WHO國際藥物監(jiān)測中心對(duì)可疑不良反應(yīng)的因果關(guān)系如何分級(jí)？
WHO國際藥物監(jiān)測中心將可疑不良反應(yīng)的因果關(guān)系分成如下級(jí)別：
1.certain
2.probable/likely
3.possible
4.unlikely
5.conditional/unclassified
6.unassessible/unclassifiable
實(shí)際上，主要是4級(jí)，即肯定（certain），很可能（probable/likely），可能（possible），不太可能（unlikely）。conditional/unclassified和unassessible/unclassifiable均不屬于因果關(guān)系的正式術(shù)語，前者是指報(bào)告資料有待作進(jìn)一步的補(bǔ)充和評(píng)價(jià)，然后再?zèng)Q定其級(jí)別；后者是由于報(bào)告資料不考試，大網(wǎng)站收集足或存在矛盾而無法評(píng)價(jià)。WHO因果關(guān)系評(píng)價(jià)的具體內(nèi)容如下：
CERTAIN
A clinical event， including laboratory test abnormality， occurring in a plausible time relationship to drug administration， and which cannot be explained by concurrent disease or chemicals. The response to withdrawal of the drug （dechallenge） should be clinically plausible. The event must be definitive pharmacologically or phenomenological， using a satisfactory rechallenge procedure if necessary.
PROBABLE/LIKELY
A clinical event， including laboratory test abnormality， with a reasonable time sequence to administration of the drug， unlikely to concurrent disease or other drugs or chemicals， and which follows a clinically reasonable response in withdrawal （dechallenge）。 Rechallenge information is not required to fulfil this definition.
POSSIBLE
A clinical event， including laboratory test abnormality， with a reasonable time sequence to administration of the drug， but which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear.
UNLIKELY
A clinical event， including laboratory test abnormality， with a temporal relationship to drug administration which makes a causal relationship improbable， and in which other drugs， chemicals or underlying disease provide plausible explanations.
CONDITIONAL/UNCLASSIFIED
A clinical event， including laboratory test abnormality， reported as an adverse reaction， about which more data is essential for a proper assessment or the additional data are under examination.
UNASSESSIBLE/UNCLASSIFIABLE
A report suggesting an adverse reaction which cannot be judged because information is insufficient or contradictory， and which cannot be supplemented or verified.
WHO國際藥物監(jiān)測中心將可疑不良反應(yīng)的因果關(guān)系分成如下級(jí)別：
1.certain
2.probable/likely
3.possible
4.unlikely
5.conditional/unclassified
6.unassessible/unclassifiable
實(shí)際上，主要是4級(jí)，即肯定（certain），很可能（probable/likely），可能（possible），不太可能（unlikely）。conditional/unclassified和unassessible/unclassifiable均不屬于因果關(guān)系的正式術(shù)語，前者是指報(bào)告資料有待作進(jìn)一步的補(bǔ)充和評(píng)價(jià)，然后再?zèng)Q定其級(jí)別；后者是由于報(bào)告資料不考試，大網(wǎng)站收集足或存在矛盾而無法評(píng)價(jià)。WHO因果關(guān)系評(píng)價(jià)的具體內(nèi)容如下：
CERTAIN
A clinical event， including laboratory test abnormality， occurring in a plausible time relationship to drug administration， and which cannot be explained by concurrent disease or chemicals. The response to withdrawal of the drug （dechallenge） should be clinically plausible. The event must be definitive pharmacologically or phenomenological， using a satisfactory rechallenge procedure if necessary.
PROBABLE/LIKELY
A clinical event， including laboratory test abnormality， with a reasonable time sequence to administration of the drug， unlikely to concurrent disease or other drugs or chemicals， and which follows a clinically reasonable response in withdrawal （dechallenge）。 Rechallenge information is not required to fulfil this definition.
POSSIBLE
A clinical event， including laboratory test abnormality， with a reasonable time sequence to administration of the drug， but which could also be explained by concurrent disease or other drugs or chemicals. Information on drug withdrawal may be lacking or unclear.
UNLIKELY
A clinical event， including laboratory test abnormality， with a temporal relationship to drug administration which makes a causal relationship improbable， and in which other drugs， chemicals or underlying disease provide plausible explanations.
CONDITIONAL/UNCLASSIFIED
A clinical event， including laboratory test abnormality， reported as an adverse reaction， about which more data is essential for a proper assessment or the additional data are under examination.
UNASSESSIBLE/UNCLASSIFIABLE
A report suggesting an adverse reaction which cannot be judged because information is insufficient or contradictory， and which cannot be supplemented or verified.