CAJ | 학술논문

目的：系统评价黄芪注射液治疗糖尿病肾病的有效性及安全性。方法：计算机检索Cochrane图书馆临床对照试验库、MEDLINE、EMBASE、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方数据库，同时手工检索相关会议论文、学位论文及所获文献的参考文献，收集黄芪注射液治疗糖尿病肾病的随机或半随机对照试验。由2名研究者独立筛选和提取资料，并按照改良Jadad评分量表对纳入文献质量进行评价，应用Rev Man 4.2.2软件进行Meta分析。结果：共纳入16个RCT，1058例DN患者。大部分试验方法学质量较低且样本含量小。“漏斗图”呈不对称分布，提示可能存在发表偏倚（提示阴性结果的试验可能未发表）及试验方法质量低下。 Meta分析结果显示：①与空白对照组相比，黄芪注射液可降低DN患者24小时尿蛋白、血尿素氮、甘油三酯，并且可改善DN患者症状和体征的总有效率；②与空白对照组相比，黄芪注射液可降低早期DN患者24小时尿白蛋白排泄率、24小时尿蛋白、血清肌酐、血尿素氮、甘油三酯、总胆固醇，但不能降低临床期和晚期DN患者的血清肌酐和总胆固醇；③黄芪注射液降低早期 DN患者的24小时尿白蛋白排泄率、血清肌酐、血尿素氮的疗效与卡托普利相似；降低早期DN患者24小时尿白蛋白排泄率、血尿素氮的疗效与奥扎格雷钠注射液相似，但降低早期DN患者血清肌酐的疗效不如奥扎格雷钠注射液。治疗期间尚未发现严重不良反应。结论：黄芪注射液可能是一种相对安全和有效治疗早期糖尿病肾病的药物。由于纳入试验方法质量低下和可能存在的发表偏倚，使本系统评价的证据强度不足，有待进一步进行高质量的大样本、随机双盲对照试验来证实。
목적：계통평개황기주사액치료당뇨병신병적유효성급안전성。방법：계산궤검색Cochrane도서관림상대조시험고、MEDLINE、EMBASE、중국학술기간전문수거고(CNKI)、중국생물의학문헌수거고(CBM)、만방수거고，동시수공검색상관회의논문、학위논문급소획문헌적삼고문헌，수집황기주사액치료당뇨병신병적수궤혹반수궤대조시험。유2명연구자독립사선화제취자료，병안조개량Jadad평분량표대납입문헌질량진행평개，응용Rev Man 4.2.2연건진행Meta분석。결과：공납입16개RCT，1058례DN환자。대부분시험방법학질량교저차양본함량소。“루두도”정불대칭분포，제시가능존재발표편의（제시음성결과적시험가능미발표）급시험방법질량저하。 Meta분석결과현시：①여공백대조조상비，황기주사액가강저DN환자24소시뇨단백、혈뇨소담、감유삼지，병차가개선DN환자증상화체정적총유효솔；②여공백대조조상비，황기주사액가강저조기DN환자24소시뇨백단백배설솔、24소시뇨단백、혈청기항、혈뇨소담、감유삼지、총담고순，단불능강저림상기화만기DN환자적혈청기항화총담고순；③황기주사액강저조기 DN환자적24소시뇨백단백배설솔、혈청기항、혈뇨소담적료효여잡탁보리상사；강저조기DN환자24소시뇨백단백배설솔、혈뇨소담적료효여오찰격뢰납주사액상사，단강저조기DN환자혈청기항적료효불여오찰격뢰납주사액。치료기간상미발현엄중불량반응。결론：황기주사액가능시일충상대안전화유효치료조기당뇨병신병적약물。유우납입시험방법질량저하화가능존재적발표편의，사본계통평개적증거강도불족，유대진일보진행고질량적대양본、수궤쌍맹대조시험래증실。
Objective: To assess the effectiveness and safety of HuangQi injection in treating diabetic nephropathy (DN) systematically. Methods: The papers about randomized or semi-randomized controlled trials (RCT) of HuangQi injection in treating DN were collected and searched in Cochrane library clinical controlled trials database, MEDLINE, EMBASE, CNKI, CBM, WangFang database, as well as related conference papers, dissertations and the reference in the obtained literature. Two investigators chose the trials and drew the informations indenpedently, the quality of the included studies was evaluated with modified Jadad rating scale, Meta analysis was performed with software Rev Man 4.2.2. Results:Altogether 16 RCTs were included and there were 1058 patients. Most of trial methodologies were of lower quality and with small sample size.“Funnel plots” were not equally distributed, which suggested that publication bias might be existed (it showed that trial with negative results might not be published) and the qualities of trial methodologies were lower. The results of Meta analysis showed:①compared with blank control group, HuangQi injection could reduce 24 hours urinary protein, blood urea nitrogen (BUN) and glycerin trilaurate (TG) of DN patients, and improve total effective rates of body signs and symptom of DN patients; ②compared with blank control group,HuangQi injection could decrease 24 hours urine albumin excretion rate (UAER), 24 hours urinary protein, serum creatinine(Scr), BUN, TG and total cholesterol(TC) of DN patients at early stage,but it couldn’t lower Scr and TC of DN patients at clinical stage and advanced stage;③HuangQi injection presented similar effects to captopril in decreasing 24 hours UAER, Scr and BUN of DN patients at early stage;it also was similar to sodium ozagrel injection in lowering 24 hours UAER and BUN of DN patients at early stage, but it showed less effects in decreasing Scr of DN patients at early stage as sodium ozagrel injection. There was no severe adverse reaction during the treatment. Conclusion:HuangQi injection might be a kind of drug which is relatively safe and effective in treating early DN. Due to low methodological quality of included trial and the might existing publication bias, the evidence is not strong enough, therefore, randomized double-blind controlled trials of high quality large sample are needed to be proved further.