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| 唑来膦酸用于儿童代谢性骨疾病有效性和安全性的系统评价 |
| 任丹阳1,杨琰茗1,涂彩霞1,吕梦伟2,沈建玲1,刘艳1,李云巍1,李惠英1 |
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| ((1. 昆明市儿童医院/ 昆明医科大学附属儿童
医院,昆明 650228;2. 昆明医科大学,昆明 650500)) |
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| 摘要: |
| 目的:系统评价唑来膦酸治疗儿童代谢性骨疾病的有效性和安全性。方法:计算机检索PubMed、the Cochrane Library、
EMBase、中国知网、维普和万方数据库、ClinicalTrials 和Cochrane Central Registry of Controlled Trials、International Clinical Trials
Registry Platform。检索时限均从建库起至2021 年12 月。收集唑来膦酸治疗儿童代谢性骨疾病的随机对照试验(RCT)、病例系
列研究和病例报告。RCT、病例系列研究和病例报告的质量评价分别采用Cochrane 偏倚风险评价手册和澳大利亚JBI 质量评
价工具。采用RevMan 5. 3 软件对RCT 进行Meta 分析,其他研究进行描述性分析。结果:共纳入研究16 项,其中4 项为RCT、2
项为病例系列研究、10 项为病例报告,未检索到关于儿童的队列研究和病例对照研究。Meta 分析结果显示,试验组与对照组有
效性结局指标腰椎骨密度评分比较差异有统计学意义(MD=0. 45,95%CI 0. 06~0. 84,P =0. 02)。对于安全性结局指标,唑来膦
酸与安慰剂(RR=1. 14,95%CI 0. 82~1. 60,P =0. 44)、其他双膦酸盐(帕米膦酸钠和阿仑膦酸钠,RR=1. 33,95%CI 0. 53~3. 35,
P =0. 55)比较差异无统计学意义。试验组与对照组在神经系统、消化系统、一般病情和用药部位及骨骼和结缔组织的不良事件
发生率相当;唑来膦酸与其他双膦酸盐在神经系统、消化系统、骨骼肌和结缔组织及骨折的不良事件发生率相当。试验组患儿
严重不良事件发生率与对照组比较差异无统计学意义(RR=2. 59,95%CI 0. 54~12. 50,P =0. 24)。结论:唑来膦酸可有效治疗
儿童骨代谢疾病;唑来膦酸与安慰剂、其他双膦酸盐药物的总体不良事件发生率、严重不良事件发生率相当,尤其是在神经系
统、消化系统及骨骼和结缔组织中的不良事件发生率相当。 |
| 关键词: 唑来膦酸 儿童 代谢性骨疾病 安全性 有效性 系统评价 |
| DOI：doi:10.13407/j.cnki.jpp.1672-108X.2024.02.012 |
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| 基金项目: |
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| Systematic Review on Efficacy and Safety of Zoledronic Acid in the Treatment of Bone Metabolic Disordersin Children |
| Ren Danyang1, Yang Yanming1, Tu Caixia1, Lyu Mengwei2, Shen Jianling1, Liu Yan1, Li Yunwei1, Li Huiying1 |
| ((1. Kunming Children’s Hospital / Children’s Hospital of Kunming Medical University, Kunming 650228, China; 2. Kunming Medical
University, Kunming 650500, China)) |
| Abstract: |
| Objective: To systematically evaluate the efficacy and safety of zoledronic acid in the treatment of bone metabolic diseases in children. Methods: PubMed, the Cochrane Library, EMBase, CNKI, VIP, Wanfang database, Clinical Trials, Cochrane Central Registry of Controlled Trials, and the International Clinical Trials Registry Platform were retrieved, the retrieval time was from the establishment of the database to Dec. 2021. Randomized controlled trials (RCT), case-control studies, case series studies and case reports related to zoledronic acid in the treatment of bone metabolic disorders were collected. Quality assessments for RCT, case series studies and case reports were performed by using the Cochrane Risk of Bias Assessment and the Australian JBI Quality Assessment, respectively. Meta-analysis was conducted by using Rev Man 5.3 software for RCT, while descriptive analysis was employed for other study types. Results: A total of 16 studies were enrolled, including 4 RCT, 2 case series studies, and 10 case reports. No cohort studies or case-control studies specifically related to children were identified. Meta-analysis results indicated a statistically significant difference in the lumbar spine bone density score of efficacy outcome measure between the zoledronic acid group and the control group (MD=0.45, 95% CI from 0.06 to 0.84, P=0.02). Regarding safety outcomes, no statistically significant differences were observed between the zoledronic acid group and the placebo group (RR=1.14, 95% CI from 0.82 to 1.60, P=0.44) or other bisphosphonates group (pamidronate, alendronate, RR=1.33, 95% CI from 0.53 to 3.35, P=0.55). The incidence of adverse events in the nervous system, digestive system, general condition, administration site and skeleton and connective tissue was comparable between the experimental group and the control group. Similarly, the incidence of adverse events related to nervous system, digestive system, skeleton and connective tissue, and fractures was comparable between experimental group and other bisphosphonates group. There was no significant difference in the incidence of severe adverse events between the experimental group and the control group (RR=2.59, 95% CI from 0.54 to 12.50, P=0.24). Conclusion: Zoledronic acid demonstrates effective efficacy for bone metabolic disorders in children. The overall incidences of adverse events and severe adverse events are comparable between zoledronic acid and placebo and other bisphosphonates, especially in terms of adverse events related to the nervous system, digestive system, and skeletonl and connective tissue.
[Keywords] zoledronic acid; children; bone metabolic disorders; safety; efficacy; systematic review |
| Key words: zoledronic acid children bone metabolic disorders safety efficacy systematic review |
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