Jan Endrikat, Alexander Ullmann, Christoph Gerlinger, Aasia Bhatti, Philipp Lengsfeld, Alexander Michel
{"title":"不同性别、种族或地区/国家的患者对碘普罗米发生过敏反应的风险是否存在差异?对来自四项观察性研究和公司药物警戒数据库的 152,233 例患者的分析。","authors":"Jan Endrikat, Alexander Ullmann, Christoph Gerlinger, Aasia Bhatti, Philipp Lengsfeld, Alexander Michel","doi":"10.1093/bjr/tqae190","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To analyse the potential impact of patients' sex, race, and region/country on the risk of hypersensitivity reactions after intra-venous or intra-arterial administration of iopromide.</p><p><strong>Methods: </strong>Two analyses were performed. (1) The \"Phase-IV-Analysis\" evaluated an integrated pooled database of 4 non-interventional studies. (2) The \"GPV-Analysis\" evaluated case reports from the company's pharmacovigilance database. The Phase-IV-Analysis was a nested case-control analysis of patients who received an injection of iopromide 300/370 mg iodine/mL. Cases had typical/unequivocal HSRs as defined by the ACR Committee on Drugs and Contrast Media 2018. The global pharmacovigilance (GPV)-Analysis was based on HSR case reports in the company database. Exposure estimates were derived from sales/market research data.</p><p><strong>Results: </strong>The Phase-IV-Analysis comprised 152 233 patients from 37 countries. In the full-analysis set 145 033, 59 412, and 146 649 patients were included in the sex, race, and region/country cohort, respectively. The GPV-Analysis was based on 78.72 million administrations for sex and 118.56 million administrations for region/country. No GPV exposure data by race were available. Sex: Phase-IV-Analysis: The HSR incidence was significantly higher for women (0.72%) vs men (0.55%) (P ≤ .0001). The unadjusted odds ratio (OR) was 1.3 (95% CI, 1.154-1.499), the adjusted OR was 1.156 (95% CI, 1.006-1.328) (P = .04). GPV-Analysis: Reporting rates were 0.0102% for women and 0.0075% for men (P < .0001). OR: 1.36 (95% CI, 1.3-1.43). Race: Phase-IV-Analysis: No significantly different HSR incidences for white (0.70%) and Asian (0.61%) patients (P = .3094) were detected. Region/country: Phase-IV-Analysis: The overall world HSR-incidence was 0.62%. Europe: 0.52%, Asia: 0.70%, United States: 0.75%, Germany: 0.51%, China: 0.41%, South Korea: 0.76%. GPV-Analysis: The overall world HSR-reporting rate was 0.015%, varying across regions/countries.</p><p><strong>Conclusion: </strong>Women showed a slightly higher risk for HSRs than men. Impact of race was not found. HSR-reporting varied by region/country.</p><p><strong>Advances in knowledge: </strong>Risk for HSRs was increased by female sex but not by race or region/country.</p>","PeriodicalId":9306,"journal":{"name":"British Journal of Radiology","volume":" ","pages":"2004-2014"},"PeriodicalIF":1.8000,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11573128/pdf/","citationCount":"0","resultStr":"{\"title\":\"Does the risk of hypersensitivity reactions to iopromide differ by sex, race, or across regions/countries? An analysis of 152 233 patients from 4 observational studies and the company's pharmacovigilance database.\",\"authors\":\"Jan Endrikat, Alexander Ullmann, Christoph Gerlinger, Aasia Bhatti, Philipp Lengsfeld, Alexander Michel\",\"doi\":\"10.1093/bjr/tqae190\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To analyse the potential impact of patients' sex, race, and region/country on the risk of hypersensitivity reactions after intra-venous or intra-arterial administration of iopromide.</p><p><strong>Methods: </strong>Two analyses were performed. (1) The \\\"Phase-IV-Analysis\\\" evaluated an integrated pooled database of 4 non-interventional studies. (2) The \\\"GPV-Analysis\\\" evaluated case reports from the company's pharmacovigilance database. The Phase-IV-Analysis was a nested case-control analysis of patients who received an injection of iopromide 300/370 mg iodine/mL. Cases had typical/unequivocal HSRs as defined by the ACR Committee on Drugs and Contrast Media 2018. The global pharmacovigilance (GPV)-Analysis was based on HSR case reports in the company database. Exposure estimates were derived from sales/market research data.</p><p><strong>Results: </strong>The Phase-IV-Analysis comprised 152 233 patients from 37 countries. In the full-analysis set 145 033, 59 412, and 146 649 patients were included in the sex, race, and region/country cohort, respectively. The GPV-Analysis was based on 78.72 million administrations for sex and 118.56 million administrations for region/country. No GPV exposure data by race were available. Sex: Phase-IV-Analysis: The HSR incidence was significantly higher for women (0.72%) vs men (0.55%) (P ≤ .0001). The unadjusted odds ratio (OR) was 1.3 (95% CI, 1.154-1.499), the adjusted OR was 1.156 (95% CI, 1.006-1.328) (P = .04). GPV-Analysis: Reporting rates were 0.0102% for women and 0.0075% for men (P < .0001). OR: 1.36 (95% CI, 1.3-1.43). Race: Phase-IV-Analysis: No significantly different HSR incidences for white (0.70%) and Asian (0.61%) patients (P = .3094) were detected. Region/country: Phase-IV-Analysis: The overall world HSR-incidence was 0.62%. Europe: 0.52%, Asia: 0.70%, United States: 0.75%, Germany: 0.51%, China: 0.41%, South Korea: 0.76%. GPV-Analysis: The overall world HSR-reporting rate was 0.015%, varying across regions/countries.</p><p><strong>Conclusion: </strong>Women showed a slightly higher risk for HSRs than men. Impact of race was not found. HSR-reporting varied by region/country.</p><p><strong>Advances in knowledge: </strong>Risk for HSRs was increased by female sex but not by race or region/country.</p>\",\"PeriodicalId\":9306,\"journal\":{\"name\":\"British Journal of Radiology\",\"volume\":\" \",\"pages\":\"2004-2014\"},\"PeriodicalIF\":1.8000,\"publicationDate\":\"2024-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11573128/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"British Journal of Radiology\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1093/bjr/tqae190\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"British Journal of Radiology","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1093/bjr/tqae190","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
Does the risk of hypersensitivity reactions to iopromide differ by sex, race, or across regions/countries? An analysis of 152 233 patients from 4 observational studies and the company's pharmacovigilance database.
Objective: To analyse the potential impact of patients' sex, race, and region/country on the risk of hypersensitivity reactions after intra-venous or intra-arterial administration of iopromide.
Methods: Two analyses were performed. (1) The "Phase-IV-Analysis" evaluated an integrated pooled database of 4 non-interventional studies. (2) The "GPV-Analysis" evaluated case reports from the company's pharmacovigilance database. The Phase-IV-Analysis was a nested case-control analysis of patients who received an injection of iopromide 300/370 mg iodine/mL. Cases had typical/unequivocal HSRs as defined by the ACR Committee on Drugs and Contrast Media 2018. The global pharmacovigilance (GPV)-Analysis was based on HSR case reports in the company database. Exposure estimates were derived from sales/market research data.
Results: The Phase-IV-Analysis comprised 152 233 patients from 37 countries. In the full-analysis set 145 033, 59 412, and 146 649 patients were included in the sex, race, and region/country cohort, respectively. The GPV-Analysis was based on 78.72 million administrations for sex and 118.56 million administrations for region/country. No GPV exposure data by race were available. Sex: Phase-IV-Analysis: The HSR incidence was significantly higher for women (0.72%) vs men (0.55%) (P ≤ .0001). The unadjusted odds ratio (OR) was 1.3 (95% CI, 1.154-1.499), the adjusted OR was 1.156 (95% CI, 1.006-1.328) (P = .04). GPV-Analysis: Reporting rates were 0.0102% for women and 0.0075% for men (P < .0001). OR: 1.36 (95% CI, 1.3-1.43). Race: Phase-IV-Analysis: No significantly different HSR incidences for white (0.70%) and Asian (0.61%) patients (P = .3094) were detected. Region/country: Phase-IV-Analysis: The overall world HSR-incidence was 0.62%. Europe: 0.52%, Asia: 0.70%, United States: 0.75%, Germany: 0.51%, China: 0.41%, South Korea: 0.76%. GPV-Analysis: The overall world HSR-reporting rate was 0.015%, varying across regions/countries.
Conclusion: Women showed a slightly higher risk for HSRs than men. Impact of race was not found. HSR-reporting varied by region/country.
Advances in knowledge: Risk for HSRs was increased by female sex but not by race or region/country.
期刊介绍:
BJR is the international research journal of the British Institute of Radiology and is the oldest scientific journal in the field of radiology and related sciences.
Dating back to 1896, BJR’s history is radiology’s history, and the journal has featured some landmark papers such as the first description of Computed Tomography "Computerized transverse axial tomography" by Godfrey Hounsfield in 1973. A valuable historical resource, the complete BJR archive has been digitized from 1896.
Quick Facts:
- 2015 Impact Factor – 1.840
- Receipt to first decision – average of 6 weeks
- Acceptance to online publication – average of 3 weeks
- ISSN: 0007-1285
- eISSN: 1748-880X
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