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我院血必净注射液的ADR集中监测研究
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| 篇名： | 我院血必净注射液的ADR集中监测研究 |
| TITLE： | |
| 摘要： | 目的：探讨血必净注射液致不良反应（ADR）的发生率、临床表现及影响因素，为该药安全合理使用提供参考。方法：对我院2012年1月－2016年12月使用血必净注射液的住院患者进行集中登记监测，统计出现ADR患者的临床特征、ADR发生时间、临床表现及转归等。结果：共监测患者3 300例，发生ADR的有81例，发生率为2.45 ％。ADR的发生无性别差异；但年龄≥60岁（6.53％），有过敏史（72.84％），原患疾病为呼吸系统疾病（3.33％）、血液系统疾病（3.11％）和中枢神经系统疾病（3.03％），与中药注射剂（34.57％）、抗菌药物（25.93％）和增强免疫类药物（14.81％）联合用药时ADR发生率较高。单日累积用药量≤50 mL者较多（36.67％）；不同单日累积用药量患者ADR的发生率比较，差异无统计学意义（P＞0.05）。38.27％的ADR发生于首次用药后30 min内；累及器官/系统以皮肤及其附件（37.04％）、心血管系统（19.75％）和胃肠系统（14.81％）为主；严重的ADR共15例（18.52％），以过敏性休克（33.33％，5/15）和全身性皮疹（20.00％，3/15）为主。所有ADR经停药或对症处理后均好转。结论：血必净注射液引发的ADR以速发型为主；当患者原患呼吸系统疾病、血液系统疾病和中枢神经系统疾病、联合用药、有过敏史及高龄时，ADR发生率较高。血必净注射液的部分ADR在药品说明书中未见描述，建议厂家及时收集ADR信息、完善药品说明书。 |
| ABSTRACT： | OBJECTIVE： To explore the incidence， clinical manifestations and influential factors of ADR induced by Xuebijing injection， and to provide reference for safe and rational use of it. METHODS： The inpatients who used Xuebijing injection in our hospital during Jan. 2012 to Dec. 2016 was registered and monitored centrally， and analyzed statistically in respects of clinical characteristics， occurrence time of ADR， clinical manifestation， outcome， etc. RESULTS： A total of 3 300 patients records were included， involving 81 ADR cases with incidence of 2.45％. There was no correlation between ADR and gender. The incidence of ADR was in high level in the patients with age over 60 years （6.53％）， history of allergy （72.84％）， original diseases as respiratory disease （3.33％）， blood system disease （3.11％） and central nervous system disease （3.03％）， and receiving combination of TCM injection （34.57％）， antibiotics （25.93％） and immune enhancer （14.81％）. Single-day culmulative amount with no more than 50 mL had relatively higher proportion （36.67％）， and there was no statistical significance in the ADR with different single-day culmulative amounts （P＞0.05）. 38.27％ of ADR occurred within 30 min after first medication. Organs/systems involved in ADR were mainly skin and its appendants （37.04％）， cardiovascular system （19.75％） and gastrointestinal system （14.81％）. Totally 15 cases had severe ADR， which were mainly anaphylactic shock （33.33％，5/15） and systemic rash （20.00％，3/15）. All ADR were recovered after drug withdrawal or symptomatic treatment. CONCLUSIONS： ADR induced by Xuebijing injection are mainly anaphylactic type. The incidence of ADR is higher in patients with primary respiratory disease， blood system disease， drug combination， allergic history and advanced age. The part of them are not mentioned in drug package inserts. Manufacturers are suggested to collect ADR information and improve drug package insets in time. |
| 期刊： | 2017年第28卷第29期 |
| 作者： | 何芳，陈赫军，张霄，何世学，李洁，董维森 |
| AUTHORS： | HE Fang，CHEN Hejun，ZHANG Xiao，HE Shixue，LI Jie，DONG Weisen |
| 关键字： | 血必净注射液；不良反应；合理用药；医院集中监测 |
| KEYWORDS： | Xuebijing injection； ADR； Rational drug use； Hospital centralized monitoring |
| 阅读数： | 159 次 |
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