苯妥英钠治疗糖尿病足溃疡的系统评价及Meta分析

Systemetic review and Meta-analysis of phenytoinum for treatment of diabetic foot ulceration

目的系统评价苯妥英钠治疗糖尿病足溃疡的有效性及安全性。方法计算机检索国内外各大数据库,手工检索主要专业期刊和相关文献的参考文献。根据纳入、排除标准,独立筛选文献并提取数据进行统计分析。结果最终纳入10项研究,共812例患者。Meta分析显示,苯妥英钠在溃疡愈合率方面[相对危险度(risk ratio,RR):1.43;95%可信区间(confidence interval)CI:0.77~2.66]略高于其他治疗方式,但差异无统计学意义(P>0.05);在肉芽组织增长率(RR:2.09;95%CI:2.05~4.10)、溃疡面积减少率[标准化均数差(standard mean difference,SMD):0.82;95%CI:0.27~1.37]、细菌培养阴性率(RR:1.49;95%CI:1.21~1.83)方面优于其他治疗方式,差异具有统计学意义(P<0.05)。2项研究结果显示苯妥英钠治疗糖尿病足溃疡可缩短住院日(P<0.05)且无严重不良反应。结论苯妥英钠可促进肉芽组织生长、减小溃疡面积,具有抗菌作用,但在其是否增加溃疡愈合率方面仍需进一步研究,建议临床审慎选择使用苯妥英钠。

Objective To evaluate the safety and effectiveness of application of phenytoin on the treatment of diabetic foot ulcers(DFUs).Methods Retrieval of major databases at home and abroad,manual retrieval of major professional journals and related literature references.According to the inclusion and exclusion criteria,the literature was independently selected,the data was extracted and analyzed statistically.Results A total of 10 studies containing 812 patients with DFUs were ultimately included.Meta-analysis showed that phenytoin sodium was slightly higher than other treatments in ulcer healing rate[risk ratio(RR):1.43;95%confidence interval(CI):0.77~2.66],but the difference was not statistically significant(P>0.05).Rate of granulation tissue growth:phenytoin was superior to other treatment(RR:2.09;95%CI:2.05~4.10).Rate of ulcer area reduction:phenytoin was superior to other treatment[standard mean difference(SMD):0.82;95%CI:0.27~1.37).Negative rate of bacterial culture:phenytoin was superior to other treatment(RR:1.49;95%CI:1.21~1.83,P<0.05).Two studies showed that phenytoin might reduce the length of hospital days(P<0.05).No serious adverse reactions occurred.Conclusion Phenytoin may benefit patients with DFUs in promoting growth of granulation,reducing ulcer area and antibacterial effect,while no benefit on rate of ulcer healing.Larger-sized randomized controlled trials are required,and a prudent choice is suggested.