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透明质酸钠治疗踝骨关节炎
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透明质酸钠治疗踝骨关节炎的随机对照双盲实验 Sodium Hyaluronate in the Treatment of Osteoarthritis of the Ankle: A Controlled, Randomized, Double-Blind Pilot Study Background: Intra-articular injections of hyaluronans have been shown to be safe and effective for the treatment of pain associated with osteoarthritis of the knee. This pilot study was undertaken to gather preliminary data on the efficacy and safety of five weekly intra-articular injections of Hyalgan (sodium hyaluronate; molecular weight, 500 to 730 kDa) as compared with saline solution for the treatment of pain associated with osteoarthritis of the ankle. Methods: Twenty patients at two test sites were randomized with use of a double-blind (blinded observer), saline solution-controlled, parallel experimental design. Patients were randomized to receive five weekly intra-articular injections of either 1 mL of sodium hyaluronate (10 mg/mL) or 1 mL of phosphate-buffered saline solution into the ankle joint. The primary outcome measurement was the ankle osteoarthritis score. Several secondary outcome measures also were assessed. Results: Significant improvement in the mean ankle osteoarthritis score from baseline was seen at all follow-up visits from one to six months in both the sodium hyaluronate group and the saline solution group (p < 0.0001). In addition, five of nine patients in the sodium hyaluronate group had >30 mm of improvement in this score, compared with one of eight patients in the control group. No withdrawals were directly attributable to the injections of sodium hyaluronate or saline solution, and no severe medication-related adverse events were observed. Conclusions: The present study suggests that five weekly intra-articular injections of sodium hyaluronate (molecular weight, 500 to 730 kDa) are well tolerated, can provide sustained relief of pain, and can improve function in patients with osteoarthritis of the ankle. These findings are consistent with those of previously published studies involving intra-articular injections of sodium hyaluronate in other joints, but they require confirmation in a large, randomized, saline solution-controlled study. 背景：已证明关节内注射透明质烷是一种治疗膝骨关节炎安全有效的方法。本次初步研究中，对有疼痛的踝骨关节炎患者进行关节腔内注射海尔根（透明质酸钠,分子量500-730 kDa）,并有关节腔内注射生理盐水组做对照，收集了五周的有关安全性和有效性的数据。 方法：共两个实验点的二十位患者参加了本次盐水对照的双盲（观察者盲）平行实验。所有患者随机接受了五周的踝关节腔内注射，注射物为透明质酸钠（10mg/mL）或1mL磷酸盐缓冲生理盐水。采用踝关节骨关节炎评分评价治疗后初步结果。同时对后期的几项测量结果进行了评估。 结果：对透明质酸钠组和生理盐水组的一到六个月随访观察可见，两组的平均踝骨关节炎评分相对于基础值都有显著的改善（p < 0.0001）。此外，九位患者中的五位改善值>30mm，而对照组的八位患者中仅有一位达此程度。尚未发现与透明质酸钠或生理盐水直接有关的撤停反应，以及任何与药物有关的严重副作用。 结论：本研究认为，踝骨关节炎的患者关节腔内注射透明质酸钠（分子量500-730kDa）五周能被很好的耐受，且能够持久的缓解疼痛并改善功能。这些发现与以前发表的有关在其它关节关节腔内注射透明质酸钠的研究报道是一致的,但仍需大型的随机的盐水对照研究证实。 |
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