Sirolimus in Kidney Transplantation: A Pilot Study in Chinese Patients

Man-Fai Lam, Terence Pok-Siu Yip, Kai-Chung Tse, Fu-Keung Li, Sing-Leung Lui, Kar-Neng Lai, Tak-Mao Chan

We conducted a pilot open-label study on the use of sirolimus in 10 Chinese patients undergoing kidney transplantation who received triple prophylactic immunosuppression comprising prednisolone, cyclosporine and sirolimus. Sirolimus was given as a 6 mg loading dose followed by 2 mg/day maintenance. All patients achieved target sirolimus trough serum concentrations exceeding 5 ng/mL. Median duration of follow-up was 22 months after transplantation. One patient developed Type Ia acute cellular rejection at 6 months, which responded to pulse steroid therapy. Graft survival was 100% at 12 months and serum creatinine was 131±36 micromol/L at 1 year. Low-density lipoprotein cholesterol and triglyceride levels were significantly increased after 2 months. Eight patients received atorvastatin, which was subsequently discontinued successfully in three patients. Infection was noted in two patients; one died of pneumocystis pneumonia 10 months after transplantation and the other had septicemia from urinary tract infection complicating graft vesicoureteric reflux. Two patients developed lymphocele in the early postoperative period, which resolved spontaneously in one patient and was treated successfully with ethanol sclerotherapy in the other. No patients developed thrombocytopenia or arthralgia. We conclude that sirolimus, when used together with prednisolone and cyclosporine, is well tolerated and effective in Chinese renal allograft recipients, and that hyperlipidemia early after transplantation is the most common adverse effect.

Key words: sirolimus, kidney transplantation, Chinese population, hyperlipidemia

本研究為一項 sirolimus 的開放式臨床試驗，對象為 10 位華裔的腎臟移植接受者，需接受含 prednisolone、cyclosporine、及 sirolimus 的三重免疫抑制治療。Sirolimus 首先以 6 mg 給予，並以 2 mg/day 作為維持劑量；所有病人的血清低谷濃度均超越 5 ng/mL。在移植術後的 22 個月（中位數）期間，僅有 1 位病人於第 6 個月出現 Ia 型急性細胞性排斥，但對脈衝式類固醇治療反應良好。在術後的 12 個月中，植入腎臟的存活率達 100%，病人於第 12 個月時之肌酸酐濃度為 131± 36 micromol/L。病人於術後 2 個月出現低密度脂蛋白膽固醇及三酸甘油脂濃度的顯著上升，有 8 人需接受降血脂藥物 atorvastatin （其中 3 人於其後成功停藥）。測試期間有 2 位病人曾發生感染，其中 1 人於術後 10 個月因 pneumocystis pneumonia 感染而去世；另 1 人則因植入腎臟發生膀胱輸尿管逆流，繼而併發泌尿道感染而出現敗血症。2 人於術後初期出現淋巴囊腫，其中 1 人的病灶自動消失，另 1 人的病灶則於硬化劑注射治療後消失。研究期間，無任何人曾發生血小板稀少或關節痛。因此，對於華裔的同種異體腎臟移植接受者，作為與 prednisolone 和 cyclosporine 合併使用的免疫抑制用藥，sirolimus 具備良好的功效及耐受性，其不良作用以術後初期之高脂血症最為常見。

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