CAJ | 학술논문

目的：探讨依维莫司临床应用药品不良反应（ADR）的特点和规律，为临床合理用药提供参考。方法：采用回顾性研究方法，收集2013年6月–2014年6月我院服用依维莫司的72例晚期肿瘤患者用药及相关不良反应的信息，按照性别、年龄、病种、ECOG评分、用药情况、不良反应累及系统/器官、临床表现以及转归情况等进行描述性统计学分析。结果：所有患者采用逐步加量法给药，72例患者共发生112例次药品不良反应，以胃肠道系统所占比例最高（40.18%），其次为呼吸系统（23.21%）；其中，1~2级不良反应占总体ADR的82.14%；3~4级不良反应主要为咳嗽（3.57%），口腔炎（2.68%），腹泻（1.79%），62.50%的ADR在用药2周内发生。ADR转归情况方面，80.56%（58/72）的患者给予支持治疗后恢复，继续服药；4例给予药物减量并对症治疗后好转；10例给予完全停药后好转。结论：采用逐步加量法的给药方式，依维莫司临床耐受性良好，ADR多数表现轻微且对症处理均可恢复。应加强对患者的随访，防止严重ADR的发生。
목적：탐토의유막사림상응용약품불량반응（ADR）적특점화규률，위림상합리용약제공삼고。방법：채용회고성연구방법，수집2013년6월–2014년6월아원복용의유막사적72례만기종류환자용약급상관불량반응적신식，안조성별、년령、병충、ECOG평분、용약정황、불량반응루급계통/기관、림상표현이급전귀정황등진행묘술성통계학분석。결과：소유환자채용축보가량법급약，72례환자공발생112례차약품불량반응，이위장도계통소점비례최고（40.18%），기차위호흡계통（23.21%）；기중，1~2급불량반응점총체ADR적82.14%；3~4급불량반응주요위해수（3.57%），구강염（2.68%），복사（1.79%），62.50%적ADR재용약2주내발생。ADR전귀정황방면，80.56%（58/72）적환자급여지지치료후회복，계속복약；4례급여약물감량병대증치료후호전；10례급여완전정약후호전。결론：채용축보가량법적급약방식，의유막사림상내수성량호，ADR다수표현경미차대증처리균가회복。응가강대환자적수방，방지엄중ADR적발생。
Objective: To observe the characteristics and regularities of the adverse drug reactions (ADRs) induced by everolimus, in order to provide reference for clinical application. Methods: A total of 72 patients in our hospital from June 2013 to June 2014 were included. ADRs induced by everolimus were collected and analyzed in respect of sex, age of the patients, entity, ECOG score, condition of drug use, organs or systems involved in ADRs, clinical manifestations, sequelae and other relavant information. Results:The everolimus was applied in a method of increasing the dose gradually. There were 112 ADRs in 72 patients, among which, the percentage of digestive system accounted for the highest (40.18%), and follwed by respiratory system (23.21%); the grade 1 –2 ADR accounted for 82.14%; the most common grade 3 –4 adverse reactions were cough (3.57%), stomatitis (2.68%), diarrhea (1.79%); 62.50% of ADRs occurred within 2 weeks. In respect of sequelae, 80.56% (58/72) of the patients recovered with supportive care, 4 cases had to reduce the dose and receive speciifc treatment;10 cases improved after drug withdrawal. Conclusion: By increasing the dose of everolimus gradually, the drug was well tolerated. Since ADRs induced by everolimus were slight, all the ADRs were well managed.It is important to enhance follow-up observations of patients to prevent some serious ADRs.