摘要
背景 本實驗係採回溯性分析南部某醫學中心進行肝臟移植之兒童病患，共收集30位病患，分成兩組比較cyclosporine的監測方式：一組是以服用cyclosporine後2小時的濃度(C2 n = 15)，另一組是以服藥前的波谷濃度(C0 n = 15)來調整劑量。 實驗方法 Cyclosporine (Neoral®) 的初始劑量是以300 mg/m2/dose，而劑量的調整是以其要求達到的預期值 (target level) 為主。兩種方式的評估內容主要評估術後3個月內急性排斥的發生、肝臟功能、腎臟功能、cyclosporine的使用劑量、不良反應、感染率。 實驗結果 兩組病患的基本資料大致相似，除了在C2組有3位病童在手術時的年紀是滿10歲，其餘病患皆與C0組相仿。整體的急性排斥的發生率C2組 ( 2/15 ; 13.3 % ) 與C0組 ( 3/15 ; 20 % ) 在統計上並無明顯差異 (P > 0.05) 。C2組的病人於術後3天即達到預期值者，沒有一位病人發生急性排斥；相反的，C0組達到預期值的天數與急性排斥之間無法有相關性。肝臟功能、腎臟功能、不良反應、感染率兩組皆無明顯差異 (P > 0.05) ，除了在C2組第12週alanine transaminase (ALT) 值是明顯比C0組高，因為在C2組有較多的病人發生肝臟動脈、肝臟靜脈栓塞、膽管炎 (7位在C2組； 4位在C0組) 而且C2組急性排斥的發生時間都在術後第2至3個月而C0組多發生在第1個月。Cyclosporine的使用劑量兩組在術後第1週及4週有明顯差異 (P < 0.05) 。術後第1週C2組劑量是39.55 mg/kg/day明顯多出C0組的 29.39 mg/kg/day (P < 0.05) 。但是當術後4週結果卻相反，C0組的 17.38 mg/kg/day明顯多出C2組劑量12.9 mg/kg/day (P < 0.05) 。 結論 使用C2或C0的監測方式在整體的急性排斥率及發炎的嚴重度在統計無差異。雖然初期C2組cyclosporine的使用劑量比較高，然而在其他安全性評估卻未見有差異，因此使用如此劑量應是安全。
並列摘要
英文摘要( Abstract ) Keywords: pediatric liver transplantation, cyclosporine, acute rejection Background. A retrospective study was conducted at a medical hospital in the southern Taiwan, involving 30 de novo pediatric liver transplant patients to compare the clinical usefulness of monitoring 2-hr post-dose cyclosporine levels (C2) (n = 15) with conventional trough cyclosporine blood levels (trough, pre-dose) (C0) (n = 15). Methods. Neoral oral therapy was initiated at 300 mg/m2/dose and dose adjusted according to predetermined C2 or C0 target level ranges. The efficacy evaluation variable was based on a composite endpoint of biopsy-proven rejection, renal function, liver function, dosage, adverse effects, infection, during the first 3 months after operation from the study. Results. Baseline characteristics were similar, except the mean age at operation. Overall incidence of acute rejection was not significantly different between the two groups (P > 0.05) . For biopsy-proven acute rejections, the incidence of moderate histological diagnosis was lower in the C2 group than in the C0 group. C2 patients who reached minimum target cyclosporine levels by day 3, the rejection rate was zero for the first 3 months, whereas there was no difference in the incidence of rejection in C0 patients, irrespective of time to reach target levels. The renal function, liver function (except in the 12 week data because C2 group the incidences of hepatic artery, venous thrombosis, cholangitis were large than C0 group) (7 in C2 and 4 in C0) and adverse effects were no difference between the two groups. The dose of cyclosporine was significantly different in the both groups on the day 7 (P < 0.05) and day 30 (P < 0.05) . On the day 7, the mean dose of C2 group (39.55 mg/ kg/day) was significantly higher than that in the C0 group (29.39 mg/kg/day) . In the contrast, on the day 30 the average dose of C2 group (12.9 mg/kg/day) was significantly lower in the C0 group (17.38 mg/kg/day). Conclusion. There was no significant different between C2 and C0 about the overall incidence of acute rejection and the histological severity of acute rejection. Although the dose was higher in C2 group within first week after operation, there was no difference about renal function and safety profile between the 2 groups.