低剂量缬更昔洛韦预防肾移植术后巨细胞病毒感染的疗效观察

Prophylaxis for cytomegalovirus with low-dose valganciclovir after renal transplantation

目的:探讨低剂量缬更昔洛韦方案预防肾移植术后巨细胞病毒(CMV)感染的有效性和安全性。方法:选择2015年1月至2017年1月于本中心行首次肾移植的受者。根据术后预防药物不同将研究对象分为两组:实验组为缬更昔洛韦组,口服缬更昔洛韦450 mg,1次/d;对照组为更昔洛韦组,口服更昔洛韦1 g,3次/d。两种药物均于术后10 d内开始服用,持续3个月,根据肌酐清除率(CrCl)进行调整剂量。术后随访1年,并规律监测CMV-DNA、肾功能、血常规、肝功能等。比较两组的CMV感染率、CMV病发生率、首次CMV阳性时间、机会性感染发生率、急性排斥反应发生率、移植肾和受者存活及药物安全性评价。结果:共纳入166例肾移植受者,实验组85例,对照组81例。实验组CMV感染率为14.1%,明显低于对照组的32.1%,差异有统计学意义(P=0.006)。实验组首次CMV阳性时间中位数(四分位数间距)为140.5 d(77.3~198.5 d),对照组为47.5 d(36.8~67.8d),差异有统计学意义(P=0.014)。实验组CMV发病率下降(4.7%比12.4%),差异无统计学意义(P=0.080)。实验组机会性感染发生率明显低于对照组(10.6%比21.0%,P=0.037)。实验组均未出现移植肾功能丧失,对照组6例(7.4%)出现移植肾功能丧失,差异有统计学意义(P=0.032)。急性排斥反应发生率、肾移植受者死亡率、药物不良反应发生率等在两组间差异无统计学意义。结论:低剂量缬更昔洛韦方案能够安全有效地预防肾移植受者术后CMV感染并显著推迟CMV感染时间。

Objective To explore the efficacy and safety of low-dose valganciclovir for preventing CMV infection after renal transplantation.Methods Patients undergoing the first renal transplantation from January 2015 to January 2017 were selected.Recipients were divided into two groups according to anti-CMV prophylactic strategy.Recipients in test group(valganciclovir group,n=85)received oral valganciclovir 450 mg once daily and those in control group(ganciclovir group,n=81)had oral ganciclovir 1g thrice daily.Both drugs were prescribed within 10 days after transplantation and maintained for 3 months.Dose adjustments were based upon renal function.All recipients were followed up for 12 months posttransplantation.CMV-DNA,renal function,blood routine and liver function were regularly monitored.The incidence of CMV infection/disease,the median time to CMV infection onset,the incidence of opportunistic infections(OI)and acute rejection,graft or recipient survival and drug safety were evaluated.Results A total of 166 renal recipients were admitted.Fewer recipients in test group(12,14.1%)than in control group(26,32.1%)had CMV infection(P=0.006).The median time to CMV infection onset was longer in test group than in control group:140.5 days(interquartile range[IQR]:77.3-198.5 days)versus 47.5 days(IQR:36.8-67.8 days)respectively(P=0.014).The CMV disease rate was lower in test group(P=0.080).The incidence of OI decreased significantly in test group(10.6%vs 21.0%,P=0.037).No patients in test group suffered allograft loss while 6 recipients(7.4%)in control group(P=0.032).Other adverse and side effects of both regimens were comparable.Conclusions Low-dose valganciclovir regimen is both safe and efficacious in preventing CMV infection among kidney transplant recipients during the first year posttransplantation.