蓝湾高纯度硫酸氨基葡萄糖治疗膝关节骨性关节炎的有效性和安全性研究
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摘要
目的评价国产蓝湾高纯度硫酸氨基葡萄糖治疗膝关节骨性关节炎的有效性和安全性。方法纳入自2017-08—2018-04北京地区和厦门地区126例膝关节骨性关节炎,随机分为3组,每组42例。A组口服国产蓝湾高纯度硫酸氨基葡萄糖(300 mg/粒,硫酸氨基葡萄糖含量为99.3%),早3粒,晚2粒。B组口服国产蓝湾高纯度硫酸氨基葡萄糖,早、中、晚各3粒。C组为对照组,口服进口硫酸氨基葡萄糖胶囊(维固力,250 mg/粒,硫酸氨基葡萄糖含量为79.6%),早、中、晚各2粒。治疗12周,停药后继续观察4周。结果治疗12周时A、B、C组Lequesne评分较治疗前明显降低,差异有统计学意义(P <0.05)。治疗12周,A组与B组治疗有效率均高于C组,差异有统计学意义(P <0.05)。治疗12周以及停药2、4周时,A组与B组Lequesne评分均低于C组,差异有统计学意义(P <0.05);但A组与B组比较差异无统计学意义(P>0.05)。高纯度硫酸氨基葡萄糖治疗膝关节骨性关节炎药效至少可以维持到停药后4周。服药期间患者血压、脉搏、血常规、尿常规、肝功能、肾功能、血糖、尿酸等指标未见异常,仅个别患者出现轻微不良反应。结论国产蓝湾高纯度硫酸氨基葡萄糖治疗膝关节骨性关节炎的安全性及效果良好,尤其是在改善症状方面的效果优于硫酸氨基葡萄糖复盐。
Objective To evaluate the efficacy and safety of domestic Lanwan high purity glucosamine sulfate(HPGS) in the treatment of knee osteoarthritis(OA). Methods All 126 cases of knee OA were selected and randomly divided into 3 groups,42 cases in each group from August 2017 to April 2018, in Beijing and Xiamen district. Group A was orally treated with domestic Lanwan HPGS(300 mg/capsule, content of glucosamine sulfate is 99.3%), with three capsules in the morning and two in the evening. Group B was orally treated with domestic Lanwan HPGS for three times a day, three capsules for each time.Group C was the control group, orally treated with imported glucosamine sulfate capsules(WEIGULI, 250 mg/capsule, content of glucosamine sulfate is 79.6%), with the dosage of 2 capsules each time, and three times a day as described. They were orally treated for 12 weeks and were assessed for drug efficacy and safety for 4 more weeks after discontinuation. Results After the treatment of 12 weeks, the Lequesne scores of group A, B and C were significantly lower than before treatment, and the difference was statistically significant(P <0.05). After the treatment of 12 weeks, the effective rates of group A and group B were all higher than group C, and the statistical difference were significant(P <0.05). The Lequesne scores of group A and B were lower than group C after the treatment of 12 weeks and after discontinuation of 2 and 4 weeks, and the statistical difference were significant(P <0.05). There was no statistically significant between group A and B(P >0.05). Lanwan HPGS maintained good efficacy in the treatment of knee OA, which could be maintained at least 4 weeks after discontinuation. During the treatment, there were no abnormal symptoms in the patients' blood pressure, pulse, blood routine, urine routine, liver function,renal function, blood sugar, uric acid and other indicators, and only a few patients had slight side effects. Conclusion Domestic Lanwan high-purity glucosamine sulfate not only shows obvious safety, but also its effect on the treatment of knee osteoarthritis, is better than glucosamine sulfate double salt, especially in the improvement of clinical symptoms.
Objective To evaluate the efficacy and safety of domestic Lanwan high purity glucosamine sulfate(HPGS) in the treatment of knee osteoarthritis(OA). Methods All 126 cases of knee OA were selected and randomly divided into 3 groups,42 cases in each group from August 2017 to April 2018, in Beijing and Xiamen district. Group A was orally treated with domestic Lanwan HPGS(300 mg/capsule, content of glucosamine sulfate is 99.3%), with three capsules in the morning and two in the evening. Group B was orally treated with domestic Lanwan HPGS for three times a day, three capsules for each time.Group C was the control group, orally treated with imported glucosamine sulfate capsules(WEIGULI, 250 mg/capsule, content of glucosamine sulfate is 79.6%), with the dosage of 2 capsules each time, and three times a day as described. They were orally treated for 12 weeks and were assessed for drug efficacy and safety for 4 more weeks after discontinuation. Results After the treatment of 12 weeks, the Lequesne scores of group A, B and C were significantly lower than before treatment, and the difference was statistically significant(P <0.05). After the treatment of 12 weeks, the effective rates of group A and group B were all higher than group C, and the statistical difference were significant(P <0.05). The Lequesne scores of group A and B were lower than group C after the treatment of 12 weeks and after discontinuation of 2 and 4 weeks, and the statistical difference were significant(P <0.05). There was no statistically significant between group A and B(P >0.05). Lanwan HPGS maintained good efficacy in the treatment of knee OA, which could be maintained at least 4 weeks after discontinuation. During the treatment, there were no abnormal symptoms in the patients' blood pressure, pulse, blood routine, urine routine, liver function,renal function, blood sugar, uric acid and other indicators, and only a few patients had slight side effects. Conclusion Domestic Lanwan high-purity glucosamine sulfate not only shows obvious safety, but also its effect on the treatment of knee osteoarthritis, is better than glucosamine sulfate double salt, especially in the improvement of clinical symptoms.
引文
[1]Moyer RF,Ratneswaran A,Beier F,et al.Osteoarthritis year in review 2014:mechanics——basic and clinical studies in osteoarthrifis[J].Osteoarthritis Cartilage,2014,22(12):1989-2002.
[2]文琼芳,黄烽.氨基葡萄糖治疗骨关节炎的争议探讨[J].中国药物应用与检测,2015,12(4):246-250.
[3]Altman R,Asch E,Bloch D,et al.Development of criteria for the classification and reporting of osteoarthritis.Classification of osteoarthritis of the knee.Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association[J].Arthritis Rheum,1986,29(8):1039-1049.
[4]Lequesne MG,Samson M.Indices of severity in osteoarthritis for weight bearing joints[J].J Rheumatol Suppl,1991,27:16-18.
[5]汪永利,卫壅绩,宋卫平,等.8支国家运动队64例国家运动员服用“蓝湾高纯硫酸氨基葡萄糖”治疗骨关节炎的临床疗效观察[J].中外医疗,2012,33:95-97.
[6]Imagawa K,de Andres MC,Hashimoto K,et al.The epigenetic effect of glucosamine and a nuclear factor-kappa B(NF-kB)inhibitor on primary human chondrocytes-implications for osteoarthritis[J].Biochem Biophys Res Commun,2011,405(3):362-367.
[7]刘康妍,凌龙,胡海澜.氨基葡萄糖在骨关节炎中的应用疗效及安全性分析[J/CD].中华关节外科杂志:电子版,2017,11(6):673-675.
[8]Bruyere O,Altman RD,Reginster JY.Efficacy and safety of glucosamine sulfate in the management of osteoarthritis:evidence from real-life setting trials and surveys[J].Semin Arthritis Rheum,2016,45(4 Suppl)S12-S17.
[9]Reginster JY,Deroisy R,Rovati LC,et al.Long-term effects of glucosamine sulphate on osteoarthritis progression:a randomised,placebo-controlled clinical trial[J].Lancet,2001,357(9252):251-256.
[10]Pavelka K,Gatterova J,Olejarova M,et al.Glucosamine sulfate use and delay of progression of knee osteoarthritis:a 3-year,randomized,placebo-controlled,double-blind study[J].Arch Intern Med,2002,162(18):2113-2123.
[11]邱贵兴,翁习生,张克,等.盐酸/硫酸氨基葡萄糖治疗骨关节炎的平行对照临床研究[J].中华医学杂志,2005,85(43):3067-3070.
[12]Hochberg MC,Martel-Pelletier J,Monfort J,et al.Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis:a multicentre,randomised,double-blind,non-inferiority trial versus celecoxib[J].Ann Rheum Dis,2016,75(1):37-44.
[13]Bruyere O,Cooper C,Pelletier JP,et al.An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally:a report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis(ESCEO)[J].Semin Arthritis Rheum,2014,44(3):253-263.
[14]Kucharz EJ,Kovalenko V,Szanto S,et al.A review of glucosamine for knee osteoarthritis:why patented crystalline glucosamine sulfate should be differentiated from other glucosamines to maximize clinical outcomes[J].Curr Med Res Opin,2016,32(6):997-1004.
[15]张斌,姚浩群,程世高.硫酸氨基葡萄糖治疗骨关节炎的应用研究进展[J].江西医学院学报,2004,44(4):123-124.
[16]Russell AS,Aghazadeh-Habashi A,Jamali F.Active ingredient consistency of commercially available glucosamine sulfate products[J].J Rheumatol,2002,29(11):2407-2409.
[17]薛延,吴树勋,黄任,等.骨膳食营养补充剂研究进展[J].食品科学技术学报,2017,35(3):25-30.
[2]文琼芳,黄烽.氨基葡萄糖治疗骨关节炎的争议探讨[J].中国药物应用与检测,2015,12(4):246-250.
[3]Altman R,Asch E,Bloch D,et al.Development of criteria for the classification and reporting of osteoarthritis.Classification of osteoarthritis of the knee.Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association[J].Arthritis Rheum,1986,29(8):1039-1049.
[4]Lequesne MG,Samson M.Indices of severity in osteoarthritis for weight bearing joints[J].J Rheumatol Suppl,1991,27:16-18.
[5]汪永利,卫壅绩,宋卫平,等.8支国家运动队64例国家运动员服用“蓝湾高纯硫酸氨基葡萄糖”治疗骨关节炎的临床疗效观察[J].中外医疗,2012,33:95-97.
[6]Imagawa K,de Andres MC,Hashimoto K,et al.The epigenetic effect of glucosamine and a nuclear factor-kappa B(NF-kB)inhibitor on primary human chondrocytes-implications for osteoarthritis[J].Biochem Biophys Res Commun,2011,405(3):362-367.
[7]刘康妍,凌龙,胡海澜.氨基葡萄糖在骨关节炎中的应用疗效及安全性分析[J/CD].中华关节外科杂志:电子版,2017,11(6):673-675.
[8]Bruyere O,Altman RD,Reginster JY.Efficacy and safety of glucosamine sulfate in the management of osteoarthritis:evidence from real-life setting trials and surveys[J].Semin Arthritis Rheum,2016,45(4 Suppl)S12-S17.
[9]Reginster JY,Deroisy R,Rovati LC,et al.Long-term effects of glucosamine sulphate on osteoarthritis progression:a randomised,placebo-controlled clinical trial[J].Lancet,2001,357(9252):251-256.
[10]Pavelka K,Gatterova J,Olejarova M,et al.Glucosamine sulfate use and delay of progression of knee osteoarthritis:a 3-year,randomized,placebo-controlled,double-blind study[J].Arch Intern Med,2002,162(18):2113-2123.
[11]邱贵兴,翁习生,张克,等.盐酸/硫酸氨基葡萄糖治疗骨关节炎的平行对照临床研究[J].中华医学杂志,2005,85(43):3067-3070.
[12]Hochberg MC,Martel-Pelletier J,Monfort J,et al.Combined chondroitin sulfate and glucosamine for painful knee osteoarthritis:a multicentre,randomised,double-blind,non-inferiority trial versus celecoxib[J].Ann Rheum Dis,2016,75(1):37-44.
[13]Bruyere O,Cooper C,Pelletier JP,et al.An algorithm recommendation for the management of knee osteoarthritis in Europe and internationally:a report from a task force of the European Society for Clinical and Economic Aspects of Osteoporosis and Osteoarthritis(ESCEO)[J].Semin Arthritis Rheum,2014,44(3):253-263.
[14]Kucharz EJ,Kovalenko V,Szanto S,et al.A review of glucosamine for knee osteoarthritis:why patented crystalline glucosamine sulfate should be differentiated from other glucosamines to maximize clinical outcomes[J].Curr Med Res Opin,2016,32(6):997-1004.
[15]张斌,姚浩群,程世高.硫酸氨基葡萄糖治疗骨关节炎的应用研究进展[J].江西医学院学报,2004,44(4):123-124.
[16]Russell AS,Aghazadeh-Habashi A,Jamali F.Active ingredient consistency of commercially available glucosamine sulfate products[J].J Rheumatol,2002,29(11):2407-2409.
[17]薛延,吴树勋,黄任,等.骨膳食营养补充剂研究进展[J].食品科学技术学报,2017,35(3):25-30.