目的 评价注射用英夫利西单抗治疗难治性溃疡性结肠炎（UC） 的疗效。方法 回顾性分析2009年10月至2012年10月期间，在中国医科大学附属第四医院肛肠外科住院并接受注射用英夫利西单抗治疗的9例中重度激素难治性UC患者的临床疗效。结果 经注射用英夫利西单抗治疗后，7例中度UC患者中，1例完全缓解，4例有效，1例疗效不详，1例无效；2例重度UC者中，1例有效，1例无效。临床缓解及治疗有效的6例患者的血红蛋白水平较治疗前上升，红细胞沉降率及C反应蛋白水平均下降。3例具有肠外表现者的肠外症状均得到改善。结论 对于激素抵抗或激素依赖的中重度UC患者，注射用英夫利西单抗可以有效缓解患者的临床症状。
Objective To evaluate and select essential medicine for acute gastroenteritis using evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Five guidelines were included, two of which were evidence-based. (2) Recommended medicines included eight antidiarrheals (of four classes) and three antemetics. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines and the quantity and quality of evidence, we offered a weak recommendation for ondansetron, metoclopramide, smectite, racecadotril and loperamide applied in the treatment of acute gastroenteritis. We made a recommendation against antibiotics, dexamethasone, kaolin-pectin, activated charcoal, attapulgite and bismuth subsalicylate. (4) Evidence from domestic studies: a result of 14 CCTs (n=1 635, low quality) indicated that in the significant efficiency and total efficiency, smectite (smecta) was superior to routine liquid infusion, norfloxacin, gentamicin or furaxone. Among these 14 CCTs, two CCTs reported smectite (smecta) caused nausea and vomiting (three cases); one CCT reported pain and distention in the abdomen (one case) and general discomfort (one case); and the rest reported no adverse reaction. A result of 10 CCTs (n=1 017, low quality) indicated that for acute diarrhea, racecadotril was superior to routine treatment in the significant efficiency (OR=2.55, 95%CI 1.64 to 3.94, Plt;0.01) and total efficiency (OR=4.32, 95%CI 2.96 to 6.30, Plt;0.01). A result of two CCTs (n=344, low quality) indicated that racecadotril was superior to smectite in the total efficiency in treating acute diarrhea. A result of two CCTs (n=1 056, low quality) indicated that racecadotril was superior to routine treatment in the total efficiency in treating acute adult diarrhea (OR=5.19, 95%CI 3.54 to 7.63, Plt;0.01). A result of two CCTs (n=182, low quality) reported children presented with nausea (two cases). A result of one CCT (n=947, low quality) reported adults presented with constipation (fifteen cases), anorexia (four cases), headache (nine cases) and abdominal pain (one case). Conclusion For acute gastroentitis, we offer a weak recommendation for smectite (powder, for oral use) used in adults (once 3 g, tid., mixed with warm water before intake), child under one year of age (3 g daily, bid.), and child above one year of age (once 3 g, qd. or bid.). Retention enema could be appiled to children with acute gastroenteritis. We also offer a weak recommendation for racecadotril (capsule) used in adults (one capsule, tid., taken continuously less than seven days). Due to the lack of evidence from clinical trials, we make a recommendation against racecadotril applied to women with pregnancy and lactation or children. In order to produce high-quality local evidence, we propose that (1) Further clinical studies should be standardized in diagnosis and criteria. (2) The design and implementation quality of clinical studies should be improved. (3) Original studies on pharmacoeconomic studies and drug applicability are needed.
Objective To assess the efficacy and safety of mesalazine versus sulfasalazine in the treatment of ulcerative colitis.Methods The literatures were searched from PubMed (1966 to January 2010), the Cochrane Library (1966 to January 2010), EMbase (1974 to January 2010), CNKI (1994 to January 2010), VIP (1989 to January 2010), and CBM (1978 to January 2010). The data were extracted, the quality of studies was evaluated according to The Cochrane Handbook, and meta-analyses were performed using RevMan 5.0 software. Results Sixteen RCTs involving 1 333 patients were included in this study. The results of meta-analyses showed that the total effective rate of the mesalazine group was significantly higher than that of the sulfasalazine group (RR=1.10, 95%CI 1.04 to 1.17, Plt;0.05), and significant differences were noted in the total remission rate (RR=1.82, 95%CI 1.14 to 2.91, Plt;0.05), while there was no significant difference in the relapse rate between the two groups (RR=0.86, 95%CI 0.57 to 1.29, Pgt;0.05). Twelve RCTs reported adverse effects and meta-analyses showed that the incidence of adverse effects was significantly lower in the mesalazine group than in the sulfasalazine group (RR=0.56, 95%CI 0.42 to 0.73, Plt;0.05). Conclusion Analyses show that mesalazine is much more effective and safe in the management of ulcerative colitis than sulfasalazine. However, there is a moderate risk of bias due to methodological quality problems in all 16 included RCTs, so more strictly-designed multi-centered randomized controlled trials with high quality in large-scale are needed to confirm this result.
Objective To evaluate the effectiveness and safety of probiotic agents for ulcerative colitis. Methods We searched electronically the Cochrane Central Register of Controlled Trials (Issue 1, 2007), MEDLINE (1978 to 2007), EMBASE (1978 to 2007), OVID Database (1978 to 2007), Chinese Biological Medicine Database (CBM Disc) (1978 to 2007), CNKI (1979 to 2007), Chinese VIP Database (1989 to 2007) and Wanfang Database (1978 to 2007). We also checked the reference lists of retrieved articles and hand-searched 4 kinds of important journals to identify randomized controlled trials of probiotic agents for ulcerative colitis. Meta-analyses were conducted with The Cochrane Collaboration’s RevMan 4.2 software. Results Thirteen trials involving 1146 patients were included. Meta-analyses showed that probiotic agents were not superior to aminosalicylates for the clinical remission rate (OR 0.93, 95% CI 0.53 to 1.66; P=0.82); but the combination of probiotic agents and aminosalicylates were superior to aminosalicylates alone (OR 2.69, 95% CI 1.57 to 4.61; P=0.0003). In terms of the clinical relapse, the rate for probiotic agents was superior to that for placebo (OR 0.03, 95% CI 0.00 to 0.15; Plt;0.0001); but not superior to aminosalicylates (OR 0.95, 95% CI 0.65 to 1.38; P=0.79). The combination of probiotic agents and aminosalicylates was not superior to aminosalicylates alone (OR 0.57, 95% CI 0.24 to 1.32; P=0.19). As for the incidence of adverse effects, probiotic agents were not superior to aminosalicylates (OR 0.85, 95% CI 0.43 to 1.70; P=0.65); and the combination of probiotic agents and aminosalicylates was not superior to aminosalicylates alone (OR 0.30, 95% CI 0.06 to 1.54; P=0.15). Conclusion Probiotic agents are not superior to aminosalicylates based on the evidence in this review, but the combination of probiotic agents and aminosalicylates is superior to aminosalicylates alone in maintaining remission. Probiotic agents are superior to placebo but not superior to aminosalicylates, and the combination of probiotic agents and aminosalicylates is not superior to aminosalicylates alone in preventing relapse. Probiotic agents have good tolerability. However, all these findings should be interpreted with caution and more clinical trials are needed.
目的 针对近期收治的1例常规治疗疗效不理想的溃疡性结肠炎患者,我们进行了证据检索和评价,以期找到更有效的治疗方法.方法 计算机检索MEDLINE(1978～2004)、CBMdisc(1978～2004)及Cochrane图书馆(2004年第3期),查找 5-氨基水杨酸(5-ASA)灌肠液治疗溃疡性结肠炎及与病情缓解有关的系统评价、临床随机对照试验等,并对所获证据进行评价.结果 高质量的临床证据表明,5-ASA灌肠液治疗溃疡性结肠炎及帮助病情缓解均优于口服5-ASA及柳氮磺胺嘧啶局部灌肠治疗.据此临床证据,结合医生经验及病人意愿,对该例患者实施5-ASA 1g+生理盐水100 ml qd,睡前保留灌肠治疗.1周后,患者临床症状明显缓解,腹泻基本停止,每天解黄色黏液便1～2次.肠镜复查,炎症较前明显减轻.出院后继续用上述方案维持治疗,每周2次.门诊随访1年,患者未再复发,也无明显副作用发生.结论 5-ASA灌肠液是控制溃疡性结肠炎活动期间病情及帮助缓解、减少复发的有效药物.
【摘要】 目的 采用循证医学的方法评价硫唑嘌呤（aiathioprine，AZA）治疗溃疡性结肠炎（ulcerative colitis，UC）的有效性和安全性。 方法 计算机检索PubMed、Cochrane library、Embase、CNKI、维普和CBM数据库收集国内外关于AZA诊疗UC的随机对照试验（ramdomized controllel trial，RCT）。按Cochrane系统评价的方法评价纳入研究质量，并进行Meta分析。 结果 共纳入5个RCT，共262例UC患者。Meta分析结果显示，AZA治疗UC在缓解率方面与安慰剂比较，差异无统计学意义[P=1.19，95%CI（0.94，1.49），P=0.14]；在复发率方面，两者比较差异有统计学意义[P=0.72，95%CI（0.54，0.95），P=0.02]；全部不良反应方面和严重不良反应方面，两者比较差异无统计学意义，Meta分析结果分别为[P=2.52，95%CI（0.82，7.74），P=0.11]和[P=4.03，95%CI（0.88，18.53），P=0.07]。 结论 系统评价结果为AZA在疗效方面优于安慰剂，在不良反应发生率方面差异无统计学意义。但由于纳入的5个研究中没有高质量的RCT，且有1个可能产生高度偏倚，使得这一结论受到影响，有必要开展更多设计严谨，大样本、多中心的RCT。【Abstract】 Objective To assess the efficacy and safety of azathio-prine in the treatment of ulcerative colitis through an evidence-based method. Methods We searched the literature from databases like PubMed, Cochrane library, CNKI, VIP, and CBM, and evaluated the quality of studies according to Cochrane systematic review. Finally, Meta-analysis was performed. Results Five randomized controlled trials (RCT) were included in this study with a total of 262 patients. Meta-analysis showed that there was no significant difference in the rate of remission between azathio-prine and placebo in treating ulcerative colitis [P=1.19, 95%CI (0.94, 1.49),P=0.14]. There was significant difference in the relapse rate between the two treating methods [P=0.72, 95%CI (0.54, 0.95),P=0.02]. In addition, there was no statistical difference in all adverse effects [P=2.52, 95%CI (0.82, 7.74),P=0.11] and serious adverse effects [P=4.03, 95%CI (0.88, 18.53),P=0.07] between the two treating methods. Conclusion In the treatment of ulcerative colitis, azathio-prine has a significant advantage in efficacy than placebo, but there is no significant difference in the rate of adverse events between the two groups. However, none of the 5 RCT included in this review has a high quality and one of them even probably has a high bias, which has a big influence on our conclusion. Consequently, multi-center large-scale randomized controlled trials of higher quality are needed to make confirmation.
【摘要】 目的 研究肥大细胞膜稳定剂色甘酸二钠（disordium cromoglycate，DC）对葡聚糖硫酸钠（dextran sulfate sodium，DSS）诱导的大鼠急性结肠炎的影响。 方法 出生80~100 d的雄性SD清洁级大鼠30只，体重180~250 g。30只大鼠随机分为3组:正常对照组（A组）、溃疡性结肠炎组（B组）和DC组（C组），每组各10只。B组和C组自由饮用40 g/L DSS溶液（4%） 7 d诱发急性结肠炎，同时C组每天按100 mg/kg腹腔注射DC 1次，A组和B组每天腹腔注射等量的生理盐水。7 d后，处死各组大鼠。对各组大鼠行疾病活动指数评分，结肠组织行大体评分、组织学评分，检测门静脉血一氧化氮浓度，结肠组织髓过氧化物酶活性。 结果 疾病活动指数评分、大体评分、组织学评分、一氧化氮浓度及髓过氧化物酶活性均表现为B组gt;C组gt;A组（Plt;0.05）。 结论 肥大细胞膜稳定剂DC对DSS诱导的大鼠急性结肠炎有一定的保护作用。【Abstract】 Objective To observe the influence of the mast cell memebrane stabilizer, disordium cromoglycate (DC), on dextran sulfate sodium (DSS)-induced colitis in rats. Methods Thirty male Sprague-Dawley (SD) rats aged 80 to 100 days with their weight ranged from 180 to 250 g were randomly divided into 3 groups: normal control group (group A), dextran sulfate sodium group (group B) and disordium cromoglycate group (group C), with 10 rats in each. Rats in group B and C drank 40 g/L DSS solution (4%) for 7 days to induce acute colitis. At the same time, intraperitoneal administration of DC (100 mg/kg) to rats in group C was carried out once a day, while the other two groups of rats were given the same amount of normal saline solution. Disease activity index (DAI), gross and histological evaluation were analyzed. NO concentration of blood from portal vein was measured. Myeloperoxidase (MPO) activity of colonic tissue was detected. Results The experimental data of group C, including DAI, gross evaluation, histological assessment, NO concentration and MPO activity, were all significantly higher than those of group A (Plt;0.05), but lower than those of group B (Plt;0.05). Conclusion Disordium cromoglycate can protect the colon of rats with DSS-induced acute colitis.