| Objective: To systematically evaluate the efficacy and safety of polidocanol injection for patients with venous malformation by Meta-analysis,and provide evidence-based medical evidence for clinical rational drug therapy.Methods: CNKI,CBM,VIP,Wanfang,Pubmed,Cochrane Library,Embase,and SCI databases were searched by combining key words and free words without language restriction to collect controlled clinical trials associated with polidocanol injection for patients with venous malformation which meets our literatures' inclusion and exclusion standards,and the relevant data extracted.The quality of each clinical trial was evaluated by Cochrane collaboration?s tool,Case Control NOS Scale and Cohort Study NOS Scale to assess the risk of bias.RevMan 5.3 software was used to perform the Meta-analysis of these literatures.Subgroup analysis was performed based on intervention measures and study design.Finally,these results were processed for analyzing sensitivity and publishing bias.Results: 18 studies were selected,including 6 randomized controlled trials,5case-control trials and 7 cohort study trials,comprising 1068 cases in experiment group and 1409 in control group,totaling 2477 cases.Based on Meta-analysis results from RevMan 5.3,local tissue ulceration and necrosis,fever,gastrointestinal reactions,nerve damage,cough and respiratory reactions after sclerotherapy in comparison with the safety of polidocanol and other clinical sclerotherapy injections for venous malformation The combined effect results showed: [OR=0.36,95%CI(0.21,0.62),P<0.05],[OR=0.35,95%CI(0.20,0.59),P<0.05],[OR=0.30,95% CI(0.12,0.75),P<0.05],[RR=0.28,95% CI(0.08,0.97),P<0.05,[OR=0.24,95% CI(0.07,0.80),P<0.05];the differences were statistically significant.In the meta-analysis of adverse reactions such as local soft tissue swelling,pain,and muscle atrophy after sclerotherapy,the combined effect size results showed: [OR=0.68,95% CI(0.31,1.48),P>0.05],[OR=0.18,95% CI(0.02,1.68),P>0.05],[RR=0.22,95% CI(0.03,1.93),P>0.05];the differences were not statistically significant.but was not statistically significant as for clinical efficacy[OR=1.37,95% CI(0.86,2.17),P>0.05].Additional sub-group analysis revealed that:(1)compared to pingyangmycin,ethanol,ethanolamine oleate and sodium glucuronate,significant differences in clinical efficacy were only observed between polidocanol and ethanolamine oleate [RR=1.44,95% CI(1.11,1.86),P<0.05] between polidocanol and pingyangmycin,ethanol or sodium glucuronate,the result was not statistically significant[RR=1.13,95% CI(0.98,1.30),P>0.05],[RR=1.00,95% CI(0.85,1.17),P>0.05],[RR=1.19,95% CI(0.90,1.58),P>0.05].(2)Classified by research design,random controlled trial group,case-controlled trial group and cohort study experimental group showed not in clinical efficacy[RR=1.09,95% CI(0.95,1.24),P>0.05],[OR=1.37,95% CI(0.50,3.75),P>0.05],[OR=1.09,95% CI(0.44,2.66),P>0.05],Sensitivity analysis showed that these results obtained from the study were stable,and the publishing bias analysis indicated that there might be a publication bias between studies,which might be caused by the included studies shares similarity in revisit duration,sclerosing agent type and research design.Conclusion: Compared to ethanol,pingyangmycin and sodium glucuronate,polidocanol injection is safer in local soft tissue necrosis,gastrointestinal reactions and nerve damage in terms of treating venous malformations.Although polidocanol holds no advantage in clinical efficacy,polidocanol injection remains a safe,and painless,thus,an optimal one. |
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