根据CONSORT HARMs声明评价雷公藤制剂相关肾毒性RCT的报告质量
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摘要
根据CONSORT HARMs声明评价以雷公藤中成药为干预或对照措施的RCT关于肾毒性的报告情况。根据CONSORT HARMs声明对纳入的雷公藤制剂相关肾毒性RCT研究进行报告质量评价,计算每个研究符合CONSORT HARMs声明的条目,评价雷公藤制剂相关RCT中其肾毒性相关不良反应的报告质量,总结国内研究肾毒性相关不良反应报告的问题。共纳入16项RCT,平均每个研究符合7个条目,雷公藤制剂相关肾毒性RCT研究的报告质量较差,报告的最不重复的条目为:使用已验证过的工具报告不良反应、提及不良反应的编码采用的标准、在方法中描述如何及何时收集不良反应的数据、描述不良反应是如何归因于雷公藤的、明确的提出是谁报告的不良反应、描述不良反应的分析方法、描述收集复发不良反应数据的方法、描述与危害相关的任何亚组分析和探索性分析。建议将来中药不良反应的相关研究,严格按照CONSORT HARMs建议的条目对研究进行详细报告。此外,也应考虑到中药自身的特点,详细的报告中药的组成、剂量、服用时间、联合用药及研究对象的辨证分型。
To evaluate the quality of randomized controlled trials( RCT) on nephrotoxicity of Tripterygium wilfordii preparations according to the CONSORT HARMs statement. The report quality of each included study was evaluated according to the CONSORT HARMs statement,and the number of entries that comply with CONSORT HARMs statement was calculated in each study to evaluate the report quality on nephrotoxicity-related adverse reactions of T. wilfordii preparations and summarize the problems in domestic studies on nephrotoxicity-related adverse reactions. A total of 16 RCTs were included,with an average of 7 entries complying with CONSORT HARMs statement per study. The report of the nephrotoxic-associated RCT of T. wilfordii preparations was of poor quality and the most non-repeating entries included the following ones: using validated tools to report adverse effects,standards for coding of the adverse reactions,describing how and when to collect data on adverse reactions in Method,describing how adverse reactions are attributed to T. wilfordii,clearly stating who has reported the adverse reactions,describing the analysis method of adverse reactions,describing the method of collecting recurrent adverse reaction data,describing any subgroup analysis and exploratory analysis associated with the hazard. We suggest that the studies on adverse reactions of traditional Chinese medicine should strictly report the entries according to the CONSORT HARMs statement,and take the characteristics of traditional Chinese medicine into account to report the details of the Chinese medicine like compositions,dose,taking time,combined medication and the dialectical typology of research objects.
To evaluate the quality of randomized controlled trials( RCT) on nephrotoxicity of Tripterygium wilfordii preparations according to the CONSORT HARMs statement. The report quality of each included study was evaluated according to the CONSORT HARMs statement,and the number of entries that comply with CONSORT HARMs statement was calculated in each study to evaluate the report quality on nephrotoxicity-related adverse reactions of T. wilfordii preparations and summarize the problems in domestic studies on nephrotoxicity-related adverse reactions. A total of 16 RCTs were included,with an average of 7 entries complying with CONSORT HARMs statement per study. The report of the nephrotoxic-associated RCT of T. wilfordii preparations was of poor quality and the most non-repeating entries included the following ones: using validated tools to report adverse effects,standards for coding of the adverse reactions,describing how and when to collect data on adverse reactions in Method,describing how adverse reactions are attributed to T. wilfordii,clearly stating who has reported the adverse reactions,describing the analysis method of adverse reactions,describing the method of collecting recurrent adverse reaction data,describing any subgroup analysis and exploratory analysis associated with the hazard. We suggest that the studies on adverse reactions of traditional Chinese medicine should strictly report the entries according to the CONSORT HARMs statement,and take the characteristics of traditional Chinese medicine into account to report the details of the Chinese medicine like compositions,dose,taking time,combined medication and the dialectical typology of research objects.
引文
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[2]Moher D,Schulz K F,Altman D G,et al.The CONSORT statement revised recommendations for improving the quality of reports of parallel-group randomized trials[J].Lancet,2001,357(9263):1191.
[3]Ioannidis J,Evans S,Gtzche P,et al.Better reporting of harms in randomized trials:an extension of the CONSORT statement[J].Ann Intern Med,2004,141(10):781.
[4]Schulz K F,Altman D G,Moher D,et al.CONSORT Group.CONSORT 2010 statement:updated guidelines for reporting parallel group randomised trials[J].Ann Intern Med,2010,152(11):726.
[5]曹珊,陈清萍.雷公藤多苷片联合缬沙坦治疗Ig A肾病蛋白尿的疗效[J].实用临床医学,2012,13(11):9.
[6]刘劲松,周琳,荣光辉.肾复康治疗原发性膜性肾病的临床研究[J].中国医药指南,2016,14(4):187.
[7]孙建平,高延霞,李琳.正清风痛宁片治疗中老年慢性肾炎临床疗效观察[J].中国老年学杂志,2007,27(22):2234.
[8]孙建平,高延霞,董晖.青藤碱制剂治疗慢性肾小球肾炎28例临床观察[J].临床荟萃,2007,22(16):1194.
[9]汪翠.中药加雷公藤多苷片治疗特发性膜性肾病疗效观察[D].武汉:湖北中医药大学,2015.
[10]达其伟,唐景晖,尚可儒,等.黄芪桂枝五物汤加减内服、熏蒸联合西药治疗类风湿关节炎30例[J].中医研究,2015,28(9):10.
[11]沈杰,张之澧.雷公藤多甙合小剂量甲氨蝶呤治疗老年性类风湿性关节炎[J].浙江中西医结合杂志,2002,12(6):334.
[12]郭立芳.祛风清热化瘀通络煎剂治疗类风湿性关节炎的临床研究[D].石家庄:河北医科大学,2007.
[13]黄飞霞.理肠汤、雷公藤多甙片口服和溃疡灵灌肠治疗活动期溃疡性结肠炎的临床观察[D].广州:广州中医药大学,2011.
[14]黄小玲,黄丽雅.雷公藤总内酯片治疗类风湿性关节炎的临床观察[J].广东药学院学报,2002,18(3):237.
[15]罗国良,陈用军,石年.消银汤治疗寻常型进展期银屑病临床疗效观察[J].中国现代医生,2011,49(2):43.
[16]沈瑞子,邱仁斌,邓惠文.青风藤汤治疗类风湿性关节炎45例疗效观察[J].新中医,2004,36(9):26.
[17]唐若余,宋卫珍.来氟米特、雷公藤多甙联合滋阴补血方治疗系统性红斑狼疮的疗效观察[J].中外医学研究,2014,12(35):99.
[18]张剑勇,谢静静,高建华,等.昆仙胶囊联合中药辨证治疗类风湿关节炎的疗效评价[J].风湿病与关节炎,2012,1(6):14.
[19]章可谓.中药内服外贴联合西药治疗类风湿关节炎49例[J].中医药学报,2008,12(6):59.
[20]周德荣.搜骨清血法治疗类风湿性关节炎临床疗效观察[J].中国中医药信息杂志,2005,12(6):68.
[21]黎元元,张承绪,谢雁鸣.中药不良反应报告表的设计要点和方法[J].中药新药与临床药理,2010,21(5):555.
[22]Higgins J P T,Green S.Chapter 14:Adverse effects.Cochrane handbook for systematic reviews of interventions.Version 5.1.0[EB/OL].(2008-09-22)[2017-11-21].http://handbook.cochrane.org/.
[23]Kidney Disease:Improving Global Outcomes(KDIGO)Acute Kidney Injury Work Group.KDIGO clinical practice guideline for acute kidney injury[J].Kidney Int,2012,2(Suppl):1.
[24]Kidney Disease:Improving Global Outcomes(KDIGO)CKD Work Group.KDIGO 2012 clinical practice guideline for the evaluation and management of chronic kidney disease[J].Kidney Int,2013(Suppl):1.
[25]The Uppsala monitoring center.Adverse Reaction Terminology WHO-ART[EB/OL].(2006-09-01)[2017-11-21].http://www.umcproducts.com/.
[26]Med DRA MSSO.Welcome to Med DRA and the MSSO[EB/OL].(2009-10-20)[2017-11-21].http://www.meddramsso.com.
[27]Tantikul C,Dhana N,Jongjarearnprasert K,et al.The utility of the World Health Organization-The Uppsala Monitoring Centre(WHO-UMC)system for the assessment of adverse drug reactions in hospitalized children[J].Asian Pac J Allergy Immunol,2008,26(2/3):77.
[28]Naranjo C A,Shear N H,Lanctot K L.Advances in the diagnosis of adverse drug reactions[J].J Clin Pharmacol,1992,32(10):897.
[29]Bate A,Lindquist M,Edwards I R,et al.A bayesian neural network method for adverse drug reaction signal generation[J].Eur J Clin Pharmacol,1998,54(4):315.
[30]药品不良反应报告和监测管理办法[J].药物不良反应杂志,2011(3):173.