Leuprolide Acetate Depot and Hormonal Add‐Back in Endometriosis: A 12‐Month Study
Leuprolide Acetate Depot and Hormonal Add‐Back in Endometriosis: A 12‐Month Study
复制标题
醋酸亮丙瑞林长效制剂和激素回加治疗子宫内膜异位症：一项为期 12 个月的研究
DOI：
10.1097/00006250-199805000-00029
复制
发表时间：
1998
影响因子：
7.2
通讯作者：
L. A. Casino
中科院分区：
文献类型：
--
作者：
M. Hornstein;E. Surrey;G. W. Weisberg;L. A. Casino
目的评价促性腺激素释放激素（GnRH）激动剂醋酸亮丙瑞林贮库型制剂单用及联合3种激素反向添加方案治疗盆腔炎相关性疼痛的疗效和安全性。方法采用多中心、随机、双盲、为期1年的临床试验方法，对201例患者进行治疗。所有患者均接受醋酸亮丙瑞林贮库型制剂3.75 mg肌肉注射，每4周一次。患者被分配到四个治疗组中的一个：A组接受炔雌醇和雌激素的安慰剂，B组接受醋酸炔诺酮5 mg/d和雌激素的安慰剂，C组接受醋酸炔诺酮5 mg/d和结合型马雌激素0.625 mg/d，D组接受醋酸炔诺酮5 mg/d和结合型马雌激素1.25 mg/d。每月评估骨盆疼痛评分，并在24周和52周后测量骨密度。结果到第8周，与基线水平相比，所有四组的盆腔疼痛评分均显着改善。D组患者因症状缺乏改善而提前终止研究的比例较高。治疗52周后，A组的骨密度损失为6.3 ± 2.3%（P ± .001），而所有三个反向添加组的骨密度均保持不变。结论醋酸亮丙瑞林贮库型制剂联合醋酸炔诺酮5 mg单药或醋酸炔诺酮和结合型马雌激素0.625 mg可有效抑制子宫内膜异位症相关盆腔疼痛症状，同时防止骨质丢失。
Objective To evaluate the efficacy and safety of a GnRH agonist, leuprolide acetate depot, alone and in combination with three hormonal add-back regimens in the management of endometriosis-associated pelvic pain. Methods Two hundred and one patients were enrolled in this multicenter, randomized, double-blind, 1-year trial. All patients were given an intramuscular injection of leuprolide acetate depot 3.75 mg every 4 weeks. Patients were assigned to one of four treatment groups: Group A received placebos for progestin and estrogen, group B received norethindrone acetate 5 mg daily and placebo for estrogen, group C received norethindrone acetate 5 mg and conjugated equine estrogens 0.625 mg daily, and group D received norethindrone acetate 5 mg and conjugated equine estrogens 1.25 mg daily. Pelvic pain scores were assessed monthly, and bone density was measured after 24 and 52 weeks. Results By week 8, all four groups showed significant improvement in pelvic pain scores compared with baseline levels. A higher proportion of group D patients terminated the study prematurely due to a lack of improvement in symptoms. Group A experienced a 6.3 ± 2.3% (P ± .001) loss in bone density after 52 weeks of treatment, whereas bone density was preserved in all three add-back groups. Conclusion The use of leuprolide acetate depot in combination with norethindrone acetate 5 mg alone, or with norethindrone acetate and conjugated equine estrogens 0.625 mg, provides effective suppression of pelvic pain symptoms associated with endometriosis while protecting against bone loss.
影响因子：
7.2
作者：
Clarkson,TB;Shively,CA;Morgan,TM;Koritnik,DR;Adams,MR;Kaplan,JR
通讯作者：
Kaplan,JR
影响因子：
39.2
作者：
ETTINGER, B;GENANT, HK;CANN, CE
通讯作者：
CANN, CE