红花注射液治疗糖尿病肾病的meta分析及试验序贯分析

Safflower Injection for Chronic Kidney Disease:A Meta-analysis and Trial Sequential Analysis

目的系统评价红花注射液治疗糖尿病肾病的临床疗效。方法计算机检索CBM、CNKI、WanFang、VIP、PubMed、The Cochrane Library、Embase等数据库,遴选红花注射液联合常规用药治疗糖尿病肾病的随机对照试验文献,检索时间限定为从建库至2018年7月。由2位研究员按纳入与排除标准独立筛选文献、提取资料、评价文献质量,采用RevMan 5.3软件进行meta分析,采用Stata 14.0软件进行Egger检验,以评估发表偏倚,若存在发表偏倚则进一步运用非参数剪补法评估偏倚对结果的影响。运用TSA v0.9软件进行试验序贯分析,运用GRADE pro 3.6软件进行证据质量评价分析。结果共纳入20个研究,包括1640例糖尿病肾病患者。Meta分析结果显示,联合红花注射液在有效率、降低血清肌酐(SCr)、降低尿素氮(BUN)水平、减少24 h尿蛋白定量等方面均优于常规用药治疗,差异均有统计学意义,但证据质量有待提高。发表偏倚检验及非参数剪补法分析结果提示有效率、BUN指标存在偏倚,但可能存在的发表偏倚未对结果造成影响。试验序贯分析结果表明2组有效率、SCr、BUN指标meta分析结果证据确切。结论红花注射液联合常规用药治疗糖尿病肾病疗效显著,可以降低患者SCr、BUN、24 h尿蛋白水平,且不良反应较少,但限于所纳入研究的质量,本研究所得结论仍需更多高质量的研究进行补充。

OBJECTIVE To systematically evaluate the clinical efficacy of safflower injection in the treatment of diabetic nephropathy.METHODS Such databases as CBM,CNKI,WanFang,VIP,PubMed,The Cochrane Library,Embase were searched in order to collect randomized controlled trials about safflower injection combined with conventional medication for diabetic nephropathy on the deadline to July 2018.Two researchers independently screened articles according to the inclusion and exclusion criteria,and assessed the risk of bias of included studies.Meta-analysis was carried by using RevMan 5.3 software,Egger test was carried by using Stata 14.0 software to evaluate publication bias,and nonparametric trim and fill method was used to evaluate the impact of publication bias on the results.Trial sequential analysis was performed by using TSA v0.9 software.GRADE pro 3.6 software was used to grade the evidence quality of key outcome indicators.RESULTS A total of 20 studies were included,including 1640 patients with diabetic nephropathy.Meta-analysis showed that the curative effect of safflower injection combined with normal treatment in the improvement of total effective rate,decrease of serum creatinine(SCr),decrease of blood urea nitrogen(BUN),decrease of 24 h proteinuria were better than normal treatment with statistically significant,however,the quality of evidence was required to be improved.The results of publication bias test showed that there were publication bias in efficiency and BUN.Nonparametric trim and fill method showed that the results of meta-analysis were stable,and the possible publication bias did not affect the results.Trial sequential analysis showed that the evidence of effective rate,SCr and BUN was definited.CONCLUSION Safflower injection combined with normal treatment can increase the total effective rate,decrease SCr,BUN and 24 h proteinuria with statistically significant and a few adverse reaction.There are some limitations due to the quality of included literatures,still need to be validated with higher quality literatures.