草乌甲素片临床应用的安全性评价
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摘要
目的分析疼痛治疗药物草乌甲素片的不良反应(ADR)报告,以期对该药上市后的安全性进行评价。方法对来源于国家药品不良反应监测中心2009—2017年的草乌甲素片ADR报告进行回顾性分析,按MedDAR系统进行数据清理及标准化。对纳入报告所涉及的患者一般情况、用药情况、ADR报告情况等资料进行统计分析。结果共纳入570例报告,ADE共涉及16个系统和器官,主要临床表现为恶心、心悸、口腔感觉减退、皮疹等。多数ADR发生在首次用药后较短时间内,近90%报告中ADR的持续时间在48 h之内。87.37%ADR与药物的关联性评价为肯定及很可能和可能,不良反应需要用药处理124例,占21.75%,不需用药处理428例,占75.09%。结论草乌甲素片临床使用过程中,ADE报告中的不良事件类型与说明书一致,在说明书规定的适应证及用法用量下有较好的安全性。
Objective To analyze the adverse drug reaction(ADR) induced by Bulleyaconitine A(BLA) tablets in pain treatment and to evaluate its post-marketing safety. Methods The reports of ADR induced by Bulleyaconitine A tablets were collected and analyzed retrospectively from National Adverse Drug Reaction Monitoring Center during 2009-2017. MedDAR system was used for data cleaning up and standardization. General information of patients, medication information, general information of ADR reports, and some other matarials, which were in the reports, were investigated and analyzed. Results A total of 570 cases were reported. ADE involved 16 systems and organs. The main clinical manifestations were nausea, palpitation, hypoesthesia of the mouth, rash etc.. Most ADRs occurred within a short period of time after the first medication, and the duration of ADRs was within48 hours in nearly 90% of the reports. 87.37% of ADR and drug association evaluation were positive, probable and possible. 124 cases(21.75%) of ADRs needed to be treated with drugs, and 428 cases(75.09%) did not need to be treated with drugs. Conclusion In the clinical use of Bulleyaconitine A tablets, the types of ADR in the wholereports are consistent with the instructions, which have better safety when indications and dosage administered according to the specification.
Objective To analyze the adverse drug reaction(ADR) induced by Bulleyaconitine A(BLA) tablets in pain treatment and to evaluate its post-marketing safety. Methods The reports of ADR induced by Bulleyaconitine A tablets were collected and analyzed retrospectively from National Adverse Drug Reaction Monitoring Center during 2009-2017. MedDAR system was used for data cleaning up and standardization. General information of patients, medication information, general information of ADR reports, and some other matarials, which were in the reports, were investigated and analyzed. Results A total of 570 cases were reported. ADE involved 16 systems and organs. The main clinical manifestations were nausea, palpitation, hypoesthesia of the mouth, rash etc.. Most ADRs occurred within a short period of time after the first medication, and the duration of ADRs was within48 hours in nearly 90% of the reports. 87.37% of ADR and drug association evaluation were positive, probable and possible. 124 cases(21.75%) of ADRs needed to be treated with drugs, and 428 cases(75.09%) did not need to be treated with drugs. Conclusion In the clinical use of Bulleyaconitine A tablets, the types of ADR in the wholereports are consistent with the instructions, which have better safety when indications and dosage administered according to the specification.
引文
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[4]刘延青,丁晓宁,王应德.草乌甲素片治疗常见慢性疼痛的临床研究[J].中国疼痛医学杂志,2011,17(5):314-315.
[5]神经病理性疼痛诊疗专家组.神经病理性疼痛诊疗专家共识[J].中国疼痛医学杂志,2013,19(12):705-710.
[6]卜擎燕,熊宁宁,邹建东,等.ICH国际医学用语词典(MedDRA):药事管理的标准医学术语集[J].中国临床药理学与治疗学,2007,12(5):586-590.
[7]陈筱云,夏晓玲,熊济民,等.草乌甲素片镇痛抗炎作用134例临床观察[J].云南中医中药杂志,1996,17(3):54-55.
[8]张源潮,杨清锐,尹宏恩.草乌甲素治疗骨关节炎及类风湿关节炎临床观察[J].中药药理与临床,2000,16(2):43.
[9]申颖,王云珍,金旭,等.不同综合疗法对老年性重度膝骨关节炎的临床观察[J].中国康复理论与实践,2010,16(8):720-722.
[10]吴玲普.草乌甲素对膝关节骨折术后运动性疼痛的干预[D].广州:广州中医药大学,2010.
[11]潘国兴,杜冬萍.草乌甲素联合玻璃酸钠关节腔内注射治疗膝关节骨性关节炎的疗效[J].上海医学,2013,36(6):523-526.
[12]徐宁,刘蕊,臧嘉捷,等.草乌甲素片治疗骨关节炎效果和安全性评价[J].中国医药,2014,9(8):1170-1173.
[13]牛占国,陈晓武,黄静,等.草乌甲素片用于烧伤创面镇痛效果的临床观察[J].吉林医学,2014,35(31):7001-7002.
[14]李翠红.草乌甲素片致不良反应1例[J].中医临床研究,2010,2(22):23.
[15]李相鸿,孙华,贾元威,等.HPLC-MS/MS法测定人血浆中草乌甲素的浓度及生物等效性研究[J].天然产物研究与开发,2011,23(6):1031-1037.
[16]冯健清,陆燕洪,庄丽华.含乌头碱类中药致重症药疹2例报告[J].吉林中医药,2012,32(4):414-415.
[17]赵艳花,金玉婷,王文林.草乌甲素胶丸致过敏性休克1例[J].中国现代应用药学,2014,31(9):1141.
[18]杨翠华.草乌甲素注射液引起过敏反应1例[J].云南医药,1995(1):75.
[2]Wang CF,Gerner P,Schmidt B,et al.Use of bulleyaconitine A as an adjuvant for prolonged cutaneous analgesia in the rat[J].Anesth Analg,2008,107(4):1397-1405.
[3]Villarreal CF,Sachs D,Cunha FQ,et al.The role of Na(V)1.8sodium channel in the maintenance of chronic inflammatory hypernociception[J].Neurosci Lett,2005,386(2):72-77.
[4]刘延青,丁晓宁,王应德.草乌甲素片治疗常见慢性疼痛的临床研究[J].中国疼痛医学杂志,2011,17(5):314-315.
[5]神经病理性疼痛诊疗专家组.神经病理性疼痛诊疗专家共识[J].中国疼痛医学杂志,2013,19(12):705-710.
[6]卜擎燕,熊宁宁,邹建东,等.ICH国际医学用语词典(MedDRA):药事管理的标准医学术语集[J].中国临床药理学与治疗学,2007,12(5):586-590.
[7]陈筱云,夏晓玲,熊济民,等.草乌甲素片镇痛抗炎作用134例临床观察[J].云南中医中药杂志,1996,17(3):54-55.
[8]张源潮,杨清锐,尹宏恩.草乌甲素治疗骨关节炎及类风湿关节炎临床观察[J].中药药理与临床,2000,16(2):43.
[9]申颖,王云珍,金旭,等.不同综合疗法对老年性重度膝骨关节炎的临床观察[J].中国康复理论与实践,2010,16(8):720-722.
[10]吴玲普.草乌甲素对膝关节骨折术后运动性疼痛的干预[D].广州:广州中医药大学,2010.
[11]潘国兴,杜冬萍.草乌甲素联合玻璃酸钠关节腔内注射治疗膝关节骨性关节炎的疗效[J].上海医学,2013,36(6):523-526.
[12]徐宁,刘蕊,臧嘉捷,等.草乌甲素片治疗骨关节炎效果和安全性评价[J].中国医药,2014,9(8):1170-1173.
[13]牛占国,陈晓武,黄静,等.草乌甲素片用于烧伤创面镇痛效果的临床观察[J].吉林医学,2014,35(31):7001-7002.
[14]李翠红.草乌甲素片致不良反应1例[J].中医临床研究,2010,2(22):23.
[15]李相鸿,孙华,贾元威,等.HPLC-MS/MS法测定人血浆中草乌甲素的浓度及生物等效性研究[J].天然产物研究与开发,2011,23(6):1031-1037.
[16]冯健清,陆燕洪,庄丽华.含乌头碱类中药致重症药疹2例报告[J].吉林中医药,2012,32(4):414-415.
[17]赵艳花,金玉婷,王文林.草乌甲素胶丸致过敏性休克1例[J].中国现代应用药学,2014,31(9):1141.
[18]杨翠华.草乌甲素注射液引起过敏反应1例[J].云南医药,1995(1):75.