Bratton Emily, Vannappagari Vani, Kobayashi Monica G
Real World Evidence Solutions, QuintilesIMS, Durham, North Carolina, United States of America.
Epidemiology and Real World Evidence, ViiV Healthcare Ltd, Research Triangle Park, North Carolina, United States of America.
PLoS One. 2017 Jun 30;12(6):e0180612. doi: 10.1371/journal.pone.0180612. eCollection 2017.
The primary study objectives were to estimate the frequencies and rates of gastrointestinal bleeding and peptic ulcerative disorder in HIV-positive patients compared with age- and sex-matched HIV-negative subjects. Data from a US insurance claims database was used for this analysis. Among 89,207 patients with HIV, 9.0% had a GI bleed, 1.0% had an upper gastrointestinal bleed, 5.6% had a lower gastrointestinal bleed, 1.9% had a peptic ulcerative disorder diagnosis, and 0.6% had both gastrointestinal/peptic ulcerative disorder. Among 267,615 HIV-negative subjects, the respective frequencies were 6.9%, 0.6%, 4.3%, 1.4%, and 0.4% (p<0.0001 for each diagnosis subcategory). After combining effect measure modifiers into comedication and comorbidity strata, gastrointestinal bleeding hazard ratios (HRs) were higher for HIV-positive patients without comedication/comorbidity, and those with comedication alone (HR, 2.73; 95% confidence interval [CI], 2.62-2.84; HR, 1.59; 95% CI, 1.47-1.71). The rate of peptic ulcerative disorder among those without a history of ulcers and no comorbidity/comedication was also elevated (HR, 2.72; 95% CI, 2.48-2.99). Hazard ratios of gastrointestinal bleeding, and peptic ulcerative disorder without a history of ulcers were lower among patients infected with HIV with comedication/comorbidity (HR, 0.64; 95% CI, 0.56-0.73; HR, 0.46; 95% CI, 0.33-0.65). Rates of gastrointestinal bleeding plus peptic ulcerative disorder followed a similar pattern. In summary, the rates of gastrointestinal/peptic ulcerative disorder events comparing HIV-infected subjects to non-HIV-infected subjects were differential based on comorbidity and comedication status.
主要研究目标是评估与年龄和性别匹配的HIV阴性受试者相比，HIV阳性患者胃肠道出血和消化性溃疡疾病的频率及发生率。本分析使用了美国保险理赔数据库的数据。在89207例HIV患者中，9.0%发生了胃肠道出血，1.0%发生上消化道出血，5.6%发生下消化道出血，1.9%被诊断为消化性溃疡疾病，0.6%同时患有胃肠道/消化性溃疡疾病。在267615例HIV阴性受试者中，相应频率分别为6.9%、0.6%、4.3%、1.4%和0.4%（每个诊断亚类的p<0.0001）。将效应测量修饰因素合并到联合用药和合并症分层后，未合并联合用药/合并症的HIV阳性患者以及仅合并联合用药的患者胃肠道出血风险比（HRs）更高（HR，2.73；95%置信区间[CI]，2.62 - 2.84；HR，1.59；95% CI，1.47 - 1.71）。在无溃疡病史且无合并症/联合用药的患者中，消化性溃疡疾病的发生率也有所升高（HR，2.72；95% CI，2.48 - 2.99）。在合并联合用药/合并症的HIV感染患者中，无溃疡病史的胃肠道出血和消化性溃疡疾病的风险比更低（HR，0.64；95% CI，0.56 - 0.73；HR，0.46；95% CI，0.33 - 0.65）。胃肠道出血加消化性溃疡疾病的发生率遵循类似模式。总之，根据合并症和联合用药状态，HIV感染受试者与非HIV感染受试者相比，胃肠道/消化性溃疡疾病事件的发生率存在差异。
