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首页> 外文期刊>The Journal of pharmacy technology: jPT : official publication of the Association of Pharmacy Technicians >Romosozumab: A Novel Agent in the Treatment for Postmenopausal Osteoporosis
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Romosozumab: A Novel Agent in the Treatment for Postmenopausal Osteoporosis

机译：罗米苏脲：绝经后骨质疏松症治疗的新试剂

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摘要

Objective: To review the safety and efficacy of romosozumab (Evenity) in the treatment of osteoporosis in women. Data Sources: An English-language search of PubMed and Medline (1966 to August 2020) was conducted using the keywords romosozumab, sclerostin inhibitor, AMG785, and osteoporosis. Manufacturer prescribing information, abstracts, fda.gov, and ClinicalTrials.gov data were incorporated for additional materials. In addition, a review of bibliographies of retrieved articles was performed to identify additional references. Study Selection/Data Extraction: Articles selected included those that described clinical studies of pharmacokinetics, efficacy, or safety of romosozumab. Data Synthesis: Romosozumab is a human monoclonal antibody that inhibits the action of sclerostin and is the first agent in its class to reach Phase III trials. Significant increases in bone mineral density and decreases in vertebral and hip fractures are demonstrated in Phase III trials. Favorable results led to its marketing approval in several countries. Major adverse cardiac events were observed in one clinical trial. Other adverse effects include arthralgia, headache, and injection site reactions. Place in Therapy: Romosozumab is the first agent to inhibit bone resorption and stimulate bone formation. Romosozumab should be reserved for postmenopausal women at highest risk for fracture and should be followed by an anti-resportive agent to maintain or further increase bone mineral density. This injectable agent should not be considered for women with a history of or at high risk of cardiovascular disease.
机译：目的：评价罗莫单抗（Evenity）治疗女性骨质疏松症的安全性和有效性。数据来源：使用关键词romosozumab、硬化蛋白抑制剂、AMG785和骨质疏松症对PubMed和Medline（1966年至2020年8月）进行了英语搜索。制造商处方信息、摘要、fda。政府和临床试验。政府数据被纳入其他材料。此外，还对检索到的文章的参考书目进行了审查，以确定其他参考文献。研究选择/数据提取：选择的文章包括描述罗莫单抗药代动力学、疗效或安全性临床研究的文章。资料综合：罗莫苏单抗是一种抑制硬化蛋白作用的人类单克隆抗体，是该类药物中第一个达到III期试验的药物。在III期试验中，骨密度显著增加，脊椎和髋部骨折显著减少。良好的结果使其在多个国家获得了市场认可。在一项临床试验中观察到重大心脏不良事件。其他不良反应包括关节痛、头痛和注射部位反应。治疗地点：罗莫单抗是第一种抑制骨吸收和刺激骨形成的药物。罗莫佐单抗应保留给绝经后骨折风险最高的女性，并应随后服用抗反应剂，以维持或进一步增加骨密度。对于有心血管疾病病史或有心血管疾病高风险的女性，不应考虑使用这种可注射药物。

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