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目的研究国产重组抗CD25人源化单克隆抗体(健尼哌)在肾移植免疫诱导应用中的有效性和安全性。方法本前瞻性研究对象选取2011年5月至2012年5月在中山大学附属第一医院器官移植中心接受初次亲属活体供肾肾移植患者共20例,随机分为实验组和对照组。实验组10例,免疫诱导给予2剂健尼哌(每剂75 mg,术中1剂、术后14 d 1剂);对照组10例,免疫诱导给予2剂巴利昔单抗(每剂20 mg,术中1剂、术后4 d 1剂)。密切随访,观察两组患者术后急性排斥反应、移植物功能延迟恢复(DGF)、感染等并发症的发生率,记录患者和移植肾的存活情况。分别于术前、术后1 d、术后3 d、术后7 d、术后14 d、术后1个月、术后3个月以及术后6个月,检测两组患者的血清肌酐、血尿素氮、外周血白细胞计数、淋巴细胞比例等实验室检测指标,比较两组间差别。分别于上述各时间点抽取患者外周静脉血2 ml,采用流式细胞仪分析两组患者调节性T细胞比例(Treg%)的变化。结果随访期间,两组患者均无死亡病例。实验组和对照组各有1例患者出现急性排斥反应,经甲泼尼龙冲击治疗及抗胸腺细胞球蛋白(ATG)治疗后,肾功能均恢复至正常。两组患者的急性排斥反应、上呼吸道感染、肺部感染、尿路感染、白细胞减少、血小板减少及DGF等并发症发生率比较,差异无统计学意义(均为P>0.05)。在各时间点上,两组患者的血清肌酐、血尿素氮、外周血白细胞计数、淋巴细胞比例比较,差异均无统计学意义(均为P>0.05)。两组患者Treg%的变化基本相似,均在术后1个月内维持较低水平,术后3个月逐渐回升,至术后6个月接近或回复到术前水平。在术前、术后3 d的时间点,两组患者的Treg%差异无统计学意义(均为P>0.05);而在术后1 d、7 d、14 d及1个月的时间点,实验组的Treg%均高于对照组,差异有统计学意义(均为P<0.05);在术后3个月、6个月的时间点,实验组的Treg%均低于对照组,差异亦有统计学意义(均为P<0.05)。结论在肾移植免疫诱导应用中,健尼哌具有和国外同类产品相似的有效性及安全性。
Objective To study the efficacy and safety of domestic recombinant anti-CD25 humanized monoclonal antibody (Jianpeipi) in the induction of renal transplantation. Methods A total of 20 prospective living donor kidney transplant recipients from May 2011 to May 2012 at the Organ Transplantation Center of the First Affiliated Hospital of Sun Yat-sen University from May 2011 to May 2012 were randomly divided into experimental group and control group. In the experimental group, 10 cases were induced with 2 doses of nipivacaine (75 mg per dose, 1 intraoperative and 1 d after operation) and 10 cases in the control group. Balibuxil (2 doses) 20 mg, 1 intraoperative, 1 d after 4 d). Close follow-up was performed to observe the incidence of postoperative acute rejection, delayed graft function (DGF), complications such as infection, and to record the survival of patients and renal allografts. Serum creatinine was measured in two groups before operation, 1 d after operation, 3 d after operation, 7 d after operation, 14 d after operation, 1 month after operation, 3 months after operation and 6 months after operation. , Blood urea nitrogen, peripheral blood leukocyte count, lymphocyte ratio and other laboratory test indicators to compare the differences between the two groups. Peripheral venous blood was collected from 2 ml patients at each time point, and the percentage of regulatory T cells (Treg%) was analyzed by flow cytometry. Results During follow-up, there were no deaths in either group. Acute rejection occurred in 1 patient in each experimental and control group. Renal function returned to normal after treatment with methylprednisolone and anti-thymocyte globulin (ATG). The incidence of acute rejection, upper respiratory tract infection, lung infection, urinary tract infection, leukopenia, thrombocytopenia and DGF in the two groups were not significantly different (all P> 0.05). At each time point, there was no significant difference in serum creatinine, blood urea nitrogen, peripheral blood leukocyte count and lymphocyte ratio between the two groups (all P> 0.05). The changes of Treg% in both groups were basically similar, both of which remained at a low level within 1 month after operation and gradually rose at 3 months after operation, approaching or returning to the preoperative level at 6 months after operation. There were no significant differences in Treg% between the two groups at preoperative and postoperative 3 days (all P> 0.05). At the time points of 1 d, 7 d, 14 d and 1 month after operation , Treg% in the experimental group were higher than that in the control group, the difference was statistically significant (all P <0.05); at the time of 3 months and 6 months after operation, the Treg% of the experimental group was lower than that of the control group, The difference was also statistically significant (both P <0.05). Conclusion In the application of renal transplantation immune induction, Jian Ni Pip has the similarities and similarities with other foreign products of effectiveness and safety.