Effectiveness and security of anisodine hydrobromide tablets in treating nonarteritic anterior ischemic optic neuropathy: a Chinese multicenter nonrandomized controlled study
Yang Mo, Song Honglu, Zhou Huanfen, Lai Mengying, Xu Quangang, Sun Mingming, Fan Ke, Cui Hongpei, Wang Haiyan, Jin Xin, Sun Chuanbin, Xiao Qing, Wang Ying, Zhao Zide, Zhang Minglian, Chang Yongye, Chen Mengping, Shen Zhanxing, Yang Hui, Xu Xiaoyu, Li Zhiqing, Xing Dongjun, Dong Yu, Yang Jinrun, Ren Qian, Li Li, Zhang Wenfang, Sun Li, Zhang Zhengpei, Li Suyan, Liu Danyan, Zhou Nalei, Luo Nali, Liu Yadong, Wei Shihui
Abstract
ObjectiveTo evaluate the efficacy and safety of oral anisodine hydrobromide tablets in the treatment of nonarteritic anterior ischemic optic neuropathy (NAION).
MethodsA multicenter nonrandomized controlled trial was conducted.A total of 282 acute NAION patients (282 eyes) were recruited from 16 hospitals in China from July 2020 to May 2021.Patients were divided into two groups according to treatment methods, which were control group (124 cases, 124 eyes) receiving regular treatment including citicoline sodium plus Ginkgo biloba leaf liquid extract or Ginkgo biloba leaf extract tablets plus mecobalamin, and experimental group (158 cases, 158 eyes) receiving treatment in control group plus oral anisodine hydrobromide tablets 1 mg, twice daily for 2 to 3 months.Best corrected visual acuity (BCVA), visual field index (VFI), peripapillary retinal nerve fiber layer (pRNFL) and radial peripapillary capillary vessel density (RPC) were assessed at 1, 2, 3, and 6 months after enrollment using the standard decimal visual acuity chart, 750i Humphery visual field analyzer, Cirrus HD-OCT 4000/Cirrus HD-OCT 5000, RTVue-XR optical coherence tomography respectively.The primary outcomes were BCVA and VFI, and the secondary outcomes were pRNFL, RPC, and the side effects during the follow-up.The study adhered to the Declaration of Helsinki.All patients were fully informed about the treatment and purpose of this study and voluntarily signed the informed consent form.The study protocol was approved by Chinese PLA General Hospital (No.S2020-021-01).
ResultsIn all, 242 patients (242 eyes) completed the follow-up of BCVA, and 98 patients (98 eyes) completed the VFI follow-up.In terms of visual function, BCVA and VFI improved significantly over time in the two groups, and BCVA and VFI were better in experimental group than in control group at various follow-up time points (all at P<0.05). In terms of structure, pRNFL gradually decreased in both groups with the extension of treatment, and pRNFL was significanthy thinner in experimental group than in control group at various follow-up time points (all at P<0.05). There was no significant difference in RPC between the two groups at the last follow-up (P>0.05). There were two cases with side effects and one case was discontinued due to side effects 25 days after enrollment.
ConclusionsOral anisodine hydrobromide can improve visual acuity and visual field in NAION and accelerate the regression of optic disc edema, with good safety.
Key words:
Optic neuropathy, ischemic; Anisodine hydrobromide; Treatment
Contributor Information
Yang Mo
Department of Ophthalmology, The First Medical Center of PLA General Hospital, Beijing 100853, China
Yang Mo is now working at Department of Neuro-ophthalmology, Eye Hospital, China Academy of Chinese Medical Sciences, Beijing 100040, China
Song Honglu
Department of Ophthalmology, The First Medical Center of PLA General Hospital, Beijing 100853, China
Zhou Huanfen
Department of Ophthalmology, The First Medical Center of PLA General Hospital, Beijing 100853, China
Lai Mengying
Department of Ophthalmology, The First Medical Center of PLA General Hospital, Beijing 100853, China
Xu Quangang
Senior Department of Ophthalmology, the Third Medical Center of PLA General Hospital, Beijing 100039, China
Sun Mingming
Senior Department of Ophthalmology, the Third Medical Center of PLA General Hospital, Beijing 100039, China
Fan Ke
Henan Provincial People's Hospital, Henan Eye Hospital, Zhengzhou 450003, China
Cui Hongpei
Henan Provincial People's Hospital, Henan Eye Hospital, Zhengzhou 450003, China
Wang Haiyan
Shaanxi Eye Hospital, Xi'an People's Hospital (Xi'an Fourth Hospital), Affiliated People's Hospital of Northwest University, Xi'an 710004, China
Jin Xin
Shaanxi Eye Hospital, Xi'an People's Hospital (Xi'an Fourth Hospital), Affiliated People's Hospital of Northwest University, Xi'an 710004, China
Sun Chuanbin
Eye Center, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou 310009, China
Xiao Qing
Eye Center, The Second Affiliated Hospital Zhejiang University School of Medicine, Hangzhou 310009, China
Wang Ying
Department of Neuro-ophthalmology, Eye Hospital, China Academy of Chinese Medical Sciences, Beijing 100040, China
Zhao Zide
Department of Neuro-ophthalmology, Eye Hospital, China Academy of Chinese Medical Sciences, Beijing 100040, China
Zhang Minglian
Hebei Eye Hospital, Xingtai 054000, China
Chang Yongye
Hebei Eye Hospital, Xingtai 054000, China
Chen Mengping
Department of Ophthalmology, Zhengzhou Second Hospital, Zhengzhou 450006, China
Shen Zhanxing
Department of Ophthalmology, Zhengzhou Second Hospital, Zhengzhou 450006, China
Yang Hui
Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou 510623, China
Xu Xiaoyu
Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou 510623, China
Li Zhiqing
Tianjin Medical University Eye Hospital, Tianjin 300392, China
Xing Dongjun
Tianjin Medical University Eye Hospital, Tianjin 300392, China
Dong Yu
Department of Ophthalmology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming 650021, China
Yang Jinrun
Department of Ophthalmology, Yunnan Provincial Hospital of Traditional Chinese Medicine, Kunming 650021, China
Ren Qian
Department of Ophthalmology, Shijiazhuang People's Hospital, Shijiazhuang 050030, China
Li Li
Department of Ophthalmology, Shijiazhuang People's Hospital, Shijiazhuang 050030, China
Zhang Wenfang
Department of Ophthalmology, Lanzhou University Second Hospital, Lanzhou 730030, China
Sun Li
Department of Ophthalmology, Lanzhou University Second Hospital, Lanzhou 730030, China
Zhang Zhengpei
Department of Ophthalmology, The Affiliated Xuzhou Municipal Hospital of Xuzhou Medical University, Xuzhou 221000, China
Li Suyan
Department of Ophthalmology, The Affiliated Xuzhou Municipal Hospital of Xuzhou Medical University, Xuzhou 221000, China
Liu Danyan
Department of Ophthalmology, The Second Hospital of Hebei Medical University, Shijiazhuang 050004, China
Zhou Nalei
Department of Ophthalmology, The Second Hospital of Hebei Medical University, Shijiazhuang 050004, China
Luo Nali
Department of Ophthalmology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou 450014, China
Liu Yadong
Department of Ophthalmology, The Second Affiliated Hospital of Zhengzhou University, Zhengzhou 450014, China
Wei Shihui
Department of Ophthalmology, The First Medical Center of PLA General Hospital, Beijing 100853, China
