The Korean Journal of Medicine

The Korean Association of Internal Medicine (대한내과학회)
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Comparison of the Naranjo and WHO-Uppsala Monitoring Centre criteria for causality assessment of adverse drug reactions

약물유해반응의 인과관계 판정을 위한 Naranjo와 WHO-UMC 지표의 비교

Son, Myoung-Kyun;Lee, Yong-Won;Jung, Han-Young;Yi, Seung-Woo;Lee, Kwang-Hoon;Kim, Seung-Up;Jeong, Jae-Heon;Park, Jae-Jun;Park, Jung-Won;Hong, Chein-Soo
손명균;이용원;정한영;이승우;이광훈;김승업;정재헌;박재준;박중원;홍천수

  • Published : 20080000
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Abstract

Background/Aims : Several criteria have been proposed to increase the objectivity, reliability and validity of causality assessment of adverse drug reactions (ADR). We compared the Naranjo probability scale and the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality categories to evaluate the validity and clinical usefulness of these criteria. Methods : We evaluated 100 ADR cases with the Naranjo probability scale and the WHO-UMC causality categories. The Spearman rank coefficient was used to determine the correlation of these criteria. The evaluation of the ADR was categorized into four groups for the Naranjo system: definite, probable, possible, and doubtful, and six groups for the WHO‐UMC: certain, probable, possible, unlikely, conditional/unclassified, and unassessable. Results : The criteria used form these two systems showed some differences when compared with the same ADR cases. The Spearman rank coefficient was 0.519 (p<0.001) and the agreement was 55% between the Naranjo probability scale and the WHO-UMC causality categories. The Naranjo probability scale includes measurements for drug concentration, objective evidence of ADR, ADR to previous exposures, responses to placebo, and the dose adjustment of drugs. However, few cases were evaluated for all of these measures. Conclusions : The Naranjo probability scale may be helpful for assessing unexpected ADRs and useful for evaluators with little experience. However, some of the items are not utilized and there are discrepancies when compared with the WHO-UMC causality criteria. (Korean J Med 74:181-187, 2008)

목적 : 약물유해반응의 인과관계를 분석함에 있어 그 객관성, 신뢰성 및 타당성을 증대시키기 위해 평가의 기준이 되는 지표들이 개발되어 왔다. 가장 널리 사용되는 평가지표인 Naranjo 지표와 WHO-UMC 지표를 비교 평가하였다. 방법 : 세브란스 병원에 입원했던 환자 및 외래 추적관찰하는 환자들 중, 약물유해반응으로 보고된 환자들 100명을 후향적으로 분석하였다. 의무기록들을 검토하여 Naranjo와 WHO-UMC 지표를 적용, 평가하였다. 결과 : Naranjo 지표와 WHO-UMC 지표의 평가를 비교 검토한 결과, 동일한 증례에 대해서 평가범주가 다르게 나타나는 경우가 많았다. WHO-UMC 지표와 비교할 때, Naranjo 지표로 평가한 결과는 상당히 관련이 있음(probable)으로 수렴되는 경향이 관찰되었다. Naranjo 지표는 위약투여에 대한 반응, 약물농도, 객관적인 검사, 이전 투약시의 반응, 약물용량조절에 대한 반응을 평가하는 항목들을 포함하고 있는데 실제로 임상에서 이런 검사 및 평가가 가능하거나 시행된 경우는 거의 없었다. 결론 : Naranjo 지표는 어느 정도 타당성을 보여주고 있으나 한국의 임상 환경에서 WHO-UMC 지표에 비해 유용성이 제한적임을 알 수 있었다.

Keywords

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