PDF(Pubmed)
Abstract：
OBJECTIVE: Following the withdrawal of propacetamol in Europe owing to safety issues, the regulatory authority of South Korea requested a post-marketing surveillance study to investigate its safety profile.
METHODS: We conducted nested case-control and case-time-control (CTC) analyses of cases and controls identified for outcomes of interest, including anaphylaxis, thrombosis, and Stevens-Johnson syndrome (SJS), using the claims database of South Korea, 2010-2019. Risk-set sampling was used to match each case with up to 10 controls for age, sex, cohort entry date, and follow-up duration. Exposure to anaphylaxis, thrombosis, and SJS was assessed within 7, 90, and 30 days of the index date, respectively. We calculated odds ratios (OR) with 95% confidence intervals (CIs) using conditional logistic regression to assess the risk of outcomes associated with propacetamol.
RESULTS: We identified cases of anaphylaxis (n=61), thrombosis (n=95), and SJS (n=1) and matched them to controls (173, 268, and 4, respectively). In the nested case-control analysis, the ORs for anaphylaxis and SJS were inestimable given the small number of propacetamol users during the risk period; meanwhile, the OR for thrombosis was 1.60 (95% CI 0.71-3.62). In the CTC design, the effect estimate was only estimated for thrombosis (OR 0.56, 95% CI 0.09-3.47).
CONCLUSIONS: In both nested case-control and CTC analyses, propacetamol was not associated with an increased risk of anaphylaxis, thrombosis, or SJS. The findings from this study, which used routinely collected clinical data, provide reassuring real-world evidence regarding the safety of propacetamol in a nationwide population to support regulatory decision-making.
METHODS: We conducted nested case-control and case-time-control (CTC) analyses of cases and controls identified for outcomes of interest, including anaphylaxis, thrombosis, and Stevens-Johnson syndrome (SJS), using the claims database of South Korea, 2010-2019. Risk-set sampling was used to match each case with up to 10 controls for age, sex, cohort entry date, and follow-up duration. Exposure to anaphylaxis, thrombosis, and SJS was assessed within 7, 90, and 30 days of the index date, respectively. We calculated odds ratios (OR) with 95% confidence intervals (CIs) using conditional logistic regression to assess the risk of outcomes associated with propacetamol.
RESULTS: We identified cases of anaphylaxis (n=61), thrombosis (n=95), and SJS (n=1) and matched them to controls (173, 268, and 4, respectively). In the nested case-control analysis, the ORs for anaphylaxis and SJS were inestimable given the small number of propacetamol users during the risk period; meanwhile, the OR for thrombosis was 1.60 (95% CI 0.71-3.62). In the CTC design, the effect estimate was only estimated for thrombosis (OR 0.56, 95% CI 0.09-3.47).
CONCLUSIONS: In both nested case-control and CTC analyses, propacetamol was not associated with an increased risk of anaphylaxis, thrombosis, or SJS. The findings from this study, which used routinely collected clinical data, provide reassuring real-world evidence regarding the safety of propacetamol in a nationwide population to support regulatory decision-making.
摘要：
目的：在欧洲因安全问题停用普帕西坦之后，韩国监管机构要求进行上市后监测研究,以调查其安全性.
方法：我们进行了巢式病例对照和病例时间对照（CTC）分析，以确定感兴趣的结果，包括过敏反应,血栓形成,和史蒂文斯-约翰逊综合征(SJS)，使用韩国的索赔数据库，2010-2019年。使用风险集抽样将每个病例与多达10个年龄对照进行匹配，性别,队列输入日期，和后续持续时间。暴露于过敏反应，血栓形成,SJS在索引日期的7、90和30天内进行了评估，分别。我们使用条件逻辑回归计算比值比（OR）和95％置信区间（CI），以评估与普帕西莫相关的结局风险。
结果：我们确定了过敏反应的病例（n=61），血栓形成（n=95），和SJS（n=1），并将它们与控件（分别为173、268和4）进行匹配。在嵌套的案例控制分析中，鉴于在风险期内使用普帕西坦的人数较少，过敏反应和SJS的OR是不可估量的；同时，血栓形成的OR为1.60(95%CI0.71-3.62)。在CTC设计中，仅对血栓形成进行了效果评估(OR0.56,95%CI0.09~3.47).
结论：在嵌套病例对照和CTC分析中，普帕西他莫与过敏反应风险增加无关,血栓形成,或SJS。这项研究的发现，使用常规收集的临床数据，提供有关普帕他莫在全国人群中的安全性的可靠的现实证据，以支持监管决策。
方法：我们进行了巢式病例对照和病例时间对照（CTC）分析，以确定感兴趣的结果，包括过敏反应,血栓形成,和史蒂文斯-约翰逊综合征(SJS)，使用韩国的索赔数据库，2010-2019年。使用风险集抽样将每个病例与多达10个年龄对照进行匹配，性别,队列输入日期，和后续持续时间。暴露于过敏反应，血栓形成,SJS在索引日期的7、90和30天内进行了评估，分别。我们使用条件逻辑回归计算比值比（OR）和95％置信区间（CI），以评估与普帕西莫相关的结局风险。
结果：我们确定了过敏反应的病例（n=61），血栓形成（n=95），和SJS（n=1），并将它们与控件（分别为173、268和4）进行匹配。在嵌套的案例控制分析中，鉴于在风险期内使用普帕西坦的人数较少，过敏反应和SJS的OR是不可估量的；同时，血栓形成的OR为1.60(95%CI0.71-3.62)。在CTC设计中，仅对血栓形成进行了效果评估(OR0.56,95%CI0.09~3.47).
结论：在嵌套病例对照和CTC分析中，普帕西他莫与过敏反应风险增加无关,血栓形成,或SJS。这项研究的发现，使用常规收集的临床数据，提供有关普帕他莫在全国人群中的安全性的可靠的现实证据，以支持监管决策。
