臨床藥師對1例阿卡波糖致皮膚不良反應的分析及文獻回顧

梅蕾蕾 任峰 張衛芳 萬瑾瑾 謝珊珊 梁佳 敖檢根 周超

中圖分類號 R969.3 文獻標志碼 A 文章編號 1001-0408（2021）20-2538-05

DOI 10.6039/j.issn.1001-0408.2021.20.17

摘 要 目的：整理、分析阿卡波糖致皮膚不良反應的臨床特點，為其治療提供參考。方法：臨床藥師參與1例阿卡波糖致皮膚不良反應患者的治療過程。該患者口服阿卡波糖片（100 mg/d）數天后出現多形紅斑，經皮膚科和臨床藥學科會診后，考慮該不良反應與阿卡波糖有關，臨床藥師建議停用該藥。臨床藥師結合上述病例，檢索萬方數據、中國知網、PubMed、Embase等數據庫，收集阿卡波糖致皮膚不良反應的病例報道，歸納、總結其一般情況（性別、年齡、用法用量等）、潛伏期、不良反應（診斷及表現）、干預及轉歸等特征。結果：醫師采納臨床藥師建議，停用阿卡波糖，并予注射用甲潑尼龍琥珀酸鈉40 mg（靜脈注射，qd）+枸地氯雷他定片8.8 mg（口服，qd）+爐甘石洗劑（外用）對癥處理，患者于10 d后好轉出院。共檢索到文獻12篇，涉及患者12例。納入分析的13例患者（包括上述臨床病例和12例文獻病例）中，男性8例、女性5例，50歲及以上患者8例;所有患者的阿卡波糖使用劑量大多未超過藥品說明書規定范圍。12例患者的原發疾病均為糖尿病。11例患者發生皮膚不良反應的潛伏期為用藥6 d內。13例患者中，不良反應診斷為皮疹的有4例、膿皰病的有3例、多形紅斑的有2例、蕁麻疹的有2例、斑丘疹的有1例、口唇腫脹的有1例;1例患者停藥后不良反應自行好轉，12例患者停藥并給予糖皮質激素或抗組胺藥等對癥治療后不良反應亦好轉;有2例患者首次皮膚不良反應好轉后再次使用了阿卡波糖，且又出現皮膚不良反應，經停藥和對癥治療后不良反應均好轉。結論：皮膚不良反應為阿卡波糖的罕見不良反應，多發于用藥6 d內，且在中老年男性患者中發生的可能性較大。當患者出現該不良反應時，應及時停藥并給予糖皮質激素或抗組胺藥等進行對癥治療。臨床藥師應做好用藥宣教，提醒患者密切監測相關指標，保證用藥安全。

關鍵詞 阿卡波糖;皮膚不良反應;臨床特點;病例分析;文獻回顧;臨床藥師

Case Analysis and Literature Review of a Case of Acarbose-induced Skin ADR by Clinical Pharmacists

MEI Leilei1，REN Feng2，ZHANG Weifang1，WAN Jinjin1，XIE Shanshan1，LIANG Jia1，AO Jiangen1，ZHOU Chao3（1. Dept. of Pharmacy， the Second Affiliated Hospital of Nanchang University， Nanchang 330006， China; 2. Jiangxi Drug Inspection Center， Nanchang 330046， China; 3. Dept. of Neurology， Jiangxi Provincial Peoples Hospital， Nanchang 330006， China）

ABSTRACT? ?OBJECTIVE： To summarize and analyze the clinical characteristics of acarbose-induced skin ADR， and to provide reference for its therapy. METHODS： Clinical pharmacists participated in the treatment of a patient with acarbose-induced skin ADR. The patient developed erythema multiforme several days after oral administration of Acarbose tablets （100 mg/d）. After consultation by dermatology and clinical pharmacy， considering that the adverse reaction was related to acarbose， clinical pharmacists suggested to stop the drug. Based on the above cases， clinical pharmacists searched Wanfang database， CNKI， PubMed， Embase and other databases to collect case reports of skin ADR caused by acarbose， summarize its general situation （gender， age， usage and dosage， etc.）， latency， ADR （diagnosis and manifestation）， intervention and outcome， etc. RESULTS： The doctor adopted the pharmacists advice， stopped the use of acarbose， and gave symptomatic treatment as Methylprednisolone sodium succinate for injection 40 mg （intravenous injection， qd）+Medloratadine tablets 8.8 mg （oral administration， qd）+Calamine lotion （for external use）. The patient improved and was discharged after 10 days. A total of 12 literatures involving 12 patients were retrieved. Among the 13 patients included in the analysis （including the above clinical case and 12 literature cases）， there were 8 males and 5 females， and 8 patients of them aged 50 and over; the dosage of acarbose in most patients was within the requirements of the drug instructions. The primary diseases of 12 patients were diabetes mellitus. The latency of skin ADR in 11 patients was within 6 days of administration. Among the 13 patients， the ADR were diagnosed as rash in 4 cases， pustulosis in 3 cases， erythema multiforme in 2 cases， urticaria in 2 cases， maculopapular rash in 1 case and lip swelling in 1 case. The ADR of 1 patient improved after drug withdrawal， and 12 patients also improved after drug withdrawal and symptomatic treatment such as glucocorticoid or antihistamine. Acarbose was re-used in 2 patients after the improvement of first skin ADR， and skin ADR occurred again， and the ADR were improved after drug withdrawal and symptomatic treatment. CONCLUSIONS： Skin ADR are acarbose-induced rare ADR， mostly within 6 days of medication， and are more likely to occur in middle-aged and older men. When the patients suffer from ADR， the drug should be stopped in time and given glucocorticoids or antihistamines for symptomatic treatment. Clinical pharmacists should do a good job in drug publicity and education， remind patients to closely monitor relevant indicators and ensure drug safety.