An open-label multi-center clinical study of the efficacy and safety of rapamycin in combination with CsA and steroid to prevent the acute rejection of kidney transplantation / 中华器官移植杂志

ABSTRACT

Objective To study the clinical efficacy and safety of rapamycin in combination with CsA and steroid to prevent the acute rejection of kidney transplantation. Methods In an open-label,multi-center study,there were 100 primary renal allograft recipients with cadaveric donors enrolled from 4 transplantation centers in China. The immunosuppressive regimen was the triple therapy of rapamycin in combination with CsA and steriod. Rapamycin was administered in 48 h after grafting. The first dose of rapamycin was 6 mg /day and the maintenance dose was 2 mg /day. Results Eighty-four recipients were followed up for more than 6 months. Rapamycin was discontinued in 16 patients because of the adverse events and other reasons. Eight patients experienced acute rejection and 7 patients were reversed by methyprednisolon therapy. In 6 of the 7 patients,the dose of rapamycin was maintained 2 mg /day. The remaining one was added to 3 mg /day. No recurrence of AR was observed in a continuous follow-up of more than half-year. The most common and significant adverse events were hyperlipoidemia and abnormal liver function.Conclusions The combination of rapamycin with CsA and steroid to treat recipients of kidney transplantation is safe and efficient. There was a low incidence of AR but a high incidence of hyperlipoidemia and abnormal liver function. The rational regulation of the dose may reduce the incidence of the side-effects. Further observation and study are required for long-term application.