目的 分析北京地区近2009~2015年间奥沙利铂致严重不良反应报告,探讨奥沙利铂致严重不良反应的特点和规律,为临床安全合理用药提供参考。方法 对2009年1 月1日~2015年12 月31日,北京市药品不良反应监测中心收集的奥沙利铂致严重不良反应报告按人群、不良反应情况等方面进行统计、分析。结果 统计时间内,共收到41份奥沙利铂严重ADR报告,占报告总数的9.36%,其中1例可能无关。分析的40例严重报告中,男性14 例,女性26例,平均年龄(56.21±12.85)岁。发生于化疗第1周期用药1例,非第1周期用药14例,余25例不详。临床表现以全身症状表现为多见。ADR发生时间在用药后0.5 min~59 d。不良反应结果为2例死亡,1例导致后遗症,9例病程延长,余28例对原患疾病影响不明显。结论 建议在使用该药时,加强中、老年人用药监测。多疗程用药者再次应用中更应密切监测患者生命体征。在治疗过程中,可通过应用抗组胺药物、糖皮质激素及延长奥沙利铂滴注时间等措施来确保患者的再次用药,根据患者的不良反应具体情况给予减量或停药,以保证患者用药安全。
Abstract
OBJECTIVE To provide clinical reference for rational drug use by retrospectively reviewing oxaliplatin induced serious adverse reaction reports in Beijing area in recent 7 years and investigating the characteristics of these adverse reactions. METHODS Oxaliplatin induced adverse effect reports received by Beijing Municipal Drug Adverse Reaction Monitoring Center from January 1,2009 to December 31, 2015, were collected and analyzed. RESULTS Forty-one serious ADR reports were related with oxaliplatin, with one case evaluated as irrelevant,which accounted for 9.36% of the total reports. The 14 male and 26 female cases were reported, with an average age of (56.21±12.85) years old. One case occurred at the first cycle of chemotherapy and 14 cases did not occur at the first cycle. The occurrence time of the rest 25 cases was not clear. The manifestations of oxaliplatin induced adverse effect usually presented as systemic symptoms. The ADR onset was 0.5 min to 59 d after drug infusion which caused 2 cases of death, 1 case of sequelae, 9 cases of delayed disease duration, and 28 cases of no significant influence. CONCLUSION Careful monitoring is suggested especially for elderly people during oxaliplatin infusion. Attention is advised for patients requiring multi-cycles of chemotherapy, especially when they started a new round of treatment. Extending infusion time as well as using antihistamines and corticosteroids are believed to be effective to decrease the risk of ADR. Treatment plan needs to be modified by evaluating patients' adverse effect. The decision of dose reduction or withdrawal is to be made, if needed, to ensure the safety of drug use.
关键词
奥沙利铂 /
不良反应 /
严重
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Key words
oxaliplatin /
adverse drug reaction /
severe
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中图分类号：
R730.53
R979.1
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参考文献
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