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Safety of a single intra-articular injection of LBSA0103 hyaluronic acid in patients with osteoarthritis of the knee: a multicenter, single-arm, prospective, cohort study
Current Medical Research and Opinion ( IF 2.3 ) Pub Date : 2021-07-15 , DOI: 10.1080/03007995.2021.1950132
Ki-Mo Jang 1 , Yong-Geun Park 2 , Won Kee Choi 3 , Young Yool Chung 4 , Kwang Kyoun Kim 5 , Jang Woo Lee 6 , Soong Joon Lee 7 , Yunae Eom 8 , Jae-Hyuk Yang 9
Affiliation  

Abstract

Objective

LBSA0103 is a recently developed high-molecular-weight, cross-linked, non-animal hyaluronic acid (HA). The safety of LBSA0103 has been investigated only in a limited number of patients, therefore this prospective study was designed. This study sought to assess the safety including injection-site reactions and adverse drug reactions after a single intra-articular injection of LBSA0103 in patients with osteoarthritis (OA) of the knee joint.

Methods

This study was a multicenter, single-arm, prospective cohort study. After screening, eligible patients with OA of the knee joint (Kellgren–Lawrence grades I–III) were enrolled, received a single intra-articular HA (LBSA0103) injection, and were followed up for two weeks. Any adverse events including injection-site reactions and adverse drug reactions were evaluated by the investigators.

Results

A total of 1949 subjects (2976 knee joints) was enrolled, all of whom received a single intra-articular injection of LBSA0103. Injection-site reactions occurred in 5.59% of enrolled subjects (109/1949), and the most frequently reported injection-site reaction was pain (4.87%), followed by swelling (1.03%). Most of the injection-site reactions were transient and resolved within 14 days without additional treatment. The incidence of adverse drug reactions other than injection-site reactions was 0.67% (13/1949). Most adverse events were of mild severity. No serious adverse events related to the study drug were reported.

Conclusions

A single intra-articular injection of LBSA0103 in patients with OA of the knee joint was safe, and no significant safety concerns were observed. As such, LBSA0103 could be safely applied as an intra-articular injection for the management of knee OA.

Trial Registration

The study was registered at ClinicalTrials.gov (identifier: NCT04369261).



中文翻译:

膝关节骨关节炎患者单次关节内注射 LBSA0103 透明质酸的安全性:一项多中心、单臂、前瞻性队列研究

摘要

客观的

LBSA0103 是最近开发的高分子量、交联、非动物透明质酸 (HA)。LBSA0103 的安全性仅在有限数量的患者中进行了研究,因此设计了这项前瞻性研究。本研究旨在评估膝关节骨关节炎 (OA) 患者单次关节内注射 LBSA0103 后的安全性,包括注射部位反应和药物不良反应。

方法

本研究是一项多中心、单臂、前瞻性队列研究。筛选后,纳入符合条件的膝关节 OA 患者(Kellgren-Lawrence I-III 级),接受单次关节内 HA(LBSA0103)注射,并随访两周。包括注射部位反应和药物不良反应在内的任何不良事件均由研究人员进行评估。

结果

共招募了 1949 名受试者(2976 个膝关节),所有受试者均接受了 LBSA0103 的单次关节内注射。5.59% 的入组受试者 (109/1949) 发生注射部位反应,最常报告的注射部位反应是疼痛 (4.87%),其次是肿胀 (1.03%)。大多数注射部位反应是短暂的,无需额外治疗即可在 14 天内解决。除注射部位反应外,药物不良反应的发生率为 0.67% (13/1949)。大多数不良事件的严重程度较轻。没有报告与研究药物相关的严重不良事件。

结论

膝关节 OA 患者单次关节内注射 LBSA0103 是安全的,没有观察到明显的安全问题。因此,LBSA0103 可以安全地用作关节内注射剂来治疗膝关节 OA。

试用注册

该研究已在 ClinicalTrials.gov 注册(标识符:NCT04369261)。

更新日期:2021-08-24
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