社團法人臺灣臨床藥學會

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【案例報告】Gemifloxacin 引起的皮疹—案例報告
Gemifloxacin、氟化恩菎類、斑丘疹、Gemifloxacin, Fluoroquinolone, Maculopapular
李梅君Mei-Chun Lee*1 、李聰明Chung-Ming Lee2 、王森洤Sheng-Chuan Wang1 、李韋瑩Wei-Ying Lee1
1臺北馬偕紀念醫院藥劑部 、2臺北馬偕紀念醫院感染科
Gemifloxacin 是新一代的口服呼吸道氟化恩菎類 (fluoroquinolone, FQ),藉由其獨特的結構變化,除了降低抗藥性的發生且對肺炎鏈球菌 (Streptococcus pneumoriae) 及非典型細菌也有良好的抗菌效果。FDA 於2003 年4 月核准治療輕到中度的社區型肺炎與慢性支氣管炎的急性惡化。
在臨床試驗中指出,gemifloxacin 最常發生的不良反應是腹瀉、皮疹與噁心。整體的皮疹發生率為2.8%,最常見是斑丘疹 (maculopapular) 在嚴重度上屬輕至中度。皮疹較普遍發生在40 歲以下,特別是女性或使用荷爾蒙替代療法的停經後婦女且會隨著治療時間延長而增加。研究顯示40 歲以下女性使用7 天後,皮疹發生率可高達12%。
有8 位患者,女性占7 位,gemifloxacin 使用超過7 天而發生全身皮膚紅疹的過敏反應,終止治療後逐漸恢復。提醒臨床同仁,上述病人因病情須使用超過7 天,應避免選用gemifloxacin,由其他抗生素取代,如levofloxacin、moxifloxacin、macrolides 或tetracyclines。
 
Gemifloxacin is a novel antibiotic belonging to a new generation of oral respiratory fluoroquinolone(FQ). The antibiotic is effective against atypical bacteria and many drug-resistant Streptococcus pneumoniae.In addition, its unique structural changes confer greater genetic barrier to resistance. It was approved to treat mild-to-moderate community-acquired pneumonia (CAP) and acute exacerbation of chronic bronchitis (AECB) by the FDA in April 2003.
The most common side effects of gemifloxacin included diarrhea, rash and nausea. The overall rate of drug-related rash was 2.8%, that most common side effect was described as a maculopapular rash that was mild to moderate in severity. Rash was far more common in patients under 40 years of age, especially in females or in post-menopausal women taking hormone replacement therapy; the rash was also increased with longer treatment duration. The incidence of rash after 7 days of treatment showed that females under 40 years of age had an incidence of 12%.
This report described 8 patients taking gemifloxacin for more than 7 days who developed generalized skin rash. All of the patients gradually recovered after discontinuation of treatment. This report serves to remind clinical physician to avoid prescribing more than 7 days of gemifloxacin, especially in the abovementioned
groups. Physicians could choose other antibiotics, such as levofloxacin, moxifloxacin, macrolides or tetracyclines.
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