论著

基于医院小儿眼科常见病种分析儿童眼科药物临床试验现状

Analysis of the current situation of clinical trials of ophthalmic drugs in children based on the common diseases of pediatric ophthalmology in hospital

:408-415
 

目的:结合医院小儿眼科常见病种调研国内儿童眼用制剂药物临床试验开展现状,为儿童眼用制剂药物临床试验的发展提供参考。方法:基于国家药物临床试验登记与信息公示平台和医院信息系统,结合郑州市第二人民医院儿童眼科病种,分析儿童眼科药物临床试验开展情况。 结果:医院门诊就诊患者以屈光不正最多(占68.49% ),其次是结膜炎(占11.25%),再次是斜视(占8.60%)。平台共检索到相关临床试验165项,儿科专用药物临床试验25项,其中延缓青少年近视方面试验24个,小儿结膜炎试验1个,其他病种药物临床试验检测结果为0;药物临床试验中以I期和Ⅲ期临床试验为主;延缓青少年近视方面试验已完成试验8项,其他都在进行中。结论:儿童眼科疾病的药物治疗尚有巨大的临床需求未满足,直接关系到了儿童健康权益保障与生命安全维护。当前国内儿童眼用制剂研发呈现企业参与度低、创新动力不足的现状,其核心制约因素在于项目少、难度大、涉及更多的伦理问题。建议通过政产学研协同创新,系统性推进儿童眼用制剂的研发进展,切实解决我国儿童眼病治疗用药难的问题,为儿童视觉健康提供有力保障。

Objective:Combined with the common diseases of pediatric ophthalmology in our hospital, the current situation of clinical trials of ophthalmic preparations for children in China was investigated to provide reference for the development of clinical trials of ophthalmic preparations for children in China. Methods:Based on the national drug clinical trial registration and information publicity platform and hospital information system, combined with the pediatric ophthalmic diseases in our hospital, the development of pediatric ophthalmic drug clinical trials was analyzed. Results:Among the outpatients in our hospital, ametropia was the most common ( 68.49 % ), followed by conjunctivitis ( 11.25 % ) and strabismus ( 8.60 % ). A total of 165 clinical trials and 25 clinical trials of pediatric drugs were retrieved from the platform, including 24 trials on delaying juvenile myopia, 1 trial on pediatric conjunctivitis, and 0 clinical trial on other diseases. Drug clinical trials were mainly phase I and phase III clinical trials. Eight trials have been completed to delay juvenile myopia, and others are in progress. Conclusions:There is still a huge clinical demand for the drug treatment of children 's eye diseases, which is directly related to the protection of children 's health rights and life safety. At present, the research and development of children 's ophthalmic preparations in China presents the current situation of low enterprise participation and insufficient innovation motivation. The core constraints are fewer projects, greater difficulty, and more ethical issues. It is suggested to systematically promote the research and development of ophthalmic preparations for children through the collaborative innovation of government, industry, university and research, so as to effectively solve the problem of difficult medication for children 's eye diseases in China and provide a strong guarantee for children 's visual health.
综述

儿童常见眼表疾病并发散光的相关研究进展

Research progress on common ocular surface diseases related to astigmatism in children

:858-866
 
散光是儿童视力发育的重要威胁之一,很多情况下其发生与眼表疾病的进展密切相关。非先天性眼表疾病如睑缘炎相关性角结膜病变、春季角结膜炎、干眼、感染性角膜炎和眼外伤等可通过慢性炎症介导的眼表微环境失衡、角膜瘢痕产生、泪膜稳定性破坏及角膜生物力学结构异常重塑等途径,导致角膜表面不规则性的产生和角膜曲率的改变。先天性眼表疾病如圆锥角膜、睑内翻和眼表肿瘤等则可通过遗传或发育异常改变眼睑结构、改变角膜曲率的对称性和机械压迫角膜产生散光,例如遗传疾病圆锥角膜的进行性角膜变薄与发生春季角结膜炎时眼表微环境的炎症性改变可协同作用加剧散光进展。针对不同病因,局部糖皮质激素滴眼液、免疫抑制剂环孢素滴眼液等药物使用和手术治疗均可改善患儿本身的病情和散光情况,只是不同疾病的治疗和散光矫正方案不尽相同。现有研究虽指出了部分儿童眼表疾病与散光的关联,但对于儿童的特异性机制部分如发育过程中免疫系统的变化、角膜可塑性差异及各种因素交互作用效应尚未完全解析。
Astigmatism is a significant threat to children's visual development and is often closely linked to the progression of ocular surface diseases. Non-congenital conditions, such as blepharitis-associated keratoconjunctivitis, vernal keratoconjunctivitis, dry eye, infectious keratitis, and ocular trauma, can induce irregularities on the corneal surface and changes in corneal curvature. This occurs through mechanisms like the ocular surface microenvironment imbalance mediated by chronic inflammation, corneal scarring, tear film instability, and abnormal corneal biomechanical remodeling. Congenital disorders, including keratoconus, entropion, and ocular surface tumors, can also lead to astigmatism. These conditions do so by causing genetic or developmental abnormalities that alter the eyelid structure, disrupt corneal symmetry, or exert mechanical pressure. Notably, there can be synergistic effects between progressive corneal thinning seen in hereditary keratoconus and the inflammatory microenvironment changes associated with vernal keratoconjunctivitis. Therapeutic interventions, such as topical corticosteroids, cyclosporine eye drops, and surgical procedures, can improve both the primary conditions and the astigmatism. However, treatment strategies vary depending on the different etiologies. Current research has established associations between pediatric ocular surface diseases and astigmatism. Nevertheless, the specific developmental mechanisms, including the  maturation of the immune system, differences in corneal plasticity, and the interactive effects of multiple factors, remain incompletely understood.
论著

汕头地区城乡中小学生双眼水平融合力的横断面调查

Cross-sectional study of youth fusional range among school children in Shantou District

:100-104
 
目的:通过三棱镜融合储备力试验检查了解正常青少年的双眼水平融像性聚散范围。方法:横断面研究,随机分层整群抽样调查。在汕头地区调查9所城乡中小学校,共7 537人。从体检学生中抽取双眼正常学生4 012名,用排状三棱镜检查双眼近距水平聚散力,在融像破裂点记录三棱镜度数。按集合与散开、年龄、性别等因素对结果作分层统计分析。结果:总体检人数7 464人,其中双眼祼眼视力≥0.8为4 012人,占体检人数的53.75%;研究对象的双眼散开运动范围平均为15.87△±10.74△,双眼集合运动范围平均为26.41△±12.04△;4~8岁组及9~11岁组的双眼集合与散开运动范围均高于12~20岁组,差异有统计学意义(P<0.05);女性的双眼集合能力高于男性。结论:在本调查人群中,双眼集合运动的储备力高于散开运动;年龄越小,双眼异向运动的储备力越强。
Objective: To investigate the fusional range by using prism bar among students in Shantou City of Guangdong Province, China. Methods: This was a cross-sectional study that included 4 012 normal eye subjects among randomly selected 7 537 students aged 6 to 19 years from 9 schools in Shantou City. Horizontal fusional range measured with prism bar. Statistical analyses were performed using SPSS statistical software to investigate the association of age, gender, vergence and divergence. Results: A total of 7 464 students were examined, including 3 928 boys and 3 536 girls, mean age 11 years. The number of students with binocular vision ≥0.8 was 4 012, accounting for 53.75% of the number of fusional examination; the mean vergence range was 15.87△±10.74△, and the mean divergence range was 26.41△±12.04△. The vergence and divergence range group of 4 to 8 years and 9 to  11 years students was higher than the group of 12 to 20 years, the difference was statistically significant (P<0.05). The vergence range of female students was higher than that of male students. Conclusion: In this study, the vergence range is higher than divergence. With an increase in ages, the range of vergence and divergence decreases.
眼科护理

15 例自膨胀水凝胶眶内植入术患儿的围手术期护理

Perioperative nursing of 15 children with self-expanding hydrogel orbital implantation

:177-180
 

本文总结了 15 例自膨胀水凝胶眶内植入术患儿围手术期的护理要点。术前主要评估患儿是否完善术前检查,给予患儿及其家属个性化的心理护理,进行术前准备以及禁食禁饮的管理。术后主要给予患儿安全管理,饮食、疼痛、眼部用药以及弹力绷带包扎护理,关注有无并发症的发生及给予相应的护理,并对患儿及其家属做好出院指导。15 例患儿均顺利完成手术,术后均出现术眼疼痛,例出现眶压增高,例出现呕吐,均得到妥善处理。术后随访 3~18 个月,患儿均获得了较为满意的眼部外观,生活质量得到了提高。

This paper summarized the nursing experience of 15 children with self-expanding hydrogel orbital implantation during perioperative period. Before operation, children were fully evaluated, given with psychological care, preoperative preparation and management of fasting and drinking. After the surgery, the patients were mainly given with safety management, diet, pain, medicine and elastic bandage dressing care. Nurses should pay attention to the occurrence of complications and give corresponding nursing care and offer useful discharge guidance for the children and their parents. All 15 children completed the operation successfully, postoperative eye pain occurred in 15 cases after operation, and the orbital pressure increased in 2 cases, 1 case vomited, and all cases were properly treated. After postoperative follow-up for 318 months, 15 children were satisfied with the appearance of the eye, and the life quality was improved. 

论著

眼科全身麻醉手术患儿的个性化护理

Individual nursing on ophthalmic children under general anesthesia operation

:152-155
 
目的:探讨个性化护理在眼科患儿全身麻醉手术中的应用效果。方法:选取于2015年7月至2016年8月中山大学附属第一医院收治的50例眼科全身麻醉手术患儿,按手术例数单、双号顺序分组,单 数为对照组,采用传统常规护理,双数为观察组,采用个性化护理。比较两组麻醉配合度与家属对护理满意度。结果:50例患儿手术顺利。对照组在麻醉及复苏过程出现烦躁与躁动情况的患儿18例,观察组为3例,对照组明显高于观察组;观察组麻醉配合度与家属对护理满意度明显高于对照组,差异均有统计学意义(P<0.05)。结论:眼科全身麻醉手术患儿运用个性化护理,可改善患儿心理状态,提高配合度,增加患儿家属的满意度。
Objective: To detect the effect of individualized nursing on ophthalmic children under general anesthesia operation. Methods: Ophthalmic children under general anesthesia operation in First Afifliated Hospital of Sun Yat-sen University were included from July 2015 to August 2016. All of children were divided into odd and even groups by the operation sequence number. The children with odd numbers were in control group and accepted traditional nursing. The children with even numbers were in experimental group and accepted individualized nursing. Anesthesia cooperation degree and family members’ satisfaction on nursing were compared between the two groups. Results: Fifty operations were proceeded successfully. 18 children appeared irritability and restlessness during anesthesia and recovery process in the control group. Irritability and restlessness were only showed in 3 children in the experimental group. The satisfaction in experimental group was much higher than  the control group, the differences were statistically signiffcant (P<0.05). Conclusion: Individualized nursing can improve the mental state and the degree of cooperation. It can also improve family members’ satisfaction.  
论著

小儿角膜移植围手术期护理

Perioperative care for corneal transplantation in children

:219-222
 
目的:减轻行角膜移植术的患儿及家属的心理负担,提高患儿对手术的耐受性,减少术后并发症。方法:对45例将进行角膜移植的患儿进行围手术期护理。结果:所有患儿经过精心的治疗和护理后均恢复良好,视力均有提高。结论:术前做好充足的准备、术前心理护理,术后严密观察生命体征和眼部敷料的情况,做好相关的生活和饮食指导,遵医嘱及时有效用药,注意患儿异常的反应及眼部的情况,及时发现并处理并发症,给予细致的出院指导,有利于患儿早日康复。
Objective: To reduce the psychological burden of the children and families who are scheduled to the corneal transplantation, and to improve the patients’ tolerance and reduce postoperative complications. Methods: The perioperative care was given to 45 patients with corneal transplantation. Results: All children were treated well by careful treatment and care. Conclusion: Before operation, comprehensive preparation and psychological nursing care should be delivered. Affer operation, the physicians and nurses should guide the patients to live a healthy lifestyle, remind them to take the drugs timely, identify the abnormal symptoms and postoperative complications in children with abnormal responses, implement effective treatment timely to accelerate postoperative recovery.

早产儿和足月儿屈光不正的分布和临床特点

Refractive Error's Distribution and Clinical Characteristics of Preterm and Full-term Children

:93-95
 

目的:观察和分析儿童眼科门诊就诊的屈光不正 3~7 岁患儿,有早产史和足月产史的患儿的屈光不正的特点和差异。

方法:屈光不正 179 例(358 眼),分为 2 组:早产史者 51 人,足月产者 128 人。1%阿托品眼膏散瞳进行视网膜带状光剪影验光。

结果:足月儿的屈光不正患儿中,以远视多见,占 157/256 眼(61.3%),对比有早产儿屈光不正的远视发病 25/102(24.5%),差异有统计学意义(P < 0.05)。有早产儿屈光不正中,以散光发病为主,占 81/102 眼(79.4%),尤以高度散光、混合散光多见,相对与足月儿,其散光发病,高度散光发病和混合散光发病眼数的差异均有显著性(P < 0.05)。

结论:散光,尤其是高度散光、复杂的混合散光是有早产儿童视力低下的重要原因。临床上散光与弱视的形成关系密切相关,因此不能忽略早产儿童视力发育,最早可提前到 2 岁即可进行屈光筛查。

Purpose: To observe the abnormal refractive state and clinical characteristics in preterm and full-term children of the Department of Pediatric Ophthalmology.

Methods: The ocular refraction status of 358 eyes in 51 preterm and 128 full-term children were checked by retinoscopy in dilated pupil after being used atropine eye drops.

Results: There were 157 eyes with hyperopia accounting for 61.3% in preterm children, and 25 eyes with hyperopia accounting for 24.5% in full-term children. The main type of refractive errors in preterm children is astigmatism, especially in high astigmatism and mixed astigmatism. The morbidity of astigmatism, hyper astigmatism, and mixed astigmatism in preterm children is higher than that in full-term children.

Conclusion: Astigmatism, especially high astigmatism and complex mixed astigmatism, are important reasons for low vision in preterm children. Clinically, there is a close relationship between astigmatism and amblyopia. Therefore, the visual development of preterm children should not be ignored, and refractive screening could be brought forward to two years old.

Objectively-measured compliance to atropine penalization treatment in children with amblyopia: a pilot study

Objectively-measured compliance to atropine penalization treatment in children with amblyopia: a pilot study

:146-152
 
Background: To date, compliance to atropine penalization in amblyopic children has only been assessed through self-report. The goal of this pilot study is to measure compliance to atropine penalization objectively.
Methods: Seven amblyopic children (3–8 years; 20/40–20/125 in the amblyopic eye) were enrolled. None had been treated with atropine previously. Children were prescribed either a twice per week or daily atropine regimen by their physicians. Compliance was defined as the percentage of days in which the atropine eye drop was taken compared to the number of doses prescribed. We used medication event monitoring system (MEMS) caps to objectively measure compliance. The MEMS caps are designed to electronically record the time and date when the bottle is opened. The parents of the children were provided a calendar log to subjectively report compliance. Participants were scheduled for return visits at 4 and 12 weeks. Weekly compliance was analyzed.
Results: At 4 weeks, objective compliance averaged 88% (range, 57–100%), while subjective compliance was 98% (range, 90–100%). The actual dose in grams and visual acuity (VA) response relationship (r=0.79, P=0.03) was signiff cantly better than the relationship between regimen and response (r=0.41, P>0.05), or the relationship between actual dose in drops and response (r=0.52, P>0.05).
Conclusions: Objective compliance to atropine penalization instructions can be monitored with MEMS, which may facilitate our understanding of the dose-response relationship. Objective compliance with atropine penalization decreases over time and varies with regimen. On average, subjective parental reporting of compliance is overestimated.  
Background: To date, compliance to atropine penalization in amblyopic children has only been assessed through self-report. The goal of this pilot study is to measure compliance to atropine penalization objectively.
Methods: Seven amblyopic children (3–8 years; 20/40–20/125 in the amblyopic eye) were enrolled. None had been treated with atropine previously. Children were prescribed either a twice per week or daily atropine regimen by their physicians. Compliance was defined as the percentage of days in which the atropine eye drop was taken compared to the number of doses prescribed. We used medication event monitoring system (MEMS) caps to objectively measure compliance. The MEMS caps are designed to electronically record the time and date when the bottle is opened. The parents of the children were provided a calendar log to subjectively report compliance. Participants were scheduled for return visits at 4 and 12 weeks. Weekly compliance was analyzed.
Results: At 4 weeks, objective compliance averaged 88% (range, 57–100%), while subjective compliance was 98% (range, 90–100%). The actual dose in grams and visual acuity (VA) response relationship (r=0.79, P=0.03) was signiff cantly better than the relationship between regimen and response (r=0.41, P>0.05), or the relationship between actual dose in drops and response (r=0.52, P>0.05).
Conclusions: Objective compliance to atropine penalization instructions can be monitored with MEMS, which may facilitate our understanding of the dose-response relationship. Objective compliance with atropine penalization decreases over time and varies with regimen. On average, subjective parental reporting of compliance is overestimated.  

Curative effects of probing alone and probing combined with nasolacrimal injection of levofloxacin ophthalmic gel on congenital duct obstruction of children from 3–12 months of age

Curative effects of probing alone and probing combined with nasolacrimal injection of levofloxacin ophthalmic gel on congenital duct obstruction of children from 3–12 months of age

:78-85
 
Background: To investigate the 1-time success rate of probing alone and nasolacrimal duct probing combined with nasolacrimal injection of levofloxacin ophthalmic gel on congenital nasolacrimal duct obstruction (CNLDO) in young children.
Methods: A retrospective case series was performed on 494 cases (647 eyes) of 3–12 month-old children with CNLDO between July 2014 and July 2015. Material obtained from the lacrimal sac was cultured to isolate infectious agents. Susceptibility testing was done. Children from 3–12 months of age who were found to be sensitive to Levofloxacin (n=493 eyes) were separated into two groups: 3–6 months of age (276 eyes) and 7–12 months of age (217 eyes). Each of the groups were then randomized into group A (138 eyes of 3–6 months of age; 102 eyes of 7–12 months of age) and group B (138 eyes of 3–6 months of age; 115 eyes of 7–12 months of age). Children in group A underwent nasolacrimal duct probing alone; those in group B underwent nasolacrimal duct probing plus nasolacrimal duct injection of levofloxacin and the efficacy of probing was evaluated.
Results: The average detection rate of pathogenic bacteria in dacryocystitis was 75.1%, and Staphylococcus aureus was found to be the main pathogenic bacteria (42.59%, 106 cases). Among children from 7–12 months of age, the 1-time success rate of nasolacrimal duct probing alone was 88.24% and the 1-time success rate of probing combined with nasolacrimal duct injection of levofloxacin ophthalmic gel was 96.52% (statistical significance, P=0.02<0.05).
Conclusions: Most pathogenic bacteria (96.81%) were sensitive to levofloxacin. Nasolacrimal duct probing combined with nasolacrimal duct injection of levofloxacin may improve the success rate of probing in children older than 6 months of age.
Background: To investigate the 1-time success rate of probing alone and nasolacrimal duct probing combined with nasolacrimal injection of levofloxacin ophthalmic gel on congenital nasolacrimal duct obstruction (CNLDO) in young children.
Methods: A retrospective case series was performed on 494 cases (647 eyes) of 3–12 month-old children with CNLDO between July 2014 and July 2015. Material obtained from the lacrimal sac was cultured to isolate infectious agents. Susceptibility testing was done. Children from 3–12 months of age who were found to be sensitive to Levofloxacin (n=493 eyes) were separated into two groups: 3–6 months of age (276 eyes) and 7–12 months of age (217 eyes). Each of the groups were then randomized into group A (138 eyes of 3–6 months of age; 102 eyes of 7–12 months of age) and group B (138 eyes of 3–6 months of age; 115 eyes of 7–12 months of age). Children in group A underwent nasolacrimal duct probing alone; those in group B underwent nasolacrimal duct probing plus nasolacrimal duct injection of levofloxacin and the efficacy of probing was evaluated.
Results: The average detection rate of pathogenic bacteria in dacryocystitis was 75.1%, and Staphylococcus aureus was found to be the main pathogenic bacteria (42.59%, 106 cases). Among children from 7–12 months of age, the 1-time success rate of nasolacrimal duct probing alone was 88.24% and the 1-time success rate of probing combined with nasolacrimal duct injection of levofloxacin ophthalmic gel was 96.52% (statistical significance, P=0.02<0.05).
Conclusions: Most pathogenic bacteria (96.81%) were sensitive to levofloxacin. Nasolacrimal duct probing combined with nasolacrimal duct injection of levofloxacin may improve the success rate of probing in children older than 6 months of age.

ETDRS对数视力表在儿童视力检查中的可重复性分析

Repeatability of ETDRS Visual Acuity Measur ement in Children

:48-52
 
目的: 探讨 ETDRS 对数视力表对儿童视力检查的可重复性及其影响的相关因素。
方法: 在流行病学调查的过程中, 随机使用 ETDRS 对数视力表, 为 250 位裸眼视力低于 0.5 和 98 位视力正常儿童进行裸眼视力重复检查。
结果: 两次视力测量之间差异的均数为0.004log±0.07; Kappa 分析结果具有很好的一致性(= 0.71) ; 性别与视力检查一致性无明显相关(= 0.845) ; 年龄与视力检查一致性有显著相关性(= 0.019) , 年龄越小视力检查一致性越差; 屈光不正与视力检查一致性也有显著相关性(= 0.000) , 近视度数在- 1.00D~- 5.00D 之间的儿童视力检查一致性相对差, 而正视眼的视力检查一致性较好。
结论: 结果提示 ETDRS 对数视力表适合儿童视力检查, 建议推广使用。
Purpose: To evaluate repeatability of the ETDRS log MAR visual acuity measurementin children and the relative influence factors.
Methods: The children (= 348) with visual acuity less than 0.5 ( equal to 0.3 logunit) in either eye,or one tenth in children with normal visual acuity were chosen todo repeatable uncorrected VA measurement with Bland-Altman analysis and Kappa analysis using ETDRS acuity chart.
Results: The mean difference of visual acuity was 0.004log±0.07. There was a significant repeatability (= 0.71) between two visual acuity examination. There were significant consistent results both on male and female patients (= 0.845) . A significant relationship was found between age and VA repeatability(= 0.019) . The VA repeatability could also be influenced by refractive error (= 0.000) . The acuity measurement in children with emmetropia (= 0.82) had a higher repeatability than in the children with myopia (= 0.66) .
Conclusions: The ETDRS visual acuity chart can provide a repeatable measure of visual acuity in children. It is recommended for clinic examination of children. 
其他期刊
  • 眼科学报

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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  • Eye Science

    主管:中华人民共和国教育部
    主办:中山大学
    承办:中山大学中山眼科中心
    主编:林浩添
    主管:中华人民共和国教育部
    主办:中山大学
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