Palui Rajan, Das Rashmi Ranjan, Roy Ayan, Kamalanathan Sadishkumar, Kar Sitanshu Sekhar, Sahoo Jayaprakash, Selvarajan Sandhiya, Satapathy Amit Kumar
Department of Endocrinology, Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry, India.
Department of Paediatrics, All India Institute of Medical Sciences, Bhubaneswar, Odisha, India.
Indian J Endocrinol Metab. 2020 Mar-Apr;24(2):206-214. doi: 10.4103/ijem.IJEM_579_19. Epub 2020 Apr 30.
Chronic hypoparathyroidism is treated conventionally with active vitamin D and high doses of calcium. Recombinant human parathyroid hormone (PTH) replacement is an attractive option for treating patients with hypoparathyroidism since it can replace the physiological action of native PTH. The aim of our study was to perform a comprehensive evaluation of the effects of PTH replacement on calcium homeostasis, bone metabolism, and daily requirement of calcium and active vitamin D.
Randomized controlled trials done in chronic hypoparathyroid patients were included in this meta-analysis. The PTH group included subjects receiving a subcutaneous injection of either PTH (1-84) or PTH (1-34) with oral calcium and/or active vitamin D. The control group included those receiving oral calcium and active vitamin D with/without subcutaneous placebo injection. The primary outcome of this meta-analysis was to compare serum calcium, 24-h urinary calcium, and severe adverse effects among PTH and control groups.
In this meta-analysis, we did not find any difference in serum calcium level between PTH and control groups [mean difference (MD) - 0.01; 95% confidence interval (CI) - 0.09, 0.06; = 0.71]. Although there was a trend towards low 24-h urinary calcium in the PTH group, the difference was not statistically significant (MD - 1.43; 95% CI - 2.89, 0.03; = 0.06). The incidence of serious adverse events was also similar in both groups (RR 1.35; 95% CI 0.58, 3.16; = 0.49).
Both PTH and active vitamin D therapies are associated with comparable serum and urine calcium levels with a similar incidence of serious adverse events in patients with chronic hypoparathyroidism.
慢性甲状旁腺功能减退症传统上采用活性维生素D和高剂量钙进行治疗。重组人甲状旁腺激素(PTH)替代疗法是治疗甲状旁腺功能减退症患者的一个有吸引力的选择,因为它可以替代天然PTH的生理作用。我们研究的目的是对PTH替代疗法对钙稳态、骨代谢以及钙和活性维生素D每日需求量的影响进行全面评估。
本荟萃分析纳入了针对慢性甲状旁腺功能减退症患者进行的随机对照试验。PTH组包括接受皮下注射PTH(1-84)或PTH(1-34)并口服钙和/或活性维生素D的受试者。对照组包括接受口服钙和活性维生素D并伴有/不伴有皮下注射安慰剂的受试者。本荟萃分析的主要结果是比较PTH组和对照组之间的血清钙、24小时尿钙以及严重不良反应。
在本荟萃分析中,我们发现PTH组和对照组之间的血清钙水平没有差异[平均差(MD)-0.01;95%置信区间(CI)-0.09,0.06;P = 0.71]。虽然PTH组有24小时尿钙降低的趋势,但差异无统计学意义(MD -1.43;95% CI -2.89,0.03;P = 0.06)。两组严重不良事件的发生率也相似(风险比1.35;95% CI 0.58,3.16;P = 0.49)。
对于慢性甲状旁腺功能减退症患者,PTH疗法和活性维生素D疗法在血清和尿钙水平方面相当,严重不良事件的发生率相似。