This study was a randomized controlled clinical trial. Sixteen kidney transplant patients with BK virus infection were randomly divided into 2 groups; 1 group received intravenous immunoglobulin, and another group received leflunomide and intravenous immunoglobulin. P < .05 was considered statistically significant.
Results of a polymerase chain reaction test for BK virus after 2 months of treatment were negative in 3 patients in the intravenous immunoglobulin group and in 7 patients in the intravenous immunoglobulin + leflunomide group. The amount of BK virus decreased significantly in each group, and a significant difference was observed between the 2 groups after 3 months (P = .014). The average level of creatinine in the intravenous immunoglobulin group at 1, 2, and 3 months after treatment was 1.7 ± 0.23, 1.8 ± 0.5, and 1.5 ± 0.3, respectively, and in the intravenous immunoglobulin + leflunomide group was 2.1 ± 0.75, 1.76 ± 0.37, and 1.4 ± 0.18, respectively (P > .05).
Although BK viral load decreased significantly in both groups, there was a significant difference between patients who received intravenous immunoglobulin versus those who received the combination of intravenous immunoglobulin + leflunomide after 3 months. The addition of leflunomide to the intravenous immunoglobulin treatment seems to have a better effect in reducing BK viral load. However, further studies with a larger sample and longer duration are needed.
方法:本研究为随机对照临床试验。将16例BK病毒感染的肾移植患者随机分为2组;1组接受静脉注射免疫球蛋白,另一组接受来氟米特和静脉注射免疫球蛋白.P<0.05被认为具有统计学意义。
结果:静脉注射免疫球蛋白组3例,静脉注射免疫球蛋白+来氟米特组7例,治疗2个月后BK病毒聚合酶链反应检测结果为阴性。各组的BK病毒量显著下降,3个月后,两组之间观察到显着差异(P=0.014)。静脉免疫球蛋白组治疗后1、2、3个月肌酐平均水平分别为1.7±0.23,1.8±0.5,1.5±0.3,静脉注射免疫球蛋白+来氟米特组分别为2.1±0.75、1.76±0.37和1.4±0.18(P>.05)。
结论:尽管BK病毒载量在两组中均显著下降,3个月后接受静脉注射免疫球蛋白的患者与接受静脉注射免疫球蛋白+来氟米特联合治疗的患者之间存在显著差异.在静脉注射免疫球蛋白治疗中加入来氟米特似乎在降低BK病毒载量方面具有更好的效果。然而,需要更大样本和更长持续时间的进一步研究.