Background The clinical efficacy and safety of mouse nerve growth factor(NGF) for injection have been evaluated by Ⅰ,Ⅱ,Ⅲ stage of clinical trials.But as a clinical drug,its adverse effects for special population should been further studied.Objective This clinical trial was to observe and assess the safety and tolerability of mouse NGF for injection during the application in juvenile and elder patients with optic nerve damage.Methods A multicenter non-randomized controlled trial for the safety evaluation of mouse NGF injection solution was performed in 100 eye centers in China.This study protocol was approved by the Ethic Committee of each drug research center,and written informed consent was obtained from the subject,legal mandatary and guardian prior to this study.Total 2046 patients who met the included criteria of optical nerve damage were enrolled.The patients were divided into the juvenile group(90 cases,＜ 18 years),youth-middle-age group (1868 cases,1 8-75 years) and older group(88 cases,＞75 years).Mouse NGF(30 μg)was intranuscularly injected once per day for 21 days in all the patients.Systolic and diastolic blood pressure,heart rate,intraocular pressure (lOP),laboratory examinations of blood and urine,blood biochemical indexes were recorded before and after injection.All adverse events were evaluated after administration of drug.Results There were 189 (189/2046,9.23％)dropped out cases,including 184 lost cases after 3 weeks of treatment and 5 withdrew cases from adverse responses of drug,with a shedding rate ＜10％ in each group.Total 1857 individuals finished this trial.No significant differences were found in the IOP,heart rate and blood pressure between before and after admninistration of grug in the juvenile group,youth-middle-age group and older group (P＞0.05).The incidence rate of the adverse response in the juvenile group,youth-middle-age group and older group was 57.78％,68.18％,60.01％ respectively,and the primary local adverse events were pain(48.89％),redness and swelling(59.09％),duration(54.49％),without significant difference in the rate of local adverse events among the three groups(X2 =2.302,P =0.324).The abnormal rates of laboratory results of blood and urine were not significantly different among the three groups(all at P＞0.05).The percentage of impaired fasting glucose was 7.46％,23.73％and 7.79％ in the juvenile group,youth-middle-age group and older group,respectively,and the percentage in the older group was higher than that in the juvenile group and the youth-middle-age group (x2 =8.685,P =0.005 ;x2 =27.720,P =0.000).Conclusions Injection of mouse NGF is well tolerated in juvenile and elder patients over the age of 75 years.%背景 注射用鼠神经生长因子(NGF)治疗视神经损伤的临床疗效和安全性已经过Ⅲ期临床试验的评价,但其在特定人群中使用的安全性和耐受性仍有待进一步证实. 目的 观察和评价应用注射用鼠NGF治疗儿童和老年视神经损伤患者的安全性和耐受性.方法 采用多中心非随机对照研究设计,在以中山大学中山眼科中心、首都医科大学附属北京同仁医院眼科、解放军总医院眼科、北京大学第一医院眼科及第三军医大学西南医院眼科等为主要研究单位的全国100个研究中心纳入各种原因所致的视神经损伤患者2046例,根据年龄分为少儿组(＜18岁)90例和老年组(＞75岁)88例,并以18 ～75岁的中青年组1 868例作为对照组.各组患者均给予注射用鼠NGF肌内注射,每次30 μg,每日1次,连续注射21 d.记录和评价指标包括各组患者用药前和用药结束时血压、心率、眼压以及血常规、尿常规和血液生化指标的变化,评价少儿和老年患者用药过程中发生的所有局部及全身不良事件. 结果 本研究共入组2046例,脱落189例(占9.23％),完成试验者1857例,其中资料完整者1834例.在脱落的病例中184例失访,均在用药3周以后；另外5例因出现局部疼痛和荨麻疹退出试验,各组病例脱落率均＜10％.与用药前比较,少儿组、老年组及中青年组患者用药后眼压、心率、血压的差异均无统计学意义(P＞0.05)；少儿组、老年组及中青年组不良事件的发生率分别为57.78％、68.18％、60.01％,局部不良事件中,3个组均以注射部位疼痛、红肿、硬结的发生率最高,分别为48.89％、59.09％、54.49％,差异无统计学意义(x2=2.302,P=0.324)；3个组间患者用药后血常规、尿常规检查的各项指标异常率差异均无统计学意义(P＞0.05)；用药后3个组患者空腹血糖异常的发生率分别为7.46％、23.73％、7.79％,老年组高于少儿组和中青年组,差异均有统计学意义(x2=8.685,P=0.005;x2=27.720,P=0.000).结论 儿童及75岁以上老年患者对注射用鼠NGF的耐受性良好.
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