目的 基于HIS真實世界評價兒童應(yīng)用注射用更昔洛韋的安全性。方法 回顧性選取2020年1月—2020年12月山西省兒童醫(yī)院使用注射用更昔洛韋的患兒進行真實世界研究，對患兒的人口學(xué)信息、臨床診斷、藥物用法用量、溶媒、聯(lián)合用藥及不良反應(yīng)（ADR）發(fā)生率進行總結(jié)分析。結(jié)果 2020年1月—2020年12月山西省兒童醫(yī)院使用注射用更昔洛韋的患兒共942例，ADR發(fā)生率為8.92%（84/942），均為一般不良反應(yīng)，主要表現(xiàn)為中性粒細胞減少和皮疹；10%葡萄糖注射液溶媒組（14.55%）及1歲及以下兒童（14.56%）ADR發(fā)生率比較高，且有統(tǒng)計學(xué)差異（P＜0.05）。結(jié)論 注射用更昔洛韋在兒童的臨床應(yīng)用存在超適應(yīng)證用藥情況；ADR多發(fā)生在用藥1周內(nèi)，程度較輕，與原患疾病、合并用藥可能相關(guān)，臨床用藥時應(yīng)注意監(jiān)測血常規(guī)、肝腎功能等，保障兒童用藥安全。

Objective To evaluate safety of ganciclovir for injection among children, and so as to provide reference for clinical rational use. Methods A real-world study was conducted on children using ganciclovir for injection between January 2020 to December 2020 in Children's Hospital of Shanxi. The demographic information, clinical diagnosis, drug usage and dosage, solvent, combined medication and the incidence of adverse reactions (ADR) were summarized and analyzed. Results The overall incidence of ADR was 8.92% (84/942); The incidence was higher in 10% glucose injection group (14.55%) and Children aged 1 and under (14.56%), and there was significant difference(P< 0.05). Conclusion The clinical application of ganciclovir for injection in children has exceeding indications, ADR mostly occur within one week after using medicin, and the degree is relatively light, which may be related to the Primary disease and combined medication. During clinical medication, attention should be paid to monitoring blood routine, liver and kidney function, so as to ensure the safety of medication for children.

R985

山西省兒童醫(yī)院院內(nèi)項目(201949)