Isacson Dag, Johansson Linnea, Bingefors Kerstin
Pharmacoepidemiology and Pharmacoeconomics, Department of Pharmacy, University of Uppsala, Uppsala, Sweden.
Ann Pharmacother. 2008 Mar;42(3):347-53. doi: 10.1345/aph.1K488. Epub 2008 Feb 26.
Adverse drug reactions (ADRs) and the safety of drugs continue to be widely discussed. However, information on the prevalence of subjectively experienced ADRs (SADRs) and their subsequent burden in the general population is largely lacking.
To analyze, from an epidemiologic perspective, SADRs with respect to occurrence and health status.
A cross-sectional mail survey to a random national sample in Sweden of inhabitants aged 18-84 years was conducted; 61% (N = 4875) of the sample answered the questionnaire. Self-reported SADRs occurring during a 2-week period of using prescription, over-the-counter (OTC), or herbal drugs were classified according to Meyler's classification of ADRs. Self-perceived health status was assessed with a visual analog scale graded from 0 (worst possible health/death) to 1 (perfect health).
SADRs were reported by 6.4% of the total study sample, 10.2% of the 2851 users of prescription drugs, 1.0% of the 2862 users of OTC drugs, and 0.1% of the 1352 users of herbal drugs. Of the total sample, 3.3% reported SADRs of the nervous system, 2.6% of the gastrointestinal system, and 0.6% of the cardiovascular system. Users of prescription drugs with SADRs reported a mean health status score of 0.655, while those who did not report SADRs scored 0.744. Among users of OTC and herbal drugs, the corresponding scores were 0.720 and 0.818, respectively. Those in the population who did not use any drugs rated their health status as 0.846.
Both the prevalence of SADRs and the magnitude of the decrease in subjective health status in respondents experiencing them reflect the importance of individual subjective perceptions for public health. However, in a cross-sectional study like this, causal relationships cannot be firmly established. Further, other factors, such as comorbidity or disappointment with treatment outcomes, could be associated with the decrease in health status.
药物不良反应（ADR）及药物安全性一直是广泛讨论的话题。然而，关于主观体验到的药物不良反应（SADR）在普通人群中的发生率及其后续负担的信息却极为匮乏。
从流行病学角度分析SADR的发生情况及健康状况。
对瑞典全国18 - 84岁居民的随机样本进行横断面邮寄调查；61%（N = 4875）的样本回答了问卷。根据Meyler的药物不良反应分类法，对在使用处方药、非处方药（OTC）或草药的2周期间内自我报告的SADR进行分类。使用视觉模拟量表评估自我感知的健康状况，量表评分从0（最差健康状况/死亡）到1（完美健康）。
在整个研究样本中，6.4%的人报告了SADR，在2851名处方药使用者中这一比例为10.2%，在2862名非处方药使用者中为1.0%，在1352名草药使用者中为0.1%。在整个样本中，3.3%的人报告了神经系统的SADR，2.6%的人报告了胃肠道系统的SADR，0.6%的人报告了心血管系统的SADR。报告有SADR的处方药使用者的平均健康状况评分为0.655，而未报告SADR的使用者评分为0.744。在非处方药和草药使用者中，相应的评分分别为0.720和0.818。未使用任何药物的人群将其健康状况评为0.846。
SADR的发生率以及经历SADR的受访者主观健康状况下降的程度都反映了个体主观认知对公共卫生的重要性。然而，在这样的横断面研究中，无法确凿地建立因果关系。此外，其他因素，如合并症或对治疗结果的失望，可能与健康状况下降有关。
