白内障伴青光眼患者采用超声乳化与小梁切除治疗后胰岛素抵抗及炎性因子的变化：自身对照研究

文题释义： 超声乳化：是指在超声波能量作用下，使2种(或2种以上)不相溶液体混合均匀形成分散物系，其中一种液体均匀分布在另一液体之中而形成乳状液的工艺过程。 眼内压：指眼球内的眼内液的压力，因此仅能用流体压力计测定。 背景：白内障伴青光眼患者经超声乳化联合小梁切除治疗后，血脂比和胰岛素敏感性与其眼内压、视力和角膜内皮细胞等疗效相关指标均相关，可能用于其疗效的辅助评估。白细胞介素是机体内炎症反应的主要参与者和调解者，且参与了白内障的病理学过程。 目的：试验将从炎性因子角度，进一步观察白内障伴青光眼患者术后炎性因子白细胞介素10、白细胞介素2及白细胞介素10水平变化，分析胰岛素敏感性与角膜内皮细胞密度的相关性，以了解其是否可用于疗效评估。 方法：此项目设计为前瞻性、单中心、开放性、自身对照研究。拟纳入来自中国云南省，昆明医科大学第一附属医院眼科的白内障伴青光眼患者160例，年龄35-65岁，均进行超声乳化联合小梁切除治疗，随访时间为术后5 d及术后1，3个月。试验资料收集和招募对象时间为2019-12-30/2020-12-30，结果分析时间为2021-05-01/30，试验完成时间为2021-06-30。试验经昆明医科大学第一附属医院医学伦理委员会批准(审批时间：2013-12-15，审批号：20131215085)。研究符合世界医学会制定的《赫尔辛基宣言》的要求，患者均签署知情同意书。试验已在中国临床试验注册中心注册(注册号：ChiCTR1900025837)，注册时间：2019-09-10，方案版本号1.0。 结果与结论：试验的主要结局指标为术后3个月反映炎性反应情况的血清白细胞介素2水平变化；次要结局指标为术前、术后5 d及1个月血清白细胞介素2水平，术前、术后5 d及术后1，3个月血清白细胞介素1β、白细胞介素10、C-反应蛋白、肿瘤坏死因子α水平、最佳矫正视力、内皮细胞密度、平均细胞面积、面积变异系数、胰岛素敏感指数及眼内压变化，术后5 d及术后1，3个月的不良反应发生率变化。课题组已于2014年1月至2017年6月完成了80例(95眼)白内障伴青光眼患者以此方法干预的小样本试验，结果显示，超声乳化联合小梁切除术治疗后最佳矫正视力明显改善，内皮细胞密度，眼内压及白细胞介素白细胞介素1β、白细胞介素2、白细胞介素10、C-反应蛋白及肿瘤坏死因子α水平明显降低(P < 0.05)，而平均细胞面积和面积变异系数及胰岛素敏感指数明显升高(P < 0.05)，所有患者在治疗过程中均无明显不良反应。试验期望验证，超声乳化联合小梁切除对白内障伴青光眼有良好治疗效果，且其作用与调节胰岛素敏感指数、角膜内皮细胞和炎症因子有关。 ORCID: 0000-0001-8388-5374(赵剑峰) 中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程

Changes in insulin resistance and inflammatory factors in cataract patients with glaucoma after phacoemulsification and trabeculectomy: a self-controlled trial

BACKGROUND:After phacoemulsification combined with trabeculectomy in patients with cataract and glaucoma,blood lipid ratio and insulin sensitivity are associated with intraocular pressure,visual acuity and corneal endothelial cells,which may be used for the evaluation of efficacy.Interleukins are the main mediators of the inflammatory response and are involved in the pathogenesis of cataract.OBJECTIVE:To examine the postoperative changes in interleukin-10,interleukin-2 and interleukin-1βlevels in patients with cataract with glaucoma,and to analyze the correlation between insulin sensitivity and corneal endothelial cell density so as to assess whether inflammatory factors can be used to evaluate efficacy.METHODS:This prospective,single-center,open-label,self-controlled clinical trial will include 160 patients with cataract combined with glaucoma,3565 years of age,from the Department of Ophthalmology,First Affiliated Hospital of Kunming Medical University in China.All patients will receive phacoemulsification and trabeculectomy,and will be followed up at 5 days and at 1 and 3 months postoperatively.Data collection and patient recruitment will begin on December 30,2019 and end on December 30,2020.Analysis of the results will be performed from May 1,2021 to May 30,2021.This study is scheduled to end on June 30,2021.This study was approved by the Medical Ethics Committee,First Affiliated Hospital of Kunming Medical University,China,on December 15,2013(approval No.20131215085),and will be performed in accordance with the principles of the Declaration of Helsinki,adopted by the World Medical Association.Written informed consent to participate will be obtained from the participants.This study was registered with the Chinese Clinical Trial Registry on September 10,2019(registration number:ChiCTR1900025837).Study protocol version is 1.0.RESULTS AND CONCLUSION:The primary outcome measure will be serum interleukin-2 level,as an index of the inflammatory response,3 months after surgery.Secondary outcome measures will include serum interleukin-2 level before and 5 days and 1 month after surgery,serum levels of interleukin-1β,interleukin-10,C-reactive protein and tumor necrosis factor-α,best corrected visual acuity,endothelial cell density,mean cell area,coefficient of variation,insulin sensitivity index and intraocular pressure before and 5 days and 1 and 3 months after surgery,and incidence of adverse reactions at 5 days and 1 and 3 months after surgery.From January 2014 to June 2017,our team undertook and completed a small-sample study of 80 cataract patients(95 eyes)with glaucoma.The best corrected visual acuity was significantly improved,endothelial cell density and intraocular pressure were significantly reduced,interleukin-1β,interleukin-2,interleukin-10,C-reactive protein and tumor necrosis factor-αlevels were significantly decreased(P<0.05),and mean cell area,coefficient of variation and insulin sensitivity index were significantly increased(P<0.05)after phacoemulsification and trabeculectomy.None of the patients had adverse reactions during the treatment.The trial will attempt to explore whether phacoemulsification combined with trabeculectomy has a good therapeutic effect in patients with cataract combined with glaucoma,and clarify whether the effect is associated with the regulation of insulin sensitivity index,corneal endothelial cells and inflammatory factors.