干扰素α%肝炎,乙型,慢性%治疗结果%儿童%Meta分析%肝炎e抗原,乙型
榦擾素α%肝炎,乙型,慢性%治療結果%兒童%Meta分析%肝炎e抗原,乙型
간우소α%간염,을형,만성%치료결과%인동%Meta분석%간염e항원,을형
Interferon-alpha%Hepatitis B,chronic%Treatment outcome%Child%Meta analysis%Hepatitis B e antigens
目的 评价IFN-α治疗HBeAg阳性慢性乙型肝炎(CHB)儿童的疗效及安全性.方法 检索美国国立医学图书馆数据库(PubMed)和中国期刊全文数据库(CHKD)从建库至2006年4月所收录的比较IFN-α与非抗病毒药物(安慰剂或空白对照)治疗HBeAg阳性CHB儿童的随机对照试验论文.由两名评价员独立筛查文献,评价质量和提取资料.采用Jadad量表及随机分配方案隐藏方法评估纳入试验的方法学质量.采用X2检验鉴定研究间异质性,使用随机效应或固定效应模型合并研究.采用敏感度分析方法探讨试验结果的影响因素.结果 共纳入7个随机对照试验,HBsAg和HBeAg阳性的CHB患儿360例.荟萃(Meta)分析结果显示,治疗结束时,IFN-α组HBeAg转阴率高于对照组[22.1%比6.7%,OR 3.56,95%CI(1.74,7.28),P=0.0005],HBV DNA转阴率高于对照组[33.7%比12.6%,OR 3.50,95%CI(2.03,6.06),P＜0.01],HBsAg转阴率高于对照组[6.5%比0.5%,OR 7.10,95%CI(1.52,33.12),P=0.01],HBeAg血清转换率高于对照组[17.3%比2.9%,OR 5.62,95%CI(1.65,19.18),P=0.006],两组差异均有统计学意义,但HBsAg血清转换与对照组相比[2.0%比0,OR 3.55,95%CI(0.35,35.93),P=0.28],ALT复常率与对照组相比[24.2%比16.2%,OR 1.72,95%CI(0.84,3.52),P=0.14],两组差异无统计学意义.结论 HBeAg阳性的CHB患儿经IFN-α治疗可达到HBeAg转阴、HBV DNA转阴、HBsAg转阴及HBeAg血清学转换的效应,但未能实现HBsAg血清学转换及ALT复常.受原研究质量和不同研究干预措施差异的影响,IFN-α的治疗效应还需要严格设计的、大样本的随机双盲对照试验来进一步验证和支持.
目的 評價IFN-α治療HBeAg暘性慢性乙型肝炎(CHB)兒童的療效及安全性.方法 檢索美國國立醫學圖書館數據庫(PubMed)和中國期刊全文數據庫(CHKD)從建庫至2006年4月所收錄的比較IFN-α與非抗病毒藥物(安慰劑或空白對照)治療HBeAg暘性CHB兒童的隨機對照試驗論文.由兩名評價員獨立篩查文獻,評價質量和提取資料.採用Jadad量錶及隨機分配方案隱藏方法評估納入試驗的方法學質量.採用X2檢驗鑒定研究間異質性,使用隨機效應或固定效應模型閤併研究.採用敏感度分析方法探討試驗結果的影響因素.結果 共納入7箇隨機對照試驗,HBsAg和HBeAg暘性的CHB患兒360例.薈萃(Meta)分析結果顯示,治療結束時,IFN-α組HBeAg轉陰率高于對照組[22.1%比6.7%,OR 3.56,95%CI(1.74,7.28),P=0.0005],HBV DNA轉陰率高于對照組[33.7%比12.6%,OR 3.50,95%CI(2.03,6.06),P＜0.01],HBsAg轉陰率高于對照組[6.5%比0.5%,OR 7.10,95%CI(1.52,33.12),P=0.01],HBeAg血清轉換率高于對照組[17.3%比2.9%,OR 5.62,95%CI(1.65,19.18),P=0.006],兩組差異均有統計學意義,但HBsAg血清轉換與對照組相比[2.0%比0,OR 3.55,95%CI(0.35,35.93),P=0.28],ALT複常率與對照組相比[24.2%比16.2%,OR 1.72,95%CI(0.84,3.52),P=0.14],兩組差異無統計學意義.結論 HBeAg暘性的CHB患兒經IFN-α治療可達到HBeAg轉陰、HBV DNA轉陰、HBsAg轉陰及HBeAg血清學轉換的效應,但未能實現HBsAg血清學轉換及ALT複常.受原研究質量和不同研究榦預措施差異的影響,IFN-α的治療效應還需要嚴格設計的、大樣本的隨機雙盲對照試驗來進一步驗證和支持.
목적 평개IFN-α치료HBeAg양성만성을형간염(CHB)인동적료효급안전성.방법 검색미국국립의학도서관수거고(PubMed)화중국기간전문수거고(CHKD)종건고지2006년4월소수록적비교IFN-α여비항병독약물(안위제혹공백대조)치료HBeAg양성CHB인동적수궤대조시험논문.유량명평개원독립사사문헌,평개질량화제취자료.채용Jadad량표급수궤분배방안은장방법평고납입시험적방법학질량.채용X2검험감정연구간이질성,사용수궤효응혹고정효응모형합병연구.채용민감도분석방법탐토시험결과적영향인소.결과 공납입7개수궤대조시험,HBsAg화HBeAg양성적CHB환인360례.회췌(Meta)분석결과현시,치료결속시,IFN-α조HBeAg전음솔고우대조조[22.1%비6.7%,OR 3.56,95%CI(1.74,7.28),P=0.0005],HBV DNA전음솔고우대조조[33.7%비12.6%,OR 3.50,95%CI(2.03,6.06),P＜0.01],HBsAg전음솔고우대조조[6.5%비0.5%,OR 7.10,95%CI(1.52,33.12),P=0.01],HBeAg혈청전환솔고우대조조[17.3%비2.9%,OR 5.62,95%CI(1.65,19.18),P=0.006],량조차이균유통계학의의,단HBsAg혈청전환여대조조상비[2.0%비0,OR 3.55,95%CI(0.35,35.93),P=0.28],ALT복상솔여대조조상비[24.2%비16.2%,OR 1.72,95%CI(0.84,3.52),P=0.14],량조차이무통계학의의.결론 HBeAg양성적CHB환인경IFN-α치료가체도HBeAg전음、HBV DNA전음、HBsAg전음급HBeAg혈청학전환적효응,단미능실현HBsAg혈청학전환급ALT복상.수원연구질량화불동연구간예조시차이적영향,IFN-α적치료효응환수요엄격설계적、대양본적수궤쌍맹대조시험래진일보험증화지지.
Objective To conduct a Meta-analysis to evaluate the efficacy and safety of interfer on-α for treating HBeAg-positive chronic hepatitis B in children.Methods PubMed and Chinese Biomedical Database were searched from the beginning to April 2006,and the references of eligible studies were manually screened.Randomized controlled trials published in the English and Chinese literature comparing interferon-α with non-antiviral interventions(placebo or no treatment)in children with chronic hepatitis B were eligible for inclusion.Studies were included if patients were treated for at least 3 months and followed up for at least 6 months after cessation of therapy.Two investigators independently assessed the quality and extracted the data.The methodological quality of trails was assessed by the Jadad-scale plus allocation concealment.Heterogeneity was examined by Chi-square test.Fixed effects model or random effects model was used to pool the data.Sensitivity analyses were used in the treatment course.Results Seven randomized controlled studies with a total of 360 child chronic hepatitis B virus carriers who were positive for hepatitis B surface antigen and hepatitis B e antigen werc identified.It was found by Meta-analysis that,compared with the control,at the end of therapy,interferon-α could significantly clear HBeAg[22.1%vs 6.7%,OR 3.56,95% CI(1.74, 7.28),P=0.000 5],HBV DNA[33.7% vs 12.6%,OR 3.50,95% CI(2.03,6.06),P＜0.01], HBsAg [6.5% vs 0.5%,OR 7.10,95% CI(1.52,33.12),P=0.01],and achieve HBeAg seroconversion [17.3% vs 2.9%,OR 5.62,95% CI(1.65,19.18),P=0.006],but was not more effective in HBsAg seroversion[2.0% vs 0,OR 3.55,95%CI(0.35,35.93),P=0.28]and alanine aminotransferase(ALT)normalization[24.2% vs 16.2%,OR 1.72,95% CI(0.84,3.52), P=0.14].Conclusions Interferon a may be efficacious in clearance of HBeAg,HBV DNA and HhsAg, and achievement of HBeAg seroversion.Little evidence is available on HBsAg seroversion and ALT normali zation.Rigorously designed large sample size randomized double blind clinical trials with large sample size are required to further confirm and support the conclusion.
