西安交通大学学报（医学版）
西安交通大學學報（醫學版）
서안교통대학학보（의학판）
JOURNAL OF XI'AN JIAOTONG UNIVERSITY(MEDICAL SCIENCES)
2015年
2期
249-256
,共8页
抗肿瘤坏死因子α制剂%溃疡性结肠炎%疗效%安全性%Meta 分析
抗腫瘤壞死因子α製劑%潰瘍性結腸炎%療效%安全性%Meta 分析
항종류배사인자α제제%궤양성결장염%료효%안전성%Meta 분석
tumor necrosis factor alpha blocking agent%ulcerative colitis%efficacy%safety%meta-analysis
目的：采用 Meta 分析方法评价抗肿瘤坏死因子α(TNF-α)制剂治疗中重度溃疡性结肠炎(UC)的疗效和安全性。方法全面检索 Cochrane 图书馆、PubMed、Embase、ISI、OVID 和中国生物医学文献数据库、中国知网、万方数据库、维普数据库中有关抗 TNF-α制剂治疗 UC 的临床随机对照试验(RCT),按照纳入与排除标准选择文献、提取资料并进行方法学质量评价后,采用 Revman 5.1软件进行 Meta 分析。结果共纳入11项 RCT,共3334例患者。Meta分析结果显示,抗 TNF-α制剂在治疗 UC 的短期应答(OR =2.51,95% CI 1.73,3.64)与短期缓解(OR =2.74,95%CI 1.80,4.16),长期应答(OR=2.98,95% CI 1.98,4.47)与长期缓解(OR =2.64,95% CI 1.89,3.67),黏膜愈合率(OR=1.89,95% CI 1.39,2.59)各个方面均优于对照组,并可以降低结肠手术切除率(OR =0.61,95% CI 0.41,0.89),改善生活质量[IBDQ 评分的均数差(MD)为14.74,95% CI 11.43,18.06],在所有报道不良反应(OR =1.14,95% CI 0.97,1.34)与严重不良反应(OR=0.78,95% CI 0.56,1.09)发生方面与对照组差异无统计学意义。结论抗肿瘤坏死因子α制剂治疗中重度 UC 不仅可以诱导缓解及长期维持,而且可以促进黏膜愈合、降低结肠手术切除率、提高生活质量,长期使用也较为安全。上述结论仍需要更多高质量 RCT 证实。
目的：採用 Meta 分析方法評價抗腫瘤壞死因子α(TNF-α)製劑治療中重度潰瘍性結腸炎(UC)的療效和安全性。方法全麵檢索 Cochrane 圖書館、PubMed、Embase、ISI、OVID 和中國生物醫學文獻數據庫、中國知網、萬方數據庫、維普數據庫中有關抗 TNF-α製劑治療 UC 的臨床隨機對照試驗(RCT),按照納入與排除標準選擇文獻、提取資料併進行方法學質量評價後,採用 Revman 5.1軟件進行 Meta 分析。結果共納入11項 RCT,共3334例患者。Meta分析結果顯示,抗 TNF-α製劑在治療 UC 的短期應答(OR =2.51,95% CI 1.73,3.64)與短期緩解(OR =2.74,95%CI 1.80,4.16),長期應答(OR=2.98,95% CI 1.98,4.47)與長期緩解(OR =2.64,95% CI 1.89,3.67),黏膜愈閤率(OR=1.89,95% CI 1.39,2.59)各箇方麵均優于對照組,併可以降低結腸手術切除率(OR =0.61,95% CI 0.41,0.89),改善生活質量[IBDQ 評分的均數差(MD)為14.74,95% CI 11.43,18.06],在所有報道不良反應(OR =1.14,95% CI 0.97,1.34)與嚴重不良反應(OR=0.78,95% CI 0.56,1.09)髮生方麵與對照組差異無統計學意義。結論抗腫瘤壞死因子α製劑治療中重度 UC 不僅可以誘導緩解及長期維持,而且可以促進黏膜愈閤、降低結腸手術切除率、提高生活質量,長期使用也較為安全。上述結論仍需要更多高質量 RCT 證實。
목적：채용 Meta 분석방법평개항종류배사인자α(TNF-α)제제치료중중도궤양성결장염(UC)적료효화안전성。방법전면검색 Cochrane 도서관、PubMed、Embase、ISI、OVID 화중국생물의학문헌수거고、중국지망、만방수거고、유보수거고중유관항 TNF-α제제치료 UC 적림상수궤대조시험(RCT),안조납입여배제표준선택문헌、제취자료병진행방법학질량평개후,채용 Revman 5.1연건진행 Meta 분석。결과공납입11항 RCT,공3334례환자。Meta분석결과현시,항 TNF-α제제재치료 UC 적단기응답(OR =2.51,95% CI 1.73,3.64)여단기완해(OR =2.74,95%CI 1.80,4.16),장기응답(OR=2.98,95% CI 1.98,4.47)여장기완해(OR =2.64,95% CI 1.89,3.67),점막유합솔(OR=1.89,95% CI 1.39,2.59)각개방면균우우대조조,병가이강저결장수술절제솔(OR =0.61,95% CI 0.41,0.89),개선생활질량[IBDQ 평분적균수차(MD)위14.74,95% CI 11.43,18.06],재소유보도불량반응(OR =1.14,95% CI 0.97,1.34)여엄중불량반응(OR=0.78,95% CI 0.56,1.09)발생방면여대조조차이무통계학의의。결론항종류배사인자α제제치료중중도 UC 불부가이유도완해급장기유지,이차가이촉진점막유합、강저결장수술절제솔、제고생활질량,장기사용야교위안전。상술결론잉수요경다고질량 RCT 증실。
ABSTRACT:Objective To evaluate the clinical therapeutic effect and safety of tumor necrosis factor alpha (TNF-α)blockers in treating moderately to severely active ulcerative colitis (UC)by meta-analysis.Methods Such databases as the Cochrane Central Register of Controlled Trials,PubMed,OVID,Embase,ISI,CBM,CNKI, VIP,and WanFang Data were searched from establishment to June 2013.All randomized clinical trials (RCTs)on tumor necrosis factor alpha blockers in treating UC were collected,and then selected on the basis of the inclusion and exclusion criteria.We assessed the methodological quality,extracted the data from the included articles and performed the meta-analysis with Revman 5.1.Results A total of 13 RCTs involving 3334 patients were analyzed.TNF-αblockers group was superior to the control group in the short-term clinical response (OR =2.5 1, 95% CI 1.73,3.64),short-term clinical remission (OR =2.74,95% CI 1.80,4.1 6),long-term clinical response (OR =2.98,95% CI 1.98,4.47),1ong-term clinical remission (OR =2.64,95% CI 1.89,3.67),and mucosal healing (OR =1.89,95% CI 1.39,2.59)compared with control group.TNF-αblockers could also reduce the rate of colectomy (OR =0.61,95% CI 0.41,0.89)and improve inflammatory bowel disease questionnaire scores (MD=14.74,95% CI 1 1.43,18.06 ).There was no significant difference between the two groups in all reported adverse effects (OR =1.14,95% CI 0.97,1.34)and serious adverse effects (OR=0.78,95% CI 0.56,1.09).Conclusion Compared with conventional therapy or placebo,TNF-αblocking agents can improve the therapeutics effect on UC in clinical response,clinical remission and mucosal healing,and also can reduce the rate of colectomy. In patients with moderately to severely active UC treated with TNF-α blocking agents,it is easier to achieve the improvement of life quality.TNF-αblocking agents treatment is safe for UC.This conclusion should be verified with more large-scale and high-quality RCTs.
