前列地尔注射液治疗糖尿病足溃疡的有效性及安全性的Meta分析  

Meta-Analysis on Efficacy and Safety of Alprostadil Injection in the Treatment of Diabetic Foot Ulcer

作　　者：秦刚新 屈可伸[2] 刘金响 阚琛 苏衍进 王黎 QIN Gangxin;QU Keshen;LIU Jinxiang;KAN Chen;SU Yanjin;WANG Li(The First Dept.of Endocrinology,Affiliated Hospital of Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712000,China;Dept.of Dermatology and Plastic Surgery,the Second Affiliated Hospital of Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712000,China;Dept.of Emergency and Intensive Care Unit,the Second Affiliated Hospital of Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712000,China;Dept.of Internal Medicine,Xi’an Third Retired Cadre Retreat of Shaanxi Military Region,Xi’an 710505,China;The Second Dept.of Endocrinology,Affiliated Hospital of Shaanxi University of Chinese Medicine,Shaanxi Xianyang 712000,China)

机构地区：[1]陕西中医药大学附属医院内分泌一科,陕西咸阳712000 [2]陕西中医药大学第二附属医院皮肤整形科,陕西咸阳712000 [3]陕西中医药大学第二附属医院急诊与重症医学科,陕西咸阳712000 [4]陕西省军区西安第三离职干部休养所内科,西安710505 [5]陕西中医药大学附属医院内分泌二科,陕西咸阳712000

出　　处：《中国医院用药评价与分析》2024年第8期962-966,972,共6页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家自然科学基金资助项目(No.82205123);陕西中医药大学附属医院院内课题(No.2020QN0013)。

摘　　要：目的:评估前列地尔注射液治疗糖尿病足溃疡的临床效果。方法:检索外文数据库(the Cochrane Library、Embase、PubMed)以及中文数据库(中国知网、万方数据库、维普数据库)公开发表的相关文献,选择前列地尔注射液辅助治疗糖尿病足的随机对照试验(对照组实施糖尿病足常规治疗,观察组在常规治疗的基础上加用前列地尔注射液治疗,无论是否联合其他药物),检索时限为建库至2023年12月,使用RevMan 5.3统计软件进行Meta分析。结果:根据文献选择标准,最终纳入18篇文献。分析结果显示,与对照组比较,观察组患者的总有效率更高(OR=5.79,95%CI=3.88~8.64,P<0.000 01),足背动脉血流速度更快(SMD=0.96,95%CI=0.59~1.33,P<0.000 01),足背动脉内径更大(SMD=0.73,95%CI=0.44~1.01,P<0.000 01),腓浅神经传导速度更快(SMD=2.66,95%CI=1.15~4.16,P=0.000 5),足溃疡面积更小(SMD=-3.42,95%CI=-6.40~-0.44,P=0.02),阻力指数更高(SMD=1.20,95%CI=0.16~2.24,P=0.02),搏动指数更高(SMD=2.23,95%CI=0.36~4.11,P=0.02),疼痛(SMD=-11.68,95%CI=-20.21~-3.15,P=0.007)、麻木(SMD=-19.41,95%CI=-29.00~-9.81,P<0.000 1)、跛行(SMD=-14.10,95%CI=-22.26~-5.94,P=0.000 7)等症状改善情况更优,上述差异均有统计学意义。结论:前列地尔注射液治疗糖尿病足溃疡可以提升治疗总效果,扩张足背动脉,加快足背动脉血液流速,降低血液阻力,促进溃疡面愈合,改善患者的临床症状,值得临床推广使用。OBJECTIVE:To evaluate the clinical effects of alprostadil injection in the treatment of diabetic foot ulcer.METHODS:The Cochrane Library,Embase,PubMed,CNKI,Wanfang Data and VIP databases were retrieved to collect the randomized controlled trial of alprostadil injection in the adjuvant treatment of diabetic foot ulcer(the control group received routine treatment of diabetes foot,and the observation group received alprostadil injection on the basis of routine treatment,regardless of whether it was combined with other drugs).The retrieval time was from the establishment of the database to Dec.2023.Meta-analysis was performed by using RevMan 5.3 statistical software.RESULTS:According to the literature selection criteria,18 articles were finally included.Compared with the control group,patients in the observation group had higher total effectiveness(OR=5.79,95%CI=3.88-8.64,P<0.00001),faster flow velocity of dorsalis pedis artery(SMD=0.96,95%CI=0.59-1.33,P<0.00001),larger internal diameter of dorsalis pedis vessels(SMD=0.73,95%CI=0.44-1.01,P<0.00001),faster conduction velocity of superficial peroneal nerve(SMD=2.66,95%CI=1.15-4.16,P=0.0005),smaller foot ulcer(SMD=-3.42,95%CI=-6.40--0.44,P=0.02),higher resistance index(SMD=1.20,95%CI=0.16-2.24,P=0.02),higher beat index(SMD=2.23,95%CI=0.36-4.11,P=0.02),better improvement of pain(SMD=-11.68,95%CI=-20.21--3.15,P=0.007),numbness(SMD=-19.41,95%CI=-29.00--9.81,P<0.0001),lameness(SMD=-14.10,95%CI=-22.26--5.94,P=0.0007)and other symptoms,with statistically significant differences.CONCLUSIONS:Alprostadil injection in the treatment of diabetic foot ulcer can improve the total therapeutic effect,dilate the dorsalis pedis artery,accelerate the blood flow rate of dorsalis pedis artery,reduce blood resistance,promote the healing of ulcer surface,and improve the clinical symptoms of patients,which is worthy of clinical promotion and application.

关 键 词：前列地尔注射液 糖尿病足溃疡 糖尿病足 安全性 系统评价 

分 类 号：R972[医药卫生—药品]