利塞膦酸钠临床研究进展
黄海英
[摘要] 利塞膦酸钠属于第三代双膦酸盐类药物。其抗骨重吸收作用强，临床上可用于变形性骨炎、骨质疏松等的治疗。而且未见严重不良反应，其主要不良反应包括消化道不良反应、血钙过低等，严重肾衰患者有必要进行监护，并适当调整药物剂量。本文综述了利塞膦酸钠作为一种新型抗代谢性骨病药物的临床前研究概况、临床药代动力学、临床评价及不良反应。
[关键词] 利塞膦酸钠；临床前研究；临床药代动力学；临床评价；不良反应
CLINICAL ADVANCE OF RISEDRONATE SODIUM
Huang Haiying
(Bethune Military Medical College of PLA，Shi jiazhuang 050081)
, http://www.100md.com
[Abstract] Risedronate sodium is the third generation bisphosphonate.It,s antiresorptive action is high,and is used to treat Paget,s disease and osteoporosis. There are no severe adverse events, the main of which include gastrointestinal adverse events and hypocalcemia,and monitor and dosage adjustment is necessary to severe renal failure. The preclinical study, clinical pharmacokinetics, clinical evaluvation and adverse reactions of risedronate sodium, a new drug for treatment of metabolic bone disease are reviewed.
, 百拇医药
[Key Words] Risedronate sodium; Preclinical study; Clinical pharmacokinetics; Clinical evaluation; Adverse reaction
[参考文献]
[1] Jeal W,Barradell LB,Mctavish D.Alendronate:a review of its pharmacological properties and therapeutic efficacy in postmenopausal osteoporosis[J].Drugs,1997,53(3):415-34
[2] Toolan BC, Shea M, Myers ER, et al. Effects of 4-amino-1-hydroxy-butylidene bisposphonate on bone biomechanics in rats[J]. J Bone Miner Res,1992,7(4):1399-406
, 百拇医药
[3] Li-QN,Liang NK,Huang LF,et al.Skeletal effects of constant and terminated use of risedronate on cortical bone in ovariectomized rats[J].J Bone Miner Metab,1999,17(1):18-22
[4] Richardson AC,Tinling SP,Chole RA.Risedronate activity in the fetal and neonatal mouse[J].Otolaryngol Heal Neck Surg,1998, 109(4): 623-33
[5] Hunziker U, Wonski TU, Miller SC. Mandibaular bone formation rats in aged ovariectomized rats treated with anti-resorptive agents alone and in combination with intermittent parathyroid hormone[J]. J Dent Res,2000,79(6): 1431-8
, http://www.100md.com
[6] Green JR,Seltenmeyer Y,Jaeggi KA,et al. Renal tolerability profile of novel potent bisphosphonate in two short-term rat models[J]. Pharmacol Toxicol, 1997,80(6):225-32
[7] Mitchell DY, Eusebio RA, Sauo Gibson NA,et al. Dose proportional pharmacokinetics of risedronate on sigle dose oral administration to healthy volunteers[J].J Clin Pharmacol,2000, 40(3):258-65
[8] Mitchell DY, St Peter JV, Eusebio RA, et al. Effect of renal function on risedronate pharmacokinetics after a single after a singer oral dose[J].J Clin Pharmcol,2000,49(3):215-22
, 百拇医药
[9] Mitchell DY,Heise MA,Pallone KA,et al.The effect of dosing regime on the pharmacokinetics of risedronate[J]. Dr J Clin Pharmacol,1999,48(4):536-42
[10] Miller PD,Brown JP,Siris ES,et al.Arandomized double -blind comparison of risedronate in the treatment of Paget,s diseases of bone[J].Am J Med,1999,106(5):513-20
[11] Brown JP, Hosking DS, Ste Marie L, et al. Risedronate, a highly effective,short-time oral treatment for Paget,s disease:a dose response study[J].Calcif Tissue Int,1999,64(2):93-9
, 百拇医药
[12] Brown JP,Chines AA,Myers WR,et al.Improvement of pagetic bone lesions with risedronate treatment: a radiologic study[J]. Bone, 2000,26(3): 263-7
[13] Mortensen L,Chines A, Myers WR，et al. Risedronate increase bone mass in an early posymenopausal population:Two years of treatment plus one year of follow[J]. J Clin Endocrinol Metab, 1998,83(2):396-405
[14] Reid DM,Hughes RA,Laan RF,et al.Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trail[J].J Bone Miner Res,2000,15 (6):1006-13
, 百拇医药
[15] Fogelman I,Ribot C,Smith R,et al. Risedronate reverse bone loss in postmenopausal women with low bone mass:results from a multination,double-blind,placebo-antrollal trial[J].J Clin Endoerinol Metab,2000,85(5):1895-900
[16] Reginster J,Minne HW,Sorensen OH,et al.Randomized trial of effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis[J].Osteoporos Int, 2000, 11 (1):83-91
[17] Eastell R,Devogelaer JP,Peel NF,et al.Prevention of bone loss with risedronate in glucocorticoid-treated rheumatoid arthritis patients[J]. Osteoporos Int,2000,11(4):331-7
[18] 许重远,贾江滨.双膦酸盐类药物的临床应用进展[J].中国药学杂志,1999,34(7):433-6, 百拇医药
[摘要] 利塞膦酸钠属于第三代双膦酸盐类药物。其抗骨重吸收作用强，临床上可用于变形性骨炎、骨质疏松等的治疗。而且未见严重不良反应，其主要不良反应包括消化道不良反应、血钙过低等，严重肾衰患者有必要进行监护，并适当调整药物剂量。本文综述了利塞膦酸钠作为一种新型抗代谢性骨病药物的临床前研究概况、临床药代动力学、临床评价及不良反应。
[关键词] 利塞膦酸钠；临床前研究；临床药代动力学；临床评价；不良反应
CLINICAL ADVANCE OF RISEDRONATE SODIUM
Huang Haiying
(Bethune Military Medical College of PLA，Shi jiazhuang 050081)
, http://www.100md.com
[Abstract] Risedronate sodium is the third generation bisphosphonate.It,s antiresorptive action is high,and is used to treat Paget,s disease and osteoporosis. There are no severe adverse events, the main of which include gastrointestinal adverse events and hypocalcemia,and monitor and dosage adjustment is necessary to severe renal failure. The preclinical study, clinical pharmacokinetics, clinical evaluvation and adverse reactions of risedronate sodium, a new drug for treatment of metabolic bone disease are reviewed.
, 百拇医药
[Key Words] Risedronate sodium; Preclinical study; Clinical pharmacokinetics; Clinical evaluation; Adverse reaction
[参考文献]
[1] Jeal W,Barradell LB,Mctavish D.Alendronate:a review of its pharmacological properties and therapeutic efficacy in postmenopausal osteoporosis[J].Drugs,1997,53(3):415-34
[2] Toolan BC, Shea M, Myers ER, et al. Effects of 4-amino-1-hydroxy-butylidene bisposphonate on bone biomechanics in rats[J]. J Bone Miner Res,1992,7(4):1399-406
, 百拇医药
[3] Li-QN,Liang NK,Huang LF,et al.Skeletal effects of constant and terminated use of risedronate on cortical bone in ovariectomized rats[J].J Bone Miner Metab,1999,17(1):18-22
[4] Richardson AC,Tinling SP,Chole RA.Risedronate activity in the fetal and neonatal mouse[J].Otolaryngol Heal Neck Surg,1998, 109(4): 623-33
[5] Hunziker U, Wonski TU, Miller SC. Mandibaular bone formation rats in aged ovariectomized rats treated with anti-resorptive agents alone and in combination with intermittent parathyroid hormone[J]. J Dent Res,2000,79(6): 1431-8
, http://www.100md.com
[6] Green JR,Seltenmeyer Y,Jaeggi KA,et al. Renal tolerability profile of novel potent bisphosphonate in two short-term rat models[J]. Pharmacol Toxicol, 1997,80(6):225-32
[7] Mitchell DY, Eusebio RA, Sauo Gibson NA,et al. Dose proportional pharmacokinetics of risedronate on sigle dose oral administration to healthy volunteers[J].J Clin Pharmacol,2000, 40(3):258-65
[8] Mitchell DY, St Peter JV, Eusebio RA, et al. Effect of renal function on risedronate pharmacokinetics after a single after a singer oral dose[J].J Clin Pharmcol,2000,49(3):215-22
, 百拇医药
[9] Mitchell DY,Heise MA,Pallone KA,et al.The effect of dosing regime on the pharmacokinetics of risedronate[J]. Dr J Clin Pharmacol,1999,48(4):536-42
[10] Miller PD,Brown JP,Siris ES,et al.Arandomized double -blind comparison of risedronate in the treatment of Paget,s diseases of bone[J].Am J Med,1999,106(5):513-20
[11] Brown JP, Hosking DS, Ste Marie L, et al. Risedronate, a highly effective,short-time oral treatment for Paget,s disease:a dose response study[J].Calcif Tissue Int,1999,64(2):93-9
, 百拇医药
[12] Brown JP,Chines AA,Myers WR,et al.Improvement of pagetic bone lesions with risedronate treatment: a radiologic study[J]. Bone, 2000,26(3): 263-7
[13] Mortensen L,Chines A, Myers WR，et al. Risedronate increase bone mass in an early posymenopausal population:Two years of treatment plus one year of follow[J]. J Clin Endocrinol Metab, 1998,83(2):396-405
[14] Reid DM,Hughes RA,Laan RF,et al.Efficacy and safety of daily risedronate in the treatment of corticosteroid-induced osteoporosis in men and women: a randomized trail[J].J Bone Miner Res,2000,15 (6):1006-13
, 百拇医药
[15] Fogelman I,Ribot C,Smith R,et al. Risedronate reverse bone loss in postmenopausal women with low bone mass:results from a multination,double-blind,placebo-antrollal trial[J].J Clin Endoerinol Metab,2000,85(5):1895-900
[16] Reginster J,Minne HW,Sorensen OH,et al.Randomized trial of effects of risedronate on vertebral fractures in women with established postmenopausal osteoporosis[J].Osteoporos Int, 2000, 11 (1):83-91
[17] Eastell R,Devogelaer JP,Peel NF,et al.Prevention of bone loss with risedronate in glucocorticoid-treated rheumatoid arthritis patients[J]. Osteoporos Int,2000,11(4):331-7
[18] 许重远,贾江滨.双膦酸盐类药物的临床应用进展[J].中国药学杂志,1999,34(7):433-6, 百拇医药