09/02/18 00:50:06 bFcCTM8X0
>>688 あまりに非科学的で笑ってしまいました。 最後の推定って・・・。
欧米の添付文書より
>Immunogenicity: Approximately 2% of patients receiving PEG-Intron (32/1759) or INTRON A (11/728)
>with or without REBETOL developed low-titer (£160) neutralizing antibodies to PEG-Intron or INTRON A.
>The clinical and pathological significance of the appearance of serum neutralizing antibodies is unknown.
>No apparent correlation of antibody development to clinical response or adverse events was observed.
>The incidence of post-treatment binding antibody ranged from 8 to 15 percent. The data reflect the percentage
>of patients whose test results were considered positive for antibodies to PEG-Intron in a Biacore assay
>that is used to measure binding antibodies, and in an antiviral neutralization assay, which measures
>serum-neutralizing antibodies. The percentage of patients whose test results were considered positive for
>antibodies is highly dependent on the sensitivity and specificity of the assays.
>Additionally the observed incidence of antibody positivity in these assays may be influenced by several factors
>including sample timing and handling, concomitant medications, and underlying disease.
>For these reasons, comparison of the incidence of antibodies to PEG-Intron with the incidence of antibodies
>to other products may be misleading.
臨床的に効果や副作用に中和抗体が影響するかどうかは明らかではないし、測定方法やサンプリング方法で
大きく影響されるので、他剤と比較するのはMisleadingだって書いてけど。