目的：探讨增殖性糖尿病视网膜病变(PDR)患者血清卵泡抑素样蛋白1(FSTL1)、血管性血友病因子裂解酶(ADAMTS13)的表达水平，分析其对视力残疾的预测价值。

方法：前瞻性研究。选取2022年1月至2024年9月华北医疗健康集团峰峰总医院就诊的糖尿病视网膜病变(DR)患者，根据DR分期将其分为非增殖期糖尿病视网膜病变(NPDR)组和PDR组，另选同期单纯2型糖尿病(T2DM)患者为T2DM组，健康体检者为对照组。采用酶联免疫吸附法检测血清FSTL1、ADAMTS13水平，对PDR组患者随访12 mo，观察视力残疾发生情况，并据此分为非视力残疾组和视力残疾组。通过Logistic回归分析PDR患者视力残疾的危险因素，受试者工作(ROC)曲线及DCA曲线评估预测价值。

结果：本研究纳入DR患者220例，其中NPDR组119例，PDR组101例。T2DM组120例，对照组120例。对照组年龄56.92±8.15岁，男66例，女54例。T2DM组年龄57.21±8.30岁，男63例，女57例。NPDR组年龄57.36±8.25岁，男60例，女59例。PDR组年龄57.45±8.22岁，男53例，女48例。PDR组中非视力残疾组68例，视力残疾组33例。非视力残疾组年龄57.26±8.14岁，男35例，女33例。视力残疾组年龄57.85±8.37岁，男18例，女15例。T2DM组、NPDR组、PDR组糖尿病病程依次延长，对照组、T2DM组、NPDR组、PDR组空腹血糖(FPG)、糖化血红蛋白(HbA1c)、FSTL1水平依次升高，ADAMTS13水平依次降低(均P<0.001)。PDR组内，Ⅳ级、Ⅴ级、Ⅵ级患者血清FSTL1水平依次升高，ADAMTS13水平依次降低(均P<0.001)。视力残疾组糖尿病病程、FPG、HbA1c、FSTL1高于非视力残疾组，ADAMTS13水平低于非视力残疾组(均P<0.001)。糖尿病病程、FSTL1、ADAMTS13是PDR患者发生视力残疾的影响因素(均P<0.001)。经ROC曲线及DCA曲线分析，联合检测血清FSTL1、ADAMTS13水平的预测价值高于单独检测(均P<0.05)。

结论：PDR患者血清FSTL1水平较高，ADAMTS13水平较低，二者与PDR严重程度相关，联合检测对PDR患者视力残疾具有较高的预测价值。

METHODS:A prospective study. From January 2022 to September 2024, patients with diabetes retinopathy(DR)were selected from Fengfeng General Hospital of North China Medical and Health Group. They were divided into non-proliferative diabetes retinopathy(NPDR)group and PDR group. In the same period, simple type 2 diabetes(T2DM)patients were selected as T2DM group, and healthy people were selected as control group. Enzyme linked immunosorbent assay was used to detect serum levels of FSTL1 and ADAMTS13. Patients in the PDR group were followed up for 12 mo to observe the occurrence of visual disability, and were accordingly divided into a non-visual disability group and a visual disability group. Risk factors for visual disability in PDR patients were analyzed by Logistic regression, and the predictive value was assessed via receiver operating characteristic(ROC)curves and decision curve analysis(DCA).

RESULTS: This study included 220 DR patients, including 119 cases in the NPDR group and 101 cases in the PDR group. There were 120 cases in the T2DM group and 120 cases in the control group. The control group had an age of 56.92±8.15 y, with 66 males and 54 females. The T2DM group had an age of 57.21±8.30 y, with 63 males and 57 females. The NPDR group had an age of 57.36±8.25 y, with 60 males and 59 females. The PDR group had an age of 57.45±8.22 y, with 53 males and 48 females. There were 68 patients without visual disability and 33 patients with visual disability in the PDR group. The non-visual disability group had a mean age of 57.26±8.14 y, including 35 males and 33 females. The visual disability group had a mean age of 57.85±8.37 y, including 18 males and 15 females. Diabetes duration was progressively longer in the T2DM, NPDR, and PDR groups. Levels of fasting plasma glucose(FPG), glycated hemoglobin(HbA1c), and FSTL1 progressively increased, while ADAMTS13 levels progressively decreased across the control, T2DM, NPDR, and PDR groups(all P<0.001). Within the PDR group, serum FSTL1 levels increased sequentially while ADAMTS13 levels decreased sequentially in patients with grade Ⅳ, Ⅴ and Ⅵ lesions(all P<0.001). The visual disability group had significantly longer diabetes duration and higher levels of FPG, HbA1c, and FSTL1, as well as lower ADAMTS13 levels, compared to the non-visual disability group(all P<0.001). The diabetes duration, FSTL1, ADAMTS13 were the influencing factors of visual disability in PDR patients(all P<0.001). ROC curve and DCA curve analysis showed that the predictive value of combined detection of serum FSTL1 and ADAMTS13 levels is higher than that of individual measurement(all P<0.05).

CONCLUSION:PDR patients have higher serum FSTL1 levels and lower ADAMTS13 levels. Both are related to the severity of PDR. The combined measurement has a high predictive value for visual disability in PDR patients.