喀什新型医疗联合体开展药品不良反应主动监测模式研究
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摘要
目的探讨喀什新型医疗联合体开展药品不良反应(ADR)主动监测模式的意义。方法选取喀什新型医疗联合体单位2017年6月至12月使用抗菌药物的住院患者672例,监测抗菌药物使用情况及ADR,统计并分析ADR发生率、发生特征、严重程度和转归情况及危险因素,评估南疆医疗联合体建设ADR主动监测计划的警示价值。结果共116例患者因抗菌药物导致ADR(17.26%),其中男54例(46.55%),女62例(53.45%);年龄3～82岁;引起最多ADR的抗菌药物种类依次为头孢菌素类(41.38%)、喹诺酮类(17.24%)、大环内酯类(13.79%)、其他(12.93%)、糖肽类(9.48%)、青霉素类(5.17%); ADR累及器官/系统最多的依次为皮肤及其附件(36.21%)、消化系统(16.38%)、全身系统(12.07%)、免疫系统(8.62%)、神经系统(7.76%); ADR严重程度分级为一般的(90.52%),新的、一般的(2.59%),新的、严重的(2.59%),严重的(4.31%);经积极治疗后治愈和好转105例(90.52%),导致后遗症1例(0.86%),死亡1例(0.86%);多因素Logistic回归分析显示,年龄、用药合理性及过敏性疾病是抗菌药物ADR发生的危险因素(P <0.05)。结论喀什新型医疗联合体开展ADR主动监测模式有助于提高区域内ADR监测水平和ADR上报率,可为药物安全性评价提供更为客观、准确的数据,夯实喀什地区ADR监测基础,从而促进合理用药。
Objective To investigate the significance of the active monitoring mode of adverse drug reaction(ADR) in Kashgar new medical consortium.Methods Totally 672 hospitalized patients treated with antibiotics in the Kashgar new medical consortium from June to December 2017 were selected to monitor the use of antibiotics and the occurrence of ADR.The incidence rate,occurrence characteristics,severity,prognosis and risk factors of ADR were analyzed,and the warning value of active monitoring plan for ADR construction in Southern Xinjiang medical consortium was evaluated.Results A total of 116 patients with ADR caused by antibiotics(17.26%),including 54 males(46.55%),62 females(53.45%),aged 3 to 82 years.The most common antibiotics causing ADR were cephalosporin(41.38%),followed by quinolones(17.24%),macrolides(13.79%),others(12.93%),glycopeptides(9.48%) and penicillins(5.17%).The most frequently involved organs and systems were skin and its attachments(36.21%),digestive system(16.38%),systemic system(12.07%),immune system(8.62%) and nervous system(7.76%).The severity of ADR was classified as general(90.52%),new and general(2.59%),new and severe(2.59%),severe(4.31%).After active treatment,105 cases(90.52%) were cured and improved,1 case(0.86%) had sequelae and 1 case(0.86%) died.Multivariate logistic regression analysis showed that age,rationality of drug use and allergic diseases were risk factors for ADR of antibiotics(P < 0.05).Conclusion The ADR active monitoring model of the Kashgar new medical consortium is helpful to improve the ADR monitoring level and the ADR reporting rate in the region,which can provide more objective and accurate data for drug safety evaluation,and strengthen the ADR monitoring basis in Kashgar,in order to promote rational drug use.
Objective To investigate the significance of the active monitoring mode of adverse drug reaction(ADR) in Kashgar new medical consortium.Methods Totally 672 hospitalized patients treated with antibiotics in the Kashgar new medical consortium from June to December 2017 were selected to monitor the use of antibiotics and the occurrence of ADR.The incidence rate,occurrence characteristics,severity,prognosis and risk factors of ADR were analyzed,and the warning value of active monitoring plan for ADR construction in Southern Xinjiang medical consortium was evaluated.Results A total of 116 patients with ADR caused by antibiotics(17.26%),including 54 males(46.55%),62 females(53.45%),aged 3 to 82 years.The most common antibiotics causing ADR were cephalosporin(41.38%),followed by quinolones(17.24%),macrolides(13.79%),others(12.93%),glycopeptides(9.48%) and penicillins(5.17%).The most frequently involved organs and systems were skin and its attachments(36.21%),digestive system(16.38%),systemic system(12.07%),immune system(8.62%) and nervous system(7.76%).The severity of ADR was classified as general(90.52%),new and general(2.59%),new and severe(2.59%),severe(4.31%).After active treatment,105 cases(90.52%) were cured and improved,1 case(0.86%) had sequelae and 1 case(0.86%) died.Multivariate logistic regression analysis showed that age,rationality of drug use and allergic diseases were risk factors for ADR of antibiotics(P < 0.05).Conclusion The ADR active monitoring model of the Kashgar new medical consortium is helpful to improve the ADR monitoring level and the ADR reporting rate in the region,which can provide more objective and accurate data for drug safety evaluation,and strengthen the ADR monitoring basis in Kashgar,in order to promote rational drug use.
引文
[1]谢英,李颖.三甲医院与县二级医院构建医疗联合体的现状研究分析---以内江市为例[J].中国卫生事业管理,2016,33(7):505-507.
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[3]安大伟,田侃,陈文静,等.新疆生产建设兵团团场医院一体化管理模式探究[J].中国医院管理,2017,37(4):68-70.
[4]张翔,齐静,高梦阳,等.医疗联合体国内外研究现状及发展动态[J].中国医院管理,2017,37(7):9-11.
[5]编辑部.2015年药品不良反应监测年度报告发布[J].中国药房,2016,27(25):3527.
[6]边永娜,张田香,任小烨,等.334例药品不良反应的医院质控负性指标监控分析[J].中国医院管理,2016,36(1):68-69.
[7]MATOS C,HRMARK L,VAN HF.Patient Reporting of Adverse Drug Reactions:An International Survey of National Competent Authorities'Views and Needs[J].Drug Safety,2016,39(11):1105-1116.
[8]WAHLANG JB,LAISHRAM PD,BRAHMA DK,et al.Adverse drug reactions due to cancer chemotherapy in a tertiary care teaching hospital[J].Therapeutic Advances in Drug Safety,2017,8(2):61.
[9]HELFENSTEIN M,ZWEIFEL S,BARTHELMES D,et al.Ocular Toxoplasmosis:Therapy-Related Adverse Drug Reactions and Their Management[J].Klin Monbl Augenheilkd,2017,234(4):556-560.
[10]曾微,李跃平,叶晶晶,等.我国医疗联合体模式的对比与研究[J].中国全科医学,2016,19(25):3003-3007.
[11]梁思园,何莉,宋宿杭,等.我国医疗联合体发展和实践典型分析[J].中国卫生政策研究,2016,9(5):42-48.
[12]LAVAN AH,GALLAGHER P.Predicting risk of adverse drug reactions in older adults[J].Therapeutic Advances in Drug Safety,2016,7(1):11.
[13]GOLDINGER SM,STIEGER P,MEIER B,et al.Cytotoxic Cutaneous Adverse Drug Reactions during Anti-PD-1 Therapy[J].Clinical Cancer Research An Official Journal of the American Association for Cancer Research,2016,22(16):4023.
[14]赵瑛,陈东生,吕永宁,等.56家大中型医疗机构药品质量安全风险评价[J].中国医院药学杂志,2016,36(3):230-233.
[15]余文浩,李玉珍,曾繁涛,等.我院433例药品不良反应报告分析[J].中国药房,2016,27(26):3640-3643.
[16]YUCEL E,SANCAR M,YUCEL A,et al.Adverse drug reactions due to drug-drug interactions with proton pump inhibitors:assessment of systematic reviews with AMSTAR method[J].Expert Opinion on Drug Safety,2016,15(2):223-236.
[17]ROSLI R,DALI AF,AZIZ NA,et al.Reported Adverse Drug Reactions in Infants:A Nationwide Analysis in Malaysia[J].Frontiers in Pharmacology,2017,8(39):30.
[18]ONAKPOYA IJ,HENEGHAN CJ,ARONSON JK.Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions:a systematic review[J].Bmc Medicine,2016,14(1):191.
[19]孙自学,龙俊睿,段光锋,等.我国医疗联合体发展的动态分析[J].中国医院管理,2016,36(10):1-4.
[20]袁海鸿,潘新宇,谢月华,等.基于医疗联合体的区域医疗信息平台建设[J].中国医院管理,2016,36(7):77-78.
[21]PEDRS C,FORMIGA F,CORBELLA X,et al.Adverse drug reactions leading to urgent hospital admission in an elderly population:prevalence and main features[J].European Journal of Clinical Pharmacology,2016,72(2):219-226.
[22]WU R,CHENG YJ,ZHU LL,et al.Impact of HLA-B*58:01allele and allopurinol-induced cutaneous adverse drug reactions:evidence from 21 pharmacogenetic studies[J].Oncotarget,2016,7(49):81870.
[23]唐慧芝,高颖.医疗联合体建设中提高药学服务能力的分析与建议[J].中国药房,2017,28(29):4161-4163.
[24]梁河,韦凤华,钟丽球.我院抗菌药物致不良反应233例分析[J].中国药房,2016,27(5):632-634.
[2]IMPICCIATORE P,MOHN A,CHIARELLI F,et al.Adverse Drug Reactions To Off-Label Drugs On A Paediatric Ward:An Italian Prospective Pilot Study[J].Paediatric&Perinatal Drug Therapy,2016,5(1):19-24.
[3]安大伟,田侃,陈文静,等.新疆生产建设兵团团场医院一体化管理模式探究[J].中国医院管理,2017,37(4):68-70.
[4]张翔,齐静,高梦阳,等.医疗联合体国内外研究现状及发展动态[J].中国医院管理,2017,37(7):9-11.
[5]编辑部.2015年药品不良反应监测年度报告发布[J].中国药房,2016,27(25):3527.
[6]边永娜,张田香,任小烨,等.334例药品不良反应的医院质控负性指标监控分析[J].中国医院管理,2016,36(1):68-69.
[7]MATOS C,HRMARK L,VAN HF.Patient Reporting of Adverse Drug Reactions:An International Survey of National Competent Authorities'Views and Needs[J].Drug Safety,2016,39(11):1105-1116.
[8]WAHLANG JB,LAISHRAM PD,BRAHMA DK,et al.Adverse drug reactions due to cancer chemotherapy in a tertiary care teaching hospital[J].Therapeutic Advances in Drug Safety,2017,8(2):61.
[9]HELFENSTEIN M,ZWEIFEL S,BARTHELMES D,et al.Ocular Toxoplasmosis:Therapy-Related Adverse Drug Reactions and Their Management[J].Klin Monbl Augenheilkd,2017,234(4):556-560.
[10]曾微,李跃平,叶晶晶,等.我国医疗联合体模式的对比与研究[J].中国全科医学,2016,19(25):3003-3007.
[11]梁思园,何莉,宋宿杭,等.我国医疗联合体发展和实践典型分析[J].中国卫生政策研究,2016,9(5):42-48.
[12]LAVAN AH,GALLAGHER P.Predicting risk of adverse drug reactions in older adults[J].Therapeutic Advances in Drug Safety,2016,7(1):11.
[13]GOLDINGER SM,STIEGER P,MEIER B,et al.Cytotoxic Cutaneous Adverse Drug Reactions during Anti-PD-1 Therapy[J].Clinical Cancer Research An Official Journal of the American Association for Cancer Research,2016,22(16):4023.
[14]赵瑛,陈东生,吕永宁,等.56家大中型医疗机构药品质量安全风险评价[J].中国医院药学杂志,2016,36(3):230-233.
[15]余文浩,李玉珍,曾繁涛,等.我院433例药品不良反应报告分析[J].中国药房,2016,27(26):3640-3643.
[16]YUCEL E,SANCAR M,YUCEL A,et al.Adverse drug reactions due to drug-drug interactions with proton pump inhibitors:assessment of systematic reviews with AMSTAR method[J].Expert Opinion on Drug Safety,2016,15(2):223-236.
[17]ROSLI R,DALI AF,AZIZ NA,et al.Reported Adverse Drug Reactions in Infants:A Nationwide Analysis in Malaysia[J].Frontiers in Pharmacology,2017,8(39):30.
[18]ONAKPOYA IJ,HENEGHAN CJ,ARONSON JK.Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions:a systematic review[J].Bmc Medicine,2016,14(1):191.
[19]孙自学,龙俊睿,段光锋,等.我国医疗联合体发展的动态分析[J].中国医院管理,2016,36(10):1-4.
[20]袁海鸿,潘新宇,谢月华,等.基于医疗联合体的区域医疗信息平台建设[J].中国医院管理,2016,36(7):77-78.
[21]PEDRS C,FORMIGA F,CORBELLA X,et al.Adverse drug reactions leading to urgent hospital admission in an elderly population:prevalence and main features[J].European Journal of Clinical Pharmacology,2016,72(2):219-226.
[22]WU R,CHENG YJ,ZHU LL,et al.Impact of HLA-B*58:01allele and allopurinol-induced cutaneous adverse drug reactions:evidence from 21 pharmacogenetic studies[J].Oncotarget,2016,7(49):81870.
[23]唐慧芝,高颖.医疗联合体建设中提高药学服务能力的分析与建议[J].中国药房,2017,28(29):4161-4163.
[24]梁河,韦凤华,钟丽球.我院抗菌药物致不良反应233例分析[J].中国药房,2016,27(5):632-634.