Efficacy of recombinant human epidermal growth factor plus sodium hyaluronate eye drops in diabetic dry eye post-cataract surgery

BACKGROUND Dry eye syndrome(DES)after diabetic cataract surgery can seriously affect the patient’s quality of life.Therefore,effective alleviation of symptoms in patients with this disease has important clinical significance.AIM To explore the clinical effect of recombinant human epidermal growth factor(rhEGF)plus sodium hyaluronate(SH)eye drops on DES after cataract surgery in patients with diabetes.METHODS We retrospectively evaluated 82 patients with diabetes who experienced DES after cataract surgery at Tianjin Beichen Hospital,Affiliated Hospital of Nankai University between April 2021 and April 2023.They were classified into an observation group(42 cases,rhEGF+SH eye drops)and a control group(40 cases,SH eye drops alone),depending on the different treatment schemes.The therapeutic efficacy,dry eye symptom score,tear film breakup time(TFBUT),basic tear secretion score[assessed using Schirmer I test(SIt)],corneal fluorescein staining(FL)score,tear inflammatory markers,adverse reactions during treat-ment,and treatment satisfaction were compared between the two groups.RESULTS Therapeutic efficacy was higher in the observation group compared with the control group.Both groups showed improved TFBUT and dry eye,as well as improved SIt and FL scores after treatment,with a more pronounced improvement in the observation group.Although no marked differences in adverse reactions were observed between the two groups,treatment satisfaction was higher in the observation group.CONCLUSION rhEGF+SH eye drops rendered clinical benefits to patients by effectively ameliorating dry eye and visual impairment with favorable efficacy,fewer adverse reactions,and high safety levels.Thus,this treatment should be promoted in clinical practice.

Potential use of a dried saliva spot(DSS)in therapeutic drug monitoring and disease diagnosis

In recent years,scientific researchers have increasingly become interested in noninvasive sampling methods for therapeutic drug monitoring and disease diagnosis.As a result,dried saliva spot(DSS),which is a sampling technique for collecting dried saliva samples,has been widely used as an alternative matrix to serum for the detection of target molecules.Coupling the DSS method with a highly sensitive detection instrument improves the efficiency of the preparation and analysis of biological samples.Furthermore,dried blood spots,dried plasma spots,and dried matrix spots,which are similar to those of the DSS method,are discussed.Compared with alternative biological fluids used in dried spot methods,including serum,tears,urine,and plasma,saliva has the advantage of convenience in terms of sample collection from children or persons with disabilities.This review aims to provide integral strategies and guidelines for dried spot methods to analyze biological samples by illustrating several dried spot methods.Herein,we summarize recent advancements in DSS methods from June 2014 to March 2021 and discuss the advantages and disadvantages of the key aspects of this method,including sample preparation and method validation.Finally,we outline the challenges and prospects of such methods in practical applications.

Recent progress of nanomedicine in managing dry eye disease

Background:Dry eye disease(DED)is a commonly reported ocular complaint that has garnered significant attention in recent research.The global occurrence of DED ranges from 5%to 50%,impacting a substantial proportion of individuals worldwide with increasing frequency.Although topical administration remains the mainstream drug delivery method for ocular diseases,it suffers from drawbacks such as low bioavailability,rapid drug metabolism,and frequent administration requirements.Fortunately,the advancements in nanomedicine offer effective solutions to address the aforementioned issues and provide significant assistance in the treatment of DED.Main text:DED is considered a multifactorial disease of the ocular surface and tear film,in which the integrity of tear film function and structure plays a crucial role in maintaining the homeostasis of the ocular surface.The conventional treatment for DED involves the utilization of artificial tear products,cyclosporin,corticosteroids,mucin secretagogues,and nonsteroidal anti-inflammatory drugs.Furthermore,nanomedicine is presently a sig-nificant field of study,with numerous clinical trials underway for various nanotherapeutics including nano-emulsions,nanosuspensions,liposomes,and micelles.Notably,some of these innovative nanoformulations have already received FDA approval as novel remedies for DED,and the advancement of nanomedicine is poised to offer enhanced prospects to solve the shortcomings of existing treatments for DED partially.Conclusions:This article provides an overview of the latest advancements in nanomedicine for DED treatment,while the field of DED treatment is expected to witness a remarkable breakthrough shortly with the development of nanomedicine,bringing promising prospects for patients worldwide suffering conditions.

药物冻干质控血清的制备及质量评价

目的 :探讨治疗药物监测 (TDM )质控血清的制备及质量评价。方法 :介绍真空冷冻干燥法制备TDM冻干质控血清及其用法。从均匀性、分装差异、稳定性、浓度设置、定值、测定干扰等方面对冻干质控血清进行质量评价。结果 :被考察冻干质控血清外观均匀 ,复溶后无沉淀 ;分装差异平均 0 .2 4 %。稳定性 :0～ 4℃放置至少 15个月 ,常温至少 6个月 ,4 5℃至少 11d ,浓度几乎无改变。浓度设置合理 ,定值准确 ,一份质控血清控制多种药物 ,且测定无相互干扰。结论 :本冻干质控血清符合治疗药物监测质控血清所需各项质量要求。

滤纸干血斑点作为检测样品在庆大霉素浓度测定中的应用

将滤纸干血斑点作为检测样品应用于庆大霉素浓度测定。该法灵敏度0.5mg/L,平均回收率103%,浓度为7.0和15.0mg/L 的批内、批间 CV 均低于7%,浓度为2.0mg/L 的批内 CV 为11.63%,批间 CV 为5.10%。滤纸干血斑点中庆大霉素浓度和相应血浆中庆大霉素浓度比较,相关性良好(r=0.9768)。4只家兔肌注庆大霉素药动学符合一室模型,平均动力学参数:Ka=3.93h^(-1),K=0.81h^(-1),Vd=2.33L,T_(1/2)=0.86h。

Clinical efficacy of 0.1% pranoprofen in treatment of dry eye patients：a multicenter, randomized, controlled clinical trial

Background Dry eye is a multifactorial disease of the tears and the ocular surface.This study aimed to investigate the clinical efficacy of a non-steroidal anti-inflammatory drug,pranoprofen,in the treatment of dry eye.Methods It is a prospective,multi-center,randomized,controlled,parallel group study.One hundred and fifteen patients with mild to moderate dry eye disease （55-60 in each treatment group） participated in this multi-center study.Patients were randomly administered with eyedrops containing 0.1％ pranoprofen （PRA） plus 0.1％ sodium hyaluronate （SH） or SH only,three times daily for 28 days,followed by a 1-week after treatment observation.Dry eye symptom score （DESS）,fluorescein corneal staining （FLCS）,tear break-up time （TBUT）,and Shirmer 1 tear test （ST1,without anesthesia） were evaluated or conducted before treatment and at each study visit.Conjunctival impression cytology was taken from the patients treated with PRA plus SH before and after treatment and real-time polymerase chain reaction （RT-PCR） was performed to detect the changes of human leukocyte antigen DR （HLA-DR） and intercellular adhesion molecule 1 （ICAM-1）.Results Patients treated with PRA plus SH showed gradual improvements of DESS,FLCS,and TBUT.Between-group comparisons of FLCS and TBUT have statistically significant differences from day 14.Good tolerance with no severe adverse events was found in both groups.Patients treated with PRA plus SH had a reduced expression level of HLA-DR and were statistically different after 28 days of therapy.Conclusions The application of PRA at a dose of 0.1％ was well tolerated and benefited to the patients with mild to moderate dry eye disease.The underlying mechanism of its efficacy may be associated with the reduction of inflammatory factors of conjunctival epithelial cells.

Dry eye disease immune responses and topical therapy

There is accumulating evidence that inflammation is one of the key components of dry eye because chronic ocular surface inflammation can be both a result as well as an initiator of dry eye.The need for continuing antiinflammatory therapy may be determined in part by the extent that non-modifiable factors such as gender and age-related aqueous or lipid or mucus production deficiencies contribute to its chronicity.This perspective examines how the need for increased dosage of a topical anti-inflammatory drug may be determined by the degree of difficulty that a topically administered drug has in accessing different sites of tear deficiency and associated inflammation.

干血斑点样品在庆大霉素浓度测定中的应用

本文将滤纸干血斑点作为检测样品,应用于荧光偏振免疫分析法测定庆大霉素血浓度。经方法学考核,得该法灵敏度为0.5mg/L,平均回收率103%(CV=2.8%),浓度为7.0和15.0mg/L 的批内、批间 CV 均低于7%。浓度为2.0mg/L 的 CV 小于12%,滤纸干血斑点中庆大霉素浓度和相应的血浆中庆大霉素浓度比较,相关良好(r=0.9768)。家兔肌注庆大霉素药物动力学符合一室模型,平均药物动力学参数:Ka=3.93h^(-1),K=0.81h^(-1),Vd=2.33 L,t 1/2=0.86 h。

HPLC法测定干血滤纸片中苯妥英的浓度

目的:建立HPLC法检测干血滤纸片中苯妥英血药浓度的方法。方法:将需要进行苯妥英血药浓度监测患者的全血滴于滤纸片上,制备含药的滤纸片样本,处理后使用HPLC法进样分析。流动相为甲醇-水(55∶45);色谱柱为Venusil XBP C18(4.6 mm×250 mm,5μm);检测波长为235 nm;柱温为35℃;流速为1.0 mL·min-1。结果:苯妥英在3.1~100.0 mg·L^(-1)范围内线性关系良好,标准曲线为Y=0.003 X+0.001(r=0.999,n=6)。方法回收率为(97.4±2.2)%,绝对回收率为(70.3±4.3)%,精密度RSD均小于5.0%,制备的干血滤纸片可在室温14 d内稳定。结论:本方法操作简便,能够将具有优势的采血方法与常规HPLC法相结合,更适合苯妥英血药浓度监测工作的持续开展。

干血斑法概述及其在器官移植免疫抑制药治疗药物监测中的研究进展

免疫抑制药广泛用于器官移植术后,具有治疗窗窄、药动学个体差异大等特点,需要进行治疗药物监测(therapeutic drug monitoring,TDM)指导个体化用药。随着质谱技术的进步和微量采样技术的发展,干血斑(dried blood spot,DBS)法逐渐应用于TDM领域,尤其在免疫抑制药TDM中的研究和报道越来越多。本文综述了DBS法在TDM中的应用及其在器官移植患者免疫抑制药TDM中的研究进展,为该方法的开发和临床应用提供参考。

用UPLC-MS/MS法检测人干血斑中氯喹和羟氯喹的浓度

目的 建立并验证一种定量检测人干血斑中氯喹和羟氯喹浓度的方法。方法 样本经打孔、液液萃取、挥干复溶后,用液相-串联质谱联用仪测定。色谱柱:BEH C18柱(2.1 mm×50.0 mm, 1.7μm),流动相:含0.5%甲酸乙腈溶液-含0.5%甲酸水溶液,梯度洗脱,流速:0.4 mL·min^(-1),进样量:2μL;电喷雾正离子模式,多反应监测。考察该方法的专属性、标准曲线与定量下限、精密度与回收率、稳定性、基质效应、打孔位置影响、载血量影响和血细胞比容影响。结果 氯喹和羟氯喹均在8.0~1 600.0 ng·mL^(-1)内线性关系良好,定量下限均为8.0 ng·mL^(-1);批内和批间相对标准偏差均在15.72%以内,稳定性良好,内标归一化的基质因子的相对标准偏差均<15%。干血斑中药物浓度与打孔位置、载血量、血细胞比容相关。结论 本方法的专属性强、准确度高、重复性好,既可用于日常治疗药物监测,亦可用于药物过量中毒检测。