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透明质酸钠凝胶(Hylan G-F 20)关节腔内注射治疗膝骨关节炎的疗效和安全性:一项系统评价

Efficacy and safety of viscosupplementation with Hylan G-F 20 for the treatment of knee osteoarthritis: a systematic review.

作者信息

Espallargues Mireia, Pons Joan M V

机构信息

Catalan Agency for Health Technology Assessment and Research, Barcelona, Spain.

出版信息

Int J Technol Assess Health Care. 2003 Winter;19(1):41-56. doi: 10.1017/s0266462303000059.

Abstract

OBJECTIVES

To review the scientific evidence on the efficacy, effectiveness, and safety of intra-articular injections of Hylan G-F 20 for the treatment of knee osteoarthritis.

METHODS

Systematic review of experimental and observational studies performed in humans up to December 1999. Qualitative and quantitative (meta-analytic) techniques were used for data synthesis.

RESULTS

A single course of intra-articular Hylan G-F 20 provides a statistically significant and clinically relevant short-term decrease of the painful symptomatology of knee osteoarthritis and improves joint function. It also seems to delay the need for knee replacement, if results observed in noncontrolled studies are confirmed. Hylan G-F 20 has a comparable efficacy to that of oral NSAID, and a smaller risk of gastrointestinal adverse effects. It seems to be well tolerated and safe, but the short follow-up in most studies limits any extrapolation of the effectiveness and safety over the longer term. There is also scarce evidence on the effect of multiple courses of Hylan G-F 20, and the scientific rigor of both experimental and nonexperimental studies reviewed is somewhat limited.

CONCLUSIONS

Whereas there is good quality scientific evidence showing that Hylan G-F 20 is a safe and well-tolerated therapy providing a short-term decrease of the pain symptoms while improving joint function, the delay of the need for knee replacement as well as the durability of the effect over the longer term have only been demonstrated in noncontrolled clinical series. The available evidence is not sufficient to reach firm conclusions on the effect of multiple courses of intra-articular injections of Hylan G-F 20 on health outcomes.

摘要

目的

回顾关节腔内注射透明质酸钠凝胶(Hylan G-F 20)治疗膝骨关节炎的疗效、有效性及安全性的科学证据。

方法

对截至1999年12月在人类中进行的实验性和观察性研究进行系统评价。采用定性和定量(荟萃分析)技术进行数据合成。

结果

关节腔内单次注射Hylan G-F 20可使膝骨关节炎的疼痛症状在短期内出现具有统计学意义且与临床相关的减轻,并改善关节功能。如果非对照研究中观察到的结果得到证实,它似乎还能推迟膝关节置换的需求。Hylan G-F 20的疗效与口服非甾体抗炎药相当,胃肠道不良反应风险较小。它似乎耐受性良好且安全,但大多数研究的随访时间较短,限制了对其长期有效性和安全性的任何推断。关于多次注射Hylan G-F 20的效果的证据也很少,且所审查的实验性和非实验性研究的科学严谨性都有所局限。

结论

尽管有高质量的科学证据表明Hylan G-F 20是一种安全且耐受性良好的治疗方法,能在短期内减轻疼痛症状并改善关节功能,但推迟膝关节置换的需求以及长期效果的持久性仅在非对照临床系列中得到证实。现有证据不足以就关节腔内多次注射Hylan G-F 20对健康结局的影响得出确凿结论。

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