市中感染症に対するclarithromycinの有効性および安全性に関する使用成績調査

Post-marketing surveillance of efficacy and safety of clarithromycin in community-acquired infectious diseases

　Clarithromycin（CAM：クラリス®錠200，クラリス®錠50小児用，クラリス®ドライシロップ10％小児用）の使用実態下における有効性および安全性の検討を行った。有効性解析対象症例7,344例における有効率は95.6％であり，成人では，呼吸器感染症（3,589例）96.8％，耳鼻科領域感染症（1,737例）94.6％，皮膚科領域感染症（259例）95.0％であり，小児では，呼吸器感染症（1,036例）94.9％，耳鼻科領域感染症（666例）94.0％，皮膚科領域感染症（18例）94.4％であった。安全性解析対象症例（7,577例）における副作用発現率は0.74％であった。

　The efficacy and safety of clarithromycin（CAM：Clarith® Tablets 200mg, Clarith® Tablets 50mg for Pediatric Use, Clarith® dry syrup for Pediatric Use）in community- acquired infectious diseases were examined as part of post-marketing surveillance for one year from September 2012 to September 2013. The survey forms for 8,581patients were collected from 1,891 medical institutions nationwide, and the efficacy and safety of CAM were evaluated in 7,344 cases subject to efficacy analysis and 7,577 cases subjected to safety analysis. The efficacy rate of CAM in the analysis set of the cases eligible for efficacy evaluation was 95.6 ％（7,024/7,344）. Efficacy by diseases was 96.8％（3,473/3,589）for adult respiratory tract infection, 94.6％（1,643/1,737）for adult otorhinolaryngologic infection, 95.0％（246/259）for adult dermatological infection, 94.9％（983/1,036）for pediatric respiratory tract infection, 94.0％（626/666）for pediatric otorhinolaryngologic infection, and 94.4％（17/18）for pediatric dermatological infection. The efficacy rate for all disease categories was more than 90％. The incidence of adverse reactions was 0.7％（56/7,577）in patients overall, 0.8％（46/5,781）in adult patients, and 0.6％（10/1,796）in pediatric patients. Major adverse reactions included 22 cases of diarrhea, 4 cases of upper abdominal pain, 4 cases of abdominal pain, 3 cases of nausea, and 3 cases of urticaria. Results were favorable for efficacy and safety.