摘要
目的:评价丹参注射液辅助治疗糖尿病肾病(DN)的有效性和安全性。方法:计算机检索Cochrane图书馆,PubMed,CBM,CNKI,VIP及万方数据库,全面收集有关丹参注射液辅助治疗DN的随机对照试验,按照Jadad评分评价纳入研究的质量,符合纳入标准的研究用RevMan 5.0软件对数据进行Meta分析。结果:共纳入9篇随机对照试验,包括723例DN患者。Meta分析结果显示:与常规治疗组相比,联用丹参组可以提高DN的治疗率[OR=5.70,95%CI(2.54,12.78),P<0.000 01]降低DN患者的24 h-UAER[MD=-38.17,95%CI(54.31,-22.02),P<0.000 1]、BUN(MD=-0.97,95%CI(-1.37,0.56),P<0.000 01]和β2-MG[MD=-0.61,95%CI(-0.91,-0.31),P<0.000 01],并能降低3期DN患者24 h-UTP[MD=-32,95%CI(-58.30～-5.70),P<0.002],但在血肌酐(Cr)、糖化血红蛋白(HbA1c)、血浆总胆固醇(TC)、三酰甘油(TG)、舒张压(DBP)、收缩压(SBP)等方面降低不明显。只有3篇研究分别报道了使用丹参注射液出现了咳嗽(5例)、球结膜出血(1例)、血管性水肿(1例)、速发型皮肤瘙痒(2例)、类静脉炎反应(12例)、腹泻(4例)、窦性心动过速(2例)等不良反应。结论:丹参注射液辅助治疗DN有一定疗效,但由于现有研究质量均存在一定方法学问题,上述结论尚需设计严格的高质量临床试验进一步证实。
Objective： To evaluate the effectiveness and safety of Danshen injection for treating diabetic nephropathy（DN）. Method： Randomized controlled trials（RCTs）on Danshen injection in treatment of DN were searched in PubMed, Cochrane Library, CMCC, VIP, CNKI, CBM, WANFANG data. Their methodological quality were evaluated with jadad method.Data were strictly extracted and Meta-analysis was Performed using Rev Man 5.0 software. Result： Nine RCTs of 723 patients of DN were included. Meta-analysis showed that：compared with basic therapy, Danshen injection was superior to routine treatment in increasing effective rate [OR=5.70,95% CI（2.54,12.78）,P〈0.000 01] and decreasing the 24 h-UTP[DN Ⅲ,MD=-32,95% CI（-58.30,-5.70）,P〈0.002],24 h-UAER[MD=-38.17,95%CI（-54.31,-22.02）,P〈0.000 1],[BUNMD=-0.97,95% CI（-1.37,0.56）,P〈0.000 1],β2-MG[MD=-0.61,95% CI（-0.91,-0.31）,P〈0.000 01], but Danshen injection had similar effects in reducing creatinine（Cr）, hemoglobin A1c（HbA1c）, total cholesterol（TC）, total glycerin（TG）, diastolic blood pressure（DBP）, Systolic blood pressure（SDP）, et al. Some side effects were observed in 3 studies, such as cough（5 patients）, bulbar conjunctiva bleeding（1 patient）, vascular edema（1 patient）, immediate skin itchingm（2 patients）, response similar to phlebitis（12 patients）, diarrhea（4 patients）, sinus tachycardia（2 patients）. Conclusion： Meta-analysis currently manifests that Danshen injection has some effect in treating patients with DN. However, the evidence is insufficient to determine the effects of Danshen injection due to low-quantity and low-quality trials. Double-blinded RCTs are needed to verify effects and relatively safe of danshen injection for DN.
出处
《中国实验方剂学杂志》
CAS
北大核心
2013年第6期353-358,共6页
Chinese Journal of Experimental Traditional Medical Formulae
关键词
丹参注射液
糖尿病肾病
随机对照试验
系统评价
Danshen injection
diabetic nephropathy
randomized controlled trial
systematic review
