西罗莫司四联免疫抑制治疗方案在肾移植术后初期的疗效及不良反应研究  

Efficacy and adverse reactions of quadruple immunosuppressive therapy with sirolimus in the first 3 months after kidney transplantation

作　　者：钱卿[1] 范敏[2] 薛冬[2] 陈荣[1] 邹素兰[1] 王莉英[1] 胡楠[1] QIAN Qing;FAN Min;XUE Dong;CHEN Rong;ZOU Su-lan;WANG Li-ying;HU Nan(Department of Pharmacy,The First People's Hospital of Changzhou,Changzhou Jiangsu 213003;Department of Urology,The First People's Hospital of Changzhou,Changzhou Jiangsu 213003)

机构地区：[1]常州市第一人民医院药学部,江苏常州213003 [2]常州市第一人民医院泌尿外科,江苏常州213003

出　　处：《中南药学》2022年第8期1923-1927,共5页Central South Pharmacy

基　　金：常州市科技计划(应用基础研究指导性)项目(No.CJ20199010);常州市卫生拔尖人才(No.2016CZBJ010)。

摘　　要：目的研究肾移植受者采用西罗莫司四联免疫抑制治疗在术后初期的疗效和不良反应。方法前瞻性收集本院泌尿外科行同种异体肾移植术受者共计69例,随机分为试验组(西罗莫司+他克莫司+吗替麦考酚酯/麦考酚钠+糖皮质激素)、对照组(他克莫司+吗替麦考酚酯/麦考酚钠+糖皮质激素)。考察移植术后1、2、3个月时的血常规、肝肾功能、血糖、估算肾小球滤过率、他克莫司谷浓度及新发糖尿病、感染等不良反应发生情况。结果移植术后1个月时,试验组的血红蛋白、红细胞压积、估算肾小球滤过率均显著低于对照组(P=0.017,P=0.014,P=0.040),血清肌酐显著高于对照组(P=0.014),但以上指标在移植术后2、3个月时未表现出显著差异。试验组的他克莫司血药谷浓度在移植术后1、2、3个月时均显著低于对照组。试验组和对照组在术后3个月内新发糖尿病的发生率分别为14.7%和11.4%,感染性疾病的发生率分别为29.4%和37.1%,两组间无明显差异。结论西罗莫司联合小剂量他克莫司、霉酚酸类药物和糖皮质激素的四联免疫抑制方案较传统经典方案,在移植术后短期内具有相似的疗效和不良反应发生率,但仍需随访期更长的大样本对照研究来进一步验证。Objective To determine the efficacy and safety of quadruple immunosuppressive regimen with sirolimus in renal transplant recipients in the early period after the transplantation.Methods We prospectively collected the data of 69 recipients who underwent allograft renal transplant in the urology department of our hospital.These recipients were randomized to a test group and a control group.The regimen of the test group comprised 4 agents:sirolimus,tacrolimus,mycophenolate mofetil/mycophenolate sodium and glucocorticoids.The control group received a conventional regimen of the other three but without sirolimus.Laboratory characteristics,trough concentration of tacrolimus and adverse reactions were assessed 1,2 and 3 months after the transplantation.Results Hemoglobin,hematocrit and estimated glomerular filtration rate were significantly lower in the test group 1 month after the transplantation than in the control group(P=0.017;P=0.014;P=0.040).In addition,the serum creatinine was significantly higher in the test group(P=0.014).But the above parameters did not significantly differ 2 and 3 months after the transplantation.The trough concentration of tacrolimus in the test group was much lower than that in the control group 1,2 and 3 months after the transplantation.The incidence of new-onset diabetes in the test group and the control group 3 months after the transplantation was 14.7% and 11.4%,and the incidence of infectious diseases was 29.4% and 37.1%,respectively.There was no significant difference in the incidence of adverse reactions in both groups.Conclusion Compared with the conventional regimen,quadruple immunosuppressive regimen with sirolimus and low-dose tacrolimus has similar efficacy and incidence of adverse reactions in the short-term after the transplantation,which still needs to be further confirmed by large-scale controlled studies with longer follow-up.

关 键 词：肾移植 西罗莫司 免疫抑制方案 疗效 不良反应 

分 类 号：R96[医药卫生—药理学]