School of Pharmacy and Pharmacology, College of Health and Medicine, University of Tasmania, Hobart, Tasmania, Australia.
Faculty of Health, University of Canberra, Canberra, Australian Capital Territory, Australia.
Rheumatology (Oxford). 2021 Mar 2;60(3):1205-1209. doi: 10.1093/rheumatology/keaa418.
Clinical trial data for the efficacy of glucosamine in OA are conflicting. Reportedly, Rotta-manufactured glucosamine products are more likely to be effective, and a possible explanation is greater bioavailability than other brands. Specifically, the aim was to compare the steady-state pharmacokinetics of Rotta- and non-Rotta-manufactured glucosamine products in healthy volunteers and examine the interindividual variability.
In a crossover design, healthy adult participants ingested 1500 mg/day of a Rotta (DONA powder sachets; imported by Mylan Health, Carole Park, QLD, Australia) and a non-Rotta (glucosamine sulphate 1500 mg one-a-day tablet; Blackmores, Warriewood, NSW, Australia) glucosamine product/brand individually for 6 days. Blood samples were collected immediately before and for 12 h after the ingestion of the last dose of each brand and analysed to determine plasma levels of glucosamine. The pharmacokinetic parameters at steady state [including the minimum (Css min) and maximum (Css max) plasma concentration of glucosamine, time to reach Css max post-dosing (Tss max) and area under the plasma concentration vs time curve (AUCss 0-12)] for each brand were calculated and statistically compared.
Fourteen participants [mean age 35.5 years (s.d. 8.8)] were recruited (64.2% males). No significant differences were observed in the pharmacokinetic parameters between the two brands. However, for both brands, the coefficient of variation for Css min, Tss max and AUCss 0-12 exceeded 20%, indicating considerable differences in the parameters between participants. No significant association of the pharmacokinetic parameters was observed with various dosing- and participant-related variables.
Substantial interindividual differences in the absorption and elimination of glucosamine could be a cause of variable clinical outcomes in OA.
The study was registered with the Australian New Zealand Clinical Trials Registry (http://www.ANZCTR.org.au/ACTRN12618000699268p.aspx), number ACTRN12618000699268p.
关于氨基葡萄糖治疗骨关节炎的疗效，临床试验数据存在争议。据报道，罗氏制造的氨基葡萄糖产品更有可能有效，其可能的解释是生物利用度高于其他品牌。具体而言，本研究旨在比较健康志愿者中罗氏和非罗氏制造的氨基葡萄糖产品的稳态药代动力学，并研究个体间的变异性。
采用交叉设计，健康成年参与者分别单独摄入 1500mg/天罗氏（DONA 粉末小袋；由澳大利亚 Mylan Health，Carole Park 进口）和非罗氏（氨基葡萄糖硫酸盐 1500mg 一日一片；Blackmores，Warriewood，新南威尔士州）氨基葡萄糖产品/品牌，连续 6 天。在每个品牌最后一次给药后立即采集血样，检测 12 小时内的血浆水平。计算每个品牌稳态时的药代动力学参数[包括最小（Css min）和最大（Css max）血浆葡萄糖胺浓度、达到 Css max 后的时间（Tss max）和血浆浓度-时间曲线下面积（AUCss 0-12）]，并进行统计学比较。
共招募了 14 名参与者（平均年龄 35.5 岁（标准差 8.8））（64.2%为男性）。两种品牌的药代动力学参数无显著差异。然而，对于两种品牌，Css min、Tss max 和 AUCss 0-12 的变异系数均超过 20%，表明参与者之间的参数差异很大。药代动力学参数与各种剂量和参与者相关变量无显著相关性。
骨关节炎患者临床疗效的差异可能是由于葡萄糖胺吸收和消除的个体间差异较大所致。
该研究在澳大利亚新西兰临床试验注册中心（http://www.ANZCTR.org.au/ACTRN12618000699268p.aspx）注册，注册号为 ACTRN12618000699268p。
