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中国临床药理学与治疗学 ›› 2005, Vol. 10 ›› Issue (2): 154-157.

• 研究原著 • 上一篇    下一篇

利多分注射剂治疗膝关节骨性关节炎的疗效与安全性

孙安修, 王宗贵1   

  1. 中国医科大学绍兴华宇医院, 绍兴312030, 浙江;
    1中国科技大学生物技术公司, 合肥233001, 安徽
  • 收稿日期:2004-10-18 修回日期:2004-12-30 出版日期:2005-02-06 发布日期:2020-11-18

Efficacy and safety of liduofen in treatment of patients with osteoarthritis of knee joint

SUN An-xiu, WANG Zong-gui1   

  1. Department of Pharmacy, Shaoxing Huayu Hospital, China Medical University, Shaoxing 312030, Zhejiang, China;
    1Biologic Technical Corporation, University of Science and Technology of China, Hefei 230001, Anhui, China
  • Received:2004-10-18 Revised:2004-12-30 Online:2005-02-06 Published:2020-11-18
  • Contact: SUN An-xiu, male,master of medicine, associate professor, specialized in clinical pharmacology. Tel:0575-5580856 E-mail:sunanxiu@yahoo.com.cn

摘要: 目的:评价利多分治疗膝关节骨性关节炎的临床疗效和安全性。方法:采用随机、双盲、平行对照方法, 研究2002 年1 月~2003 年12 月间, 136 例病人使用利多分与奥尔芬-75 的疗效与安全性。病人随机分为2 组, 给以75 mg (以双氯芬酸计) 利多分或75 mg(以双氯芬酸计) 奥尔芬-75, 每日1 次, 7天1 个疗程。结果:治疗后, 对于休息痛、运动性疼痛、关节肿胀、关节压痛、关节屈伸功能, 采用10 cm目视模拟标尺法, 利多分与奥尔芬-75 疗效相当:利多分组疼痛改善率治疗d 3 为57.97%, d 5 为93.87%, d 7 为96.94%;奥尔芬-75 组疼痛改善率治疗d 3 为62.69%, d 5 为95.76%, d 7 为97.88%;利多分与奥尔芬-75 的有效率分别为56.72%和55.07%, 总改善率分别为89.85%和92.54%(P>0.05);利多分无不良反应发生, 奥尔芬-75 不良反应发生率为1.49%(P>0.05) 。结论:利多分注射剂治疗膝关节骨性关节炎安全有效, 与奥尔芬-75 相比无显著性差别。

关键词: 利多分, 奥尔芬-75, 注射剂, 疗效, 不良反应, 膝关节骨性关节炎

Abstract: AIM: To investigate the efficacy and safety of liduofen in the treatment of patients with osteoarthritis of the knee joint.METHODS: A randomized, double-blind, parallel-controlled, multi-centre study was adapted to compare the efficacy and safety between liduofen and Olfen-75 in 136 patients.Patients were randomly assigned into two groups:liduofen group which was received 75 mg (diclofenac) Liduofen injection (n=69) once a day for seven days and Olfen group which was received 75 mg (diclofenac) Olfen-75 injection (n=67) once a day for seven days.RESULTS: After the treatment, similar improvements for rest pain, pain on exercise, swelling of joint, pressing pain of joint, knee joint bend extend function measured using a 10 cm visual analogue scale was performed in two groups.In Olfen-75 group, the rate of efficacy was 62.69% in the 3rd day, 95.76% in the 5th day and 97.88% in the 7th day. While in liduofen group, the rate of efficacy was 57.97% in the 3rd day, 93.87% in the 5th day and 96.94% in the 7th day.In liduofen and Olfen-75 groups, the progressive rates were 56.72% and 55.07%, respectively. The total improvement rates were 89.85% and 92.54% respectively (P>0.05), and the rates of side effects were 0% and 1.49%, respectively (P>0.05).CONCLUSION: Liduofen is an effective and safty drug inthe treatment of patients with osteoarthritis of the knee joint. There is no significant difference on efficacy and safety between the two groups using liduofen and Olfen-75.

Key words: liduofen, Olfen-75, injection, efficacy, sideeffects, osteoarthritis of the knee joint

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