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1、丹红注射液治疗特发性肺纤维化临床疗效及安全性的Meta分析[摘要]计算机检索Pubmed,EMbase,WebofScience,CochraneLibrary,CNKI,CBM,万方数据库,VIP,检索时限均从建库至2016年5月,同吋补充互联网及手检相关杂志的文献,纳入冇关丹红注射液治疗特发性肺纤维化的随机对照试验(RCT)和半随机对照试验(quasi-RCT),并追溯纳入文献的参考文献。由2名研究者按纳入与排除标准独立筛选文献、提取资料并评价质量后,使用RevMan5.3进行Meta分析,系统评价丹红注射液治疗特发性肺纤维化的疗效和安全性。
2、共纳入12个RCT,包括844例患者,试验组423例,对照组421例。Meta分析结果显示:与对照组比较,丹红注射液组对临床有效率[RR二1.36,95%CT(1.25,1.49),P<0.00001],DLC0提高值[MD=4.25,95%CI(3.32,5.18),P<0.00001],Pa02提高值[MD二14.51,95%CI(12.35,16.68),P<0.00001]的改善作用更显著,差异具有统计学意义。描述性分析结果显示丹红注射液能显著降低血清TGF-B1含量。试验组不良反应症状较轻、发生率低,提示丹红注射液治疗特发性肺纤维化的近
3、期安全性较高,耐受性良好。现有证据表明,短期内(〈12周)使用丹红注射液可改善特发性肺纤维化患者的临床情况、提高DLC0及P&02、降低血清TGF-B1含量,且不良反应少,安全性较高。但由丁纳入研究的局限性,急需高质量RCT更深入更全面地探究丹红注射液对特发性肺纤维化的短期及长期冇效性及安全性。[关键词]丹红注射液;特发性肺纤维化;系统评价;Meb分析;随机对照试验[Abstract]TosystematicallyreviewtheefficacyandsafetyofDanhonginjectionforpatientswithidiopat
4、hicpulmonaryfibrosis(IPF),tworesearcherselectronicallysearchedPubMecl,EMbase,WebofScienee,CochraneLibrary,CNK1,CBM,WanFangDataandVIPdatabasesfromthedateofestab1ishmenttoMay2016foral1randomizedcontrolledtrials(RCTs)andquasi-RCTsontheuseofDanhonginjectioninpatientswithTPF.Manua
5、lsearchinrelevantjournalsandsearchofrelevantliteratureonotherwebsiteswerealsoperformed.ThedataextractionandqualityassessmentofincludedRCTsandquasi-RCTwereconductedbytworeviewersindependently.Then,Meta-analysiswasconductedbyusingRevMan5.3software・Atotalof12RCTsinvolving844pati
6、entswereincluded,423casesinexperimentgroupand421casesincontrolgroup.Theresultsofmeta-analysisindicatedthattheDanhonginjectiongroupwassuperiorthanthecontrolgroupinclinicaleffectiveness(RR=1.36,95%CI1.25to1.49,P<0.00001),increasedDLCOvalue(MD=4.25,95%CT3.32to5.18,P<0.00001),and
7、increasedPa02value(MD=14.51,95%CI12.35to16.68,P<0.00001)・TheanalysisresultsshowedthatDanhonginjectioncouldsignificantlyreducethelevelofTGF-B1inserum.TherewerenoseriousorfrequentlyhappenedadverseeffectsintheDanhonginjectiongroup,indicatinghighsafetyandgoodtoleranceofDanhonginj
8、ectionintreatmentofIPF.ThecurrentevidencessuggestedthatDanhonginject