血脂康治疗高脂血症系统评价的再评价
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摘要
目的评估血脂康治疗高脂血症(Hyperlipidemia,HLP)有效性的系统评价现有证据,为决策者和研究者提供参考。方法计算机检索Cochrane Library、PubMed、Embase、中国知网(CNKI)、中国生物医学文献数据库(CBM)和万方数据库(WanFang Data),收集血脂康治疗HLP的系统评价/Meta分析的文献,检索时间均为从建库至2017年12月31日。采用AMSTAR量表评价纳入HLP系统评价的方法学质量,同时采用GRADE系统对纳入的结局指标进行证据质量分级。结果共纳入8项系统评价,AMSTAR量表评价结果显示,存在问题条目有"是否提供了前期设计方案""是否提供了纳入和排除的研究文献清单"和"是否说明相关利益冲突",8项系统评价均未提及。平均AMSTAR评分为5.75分,其中2项(25%)为低质量,6项(75%)为中等质量。GRADE分级结果显示,结局指标胆固醇(TC)、甘油三酯(TG)、低密度脂蛋白胆固醇(LDL-C)、高密度脂蛋白胆固醇(HDL-C)、有效率的证据质量为低或极低。导致降级最主要因素为偏倚风险,其次为发表偏倚。结论血脂康治疗高脂血症的系统评价/Meta分析的方法学质量总体不高,证据质量等级普遍较低,建议今后的临床试验和系统评价/Meta分析均应严格遵循科学设计要求,从而为决策提供更高质量的证据。
Objective To evaluate the effectiveness of Xuezhikang for hyperlipidemia(HLP), and to provideevidence for policy makers and researchers. Methods A comprehensive literature search was performed on CochraneLibrary,PubMed,embase,CNKI,China Biomedical Literature Database(CBM) and WanFang Data,and datewere retrieved from the inception of databases until December 31,2017. The methodological quality of systematicreviews was evaluated using the AMSTAR scale,and quality of evidence was graded by including outcomes applyingthe GRADE system. Results A total of 8 systematic reviews were included. The results of the AMSTAR showed thatthere were 8 items which were not mentioned, such as "whether a previous design proposal was provided","whether the inclusion and list of excluded research eocuments" and "whether explaining related conflicts ofinterest". The average AMSTAR score was 5.75,of which 2 (25%) were of low level and 6(75%) were of moderate. The GRADE grading results showed that the quality of evidence for outcomes such as cholesterol(TC),triglyceride(TG),low density lipoprotein cholesterol(LDL-C),high density lipoprotein cholesterol(HDL-C),and efficacy were low or very low. The most important factor was the bias risk, followed by publication bias.Conclusion The methodological quality of systematic review/meta-analysis of hyperlipidemia with Xuezhikang is nothigh,and the quality of evidence is generally low. It is proposed that the future clinical trials and systematic review/meta-analysis should strictly follow the requirements of scientific research principles so as to provide high-qualityevidence for decision making.
Objective To evaluate the effectiveness of Xuezhikang for hyperlipidemia(HLP), and to provideevidence for policy makers and researchers. Methods A comprehensive literature search was performed on CochraneLibrary,PubMed,embase,CNKI,China Biomedical Literature Database(CBM) and WanFang Data,and datewere retrieved from the inception of databases until December 31,2017. The methodological quality of systematicreviews was evaluated using the AMSTAR scale,and quality of evidence was graded by including outcomes applyingthe GRADE system. Results A total of 8 systematic reviews were included. The results of the AMSTAR showed thatthere were 8 items which were not mentioned, such as "whether a previous design proposal was provided","whether the inclusion and list of excluded research eocuments" and "whether explaining related conflicts ofinterest". The average AMSTAR score was 5.75,of which 2 (25%) were of low level and 6(75%) were of moderate. The GRADE grading results showed that the quality of evidence for outcomes such as cholesterol(TC),triglyceride(TG),low density lipoprotein cholesterol(LDL-C),high density lipoprotein cholesterol(HDL-C),and efficacy were low or very low. The most important factor was the bias risk, followed by publication bias.Conclusion The methodological quality of systematic review/meta-analysis of hyperlipidemia with Xuezhikang is nothigh,and the quality of evidence is generally low. It is proposed that the future clinical trials and systematic review/meta-analysis should strictly follow the requirements of scientific research principles so as to provide high-qualityevidence for decision making.
引文
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[12]王卫霞,陈可冀.血脂康胶囊治疗高脂血症有效性和安全性的系统评价[J].中国循证医学杂志,2006,6(5):352-360.
[13]徐智超,唐海沁,张亚文,等.血脂康与他汀类药物调脂效果对比及安全性分析[J].中国临床保健杂志,2017,20(1):28-32.
[14]杜建平,赵自明,夏能能,等.原发性高脂血症患者血脂康调脂有效性临床再评价[J].华西医学,2015,30(2):254-262.
[15]张宝珍,张凯,刘玉珍.针灸丰隆治疗高脂血症临床随机对照试验Meta分析[J].中国中医药信息杂志,2014,21(8):11-15.
[16]李广林.艾灸治疗高脂血症的系统评价[D].南京:南京中医药大学,2014.
[17]台红祥.脂必妥治疗高脂血症的系统评价[D].天津:天津医科大学,2015.
[18]JADAD A R,COOK D J,JONES A,et al.Methodology and reports of systematic reviews and meta-analyses:A comparison of cochrane reviews with articles published in paper-based journals[J].The Journal of the American Medical Association,1998,280(3):278-280.
[19]李静,李幼平.不断完善与发展的Cochrane系统评价[J].中国循证医学杂志,2008,8(9):742-743.
[20]屈云,何俐,刘鸣.Cochrane系统评价的基本方法[J].中国组织工程研究,2003,7(4):532-533.
[2]陈灏珠.我国人群血脂水平现状和高脂血症的治疗[J].中西医结合杂志,2004,2(2):81-82.
[3]周瑞海,高海青.高脂血症药物治疗研究现状[J].中国临床药理学杂志,1999,15(1):58-62.
[4]BUCHER H C,GRIFFITH L E,GUYATT G H.Systematic review on the risk and benefit of different cholesterol-lowering interventions[J].Arteriosclerosis Thrombosis&Vascular Biology,1999,19(2):187.
[5]CASTELLI W P.Cholesterol and lipids in the risk of coronary artery disease-the Framingham Heart Study[J].Canadian Journal of Cardiology,1988,4(Suppl A):5A.
[6]GUYATT G H,OXMAN A D,MONTORI V.GRADE指南(Ⅴ):证据质量评价--发表偏倚[J].中国循证医学杂志,2011,11(12):1430-1434.
[7]SHEA B J,GRIMSHAW J M,WELLS G A,et al.Development of AMSTAR:a measurement tool to assess the methodological quality of systematic reviews[J].BMC Medical Research Methodology,2007,7(1):1-7.
[8]GRADE WORKING GROUP.Grading quality of evidence and strength of recommendations[J].BMJ,2004,328:1490.
[9]曾宪涛,冷卫东,李胜,等.如何正确理解及使用GRADE系统[J].中国循证医学杂志,2011,11(9):985-990.
[10]赵自明,杜建平,夏能能.高脂血症患者血脂康1.2g/d治疗8周后调脂效应的Meta分析[J].按摩与康复医学,2014,5(2):108-113.
[11]杜建平,赵自明,夏能能.血脂康高脂血症患者调脂效应自身对照研究的Meta分析[J].按摩与康复医学,2014,5(1):114-118.
[12]王卫霞,陈可冀.血脂康胶囊治疗高脂血症有效性和安全性的系统评价[J].中国循证医学杂志,2006,6(5):352-360.
[13]徐智超,唐海沁,张亚文,等.血脂康与他汀类药物调脂效果对比及安全性分析[J].中国临床保健杂志,2017,20(1):28-32.
[14]杜建平,赵自明,夏能能,等.原发性高脂血症患者血脂康调脂有效性临床再评价[J].华西医学,2015,30(2):254-262.
[15]张宝珍,张凯,刘玉珍.针灸丰隆治疗高脂血症临床随机对照试验Meta分析[J].中国中医药信息杂志,2014,21(8):11-15.
[16]李广林.艾灸治疗高脂血症的系统评价[D].南京:南京中医药大学,2014.
[17]台红祥.脂必妥治疗高脂血症的系统评价[D].天津:天津医科大学,2015.
[18]JADAD A R,COOK D J,JONES A,et al.Methodology and reports of systematic reviews and meta-analyses:A comparison of cochrane reviews with articles published in paper-based journals[J].The Journal of the American Medical Association,1998,280(3):278-280.
[19]李静,李幼平.不断完善与发展的Cochrane系统评价[J].中国循证医学杂志,2008,8(9):742-743.
[20]屈云,何俐,刘鸣.Cochrane系统评价的基本方法[J].中国组织工程研究,2003,7(4):532-533.