更昔洛韦预防肾移植术后巨细胞病毒感染的前瞻性随机对照研究

Prophylaxis of cytomegalovirus infection with ganciclovir in renal transplant recipients: a prospective randomized controlled study

目的研究更昔洛韦对肾移植术后巨细胞病毒(CMV)感染的预防作用。方法选取2004年行首次肾移植的55例患者,所有患者术后均常规应用环孢素A+霉酚酸酯+激素的免疫抑制方案。将患者随机分为2组,A组27例,从肾移植术后第2周起静脉滴注更昔洛韦5mg.kg-1.d-1,共30d,预防CMV感染;B组28例,没有针对CMV感染进行预防性用药。所有患者肾移植术后均随访6个月,检测其血清中CMV-IgG、CMV-IgM及CMV-DNA的表达,统计肾移植术后6个月时CMV感染率、CMV病的患病率、CMV感染时间、CMV病临床缓解时间、急性排斥反应发生率以及药物不良反应等项目。结果A、B两组患者的CMV感染率分别为37%和25%,CMV患病率分别为22.2%和14.3%,两组相比,差异无统计学意义。A组术后发现CMV感染时间较B组明显延迟(P<0.05),且发生CMV病后的临床缓解时间较B组显著缩短(P<0.05)。A、B两组急性排斥反应发生率分别为11.1%和21.4%,两组比较,差异无统计学意义。1例患者应用更昔洛韦后发生白细胞数减少,经集落刺激因子治疗后恢复。结论肾移植术后静脉滴注更昔洛韦对降低CMV感染率及发病率无明显作用,但可明显延迟肾移植术后CMV感染的发生时间,并显著缩短CMV发病后的临床症状缓解时间。提示肾移植术后CMV感染的预防性用药可能需要更长的时间。

Objective To investigate the prophylactic treatment of cytomegalovirus （CMV） infection in renal transplant patients. Methods Fifty-five patients were divided into two groups. Group A （n = 27） was administered with ganciclovir （5 mg/kg every day） intravenously for 30 days. Group B （n = 28） was the control group. According to donor （D） or recipient （R） CMV antibody categories, each group had D^＋/R^- , D^-/R^＋ , D^＋/R^＋ three subgroups. All patients were followed up prospectively for 6 months with measurements of CMV antibody, CMV-DNA antigen, acute rejection for monitoring activity of CMV infections. Results The rate of CMV infection and disease was similar in both groups. The delay between transplantation and CMV infection was significantly longer in the ganciclovir group than in the control group （70. 1 ± 14. 9 vs 50. 2 ± 9. 8, P〈0. 05）. And less severe CMV disease was observed in the ganciclovir group. The days of CMV disease remission were shorter in ganciclovir group than in control group （7. 0 ± 1.2 vs 13.0±1.0, P〈0. 05）. No significant sideeffect was observed during ganciclovir administration. Conclusions Conclusion Prophylactic ganciclovir administration for 30 days after renal transplantation does not prevent CMV infection, but prolongs the incubation period. Longer prophylaxis by ganciclovior may be needed in these patients.