The Effect of Pharmaceutical Care on the Variation of Tacrolimus Concentration in Patients after Liver or Kidney Transplantation

目的:评估药学监护(PhC)对剂量校正全血他克莫司(TAC)谷浓度,免疫抑制治疗依从性及临床预后的影响.方法:纳入238例肝肾移植接受者,将患者随机分为PhC(n=119)组与对照组(n=119),从肝肾移植术后3天到90天,PhC组接受由药剂师提供的PhC治疗,对照组由医护人员进行标准治疗,在移植后第1、3、5、和7天检测并比较患者校正全血TAC低谷浓度,并计算个体内变异性变异系数(CV).比较两组患者巴塞尔坚持免疫抑制药物治疗量表(BAASIS)评分与临床预后.结果:PhC和对照组CV比较差异无统计学意义(31.5± 12.4％ vs 32.6± 16.2％,P=0.674);预定义TAC目标浓度范围内患者比例无显著差异(均P＞0.05);第28天(16.7％ vs.25.8％,P=0.135)与第90天(27.1％ vs.24.6％,P=0.457)时,PhC与对照组的依从性差患者所占的百分率比较,差异无统计学意义.两组患者临床预后比较,差异无统计学意义(均P＞0.05).结论:肝肾脏移植后3个月内,应用药学监护治疗与剂量校正全血TAC谷浓度的个体内变异性降低、依从性或早期移植患者预后无关.Objective:To evaluate the effects of pharmaceutical care (PhC) on the dose corrected whole blood tacrolimus (TAC) valley concentration,immune suppression therapy compliance and clinical prognosis.Methods:238 patients of liver or kidney transplant recipients were included,and they were randomly divided into PhC group (n=119) and control group (n=119).After renal transplantation,from 3 days to 90 days,the PhC group received PhC treatment from a pharmacist,while the control group received standard treatment.At dl,d3,d5,d7 after transplantation,we detected and compared the dose corrected whole blood TAC Valley concentration,and calculated the coefficient of variation (CV).We also compared the scores of Basel Assessment of Adherence to Immunosuppressive Medications Scale (BAASIS) and clinical prognosis between the two groups of patients.Results:The CV had no significant difference between the PhC group and the control group ((31.5± 12.4)％ vs.(32.6± 16.2)％,P=0.674).There was no significant difference in the proportion of patients within a predefined TAC target concentration range (P＞0.05).There was also no significant difference between PhC group and control group in the percentage of patients with poor compliance at Day 28 (16.7％ vs.25.8％,P =0.135) and day 90 (27.1％ vs.24.6％,P =0.457).The clinical outcome also had no significant difference between the two groups (all P ＞ 0.05).Conclusion:Within the first 3 months after liver or renal transplantation,the use of pharmaceutical care in the treatment of patients with a dose correction of whole blood TAC Valley concentration was not associated with a variability of reduction in the individual,adherence or prognosis of patients with early transplantation.广东省科技计划项目; 深圳市科技创新委员会立项项目81493-14971