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。
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,ClinicalTrials,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 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 RevMan 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 experimental 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 and the placebo(RR=1.14,95% CI from 0.82 to 1.60,P=0.44) or other bisphosphonates(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.
作者
任丹阳
杨琰茗
涂彩霞
吕梦伟
沈建玲
刘艳
李云巍
李惠英
Ren Danyang;Yang Yanming;Tu Caixia;Lyu Mengwei;Shen Jianling;Liu Yan;Li Yunwei;Li Huiying(Kunming Children’s Hospital/Children’s Hospital of Kunming Medical University,Kunming 650228,China;Kunming Medical University,Kunming 650500,China)
出处
《儿科药学杂志》
CAS
2024年第2期44-50,共7页
Journal of Pediatric Pharmacy
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
zoledronic acid
children
bone metabolic disorders
safety
efficacy
systematic review
