多柔比星脂质体制剂与非脂质体制剂的不良反应/事件评价

Adverse drug reactions of liposomal doxombicin reported in China

目的:根据现有证据评价多柔比星脂质体在国内的不良反应/事件(ADR/ADE)发生情况,促进临床安全合理用药。方法:以"多柔比星"、"阿霉素"、"脂质体"、"不良反应"、"不良事件"为检索词检索中国期刊全文数据库(CNKI),并提取资料。结果:本研究共纳入567例多柔比星脂质体和332例多柔比星非脂质体剂型的ADR/ADE。根据对现有已发表的研究结果统计,明确分型的ADR/ADE中轻型共604例,占83.19%;重型ADR/ADE共122例,占16.81%。轻型ADR/ADE以血液系统、消化系统、脱发及乏力为主,合计占轻型的77.48%(468/604);重型ADR/ADE也集中于血液系统,达71.31%(87/122)。与非脂质体制剂相比,在治疗肝癌、多发性骨髓瘤、晚期胃癌和非霍奇金淋巴瘤时,使用多柔比星脂质体治疗的患者白细胞减少、恶心呕吐、脱发、感染等ADR/ADE的发生显著减少(P均<0.05)。结论:多柔比星脂质体制剂的ADR/ADE发生风险较低,患者虽可耐受心脏毒性,但仍建议对心脏异常的患者采取常规心电图监测。

Objective： To evaluate the adverse drug reactions （ADR）/adverse drug events （ADE） of liposomal doxombicin based on evidence. Methods： The database of Chinese CNKI was searched and data for ADR or ADE of doxombicin were collected. Results： ADR/ADE data from 567 patients with liposomal doxombicin and 332 patients with non-liposomal doxombicin were analyzed. According to the published research results, light ADR/ ADE accounted for 83. 19% （604/726） of total ADR/ADE, and severe ADR/ADE for 16.81% （122/726）. Clinical manifestations of light ADR/ADE mainly included reactions of skin and mucous membranes, gastrointesti- nal tract and blood system （77.48% , 468/604） ; those of severe ADR/ADE mainly included reactions of blood system （71.31%, 87/122）. The incidence of liposomal doxombicin-related ADR/ADE, such as aleucocytosis, nausea and vomiting, alopecie and infection, was lower than that of non-liposomal doxombicin in treating hepatoma, multiple myeloma, advanced carcinoma of stomach and non-Hodgkin lymphoma （P 〈 0.05 ）. Conclusion： Based on current evidence, risk of liposomal doxombicin related ADR/ADE, particularly cardiac toxicity, is low in the duration of combination chemotherapy. However, a conventional ECG detection is needed when dealing with patients with heart diseases.