背景:患有慢性肾脏疾病的儿童的矿物质和骨骼疾病可导致钙异常,磷,甲状旁腺激素,和维生素D,如果不及时治疗会导致生长受损,骨畸形,骨折,血管钙化.Cinacalcet是一种拟钙剂,广泛用作降低成人甲状旁腺激素水平的疗法,副作用之一是低钙血症。由于该组中缺乏随机临床试验,儿科人群的安全性分析受到质疑。
目的:评估在患有慢性肾脏疾病的矿物质和骨骼疾病的儿童和青少年中使用西那卡塞的症状性低钙血症或其他不良事件(严重或非严重)的发作。
方法:书目搜索确定了1927年至2023年8月的2699篇参考文献(57LILACS,44WebofScience,686PubMed,131科克伦,1246Scopus,535Embase)。从发现的文章的参考书目中添加了4个参考文献,从灰色文献(临床试验)中添加了12个参考文献。在完整分析的77项研究中,68人被排除在外,因为他们不符合以下标准:人口,研究类型,药物,出版物类型和1篇未显示结果的文章(灰色文献)。
方法:149例年龄在0-18岁的慢性肾脏病和矿物骨疾病患者接受西那卡塞治疗。
方法:检查了9项符合条件的研究类型,尺寸,干预,并报告结果。
结果:致命不良事件发生率为0.2%,严重不良事件发生率为16%(p<0.01,I2=69%),除了10.7%的低钙血症,总计占总不良事件的45.7%。
结论:在大约50%的研究中,患者的人口统计学信息和临床特征存在偏差,大多数研究是病例系列。
结论:如果用于儿科人群,应仔细监测拟钙剂西那卡塞的血清钙水平,并注意可能的不良事件,尤其是50个月以下的儿童。
■CRD42019132809。
BACKGROUND: Mineral and bone disease in children with chronic kidney disease can cause abnormalities in calcium, phosphorus, parathyroid hormone, and vitamin D and when left untreated can result in impaired growth, bone deformities, fractures, and vascular calcification. Cinacalcet is a calcimimetic widely used as a therapy to reduce parathyroid hormone levels in the adult population, with
hypocalcemia among its side effects. The analysis of safety in the pediatric population is questioned due to the scarcity of randomized clinical trials in this group.
OBJECTIVE: To assess the onset of symptomatic
hypocalcemia or other adverse events (serious or non-serious) with the use of cinacalcet in children and adolescents with mineral and bone disorder in chronic kidney disease.
METHODS: The bibliographic search identified 2699 references from 1927 to August/2023 (57 LILACS, 44 Web of Science, 686 PubMed, 131 Cochrane, 1246 Scopus, 535 Embase). Four references were added from the bibliography of articles found and 12 references from the gray literature (Clinical Trials). Of the 77 studies analyzed in full, 68 were excluded because they did not meet the following criteria: population, types of studies, medication, publication types and 1 article that did not present results (gray literature).
METHODS: There were 149 patients aged 0-18 years old with Chronic Kidney Disease and mineral bone disorder who received cinacalcet.
METHODS: Nine eligible studies were examined for study type, size, intervention, and reported outcomes.
RESULTS: There was an incidence of 0.2% of fatal adverse events and 16% of serious adverse events (p < 0.01 and I2 = 69%), in addition to 10.7% of
hypocalcemia, totaling 45.7% of total adverse events.
CONCLUSIONS: There was a bias in demographic information and clinical characteristics of patients in about 50% of the studies and the majority of the studies were case series.
CONCLUSIONS: If used in the pediatric population, the calcimimetic cinacalcet should be carefully monitored for serum calcium levels and attention to possible adverse events, especially in children under 50 months.
UNASSIGNED: CRD42019132809.