剂效果好,但合用其他药物时,益生菌无明显优势;二者在UC治疗中的安全性相近.     

乌司奴单抗治疗中-重度活动性克罗恩病疗效和安全性的Meta分析

目的系统评价乌司奴单抗治疗中-重度活动性克罗恩病(Crohn’s disease, CD)的有效性和安全性。方法系统检索PubMed、Embase、Cochrane Library数据库关于乌司奴单抗治疗中-重度活动性CD疗效的随机对照试验(RCTs),应用Revman 5.3软件进行Meta分析。结果共纳入10项研究,共10 536例患者。Meta分析结果显示:(1)疗效:(1)诱导期:乌司奴单抗治疗中-重度活动性CD临床反应率、临床缓解率、内镜缓解率均高于安慰剂组(OR=2.36,95%CI:2.09～2.65,P0.00001;OR=2.27,95%CI:1.85～2.77,P0.00001;OR=2.90,95%CI:1.88～4.48,P0.00001),其中乌司奴单抗在诱导既往TNF-拮抗剂治疗失败或常规治疗失败中-重度活动期CD的临床反应率、临床缓解率均优于安慰剂;1篇文献认为,乌司奴单抗(9%,14/155)在诱导中-重度活动期CD的黏膜愈合疗效方面优于安慰剂(4%,4/97)。(2)维持期:乌司奴单抗治疗维持期CD临床缓解率、临床反应率均高于安慰剂组(OR=1.97,95%CI:1.63～2.38,P0.00001;OR=2.09,95%CI:1.69～2.59,P0.00001);1篇文献认为,乌司奴单抗(13%,6/46)在诱导中-重度活动期CD的黏膜愈合疗效方面优于安慰剂(4%,1/24)。(2)安全性:在诱导期和维持期,乌司奴单抗组和安慰剂组引发的不良反应相比,差异无统计学意义(P0.05)。结论乌司奴单抗用于中-重度活动性CD的诱导和维持缓解有效、安全。     

Meta-analysis: the effect and adverse events of Lactobacilli versus placebo in maintenance therapy for Crohn disease

Background:  Lactobacilli are used in an attempt to maintain remission for Crohn disease. The aim of this study was to evaluate the efficacy and adverse events of Lactobacilli compared with placebo in maintenance therapy for Crohn disease.
Methods:  We searched MEDLINE, EMBASE, the Cochrane Controlled Trials Register, OVID and BIOSIS. All randomized trials comparing Lactobacilli with placebo in maintenance therapy for Crohn disease were included.
Results:  Six randomized controlled trials with a total of 359 participants met the inclusion criteria. From the meta-analyses, the relative risk (RR) of clinical relapse rate was 1.15 (95% confidence interval (CI) 0.90–1.48) comparing Lactobacilli with placebo and RR of endoscopic relapse rate was 1.31 (95%CI 0.57–3.00). Subgroup analyses showed RR for clinical relapse rates of Lactobacilli versus placebo was 0.99 (95%CI 0.76–1.29) in adults, 1.85 (95%CI 1.00–3.41) in children, 1.68 (95%CI 1.07–2.64) in Lactobacillus rhamnosus strain GG and 0.91 (95%CI 0.68–1.23) in Lactobacillus johnsonii respectively. The pooled RR of adverse events was 0.83 (95%CI 0.61–1.12).
Conclusion:  Our meta-analysis suggests that compared with placebo, administration of L. rhamnosus strain GG as maintenance therapy may increase the relapse rates of Crohn disease. L. johnsonii is inefficacious in reducing the incidence of relapse.     

Sulfasalazine and Mesalazine for the Maintenance Therapy of Crohn's Disease: A Meta-analysis

Objective: The aim of this meta-analysis was to determine whether therapy with sulfasalazine or mesalazine is effective in the maintenance of clinical remission in patients with Crohn's disease. Methods: Computerized searches of bibliographic databases were carried out to identify studies published up to October 1993 that were randomized controlled trials of sulfasalazine or mesalazine as single drug therapy in the prevention of symptomatic disease relapse in quiescent Crohn's disease. We extracted and statistically aggregated data from the trials, using a fixed effects model. Results: A total of 10 eligible trials involving a total of 1022 patients were identified. Therapy with sulfasalazine or mesalazine reduces the risk of clinical relapse of Crohn's disease after 12 months [relative risk (RR) = 0.77, 95% confidence interval (CI) 0.64–0.92]. The benefit is less apparent at 3–6 months [RR = 0.86, 95% CI 0.67–1.09]. Subgroup analysis indicated that therapeutic benefit exists for mesalazine but not for sulfasalazine [RR for mesalazine = 0.63, 95% CI 0.50–0.79; RR for sulfasalazine = 1.08, 95% CI 0.81–1.44]. Conclusions: Maintenance therapy with mesalazine or sulfasalazine reduces the risk of clinical disease relapse in Crohn's disease after 1 yr. This benefit is seen primarily in the more recent studies that have used mesalazine as the therapeutic agent.     

A Meta-Analysis on the Efficacy of Probiotics for Maintenance of Remission and Prevention of Clinical and Endoscopic Relapse in Crohn’s Disease

OBJECTIVE: To evaluate whether probiotics maintain remission in patients with Crohn's disease (CD). DESIGN: A meta-analysis of controlled clinical trials. METHODS: PUBMED and Cochrane Central Register of Controlled Trials were searched for clinical trial studies investigated the efficacy of probiotics for the maintenance of remission in Crohn's disease. Clinical relapse and endoscopic relapse were the key outcomes of interest. Data were searched within the time period of 1966 through May 2007. RESULT: Eight randomized placebo-controlled clinical trials met our criteria and were included in the analysis. Seven determined clinical relapse and three evaluated endoscopic relapse among patients with CD received probiotics for maintenance of remission. Pooling of seven trials for the outcome of clinical relapse yielded an odds ratio of 0.92 (95% confidence interval of 0.52-1.62, P = 0.8853), a nonsignificant odds ratio. The odds ratio for three studies for the outcome of endoscopic relapse was 0.97 (95% confidence interval of 0.54-1.78, P = 0.93), a nonsignificant odds ratio. CONCLUSION: This meta-analysis fails to demonstrate the efficacy of probiotics in maintaining remission and preventing clinical and endoscopic recurrence in CD. It is suggested to use probiotic preparations containing a mixture of lactobacillus with E. coli or Saccharomyces.     

Antibiotic therapy in inflammatory bowel disease: a systematic review and meta-analysis

The etiology of inflammatory bowel disease (IBD) is unknown but may relate to an unidentified bacterial pathogen or an immunological reaction to gut microbiota. Antibiotics have therefore been proposed as a therapy for Crohn's disease (CD) and ulcerative colitis (UC) to induce remission in active disease to prevent relapse. Current data are conflicting and we therefore conducted a systematic review of randomized controlled trials (RCTs) evaluating antibiotics in IBD. Only parallel group RCTs were considered eligible. Studies with adult patients receiving any dose of therapy for at least 7 days and up to 16 weeks for active disease, or at least 6 months of follow-up for preventing relapse in quiescent disease were analyzed. We included any antibiotics alone or in combination using predefined definitions of remission and relapse. Two reviewers independently assessed eligibility and extracted data. The primary outcome was remission or relapse using an intention-to-treat methodology. The data were summarized using relative risk (RR) and pooled using a random effects model. For active CD, there were 10 RCTs involving 1,160 patients. There was a statistically significant effect of antibiotics being superior to placebo (RR of active CD not in remission=0.85; 95% confidence interval (CI)=0.73-0.99, P=0.03). There was moderate heterogeneity between results (I(2)=48%) and a diverse number of antibiotics were tested (anti-tuberculosis therapy, macrolides, fluroquinolones, 5-nitroimidazoles, and rifaximin) either alone or in combination. Rifamycin derivatives either alone or in combination with other antibiotics appeared to have a significant effect at inducing remission in active CD. In perianal CD fistula there were three trials evaluating 123 patients using either ciprofloxacin or metronidazole. There was a statistically significant effect in reducing fistula drainage (RR=0.8; 95% CI=0.66-0.98) with no heterogeneity (I(2)=0%) and an number needed to treat 5 (95% CI=3-20). For quiescent CD, there were 3 RCTs involving 186 patients treated with different antibiotics combinations (all including antimycobacterials) vs. placebo. There was a statistically significant effect in favor of antibiotics vs. placebo (RR of relapse=0.62; 95% CI=0.46-0.84), with no heterogeneity (I(2)=0%). In active UC, there were 9 RCTs with 662 patients and there was a statistically significant benefit for antibiotics inducing remission (RR of UC not in remission=0.64; 95% CI=0.43-0.96). There was moderate heterogeneity (I(2)=69%) and antibiotics used were all different single or combination drugs. Antibiotic therapy may induce remission in active CD and UC, although the diverse number of antibiotics tested means the data are difficult to interpret. This systematic review is a mandate for further trials of antibiotic therapy in IBD.     

A meta-analysis of antimycobacterial therapy for Crohn's disease

OBJECTIVE: Various therapies have been studied for the treatment of Crohn's disease, including antimycobacterial therapy. Meta-analysis was used to evaluate the effect of antimycobacterial therapy in patients with Crohn's disease. METHODS: Randomized, controlled trials comparing antimycobacterial therapy with placebo were identified. Key outcome data were abstracted and the results were pooled to yield odds ratios for maintenance of remission in treated versus control groups. RESULTS: A total of eight randomized trials were identified. Six trials were fully published and were included in the primary analysis. Two trials used antimycobacterial therapy in combination with corticosteroids to induce remission in patients with active Crohn's disease, followed by maintenance therapy with antimycobacterial agents. In these trials, control patients received corticosteroids to induce remission but no antimycobacterial therapy. Pooling of these trials yielded an odds ratio of maintenance of remission in treatment versus control of 3.37 (95% confidence interval [CI], 1.38-8.24) in favor of antimycobacterial therapy. The remaining four trials used antimycobacterial therapy combined with standard therapy in patients with Crohn's disease. In these trials, control patients received standard therapy alone. Pooling of these trials yielded an odds ratio of maintenance of remission in treatment versus control of 0.69 (95% CI, 0.39-1.21) in favor of standard therapy. CONCLUSIONS: These results suggest that antimycobacterial therapy is effective in maintaining remission in patients with Crohn's disease after a course of corticosteroids combined with antimycobacterial therapy to induce remission. Treatment of Crohn's disease with antimycobacterial therapy does not seem to be effective without a course of corticosteroids to induce remission. Because of the small number of studies included in this meta-analysis, the results should be interpreted with caution.     

Adverse events with bismuth salts for Helicobacter pylori eradication： Systematic review and meta-analysis

AIM： To assess the safety of bismuth used in Helicobacter pylori （H pylorl） eradication therapy regimens. METHODS： We conducted a systematic review and meta-analysis. MEDLINE and EMBASE were searched （up to October 2007） to identify randomised controlled tri- als comparing bismuth with placebo or no treatment, or bismuth salts in combination with antibiotics as part of eradication therapy with the same dose and duration of antibiotics alone or, in combination, with acid suppresion. Total numbers of adverse events were recorded. Data were pooled and expressed as relative risks with 95% confidence intervals （CI）.RESULTS： We identified 35 randomised controlled trials containing 4763 patients. There were no serious adverse events occurring with bismuth therapy. There was no statistically significant difference detected in total adverse events with bismuth rrelative risk （RR） = 1.01; 95% CI： 0.87-1.16], specific individual adverse events, with the exception of dark stools （RR = 5.06; 95% CI： 1.59-16.12）, or adverse events leading to withdrawal of therapy （RR = 0.86; 95% CI： 0.54-1.37）. CONCLUSION： Bismuth for the treatment of H py/ori is safe and well-tolerated. The only adverse event occurring significantly more commonly was dark stools.     

How effective are current drugs for Crohn's disease? A meta-analysis.

We have conducted a meta-analysis of 12 placebo controlled trials to determine the efficacy of single drug therapy in Crohn's disease for both induction (seven trials) and maintenance (five trials) of remission. A total of 767 and 796 patients were studied, respectively. Various clinical criteria of success were analyzed. The Dersimonian-Laird method for meta-analysis was used to calculate the risk difference (RD). Therapeutic advantage, defined as the difference between drug and placebo response, was also determined. Using various criteria of success, we found that single drug therapy conferred an 11-29% therapeutic advantage (RD = 0.13-0.33) over placebo for the induction of remission. In trials for maintenance, no therapeutic advantage was found for single drug therapy over placebo. All forms of maintenance therapy followed nearly identical linear rates of relapse over time, showing an approximately 90% maintenance of remission rate at 3 months, which decreased to 25% at 36 months. In conclusion, meta-analysis has established a standard of reference against which future drug trials can be compared. This standard of reference for drug and placebo rates, as well as the corresponding risk differences and therapeutic advantages can help determine the relative value of newer agents in the therapy of Crohn's disease.     

The effect of interventions to prevent cardiovascular disease in patients with type 2 diabetes mellitus.

PURPOSE: Cardiovascular complications account for over 50% of mortality among patients with type 2 diabetes mellitus. We quantify the cardiovascular benefit of lowering cholesterol, blood pressure, and glucose levels in these patients. METHODS: We conducted a meta-analysis of randomized controlled trials in type 2 diabetes or diabetes subgroups, comparing the cardiovascular effects of intensive medication control of risk factor levels in standard therapy or placebo. We identified trials by searching MEDLINE (1966 to 2000) and review articles. Treatment details, patient characteristics, and outcome events were obtained using a specified protocol. Data were pooled using fixed-effects models. RESULTS: Seven serum cholesterol-lowering trials, six blood pressure-lowering trials, and five blood glucose-lowering trials met eligibility criteria. For aggregate cardiac events (coronary heart disease death and nonfatal myocardial infarction), cholesterol lowering [rate ratio (RR) = 0.75; 95% confidence interval (CI): 0.61 to 0.93) and blood pressure lowering (RR = 0.73; 95% CI: 0.57 to 0.94) produced large, significant effects, whereas intensive glucose lowering reduced events without reaching statistical significance (RR = 0.87; 95% CI: 0.74 to 1.01). We observed this pattern for all individual cardiovascular outcomes. For cholesterol-lowering and blood pressure-lowering therapy, 69 to 300 person-years of treatment were needed to prevent one cardiovascular event. CONCLUSION: The evidence from these clinical trials demonstrates that lipid and blood pressure lowering in patients with type 2 diabetes is associated with substantial cardiovascular benefits. Intensive glucose lowering is essential for the prevention of microvascular disease, but improvements in cholesterol and blood pressure levels are central to reducing cardiovascular disease in these patients.     

Oral 5-aminosalicylic acid (Asacol) in the maintenance treatment of Crohn's disease. The Italian IBD Study Group.

A randomized, placebo-controlled multicenter trial was conducted to evaluate the efficacy and safety of a delayed-release formulation of 5-aminosalicylic acid (5-ASA) (Asacol; Giuliani & Bracco, Milan, Italy) for prevention of clinical relapse in 125 patients with inactive Crohn's disease. Patients in remission [Crohn's Disease Activity Index (CDAI) less than 150] between 3 months and 2 years were randomly allocated to receive either 800 mg 5-ASA three times daily (n = 64) or placebo (n = 61) for up to 12 months or until relapse of symptoms. Relapse was defined by a CDAI greater than 150, with a minimum increase of 100 points over the baseline value. The cumulative relapse rates were 12% in the 5-ASA group and 22% in the placebo group at 3 months [95% confidence interval (CI) for the difference, -4 to 24]; 28% and 41%, respectively, at 6 months (95% CI, -4 to 30); and 34% and 55%, respectively, at 12 months (95% CI, 3-39; P = 0.02, log rank test). Significant decrease in the risk of relapse was found in patients with ileitis, in those with previous bowel resection and, in those with prolonged prestudy remission. Eight patients (5 on 5-ASA, 3 on placebo) withdrew from the study because of adverse reactions, but no major clinical or laboratory adverse effect was observed. It is concluded that oral 5-ASA coated with Eudragit S (Rohn Pharma GmbH, Wieterstadt, Germany), 2.4 g daily, is safe and seems superior to placebo in preventing or delaying clinical relapse in Crohn's disease, especially in milder cases and in ileal disease.     

Safety of carotid artery stenting for symptomatic carotid artery disease: a meta-analysis.

AIMS: Clinical trials comparing carotid artery stenting (CAS) with carotid endarterectomy (CEA) for patients with symptomatic carotid artery disease have produced conflicting results. We performed a meta-analysis to systematically evaluate currently available data by comparing CAS with CEA in patients with symptomatic carotid artery disease. METHODS AND RESULTS: We searched MEDLINE, Embase, ISI Web of Knowledge, Current Contents, International Pharmaceutical Abstracts databases, the Cochrane Central Register of Controlled Trials, and scientific meeting abstracts up to 31 October 2006 and then calculated summary risk ratios (RRs) for mortality, stroke, disabling stroke, and death using random- and fixed-effect models. Data from five trials with 2122 patients were pooled. There was no difference in risk of 30-day mortality (summary RR 0.57, 95% CI 0.22-1.47, P = 0.25), stroke (summary RR 1.64, 95% CI 0.67-4.00, P = 0.34), disabling stroke (summary RR 1.67, 95% CI 0.50-5.62, P = 0.50), death and stroke (summary RR 1.54, 95% CI 0.81-2.92, P = 0.19), or death and disabling stroke (summary RR 1.19, 95% CI 0.57-2.51, P = 0.64) among patients randomized to CAS, compared with CEA. CONCLUSIONS: No significant differences could be identified between CAS and CEA in the treatment of patients with symptomatic carotid artery disease. Larger randomized controlled trials are warranted to compare the two strategies.