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透明质酸和硫酸氨基葡萄糖治疗成人大骨节病:一项整群随机、安慰剂对照研究。

Hyaluronic acid and glucosamine sulfate for adult Kashin-Beck disease: a cluster-randomized, placebo-controlled study.

作者信息

Xia Chuan-Tao, Yu Fang-Fang, Ren Feng-Ling, Fang Hua, Guo Xiong

机构信息

Institute of Endemic Diseases of School of Public Health, Health Science Center, Xi'an Jiaotong University, Xi'an, 710061, People's Republic of China.

Key Laboratory of Environment and Genes Related to Diseases, Ministry of Education, Xi'an, 710061, People's Republic of China.

出版信息

Clin Rheumatol. 2016 May;35(5):1263-70. doi: 10.1007/s10067-014-2809-6. Epub 2014 Nov 12.

Abstract

To evaluate the efficacy and safety of hyaluronic acid (HA) and glucosamine sulfate (GS) in alleviating symptoms and improving function of Kashin-Beck disease (KBD). A cluster-randomized, placebo-controlled trial was conducted in 150 patients with KBD. Participants were randomly allocated to receive intra-articular injection hyaluronic acid (IAHA) for 4 weeks, oral GS for 12 weeks, or oral placebo for 12 weeks. The primary outcome measures were 20 % and 50 % reductions in pain from baseline measured by the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index. Secondary outcome measures included WOMAC index parameters of pain, stiffness, and physical function. The third outcome measure was mean change in Lequence score. HA and GS were effective in reducing WOMAC pain by 20 % (differences of 43.5 % and 25.4 %) and 50 % (differences of 43.4 % and 26.9 %). Both HA and GS significantly reduced WOMAC pain, WOMAC stiffness, and WOMAC normalized score compared with placebo group (all P < 0.05). IAHA was significantly more effective than oral GS in improving WOMAC normalized score (P = 0.034), pain (P = 0.002), stiffness (P = 0.018), and function (P = 0.044). The results indicate that HA and GS were more effective than placebo in treating KBD and HA was more effective than GS.

摘要

评估透明质酸(HA)和硫酸氨基葡萄糖(GS)缓解大骨节病(KBD)症状及改善功能的疗效和安全性。对150例大骨节病患者进行了一项整群随机、安慰剂对照试验。参与者被随机分配接受为期4周的关节腔内注射透明质酸(IAHA)、为期12周的口服硫酸氨基葡萄糖或为期12周的口服安慰剂。主要结局指标是根据西安大略和麦克马斯特大学骨关节炎指数(WOMAC)测量,疼痛较基线水平降低20%和50%。次要结局指标包括WOMAC指数中的疼痛、僵硬和身体功能参数。第三个结局指标是Lequence评分的平均变化。透明质酸和硫酸氨基葡萄糖分别使WOMAC疼痛降低20%(差异分别为43.5%和25.4%)和50%(差异分别为43.4%和26.9%)。与安慰剂组相比,透明质酸和硫酸氨基葡萄糖均显著降低了WOMAC疼痛、WOMAC僵硬和WOMAC标准化评分(所有P<0.05)。在改善WOMAC标准化评分(P=0.034)、疼痛(P=0.002)、僵硬(P=0.018)和功能(P=0.044)方面,关节腔内注射透明质酸显著优于口服硫酸氨基葡萄糖。结果表明,透明质酸和硫酸氨基葡萄糖治疗大骨节病比安慰剂更有效,且透明质酸比硫酸氨基葡萄糖更有效。

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