Chinese Medical Sciences Journal ›› 2023, Vol. 38 ›› Issue (2): 77-93.doi: 10.24920/004213
• 指南与共识 • 下一篇
陈有信1,2,张誉清3,4,5,6,陈长征7,戴虹8,李甦雁9,马翔10,孙晓东11,唐仕波12,王雨生13,魏文斌14,文峰15,徐格致16,于伟泓1,2,张美霞17,赵明威18,张阳19,齐方19,许迅20,*(),黎晓新21,22,*()
接受日期:
2023-04-06
出版日期:
2023-06-30
发布日期:
2023-05-31
You-Xin Chen1,2,Yu-Qing Zhang3,4,5,6,Chang-Zheng Chen7,Hong Dai8,Su-Yan Li9,Xiang Ma10,Xiao-Dong Sun11,Shi-Bo Tang12,Yu-Sheng Wang13,Wen-Bin Wei14,Feng Wen15,Ge-Zhi Xu16,Wei-Hong Yu1,2,Mei-Xia Zhang17,Ming-Wei Zhao18,Yang Zhang19,Fang Qi19,Xun Xu20,*(),Xiao-Xin Li21,22,*()
Accepted:
2023-04-06
Published:
2023-06-30
Online:
2023-05-31
Contact:
*Xun Xu, E-mail: 摘要:
背景 在中国,新生血管性年龄相关黄斑变性患者中约有40%患有多灶性脉络膜血管病变(polypoidal choroidal vasculopathy,PCV)。PCV会导致反复视网膜色素上皮脱离(pigment epithelium detachment, PED)、广泛的视网膜下或玻璃体内出血,以及严重的视力损失。近年来,已有多种该病的治疗方法在中国使用,临床医生需要获得治疗PCV的全面经验。
方法 由14名具有专业背景的眼科专家形成指南专家组,重点关注如下方面问题和相应的结局:非活动性PCV患者的治疗选择;未经治疗的PCV患者的治疗选择,包括抗血管内皮生长因子(vascular endothelial growth factor,VEGF)单药治疗、光动力疗法(photodynamic therapy,PDT)单药治疗或联合治疗;抗VEGF负荷治疗后仍有持续性视网膜下液(subretinal fluid,SRF)或视网膜内液(intraretinal fluid,IRF)的患者,以及伴有大量视网膜下出血的患者的治疗选择。证据整合团队在各个问题下进行系统评价,为推荐意见的形成提供依据。本指南采用GRADE方法评估证据的可信性,并确定推荐的强度。
结果 指南专家组共形成了以下六条弱强度推荐意见:(1)对于非活动性PCV患者,建议观察而非立即治疗;(2)对于未经治疗的PCV患者,建议采用抗VEGF单药治疗或抗VEGF联合PDT,而非单独使用PDT;(3)对于拟进行抗VEGF联合PDT治疗的PCV患者,建议采用延迟/挽救PDT而非起始联合PDT;(4)对于拟进行抗VEGF单药治疗的PCV患者,建议在完成三个月负荷治疗后采用“治疗和延长”(treat and extend,T&E)方案,而非“按需治疗” (pro re nata,PRN)方案;(5)对于抗VEGF负荷治疗三个月后在光学相干断层扫描(optical coherence tomography,OCT)上出现持续性SRF或IRF的患者,建议继续抗VEGF治疗而非停药观察;(6)对于伴有新鲜大量视网膜出血且累及黄斑区的PCV患者,建议进行玻璃体切除术联合玻璃体腔内注射组织纤溶酶原激活剂及气体填充,而非抗VEGF单药治疗。
结论 本指南共形成6条推荐意见,以支持PCV患者的最佳治疗选择。
You-Xin Chen, Yu-Qing Zhang, Chang-Zheng Chen, Hong Dai, Su-Yan Li, Xiang Ma, Xiao-Dong Sun, Shi-Bo Tang, Yu-Sheng Wang, Wen-Bin Wei, Feng Wen, Ge-Zhi Xu, Wei-Hong Yu, Mei-Xia Zhang, Ming-Wei Zhao, Yang Zhang, Fang Qi, Xun Xu, Xiao-Xin Li. Chinese Guideline on the Management of Polypoidal Choroidal Vasculopathy (2022)[J].Chinese Medical Sciences Journal, 2023, 38(2): 77-93.
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BOX 1: SUMMARY OF RECOMMENDATIONS | |
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1 | For treatment-na?ve polypoidal choroidal vasculopathy (PCV) patients with inactive polypoidal lesions, the guideline panel suggests observation over the initiation of treatment (conditional recommendation, very low certainty in the estimated effects). |
Remarks: Close follow-up and monitoring are essential, especially for patients with high-risk factors (such as cigarette smoking, higher body mass index, and abnormal serum levels of inflammatory markers). | |
2 | For treatment-na?ve PCV patients, the guideline panel suggests either anti-VEGF monotherapy or combined anti-VEGF and PDT rather than PDT monotherapy (conditional recommendation, low to very low certainty in the estimated effects). |
Remarks: The choice may depend on the patient’s condition (such as the size or location of polypoidal lesions and the height of PED) or specific types of anti-VEGF agents. | |
3 | For PCV patients who plan to initiate anti-VEGF combined with PDT treatment, the guideline panel suggests later/rescue PDT over initial PDT (conditional recommendation, low certainty in the estimated effects). |
Remarks: The timing of later PDT may be at least after three months of anti-VEGF according to treatment criteria of PDT (such as if polypoidal lesions are seen with subretinal fluid on the ICGA images obtained) | |
4 | For PCV patients who plan to initiate the treatment with anti-VEGF, the guideline panel suggests treat and extend (T&E) over the pro re nata (PRN) regimen following three monthly loading doses (conditional recommendation, very low certainty in the estimated effects). |
Remarks: The T&E regimen increases the number of injections compared to the PRN regimen, although it reduces the number of visits. The follow-up should consider the morphological changes of the fundus and pay more attention to the functional or conscious symptoms of the affected eye. The interval of T&E can be referred to in the ALTAIR study. | |
5 | For PCV patients with persistent subretinal fluid (SRF) or intraretinal fluid (IRF) on optical coherence tomography (OCT) after three monthly anti-VEGF treatments, the guideline panel suggests proceeding with anti-VEGF treatment over observation (conditional recommendation, very low certainty of the estimated effects). |
Remarks: Clinicians should closely monitor the change in fundus morphology and function of the affected eye (or subjective symptoms) during follow-up and may consider stopping treatment when no clear benefit to visual acuity with further injection is expected, such as extensive subretinal scar formation. | |
6 | For PCV patients with massive subretinal hemorrhage (equal or more than four optic disc areas) involving the central macula within the onset of 14 days, the panel suggests vitrectomy in combination with tissue-plasminogen activator (tPA) intraocular injection and gas tamponade over anti-VEGF monotherapy (conditional recommendation, very low certainty in the estimated effects). |
Remarks: Surgery may also benefit PCV patients with subretinal hemorrhage combined with vitreous hemorrhage; clinicians might consider using complementary therapy (e.g., pneumatic displacement, anti-VEGF, PDT, and tPA). |
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