Department of ObGyn, The Reading Hospital/Tower Health, Reading, PA.
Department of ObGyn, Sidney Kimmel Medical College at Thomas Jefferson University, Philadelphia, PA.
Menopause. 2021 May 10;28(8):867-874. doi: 10.1097/GME.0000000000001782.
To assess the safety and serum estradiol (E2) and total testosterone (T) concentrations in postmenopausal women treated with Pellet Hormonal Therapy (PHT) and Food and Drug Administration approved Hormonal Therapy (FHT).
A total of 539 postmenopausal women were identified, including 384 on PHT and 155 on FHT. Data extracted from medical records include demographics, indication for hormone therapy, treatment duration, side effects, serum E2 and T levels, and frequency of laboratory follow-up.
The incidence of overall side effects was significantly higher in PHT compared with FHT (221 [57.6%] vs 23 [14.8%], P < 0.00001, odds ratio [95% CI] =8.0[4.5-14.2]). When examining women with an intact uterus prior to hormone therapy initiation, 55.3% (136/246) on PHT vs 15.2% (12/79) on FHT had at least one episode of abnormal uterine bleeding (P < 0.0001, odds ratio [95% CI] = 7.9[3.6-17.0]). Furthermore, a significantly higher proportion of women on PHT (20.3% [50/246]), compared with 6.3% (5/79) on FHT, had a hysterectomy (P = 0.036, odds ratio [95% CI] = 3.2[1.1-9.3]). Both mean (SD, Min-Max) peak E2 (pg/mL) and peak T (ng/dL) are significantly higher in the PHT group than those in the FHT group (E2: 237.70 [168.55, 10-1,111] vs 93.45 [130.77, 5.5-465.8], T: 194.04 [84.94, 4.3-599] vs 15.59 [19.52, 0.2-70], P < 0.00001). Of those on PHT, four women had E2 level > 1,000 pg/mL and nine women with T level > 400 ng/dL.
Women on PHT had a significantly higher incidence of side effects than FHT as well as a significantly higher supraphysiological level of peak E2 and T during the treatment.
评估接受经皮激素治疗（PHT）和美国食品和药物管理局批准的激素治疗（FHT）的绝经后妇女的安全性以及血清雌二醇（E2）和总睾酮（T）浓度。
共确定了 539 名绝经后妇女，其中 384 名接受 PHT 治疗，155 名接受 FHT 治疗。从病历中提取的数据包括人口统计学资料、激素治疗的适应证、治疗持续时间、副作用、血清 E2 和 T 水平以及实验室随访频率。
与 FHT 相比，PHT 的总体副作用发生率显著更高（221 [57.6%] 与 23 [14.8%]，P<0.00001，比值比[95%CI] = 8.0[4.5-14.2]）。在开始激素治疗前子宫完整的妇女中，与 FHT 相比（55.3% [136/246] 与 15.2% [12/79]），PHT 组中至少有一次异常子宫出血的发生率更高（P<0.0001，比值比[95%CI] = 7.9[3.6-17.0]）。此外，与 FHT 组（6.3% [5/79]）相比，PHT 组（20.3% [50/246]）中进行子宫切除术的妇女比例显著更高（P=0.036，比值比[95%CI] = 3.2[1.1-9.3]）。PHT 组的平均（SD，最小-最大）峰值 E2（pg/mL）和峰值 T（ng/dL）均显著高于 FHT 组（E2：237.70 [168.55，10-1,111] 与 93.45 [130.77，5.5-465.8]，T：194.04 [84.94，4.3-599] 与 15.59 [19.52，0.2-70]，P<0.00001）。在接受 PHT 治疗的患者中，有 4 名女性的 E2 水平>1000 pg/mL，9 名女性的 T 水平>400 ng/dL。
与 FHT 相比，接受 PHT 治疗的女性副作用发生率显著更高，治疗期间血清 E2 和 T 的峰值水平也显著更高。
