关键词: cancer children medication safety mortality rhGH cancer children medication safety mortality rhGH

来  源:   DOI:10.3389/fped.2022.866295   PDF(Pubmed)

Abstract:
UNASSIGNED: The safety of recombinant human growth hormone (rhGH) treatment in childhood and the role of rhGH therapy in promoting tumorigenesis and progression have been the subject of debate for decades. We aimed to systematically assess the relationship between rhGH therapy in children and adolescents and clinical outcomes, including all-cause mortality, cancer mortality, cancer incidence, and risk of the second neoplasm.
UNASSIGNED: Literature retrieval, study selection, and data extraction were completed independently and in duplicate. Effect-size estimates are expressed as standardized mortality ratios (SMRs), standardized incidence ratio (SIR), and relative risk (RR) with a 95% CI.
UNASSIGNED: Data from 24 articles, involving 254,776 persons, were meta-analyzed. Overall analyses revealed the association of rhGH therapy was not statistically significant with all-cause mortality (SMR = 1.28; 95% CI: 0.58-2.84; P = 0.547; I 2 = 99.2%; Tau2 = 2.154) and cancer mortality (SMR = 2.59; 95% CI: 0.55-12.09; P = 0.228; I 2 = 96.7%; Tau2 = 2.361) and also cancer incidence (SIR = 1.54; 95% CI: 0.68-3.47; P = 0.229; I 2 = 97.5%; Tau2 = 2.287), yet statistical significance was observed for second neoplasm (RR = 1.77; 95% CI: 1.33-2.35; P = 0.001; I 2 = 26.7%; Tau2 = 0.055). Differences in the geographic region, gender, treatment duration, mean rhGH dose, overall rhGH exposure dose, and initial disease accounted for heterogeneity in the subgroup analyses.
UNASSIGNED: Our findings indicate that the rhGH therapy is not related to all-cause mortality and cancer mortality and cancer incidence, yet it seems to trigger a second tumor risk. Future prospective studies are needed to confirm our findings and answer the more challenging question regarding the optimal dose of rhGH therapy in children and adolescents.
摘要:
未经证实:儿童时期重组人生长激素(rhGH)治疗的安全性以及rhGH治疗在促进肿瘤发生和发展中的作用一直是争论的话题。我们旨在系统地评估儿童和青少年rhGH治疗与临床结果之间的关系。包括全因死亡率,癌症死亡率,癌症发病率,和第二次肿瘤的风险。
未经批准:文献检索,研究选择,和数据提取独立完成,一式两份。效应大小估计值表示为标准化死亡率比率(SMR),标准化发病率(SIR),和相对风险(RR),CI为95%。
未经评估:来自24篇文章的数据,涉及254,776人,进行了荟萃分析。总体分析显示,rhGH治疗与全因死亡率无统计学意义(SMR=1.28;95%CI:0.58-2.84;P=0.547;I2=99.2%;Tau2=2.154)和癌症死亡率(SMR=2.59;95%CI:0.55-12.09;P=0.228;I2=96.7;Tau2=2.361)以及癌症发病率(SIR=0.47-然而,对于第二次肿瘤,观察到统计学意义(RR=1.77;95%CI:1.33-2.35;P=0.001;I2=26.7%;Tau2=0.055).地理区域的差异,性别,治疗持续时间,平均rhGH剂量,rhGH总暴露剂量,和初始疾病在亚组分析中占异质性。
未经评估:我们的研究结果表明,rhGH治疗与全因死亡率、癌症死亡率和癌症发病率无关。但它似乎会引发第二次肿瘤风险。需要未来的前瞻性研究来证实我们的发现,并回答关于儿童和青少年rhGH治疗最佳剂量的更具挑战性的问题。
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