Kempen John H, Daniel Ebenezer, Dunn James P, Foster C Stephen, Gangaputra Sapna, Hanish Asaf, Helzlsouer Kathy J, Jabs Douglas A, Kaçmaz R Oktay, Levy-Clarke Grace A, Liesegang Teresa L, Newcomb Craig W, Nussenblatt Robert B, Pujari Siddharth S, Rosenbaum James T, Suhler Eric B, Thorne Jennifer E
Ocular Inflammation Service, Scheie Eye Institute, University of Pennsylvania, Philadelphia, PA 19104, USA.
BMJ. 2009 Jul 3;339:b2480. doi: 10.1136/bmj.b2480.
CONTEXT: Whether immunosuppressive treatment adversely affects survival is unclear. OBJECTIVE: To assess whether immunosuppressive drugs increase mortality. DESIGN: Retrospective cohort study evaluating overall and cancer mortality in relation to immunosuppressive drug exposure among patients with ocular inflammatory diseases. Demographic, clinical, and treatment data derived from medical records, and mortality results from United States National Death Index linkage. The cohort's mortality risk was compared with US vital statistics using standardised mortality ratios. Overall and cancer mortality in relation to use or non-use of immunosuppressive drugs within the cohort was studied with survival analysis. SETTING: Five tertiary ocular inflammation clinics. Patients 7957 US residents with non-infectious ocular inflammation, 2340 of whom received immunosuppressive drugs during follow up. Exposures Use of antimetabolites, T cell inhibitors, alkylating agents, and tumour necrosis factor inhibitors. MAIN OUTCOME MEASURES: Overall mortality, cancer mortality. RESULTS: Over 66 802 person years (17 316 after exposure to immunosuppressive drugs), 936 patients died (1.4/100 person years), 230 (24.6%) from cancer. For patients unexposed to immunosuppressive treatment, risks of death overall (standardised mortality ratio 1.02, 95% confidence interval [CI] 0.94 to 1.11) and from cancer (1.10, 0.93 to 1.29) were similar to those of the US population. Patients who used azathioprine, methotrexate, mycophenolate mofetil, ciclosporin, systemic corticosteroids, or dapsone had overall and cancer mortality similar to that of patients who never took immunosuppressive drugs. In patients who used cyclophosphamide, overall mortality was not increased and cancer mortality was non-significantly increased. Tumour necrosis factor inhibitors were associated with increased overall (adjusted hazard ratio [HR] 1.99, 95% CI 1.00 to 3.98) and cancer mortality (adjusted HR 3.83, 1.13 to 13.01). CONCLUSIONS: Most commonly used immunosuppressive drugs do not seem to increase overall or cancer mortality. Our results suggesting that tumour necrosis factor inhibitors might increase mortality are less robust than the other findings; additional evidence is needed.
背景：免疫抑制治疗是否会对生存率产生不利影响尚不清楚。 目的：评估免疫抑制药物是否会增加死亡率。 设计：回顾性队列研究，评估眼部炎性疾病患者中与免疫抑制药物暴露相关的总体死亡率和癌症死亡率。人口统计学、临床和治疗数据来源于病历，死亡率结果来自美国国家死亡指数链接。使用标准化死亡率比将该队列的死亡风险与美国生命统计数据进行比较。通过生存分析研究该队列中使用或未使用免疫抑制药物的总体死亡率和癌症死亡率。 地点：五家三级眼部炎症诊所。患者为7957名患有非感染性眼部炎症的美国居民，其中2340人在随访期间接受了免疫抑制药物治疗。暴露情况包括使用抗代谢物、T细胞抑制剂、烷化剂和肿瘤坏死因子抑制剂。 主要观察指标：总体死亡率、癌症死亡率。 结果：在超过66802人年（接触免疫抑制药物后为17316人年）的时间里，936名患者死亡（1.4/100人年），230人（24.6%）死于癌症。对于未接受免疫抑制治疗的患者，总体死亡风险（标准化死亡率比为1.02，95%置信区间[CI]为0.94至1.11）和癌症死亡风险（1.10，0.93至1.29）与美国人群相似。使用硫唑嘌呤、甲氨蝶呤、霉酚酸酯、环孢素、全身用皮质类固醇或氨苯砜的患者的总体死亡率和癌症死亡率与从未服用免疫抑制药物的患者相似。使用环磷酰胺的患者，总体死亡率没有增加，癌症死亡率虽有增加但无统计学意义。肿瘤坏死因子抑制剂与总体死亡率增加（调整后的风险比[HR]为1.99，95%CI为1.00至3.98）和癌症死亡率增加（调整后的HR为3.83，1.13至13.01）相关。 结论：最常用的免疫抑制药物似乎不会增加总体死亡率或癌症死亡率。我们关于肿瘤坏死因子抑制剂可能增加死亡率的结果不如其他发现可靠；需要更多证据。
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