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眼周曲安奈德醋酸酯注射治疗眼肌型重症肌无力的疗效和安全性的对照临床研究。

A controlled clinical study on efficacy and safety of periocular triamcinolone acetonide injection for treating ocular myasthenia gravis.

机构信息

Department of Opthalmology, Aier Eye Hospital of Wuhan University, No. 481, Zhongshan Road, Wuchang District, Wuhan, 430060, China.

Department of Neurology, RenMin Hospital of Wuhan University, Wuhan, China.

出版信息

BMC Ophthalmol. 2024 Jan 22;24(1):33. doi: 10.1186/s12886-024-03313-z.

DOI:10.1186/s12886-024-03313-z
PMID:38254041
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10804469/
Abstract

OBJECTIVE

To evaluate the efficacy and safety of peribulbar triamcinolone acetonide injection for treating ocular myasthenia gravis (OMG), with a comparison of traditional oral drug therapy.

METHODS

A total of 22 patients with OMG who received periocular triamcinolone acetonide injection (initially 20 mg weekly, then once per month later if symptoms were improved) from July 2019 to July 2022 were evaluated by a comparison of symptom degree before and after treatment. Adverse reactions were also monitored during the period of treatment. The period of follow-up was more than 6 months. Additionally, a comparison of the treatment efficacy between this periocular injection and traditional oral administration was performed in OMG patients.

RESULTS

After 4 weeks of treatment, the degree of ptosis in OMG patients decreased to -3.00 ± 0.69, compared to the value (-0.86 ± 1.32) before treatment. The degree of ophthalmoplegia also decreased from 3.12 ± 0.72 to 0.86 ± 0.88 (P < 0.001) after treatment. The achievement rates of minimal manifestations status (MMS)for ptosis and ophthalmoplegia after 4 week-treatment were 86.3% and 75%, respectively, while they were 50% and 30% in patients with traditional oral administration. There was statistically significant difference only in MMS (rather than symptom relief rate and generalization conversion rate) between two groups. No serious complications (except for intraorbital hematoma) were found in OMG patients during the treatment period.

CONCLUSION

Repeated peribulbar injection of triamcinolone acetonide can effectively alleviate the initial symptoms of OMG patients. However, the evaluation of its long-term efficacy is still needed.

CLINICAL TRIAL REGISTRY

This study has been clinically registered by Chinese Clinical Trial Registry (ChiCTR), first trial registration date:05/07/2019, registration number: ChiCTR1900024285.

摘要

目的

评估球周曲安奈德注射治疗眼肌型重症肌无力(OMG)的疗效和安全性,并与传统口服药物治疗进行比较。

方法

回顾性分析 2019 年 7 月至 2022 年 7 月期间,22 例 OMG 患者接受球周曲安奈德注射治疗(初始剂量为 20mg/周,症状改善后每月 1 次)。通过治疗前后症状严重程度的比较评估疗效,同时监测治疗期间的不良反应。随访时间超过 6 个月。此外,比较了球周注射与传统口服治疗 OMG 的疗效。

结果

治疗 4 周后,OMG 患者的上睑下垂程度从(-0.86±1.32)降至(-3.00±0.69),眼外肌麻痹程度从(3.12±0.72)降至(0.86±0.88)(P<0.001)。4 周治疗后,上睑下垂和眼外肌麻痹达到最小疾病活动状态(MMS)的比例分别为 86.3%和 75%,而传统口服组分别为 50%和 30%。两组间仅在 MMS 方面存在统计学差异(而非症状缓解率和泛化转化率)。在治疗期间,OMG 患者未出现严重并发症(除眶内血肿外)。

结论

重复球周注射曲安奈德可有效缓解 OMG 患者的首发症状,但仍需评估其长期疗效。

临床试验注册

本研究已在中国临床试验注册中心(ChiCTR)进行临床注册,首次注册日期为 2019 年 5 月 7 日,注册号为 ChiCTR1900024285。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c056/10804469/9a65f73abb81/12886_2024_3313_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c056/10804469/81d4a7a620cc/12886_2024_3313_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c056/10804469/9a65f73abb81/12886_2024_3313_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c056/10804469/81d4a7a620cc/12886_2024_3313_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c056/10804469/9a65f73abb81/12886_2024_3313_Fig2_HTML.jpg

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