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[大关节骨关节炎中硫酸氨基葡聚糖多硫酸盐(Arteparon)与生理盐水的比较。一项多中心双盲研究的结果]

[Comparison of glycosaminoglycan polysulfate (Arteparon) and physiological saline solution in arthrosis of the large joints. Results of a multicenter double-blind study].

作者信息

Siegmeth W, Radi I

出版信息

Z Rheumatol. 1983 Jul-Aug;42(4):223-8.

PMID:6228080
Abstract

In a double-blind study, glycosaminoglycan polysulfate (GAGPS, Arteparon) was compared to saline solution: both preparations were applied intramuscularly in two groups of 70 patients, each over a period of 8 weeks. The patients were suffering from pain and impaired function of the knee and hip joints. To assess the therapeutic efficacy, the following parameters were employed: pain, joint mobility, and walking distance. The post trial observation period lasted for 6 months. In the GAGPS group, a statistically significant improvement compared to the results in the saline group was noted during the 2nd and 6th months of observation respectively. The global assessment by investigator and patient at the end of the observation period was superior in the GAGPS group to that in the saline group. While the difference regarding the onset of pain remission between the GAGPS and the saline groups was insignificant, the rate of complete relief from pain was better in the GAGPS group, and pain worsened in fewer incidences in this group, too. Laboratory findings did not reveal any detrimental effect of either treatment with respect to hematology, blood chemistry, or urinalysis. 3 patients of the GAGPS group developed harmless hematomas of short duration at the site of injection.

摘要

在一项双盲研究中,将硫酸氨基葡聚糖(GAGPS,商品名:安特罗)与生理盐水进行了比较:两种制剂分别对两组各70例患者进行肌肉注射,疗程均为8周。这些患者患有膝关节和髋关节疼痛且功能受损。为评估治疗效果,采用了以下参数:疼痛、关节活动度和行走距离。试验后的观察期持续6个月。在GAGPS组,分别在观察的第2个月和第6个月时,与生理盐水组的结果相比,观察到有统计学意义的改善。观察期末研究者和患者的整体评估结果显示,GAGPS组优于生理盐水组。虽然GAGPS组和生理盐水组在疼痛缓解开始时间上的差异不显著,但GAGPS组的疼痛完全缓解率更高,且该组疼痛恶化的发生率也更低。实验室检查结果未显示任何一种治疗在血液学、血液化学或尿液分析方面有不良影响。GAGPS组有3例患者在注射部位出现了短期无害的血肿。

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