雷珠单抗玻璃体内注射治疗早产儿视网膜病变

〔摘 要〕 目的：探讨雷珠单抗玻璃体内注射治疗对早产儿视网膜病变（ROP）患儿视网膜功能发育的影响。 方法：选取2019 年 2 月至 2021 年 2 月南昌大学第二附属医院收治的 ROP 患儿 106 例（共 212 眼）,按照计算机分组法将其分为激光组（激光手术方案,53 例,106 眼）和雷珠组（璃体内注射雷珠单抗方案,53 例,106 眼）。观察两组患儿临床疗效、视网膜功能发育情况。 结果：雷珠组患儿治疗总有效率为 92.45 %,高于激光组的 77.36 %,差异具有统计学意义（P ＜ 0.05）。治疗后,雷珠组患儿视锥细胞 b 波振幅、视杆细胞 b 波振幅均高于激光组,血管内皮生长因子 A 水平低于激光组,差异均具有统计学意义（P ＜ 0.05）。术后,两组患者不良事件发生率比较差异无统计学意义（P ＞ 0.05）。 结论：相比激光手术,玻璃体内注射雷珠单抗治疗 ROP 能提高临床疗效,更易促进患儿视网膜功能发育,且安全性较高。     

雷珠单抗治疗白内障术后黄斑囊样水肿的效果

目的 探讨玻璃体腔注射雷珠单抗治疗白内障术后人工晶体眼黄斑囊样水肿(PCME)的有效性和安全性.方法 对5例局部激素和非甾体类消炎药治疗无效的PCME患者采用玻璃体腔注射雷珠单抗治疗.比较治疗前后最佳矫正视力(BCVA)和中央视网膜厚度(CRT).结果 与治疗前比较,治疗后BCVA和CRT均改善[0.18±0.06 vs.0.62±0.11和(730.80±42.66) μmvs.(245.80±18.54) μm](P＜0.01).随访5-12个月,未见复发,亦无局部和全身不良反应.结论 玻璃体腔注射雷珠单抗是一种安全有效的治疗PCME的方法.     

Comparison of intravitreal ranibizumab between phakic and pseudophakic neovascular age-related macular degeneration patients: Two-year results

Background and objective

To compare the efficacy of intravitreal ranibizumab (IVR) for the treatment of neovascular age-related macular degeneration (nAMD) between phakic and pseudophakic eyes after a follow-up of two years.

Materials and methods

Data were analyzed retrospectively. The newly diagnosed and treatment naïve nAMD patients were included in the study. The patients were divided into two subgroups: phakic group, and pseudophakic. All patients received 3 consecutive monthly IVR injections, and then the treatment was continued on an as-needed regimen. Patients were examined monthly, and the data at the baseline, at month 6, 12, 18, and 24 were evaluated. The changes in best corrected visual acuity (BCVA), central retinal thickness (CRT), and the number of injections were compared between the two groups.

Results

The study included 92 eyes of 87 patients (58 phakic, 34 pseudophakic). Mean logarithm of the minimal angle of resolution (LogMAR) VA at the baseline, and at month 6, 12, 18, and 24 was 0.89, 0.74, 0.75, 0.73, and 0.75, in the phakic group; and 0.79, 0.71, 0.66, 0.70, and 0.70 in the pseudophakic group, respectively. The change in mean BCVA from the baseline to month 6, 12, 18, and 24 was not statistically different between the two groups (p = 0.4, p = 0.9, p = 0.5, p = 0.6, respectively). Mean injection number at month 24 was 7.9 and 8.1 in the phakic and pseudophakic group, respectively (p = 0.7).

Conclusion

Intravitreal ranibizumab treatment on an as-needed treatment regimen is effective in preserving vision and improving central retinal thickness in both the phakic and pseudophakic group of nAMD patients. The functional and anatomical outcomes of the treatment, and the number of injections were similar in the phakic and pseudophakic nAMD patients after a follow-up time of 24 months.     

Clinical efficacy and safety of Razumab® (CESAR) study: Our experience with the world's first biosimilar Ranibizumab

Purpose:The aim of this study was to evaluate the efficacy and safety of Razumab (the biosimilar Ranibizumab by Intas Pharmaceuticals Ltd.) for the treatment of chorioretinal vascular diseases such as diabetic macular edema (DME), choroidal neovascular membrane (CNVM), and macular edema secondary to retinal vein occlusion (RVO).Methods:We conducted a single-center, retrospective study, including patients with DME, CNVM, and RVO, who had received treatment with Razumab® between October 2018 and September 2019. Primary outcome measures were the changes in corrected distance visual acuity (CDVA) and central foveal thickness (CFT) from baseline to 1 month and 3 months. Secondary outcome measures included intraocular pressure (IOP) at day 1, any signs of ocular inflammation or systemic adverse events during the follow-up.Results:One hundred and fifty-three eyes of 141 patients were analyzed. The indications included DME in 70 (45.8%) eyes, CNVM in 70 (45.8%) eyes, and RVO in 13 (8.4%) eyes. Mean CDVA improved from baseline (0.62 ± 0.44) to month 1 (0.45 ± 0.42) and maintained till 3 months (0.42 ± 0.44; P < 0.001). Mean CFT showed significant reduction from baseline (405.68 ± 192.422 μm) to month 1 (286.08 ± 118.36 μm) and month 3 (271 ± 104.24 μm; P < 0.001). None of the eyes recorded IOP >20 mmHg on day 1. No evidence of ocular toxicity or systemic adverse event was noted.Conclusion:Razumab® showed a rapid improvement in CDVA and CFT in most of the eyes with efficacy observed as early as 1 month and maintained till 3 months. The biosimilar Ranibizumab can be a safe and effective low-cost drug for treating macular diseases.     

雷珠单抗治疗伴或不伴视网膜前出血的ROP的疗效观察

目的:对比研究玻璃体腔注射雷珠单抗治疗伴或不伴视网膜前出血(PRH)的早产儿视网膜病变(ROP)的疗效。方法:收集2017-04/2018-01在本院行玻璃体腔注射雷珠单抗治疗的ROP患儿34例66眼进行回顾性分析研究。将所有患儿按照有无PRH分成两组:ROP伴PRH组26眼与ROP不伴PRH组40眼。所有患儿均在表面麻醉下行玻璃体腔注射雷珠单抗,对患儿术后情况进行观察,分析两组患儿的一次治愈及需要二次治疗情况。结果:经过首次玻璃体腔注射雷珠单抗治疗后随访至12mo,ROP伴PRH组和ROP不伴PRH组患儿一次治愈构成比分别为65%(17眼)和98%(39眼),需要二次治疗的构成比分别为35%(9眼)和2%(1眼)。需要二次治疗病例经过二次玻璃体腔注射雷珠单抗药物治疗,均全部治愈。两组间的一次治愈构成比有差异(P<0.05)。结论:玻璃体腔注射雷珠单抗治疗伴PRH的ROP的一次治愈效果明显低于不伴PRH的ROP的患儿,需要二次治疗病例经过再次玻璃体腔注射雷珠单抗治疗可以得到治愈。     

Assessment of Patient Pain Experience during Intravitreal 27-Gauge Bevacizumab and 30-Gauge Ranibizumab Injection

PurposeTo compare pain scores of patients during intravitreal 27-gauge bevacizumab and 30-gauge ranibizumab injection procedures.MethodsSeventy eyes of 70 patients who had not previously undergone intravitreal anti-vascular endothelial growth factor therapy were included in this study. Thirty-five patients received ranibizumab and 35 patients received bevacizumab. The diagnoses of the patients were: 27 age related macular degeneration, 15 diabetic macular edema, 9 diabetic vitreous hemorrhage, 6 central retinal vein occlusion, 11 branch retinal vein occlusion and 2 central serous chorioretinopathy. Bevacizumab (1.25 mg/0.05 mL) was injected into the vitreous cavity using a 27-gauge needle, and ranibizumab (0.5 mg/0.05 mL) was injected with 30-gauge needle. Patients were asked just after the injection to rate their perceived pain during the injection using the visual analogue scale (VAS) of 0 (no pain) to 10 (unbearable/worst pain). The average of these scores was used as the primary outcome.ResultsThe VAS pain scores in the ranibizumab and bevacizumab groups were 1.06 ± 0.91 (range, 0 to 3) and 1.94 ± 1.55 (range, 0 to 7), respectively, a significant difference (p = 0.005). Patients <65 and ≥65 years of age in both the ranibizumab and bevacizumab groups were then compared. For patients <65, there was a significant difference in the average VAS pain scores between groups (p = 0.003). However, for patients ≥65 years, there was not a significant difference in the average VAS pain scores between groups (p = 0.238). Female and male patients in both ranibizumab and bevacizumab groups were also compared. For female patients, there was a significant difference in the average VAS pain scores between groups (p = 0.016), although not for male patients (p = 0.078).ConclusionsThirty-gauge intravitreal injection is more comfortable than 27-gauge injection. Injection of bevacizumab with 30-gauge needle syringes may be more tolerable for patients.     

光动力学疗法联合雷珠单抗对比雷珠单抗治疗湿性AMD有效性和安全性的Meta分析

目的 系统评价光动力学疗法联合雷珠单抗对比雷珠单抗单独治疗湿性AMD的有效性和安全性.方法 Meta分析.检索美国国立医学图书馆、荷兰医学文摘、循证医学数据库、中国期刊全文数据库、万方数据库,共纳入6篇随机对照试验,共626眼,其中单纯注药组323眼,联合治疗组303眼.遵循Cochrane Handbook 5.0质量评价原则评价纳入研究的质量,然后采用Revman 5.0软件进行统计学处理.结果 Meta分析结果显示：①最佳矫正视力（EDTRS）：治疗1年后,单纯注药组视力改善效果好于联合治疗组,差异有统计学意义[WMD=-2.84,95％CI（0.25～5.43）,P＜0.05].其中单纯注药组比联合治疗组最佳矫正视力提高≥15个视标的发生率更高,差异有统计学意义[W MD=0.66,95％CI（0.45～0.96）,P＜0.05];而2组最佳矫正视力丢失≥15个视标的发生率比较,差异无统计学意义[WMD=1.37,95％CI（0.78～2.41）,P＞0.05].②中央视网膜厚度：治疗1年后,2组视网膜厚度变化比较,差异无统计学意义[WMD=-3.17,95％CI（-25.64～31.97）,P＞0.05].③病灶大小：治疗1年后,2组病灶大小变化比较,差异无统计学意义[WMD=0.24,95％CI（-0.38～0.86）,P＞0.05].④注药次数：治疗1年后,2组注药次数比较,差异无统计学意义[W MD=-1.00,95％CI （-2.56～0.56）,P＞0.05].⑤并发症：视网膜出血：联合治疗组比单纯注药组视网膜出血的发生率更高,差异有统计学意义[RR=2.65,95％CI（1.04～6.71）,P＜0.05].结论 单独雷珠单抗相比光动力学疗法联合雷珠单抗治疗湿性AMD改善最佳矫正视力的效果更好,但在视网膜厚度、病灶大小、注药次数方面,两者的差异无统计学意义.联合治疗并发视网膜出血的风险较高.     

Ranibizumab治疗湿性年龄相关性黄斑变性的安全性分析

湿性年龄相关性黄斑变性（AMD）的主要病理改变为脉络膜新生血管（CNV）的形成,血管内皮生长因子（VEGF）水平的升高是其重要的发病机制之一。Ranibizumab是一种重组人源化抗VEGF单克隆抗体片段,能够抑制新生血管形成,玻璃体腔内注射ranibizumab治疗湿性AMD的疗效已得到多项临床研究的证实。此外,玻璃体腔内注射ranibizumab的耐受性良好,眼内与全身不良反应的风险未显著增加。其主要眼内不良事件为眼部炎症和一过性眼压升高,但发生率较低。主要的严重眼内不良事件的发生率〈4％。Ranibizumab应用后心脑血管意外的发生风险无显著增加,采取在每月随访监测的基础上降低注射频率的方法可能得到最佳的风险获益比。就近年来湿性AMD患者应用ranibizumab治疗的临床试验为基础,从循证医学角度讨论其玻璃体腔内注射的安全性。     

抗VEGF联合视网膜光凝在治疗PDR中的相互影响和协同作用

目的：观察雷珠单抗联合激光在治疗增生期糖尿病视网膜病变(proliferative diabetic retinopathy, PDR)过程中的相互影响作用。

方法：2014-12/2015-08同期收治的增生期糖尿病视网膜病变合并黄斑水肿患者分为两组。雷珠单抗联合激光治疗组30例48眼,单纯激光组28例45眼。联合治疗组在玻璃体腔注射雷珠单抗后1wk,复查FFA,随后进行全视网膜光凝。单纯激光组仅行全视网膜光凝。观察和记录两组患者治疗后1、4、8wk时的最佳矫正视力,OCT测量黄斑厚度。

结果：治疗后1、4、8wk时,两组间最佳矫正视力、黄斑中心厚度差异均有统计学意义(P<0.05)。单纯激光组治疗后1wk后,视力有所下降,黄斑中心厚度增加。治疗后4、8wk时,视力逐渐改善,黄斑厚度降低。注药后1wk,FFA显示联合治疗组所有眼视网膜渗漏改善,新生血管膜不同程度退缩。未见眼内注射和眼底激光导致的相关并发症等情况。

结论：雷珠单抗联合激光治疗,早期即可改善患者视力,减轻黄斑水肿。抗VEGF治疗和激光光凝可在一定程度上起到协同作用。前者拮抗已经高表达的VEGF,改善黄斑水肿和微血管功能,增强激光疗效。有效的光凝又可进一步改善视网膜缺血缺氧状态,抑制VEGF的过多表达。