注射用唑来膦酸药品不良反应文献及临床病例分析

摘要/Abstract

摘要： 目的总结分析注射用唑来磷酸致药品不良反应发生（ADR）的规律和特点,为临床安全用药提供参考。方法收集我院2012年10月~ 2018年11月使用注射用唑来膦酸致ADR并上报至国家药品不良反应监测中心的病例报告;同时检索中国期刊网全文数据库、万方数据库以及维普中文期刊全文数据库中符合纳入标准的病例报道。将二者提取出的病例信息分别进行归纳分析。结果无论临床病例还是文献病例患者年龄主要分布在40岁以上,分别为91.14％和96.30%;所患疾病均为恶性肿瘤伴骨相关疾病,肿瘤原发病灶以肺癌和乳腺癌居多。临床病例中ADR累及系统-器官以全身性反应的最多（78.57％）,文献报道则以骨骼肌肉系统居多（51.85％）。严重病例共收集到28例,除1例来自临床病例外,其余27例均来自文献,其中用药后发生颌骨坏死的严重病例有13例,用药后死亡病例1例。结论该药急性期ADR多数转归良好,应警惕其可能发生的延迟性严重不良反应,特别是罕见的颌骨坏死反应,建议用药后加强ADR监测,促进临床用药安全。

关键词: 注射用唑来膦酸, 恶性肿瘤, 颌骨坏死, 药品不良反应

Abstract: Objective To summarize and analyze the regularity and characteristics of adverse drug reactions (ADR) in clinical use of zoledronic acid injection, so as to provide reference for clinical safe medication. Methods Cases of ADR induced by the use of zoledronic acid injection and reported to the national adverse drug reaction monitoring center from October 2012 to November 2018 were included. At the same time articles in the CNKI database, Wanfang database and VIP Chinese full-text database were searched, and the patients in the references which met the inclusion criteria were extracted. Then the ADR information of the patients both from the hospital and the literatures were analyzed together. Results The age of patients in both clinical cases and literature cases was mainly over 40 years old, accounting for 91.14% and 96.30% of all patients with medication respectively. All the patients suffered from malignant tumor with bone related diseases, and the primary tumor lesions were mainly lung cancer and breast cancer. In clinical cases, systemic response was the most involved organ/system of ADR(78.57%), while musculoskeletal system was the most reported (51.85%) in literature. A total of 28 severe cases were collected, except one from clinical cases, and the remaining 27 cases were all from literature. Among them, there were 13 severe cases of jaw necrosis and 1 death. Conclusion Most of ADR in the acute phase of this drug have achieved good results, and we should be alert to the possible delayed severe adverse reactions, especially the rare osteonecrosis of the jaw. It is suggested that ADR monitoring should be strengthened during the period of medication to promote the safety of clinical drug use.

Key words: zoledronic acid injection, malignant tumor, osteonecrosis of the jaws, adverse drug reactions

中图分类号:

R994.11

王芳芳, 陈维红, 何志强, 胡雪. 注射用唑来膦酸药品不良反应文献及临床病例分析[J]. 中国药物警戒, 2019, 16(4): 223-227.

WANG Fangfang, CHEN Weihong, HE Zhiqiang, HU Xue. Analysis of Literature and Clinical Cases of Adverse Drug Reactions Induced by Zoledronic Acid Injection[J]. Chinese Journal of Pharmacovigilance, 2019, 16(4): 223-227.

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