去甲万古霉素在造血干细胞移植患者中应用的安全性和有效性研究

Efficacy and safety of norvancomycin in patients receiving hematopoietic stem cell transplantation

目的评价注射用去甲万古霉素在造血干细胞移植(HSCT)患者中应用的安全性和有效性,为临床用药提供依据。方法观察去甲万古霉素静脉用药的HSCT住院患者在用药期间发生的任何不良事件,判断不良事件与药物的关系、计算不良反应发生率,并观察疗效。结果2004年5月至2007年5月共入选病例95例,其中可进行临床和实验室安全性评价者93例。出现不良反应者共15例,不良反应发生率为16.1%。其中肾功能损害7例(7.5%)、肝功能损害4例(4.3%)、肝肾损害伴血尿者1例(1.1%)、肠道菌群失调1例(1.1%)、耳鸣1例(1.1%)、血栓性静脉炎1例(1.1%)。年龄≥45岁,合并应用其他易造成肾脏损伤药物(氨基糖苷类抗生素、两性霉素B、膦甲酸钠)都是造成肾脏损害的高危因素。而以上因素均不是肝脏损害的高危因素。可评价疗效的81例中,47例有效,总有效率58.0%。结论注射用去甲万古霉素在HSCT患者的临床应用中有一定的疗效,但不良反应发生率较一般人群高,合并应用其他易造成肾脏损伤药物(氨基糖苷类抗生素、两性霉素B、膦甲酸钠)易发生肾脏损害。

Objective To study the safety and efficacy of norvancomycin in hematopoietic stem cell transplantation（HSCT）and provide the evidence for clinical practice.Methods Ninety-five patients who received intravenous infusion of norvancomycin were enrolled in this study between May 2004 and May 2007.All adverse events and their relationship with norvancomycin were evaluated during norvancomycin therapy.The incidence of adverse event and efficacy of norvancomycin were calculated.Results Of the 95 cases,93 were qualified for clinical and laboratory safety evaluation.Adverse drug reaction was identified in 15 cases,including renal impairment（7,7.5%）and hepatic impairment（4,4.3%）,hepatic and renal impairment with hematuria（1,1.1%）,intestinal flora disequilibrium（1,1.1%）,tinnitus（1,1.1%）,and thrombophlebitis（1,1.1%）.The incidence of adverse reaction was 16.1%.The high risk factors were age of 45 years or older and/or concomitant treatment with other drugs（aminoglycosides,amphotericin B,foscarnet sodium）which may cause kidney damage.None of these was risk factor of hepatic impairment.Of the 81 efficacy evaluable cases,47（58.0%）responded well to the therapy.Conclusions The incidence of adverse events of parenteral norvancomycin in HSCT recipients is higher than that in general population.Parenteral norvancomycin combined with other nephrotoxic drugs（aminoglycosides,amphotericin B,foscarnet sodium）may cause kidney damage.