生肌玉红膏治疗糖尿病足溃疡疗效的系统评价

杜玉青 李友山 刘亚莉 陈润铭 刘凤桐 赵金超 安琪 董学宇 杨敏

摘要 目的：系统评价外敷生肌玉红膏治疗糖尿病足溃疡的临床疗效。方法：检索国家知识基础设施数据库（CNKI）、中国学术期刊数据库（CSPD）、中文科技期刊数据库（CCD）、Web of Science、PubMed、The Cochrane Library、CBN数据库，搜集生肌玉红膏治疗糖尿病足溃疡的随机对照研究，检索时间均从建库至2019年11月31日。由2名研究者筛选符合纳入标准的文献、提取有效资料，应用RevMan5.3软件评价文献偏倚风险并进行系统评价。结果：共纳入9篇随机对照试验（RCT），包括696例患者，纳入文献质量偏低。Meta分析结果显示：外敷生肌玉红膏能够提高糖尿病足溃疡总有效率（MD=4.76，95%CI为2.89～7.85），P<0.000 1），缩短创面愈合时间（MD=-4.90，95%CI为-5.77～-4.03），P<0.000 01），差异有统计学意义;对降低空腹血糖（MD=-0.08，95%CI为-0.71～0.55），P=0.80）及不良反应发生率（MD=1.01，95%CI为0.33～3.10，P=0.98），差异无统计学意义。结论：当前证据表明，生肌玉红膏治疗糖尿病足溃疡疗效显著。须提高纳入文献数量和质量，增加研究客观性和准确性。

关键词 生肌玉红膏;外治;糖尿病足溃疡;疗效;不良反应;系统评价;Meta分析

Abstract Objective：To do systematic review and meta analysis of the clinical efficacy of external application of Shengji Yuhong Ointment in the treatment of diabetic foot ulcer.Methods：Databases of CNKI，Wanfang，VIP，Web of science，PubMed，the Cochrane Library and CBN were searched by computer，and the randomized controlled trials of Shengji Yuhong Ointment in the treatment of diabetic foot ulcer were collected.The retrieval time was from the establishment of the database to November 31，2019.The literature that meet the inclusion criteria were screened by two researchers，and the effective data were extracted.The risk of literature bias was evaluated by RevMan5.3 software and meta analysis and systematic evaluation were carried out.Results：A total of 9 RCT，papers including 696 patients were included，and the quality of the included literature was on the low side.The results of meta analysis showed that external application of Shengji Yuhong ointment could improve the total effective rate of diabetic foot ulcer（MD=4.76，95%CI 2.89 to 7.85，P<0.000 1），shorten the wound healing time （MD=-4.90，95%CI -5.77 to -4.03，P<0.000 01），and reduce the incidence of fasting blood glucose （MD=-0.08，95%CI -0.71 to 0.55，P=0.80） and adverse reactions （MD=1.01，95%CI 0.33 to 3.10，P=0.98）.Conclusion：the current evidence shows that Shengji Yuhong Ointment is effective in the treatment of diabetic foot ulcer.It is necessary to improve the quantity and quality of the included literature and increase the objectivity and accuracy of the research.

Keywords Shengji Yuhong Ointment; External treatment; Diabetic foot ulcer; Efficacy; Adverse reactions; Systematic review; Meta analysis

中图分类号：R289.5;R587.1文献标识码：Adoi：10.3969/j.issn.1673-7202.2021.22.014

近年来，糖尿病足部潰疡（Diabetic Foot Ulcer，DFU）在我国疾病谱中的比例渐增，是糖尿病严重并发症之一。世界卫生组织（WHO）将其定义由下肢缺血、神经病变及局部感染3种因素作用下出现下肢远端神经障碍和周围血管病变，主要临床表现为足部感染、皮肤破溃，重者可累及破坏深层组织，发生坏疽[1]。流行病学调查显示，进入21世纪以来糖尿病患病人数在世界范围迅速增长，并预测在某一时间段15%糖尿病患者将发生足溃疡或坏疽[2]。……