| 刘磊,索婷婷,张彦收,等.病人在化疗后主观性不良事件评价中的作用[J].安徽医药,2020,24(6):1268-1272. |
| 病人在化疗后主观性不良事件评价中的作用 |
| Study on the role of patients in subjective adverse events assessment after chemotherapy |
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| DOI：10.3969/j.issn.1009?6469.2020.06.053 |
| 中文关键词: 抗肿瘤联合化疗方案/副作用 药物警戒性 乳腺肿瘤 病人 不良事件通用术语标准( CTCAE) |
| 英文关键词: Antineoplastic combined chemotherapy protocols/adverse effects Pharmacovigilance Breast neoplasms Patients Common terminology criteria for adverse events(CTCAE) |
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| 中文摘要: |
| 目的探讨病人在主观性不良事件评价中的作用。方法连续性收集 2019年 4—7月河北医科大学第四医院乳腺中心日间化疗病房 384例病人的一般信息。每例病人需填写病人版不良事件通用术语标准( PRO?CTCAE)量表(包含 6种化疗后常见的主观性不良事件:恶心、呕吐、腹泻、疲乏、疼痛、便秘)，每名主管医生评估病人时填写包含相同不良事件的不良事件通用术语标准( CTCAE)量表，比较临床医生与病人对主观性不良事件评价的差异性。结果临床医生主观性不良事件总体上报率 48.5%低于病人 72.4%。将两者对主观性不良事件的总体上报率进行一致性分析，两者主观性不良事件总体上报率一致性一般( k＝0.263，P＜0.001)。临床医生主观性不良事件的评分最高为 2分，病人主观性不良事件的评分最高为 4分，评分差异以 1分居多，病人评分常大于临床医生评分。将两者对主观性不良事件的评分进行一致性分析，两者主观性不良事件评分的一致性一般(均 Weighted Kappa＜0.4)。将两者主观性不良事件总体评分进行一致性分析，两者主观性不良事件总体评分一致性一般［ k(95%CI)＝0.225(0.210~0.239)，P＜0.001］。结论临床医生与病人在主观性不良事件评价的差异性证明病人可作为补充手段纳入主观性不良事件评估，提高临床医生对药品不良事件评估的及时性和准确性。 |
| 英文摘要: |
| Objective To explore the role of patients in subjective adverse drug events assessment.Methods The general informa?tion of 384 patients in the day chemotherapy room，Breast Center of the Fourth Hospital of Hebei Medical University from April to July 2019 was continuously collected.Patients completed a Simplified Chinese version of PRO?CTCAE including six common ad?verse events of chemotherapy:nausea，vomiting，diarrhea，fatigue，pain and constipation.Clinicians completed the Common Terminol? ogy Criteria for Adverse Events(CTCAE)with the same subjective adverse events.The differences between clinicians and patients in evaluating subjective adverse events were compared.Results The overall reporting rate of subjective adverse events of clini? cians(48.5%)was lower than that of patients(72.4%).To analyze theconsistency of the overall reporting rate of subjective ad? verse events，and the consistency for overall reporting rate between clinicians and patients was fairly agreed(k＝0.263，P＜0.001). The clinician’s highest score for the six subjective adverse events was 2，and the patient’s highest score was 4，and the most dis? crepancies were within one point.Patient scores were often greater than clinician scores.When considering the grade difference，we utilize weighted kappa coefficient to analysis，and agreement between patients and clinicians was fair(k＜0.4)the overall scores of subjective adverse events of clinicians and patients were slightly consistent［k(95%CI)＝0.225(0.210-0.239)，P，＜0.001］.Conclu?sion The difference in the evaluation of subjective adverse events between clinicians and patients proves that patients can be in?cluded in the assessment of subjective adverse events as a supplementary method to improve the timeliness and accuracy of clinical evaluation of subjective adverse events. |
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