漢方薬による間質性肺炎と肝障害に関する薬剤疫学的検討

抄録

In Japan, traditional herbal medicines (kampo medicines) have been widely used for various diseases as relatively safer drugs than Western medicines. However, serious adverse-events such as interstitial pneumonia (IP) and liver dysfunction (LD) have recently been reported. In this study, IP and LD associated with Kampo medicines were reviewed pharmacoepidemiologically to establish an effective monitoring protocol and appropriate treatment schedules while also elucidating the possible ingredients for IP and LD. Medline, JICST and J-Medicine databases were searched for IP and LD induced by Kampo medicines published in 1984-2000. Thirty-five cases of IP including 8 mortal cases and 28 cases of LD have been reported. As initial symptoms, 60-80% of IP patients developed dyspnea, fever and cough. On the other hand, the initial symptoms for LD patients were not characterized. Stopping the medications improved the symptoms in 29% of IP and 54% of LD patients. A total of 72 % of IP and 7 % of LD patients required corticosteroid treatment. Scutellariae radix was contained in Kampo medicines for 94% of IP patients and 89% of LD patients. A challenge test was positive in 9 cases of IP and 10 cases of LD. Scutellariae radix was contained in all positive Kampo medicines. Our review suggested that Scutellariae radix was a possible ingredient responsible for IP and LD. Monitoring the initial symptoms and immediately stopping medications were important steps for avoiding serious adverse-events associated with Kampo medicines.