Meta-analysis Of Efficacy And Safety Of Bleomycin In Hemangioma And Vascular Malformation Injection Treatment

Background:Hemangiomas and vascular malformations are common vascular diseases whose pathogenesis is not well-known. Those vascular diseases were called by a joint name as "hemangiomas" through the morphological classifications before. In1982, Mulliken et al divided those vascular diseases into hemangiomas and vascular malformations. Hemangiomas are charactered by the high proliferation rate and density of vascular endothelial cells in proliferative phase, while the cell division rate is regular in vascular malformations regarded as vascular structural abnormalities rooted in embryonic vasculogenesis. In the new category, some of so-called "hemangiomas" were vascular malformations actually and that were treated in hemangiomas like manner. Hemangiomas and vascular malformations differ from each other in both pathogenesis and prognosis, nevertheless they have many similarities in therapeutic methods. They could both be treated by injection therapy, as an example, which has been widely used for its conveniency and efficiency. Bleomycin is one of the most popular injectable drugs nowadays, while there is little evidence-based medicine support for the efficacy and safety of it in hemangiomas and vascular malformation treatment.Objective:To systemically evaluate the efficacy and safety of Bleomycin in hemangioma and vascular malformation injection treatment through meta-analysis, while the article would help provide evidence-based support for clinical drug application.Method:A systematic search through PubMed, Embase, Cochrane library, Wiley, CBM, CNKI, VIP, Wanfang databases was conducted by two separated estimators screening the published literatures of controlled trial in the field of Bleomycin injection for hemangioma and vascular malformation treatment by December2013. We used RevMan5.2to review the effectiveness, adverse effects, dosage and time of treatment then conducted the statistic analysis by typing all the data into this software of the clinical trial which satisfy the including criteria. The outcome was indicated by OR and it’s95%CI. The publication bias was showed by funnel plot. The sensitivity analysis was conducted by changing the initial analysis model.Results:19studies met the final inclusion criteria for meta-analysis. The efficacy of bleomycin is higher than steroids in hemangioma and vascular malformation injection treatment (OR=19.42,95%CI:3.67-102.92, P=0.0005). While the adverse effects rates of two groups have no statistical differences (OR=0.53,95%CI:0.17-1.64,P=0.27). Bleomycin has higher effective rate (OR=5.67,95%CI:1.58-20.39, P=0.008) and lower adverse effects rate(OR=0.04,95%CI:0.00-0.66,P=0.02) than sodium morrhuate. Bleomycin has lower adverse effects rate than sodium tetradecyl sulphate (OR=0.15,95%CI:0.05-0.43, P=0.0004). While the effective rates of two groups have no significant statistical differences (OR=2.67,95%CI:0.84-8.46,P=0.10). Bleomycin is not as effective as ethanol in vascular malformation injection treatment (OR=0.11,95%CI:0.04-0.32,P<0.0001). While the severe adverse effects rate of bleomycin is much lower than ethanol (OR=0.22,95%CI:0.10-0.46,P<0.0001). When combined with steroids, the efficacy increase (OR=6.40,95%CI:2.07-19.80,P=0.001), the adverse effects rates of two groups have no significant statistical differences (OR=0.46,95%CI:0.20-1.07,P=0.07). The group of bleomycin combined with steroids is more effective than sodium morrhuate group (OR=8.20,95%CI:3.73-18.04,P<0.00001). While the adverse effects rate of bleomycin combined with prednison subgroup is lower than sodium morrhuate (OR=0.29,95%CI:0.12-0.73,P=0.008).Conclusion:The result of this meta-analysis shows that bleomycin could obviously decrease the mass volume and improve the appearance in both hemangioma and vascular malformation lesions. The efficacies are remarkable in both bleomycin and bleomycin combined groups. Bleomycin is more effective for hemangiomas and vascular malformations than steroids and sodium morrhuate, and it is as effective as sodium tetradecyl sulphate, but not as effective as ethanol in vascular malformation treatment. The incidence of adverse effects of bleomycin is significantly lower than sodium tetradecyl sulphate and ethanol. When combined with steroids, the efficacy will increase. To forward assess the efficacy and safety of bleomycin, more large-scale, double-blind, controlled trails are needed imperatively.