Trends in mortality and morbidity of bullous pemphigoid before and after approval of intravenous immunoglobulin in Japan: An interrupted time-series analysis
Trends in mortality and morbidity of bullous pemphigoid before and after approval of intravenous immunoglobulin in Japan: An interrupted time-series analysis
复制标题
日本批准静脉注射免疫球蛋白前后大疱性类天疱疮的死亡率和发病率趋势：间断时间序列分析
DOI：
10.1093/ced/llad086
复制
发表时间：
2023
影响因子：
4.1
通讯作者：
Yasunaga Hideo
中科院分区：
文献类型：
--
作者：
Miyachi Hideaki;Konishi Takaaki;Hashimoto Yohei;Matsui Hiroki;Fushimi Kiyohide;Inozume Takashi;Matsue Hiroyuki;Yasunaga Hideo
背景：静脉注射免疫球蛋白（IVIg）已被报道为治疗大疱性类天疱疮的有效方法。然而，IVIg批准对实际结果的影响尚不清楚。目的利用全国住院患者数据库，探讨IVIg批准对大疱性类天疱疮患者的影响。方法使用日本诊断程序组合数据库，我们确定了2010年7月至2020年3月期间因大疱性类天疱疮住院并接受全身皮质类固醇治疗的14 229例患者。我们进行了一项中断时间序列分析，比较2015年11月日本全民健康保险系统批准大疱性类天疱疮IVIg报销前后入院患者的住院死亡率和发病率。结果IVIg报销前住院死亡率为5.5%，报销后住院死亡率为4.5%。IVIg获批后，18%的患者接受了IVIg治疗。根据中断时间序列分析，住院死亡率在批准时显著下降[-1.2%，95%可信区间(CI) -2.0至-0.3，P= 0.009]，批准后呈下降趋势（-0.4%,95% CI -0.7至-0.1，P= 0.005）。院内发病率在批准后也呈现下降趋势。结论sivig批准与大疱性类天疱疮住院患者较低的住院死亡率和发病率相关。
BackgroundIntravenous immunoglobulin (IVIg) has been reported to be an effective treatment for bullous pemphigoid. However, the impact of IVIg approval on real-world outcomes remains unclear.ObjectivesTo investigate the effect of IVIg approval on patients with bullous pemphigoid using a national inpatient database.MethodsUsing the Japanese Diagnosis Procedure Combination database, we identified 14 229 patients admitted to hospital for bullous pemphigoid and treated with systemic corticosteroids between July 2010 and March 2020. We conducted an interrupted time-series analysis to compare in-hospital mortality and morbidity between the patients admitted before and after the approval of reimbursement of IVIg for bullous pemphigoid in the Japanese universal health insurance system in November 2015.ResultsIn-hospital mortality was 5.5% before and 4.5% after the approval of IVIg reimbursement. After the IVIg approval, 18% of the patients were treated with IVIg. Based on the interrupted time-series analysis, in-hospital mortality significantly decreased at the time of approval [–1.2%, 95% confidence interval (CI) –2.0 to –0.3,P= 0.009] and a downward trend was observed after the approval (–0.4% annual rate, 95% CI –0.7 to –0.1,P= 0.005). In-hospital morbidity also demonstrated a downward trend after the approval.ConclusionsIVIg approval is associated with lower in-hospital mortality and morbidity in inpatients with bullous pemphigoid.