专家共识

眼科感染性疾病临时配制滴眼液的配制与使用专家共识

Expert consensus on the preparation and use of temporarily compounded eye drops for eye infectious diseases

:507-514
 
在感染性眼科疾病的诊疗过程中,商品化眼用制剂尚未能完全满足临床治疗需求,在治疗一些现有眼用制剂未能满足治疗需求的感染性眼病时,需要采用临时配制的滴眼液来进行治疗。由于目前国内尚无临时配制滴眼液的规范或者标准,广东省药学会眼科药学专家委员会组织相关专家讨论,制定了治疗感染性眼部疾病临时配制滴眼液专家共识,以提升临床所需临配制剂的可及性,供国内从事临时配制滴眼液相关工作的同行借鉴。
Commercial eye drops fail to fully meet the therapeutic requirements for infectious ocular diseases. When treating certain infectious ocular diseases where existing ophthalmic preparations are inadequate, extemporaneously prepared eye drops become necessary. Given the absence of regulations or standards for extemporaneously prepared eye drops in China, the Ophthalmic Pharmacy Expert Committee of the Guangdong Pharmaceutical Association organized relevant experts relevant experts to establish a standard for the extemporaneous preparation of eye drops after rigorous discussions. This initiative aims to enhance the accessibility of extemporaneously prepared eye drops and provide reference for ophthalmologists, pharmacy workers, and users of ophthalmic extemporaneously preparations.
论著

白内障手术患者围手术期非甾体抗炎滴眼液使用合理性分析

Analysis of the rational use of nonsteroidal antiinflammatory eye drops in perioperative patients undergoing cataract surgery

:515-521
 
目的: 探讨白内障手术患者围手术期非甾体抗炎药(non-steroidal anti-inflammatory drugs, NSAIDs)滴眼液应用的合理性,为优化临床用药方案提供依据。方法:采用回顾性研究方法,分析郑州市第二人民医院2024年100例(100眼)行白内障超声乳化并人工晶状体植入手术患者的临床数据,依据药品说明书、《我国白内障围手术期非感染性炎症反应防治专家共识(2015年)》《中国成人白内障摘除手术指南(2023年)》《中国激光角膜屈光手术围手术期用药专家共识(2024年)》等指南/共识制定评价标准,评价NSAIDs滴眼液的用药频次、疗程及术前预防性抗炎处理的规范性。结果:35%的病例存在用药不合理,共发现88项问题,包括用药频次错误(7.96%)、超疗程(22.72%)及术前用药不当(69.32%)。其中,65%糖尿病患者术前未启动NSAIDs预处理,41%非糖尿病患者术前1 d使用NSAIDs;溴芬酸钠滴眼液疗程超过10天者占20.45%,可能增加肝损伤风险。结论:医疗机构应采取积极有效措施,如制定个体化用药方案、加强合理用药培训、开展专项处方点评等,切实促进NSAIDs滴眼液在白内障手术患者围手术期的合理使用,保障患者的用药安全与治疗效果,提高医疗服务质量和患者满意度。
Objective: To investigate the rationality of perioperative application of non-steroidal anti-inflammatory drugs (NSAIDs) eye drops in patients undergoing cataract surgery, thereby providing evidence for optimizing clinical medication protocols. Methods: A retrospective study method was used to analyse the clinical data of 100 patients (100 eyes) who underwent cataract ultrasonoemulsification with IOL implantation in 2024 at the Second People's Hospital of Zhengzhou City, and the evaluation criteria were developed based on the instructions of the medication, the Chinese expert consensus on prevention and management of non-infectious inflammatory responses in the perioperative period of cataract surgery (2015), the Chinese guideline for cataract surgery in adults (2023), and the Chinese expert consensus on the perioperative medication in laser corneal refractive surgery(2024)" and other guidelines/consensus to develop evaluation criteria to evaluate the standardisation of NSAIDs eye drops in terms of frequency of dosing, duration of treatment, and preoperative prophylactic anti-inflammatory treatment. Results: Irrational medication use was identified in 35% of cases, with a total of 88 issues categorized as follows: incorrect dosage frequency (7.96%), prolonged treatment duration (22.72%), and inappropriate preoperative medication (69.32%). Notably, 65% of diabetic patients failed to initiate NSAIDs pretreatment preoperatively as recommended by guidelines, while 41% of non-diabetic patients received NSAIDs one day before surgery. Prolonged use of bromfenac eye drops (>10 days) was observed in 20.45% of cases, potentially increasing the risk of liver injury. Conclusions: Medical institutions should take active and effective measures, such as formulating individualised medication plans, strengthening training on rational use of medication, and carrying out special prescription reviews, etc., to effectively promote the rational use of NSAIDs eye drops in the perioperative period of patients undergoing cataract surgery, to safeguard the safety of patients' use of medication and therapeutic efficacy, and to improve the quality of healthcare services and patients' satisfaction.
论著

高效液相色谱法测定曲伏前列素滴眼液中曲伏前列素含量

Determination of content of travoprost in travoprost eye drops by HPLC

:600-607
 
目的:建立高效液相色谱法(high-performance liquid chromatography, HPLC)测定曲伏前列素滴眼液中曲伏前列素含量。方法:采用Dikma C18色谱柱(50 mm×4.6 mm, 3 μm);以磷酸溶液(取磷酸1.0 mL,用水稀释至1 000 mL,用1 mol/L氢氧化钠溶液调节pH至2.8)-乙腈(67:33)为流动相;流速为每分钟3.0 mL;柱温为25℃;检测波长为220 nm;进样体积30 μL。结果:曲伏前列素在20.28~70.98 μg /mL(= 0.999 5)范围内线性关系良好,平均回收率为100.3%,相对标准偏差(relative standard deviatio, RSD)为2.0% (= 9),该方法重现性好。对照品溶液和供试品溶液在室温放置48 h基本稳定。结论:该方法可用于曲伏前列素滴眼液中的曲伏前列素含量测定。
Objective: To establish a high-performance liquid chromatography (HPLC) method for the determination of content of Travoprost in Travoprost Eye Drops. Methods: The analytic column was Dikma C18 (50 mm×4.6 mm, 3 μm) . Using phosphoric acid solution (take 1.0 mL of phosphoric acid, dilute with water and make up to 1 000 mL, adjust the pH to 2.8 with 1 mol/L sodium hydroxide solution)-acetonitrile (67:33) as mobile phase. The flow rate is 3.0 mL/min. The column temperature is 25 ℃; The detection wavelength is 220 nm. The injection volume is 30 μL. Results: The linear range of travoprost showed were well shown within 20.28-70.98 μg/mL(r=0.998). The average recovery rate of travoprost was 100.3% with relative standard deviation (RSD) 2.0% (n=9). The method had high reproducibility. The reference solution and the test solution remain stable at room temperature for 48 hours. Conclusion: The method can be used for the determination of content of travoprost in Travoprost Eye Drops.
论著

高效液相色谱法测定曲伏噻吗滴眼液中曲伏前列素有关物质

Determination of related substances of travoprost in travoprost and timolol maleate eye drops by HPLC

:471-482
 
目的:建立高效液相色谱法(high-performance liquid chromatography,HPLC)测定曲伏噻吗滴眼液中曲伏前列素有关物质。方法:采用Agilent SB-C18色谱柱(50 mm×2.1 mm,2.7 μm);以磷酸溶液(取磷酸2.0 mL,加水稀释并定容至1 000 mL,用氢氧化钠溶液调节pH至3.0)为流动相A,乙腈为流动相B,洗脱梯度;流速为每分钟3.0 mL;柱温为30 ℃;检测波长为220 nm;进样体积100 μL。结果:在该色谱条件下,曲伏前列素与各杂质均可良好分离;在酸、碱、氧化、高温和强光破坏条件下,曲伏前列素峰纯度合格,物料守恒。曲伏前列素、5,6-反式曲伏前列素和15-酮曲伏前列素分别在0.041~3.245 μg/mL(r=1.000 0)、0.040~3.229 μg/mL(r=1.000 0)、0.039~3.088 μg/mL(r=0.999 9)范围内线性关系良好,其最低检测限分别为0.020、0.020和0.020 μg/mL;6份样品中5,6-反式曲伏前列素的含量相对标准偏差(relative standard deviatio,RSD)为0.2% (n=6),15-酮曲伏前列素的含量RSD为0.3% (n=6),重复性良好;对照品溶液和供试品溶液在室温条件下放置100h稳定,5,6-反式曲伏前列素的平均回收率为95.2%,相对标准偏差RSD为0.5% (n=9),15-酮曲伏前列素的平均回收率为92.7%,RSD为1.2% (n=9)该方法重现性好。结论:本方法简便、快速、准确。适用于检测曲伏噻吗滴眼液中的曲伏前列素有关物质。
Objective: To develop a high-performance liquid chromatography (HPLC) method for the determination of related substances in Travoprost and Timolol Maleate Eye Drops, sepcifically focusing on Travoprost and its impurities. Methods: The analytic column used was an Agilent SB-C18 (50 mm × 2.1 mm,2.7 μm) . A phosphoric acid solution (prepared by diluting 2.0 mL of phosphoric acid with water tto final volume of 1,000 mL and adjust the pH to 3.0 with sodium hydroxide solution) was used as mobile phase A, while acetonitrile served as mobile phase B. The elution was performed using a gradient program at a flow rate of 3.0 mL/min. The detection wavelength was set at 220 nm, and the column temperature was maintained at 30 ℃. The injection volume is 100 μL. Results: Under the described chromatographic condition, Travoprost and its various impurities were well separated. The purity of the Travoprost peak was qualified, and the material remained stable under conditions of acid, alkali, oxidation, high temperature, and strong light exposure. The linear ranges for Travoprost, 5,6-trans-Travoprost, and 15-keto-Travoprost were determined to be 0.041~3.245 μg/mL(r=1.0000), 0.040~3.229 μg/mL(r=1.0000), 0.039~3.088 μg/mL(r=0.9999), respectively. The lowest detection limits for these compounds were all 0.020 μg/mL, The relative standard deviation (RSD) for the content of 5,6-trans-travoprost and 15 keto trovopros in six samples were 0.2% (n=6) and 0.3% (n=6), respectively, indicating good reproducibility. Both the reference solution and the test solution remained stable at room temperature for 100 hours,The average recovery rates for 5,6-trans-Travoprost and 15-keto-Travoprost were 95.2% (RSD 0.5%,n=9) and 92.7% (RSD 1.2%, n=9) respectively, further confirming the high reproducibility of the method. Conclusions: The developed HPLC method is simple, rapid, and accurate, making it suitable for the determination of related substances in Travoprost and Timolol Maleate Eye Drops.
论著

基于 OpenFDA 数据库的盐酸环喷托酯滴眼液不良反应信号检索与分析

Retrieval and analysis of cyclopentolate hydrochloride eye drops related adverse drug reaction signals based on OpenFDA

:331-339
 

目的:利用美国食品药品监督管理局公共数据开放项目(OpenFDA)检索并分析盐酸环喷托酯滴眼液药品不良反应adverse drug reactionsADRs的报告情况,为临床安全用药提供参考 方法: 盐酸环喷托酯滴眼液作为检索词,在OpenFDA数据库中检索200411日至202481日期间盐酸环喷托酯滴眼液相关ADRs的所有信息,对检索到的数据进行分析。 结果:共检索到盐酸环喷托酯滴眼液相关ADRs 11851185患者中,剔除性别不详,女性男性分别为516和48343.54% vs 40.76%;剔除年龄不详后,ADRs发生率较高的是65~<80患者221例,18.65%50~<65患者176例,14.85%3~<13患者140例,11.81%)。盐酸环喷托酯滴眼液发生率较高ADRs眼器官疾病(767例,64.73%神经系统疾病(254例,21.43%及胃肠系统疾病(228例,19.24% 结论:盐酸环喷托酯滴眼液可发生眼局部和全身ADRs临床在使用时应详细询问患者疾病史和用药史,加强用药监护,提高患者用药的安全性。

Objective: To retrieve and analyze adverse drug reactions (ADRs) of cyclopentolate hydrochloride eye drops on the US Food and drug Administration Public Data Open Project (OpenFDA), so as to provide reference for clinical rational drug use. Methods: Using "Cyclopentolate hydrochloride eye drops" as the search term, retrieve all information related to ADRs of cyclopentolate hydrochloride eye drops from the OpenFDA database from January 1, 2004 to August 1, 2024, and analyze the retrieved data  Results: A total of 1 185 cases of ADRs associated with cyclopentolate hydrochloride eye drops were found. Among the 1185 patients, 516 were female and 483 were male ( 43.54 % vs 40.76 % ) after excluding the unknown gender. After excluding patients with unknown age, the incidence of ADRs was higher in patients aged 65~ < 80 years old ( 221 cases, 18.65 % ), 50~< 65 years old ( 176 cases, 14.85 % ), and 3~ < 13 years old ( 140 cases, 11.81 % ). The ADRs with high incidence of cyclopentolate hydrochloride eye drops were ocular organ diseases ( 767 cases, 64.73 % ), nervous system diseases ( 254 cases, 21.43 % ) and gastrointestinal system diseases ( 228 cases, 19.24 % ). Conclusions: Cyclopentolate hydrochloride eye drops can cause local and systemic adverse reactions. In clinical use, the patient 's disease history and medication history should be asked in detail, and medication monitoring should be strengthened to improve the safety of patient medication.

论著

3种滴眼液对麻醉小鼠可逆性白内障的保护作用

Effect of eye drops on the development of cataract in anesthetized mice

:60-63
 
目的:探讨3种不同的滴眼液在麻醉小鼠晶状体浑浊中的保护作用。方法:将20只6周龄C57BL/6j小鼠分为4组,A组为自然暴露组(对照组),B组为滴用透明质酸钠组,C组为滴用甲基纤维素滴眼液组,D组为滴用生理盐水组。分别于麻醉后10,20,30,45和60 min观察小鼠晶状体浑浊情况。结果:与A组相比,3种滴眼液均不同程度地延长小鼠晶状体浑浊的时间;30 min时,4组小鼠浑浊 发生率分别为90%,50%,50%和10%,并延缓晶状体浑浊的进展;60 min时,4组小鼠3级浑浊的发生率为30%,10%,10%和0,其中生理盐水的作用效果最优,可以明显延迟晶状体变浑浊的时间。结论:麻醉小鼠的晶状体浑浊程度可以被相关滴眼液延缓,适用于短时间的眼科检查和处理,又因其经济易得,可广泛应用于小鼠活体的眼科检查中。
Objective: To study the effect of saline, carboxymethylcellulose sodium eye drops and sodium hyaluronate gel to stop the development of cataract in anesthetized mice. Methods: Twenty C57BL/6j mice, aged 6 weeks, were divided into four groups, group A was naturally exposed to air, group B was treated with sodium hyaluronate gel, group C was treated with carboxymethylcellulose sodium eye drops and group D was treated with saline. The lens opacity was observed at 10, 20, 30, 45 and 60 min after the start of the experiment. Results: Compared with group A, the eye drops delayed the development of lens opacity in varying degrees. At 30 min, the incidence rate of cataract in group A, B, C and D was 90%, 50%, 50% and 10%, respectively. At 60 min, the incidence rate of grade 3 cataract in group A, B, C and D was 30%, 10%, 10% and 0 respectively, saline did the best, which can significantly slow the process. Conclusion: Cataract development can be slowed by the protective eye drops. This finding is relevant for those experimental settings in which clear ocular media are required. 
眼科麻醉专题

盐酸奥布卡因滴眼液在眼科临床中的应用

Research progress on the application of oxybuprocaine hydrochloride eye drops in ophthalmology

:563-570
 
大部分眼科手术/操作具有创伤小、疼痛刺激轻等特点,因此,选择眼表面麻醉即可满足手术的镇痛的需要,促进了眼科日间手术的广泛开展。其中,盐酸奥布卡因滴眼液是常用的眼科表面麻醉剂,具有麻醉起效迅速、镇痛作用强、持续时间久(约13 min)等特点,已经广泛应用在眼内手术中,在使用过程中,盐酸奥布卡因滴眼液对瞳孔及血管无影响,保证了眼内手术的安全。盐酸奥布卡因滴眼液能提供良好的眼表环境,对角膜厚度及角膜上皮厚度影响轻微,从而满足屈光手术的需要。此外,盐酸奥布卡因滴眼液能提供良好的术后镇痛,减少术后镇痛药物的使用,降低斜视术后患儿的躁动发生率。不含防腐剂的表面麻醉剂不影响麻醉剂的起效时间及镇痛效果,对眼表的影响轻微,从而创造良好的手术操作环境,提高手术效果,降低并发症和手术风险,是眼科手术中较为理想的表面麻醉药物。文章就盐酸奥布卡因滴眼液的作用机制及麻醉效果、药代动力学、临床疗效、安全性等进行综述。
Most ophthalmic surgeries are characterized by small incisions and mild pain, therein, the choice of topical anesthesia can meet the needs of surgeries and accelerate ophthalmic surgeries to be conducted in day surgery model. 0.4% oxybuprocaine hydrochloride eye drops is one of commonly used topical anesthetics for ophthalmic surgery, which has the characteristics of rapid onset and sufficient analgesia with long duration (about 13 minutes). Oxybuprocaine hydrochloride eye drops has been widely and safely used in intraocular surgery without affecting the pupil and blood vessels. Meanwhile, oxybuprocaine hydrochloride eye drops has negligible effects on corneal thickness and corneal epithelial thickness to meet the needs of refractive surgery. In addition, oxybuprocaine hydrochloride eye drops can provide sufficient postoperative analgesia, reduce the use of postoperative analgesics and the incidence of emergence agitation in children after strabismus surgery. The preservative-free topical anesthetic would be one of ideal topical anesthetics as it can provide a good surgical condition and reduce complications and risks of post-operative infections without changing the onset time and analgesia effects. This article provides a review of the mechanism, analgesia, pharmacokinetics, clinical efficacy, and safety profiles of 0.4% oxybuprocaine hydrochloride eye drops.
综述

2019年血源性滴眼液治疗重度干眼专家共识解读

Interpretation of expert consensus on the treatment of severe dry eye with blood-based eye drops in 2019

:293-298
 
血源性滴眼液是治疗干眼的一种有效的治疗方法。来源可分为自体、供体,其中供体来源又可分为成人外周血及脐带血,并以血清、富血小板血浆、血小板来源生长因子以及血小板裂解产物的形式制成。由于各种血液制品的原理及适应症不同,本文将对不同血源性滴眼液制品的制备及面临的挑战的共识问题进行解读。
Blood-based eye drops can be used effectively in the treatment of dry eyes. The sources of blood-based eye drops can be divided into autologous and donor, and donor sources can be divided into adult peripheral blood and umbilical cord blood, which are prepared in the form of serum, platelet-rich plasma, platelet-derived growth facters and platelet lysate. Due to the different principles and indications of various blood products, the consensus issues on the preparation and challenges of different blood-based eye drop products are reviewed.
论著

高效液相色谱法同时测定盐酸丁卡因滴眼液中盐酸丁卡因和羟苯乙酯的含量

Determination of tetracaine hydrochloride and ethyl hydrobenzoate in tetracaine hydrochloride eye drops by HPLC

:291-297
 
目的:建立高效液相色谱法(high-performance liquid chromatography,HPLC)测定盐酸丁卡因滴眼液中盐酸丁卡因和羟苯乙酯的含量。方法:采用Agilent Eclipse PLUS C18色谱柱(250 mm ×4.6 mm,5 μm);以1%三乙胺溶液(三乙胺10 mL,加水990 mL,用冰醋酸调节pH值至5.0±0.5)-乙腈(65 : 35)为流动相,流速为1.0 mL/min;柱温为30 ℃;检测波长为256 nm;进样体积20 μL。结果:盐酸丁卡因在0.05~0.36 mg/mL范围内线性关系良好( r =1.000),平均回收率为99.2%,相对标准偏差(relative standard deviation,RSD)为0.3%(n=9),羟苯乙酯在3.02~24.14 μg/mL范围内线性关系良好(r=1.000),平均回收率为98.2%,RSD为0.4%(n=9),该方法重现性好。对照品溶液和供试品溶液在室温放置24 h基本稳定;结论:本方法简便、快速、准确。适用于检测盐酸丁卡因滴眼液中盐酸丁卡因和羟苯乙酯的含量。
Objective: To establish a high-performance liquid chromatography (HPLC) method for the determination of tetracaine hydrochloride and ethyl hydrobenzoate in tetracaine hydrochloride eye drops. Methods: The analytic column was Agilent Eclipse Plus C18 (4.6 mm ×250 mm, 5 μm) and the mobile phase was 1% triethylamine solution (10 mL triethylamine and 990 mL water, pH adjusted to 5.0±0.5 with glacial acetic acid) - acetonitrile (65:35) at a flow rate of 1.0 mL/min. The detection wavelength was 256 nm and the column temperature was 30 ℃. The injection volume was 20 μL. Results: The linear range of tetracaine hydrochloride was well shown within 0.05–0.36 mg/mL (r=1.000). The average recovery rate of tetracaine hydrochloride was 99.2% with relative standard deviation (RSD) 0.3% (n=9). The linear range of ethyl hydrobenzoate was well shown within 3.02–24.14 μg/mL (r=1.000). The average recovery rate of tetracaine hydrochloride was 98.2% with RSD 0.4%(n=9). The method had high reproducibility. The reference solution and testing solution were stable for 24 h in room. Conclusion: The method is simple, quick and accurate, which is suitable for the determination of tetracaine hydrochloride and ethyl hydrobenzoate in tetracaine hydrochloride eye drops.
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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