Schneeweiss Sebastian, Doherty Mike, Zhu Shao, Funch Donnie, Schlienger Raymond G, Fernandez-Vidaurre Carlos, Seeger John D
Department of Epidemiology, Harvard School of Public Health, Boston, MA, USA.
Dermatology. 2009;219(1):7-21. doi: 10.1159/000209289. Epub 2009 Mar 17.
BACKGROUND/AIMS: A potential risk of lymphoma associated with the use of topical calcineurin inhibitors is debated. We assessed the risk of lymphoma among patients treated with topical pimecrolimus, tacrolimus or corticosteroids.
We conducted a cohort study using health insurance claims data. Cohorts of initiators of topical pimecrolimus, tacrolimus and corticosteroids, along with cohorts of persons with untreated dermatitis and randomly sampled enrollees were identified from January 2002 to June 2006. Lymphomas were identified using insurance claims and adjudicated by medical records review. We adjusted for confounders by propensity score matching.
Among 92,585 pimecrolimus initiators contributing 121,289 person-years of follow-up, we identified 26 lymphomas yielding an incidence of 21/100,000 person-years. This incidence of lymphoma was similar to that among tacrolimus users (rate ratio, RR = 1.16; 95% confidence interval, CI = 0.74-1.82) as well as corticosteroid users (RR = 1.15; 95% CI = 0.49-2.72). All three topical treatments were associated with an increased risk of lymphoma compared with the general population (RR(Pim) = 2.89; RR(Tac) = 2.82; RR(Cort) = 2.10) suggesting increased detection of preexisting lymphomas.
This study did not find an increased risk of lymphoma among initiators of topical pimecrolimus relative to other topical agents during an average follow-up of 1.3 years. Longer-term studies may be needed.
背景/目的：外用钙调神经磷酸酶抑制剂与淋巴瘤的潜在关联存在争议。我们评估了外用吡美莫司、他克莫司或皮质类固醇治疗的患者发生淋巴瘤的风险。
我们利用健康保险理赔数据进行了一项队列研究。从2002年1月至2006年6月确定了外用吡美莫司、他克莫司和皮质类固醇的起始者队列，以及未治疗的皮炎患者队列和随机抽样的参保者队列。通过保险理赔识别淋巴瘤，并经病历审查判定。我们通过倾向评分匹配对混杂因素进行了调整。
在92,585名吡美莫司起始者中，随访121,289人年，我们识别出26例淋巴瘤，发病率为21/100,000人年。这种淋巴瘤发病率与他克莫司使用者（率比，RR = 1.16；95%置信区间，CI = 0.74 - 1.82）以及皮质类固醇使用者（RR = 1.15；95% CI = 0.49 - 2.72）相似。与普通人群相比，所有三种外用治疗均与淋巴瘤风险增加相关（RR(Pim) = 2.89；RR(Tac) = 2.82；RR(Cort) = 2.10），提示对已存在淋巴瘤的检测增加。
本研究未发现外用吡美莫司起始者在平均1.3年的随访期间相对于其他外用药物发生淋巴瘤的风险增加。可能需要进行长期研究。
