Comparative study of application of standard double-and single-dose of basiliximab in renal transplantation
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摘要:
目的 比较标准双剂巴利昔单抗与单剂巴利昔单抗在肾移植中的作用及安全性。 方法 研究对象为2008年1月至2011年5月在武汉大学人民医院泌尿外科接受同种异体尸体肾移植的121例患者。按接受巴利昔单抗的方式分为两组。标准双剂巴利昔单抗组(双剂组), 53例, 按产品说明书分别于术前和术后第4日静脉注射巴利昔单抗20 mg; 单剂巴利昔单抗组(单剂组), 68例, 术前应用巴利昔单抗20 mg。监测两组患者围手术期免疫功能的变化。比较两组患者不良反应发生情况[移植物功能延迟恢复(DGF)、急性排斥反应、肺部感染]和人、肾存活情况。 结果 两组患者术前体液免疫和细胞免疫功能比较, 差异无统计学意义。与术前相比, 术后第5日两组患者的细胞免疫和体液免疫功能受到不同程度的抑制(均为P < 0.05), 同时与单剂组相比, 双剂组的细胞免疫功能和体液免疫功能均明显受抑制(均为P < 0.05);与术后第5日相比, 术后第15日两组患者的细胞免疫和体液免疫功能均不同程度恢复, 但仍较术前明显降低(CD3、CD4、IgM、IgA), 部分指标显示持续抑制水平, 较术后第5日仍持续下降(CD8、IgG)。双剂组和单剂组患者的DGF发生率分别为8%、7%, 随访1年内排斥反应发生率分别为13%、12%, 肺部感染发生率分别为9%、10%, 两组比较差异均无统计学意义(均为P>0.05)。双剂组和单剂组患者的1年人存活率分别为94%、98%, 移植肾存活率分别为93%、96%, 两组比较差异均无统计学意义(均为P>0.05)。 结论 肾移植中应用单剂或双剂巴利昔单抗同样有效, 不增加不良反应发生率, 1年人、肾存活率相当。围手术期检测免疫功能可以有效指导个体化免疫诱导治疗。 Abstract:Objective To compare clinical efficacy and safety between standard double-and single-dose of basiliximab in renal transplantation. Methods A total of 121 patients undergoing allogeneic cadaveric renal transplantation in Department of Urology of Renmin Hopsital of Wuhan University from January 2008 to May 2011 were recruited as study subjects. Among them, 53 patients were assigned into the double-dose of basiliximab group and they were intravenously administered with 20 mg of basiliximab before and 4 d after surgery according to product description. Sixty-eight cases were allocated in the single-dose of basiliximab group and they were given with 20 mg of basiliximab before renal transplantation. The changes of immune function in two groups during perioperative period were monitored. The incidence of adverse reactions including delayed graft function (DGF), acute rejection, pulmonary infection and the survival of patients and renal grafts were statistically compared between two groups. Results There was no significant difference in preoperative humoral immune and cellular immune function between two groups. Compared with preoperative period, cellular and humoral immune function in both groups were inhibited by varying degree at 5 d after surgery (both in P < 0.05). Compared with patients in the single-dose group, cellular and humoral immune functions were evidently suppressed in the double-dose group (both in P < 0.05). Compared with the parameters assessed at 5 d after surgery, cellular and humoral immune functions were restored to varying degree at 15 d after surgery, whereas still significantly lower than preoperative levels (CD3, CD4, IgM and IgA). Partial parameters (CD8 and IgG) were persistently inhibited and continued to decline compared with the levels at 5 d after surgery. The incidence of DGF was 8% in the double-dose group, and 7% in the single-dose group. During 1-year follow-up, the rejection rates in the double-and single-dose groups were 13% and 12%, and the incidence of pulmonary infection was 9% and 10%. No statistical significance was noted between two groups in terms of these parameters (all in P>0.05). The 1-year survival of patients in the double-and single-dose groups was 94% and 98%, 93% and 96% for the survival of renal grafts. No statistical significance was found between two groups (both in P>0.05). Conclusions Both double-and single-dose of basiliximab are efficacious in renal transplantation and do not increase the incidence of adverse reaction. The 1-year survival rates of patients and renal grafts between two groups are almost equivalent. Detection of immune function during perioperative period effectively guides individualized immune induction therapy. -
Key words:
- Renal transplantation /
- Basiliximab /
- Immune induction /
- Adverse reaction
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表 1 两组患者围手术期细胞免疫功能指标的变化
Table 1. hanges of preoperative indexes of cellular immune function of patients between two groups (x±s)
指标 双剂组(n=53) 单剂组(n=68) CD3 术前 0.659±0.145 0.700±0.070 术后第5日 0.486±0.179a 0.639±0.217a 术后第15日 0.607±0.113b 0.666±0.176 CD4 术前 0.397±0.120 0.434±0.112 术后第5日 0.269±0.152a 0.355±0.010a 术后第15日 0.344±0.088b 0.365±0.096b CD8 术前 0.232±0.068 0.214±0.043 术后第5日 0.185±0.083a 0.196±0.071a 术后第15日 0.182±0.044b 0.161±0.090b 注:与术前比较,aP < 0.05;与术后第5日比较,bP < 0.05 表 2 两组患者围手术期体液免疫功能指标的变化
Table 2. Changes of preoperative indexes of humoral immune function of patients between two groups (x±s)
指标 双剂组(n=53) 单剂组(n=68) IgG(g/L) 术前 13.8±2.9 16.1±6.5 术后第5日 8.7±2.2a 9.1±3.1a 术后第15日 7.4±1.8b 8.3±3.3b IgM(mg/L) 术前 1 330±570 1 200±360 术后第5日 1 040±560a 920±190a 术后第15日 1 130±680b 1 040±360b IgA(mg/L) 术前 2 810±1 150 2 170±1 080 术后第5日 1 830±830a 1 420±620a 术后第15日 1 950±750b 1 630±790b 注:与术前比较,aP < 0.05;与术后第5日比较,bP < 0.05 -
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