Department of Experimental Medicine, Sapienza University of Rome, Rome, Italy.
Oncological Endocrinology Unit, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) Regina Elena National Cancer Institute, Rome, Italy.
J Bone Miner Res. 2022 Jul;37(7):1233-1250. doi: 10.1002/jbmr.4566. Epub 2022 May 20.
Hypoparathyroidism is the only endocrine deficiency for which hormone replacement therapy is not the standard of care. Although conventional treatments may control hypocalcaemia, other complications such as hyperphosphatemia, kidney stones, peripheral calcifications, and bone disease remain unmet needs. This meta-analysis (PROSPERO registration number CRD42019126881) aims to evaluate and compare the efficacy and safety of PTH and PTH in restoring calcium metabolism in chronic hypoparathyroidism. EMBASE, PubMed, and CENTRAL databases were searched for randomized clinical trials or prospective studies published between January 1996 and March 2021. English-language trials reporting data on replacement with PTH or PTH in chronic hypoparathyroidism were selected. Three authors extracted outcomes, one author performed quality control, all assessed the risk of biases. Overall, data from 25 studies on 588 patients were analyzed. PTH therapy had a neutral effect on calcium levels, while lowering serum phosphate (-0.21 mmol/L; 95% confidence interval [CI], -0.31 to -0.11 mmol/L; p < 0.001) and urinary calcium excretion (-1.21 mmol/24 h; 95% CI, -2.03 to -0.41 mmol/24 h; p = 0.003). Calcium phosphate product decreased under PTH therapy only. Both treatments enabled a significant reduction in calcium and calcitriol supplementation. PTH therapy increased bone turnover markers and lumbar spine mineral density. Quality of life improved and there was no difference in the safety profile between PTH and conventionally treated patients. Results for most outcomes were similar for the two treatments. Limitations of the study included considerable population overlap between the reports, incomplete data, and heterogeneity in the protocol design. In conclusion, the meta-analysis of data from the largest collection to date of hypoparathyroid patients shows that PTH therapy is safe, well-tolerated, and effective in normalizing serum phosphate and urinary calcium excretion, as well as enabling a reduction in calcium and vitamin D use and improving quality of life. © 2022 The Authors. Journal of Bone and Mineral Research published by Wiley Periodicals LLC on behalf of American Society for Bone and Mineral Research (ASBMR).
甲状旁腺功能减退症是唯一一种其激素替代疗法不是标准治疗方法的内分泌缺乏症。虽然传统治疗可以控制低钙血症，但其他并发症，如高磷血症、肾结石、周围钙化和骨病，仍然是未满足的需求。这项荟萃分析（PROSPERO 注册号 CRD42019126881）旨在评估和比较 PTH 和 PTH 在恢复慢性甲状旁腺功能减退症钙代谢中的疗效和安全性。在 1996 年 1 月至 2021 年 3 月期间，检索了 EMBASE、PubMed 和 CENTRAL 数据库中发表的随机临床试验或前瞻性研究。选择了报告使用 PTH 或 PTH 替代治疗慢性甲状旁腺功能减退症的英语试验。三名作者提取结果，一名作者进行质量控制，所有作者评估偏倚风险。总体而言，分析了来自 25 项研究的 588 名患者的数据。PTH 治疗对钙水平没有影响，而降低血清磷酸盐（-0.21mmol/L；95%置信区间 [CI]，-0.31 至 -0.11mmol/L；p<0.001）和尿钙排泄（-1.21mmol/24h；95%CI，-2.03 至 -0.41mmol/24h；p=0.003）。只有在 PTH 治疗下，钙磷乘积才会降低。两种治疗都能显著减少钙和骨化三醇的补充。PTH 治疗增加了骨转换标志物和腰椎骨密度。生活质量得到改善，且 PTH 治疗组和常规治疗组的安全性无差异。大多数结果的治疗效果相似。该研究的局限性包括报告中人群重叠较多、数据不完整以及方案设计存在异质性。总之，对迄今为止最大的甲状旁腺功能减退症患者数据集进行的荟萃分析表明，PTH 治疗安全、耐受良好，可有效使血清磷酸盐和尿钙排泄正常化，减少钙和维生素 D 的使用，并改善生活质量。
