丹参酮ⅡA磺酸钠注射液治疗糖尿病肾病疗效的meta分析

Meta Analysis of Therapeutic Efficacy of Sodium Tanshinone ⅡA Sulfonate Injection in Treatment of Diabetic Kidney Disease

关键词:  丹参酮ⅡA磺酸钠注射液  糖尿病肾病  meta分析  有效性

Key words:  sodium tanshinone ⅡA sulfonate injection  diabetic kidney disease  meta-analysis  efficacy

摘要:

目的 系统评价丹参酮ⅡA磺酸钠注射液治疗糖尿病肾病（diabetic kidney disease，DKD）的疗效，为临床合理应用提供一定的参考依据。方法 检索PubMed、中国期刊全文数据库、维普中文科技期刊数据库、万方数字化期刊全文库、中国生物医学文献数据库，并收集有关丹参酮ⅡA磺酸钠注射液治疗DKD临床试验的文献报道。根据纳入及排除标准进行文献的筛选，评价纳入的文献质量和提取有效信息后采用RevMan 5.3软件进行相关数据的meta分析。结果 共纳入15篇随机对照试验（randomized controlled trials，RCTs），总计1 202份病例。Meta分析结果显示，试验组与对照组的总有效率[RR=1.44，95%CI（1.12，1.84），P=0.005]；尿白蛋白排泄率[MD=–20.18，95%CI（–33.76，–6.59），P=0.004]；24 h尿蛋白定量[MD=–0.35，95%CI（–0.45，–0.26），P<0.000 01]；总胆固醇[MD=–0.69，95%CI（–1.00，–0.37），P<0.000 1]；甘油三酯[MD=–0.58，95%CI（–0.89，–0.26），P=0.000 3]；血肌酐[MD=–15.44，95%CI（–24.71，–6.17），P=0.001]均有统计学差异。2组空腹血糖无统计学差异[MD=–0.22，95%CI（–0.51，0.06），P=0.12]。结论 现有证据表明，丹参酮ⅡA磺酸钠注射液对DKD患者的空腹血糖无明显影响，但能显著减少其尿蛋白、血肌酐及血脂水平。然而，由于目前临床尚缺少针对DKD各阶段设计的RCTs试验，导致本研究纳入标准较为宽泛，结果缺乏针对性，各组间异质性明显。因此尚需要更多相关的高质量大样本的RCTs试验，进一步研究丹参酮ⅡA磺酸钠注射液用于辅助治疗DKD的临床有效性。

Abstract:

OBJECTIVE To systematically evaluate the therapeutic efficacy of sodium tanshinoneⅡA sulfonate injection in the treatment of diabetic kidney disease(DKD), and provide a certain reference for clinical rational application. METHODS Retrieved from PubMed, CNKI, VIP, Wanfang and CBM database, the trials about sodium tanshinoneⅡA sulfonate injection in treatment of DKD were collected. And studies were screened according to inclusion and excluding criteria. Meta-analysis of included studies was performed using RevMan 5.3 software after quality evaluation and valid data extraction. RESULTS A total of 15 randomized controlled trials(RCTs) were included, involving 1 202 patients. Meta-analysis showed that experimental group and control group had statistically difference in clinical efficacy[RR=1.44, 95%CI(1.12, 1.84), P=0.005], urinary albumin excretion rate[MD=-20.18, 95%CI(-33.76, -6.59), P=0.004], 24 h urinary protein excretion[MD=-0.35, 95%CI(-0.45, -0.26), P<0.000 01], total cholesterol[MD=-0.69, 95%CI(-1.00, -0.37), P<0.000 1], triacylglycerol[MD=-0.58, 95%CI(-0.89, -0.26), P=0.000 3], serum creatinine[MD=-15.44, 95%CI(-24.71, -6.17), P=0.001]. But there was no statistically difference in fasting plasma glucose[MD=-0.22, 95%CI(-0.51, 0.06), P=0.12]. CONCLUSION Evidence show that sodium tanshinone Ⅱ A sulfonate injection has no significant effect on fasting blood glucose in DKD patient, but it can significantly reduce the urine protein, serum creatinine and blood lipid level.However, due to the lack of clinical RCTs designed for all stages of DKD at present, the inclusion criteria of this study is relatively broad, and the results are lack of pertinence, with obvious inter-group heterogeneity. So it still need more relevant high-quality RCTs with large sample for further study of the clinical effect for sodium tanshinoneⅡA sulfonate injection in adjuvant treatment of DKD.