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Objective:To evaluate the efficacy and safety of oral anisodine hydrobromide tablets in the treatment of nonarteritic anterior ischemic optic neuropathy (NAION).Methods:A 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). Results:In 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. Conclusions:Oral anisodine hydrobromide can improve visual acuity and visual field in NAION and accelerate the regression of optic disc edema, with good safety.
RESUMO
Objective To evaluate the efficacy and safety of repeated treatments with low-dose rituximab for relapsing neuromyelitis optica spectrum disorder (NMOSD).Methods A perspective study.21 patients who were diagnosed with NMOSD one year ago were recruited for rituximab treatment.Of 21 patients,one was male,20 were females.Onset age was 10-51 years,the mean onset age was (26.2± 12.0) years.Duration of disease was 2.3-25.8 years,the mean duration was (9.2 ± 5.9) years.Best corrected vision activity (BCVA),expanded disability status scale (EDSS),annualized relapsing rate (ARR) were valued to investigate the efficacy and safety of repeated treatments with low-dose rituximab.The BCVA was examined using Snellen chart,and converted to logMAR.The mean BCVA was 1.13 ± 1.09,the mean BCVA in better eyes was 0.4±0.68,the mean BCVA in latter eyes was 1.87±0.90.The mean EDSS was 3.09±0.70.The mean ARR was 1.04± 0.65.All patients underwent two cycles of RTX treatment.The annually induction treatment was RTX 100 mg per week for 4 weeks.Of 21 patients,12 patients had treatment within one month after attack.The mean follow-up period was (28.4±4.9) months.The side effects were recorded,BCVA,EDSS,ARR were valued to investigate the efficacy and safety of repeated treatments with low-dose rituximab.Paired t test,independent sample t test and Chi-squared test were used.Results The mean BCVA at last follow-up was 0.62 ± 0.91,the mean BCVA in better eye was 0.62±0.91,the BCVA in latter eye was 1.0± 1.01.The mean EDSS was 2.26± 1.07.The mean ARR was 0.21 ± 0.3.After the treatment,patient had significant improvement on BCVA in worst eye (t=4.256),ARR (t=2.900),EDSS (t=4.620) with the significant differences (P＜0.05).Thirteen relapses in 9 patients were observed.B lymph cells were more than 0.01％ in all relapses.There was no significant difference on the BCVA in better eye (t=1.840,P＞0.05).There were 9 patients had relapse,13 times in total.Of 13 relapses,B lymph cell count was performed in 12 relapses,and the counts were 0.01％-0.14％.There were no significant difference between relapsed patients and non-relapsed patients on onset age (t=0.67,P=0.51),whether underwent plasma exchange treatment (x2=1.61,P＞ 0.05),with/without auto-immune antibody ratio (x2=1.61,P＞ 0.05).Of 21 patients,8 patients had side effects,including 5 patients with infection,4 patients with chest congestion,3 patients with hair losing,2 patients with skin rashes,headache and short of breath,1 patient with tinnitus,palpitation and fatigue.Four patients had more than one symptom.Of all patients who had side effects,slowing down the infusion speed of RTX or infusing 5 mg of dexamethasone could relieve the discomfort.Conclusion Lose-dose rituximab reduces the frequency of NMOSD relapses and is well tolerated.