摘要
目的:系统评价胰激肽原酶联合前列地尔治疗早期糖尿病足的有效性。方法:计算机检索PubMed、EMBase、Web of Science、the Cochrane Library临床对照试验资料库、中国生物医学文献数据库、中国知网数据库及维普数据库,搜集前列地尔联合胰激肽原酶治疗早期糖尿病足的随机对照试验(在常规治疗基础上,对照组患者采用前列地尔治疗,观察组患者采用胰激肽原酶联合前列地尔治疗)。按照纳入与排除标准筛选文献,提取资料并进行方法学质量评价后,采用RevMan 5.3软件进行荟萃分析(Meta分析)。结果:最终纳入12篇文献,共832例患者。Meta分析结果显示,观察组患者的临床总有效率(OR=6.54,95%CI=3.52~12.13,P<0.00001)、踝肱指数(MD=0.14,95%CI=0.13~0.16,P<0.00001)明显高于对照组,足背动脉血流速度明显快于对照组(MD=0.16,95%CI=0.13~0.18,P<0.00001),白细胞介素6(MD=-3.83,95%CI=-5.23^-2.42,P<0.00001)、C反应蛋白(MD=-2.82,95%CI=-3.87^-1.77,P<0.00001)等炎性因子水平明显低于对照组,差异均有统计学意义;两组患者肿瘤坏死因子α水平的差异无统计学意义(MD=-0.71,95%CI=-3.12~1.71,P=0.57)。结论:胰激肽原酶联合前列地尔治疗可发挥协同作用,显著提高早期糖尿病足患者的临床总有效率,改善足背动脉血流速度、踝肱指数,降低白细胞介素6、C反应蛋白水平。因纳入的研究数量不多、质量不高,仍需开展更多高质量、大样本的随机对照试验对上述结论加以验证。
OBJECTIVE:To systematically evaluate the efficacy of kallidinogenase combined with alprostadil in treatment of early diabetic foot.METHODS:Randomized controlled trials of kallidinogenase combined with alprostadil in treatment of early diabetic foot(on the basis of conventional therapy,the control group was treated with alprostadil,the observation group was given kallidinogenase combined with alprostadil)were retrieved from Pubmed,EMBase,Web of Science,the Cochrane Library,CBM,CNKI and VIP databases.Literature screening was proceeded according to inclusion and exclusion criteria,after data extraction and methodology quality evaluation,RevMan 5.3 was adopted to conduct Meta-analysis.RESULTS:A total of 12 studies were involved,including 832 patients.Results of Meta analysis indicated than the total effective rate(OR=6.54,95%CI=3.52-12.13,P<0.00001)and ankle brachial pressure index(MD=0.14,95%CI=0.13-0.16,P<0.00001)of observation group were significantly higher than those of the control group,the artery flow velocity in foot dorsal of observation group was significantly faster than that of the control group(MD=0.16,95%CI=0.13-0.18,P<0.00001),the interleukin-6(MD=-3.83,95%CI=-5.23--2.42,P<0.00001)and C-reactive protein(MD=-2.82,95%CI=-3.87--1.77,P<0.00001)levels of observation group were significantly lower than those of the control group,with statistically significant differences;there was no statistical significance in difference of tumor necrosis factorαlevels between two groups(MD=-0.71,95%CI=-3.12-1.71,P=0.57).CONCLUSIONS:The combination of kallidinogenase and alprostadil can significantly promote the total effective rate of early diabetic foot,improve the artery flow velocity in foot dorsal and Ankle Brachial Pressure Index,reduce the levels of interleukin-6 and C-reactive protein.Due to the small number of studies included and its low quality,more high-quality and large-sample randomized controlled trials are still needed to verify the above conclusions.
作者
徐卓
秦旭华
王涛
李浩田
王丹
赵艳玲
XU Zhuo;QIN Xuhua;WANG Tao;LI Haotian;WANG Dan;ZHAO Yanling(School of Pharmacy,Chengdu University of Traditional Chinese Medicine,Sichuan Chengdu 611137,China;Dept.of Pharmacy,the Fifth Medical Center of Chinese PLA General Hospital,Beijing 100039,China)
出处
《中国医院用药评价与分析》
2019年第10期1162-1166,共5页
Evaluation and Analysis of Drug-use in Hospitals of China
基金
重大新药创制国家科技重大专项(No.2015ZX09J15102-004)
