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\u4e0a\u6d77<\/span>2022\u5e7411\u670810\u65e5<\/span> \/\u7f8e\u901a\u793e\/ — \u7eff\u53f6\u5236\u836f\u96c6\u56e2\u5ba3\u5e03\uff0c\u5176\u63a7\u80a1\u5b50\u516c\u53f8\u535a\u5b89\u751f\u7269\u81ea\u4e3b\u7814\u5236\u7684\u5730\u8212\u5355\u6297\u6ce8\u5c04\u6db2\uff08\u535a\u4f18\u500d®<\/sup>\uff09\u6b63\u5f0f\u83b7\u5f97\u56fd\u5bb6\u836f\u54c1\u76d1\u7763\u7ba1\u7406\u5c40\u7684\u4e0a\u5e02\u6279\u51c6\uff0c\u7528\u4e8e\u9aa8\u6298\u9ad8\u98ce\u9669\u7684\u7edd\u7ecf\u540e\u5987\u5973\u7684\u9aa8\u8d28\u758f\u677e\u75c7\uff1b\u5728\u7edd\u7ecf\u540e\u5987\u5973\u4e2d\uff0c\u672c\u54c1\u53ef\u663e\u8457\u964d\u4f4e\u690e\u4f53\u3001\u975e\u690e\u4f53\u548c\u9acb\u90e8\u9aa8\u6298\u7684\u98ce\u9669\u3002\u535a\u4f18\u500d®<\/sup>\u662f\u5168\u7403\u9996\u4e2a\u83b7\u6279\u4e0a\u5e02\u7684Prolia®<\/sup>\uff08\u666e\u7f57\u529b®<\/sup>\uff09\u751f\u7269\u7c7b\u4f3c\u836f\u3002\u9664\u4e86\u4e2d\u56fd\u7533\u62a5\uff0c\u535a\u5b89\u751f\u7269\u4e5f\u5728\u6b27\u3001\u7f8e\u540c\u6b65\u8fdb\u884c\u535a\u4f18\u500d®<\/sup>\u7684\u56fd\u9645\u4e34\u5e8a\u548c\u6ce8\u518c\uff0c\u5e76\u8ba1\u5212\u5c06\u672c\u54c1\u63a8\u5e7f\u81f3\u5168\u7403\u5e02\u573a\u3002<\/p>\n

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\u535a\u4f18\u500d®<\/sup>\u9075\u5faa\u751f\u7269\u7c7b\u4f3c\u836f\u76f8\u5173\u7814\u7a76\u6307\u5357\uff0c\u901a\u8fc7\u836f\u5b66\u3001\u975e\u4e34\u5e8a\u3001\u4eba\u4f53\u836f\u4ee3\u52a8\u529b\u5b66\u3001\u4e34\u5e8a\u6709\u6548\u6027\u4e00\u7cfb\u5217\u9010\u6b65\u9012\u8fdb\u7684\u7814\u7a76\uff0c\u79d1\u5b66\u3001\u4e25\u8c28\u3001\u5b8c\u6574\u5730\u786e\u8bc1\u4e86\u535a\u4f18\u500d®<\/sup>\u4e0e\u539f\u7814\u53c2\u7167\u836f\u7684\u6574\u4f53\u76f8\u4f3c\u6027\uff0c\u4e8c\u8005\u7684\u8d28\u91cf\u3001\u5b89\u5168\u6027\u548c\u6709\u6548\u6027\u9ad8\u5ea6\u76f8\u4f3c\uff0c\u65e0\u4e34\u5e8a\u610f\u4e49\u4e0a\u7684\u5dee\u5f02\u3002\u535a\u4f18\u500d®<\/sup>\u5b8c\u6210\u7684\u4e24\u4e2aI\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7684\u7ed3\u679c\u5206\u522b\u5df2\u5728\u300aExpert Opinion on Investigational Drugs\u300b[1]<\/sup>\u548c\u300aFrontiers in Pharmacology\u300b[2]<\/sup>\u53d1\u8868\uff0cIII\u671f\u4e34\u5e8a\u8bd5\u9a8c\u7ed3\u679c\u5df2\u5728\u300aJournal of Orthopaedic Translation\u300b[3]<\/sup>\u53d1\u8868\u3002<\/p>\n

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\u53c2\u8003\u6587\u732e\uff1a<\/p>\n

\n\n\n\n\n\n\n\n\n\n\n\n
\n

[1] Wang S, Yang X, Huang J, et al. Pharmacokinetics, pharmacodynamics, safety, and immunogenicity of a biosimilar of denosumab (LY06006): a randomized, double-blind, single-dose, parallel-controlled clinical study in healthy Chinese subjects [J]. Expert Opin Investig Drugs, 2022,31:1133-1142.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[2] Niu S, Chen M, Yan D, et al. A Randomized Controlled Dose-Escalation Study of LY06006, a Recombinant Humanized Monoclonal Antibody to RANKL, in Chinese Healthy Adults [J]. Frontiers in Pharmacology, 2022,13:893166.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[3] Gu J, Zhang H, Xue Q, et al. Denosumab biosimilar (LY06006) in Chinese postmenopausal osteoporotic women: A randomized, double-blind, placebo-controlled, multicenter phase III study [J]. Journal of Orthopaedic Translation, 2023,38:117-125.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[4] \u4e2d\u534e\u533b\u5b66\u4f1a\u9aa8\u8d28\u758f\u677e\u548c\u9aa8\u77ff\u76d0\u75be\u75c5\u5206\u4f1a. \u539f\u53d1\u6027\u9aa8\u8d28\u758f\u677e\u75c7\u8bca\u7597\u6307\u5357 (2017) [J]. \u4e2d\u534e\u9aa8\u8d28\u758f\u677e\u548c\u9aa8\u77ff\u76d0\u75be\u75c5\u6742\u5fd7, 2017,10: 413-443.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[5] \u4e2d\u534e\u533b\u5b66\u4f1a\u9aa8\u8d28\u758f\u677e\u548c\u9aa8\u77ff\u76d0\u75be\u75c5\u5206\u4f1a. \u5730\u8212\u5355\u6297\u5728\u9aa8\u8d28\u758f\u677e\u75c7\u4e34\u5e8a\u5408\u7406\u7528\u836f\u7684\u4e2d\u56fd\u4e13\u5bb6\u5efa\u8bae[J]. \u4e2d\u534e\u9aa8\u8d28\u758f\u677e\u548c\u9aa8\u77ff\u76d0\u75be\u75c5\u6742\u5fd7, 2020,11: 499-508.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[6] Camacho PM, Petak SM, Binkley N, et al. American Association of Clinical Endocrinologists\/ American College of Endocrinology Clinical Practice Guidelines for the diagnosis and treatment of postmenopausal osteoporosis-2020 update [J]. Endocr Pract, 2020,26: 1-46.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[7] Shoback D, Rosen CJ, Black DM, et al. Pharmacological management of osteoporosis in postmenopausal women: an endocrine society guideline update [J]. J Clin Endocrinol Metab, 2020, 105: 587-594.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[8] Kanis JA, Cooper C, Rizzoli R, et al. European guidance for the diagnosis and management of osteoporosis in postmenopausal women [J]. Osteoporos Int, 2019, 30: 3-44.<\/span><\/p>\n<\/td>\n<\/tr>\n

\n

[9] \u5f17\u82e5\u65af\u7279\u6c99\u5229\u6587\u62a5\u544a<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n

 <\/p>\n","protected":false},"excerpt":{"rendered":"

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\u53c2\u8003\u6587\u732e\uff1a [1] Wang S, Yang X, Huang J, et al. 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