Chaipichit Nataporn, Krska Janet, Pratipanawatr Thongchai, Uchaipichat Verawan, Jarernsiripornkul Narumol
Division of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand.
Eur J Clin Pharmacol. 2014 May;70(5):607-15. doi: 10.1007/s00228-014-1653-6. Epub 2014 Feb 16.
To explore how Thai patients assess symptoms as adverse drug reactions (ADRs).
Out-patients at two hospitals in Thailand previously reporting suspected ADRs to statins were purposively selected to cover factors relevant to the accuracy of ADR reports. Semi-structured interviews explored the mechanisms participants used to work out whether their symptoms were related to their statin. All interviews were audio-recorded, transcribed and independently thematically analyzed by two researchers.
One hundred interviews were suitable for analysis; 52 were male, age range was 36 to 77 years (mean ± S.D.: 59.83 ± 9.14) and most (92) were taking other medicines in addition to statins. Patient assessment of symptoms as ADRs fell into two major themes: medicine-related factors and external factors. Timing relationships were mentioned most frequently (74), followed by information received (55), seeing similar symptoms in others (7) and diagnosis through blood tests (4). Use of multiple medicines, consideration of the medicine versus diseases, symptoms occurring with more than one medicine or relieved through treatment reduced confidence in ADR attribution. Many participants proposed alternative explanations for symptoms, including old age. Lack of information and knowledge were obstacles to the assessment process.
Patients assessed possible ADRs most often by considering timing relationships. While they also used medicine information, Thai patients received inadequate information to help them assess their symptoms. Patients expressed uncertainty and difficulties in deciding attribution when concomitant medicines and diseases were involved. The findings could support the development of a patient-friendly systematic tool for identifying and assessing possible ADRs.
探讨泰国患者如何将症状评估为药物不良反应（ADR）。
有目的地选取泰国两家医院之前报告过他汀类药物疑似ADR的门诊患者，以涵盖与ADR报告准确性相关的因素。通过半结构化访谈探究参与者用于判断其症状是否与他汀类药物有关的机制。所有访谈均进行录音、转录，并由两名研究人员独立进行主题分析。
100份访谈适合进行分析；其中52名男性，年龄范围为36至77岁（平均±标准差：59.83±9.14），大多数（92名）患者除服用他汀类药物外还在服用其他药物。患者将症状评估为ADR主要分为两个主题：药物相关因素和外部因素。最常被提及的是时间关系（74例），其次是所获得的信息（55例）、在他人身上看到类似症状（7例）以及通过血液检查进行诊断（4例）。使用多种药物、对药物与疾病的考虑、一种以上药物出现的症状或经治疗缓解的症状会降低对ADR归因的信心。许多参与者对症状提出了其他解释，包括年龄较大。信息和知识的缺乏是评估过程中的障碍。
患者最常通过考虑时间关系来评估可能的ADR。虽然他们也利用药物信息，但泰国患者获得的信息不足以帮助他们评估症状。当涉及合并用药和疾病时，患者在确定归因方面表现出不确定性和困难。这些发现可为开发一种方便患者使用的系统工具以识别和评估可能的ADR提供支持。
