背景:当垂体没有产生足够的生长激素时,就会发生生长激素缺乏症。Norditropin®,重组人生长激素,和Sogroya®,白蛋白结合生长激素衍生物,为生长激素缺乏症患者开处方。这项系统评价评估了疗效,安全,患者满意度与Norditropin和Sogroya相关。
方法:我们系统地搜索了PubMed,WebofScience,和Scopus数据库以确定合格的比较研究。直到2023年6月发表的所有研究都包括在我们的分析中。我们对儿童的结果包括身高速度和身高速度标准差得分。相比之下,成人结局包括不良事件,胰岛素样生长因子1-标准差评分(IGF-1SDS),和药物治疗满意度问卷-9(TSQM-9)。结果报告为比值比(OR)和平均差(MD),置信区间为95%(95%CI)。
结果:10项研究包括1058名参与者(665名儿童和393名成人)纳入荟萃分析。在儿童中,将0.034和0.067mg/kg/天剂量的Norditropin与0.04、0.08、0.16和0.24mg/kg/周剂量的Sogroya进行比较。结果表明,与Sogroya0.04mg/kg/天相比,Norditropin对身高速度(MD-2.01,95%CI-3.7至-2.12,p<0.00001)和身高速度标准偏差评分(平均差-3.61,95%CI-5.06至-2.16,p<0.00001)具有良好的影响。其他剂量显示出相当的结果。在成年人中,唯一显著的副作用是皮疹,有利于Sogroya(OR0.1,95%CI0.04-0.27,p<0.00001)。此外,Sogroya组的IGF-1SDS显着高于Norditropin组(MD0.25,95%CI0.02-0.48,p=0.03)。此外,TSQM-9问卷的总分,其中包括三个领域:便利性,有效性,和满意,Sogroya组显著高于Norditropin组(OR6.36,95%CI3.92-8.8,p<0.00001)。
结论:Norditropin和Sogroya显示出相当的疗效和安全性,除了Norditropin组的皮疹患病率,Sogroya在成年人中的满意度更高。需要更多患者的高质量研究来证实这些结果。
BACKGROUND: Growth hormone deficiency occurs when the pituitary gland does not produce enough growth hormone. Norditropin®, a recombinant human growth hormone, and Sogroya®, an albumin-binding growth hormone derivative, are prescribed for patients with growth hormone deficiency. This systematic
review assesses the efficacy, safety, and patient satisfaction associated with Norditropin and Sogroya.
METHODS: We systematically searched PubMed, Web of Science, and Scopus databases to identify eligible comparative studies. All studies published until June 2023 were included in our analysis. Our outcomes for children included height velocity and height velocity standard deviation score. In contrast, adult outcomes included adverse events, insulin-like growth factor 1-standard deviation score (IGF-1 SDS), and the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9). Results are reported as odds ratio (OR) and mean difference (MD) with a 95% confidence interval (95% CI).
RESULTS: Ten studies involving 1058 participants (665 children and 393 adults) were included in the meta-analysis. In children, Norditropin at doses of 0.034 and 0.067 mg/kg/day was compared to Sogroya at doses of 0.04, 0.08, 0.16, and 0.24 mg/kg/week. The results showed that 0.034 mg/kg/day Norditropin had a favorable impact on height velocity (MD -2.01, 95% CI -3.7 to -2.12, p < 0.00001) and height velocity standard deviation score (Mean Difference -3.61, 95% CI -5.06 to -2.16, p < 0.00001) when compared to Sogroya 0.04 mg/kg/day. Other doses showed comparable results. In adults, the only significant side effect noted was rash, which favored Sogroya (OR 0.1, 95% CI 0.04-0.27, p < 0.00001). Additionally, IGF-1 SDS was significantly higher in the Sogroya group than in the Norditropin group (MD 0.25, 95% CI 0.02-0.48, p = 0.03). Furthermore, the overall score of the TSQM-9 questionnaire, which includes three domains: convenience, effectiveness, and satisfaction, was significantly higher in the Sogroya group compared to the Norditropin group (OR 6.36, 95% CI 3.92-8.8, p < 0.00001).
CONCLUSIONS: Norditropin and Sogroya showed comparable efficacy and safety profiles, except for the prevalence of rash in the Norditropin group, and Sogroya has higher satisfaction among adults. More high-quality studies with more patients are required to confirm these results.