title: Clinical effectiveness of gene therapy on critical limb ischemia: a meta-analysis of 5 randomized controlled clinical trials.
abstract: Therapeutic angiogenesis using gene therapy is a novel strategy for the treatment of critical limb ischemia (CLI). We conducted a meta-analysis to evaluate the efficacy and safety of gene therapy for the treatment of CLI with no option of revascularization. Randomized placebo controlled trials of gene therapy on CLI were identified by searching PubMed (from 1990 to October 2013) and EMBASE (from 1990 to October 2013). Five eligible studies were selected for the meta-analysis. Among these studies, a total of 425 patients received gene therapy of either fibroblast growth factor 1 or hepatocyte growth factor, and 365 patients were given placebo. No statistical differences were observed between the 2 groups in major amputation or death at 1 year (risk ratio [RR], 0.83; 95% confidence interval [CI], 0.51-1.39; P = .48) and wound healing at 6 months (RR, 1.55; 95% CI, 0.73-3.28; P = .25). Gene therapy had similar occurrence of serious adverse events as control (RR, 1.05; 95% CI, 0.97-1.14; P = .23).
authors.affiliation: Anesthesia and Operation Center, Chinese PLA General Hospital, Beijing 100853, China Department of Anesthesiology, PLA No. 306 Hospital, Beijing, China.
authors.forename: Yu-Liang
authors.initials: YL
authors.lastname: Miao
authors.affiliation: Department of Anesthesiology, PLA No. 306 Hospital, Beijing, China.
authors.forename: Wei
authors.initials: W
authors.lastname: Wu
authors.affiliation: Department of Anesthesiology, PLA No. 306 Hospital, Beijing, China.
authors.forename: Bao-Wei
authors.initials: BW
authors.lastname: Li
authors.affiliation: Department of Anesthesiology, PLA No. 306 Hospital, Beijing, China.
authors.forename: Wei-Wu
authors.initials: WW
authors.lastname: Fang
authors.affiliation: Department of Anesthesiology, PLA No. 306 Hospital, Beijing, China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Liu
authors.affiliation: Department of Cardiothoracic Surgery, PLA No. 306 Hospital, Beijing, China.
authors.forename: Lu
authors.initials: L
authors.lastname: Li
authors.affiliation: Anesthesia and Operation Center, Chinese PLA General Hospital, Beijing 100853, China weidongmi@126.com.
authors.forename: Wei-Dong
authors.initials: WD
authors.lastname: Mi
mesh_terms: D000671:Amputation, Surgical; D042501:Angiogenic Proteins / Q000096:biosynthesis* / Q000235:genetics; D016009:Chi-Square Distribution; D016638:Critical Illness; D019317:Evidence-Based Medicine; D005121:Extremities / Q000098:blood supply*; D016220:Fibroblast Growth Factor 1 / Q000096:biosynthesis / Q000235:genetics; D015316:Genetic Therapy / Q000009:adverse effects / Q000401:mortality; D017228:Hepatocyte Growth Factor / Q000096:biosynthesis / Q000235:genetics; D006801:Humans; D007511:Ischemia / Q000175:diagnosis / Q000235:genetics / Q000378:metabolism / Q000401:mortality / Q000503:physiopathology / Q000628:therapy*; D023821:Limb Salvage; D018919:Neovascularization, Physiologic / Q000235:genetics*; D016017:Odds Ratio; D016032:Randomized Controlled Trials as Topic; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing
chemical_list: D042501:Angiogenic Proteins; C066855:HGF protein, human; D016220:Fibroblast Growth Factor 1; D017228:Hepatocyte Growth Factor
keywords: critical limb ischemia; gene therapy; meta-analysis