论文部分内容阅读
目的 :观察单剂赛尼哌联合低剂量普乐可复 (FK5 0 6)对肾移植急性排斥反应 (AR)的预防作用及其安全性。方法 :将同期首次肾移植受者随机分成两组 ,每组 2 0例。 (1)观察组 (单剂赛尼哌联合低剂量FK 5 0 6+MMF+Pred) ;(2 )对照组 (常规剂量FK5 0 6+MMF +Pred)。两组受者HLA错配≤ 3 ,CDC及PRA试验均阴性 ,且两组间性别、年龄、原发病、冷热缺血时间、血透时间、HBsAg阳性率均无统计学差异。应用微粒子酶免疫分析法测定所有受者口服FK5 0 6后 12h的血药谷浓度 ,观察组和对照组谷浓度的控制范围分别为 5～ 10 μg/L和 10～ 15 μg/L。观察术后 60d排斥反应的发生、药物的肾毒性和肝功能异常情况。结果 :观察组和对照组谷浓度均值分别为 (7 2±2 6) μg/L和 (12 1± 3 8) μg/L ,两组全血FK5 0 6谷浓度均值差异具有显著性 (P <0 0 5 )。术后发生急性排斥反应 ,观察组 1例次 ,对照组 2例次 (P >0 0 5 ) ;肾毒性 ,观察组 0例次 ,对照组 5例次 (P <0 0 5 ) ;肝功能异常 ,观察组4例次 ,对照组 6例次 (P >0 0 5 )。结论 :术前使用单剂赛尼哌 ,术后FK5 0 6谷浓度维持在 5～ 10 μg/L水平 ,既能有效预防AR发生 ,又能减少FK5 0 6的肾毒性
OBJECTIVE: To observe the preventive effect and safety of single dose of saenipide combined with low dose of levofloxacin (FK506) on acute rejection (AR) after renal transplantation. Methods: The first recipients of renal transplantation during the same period were randomly divided into two groups, 20 cases in each group. (1) observation group (single dose of saenipide combined with low dose FK506 + MMF + Pred); (2) control group (conventional dose of FK506 + MMF + Pred). HLA mismatch between the two groups of patients ≤ 3, CDC and PRA test were negative, and the two groups of gender, age, primary disease, ischemia-reperfusion time, hemodialysis time, HBsAg-positive rate was no significant difference. The concentration of plasma trough was measured 12 h after oral administration of FK5 0 6 by microenzyme immunoassay. The control range of trough concentration in observation group and control group was 5 ~ 10 μg / L and 10 ~ 15 μg / L, respectively. The incidence of rejection, the nephrotoxicity and abnormal liver function were observed 60 days after operation. Results: The mean trough concentrations of observation group and control group were (72 ± 2 6) μg / L and (12 1 ± 38) μg / L, respectively <0 0 5). Acute rejection occurred after operation in observation group 1 case, control group 2 cases (P 0 05), nephrotoxicity group 0 cases, control group 5 cases (P 0 05), liver function Abnormalities were observed in 4 cases and 6 cases in control group (P> 0.05). CONCLUSION: Preoperative single dose of saenipide is effective in preventing the occurrence of AR and reducing the nephrotoxicity of FK506 after postoperative maintenance of the concentration of FK506 in the range of 5 ~ 10 μg / L