2022年中国眼科药物临床试验进展

目的:了解2022年我国眼科药物临床试验的进展,探讨其与2014～2021年的变化,为新药研发、临床试验的实施提供最新数据参考,为相关决策提供依据。方法:采用横断面研究,检索国家药品监督管理局“药物临床试验登记与信息公示平台”数据库,纳入公示日期为2022-01-01/12-31且适应证为眼病的眼科药物临床试验。描述眼科药物试验整体情况、适应证及试验分期及占比情况、实施效率、主要研究者的地域分布情况。结果:2022年我国眼科药物临床试验共公示55项,占所有临床试验的1.66%,呈稳步增长趋势,以化学药物占比最高为58.18%。开展试验最多的前三个适应证为年龄相关性黄斑变性、近视、干眼。开展基因治疗药物临床试验2项。7个药物品种开展≥2项临床试验,其中以硫酸阿托品、重组抗血管内皮生长因子(VEGF)人源化单克隆抗体开展数量最多,分别为7、5项。试验分期以Ⅰ期、Ⅲ期为主,分别占比36.36%、27.27%。2022年Ⅰ期试验启动耗时为2.72(0.77,3.47)mo,较2014～2021年的启动耗时3.87(3.00,6.30)mo显著缩短(Z=-2.630,P=0.009),BE、Ⅱ、...     

我国眼科新药临床试验发展趋势分析

目的：宏观了解2015—2020年中国眼科药物临床试验情况，为我国眼科药物的研发和临床研究提供最新数据参考，为相关决策提供依据。方法：自国家药品监督管理总局药物临床试验登记与信息公示平台登记数据库提取2015—2020年登记的眼科药物临床试验和相关试验药物信息，汇总分析眼科药物临床试验数量、试验分期、试验范围、适应证、药物类型等。结果：2015年1月1日至2020年12月31日共登记98项眼科临床试验。统计每年眼科药物临床试验登记数量，2020年登记的数量最多(28项，占28.57%)；申办方类型中，国内制药企业(75项，占76.53%)发起的眼科药物临床试验数量远高于外资制药企业(23项，占23.47%)；试验分期中，Ⅰ期临床试验最多(35项，占35.71%),Ⅲ期次之(30项，占30.61%)；药物类型中，生物制品数量最多(55项，占56.12%)，化学药物次之(36项，占36.73%)。结论：近6年来，我国眼科药物临床试验进入蓬勃发展时期，尤其是眼底科领域，近2年发展迅速。在创新药领域，国内制药企业已成为眼科新药研发的中坚力量。但创新药大部分集中在眼底科领域，在青光眼、干眼等领域...     

光相干断层扫描在观察特发性黄斑裂孔 病程进展中的应用

目的应用光相干断层扫描（OCT）对临床诊断为Ⅰ～Ⅳ期特发性黄斑裂孔患眼进行随诊观察，了解其裂孔进展过程及与玻璃体后分离的相互关系。方法按Gass的临床分期标准，结合OCT图像特征，诊断特发性黄斑裂孔Ⅰ～Ⅳ期未行手术治疗的72只眼，进行OCT随诊检查。结果Ⅰ～Ⅳ期裂孔分别为23、19、11、19只眼，随诊时间最长43个月（平均13.4个月），每只眼OCT检查次数2～10次（平均4.7次），在随诊期间，Ⅰ期裂孔23只眼，9只眼(39.1%)进展为Ⅱ～Ⅲ期裂孔,2只眼玻璃体后脱离（PVD）后中心凹曲线恢复正常；Ⅱ期裂孔19只眼，13只眼(68.4%)进展为Ⅲ～Ⅳ期裂孔,有1只眼PVD后裂孔自行愈合；Ⅲ期裂孔11只眼，5只眼(45.5%)进展为Ⅳ期裂孔，1只眼12个月后裂孔部分自行愈合。OCT图像显示，玻璃体从黄斑中心凹周围开始与视网膜分离，直至完全后脱离的过程与黄斑裂孔进展过程一致。在随诊期间，15只眼因病程进展接受手术治疗。结论黄斑裂孔形成和发展与玻璃体后脱离的发生密切相关。OCT可直观显示黄斑裂孔的进展变化，对提供IMH的分期诊断和手术指征有较大帮助。(中华眼底病杂志,2005,21:79-82)     

特发性黄斑裂孔的临床观察

目的 观察特发性黄斑裂孔的临床特点和视力。 方法 回顾性分析特发性黄斑裂孔病例18例23只眼的临床表现；按Gass的标准分期；随访6-120。 结果 初诊时黄斑裂孔Ⅰ～Ⅳ期依次为5，4，10，3只眼，随访期间发生黄斑裂孔1只眼。随访末次时，黄斑裂孔Ⅰ～Ⅳ期依次为2，2，9，8只眼，自愈2只眼。主诉患病时间Ⅰ期5～8个月，Ⅱ期8～20个月，Ⅲ期12～126个月。初诊时，平均视力Ⅰ期0.7,Ⅱ期0.55，Ⅲ期0.08，Ⅳ期0.08。初诊时FFA：Ⅰ期无明显异常，Ⅱ～Ⅳ期黄斑部透见脉络膜荧光17只眼。 结论 特发性黄斑裂孔患者随着病程延长，前期黄斑裂孔多发展成全层裂孔，全层裂孔扩大，视力减退。 (中华眼底病杂志,1998,14:222-223)     

单剂量眼科表面麻醉剂盐酸丙美卡因的临床应用观察

目的探讨单剂量眼科表面麻醉剂盐酸丙美卡因在眼科使用的临床效果和安全性。方法选择2012年6月至2013年6月期间,在首都医科大学附属北京朝阳医院眼科行检查、治疗、手术的患者430例(597只眼)。其中,住院患者204例(301只眼),门诊患者226例(296只眼)。所有患者常规给予单剂量眼科表面麻醉剂盐酸丙美卡因滴眼液,采用视觉模拟评分法(VAS)评估局部麻醉的效果,采用频数和百分比进行描述。结果除2例慢性泪囊炎老年患者外,所麻醉患眼均获满意效果,且无角膜损伤和无交叉感染发生。(1)采用表面麻醉进行各种眼部手术的麻醉效果:白内障手术Ⅰ级94.92%(243/256),Ⅱ级5.08%(13/256),Ⅲ级0;抗青光眼手术Ⅰ级83.33%(5/6),Ⅱ级16.67%(1/6),Ⅲ级0;翼状胬肉切除术Ⅰ级62.50%(10/16),Ⅱ级37.50%(6/16),Ⅲ级0;玻璃体腔注药Ⅰ级100.00%(23/23),Ⅱ级0,Ⅲ级0。(2)采用表面麻醉进行各种眼部门诊操作的麻醉效果:角结膜异物取出Ⅰ级93.42%(71/76),Ⅱ级6.58%(5/76),Ⅲ级0;泪道探通Ⅰ级68.42%(26/38),Ⅱ级26.32%(10/38),Ⅲ级5.26%(2/38);角结膜拆线Ⅰ级92.31%(60/65),Ⅱ级7.69%(5/65),Ⅲ级0;眼科检查Ⅰ级100.00%(82/82),Ⅱ级0,Ⅲ级0。结论单剂量眼科表面麻醉剂盐酸丙美卡因表面麻醉剂临床应用安全、有效、便捷,值得推广使用。     

以新生儿重症监护病房为中心的早产儿视网膜病变筛查模式的初步探讨

目的 探讨以新生儿重症监护病房（NICU）为中心的早产儿视网膜病变（ROP）筛查模式的特点.设计回顾性病例系列.研究对象2007年1月至2009年12月在连云港市第一人民医院住院的符合ROP筛查标准的340例患儿.方法 回顾340例患儿ROP筛查的登记记录.按筛查工作模式的不同分为以眼科为中心的筛查模式组（Ⅰ组,n=101）和以NICU为中心的筛查模式组（Ⅱ组,n=239）.前者系由NICU医师邀请眼科医师来NICU检查住院患儿,患儿出院后定期到眼科门诊由固定的眼科医师复诊 后者系在NICU设置眼底检查室,眼科医师除负责在此检查患儿并确定下一步处置方案外,其余工作均由NICU医师负责完成.分析两组间ROP的筛查完成率差异.主要指标筛查率、筛查完成率.结果 Ⅰ组、Ⅱ组的筛查率分别为95.05%（96/101）和92.89%（222/239）（x2=0.742,P=0.863）.Ⅰ组、Ⅱ组的筛查完成率分别为24.75%（25/101）和73.64%（176/239）（x2=83.0,P=0.000）.结论 以新生儿重症监护病房为中心的ROP筛查模式能够更有效地提高ROP高危患儿的筛查完成率.     

康柏西普治疗新生血管性老年性黄斑变性中1型黄斑新生血管合并不同类型视网膜色素上皮脱离的疗效观察

目的观察玻璃体腔注射康柏西普(IVC)治疗新生血管性老年性黄斑变性(nAMD)中1型黄斑新生血管(MNV)伴不同类型视网膜色素上皮脱离(PED)的疗效。方法回顾性临床研究。2018年6月至2021年6月于解放军中部战区总医院眼科检查确诊的nAMD中1型MNV伴不同类型PED患者42例42只眼纳入研究。所有患眼均行最佳矫正视力(BCVA)及光相干断层扫描(OCT)检查。OCT检查采用日本Topcon公司3D-OCT 2000仪进行, 对黄斑中心凹进行扫描, 测量其PED高度(PEDH)、PED面积(PEDA)、PED体积(PEDV)、黄斑中心凹厚度(CFT)。根据PED的OCT图像特征, 将患眼分为浆液性PED (sPED)、纤维血管性PED (fPED)、出血性PED (hPED), 并据此分组。42只眼中, sPED组、fPED组、hPED组分别为16 (38.1%, 16/42)、14 (33.3%, 14/42)、12 (28.6%, 12/42)只眼。所有患者均接受IVC治疗, 每一个月1次, 连续3个月, 其后经评估按需治疗。治疗后3、6、12个月复查BCVA及OCT, 对比...     

糖尿病性黄斑病变的临床分析

目的：本文通过对63例（113只眼）糖尿病性视网膜病变（diabetic retinopathy,DR)的分析，探讨对糖病性黄斑病变（diabetic maculopathy,DM)独立分型的必要性以及DM分期对激光治疗DR的指导意义。方法：Ⅱ型糖尿病人63例，113例只眼，行眼底荧光血管造影及眼科常规检查，根据结果将DR分为Ⅴ期，DM分为Ⅳ期。结果：（1）不同分期DR与中心视力的关系：DRⅠ-Ⅳ期中心视力在0．2－0．5的低视力眼分别为33．3％，36％、54％、54．5％，DRⅢ、Ⅳ期视力0．04以下分别为17．4％、45．5％，DR愈重，视力下降愈重。（2）DR与DM的关系：Ⅰ-Ⅴ期DR发和DM的眼分别为52．4％、72％、78．3％、100％、100％。随着DR的加重，DM也随之加重，但Ⅱ、Ⅲ期DR有黄斑未受累病例。DRⅠ-Ⅲ期，发生DM占51．3％，非增殖期DR中，DM对视力带来损害是明显的，（3）不同分期DM对中心视力的影响；发生DM后视力均有所下降，视力0．3以上，DM大多处于Ⅱ期或以下，视力0．2以下大多进入DMⅢ期、Ⅳ期。结论：DR与DM虽然有共同的发病机制，但不完全平行，对DM单独分期完全必要，DM独立分型对激光治疗具有重要指导意义。DMⅡ期为最佳光凝时机，可以改善或保存视力。DMⅢ期进行激光治疗可以减轻黄斑水肿，防止视力进一步下降。DMⅣ期进行光疑治疗对视功能恢复收效甚微，DMⅢ期及DMⅣ期已失去了激光治疗最佳时机。     

超高度近视LASEK术中应用MMC的疗效与安全性分析

目的：探讨准分子激光上皮瓣下角膜磨镶术( laser-assisted subepithelial keratomileusis,LASEK)中应用0.2g/L丝裂霉素C( mitomycin C,MMC)治疗超高度近视的疗效和安全性。
　　方法：选择LASEK联合MMC治疗的超高度近视患者182例364眼,等效球镜-9.0~-10.25D,随机分为四组,Ⅰ组术中MMC应用时间为10s,Ⅱ组MMC应用时间为25s,Ⅲ组为40s,Ⅳ组为55s。术后随访6mo,观察各组术眼的疗效和安全性,随访指标包括裸眼视力( uncorrected visual acuity,UCVA)、残留屈光度、角膜上皮下雾状混浊( haze)的发生率、角膜上皮愈合时间以及角膜内皮细胞的密度和变异系数。
　　结果：术后随访6mo,Ⅱ组、Ⅲ组、Ⅳ组患者UCVA≥0.8者分别为94.0%、92.3%、93.8%,明显好于Ⅰ组(76.3%),差异有显著统计学意义(χ2=19.610,P=0.000);Ⅱ组、Ⅲ组、Ⅳ组患者残留屈光度位于±0.5D 以内者分别为95.2%、93.3%、92.7%,明显高于Ⅰ组(78.8%),差异有显著统计学意义(χ2=16.329,P=0.001)。术后6mo时Ⅰ组haze的发生率高于其余三组,差异有显著统计学意义(Hc=50.110,P=0.000);各组术后角膜上皮细胞愈合时间之间比较,差异无统计学差异(χ2=11.611,P>0.05);术后各组角膜内皮细胞密度分别为3071.3±284.4个/mm2(Ⅰ组)、3105.6±337.8个/mm2(Ⅱ组)、2986.3±304.1个/mm2(Ⅲ组)、3088.7±372.5个/mm2(Ⅳ组),与术前比较差异无统计学意义(P>0.05);变异系数分别为24.72±6.52(Ⅰ组)、22.93±6.74(Ⅱ组)、24.38±6.63(Ⅲ组)、23.14±7.22(Ⅳ组),与术前比较无统计学差异(P>0.05)。
　　结论：LASEK联合MMC治疗超高度近视具有良好的效果和安全性,0.2 g/L MMC作用25 s的应用时间能有效抑制haze的形成,又能减少MMC潜在不良反应的发生率。     

糖尿病患者有临床意义黄斑水肿的OCT临床分型

目的 用光学相干断层扫描(OCT)研究糖尿病患者有临床意义的黄斑水肿(CSME)的临床分型.方法 对75例患者104只眼,经裂隙灯三面镜检查诊断为糖尿病性视网膜病变Ⅰ-Ⅳ期(包括Ⅳ期)者,行眼底荧光血管造影(FFA)及黄斑区光学相干断层扫描(OCT)检查,根据1985年CSME诊断标准诊断为CSME,对其OCT图像进行分型.结果 糖尿病患者CSME的OCT分型分为五型:弥漫性黄斑水肿占37.5%(39/104),黄斑囊样水肿占20.2%(211104),弥漫性黄斑水肿伴浆液性神经上皮层脱离占18.3%(191104),黄斑前膜伴神经上皮层水肿占13.5%(14/104),后玻璃体牵引伴黄斑水肿10.6%(11/104);另有黄斑前膜伴裂孔形成1例.结论 OCT对CSME的诊断以及治疗后的随访有重要的价值,是临床观察CSME必不可少的检查手段.     

复合式小梁切除术联合醛化脐带静脉管植入治疗难治性青光眼

目的:评价醛化脐带静脉管(human umbilical vein,HUV)在复合式小梁切除术中治疗难治性青光眼的临床疗效。方法:具有高危因素如新生血管、葡萄膜炎、无晶状体、人工晶状体和发育性的难治性青光眼28例28眼。15例行复合式小梁切除术联合巩膜瓣下HUV植入,13例行复合式小梁切除术。术后观察、比较的指标包括:手术成功率、术后眼内压(intraocular pressure,IOP)、抗青光眼药物使用数量以及术后并发症。所有研究对象随访12mo。结果:术后6mo,手术完全成功:HUV组12/15(80.0%),对照组8/13(61.5%);术后12mo,手术完全成功:HUV组11/15(73.3%),对照组6/13(46.2%)。术后12mo,HUV组和对照组IOP分别从术前50.9±12.2,49.7±11.7mmHg降至17.3±1.1,20.9±2.2mmHg(P=0.00)。由于滤过过强,对照组术后早期出现低眼压2例,HUV组无低眼压;对照组出现包裹性滤过泡4例,HUV组仅出现1例。结论:复合式小梁切除术联合HUV治疗难治性青光眼与复合式小梁切除术相比,具有手术成功率高,术后IOP控制良好、平稳,术后并发症发生率低的特点。     

Intraoperative mitomycin C 0.02% for pterygium: effect of duration of application on recurrence rate

PURPOSE: To compare the effect of a 3- and 5-minute intraoperative application of topical mitomycin C 0.02% on the recurrence of pterygium. METHODS: A comparative, prospective clinical design was used. The study population consisted of 134 consecutive patients with unilateral primary advanced pterygium (growth of 3 mm or more horizontally from the limbus). All underwent excision of the lesion, leaving the sclera bare. At completion of surgery, topical mitomycin C 0.02% was applied for 3 minutes in the first 60 patients (group A) and for 5 minutes in the remaining 74 patients (group B). The patients were followed for 26 months by slit-lamp biomicroscopic examination of the anterior segment. Recurrent pterygium was defined as the postoperative appearance of a fibrovascular tissue crossing the limbus. RESULTS: After 12 months of follow-up, pterygium recurred in 20 patients (33.3%) in group A and in two patients (2.7%) in group B. After 15 months, the recurrence rates were 36.6% and 5.4%, respectively, and remained unchanged at 26 months. There were no cases of drug toxicity in either group. CONCLUSIONS: Five-minute intraoperative application of a single dose of 0.02% mitomycin C is safe and more effective than a 3-minute application in recurrence of pterygium.     

眼科门诊药物临床试验标准操作规程探讨

目的:探讨眼科门诊进行药物临床试验的标准操作规程。方法:对南通大学附属医院已经在门诊完成的2种眼药水的药物临床试验方案设计、实施情况、受试者选择、知情同意、药物管理和质量控制等进行回顾。结果:两种药物临床试验得以成功完成。通过试验,探索出了一套眼科门诊进行药物临床试验工作的标准操作规程。结论:眼科门诊进行眼药水的药物临床试验与其他药物剂型及在住院患者中进行临床试验相比,有其特殊性,良好的方案设计、专人负责、严格按照GCP进行是保证药物临床试验顺利完成的关键。     

Understanding pre-market approval and labeling differences of two leading customized ablation platforms: a call for reform at the FDA

PURPOSE: To analyze the Food and Drug Administration (FDA) pre-market approval reported data for two currently available wavefront-guided excimer laser systems. METHODS: VISX and Alcon myopic wavefront laser in situ keratomileusis (LASIK) trials were analyzed based on public information available in the pre-market approval documents. RESULTS: Clinical tests and outcomes reporting varied between pre-market approvals. One pre-market approval reported contrast sensitivity whereas the other did not, although data was collected in both studies. Based on the FDA definition of "accountability," one pre-market approval reported 12-month accountability of 97.7% although only 24.5% of patients were analyzed at that interval. One pre-market approval reported 6-month results whereas the other reported 6- and 12-month results. One pre-market approval reported grouped pre- and postoperative subjective survey results; the other reported individual changes in pre- to postoperative subjective symptoms. CONCLUSION: We recommend an FDA revision to the definition of "accountability" and also recommend future FDA refractive surgery trials be guided by standardized criteria.     

A three‐year follow‐up of ranibizumab treatment of exudative AMD: impact on the outcome of carrying forward the last acuity observation in drop‐outs

Purpose: To analyse a 3‐year clinical patient cohort of ranibizumab treatment of exudative age‐related macular degeneration (AMD), to investigate the impact on visual outcome of carrying forward the last acuity observation in drop‐outs and to explore possible differences between the early and the late phase of the study. Methods: A retrospective study of 312 eyes with neovascular AMD. The patients were followed up monthly, received three initial monthly injections of 0.5 mg ranibizumab and were re‐treated pro re nata (PRN). Time‐domain optical coherence tomography (TD‐OCT) was used until spectral‐domain (SD)‐OCT was introduced during the last year of enrolment. Sixty‐five patients were discontinued from the study. Primary outcome: change in best corrected visual acuity (BCVA). Results: Best corrected visual acuity was 58.4 (CI 56.9–59.9) ETDRS (Early Treatment Diabetic Retinopathy Study) letters. At three months, it had increased by 4.1 letters (p = 0.0004), at 12 months by 1.8 letters, at 24 months by 1.0 letter and at 36 months by 0.1 letter. However, if the last available acuity of drop‐outs was carried forward one step and included, acuity had increased by 3.9 letters at 3 months (p < 0.0001) and by 1.0 letter at 12 months but had decreased by 3.8 letters at 24 months (p = 0.019) and by 4.1 letters (p = 0.003) at 36 months. At 24 months, the result was significantly (p = 0.030) less favourable when drop‐outs were included. In patients enrolled during the late phase, BCVA was 59.3 (CI 56.7–62.0). It had increased by 5.7 letters (p < 0.0001) at three months and by 5.8 letters at 12 months (p = 0.0016). In patients enrolled during the early phase, BCVA was 57.9 (CI 55.0–60.8). At three months, it had increased by 3.5 letters (p = 0.0008), but at 12 months, it had decreased by 2.3 letters (ns). The result at 12 months was significantly (p = 0.0033) better for the late than for the early phase. The number of injections was also significantly (p = 0.011) higher in the late phase. Adverse events were similar to those in earlier clinical trials. Conclusions: The results of this 3‐year cohort showed that the initial average acuity could be maintained over 36 months, which was comparable to those of many other clinical cohorts. However, if the last available acuity of drop‐outs was carried forward one step and included, the acuity figures would have fallen significantly. The results in patients enrolled during the late phase of the study were fairly similar to those in clinical trials.     

Clinical outcomes of the PAUL® glaucoma implant: One-year results

Background

To report one-year outcomes from a single-centre cohort undergoing PAUL® Glaucoma Implant (PGI) surgery.

Methods

Retrospective review of patients undergoing PGI surgery at the University Eye Hospital Bonn, Germany, from April 2021 to September 2021.

Results

Forty-five eyes of 41 patients were included. Qualified and complete success rates (95% CI) were 95.6% (88.9%–100%) and 73.3% (60%–86.7%) for Criterion A (IOP ≤ 21 mmHg), 84.4% (73.3%–93.3%) and 74.4% (51.1%–80.0%) for Criterion B (IOP ≤ 18 mmHg), 62.2% (48.9%–75.6%) and 46.7% (31.2%–62.2%) for Criterion C (IOP ≤ 15 mmHg) and 26.7% (13.3%–40.0%) and 22.2% (11.1%–33.3%) for Criterion D (IOP ≤ 12 mmHg), respectively. Mean IOP decreased from 26.1 mmHg (7–48 mmHg) to 12.0 mmHg (3–24 mmHg) (reduction of 48.83%) after 12 months with a reduction of IOP-lowering agents from 0.5 (0–3). One eye (2.2%) needed an injection of viscoelastic due to significant hypotony with AC shallowing, and four eyes (8.9%) developed choroidal detachments due to hypotony which resolved without further interventions after 6 weeks. Three patients (6.7%) developed tube exposure which required conjunctival revision with an additional pericardial patch graft. An intraluminal prolene stent was removed in 19 eyes (42.2%) after a mean time period of 8.4 months (2–12 m). Mean IOP before the removal was 21.9 mmHg (12–38 mmHg) and decreased to 11.3 mmHg (6–16 mmHg).

Conclusions

PGI surgery is an effective procedure for reducing IOP and pressure-lowering therapy. An intraluminal prolene stent impedes hypotony in the early postoperative phase and enables further IOP lowering without additional interventions during the postoperative course.     

儿童视力自动检测系统在婴幼儿视力评价 中的初步应用

目的：采用北京大学第一医院与北京大学信息科学技术学院、心理与认知科学学院共同研制开发的 儿童条栅视力自动检测系统（AACP）对婴幼儿视力进行测量,探讨该系统的应用价值。方法：前瞻 性临床研究。于2018年2月至2021年10月利用北京大学多个院系联合研制开发的AACP,对5个月 ~6岁儿童进行视力自动检测,并同时使用条栅视力检测卡（TAC-II）进行人工检测,将2种检测所得 结果做对比研究。采用Wilcoxon检验进行2种视力间的差异比较,Spearman相关进行相关性分析, Bland-Altman图进行一致性分析。结果：33例（66眼）3~6岁儿童全部完成AACP与TAC-II的双眼视 力检测,其中30例（54眼）儿童完成AACP与TAC-II的单眼视力检测,双眼视力检查完成率100%, 单眼检查完成率90.0%。194例（388眼）5~30个月龄婴幼儿中,141例（282眼）完成2种检测方法的双 眼视力检测并得到有效数据,完成率为72.7%。33例3~6岁儿童的AACP与TAC-II双眼视力及单眼视 力均呈正相关（r=0.40,P=0.021;r=0.55,P<0.001）。141例5~30月龄婴幼儿的AACP与TAC-II双眼 视力有较强的相关性（r=0.88,P<0.001）,相关系数高于3~6岁儿童,Bland-Altman图显示90.8%的点 在一致性范围内,不同月龄间AACP与TAC-II视力均存在明显正相关（r=0.82~0.94,均P<0.05）,不 同月龄间AACP视力差异有统计学意义（H=32.02,P<0.001）,视力随月龄增长而逐渐递增。结论： AACP与TAC-II所得到的婴幼儿视力结果存在正相关,在低年龄婴幼儿中有更好的相关性和一致性。 AACP有望成为适合临床条栅视力评估及婴幼儿视力筛查的检查工具。     

The effect of etanercept on Graves' ophthalmopathy: a pilot study

PURPOSE: To assess the effect of etanercept, an antitumour necrosis factor (anti-TNF) drug, on clinical signs in Graves' ophthalmopathy (GO). METHODS: A total of 10 consecutive patients (seven female, three male) with recent-onset, active, mildly-to-moderately severe GO were treated with subcutaneous injections of 25 mg etanercept (Enbrel) twice weekly during 12 weeks. The average age was 50 years (range: 39-59 years). The average duration of GO was 4 months (range: 2-6 months). All patients were at least 2 months euthyroid with medication. The mean pretreatment clinical activity score (CAS) was 4 (range: 3-6). RESULTS: The mean CAS prior to treatment was 4, at 6 weeks 2.6, and at 12 weeks 1.6. The mean ophthalmopathy index (OI) prior to treatment was 5.8, at 6 weeks 4.8, and at 12 weeks 4.4. Thus, after 12 weeks of treatment the mean CAS had decreased by 2.4+/-1.3 (60%), and the mean OI had decreased by 1.4+/-1.2 (24%). The main decrease of the CAS and OI was noted at 6 weeks of treatment. The difference was particularly evident on soft-tissue changes, including periocular chemosis and redness. The mean exophthalmometry values did not change. In all, 60% percent of patients reported moderate to marked improvement. In three patients, the GO flared up again after cessation of treatment. There were no serious adverse events or side effects during a mean follow-up time of 18 months. CONCLUSIONS: This study strongly suggests that etanercept may suppress the clinical signs in GO, but randomized controlled trials are needed to further evaluate the effect of anti-TNF treatment and to compare its side-effects with those of corticosteroids.     

从循证医学角度分析中华眼科杂志已发表临床疗效研究论文的质量

目的探讨我国眼科领域的临床疗效研究水平,为循证医学(EBM)研究提供可靠证据。方法按照EBM标准,对中华眼科杂志1983—2002年间,发表的全部涉及临床疗效的论文进行检索和分析。结果临床疗效研究论文共152篇;其中属于随机对照试验35篇,临床对照试验8篇,共计43篇,占临床疗效研究论文的28．1％,且在随机分组、对照设置、盲法、基线资料、随访、失访、并发症报告及统计分析等方面均存在较多问题。在属于对照实验的论文中,有10篇(23．3％)论文描述了随机或半随机分组的具体方法;采用安慰剂对照和开放对照的文章分别是3篇(7．0％)和9篇(20．9％);盲法研究性论文7篇(16．3％);有随访结果,并提供较为详细随访资料的论文25篇(58．1％);未见分析混杂、偏倚、干扰和沾染等因素影响临床疗效研究质量的论文;未见在项目设计时进行了样本含量估算的论文;15篇(34．9％)论文中的部分或全部数据未标明显著性检验方法,仅有P值。结论我国眼科领域的部分临床科研设计方法不够严谨,从而影响研究结果的真实性和可靠性。重视对眼科医师进行临床科研设计方法的培训,严格控制研究质量,对提高我国的临床疗效研究水平至关重要。     

影响外源性眼内炎患者眼内液细菌培养阳性率的相关因素与药敏分析

目的 探究外源性感染性眼内炎患者眼内液中细菌培养阳性率的影响因素、病原菌构成及耐药情况,为外源性眼内炎提供有效的诊疗依据,指导临床合理用药。方法 回顾性收集并分析2011年5月至2021年5月在浙江省人民医院确诊、治疗且随访4～6个月的外源性感染性眼内炎患者的眼内液标本,共收集69眼的105例标本。记录性别、年龄、病程、发病季节、病因、入院视力、标本来源、手术次数、眼内异物状态、玻璃体内抗生素注射史、全身抗生素使用史、基础疾病等,并用二元logistic回归模型对细菌培养阳性率的相关影响因素进行分析。对获取的细菌培养及药敏试验结果进行统计分析。结果 培养阳性者眼内液标本种类、眼内异物状态、内眼手术后眼内炎、玻璃体内抗生素注射史、全身抗生素使用史的患者比例均高于培养阴性者(均为P<0.05)。二元logistic回归分析结果显示,玻璃体内标本(P<0.001)、眼内异物状态(P=0.020)、玻璃体内抗生素注射史(P=0.007)是眼内液细菌培养阳性的相关影响因素。36株外源性眼内炎致病菌中,革兰阳性菌占75.0%(27株),其中凝固酶阴性葡萄球菌占66.7%(18株)。未检...