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206例乳腺癌患者抗肿瘤药物应用评价分析
Rational Use Analysis of Antitumor Drugs in 206 Patients with Breast Cancer
  
DOI:
中文关键词:  乳腺癌  抗肿瘤药物  指南  有效性  合理用药  安全用药
英文关键词:Breast cancer  Antitumor drugs  Guideline  Efficacy  Rational drug use  Safe medication
基金项目:陕西省重点研发计划项目(编号:2017SF-089),陕西省自然科学基础研究计划项目(编号:2014JM4101),西安交通大学第一附属医院临床研究项目(编号:XJTU1AF CRF-2016-021)
作者单位
尤海生1 高乾2 高春侠1 陈思颖1 张玮1 潘国华1 马瑛1 董亚琳1 1.西安交通大学第一附属医院药学部 西安 7100612.银川市第一人民医院药剂科 
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中文摘要:
      摘 要 目的:评价医院乳腺癌患者抗肿瘤药物的使用情况,为临床合理用药提供参考。 方法:回顾性研究206例转移性乳腺癌患者治疗方案,依据药品说明书和临床实践指南对抗肿瘤药物使用的合理性进行评价。按照实体瘤的疗效评价标准(RECIST)评价有效性;按照不良事件评价标准 (CTACE4.03)分析安全性;对患者的住院费、药费和抗肿瘤药物费用进行统计分析。 结果:疗效评价表明客观缓解率为16.0%(33/206),疾病控制率为65.0%(134/206),疾病进展为7.8%(16/206),未评价的患者为27.2%(56/206)。化疗方案选择合理为80.1%(165/206),化疗方案无依据为19.9%(41/206),给药途径与溶媒超说明书为4.8%(10/206),平均相对剂量强度为89.6%。不良事件多为轻度,Ⅲ级以上严重不良事件发生率为3.0%。住院费用、药物费用、抗肿瘤药费中位数分别为7 870,6 082,3 983元。 结论:抗肿瘤药物疗效与不良反应发生率均偏低,可能与多个化疗方案平均剂量低于指南标准剂量相关;需进一步改进用药剂量低、治疗方案选择缺乏依据、给药途径与溶媒用量错误等不合理用药情况。
英文摘要:
      ABSTRACT Objective:The use of anti tumor drugs were evaluated in breast cancer patients in hospitals to provide evidences for clinical rational drug use. Methods:206 patients with metastatic breast cancer of a retrospective study were evaluated, according to the drug instructions and clinical practice guidelines. Effectiveness was evaluated according to RECIST 4.03 standards. Safety was evaluated according to the CTACE 4.03 criteria for adverse events. The economic evaluation included the hospitalization costs, drug costs, and anti cancer drug costs for treatment. Results: Efficacy evaluation showed that the objective response rate was 16.0% (33/206), the disease control rate was 65.0% (134/206), the disease progression was 7.8% (16/206), and the unevaluated patients were 27.2% (56/206). The rationale chemotherapy regimen accounted for 80.1% (165/206), the chemotherapy regimen with lack of evidence made up 19.9% (41/206), and patients of route of administration and off label were 4.8% (10/206). The average dose intensity was 89.6%. Most of the adverse drug reactions were mild, and severe adverse drug reaction with more than Grade Ⅲ accounted for 3.0%. The median value of hospitalization costs, treatment cost, and antitumor cost was 7 870, 6 082, 3 983 yuan, respectively. Conclusion: The efficacy and adverse reaction rates of anti tumor drugs in the present study were lower incidence, which might be related to the average dose of chemotherapy regimens being lower than those of the standard of guideline. Therefore, it is necessary to further improve the irrational use of drugs, such as lower dose intensity, lack of evidences for treatment regimens, incorrect route of administration, and inappropriate amount of solvent.
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