肿瘤坏死因子抑制剂与风湿性疾病患者周围神经病的风险。
Tumor necrosis factor inhibitors and risk of peripheral neuropathy in patients with rheumatic diseases.
机构信息
Department of Ophthalmology and Visual Sciences and Pharmacology, University of British Columbia, The Eye Care Center, Room 323-2550 Willow Street, Vancouver, BC V5Z 3N9, Canada.
Department of Ophthalmology and Visual Sciences and Pharmacology, University of British Columbia, The Eye Care Center, Room 323-2550 Willow Street, Vancouver, BC V5Z 3N9, Canada; Department of Medicine, Faculty of Medicine, University of British Columbia, Vancouver, Canada.
出版信息
Semin Arthritis Rheum. 2019 Jun;48(6):1083-1086. doi: 10.1016/j.semarthrit.2018.09.006. Epub 2018 Sep 27.
IMPORTANCE
Tumor necrosis factor inhibitors (TNFi) are widely used in the treatment of a variety of autoimmune diseases. A number of case reports have linked TNFi to neurologic adverse events including peripheral neuropathy (PN) in patients with rheumatic diseases.
OBJECTIVES
To quantify the risk of peripheral neuropathy with TNFi in patients with rheumatic diseases.
DESIGN
Nested-Case Control study within a cohort of patients with rheumatic diseases.
SETTING
PharMetrics Plus™ health claims database from the United States.
PARTICIPANTS
From a random sample of 9,053,240 subjects from the PharMetrics Plus™ database a cohort of patients with rheumatic diseases who had two physician visit codes for rheumatoid arthritis, ankylosing spondylitis and psoriasis in addition to a medication used in the treatment of each condition from 2006 to 2016 was created.
EXPOSURE
We created different risk periods of current use (day 0-60), recent use (day 61-180) and past use (day 180-365) from the index date.
MAIN OUTCOME MEASURES
New cases of PN were identified from the rheumatic disease cohort. Each case was matched to 10 controls by calendar time and age using density based sampling. Rate ratios (RRs) for new users of TNFi were computed using conditional logistic regression adjusting for gender, vitamin B deficiency, fluoroquinolone use, HIV, viral hepatitis, chronic renal failure and diabetes.
RESULTS
Among a cohort of 61,570 patients with rheumatic diseases 1358 cases of PN and 13,580 corresponding controls were identified. The adjusted rate ratio (RR) of PN among recent users of TNFi was 1.14 (95% CI:0.90-1.43). The RR for past use of TNFi was 2.77 (95% CI:1.67-4.58). Past users who used three or more prescriptions had a higher risk of PN 3.49 (1.63-7.49). The RRs did not change when the risk of PN with TNFi was compared to those taking methotrexate and one additional disease modifying anti rheumatic drug (DMARD) for recent and past use (RR = 0.95 [95% CI:0.72-1.24] and RR = 2.30 (1.37-3.87), respectively).
CONCLUSIONS
Patients with rheumatic diseases who are past users of TNFi are at higher risk of developing PN compared to those taking methotrexate and one additional DMARD.
重要性
肿瘤坏死因子抑制剂（TNFi）广泛用于治疗各种自身免疫性疾病。一些病例报告将 TNFi 与神经不良反应联系起来，包括风湿性疾病患者的周围神经病（PN）。
目的
量化风湿性疾病患者使用 TNFi 后发生周围神经病的风险。
设计
风湿性疾病患者队列内的巢式病例对照研究。
设置
来自美国 PharMetrics Plus ™健康索赔数据库。
参与者
从 PharMetrics Plus ™数据库中的 9053240 名受试者中随机抽取，创建了一个风湿性疾病患者队列，这些患者在 2006 年至 2016 年期间除了使用每种疾病的治疗药物外，还具有两个用于治疗类风湿关节炎、强直性脊柱炎和银屑病的医师就诊代码。
暴露
我们从索引日期开始创建了当前使用（第 0-60 天）、近期使用（第 61-180 天）和过去使用（第 180-365 天）的不同风险期。
主要观察结果
从风湿性疾病队列中确定了新的 PN 病例。每个病例都通过基于密度的抽样按日历时间和年龄与 10 个对照匹配。使用条件逻辑回归调整性别、维生素 B 缺乏、氟喹诺酮类药物使用、HIV、病毒性肝炎、慢性肾功能衰竭和糖尿病后，计算新使用 TNFi 的患者的新发生率比值比（RR）。
结果
在 61570 名风湿性疾病患者的队列中，发现了 1358 例 PN 病例和 13580 例相应对照。近期使用 TNFi 的患者发生 PN 的调整 RR 为 1.14（95%CI：0.90-1.43）。过去使用 TNFi 的 RR 为 2.77（95%CI：1.67-4.58）。过去使用三种或更多处方的患者发生 PN 的风险更高，为 3.49（1.63-7.49）。当将 TNFi 引起的 PN 风险与接受甲氨蝶呤和另外一种疾病修饰抗风湿药物（DMARD）治疗的患者进行比较时，RR 值没有变化（最近使用的 RR=0.95[95%CI：0.72-1.24]和 RR=2.30[1.37-3.87]）。
结论
与接受甲氨蝶呤和另外一种 DMARD 治疗的患者相比，过去使用 TNFi 的风湿性疾病患者发生 PN 的风险更高。
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