临床药师利用证据质量评价方法制订我院疏血通注射液临床应用规范的实践
|
摘要
目的:为加强重点监控药物的临床使用管理和促进临床合理用药提供参考。方法:介绍怀化市第一人民医院(简称我院)临床药师以循证医学为基础,以重点监控药物疏血通注射液为例,全面检索其在国内外临床研究中的临床证据,将纳入文献参照GRADE证据质量分级和推荐强度系统进行分级,评价疏血通注射液各适应证的循证医学证据,制订我院疏血通注射液的临床应用规范的实践。结果:我院制订的疏血通注射液临床应用规范的主要内容为用于急性缺血性脑梗死时有A级证据支持,但为弱推荐,仅用于辅助治疗;用于抗凝(预防深部静脉血栓形成)、糖尿病周围神经病变时有B级证据支持,为弱推荐;用于其他适应证时只有C级或D级证据支持,为反对使用的强推荐。结论:临床药师通过证据质量评价方法制订药物的临床应用规范,可为重点监控药物的临床使用管理提供参考,可在临床合理用药中发挥重要作用。
OBJECTIVE:To provide reference for strengthening clinical application of key monitoring drugs and promoting rational drug use in clinic. METHODS:Based on evidence-based medicine,taking key monitoring drugs Shuxuetong injection as example,clinical evidence of domestic and foreign clinical studies were collected. The included literatures were graded according to the quality of GRADE evidence and recommended strength system. Evidence-based medicine evidence for the indications of Shuxuetong injection were evaluated,and criterion for clinical use of Shuxuetong injection was formulated in Huaihua First People's Hospital(our hospital). RESULTS:The main content of criterion for clinical application of Shuxuetong injection formulated by our hospital was that there was A-level evidence support for acute ischemic cerebral infarction,but it was weakly recommended and only used for adjuvant therapy;there was B-level evidence support for anticoagulation(for preventing DVT),diabetic peripheral nerve lesion,but it was weakly recommended;there was only C-level or D-level evidence support for other indications,it was strongly recommendation against use. CONCLUSIONS:Clinical pharmacists formulate the criterion for clinical application of Shuxuetong injection by evidence quality evaluation method, provide reference for clinical application management of key monitoring drug and play an important effect on rational drug use in clinic.
OBJECTIVE:To provide reference for strengthening clinical application of key monitoring drugs and promoting rational drug use in clinic. METHODS:Based on evidence-based medicine,taking key monitoring drugs Shuxuetong injection as example,clinical evidence of domestic and foreign clinical studies were collected. The included literatures were graded according to the quality of GRADE evidence and recommended strength system. Evidence-based medicine evidence for the indications of Shuxuetong injection were evaluated,and criterion for clinical use of Shuxuetong injection was formulated in Huaihua First People's Hospital(our hospital). RESULTS:The main content of criterion for clinical application of Shuxuetong injection formulated by our hospital was that there was A-level evidence support for acute ischemic cerebral infarction,but it was weakly recommended and only used for adjuvant therapy;there was B-level evidence support for anticoagulation(for preventing DVT),diabetic peripheral nerve lesion,but it was weakly recommended;there was only C-level or D-level evidence support for other indications,it was strongly recommendation against use. CONCLUSIONS:Clinical pharmacists formulate the criterion for clinical application of Shuxuetong injection by evidence quality evaluation method, provide reference for clinical application management of key monitoring drug and play an important effect on rational drug use in clinic.
引文
[1]国家卫生和计划生育委员会. 2017年卫生计生工作要点[S]. 2017-01-13.
[2]国务院办公厅.国务院办公厅关于进一步改革完善药品生产流通使用政策的若干意见[S]. 2017-02-09.
[3]聂娟,潘洁.我院重点监控品种使用分析及管控对策思考[J].中南药学杂志,2018,16(2):247-250.
[4]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.
[5]罗杰,冷卫东.系统评价/Meta分析理论与实践[M].北京:军事医学科学出版社,2014:160-165.
[6]邓紫薇,金远香,王宏强,等.证据质量评价方法在我院临床药学实践工作中的应用[J].中国药房,2018,29(15):2109-2113.
[7] GUYATT GH,OXMAN AD,VIST GE,et al. GRADE:an emerging consensus on rating quality of evidence and strength of recommendations[J]. BMJ,2008,336(7650):924-926.
[8]杜宝俊,谢志敏.中药新药临床疗效评价中常见问题分析及对策[J].中医杂志,2009,50(12):1075-1078.
[9]刘为民,刘保延,谢雁鸣,等.疏血通注射液治疗脑梗塞的系统评价[J].中国循证医学杂志,2006,6(4):261-266.
[10]张越伦,廖星,吕志国,等.疏血通注射液治疗进展性脑梗死的Meta评价[J].中国中药杂志,2012,37(18):2274-2278.
[11]李洁,陈赫军,董维森,等.疏血通注射液治疗急性脑梗死临床疗效和安全性的系统评价[J].药物评价研究,2017,40(10):1488-1494.
[12]丁玉峰,胡敦梅,徐传新.疏血通注射液治疗急性脑梗死的系统评价[J].中国医院药学杂志,2011,31(22):1846-1850.
[13]苏娜,徐珽,唐尧.疏血通联合依达拉奉治疗急性脑梗死的系统评价[J].中国药房,2010,21(36):3426-3429.
[14]何杏仪,陈丽敏,陈棉智,等.疏血通注射液预防骨科术后深静脉血栓的有效性级安全性Meta分析[J].广西中医药杂志,2017,40(6):45-49.
[15]赵锡丽,李生兵,徐秋,等.疏血通注射液治疗糖尿病外周神经病变疗效的Meta分析[J].重庆医科大学学报,2009,34(7):930-933.
[16]孙心怡,缪鋆鋆,王丽娟,等.疏血通联合硫辛酸治疗糖尿病周围神经病变的Meta分析[J].世界中医药杂志,2016,11(10):2138-2144.
[17]李学远,杜芬,程文林,等.疏血通治疗不稳定型心绞痛随机对照试验的系统评价[J].现代中西医结合杂志,2010,19(18):2231-2233.
[18]严叶霞.疏血通注射液与4种溶媒配伍稳定性考察[J].中国药师,2013,16(7):1084-1085.
[19]吴泰相,卞兆祥,商洪才,等.从中药复方临床随机对照试验报告规范2017:CONSORT声明的扩展、说明与详述的正式发表谈我国临床试验的变革[J].中国循证医学杂志,2017,17(9):993-998.
[2]国务院办公厅.国务院办公厅关于进一步改革完善药品生产流通使用政策的若干意见[S]. 2017-02-09.
[3]聂娟,潘洁.我院重点监控品种使用分析及管控对策思考[J].中南药学杂志,2018,16(2):247-250.
[4]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.
[5]罗杰,冷卫东.系统评价/Meta分析理论与实践[M].北京:军事医学科学出版社,2014:160-165.
[6]邓紫薇,金远香,王宏强,等.证据质量评价方法在我院临床药学实践工作中的应用[J].中国药房,2018,29(15):2109-2113.
[7] GUYATT GH,OXMAN AD,VIST GE,et al. GRADE:an emerging consensus on rating quality of evidence and strength of recommendations[J]. BMJ,2008,336(7650):924-926.
[8]杜宝俊,谢志敏.中药新药临床疗效评价中常见问题分析及对策[J].中医杂志,2009,50(12):1075-1078.
[9]刘为民,刘保延,谢雁鸣,等.疏血通注射液治疗脑梗塞的系统评价[J].中国循证医学杂志,2006,6(4):261-266.
[10]张越伦,廖星,吕志国,等.疏血通注射液治疗进展性脑梗死的Meta评价[J].中国中药杂志,2012,37(18):2274-2278.
[11]李洁,陈赫军,董维森,等.疏血通注射液治疗急性脑梗死临床疗效和安全性的系统评价[J].药物评价研究,2017,40(10):1488-1494.
[12]丁玉峰,胡敦梅,徐传新.疏血通注射液治疗急性脑梗死的系统评价[J].中国医院药学杂志,2011,31(22):1846-1850.
[13]苏娜,徐珽,唐尧.疏血通联合依达拉奉治疗急性脑梗死的系统评价[J].中国药房,2010,21(36):3426-3429.
[14]何杏仪,陈丽敏,陈棉智,等.疏血通注射液预防骨科术后深静脉血栓的有效性级安全性Meta分析[J].广西中医药杂志,2017,40(6):45-49.
[15]赵锡丽,李生兵,徐秋,等.疏血通注射液治疗糖尿病外周神经病变疗效的Meta分析[J].重庆医科大学学报,2009,34(7):930-933.
[16]孙心怡,缪鋆鋆,王丽娟,等.疏血通联合硫辛酸治疗糖尿病周围神经病变的Meta分析[J].世界中医药杂志,2016,11(10):2138-2144.
[17]李学远,杜芬,程文林,等.疏血通治疗不稳定型心绞痛随机对照试验的系统评价[J].现代中西医结合杂志,2010,19(18):2231-2233.
[18]严叶霞.疏血通注射液与4种溶媒配伍稳定性考察[J].中国药师,2013,16(7):1084-1085.
[19]吴泰相,卞兆祥,商洪才,等.从中药复方临床随机对照试验报告规范2017:CONSORT声明的扩展、说明与详述的正式发表谈我国临床试验的变革[J].中国循证医学杂志,2017,17(9):993-998.