Grady Deborah, Ettinger Bruce, Moscarelli Elena, Plouffe Leo, Sarkar Somnath, Ciaccia Angelina, Cummings Steven
University of California-San Francisco, 1634 Divisadero Street, Suite 600, San Francisco, CA 94115, USA.
Obstet Gynecol. 2004 Oct;104(4):837-44. doi: 10.1097/01.AOG.0000137349.79204.b8.
To examine the effect of raloxifene on major adverse events that occur with postmenopausal estrogen therapy or tamoxifen.
The Multiple Outcomes of Raloxifene Evaluation, a multicenter, randomized, double-blind trial, enrolled 7,705 postmenopausal women with osteoporosis. Women were randomly assigned to raloxifene 60 mg/d or 120 mg/d or placebo. Outcomes included venous thromboembolism, cataracts, gallbladder disease, and endometrial hyperplasia or cancer.
During a mean follow-up of 3.3 years, raloxifene was associated with an increased risk for venous thromboembolism (relative risk [RR] 2.1; 95% confidence interval [CI] 1.2-3.8). The excess event rate was 1.8 per 1,000 woman-years (95% CI -0.5-4.1), and the number needed to treat to cause 1 event was 170 (95% CI 100-582) over 3.3 years. Risk in the raloxifene group was higher than in the placebo group for the first 2 years, but decreased to about the same rate as in the placebo group thereafter. Raloxifene did not increase risk for cataracts (RR 0.9; 95% CI 0.8-1.1), gallbladder disease (RR 1.0; 95% CI 0.7-1.3), endometrial hyperplasia (RR 1.3; 95% CI 0.4-5.1), or endometrial cancer (RR 0.9; 95% CI 0.3-2.7).
Raloxifene was associated with an increased risk for venous thromboembolism, but there was no increased risk for cataracts, gallbladder disease, endometrial hyperplasia, or endometrial cancer.
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研究雷洛昔芬对绝经后雌激素治疗或他莫昔芬治疗时发生的主要不良事件的影响。
雷洛昔芬评估多结局研究是一项多中心、随机、双盲试验，纳入了7705例绝经后骨质疏松妇女。将这些妇女随机分配至雷洛昔芬60mg/d组、120mg/d组或安慰剂组。结局指标包括静脉血栓栓塞、白内障、胆囊疾病以及子宫内膜增生或癌症。
在平均3.3年的随访期间，雷洛昔芬与静脉血栓栓塞风险增加相关（相对风险[RR]2.1；95%置信区间[CI]1.2 - 3.8）。每1000妇女年的额外事件发生率为1.8（95%CI - 0.5 - 4.1），在3.3年中导致1例事件所需治疗的人数为170（95%CI 100 - 582）。雷洛昔芬组在前2年的风险高于安慰剂组，但此后降至与安慰剂组大致相同的水平。雷洛昔芬未增加白内障（RR 0.9；95%CI 0.8 - 1.1）、胆囊疾病（RR 1.0；95%CI 0.7 - 1.3）、子宫内膜增生（RR 1.3；95%CI 0.4 - 5.1）或子宫内膜癌（RR 0.9；95%CI 0.3 - 2.7）的风险。
雷洛昔芬与静脉血栓栓塞风险增加相关，但未增加白内障、胆囊疾病、子宫内膜增生或子宫内膜癌的风险。
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