[关键词]
[摘要]
对比真实世界中不同中医证型增殖型糖尿病视网膜病变(PDR)患者行抗血管内皮生长因子(VEGF)联合玻璃体 切除术(PPV)治疗的临床疗效。【方法】采用前瞻性真实世界研究方法,纳入2019年3月至2019年12月在广州中医药大学第 一附属医院眼科行抗VEGF联合PPV治疗的PDR患者36例(42只眼),根据中医辨证分型,分为气阴两虚兼络脉瘀阻证15例 (18只眼)、肝肾亏虚兼目络失养证14例(17只眼)、阴阳两虚兼血瘀痰凝证7例(7只眼)。患者先行抗VEGF治疗,5~7 d后 行PPV治疗,在抗VEGF治疗和PPV术中抽取房水。比较不同中医证型PDR患者的疗效,术前和术后3个月患眼的最佳矫正 视力(BCVA),抗VEGF治疗前后的房水细胞因子水平,术后3个月黄斑中心凹视网膜厚度(CRT)、中心凹无血管灌注区 (FAZ)面积和黄斑中心、内环、外环、完整血流密度以及术后并发症情况。【结果】(1)不同中医证型PDR患者的疗效比较, 差异有统计学意义(P<0.05)。其中,以气阴两虚兼络脉瘀阻证的疗效最优,其次为肝肾亏虚兼目络失养证,再次为阴阳两 虚兼血瘀痰凝证,其总有效率分别为88.89%(16/18)、52.94%(9/17)、42.86%(3/7)。(2)术后3个月,气阴两虚兼络脉瘀阻证 患者的最小分辨角的对数视力(LogMAR)BCVA明显优于阴阳两虚兼血瘀痰凝证,差异有统计学意义(P<0.05);3种中医证 型患者抗VEGF治疗后的房水VEGF-A水平均明显低于治疗前,气阴两虚兼络脉瘀阻证患者抗VEGF治疗后的房水胎盘生长 因子(PLGF)、血管生成素样蛋白4(ANGPTL4)水平明显高于治疗前,肝肾亏虚兼目络失养证患者抗VEGF治疗后的房水白细 胞介素8(IL-8)水平明显高于治疗前,差异均有统计学意义(P<0.05或P<0.01);在黄斑外环、完整血流密度方面,气阴两 虚兼络脉瘀阻证、肝肾亏虚兼目络失养证明显大于阴阳两虚兼血瘀痰凝证,差异均有统计学意义(P<0.05);而在CRT、 FAZ面积和黄斑中心、内环血流密度方面,3种中医证型间比较,差异均无统计学意义(P>0.05)。(3)术后并发症方面,阴阳 两虚兼血瘀痰凝证的发生比例较高,但差异无统计学意义(P>0.05)。【结论】真实世界中不同中医证型PDR患者行抗VEGF 联合PPV治疗以气阴两虚兼络脉瘀阻证疗效最好,其次为肝肾亏虚兼目络失养证,再次为阴阳两虚兼血瘀痰凝证;不同中 医证型PDR患者抗VEGF治疗后房水细胞因子的变化不完全相同;术后3个月时气阴两虚兼络脉瘀阻证和肝肾亏虚兼目络失 养证患者黄斑外环、完整血流密度较大,治疗的预后可能会更好。
[Key word]
[Abstract]
To compare the clinical efficacy of anti-vascular endothelial growth factor(VEGF)combined with pars plana vitrectomy(PPV)treatment for patients with proliferative diabetic retinopathy(PDR)of differenttraditional Chinese medicine(TCM)syndrome types in the real world. Methods A prospective real-world study was performed in the 36 patients(involving 42 eyes)with PDR treated by anti-VEGF combined with PPV in the Department of Ophthalmology of the First Affiliated Hospital of Guangzhou University of Chinese Medicine from March 2019 to December 2019. According to the TCM syndrome manifestations,the patients were differentiated as qi-yin deficiency complicated with blood stasis obstructing collaterals type(15 cases,involving 18 eyes;shorten as qi-yin deficiency type), liver-kidney deficiency and ocular collaterals failing in the nourishment type (14 cases,involving 17 eyes;shorten as liver-kidney deficiency type),and yin-yang deficiency complicated with blood stasis and phlegm coagulation type(7 cases ,involving 7 eyes ;shorten as yin-yang deficiency type). The patients were treated with anti-VEGF therapy first and then received PPV after 5-7 days. Aqueous humor was sampled during anti-VEGF therapy and PPV. After treatment, the efficacy of PDR patients with different TCM syndromes was compared. Moreover,the patients were observed in the best corrected visual acuity(BCVA)of the affected eyes before surgery and 3 months after surgery,levels of cytokines in the aqueous humor before and after anti-VEGF treatment,macular central retinal thickness(CRT),area of the foveal avascular zone(FAZ),the blood density of macular center, inner ring, outer ring and intact macula 3 months after surgery, and the postoperative complications. Results(1)The difference of the therapeutic efficacy of PDR patients with various TCM syndrome types was statistically significant(P<0.05). Among 3 syndrome types,the best efficacy was found in the qi-yin deficiency type,followed by liver-kidney deficiency type,and then yin-yang deficiency type,with the total efficacy rate being 88.89%(16/18), 52.94%(9/17), and 42.86%(3/7), respectively.(2)Three months after surgery,the logarithmic value of minimum angle of resolution(LogMAR)for BCVA of patients with qi- yin deficiency type was significantly superior to that of patients with yin- yang deficiency type, with the difference being statistically significant(P<0.05). After the anti-VEGF treatment,the levels of cytokines in the aqueous humor of the patients varied in the 3 syndrome types:vascular endothelial growth factor A(VEGF-A) level in the patients with the 3 syndrome types was significantly lower, placental growth factor(PLGF)and angiopoietin- like protein 4(ANGPTL4)levels in the patients with qi- yin deficiency type were higher, and interleukin 8(IL- 8) level in the patients with liver- kidney deficiency type was higher than those before treatment,and the differences were statistically significant(P<0.05 or P<0.01). The blood density of macular outer ring and intact macula in the patients with qi-yin deficiency type and liver-kidney deficiency type was larger than that in the patients with yin-yang deficiency type, and the differences were statistically significant(P< 0.05). However,the differences of CRT,FAZ area,and blood density of macular center and inner ring among the 3 syndrome types were not statistically significant(P>0.05).(3)The incidence of postoperative complications in the patients with yin-yang deficiency type was relatively high,but the difference among the 3 syndrome types was not statistically significant (P>0.05). Conclusion In the real world, the best efficacy of anti- VEGF combined with PPV treatment in PDR patients with different TCM syndrome types can be achieved in the patients differentiated as qi-yin deficiency type,followed by liver-kidney deficiency type,and then yin-yang deficiency type. After anti-VEGF treatment,the levels of cytokines in the aqueous humor of the patients vary in the 3 syndrome types. Three months after the operation,the patients with qi-yin deficiency type and liver-kidney deficiency type have larger blood density of macular outer ring and intact macula,and exert good prognosis.
[中图分类号]
R276.7
[基金项目]
国家中医药管理局中医眼科专病循证能力提升建设资助项目(编号:2019XZZX-YK003);关国华全国名老中医药专家传承工作 室项目(国中医药人教教育便函[2018]74号);广州中医药大学2019年学科研究重大项目(编号:XK2019015)