临床药师对1例阿卡波糖致皮肤不良反应的分析及文献回顾

梅蕾蕾 任峰 张卫芳 万瑾瑾 谢珊珊 梁佳 敖检根 周超

中圖分类号 R969.3 文献标志码 A 文章编号 1001-0408（2021）20-2538-05

DOI 10.6039/j.issn.1001-0408.2021.20.17

摘 要 目的：整理、分析阿卡波糖致皮肤不良反应的临床特点，为其治疗提供参考。方法：临床药师参与1例阿卡波糖致皮肤不良反应患者的治疗过程。该患者口服阿卡波糖片（100 mg/d）数天后出现多形红斑，经皮肤科和临床药学科会诊后，考虑该不良反应与阿卡波糖有关，临床药师建议停用该药。临床药师结合上述病例，检索万方数据、中国知网、PubMed、Embase等数据库，收集阿卡波糖致皮肤不良反应的病例报道，归纳、总结其一般情况（性别、年龄、用法用量等）、潜伏期、不良反应（诊断及表现）、干预及转归等特征。结果：医师采纳临床药师建议，停用阿卡波糖，并予注射用甲泼尼龙琥珀酸钠40 mg（静脉注射，qd）+枸地氯雷他定片8.8 mg（口服，qd）+炉甘石洗剂（外用）对症处理，患者于10 d后好转出院。共检索到文献12篇，涉及患者12例。纳入分析的13例患者（包括上述临床病例和12例文献病例）中，男性8例、女性5例，50岁及以上患者8例;所有患者的阿卡波糖使用剂量大多未超过药品说明书规定范围。12例患者的原发疾病均为糖尿病。11例患者发生皮肤不良反应的潜伏期为用药6 d内。13例患者中，不良反应诊断为皮疹的有4例、脓疱病的有3例、多形红斑的有2例、荨麻疹的有2例、斑丘疹的有1例、口唇肿胀的有1例;1例患者停药后不良反应自行好转，12例患者停药并给予糖皮质激素或抗组胺药等对症治疗后不良反应亦好转;有2例患者首次皮肤不良反应好转后再次使用了阿卡波糖，且又出现皮肤不良反应，经停药和对症治疗后不良反应均好转。结论：皮肤不良反应为阿卡波糖的罕见不良反应，多发于用药6 d内，且在中老年男性患者中发生的可能性较大。当患者出现该不良反应时，应及时停药并给予糖皮质激素或抗组胺药等进行对症治疗。临床药师应做好用药宣教，提醒患者密切监测相关指标，保证用药安全。

关键词 阿卡波糖;皮肤不良反应;临床特点;病例分析;文献回顾;临床药师

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.