From the Groupe d'analyse Ltée, Montréal, Quebec, Canada.
Analysis Group Inc, Boston, MA.
Menopause. 2018 Nov;25(11):1297-1305. doi: 10.1097/GME.0000000000001232.
The aim of this study was to quantify the magnitude of risk reduction for venous thromboembolism events associated with an estradiol transdermal system relative to oral estrogen-only hormone therapy agents.
A claims analysis was conducted using the Thomson Reuters MarketScan database from January 2002 to October 2009. Participants 35 years or older who were newly using an estradiol transdermal system or an oral estrogen-only hormone therapy with two or more dispensings were analyzed. Venous thromboembolism was defined as one or more diagnosis codes for deep vein thrombosis or pulmonary embolism. Cohorts of estradiol transdermal system and oral estrogen-only hormone therapy were matched 1:1 based on both exact factor and propensity score matching, and an incidence rate ratio was used to compare the rates of venous thromboembolism between the matched cohorts. Remaining baseline imbalances from matching were included as covariates in multivariate adjustments.
Among the matched estradiol transdermal system and oral estrogen-only hormone therapy users (27,018 women in each group), the mean age of the cohorts was 48.9 years; in each cohort, 6,044 (22.4%) and 1,788 (6.6%) participants had a hysterectomy and an oophorectomy at baseline, respectively. A total of 115 estradiol transdermal system users developed venous thromboembolism, compared with 164 women in the estrogen-only hormone therapy cohort (unadjusted incidence rate ratio, 0.72; 95% CI, 0.57-0.91; P = 0.006). After adjustment for confounding factors, the incidence of venous thromboembolism remained significantly lower for estradiol transdermal system users than for estrogen-only hormone therapy users.
This large population-based study suggests that participants receiving an estradiol transdermal system have a significantly lower incidence of venous thromboembolism than do participants receiving oral estrogen-only hormone therapy.
本研究旨在定量评估雌二醇透皮系统相对于口服雌激素单药激素治疗药物与静脉血栓栓塞事件相关的风险降低程度。
使用 Thomson Reuters MarketScan 数据库，于 2002 年 1 月至 2009 年 10 月进行了一项索赔分析。分析对象为新开始使用雌二醇透皮系统或口服雌激素单药激素治疗、且有两次或更多次配药的 35 岁及以上的患者。静脉血栓栓塞的定义是一次或多次深静脉血栓或肺栓塞的诊断代码。基于精确因素和倾向评分匹配，将雌二醇透皮系统和口服雌激素单药激素治疗队列 1:1 匹配，采用发病率比值比较匹配队列之间静脉血栓栓塞的发生率。将匹配后仍存在的基线不平衡因素作为协变量纳入多变量调整。
在匹配的雌二醇透皮系统和口服雌激素单药激素治疗使用者中（每组 27018 名女性），队列的平均年龄为 48.9 岁；在每个队列中，分别有 6044 名（22.4%）和 1788 名（6.6%）患者在基线时行子宫切除术和卵巢切除术。雌二醇透皮系统使用者中共有 115 例发生静脉血栓栓塞，而雌激素单药激素治疗组有 164 例（未调整发病率比值，0.72；95%CI，0.57-0.91；P=0.006）。调整混杂因素后，雌二醇透皮系统使用者的静脉血栓栓塞发生率仍显著低于雌激素单药激素治疗使用者。
这项基于人群的大型研究表明，接受雌二醇透皮系统治疗的参与者发生静脉血栓栓塞的风险明显低于接受口服雌激素单药激素治疗的参与者。
