1例坎地沙坦致不良反应慢病患者实施药物治疗管理的实践
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摘要
目的:为评价药物与药品不良反应(ADR)的关联性及实施药物治疗管理(MTM)提供参考。方法:回顾性分析天津市第三中心医院门诊收治的1例服用坎地沙坦后出现白细胞、血小板减少及肝脏生化学检查异常等ADR的慢病(高血压合并冠心病)老年患者的临床资料,MTM药师采用Naranjo评估量表法分析坎地沙坦与ADR的关联性,并联合Roussel Uclaf因果关系评价法(简称RUCAM法)分析患者肝脏生化学检查异常的原因,根据结果对患者进行用药重整,配合医师制订个体化用药方案并跟踪随访。结果:采用Naranjo评估量表法,分析结果为坎地沙坦与ADR关联性为"很可能有关";采用RUCAM法,分析结果为坎地沙坦与肝脏生化学检查异常之间关联性为"很可能"。MTM药师建议及时停用坎地沙坦并调整患者用药,医师及患者采纳药师建议,患者停药38天后,ADR症状消失,白细胞、血小板计数和肝脏生化学检查结果均正常。调整用药后随访6个月,患者血压恢复正常,情况良好。结论:Naranjo评估量表法和RUCAM法在评价药物与ADR及肝毒性关联性上简单可行,二者在评价药物与肝毒性相关性上具有一致性,在评价含肝脏生化学检查异常ADR相关性时可联用Naranjo评估量表法和RUCAM法进行分析。
OBJECTIVE:To provide reference for the evaluation of the correlation between drugs and adverse drug reaction(ADR)and the implementation of medication therapy management(MTM). METHODS:Clinical information of a elderly patient with chronic disease(hypertension and coronary heart disease) whose suffered from leukocyte and platelet counts reduction and abnormal liver biochemical examination after taking candesartan were analyzed retrospectively in outpatient department of Tianjin Third Central Hospital. MTM pharmacists analyzed the correlation of candesartan with ADR using Naranjo evaluation scale method.The reasons for abnormal liver biochemical examination were analyzed by Naranjo evaluation scale method combined with Roussel Uclaf causality analysis method(called RUCAM method for short). The medication reconciliation was conducted according to the results,and pharmacists cooperated with doctors to set individualized medication regimen and follow-up. RESULTS:By Naranjo evaluation scale method,analysis results showed that candesartan was"probably related"to ADR. By RUCAM method,analysis results showed that candesartan was "probably related" to liver biochemical abnormalities. MTM pharmacists suggested that candesartan should be stopped in time and the patient's medication should be adjusted. The physician and the patient adopted the pharmacist's advice. After 38 days of drug withdrawal,the patient's ADR symptoms disappeared,and leukocyte count,platelet count and liver biochemical examination were normal. After adjustment of medication,the patient was followed up for 6 months with normal blood pressure. CONCLUSIONS:Naranjo evaluation scale method and RUCAM are simple and feasible in evaluatingthe correlation of drugs with ADR and hepatotoxicity. The two methods are consistent in evaluating the correlation between drugs and hepatotoxicity. Naranjo scale method and RUCAM method can be combined to analyze the correlation between drugs and ADR with abnormal liver biochemical examination.
OBJECTIVE:To provide reference for the evaluation of the correlation between drugs and adverse drug reaction(ADR)and the implementation of medication therapy management(MTM). METHODS:Clinical information of a elderly patient with chronic disease(hypertension and coronary heart disease) whose suffered from leukocyte and platelet counts reduction and abnormal liver biochemical examination after taking candesartan were analyzed retrospectively in outpatient department of Tianjin Third Central Hospital. MTM pharmacists analyzed the correlation of candesartan with ADR using Naranjo evaluation scale method.The reasons for abnormal liver biochemical examination were analyzed by Naranjo evaluation scale method combined with Roussel Uclaf causality analysis method(called RUCAM method for short). The medication reconciliation was conducted according to the results,and pharmacists cooperated with doctors to set individualized medication regimen and follow-up. RESULTS:By Naranjo evaluation scale method,analysis results showed that candesartan was"probably related"to ADR. By RUCAM method,analysis results showed that candesartan was "probably related" to liver biochemical abnormalities. MTM pharmacists suggested that candesartan should be stopped in time and the patient's medication should be adjusted. The physician and the patient adopted the pharmacist's advice. After 38 days of drug withdrawal,the patient's ADR symptoms disappeared,and leukocyte count,platelet count and liver biochemical examination were normal. After adjustment of medication,the patient was followed up for 6 months with normal blood pressure. CONCLUSIONS:Naranjo evaluation scale method and RUCAM are simple and feasible in evaluatingthe correlation of drugs with ADR and hepatotoxicity. The two methods are consistent in evaluating the correlation between drugs and hepatotoxicity. Naranjo scale method and RUCAM method can be combined to analyze the correlation between drugs and ADR with abnormal liver biochemical examination.
引文
[1]毛静怡,柳丽丽,潘永卉.美国药物治疗管理对我国药学服务的启示[J].现代药物与临床,2017,10(32):2031-2035.
[2]郑飞跃,吴燕,饶跃峰,等.诺氏评估量表在药物不良反应评价中的作用及实例分析[J].中国药学杂志,2012,47(8):650-652.
[3]李继瑾.Naranjo药物不良反应评分系统不适用药物性肝损伤因果评价[J].肝脏,2008,13(6):495-498.
[4]中华医学会肝病学分会药物性肝病学组.药物性肝损伤诊治指南[J].肝脏,2017.DOI:10.3969/j.issn.1008-1704.2015.10.002.
[5]王晓丽.合理应用坎地沙坦警惕临床不良反应[J].中国保健营养,2013(6):300.
[6]JIMéNEZ-SáENZ M,ARROYO Q,SANJUAN M,et al.Candesartan-induced cholestatic hepatitis:a case report[J].Gastroenterol Hepatol,2010,33(1):66-67.
[7]LAMMEL-LINDEMANN JA,FLORES-VILLALBA E,MARTAGóN AJ,et al.Noncholestatic acute hepatocellular injury following candesartan administration[J].Br JClin Pharmacol,2018,84(1):204-207.
[8]PAMIES E,MORILLO SG,VALLEJO I.Acute hepatitis induced by candesartan[J].Med Clin,2000,115(18):719.
[9]GONZALES-JIMENEZ D,VARELA JM,CALDERON E,et al.Candesartan and acute liver injury[J].Eur J Clin Pharmacol,2000,56(9/10):769-770.
[10]张文凌,陈娅蓓.坎地沙坦酯治疗原发性高血压有效性、安全性的Meta分析[J].中国老年学杂志,2012,32(19):4124-4126.
[11]美国卫生及公共服务部,国立卫生研究院,国家癌症研究所.常见不良反应事件评价标准(CTCAE)4.0版[S].2009-05-28.
[12]国家卫生计生委合理用药专家委员会,中国药师协会.冠心病合理用药指南:第2版[J].中国医学前沿杂志(电子版),2018,10(6):1-130.
[13]LO KS.Angioedema associated with candesartan[J].Pharmacotherapy,2002,22(9):1176-1179.
[14]刘萍.坎地沙坦酯片治疗老年轻中度高血压的疗效和不良反应观察[J].淮海医药,2013,31(1):74-75.
[15]唐毅辉,苗蔚.坎地沙坦与苯那普利治疗高血压的疗效对比及不良反应分析[J].临床医学研究与实践,2017,2(4):27-28.
[16]黄强.坎地沙坦与厄贝沙坦降压疗效与不良反应分析[J].深圳中西医结合杂志,2017,27(10):95-96.
[17]赵瑛,华小黎,伍三兰,等.坎地沙坦治疗原发性高血压和慢性心力衰竭的Meta分析[J].中国医院药学杂志,2015,35(8):725-730.
[2]郑飞跃,吴燕,饶跃峰,等.诺氏评估量表在药物不良反应评价中的作用及实例分析[J].中国药学杂志,2012,47(8):650-652.
[3]李继瑾.Naranjo药物不良反应评分系统不适用药物性肝损伤因果评价[J].肝脏,2008,13(6):495-498.
[4]中华医学会肝病学分会药物性肝病学组.药物性肝损伤诊治指南[J].肝脏,2017.DOI:10.3969/j.issn.1008-1704.2015.10.002.
[5]王晓丽.合理应用坎地沙坦警惕临床不良反应[J].中国保健营养,2013(6):300.
[6]JIMéNEZ-SáENZ M,ARROYO Q,SANJUAN M,et al.Candesartan-induced cholestatic hepatitis:a case report[J].Gastroenterol Hepatol,2010,33(1):66-67.
[7]LAMMEL-LINDEMANN JA,FLORES-VILLALBA E,MARTAGóN AJ,et al.Noncholestatic acute hepatocellular injury following candesartan administration[J].Br JClin Pharmacol,2018,84(1):204-207.
[8]PAMIES E,MORILLO SG,VALLEJO I.Acute hepatitis induced by candesartan[J].Med Clin,2000,115(18):719.
[9]GONZALES-JIMENEZ D,VARELA JM,CALDERON E,et al.Candesartan and acute liver injury[J].Eur J Clin Pharmacol,2000,56(9/10):769-770.
[10]张文凌,陈娅蓓.坎地沙坦酯治疗原发性高血压有效性、安全性的Meta分析[J].中国老年学杂志,2012,32(19):4124-4126.
[11]美国卫生及公共服务部,国立卫生研究院,国家癌症研究所.常见不良反应事件评价标准(CTCAE)4.0版[S].2009-05-28.
[12]国家卫生计生委合理用药专家委员会,中国药师协会.冠心病合理用药指南:第2版[J].中国医学前沿杂志(电子版),2018,10(6):1-130.
[13]LO KS.Angioedema associated with candesartan[J].Pharmacotherapy,2002,22(9):1176-1179.
[14]刘萍.坎地沙坦酯片治疗老年轻中度高血压的疗效和不良反应观察[J].淮海医药,2013,31(1):74-75.
[15]唐毅辉,苗蔚.坎地沙坦与苯那普利治疗高血压的疗效对比及不良反应分析[J].临床医学研究与实践,2017,2(4):27-28.
[16]黄强.坎地沙坦与厄贝沙坦降压疗效与不良反应分析[J].深圳中西医结合杂志,2017,27(10):95-96.
[17]赵瑛,华小黎,伍三兰,等.坎地沙坦治疗原发性高血压和慢性心力衰竭的Meta分析[J].中国医院药学杂志,2015,35(8):725-730.