Jarernsiripornkul Narumol, Krska Janet, Richards R Michael E, Capps Phillip A G
Department of Clinical Pharmacy, Khon Kaen University, Thailand.
Eur J Pain. 2003;7(3):219-24. doi: 10.1016/S1090-3801(02)00114-3.
Patients' perceptions of adverse effects caused by the medicines they are prescribed may influence how they use these medicines. Little is known about patients' perceptions of the adverse effects of specific drugs in everyday use and whether these differ from those identified by clinical trials and standard post-marketing surveillance methods.
To compare reports of perceived adverse drug reactions (ADRs) obtained directly from patients taking tramadol to those found in clinical trials and two methods of post-marketing surveillance.
Postal questionnaire distributed to 1048 patients who had a prescription for tramadol dispensed over a 3-month period.
Most (84%) of the 344 respondents reported at least one symptom perceived as an ADR to tramadol. Dry mouth, light-headedness and constipation were most commonly reported. Almost half (48%) rated their most bothersome symptom as at least moderate and 43% claimed to have reported symptoms to their doctor. Perceived problems had led 38 respondents to stop taking tramadol. The 10 most frequently reported symptoms were all previously reported ADRs to tramadol. Although relatively minor, all 10 also appeared in reports to the UK Committee on the Safety of Medicines (CSM) and in prescription event monitoring. For many symptoms, the estimated range of frequency was in line with published reports, but considerably higher than that of post-marketing surveillance methods.
Symptoms were reported by the majority of respondents and for many symptoms the frequency was high. Many patients did not report symptoms they perceived to be adverse effects to their doctor. The results indicate that patient perceptions of potential ADRs are relevant and should be an integral part of a pain management strategy.
患者对所服用药物不良反应的认知可能会影响他们对这些药物的使用方式。对于患者在日常使用中对特定药物不良反应的认知，以及这些认知是否与临床试验和标准上市后监测方法所确定的认知有所不同，我们知之甚少。
比较直接从服用曲马多的患者那里获得的药物不良反应（ADR）报告与临床试验及两种上市后监测方法中发现的报告。
向在3个月期间开具过曲马多处方的1048名患者发放邮政调查问卷。
344名受访者中，大多数（84%）报告至少有一种被视为曲马多ADR的症状。口干、头晕和便秘是最常报告的症状。近一半（48%）的受访者将他们最困扰症状的严重程度评为至少中等，43%的受访者声称已向医生报告过症状。所察觉到的问题导致38名受访者停止服用曲马多。最常报告的10种症状均为之前报告过的曲马多ADR。尽管相对较轻，但这10种症状也都出现在提交给英国药品安全委员会（CSM）的报告以及处方事件监测中。对于许多症状，估计的频率范围与已发表报告一致，但远高于上市后监测方法所显示的频率。
大多数受访者报告了症状，而且许多症状的频率较高。许多患者没有向医生报告他们认为是不良反应的症状。结果表明，患者对潜在ADR的认知是相关的，应成为疼痛管理策略的一个组成部分。
