Plosker G L, McTavish D
Adis International Limited, Auckland, New Zealand.
Drugs Aging. 1996 May;8(5):378-400. doi: 10.2165/00002512-199608050-00006.
Osteoporosis is a common problem among postmenopausal women and is associated with significant morbidity, mortality and costs primarily resulting from osteoporotic fractures. Salcatonin (salmon calcitonin) inhibits osteoclastic bone resorption and is approximately 40 to 50 times more potent than human calcitonin. In most randomised trials in which intranasal salcatonin (usually 50 to 200 IU/day plus oral calcium supplements) was administered for 1 to 5 years to postmenopausal women for prevention of osteoporosis, bone mineral density or content of the lumbar spine increased by approximately 1 to 3% from baseline. In contrast, postmenopausal women receiving only oral calcium supplements typically had reductions in bone mineral density or content of about 3 to 6%. The difference between treatment groups was statistically significant in essentially all studies. Although changes in bone mineral density or content were broadly similar in studies of postmenopausal women with established osteoporosis to those in postmenopausal women receiving therapy for prevention of the disease, studies in women with established osteoporosis did not usually demonstrate statistically significant differences between treatment groups. Also in postmenopausal women with established osteoporosis, intranasal salcatonin reduced pain and/or analgesic consumption in some trials and, in a limited number of studies of relatively short duration (i.e. < or = 2 years), the incidence of osteoporotic fractures. A large multicentre 5-year study with adequate statistical power to confirm the effect of intranasal salcatonin on reducing osteoporotic fracture rates in postmenopausal women is currently under way. The intranasal formulation of salcatonin offers a more convenient and better tolerated alternative to the parenteral formulation of the drug which is administered by regular subcutaneous or intramuscular injections. Adverse events associated with the intranasal formulation are generally mild and transient, usually involving local reactions such as nasal discomfort, rhinorrhoea or rhinitis. Thus, for postmenopausal women unable or unwilling to tolerate long term hormone replacement therapy, intranasal salcatonin is an attractive alternative for the management of osteoporosis.
骨质疏松症是绝经后女性的常见问题,与主要由骨质疏松性骨折导致的显著发病率、死亡率及费用相关。鲑降钙素抑制破骨细胞的骨吸收,其效力比人降钙素约强40至50倍。在大多数随机试验中,给绝经后女性鼻内使用鲑降钙素(通常为50至200IU/天加口服钙补充剂)1至5年以预防骨质疏松症,腰椎的骨矿物质密度或骨量较基线水平增加了约1%至3%。相比之下,仅接受口服钙补充剂的绝经后女性,其骨矿物质密度或骨量通常降低约3%至6%。在基本上所有研究中,治疗组之间的差异具有统计学意义。尽管在患有已确诊骨质疏松症的绝经后女性中的研究,其骨矿物质密度或骨量变化与接受预防疾病治疗的绝经后女性的研究大致相似,但在患有已确诊骨质疏松症的女性中的研究通常未显示治疗组之间具有统计学意义的差异。同样在患有已确诊骨质疏松症的绝经后女性中,鼻内使用鲑降钙素在一些试验中减轻了疼痛和/或减少了镇痛药的使用,并且在数量有限的相对短期(即≤2年)研究中,降低了骨质疏松性骨折的发生率。一项大型多中心5年研究目前正在进行,该研究具有足够的统计效力以证实鼻内使用鲑降钙素对降低绝经后女性骨质疏松性骨折发生率的作用。鲑降钙素的鼻内制剂为该药物的肠胃外制剂提供了一种更方便且耐受性更好的替代选择,肠胃外制剂通过定期皮下或肌肉注射给药。与鼻内制剂相关的不良事件通常较轻且为一过性,通常涉及局部反应,如鼻部不适、鼻溢或鼻炎。因此,对于无法或不愿耐受长期激素替代疗法的绝经后女性,鼻内使用鲑降钙素是治疗骨质疏松症的一种有吸引力的替代方法。