以喜炎平注射液为例探究处方序列对称分析对过敏信号的检出能力
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摘要
目的:研究喜炎平注射液与过敏反应的关系以及处方序列对称分析(PSSA)对过敏反应信号的检出能力。方法:提取2015年全国基本医疗保险抽样数据库中处方过喜炎平注射液和抗过敏药的患者进行处方序列对称分析。以抗组胺药、糖皮质激素、钙剂和肾上腺素作为过敏反应的标签药,计算调整序列比(ASR)作为评估相关性的效应指标。结果:研究共纳入6 629例患者,其中4 503例患者在同一天处方喜炎平注射液和抗过敏药。纳入同一天处方两种药物的患者时ASR(95%CI)为2.45(2.33,2.59),排除同一天处方两种药物的患者时ASR(95%CI)为2.00(1.83,2.19)。各类抗过敏药均可识别出安全信号。结论:喜炎平注射液和过敏反应之间可能存在关联,PSSA可以通过对标签药的选择以及纳入同一天处方指示药和标签药的患者,增加对过敏反应的探测能力。
Objective: To study the association between Xiyanping injection and allergic reactions and the ability of signal detecting of prescription sequence symmetry analysis(PSSA). Methods:PSSA was conducted using the records of patients who were prescribed both Xiyanping injection and antiallergic drugs in 2015 from Chinese basic medical insurance database. Antihistamines, glucocorticoids, calcium gluconate and adrenaline were selected as the proxy of allergic reactions. Patients newly prescribed Xiyanping injection and antiallergic drugs on the same day were included. Adjusted sequence ratio(ASR) was calculated to measure the signal of allergic reaction. Results:6 629 patients were included and 4 503 patients were prescribed Xiyanping injection and antiallergic drugs on the same day. The ASRs(95%CI) were 2.45(2.33, 2.59) when including patients with the same prescription date of Xiyanping injection and antiallergic drugs and 2.00(1.83, 2.19) when excluding thoses patients. Signals were detected by each of the four kinds of antiallergic drugs. Conclusion:PSSA indicated that there might be potential association between Xiyanping injection use and allergic reactions. The ability of detecting allergic reactions of PSSA can be improved by choosing appropriate marker drugs and including patients who newly prescribed index drugs and marker drugs on the same day.
Objective: To study the association between Xiyanping injection and allergic reactions and the ability of signal detecting of prescription sequence symmetry analysis(PSSA). Methods:PSSA was conducted using the records of patients who were prescribed both Xiyanping injection and antiallergic drugs in 2015 from Chinese basic medical insurance database. Antihistamines, glucocorticoids, calcium gluconate and adrenaline were selected as the proxy of allergic reactions. Patients newly prescribed Xiyanping injection and antiallergic drugs on the same day were included. Adjusted sequence ratio(ASR) was calculated to measure the signal of allergic reaction. Results:6 629 patients were included and 4 503 patients were prescribed Xiyanping injection and antiallergic drugs on the same day. The ASRs(95%CI) were 2.45(2.33, 2.59) when including patients with the same prescription date of Xiyanping injection and antiallergic drugs and 2.00(1.83, 2.19) when excluding thoses patients. Signals were detected by each of the four kinds of antiallergic drugs. Conclusion:PSSA indicated that there might be potential association between Xiyanping injection use and allergic reactions. The ability of detecting allergic reactions of PSSA can be improved by choosing appropriate marker drugs and including patients who newly prescribed index drugs and marker drugs on the same day.
引文
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10 王志飞,向永洋,谢雁鸣.基于自发呈报系统的喜炎平注射液不良反应风险预警研究[J].中国中药杂志,2013,38(18):3008-3012
11 杨小玲,程帆,刘艳红,等.喜炎平注射液与15种药物配伍稳定性考察[J].中国新药杂志,2013,22(20):2374-2378
12 毕凤兰,张力.中药注射剂安全性问题探讨[J].中国药物警戒,2012,9(2):89-92
13 赵保胜,李春娜,范冰舵,等.中药注射剂安全性研究现状及对策[J].临床药物治疗杂志,2013,11(5):15-18
14 糖皮质激素类药物临床应用指导原则(节选)[J].药物不良反应杂志,2011,13(1):40-44
15 Kuna P,Jurkiewicz D,Czarnecka-Operacz MM,et al.The role and choice criteria of antihistamines in allergy management-expert opinion[J].Postepy Dermatol Alergol,2016,33(6):397-410
16 Wahab IA,Pratt NL,Wiese MD,et al.The validity of sequence symmetry analysis (SSA) for adverse drug reaction signal detection[J].Pharmacoepidemiol Drug Saf,2013,22(5):496-502
17 Maclure M,Fireman B,Nelson JC,et al.When should case-only designs be used for safety monitoring of medical products?[J].Pharmacoepidemiol Drug Saf,2012,21(Suppl 1):50-61
18 Pratt NL,Ilomaki J,Raymond C,et al.The performance of sequence symmetry analysis as a tool for post-market surveillance of newly marketed medicines:a simulation study[J].BMC Med Res Methodol,2014,14:66
19 Takeuchi Y,Shinozaki T,Matsuyama Y.A comparison of estimators from self-controlled case series,case-crossover design,and sequence symmetry analysis for pharmacoepidemiological studies[J].BMC Med Res Methodol,2018,18(1):4
20 李海龙,赵厚宇,周一帆,等.基于电子医疗数据库的药品不良反应信号挖掘方法概述[J].药物流行病学杂志,2018,27(8):541-549
2 Hallas J.Evidence of depression provoked by cardiovascular medication:a prescription sequence symmetry analysis[J].Epidemiology,1996,7(5):478-484
3 陶庆梅,詹思延.处方序列分析与处方序列对称分析在药物流行病学中的应用[J].药物流行病学杂志,2012,21(10):517-519
4 方任飞,潘昱廷,詹思延.处方序列对称分析研究现状的文献计量分析[J].药物流行病学杂志,2016,25(2):108-112
5 方任飞,李静湖,张杰,等.基于处方序列对称分析的他汀类药物肝脏安全性研究[J].中华流行病学杂志,2016,37(7):935-939
6 林强,张纾.270例喜炎平注射液不良反应/事件病例报告的分析[J].中国药物警戒,2012,9(12):751-754
7 王青宇,曹珍,高钟丽,等.喜炎平注射液不良反应的Meta分析[J].中药药理与临床,2016,32(4):141-147
8 阎锡新,关继涛.变应性疾病防治指南[M].石家庄:河北科学技术出版社,2009:1-300
9 Muraro A,Roberts G,Worm M,et al.Anaphylaxis:guidelines from the European Academy of Allergy and Clinical Immunology[J].Allergy,2014,69(8):1026-1045
10 王志飞,向永洋,谢雁鸣.基于自发呈报系统的喜炎平注射液不良反应风险预警研究[J].中国中药杂志,2013,38(18):3008-3012
11 杨小玲,程帆,刘艳红,等.喜炎平注射液与15种药物配伍稳定性考察[J].中国新药杂志,2013,22(20):2374-2378
12 毕凤兰,张力.中药注射剂安全性问题探讨[J].中国药物警戒,2012,9(2):89-92
13 赵保胜,李春娜,范冰舵,等.中药注射剂安全性研究现状及对策[J].临床药物治疗杂志,2013,11(5):15-18
14 糖皮质激素类药物临床应用指导原则(节选)[J].药物不良反应杂志,2011,13(1):40-44
15 Kuna P,Jurkiewicz D,Czarnecka-Operacz MM,et al.The role and choice criteria of antihistamines in allergy management-expert opinion[J].Postepy Dermatol Alergol,2016,33(6):397-410
16 Wahab IA,Pratt NL,Wiese MD,et al.The validity of sequence symmetry analysis (SSA) for adverse drug reaction signal detection[J].Pharmacoepidemiol Drug Saf,2013,22(5):496-502
17 Maclure M,Fireman B,Nelson JC,et al.When should case-only designs be used for safety monitoring of medical products?[J].Pharmacoepidemiol Drug Saf,2012,21(Suppl 1):50-61
18 Pratt NL,Ilomaki J,Raymond C,et al.The performance of sequence symmetry analysis as a tool for post-market surveillance of newly marketed medicines:a simulation study[J].BMC Med Res Methodol,2014,14:66
19 Takeuchi Y,Shinozaki T,Matsuyama Y.A comparison of estimators from self-controlled case series,case-crossover design,and sequence symmetry analysis for pharmacoepidemiological studies[J].BMC Med Res Methodol,2018,18(1):4
20 李海龙,赵厚宇,周一帆,等.基于电子医疗数据库的药品不良反应信号挖掘方法概述[J].药物流行病学杂志,2018,27(8):541-549
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