贝伐珠单抗不良反应的文献计量分析

Bibliometric Analysis of Bevacizumab-induced ADR

目的:对贝伐珠单抗在临床应用的安全性进行评价,为其临床合理、安全使用提供参考。方法:利用文献计量分析的方法,以"贝伐单抗""贝伐珠单抗""安维汀""不良反应""Avastin""Bevacizumab""Adverse reaction"为关键词,检索Pub Med、Ovid、Web of Science、中国期刊全文数据库、维普和万方数据库自建库起至2015年12月收录的文献。采用End Note X7软件对检索到的文献进行去重、分类,利用Excel 2007软件对纳入文献的发表时间、发表国家、适应证、药品不良反应(ADR)累及器官/系统及临床表现进行分析。结果:共纳入文献240篇,其中论著199篇、综述19篇、病例报道22篇。贝伐珠单抗用于恶性实体瘤时常见的ADR有高血压、出血、动脉/静脉血栓、蛋白尿等,与说明书相符;而说明书中记载的常见ADR腹泻、便秘未见相关报道;此外,心力衰竭可能是被忽略的严重的ADR。大剂量是发生高血压的高危因素;肿瘤部位和类型与出血的风险相关;高龄和血栓病史是发生血栓的高危因素。在超适应证用于眼部新生血管疾病时的ADR包括角膜擦伤、晶状体损伤、眼内炎、眼压升高、视网膜脱落和葡萄膜炎等。结论:临床医师、药师在选择贝伐珠单抗治疗相关疾病时应排除使用该药可能发生严重的ADR的高危人群,并对其常见的ADR进行合理监测,选择合适的剂量和疗程,发生ADR时要及时正确地处理。

OBJECTIVE： To evaluate the safety of clinical application of bevacizumab, and to provide reference for rational and safe use of it. METHODS： Using ＂beifa dankang beifazhu dankang anweiting buliang fanying Avastin Bevacizumab ADR＂ as keywords, literatures about bevacizumab-induced ADR were retrieved from PubMed, Ovid, Web of Science, CJFD, VIP, Wanfang database from the establishment of database to Dec. 2015, all of which were collected and categorized by EndNote X7 software. Included literatures were analyzed by using Excel 2007 in respects of publication time and country, indications, organs/systems involved in ADR, clinical manifestations, etc. RESULTS： A total of 240 literatures were included. There were 199 original articles, 19 reviews and 22 case reports. When bevacizumba was used for malignant solid tumor, the common ADRs were mainly hypertension, hemorrhage, thromboembolism, proteinuria, which were consistent with package inserts of bevacizumba. But the common ADRs diarrhea and constipation as the package inserts described were not found in the included literatures. In addition, heart failure may be a severe ADR which was neglected. High dose was risk factor of hypertension; the location and type of a tumor were associated with hemorrhage; advanced age and history of thrombosis were the risk factors of thromboembolism. ADRs induced by super-indication use of bevacizumab for ocular neovascularization were corneal abrasion, crystalline lens injury, endophthalmitis, increased intraocular pressure, ablatio retinae, uveitis, etc. CONCLUSIONS： When applying bevacizumab, clinical physicians and pharmacists should rule out the high risk population and strengthen ADR monitoring, select suitable dose and course and deal with ADR properly.