Department of Geriatrics, The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
Jiangsu Key Laboratory of Pediatrics, Nanjing Medical University, Nanjing, China.
Horm Metab Res. 2021 Nov;53(11):730-737. doi: 10.1055/a-1655-4362. Epub 2021 Nov 5.
As a selective estrogen receptor modulator (SERM), raloxifene is used in healthy postmenopausal women to prevent bone loss and reduce fractures. However, the benefit of raloxifene is uncertain in the treatment of osteoporosis among patients with end-stage renal disease (ESRD) or those who require maintenance dialysis. We assessed the safety and efficacy of raloxifene in this particular population. Studies were selected from PubMed, Springer, CNKI (Chinese National Knowledge Infrastructure) and Wanfang Database. Randomized controlled trials (RCTs) and prospective studies with control/placebo groups were included. Five studies were included with a total of 244 participants (121 patients in the raloxifene group and 123 patients in the placebo/control group). The median duration of treatment was 12 months. The incidence rate of side effects of raloxifene was 0/121 (0%). There was a significant improvement of lumbar spine bone mineral density (BMD) levels in the raloxifene group compared with the placebo group (MD: 33.88, 95% CI: 10.93, 56.84, p=0.004). There was no significant difference concerning the improvement of femoral neck BMD (MD: 8.42, 95% CI: -10.21, 27.04, p=0.38), intact parathyroid hormone (iPTH) (MD: -12.62, 95% CI: -35.36, 10.13, p=0.28), calcium (MD: -0.08, 95% CI: -0.61, 0.44, p=0.76), phosphorus (MD: 0.18, 95% CI: -0.12, 0.48, p=0.23) or bone alkaline phosphatase (BAP) (MD: -4.33, 95% CI: -14.44, 5.79, p=0.40). Raloxifene seems to be effective in improving the lumbar spine BMD in postmenopausal women with ESRD. More large RCTs are necessary to evaluate the long-term safety of raloxifene in uremic patients.
作为一种选择性雌激素受体调节剂 (SERM)，雷洛昔芬用于预防绝经后健康女性的骨质流失和减少骨折。然而，雷洛昔芬在治疗终末期肾病 (ESRD) 或需要维持透析的患者的骨质疏松症中的益处尚不确定。我们评估了雷洛昔芬在这一特定人群中的安全性和疗效。研究从 PubMed、Springer、CNKI（中国国家知识基础设施）和万方数据库中选取。纳入随机对照试验 (RCT) 和有对照组/安慰剂组的前瞻性研究。共纳入 5 项研究，共计 244 名参与者（雷洛昔芬组 121 例，安慰剂/对照组 123 例）。治疗的中位时间为 12 个月。雷洛昔芬的不良反应发生率为 0/121（0%）。雷洛昔芬组腰椎骨密度（BMD）水平的改善明显优于安慰剂组（MD：33.88，95%CI：10.93，56.84，p=0.004）。股骨颈 BMD 的改善无显著差异（MD：8.42，95%CI：-10.21，27.04，p=0.38），完整甲状旁腺激素（iPTH）（MD：-12.62，95%CI：-35.36，10.13，p=0.28），钙（MD：-0.08，95%CI：-0.61，0.44，p=0.76），磷（MD：0.18，95%CI：-0.12，0.48，p=0.23）或骨碱性磷酸酶（BAP）（MD：-4.33，95%CI：-14.44，5.79，p=0.40）。雷洛昔芬似乎能有效改善 ESRD 绝经后女性的腰椎 BMD。需要更多的大型 RCT 来评估雷洛昔芬在尿毒症患者中的长期安全性。
