论著

某院眼科万古霉素使用情况调查分析及超说明书用药评价

Investigation and analysis of vancomycin use in a hospital ophthalmology department and evaluation of off-label drug use

:528-537
 
目的:调查眼科万古霉素使用情况,并对超说明书用药进行评价,为临床提供参考。方法 :采用回顾性分析法,选取郑州市第二人民医院2022年1月1日—2024年12月眼科使用万古霉素的159例住院患者为研究对象,对患者基本信息、万古霉素的使用情况、微生物送检情况及超说明书用药情况等进行评价分析。结果:159例患者中男性占比76.1%,主要分布在眼底病病区,致病因素主要为眼外伤(102/159,64.15%),其次为手术源性(36/159,22.64%)。给药途径主要为玻璃体腔注射,以治疗用药为主,多联合头孢他啶治疗眼内感染。病原菌送检率为75.47%,标本检出率为35.07%。其中革兰阳性菌33例,占80.49%,主要为表皮葡萄球菌;革兰阴性菌5例,占12.20%,有大肠埃希菌、铜绿假单胞菌等;真菌4例,占9.76%,主要为曲霉菌。超说明书用药包括玻璃体腔注射、眼内灌洗及超适应证用于眼内炎的预防。玻璃体腔注射超说明书用药推荐等级及证据强度高于眼内灌洗和超适应证。结论 :万古霉素在眼科临床应用广泛,应严格掌握适应证和用法用量。对于超说明书用药,应在充分评估其合理性和安全性后谨慎使用。本研究对万古霉素的规范化使用及药品说明书修订和个体化治疗具有重要的临床价值和现实意义。
Objective: To investigate the use of vancomycin in ophthalmology department and evaluate its off-label drug use, thereby providing references for clinical practice. Methods: A retrospective analysis was conducted, selecting 159 inpatients who received vancomycin treatment in the Department of Ophthalmology of our hospital from January 1, 2022 to December 31, 2024. The basic information of the patients, details of vancomycin, microbial testing results, and off-label drug use were evaluated and analyzed. Results: Among the 159 patients, male patients accounted for 76.1%, and there were mainly distributed in the fundus disease area. The primary pathogenic factor was ocular trauma (102/159,64.15%), followed by surgical causes (36/159,22.64%). The main route of vancomycin administration was intravitreal injection, primarily for therapeutic purposes. It was often combined with ceftazidime to treat intraocular infections. The submission rate of pathogenic bacteria was 75.47%, and the specimen detection rate was 35.07%. There were 33 cases of gram-positive bacteria, accounting for 80.49%, mainly Staphylococcus epidermidis; 5 cases of gram-negative bacteria, accounting for 12.20%, including Escherichia coli, Pseudomonas aeruginosa, etc.; and 4 cases of fungi, accounting for 9.76%, mainly Aspergillus. Off-label drug use included intravitreal injections, intraocular lavage, and the use of drugs highly suitable for the preventing endophthalmitis. Endogenous infections were mainly caused by gram-negative bacteria. The evidence-based medicine support for vancomycin intravitreal injection in the treatment of endophthalmitis is strong. The recommended grade and evidence strength of off-label use of intravitreal injection are higher than those of intraocular lavage and off-label use. Conclusions: Vancomycin is widely used in ophthalmology, and its indications, usage, and dosage should be strictly controlled. Off-label drug use should be used with caution after a comprehensive evaluation of its rationality and safety. This study holds significant clinical value and practical significance for the standardized use of vancomycin, the revision of drug instructions, and individualized treatment.
论著

神经眼科超说明书用药情况调查分析——以郑州市第二人民医院为例

Investigation and analysis on off-label medication use in neuro-ophthalmology: a case study of Zhengzhou Second People's Hospital

:548-556
 
目的:调查神经眼科用药现状,并对其超说明书用药进行评价,探索科学有效的管理策略,为神经眼科的临床合理用药提供参考。方法:随机抽取2023年7—12月郑州市第二人民医院神经眼科处方,依据国家药品监督管理局核准的药品说明书、美国食品药品监督管理局(Food and Drug Administration, FDA)说明书及PubMed、Micromedex等循证医学数据库证据判断超说明书用药类型,并对其进行分类(包括超适应证、超剂量、超疗程、超给药途径等)。同时基于Thomson分级理论建立三级评价标准,分别为A级(高证据等级,仅需口头告知),B级(中证据等级,需在病历或病程中详细记录),C级(低证据等级,须患者签署书面知情同意书)。通过处方前置审核系统干预,对未纳入评价标准的超说明书用药进行实时拦截与分级警示,比较2023年下半年(干预前)与2024年下半年(干预后)超说明书用药处方的不合理率变化。 结果:干预前共抽取超说明书处方370张,超说明书类型主要为超适应证、超给药途径和超剂量及次。干预后,共抽取超说明书用药560张,超说明书用药不合理率从9.2%(34/370)降至2.9%(16/560)。结论:神经眼科超说明书用药普遍,主要源于视神经炎、缺血性视神经病变等复杂疾病的治疗需求与药品审批滞后之间的矛盾。基于循证医学证据构建分级管理体系,结合信息化实时干预,可有效规范超说明书用药行为,降低医疗风险。
Objective: To investigate the current status of medication use in neuro-ophthalmology, evaluate off-label drug use, and explore scientific and effective management strategies, providing references for rational drug use in neuro-ophthalmology clinical practice. Methods: We Randomly selected neuro-ophthalmology prescriptions from July to December 2023 in our hospital. By refering to the drug instructions approved by the National Medical Products Administration, FDA instructions, and evidence from evidence-based medical databases such as PubMed and Micromedex, we identified and classified the types of off-label drug use, including off-label indications, off-label doses, off-label courses, off-label administration routes, among others. Simultaneously, based on the Thomson classification theory, we established a threelevel evaluation standard: Level A (high evidence level, requiring only oral notification); Level B (medium evidence level, necessitating detailed records in the medical record or medical course); Level C (low evidence level, demanding patients sign a written informed consent form). Through the intervention of pre-prescription review system, we carried out real-time interception and classification warnings for off-label drug use not covered in the evaluation standards. We then compared the changes in the unreasonable rate of off-label drug use prescriptions from the second half of 2023 (before intervention) to the second half of 2024 (after intervention). Results: Before the intervention, a total of 1852 prescriptions were selected, with the proportion of off-label drug use at 19.98% (370 prescriptions), primarily involving off-label indications (90.27%). After the intervention, the unreasonable rate of off-label drug use decreased from 9.2% (34/370) to 2.9% (16/560). Conclusions: Off-label drug use is prevalent in neuro-ophthalmology, mainly due to the conflict between the treatment requirements for complex diseases such as optic neuritis and ischemic optic neuropathy and the delay in drug approval. By constructing a hierarchical management system based on evidence-based medical evidence and combing it with real-time information-based intervention, we can effectively regulate off-label drug use behavior and reduce medical risks.
论著

基于循证医学证据的眼科超说明书用药情况调查与分析

Evidence-based analysis of off-label drug use in ophthalmology

:25-35
 
目的:分析眼科超说明书用药使用情况,为眼科临床合理用药提供有效、安全的循证参考依据。方法:考察并收集21家爱尔眼科医院集团眼科中心城市及省会级医院备案的超说明书用药情况,同时抽查处方、医嘱用药,对超说明书用药情况进行充分论证评估,参考广东省、山东省等超说明书用药共识、文献,进行统计、分析和归纳,并征求相关眼科临床专家意见。结果:梳理指南、共识及期刊论文等循证医学证据,得出超说明书用药推荐级别1级8项、2级29项、3级24项,并编写了供集团内使用的《眼科医院眼科超药品说明书用药参考目录(2021年版)》,便于临床参考使用。在眼科常用有32种超说明书药品,61项超说明书用药,其中超给药途径32项(52.5%)、超适应证用药13项(21.3%)、超适应证合并超给药途径14项(23.0%)。超说明书品种及超说明用药项目数均以抗菌药物最多,分别为13个(40.6%)品种,26项(42.6%)。结论:眼科因特殊的给药途径,超说明书用药比较普遍,而如抗菌药物注射剂使用眼内注射或滴眼等超说明书用药方式对某些急性眼内感染性疾病起到了很好的治疗效果。规范眼科超说明书用药,是防范医疗风险的必要措施。
Objective: To investigate off-label ophthalmic medications, and provide an effective and safe evidence-based reference for the rational use of ophthalmic drugs. Methods: On the basis of collecting the off-label drug use recorded in 21 Aier Eye Hospital Group which including ophthalmic central cities and provincial capital level hospitals, and spot checking the prescription and doctor’s order drug use, this article conducted full demonstration and evaluation of off-label drug use which referred to the off-label drug used consensus of Guangdong and Shandong, and other literature on the off-label drug use in ophthalmology. The paper conducted statistics, analysis and induction, and solicited the opinions of relevant ophthalmology clinical experts. Results: Sorting out the evidence of the guides,consensus, journal papers and other evidence-based medicine in ophthalmic medication, recommending 8 items of level 1, 29 items of level 2, and 24 items of level 3, we compiled the “Reference catalogue for the off-label drug use in ophthalmic hospital (2021 edition)” within the group which can providing reference for clinical use. There were 61 off-label drugs commonly used in ophthalmology, involving 32 drugs. Among them, 32 items (52.5%) were used by over administration route, 13 items (21.3%) were used by over indication, and 14 items (23.0%) were used by over indication and administration route. Antibacterial drugs were the most frequently used in the varieties and items of off-label drug use, accounting for 13 (40.6%) and 26 (42.6%) respectively. Conclusion: Ophthalmic off-label medications are common owing to the special route of administration. Such as intraocular injection or eye drop have played a good role in the treatment of some ocular infectious diseases. Standardizing the off-label drug use of ophthalmology is an effective measure to reducing medical risks.
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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