雷帕鸣治疗肾移植疗效如何？

The main ingredient of (Rapamune) is sirolimus. Rapamune is suitable for patients receiving kidney transplants to prevent organ rejection. It is recommended that Rapamune preparations be used in combination with cyclosporine and corticosteroids.

To evaluate the safety and efficacy of Rapamune in preventing organ rejection after kidney transplantation, two randomized, double-blind, multicenter controlled trials were conducted. The two trials compared two doses of rapamune oral solution (2 mg and 5 mg once daily) with azathioprine (Trial 1) or placebo (Trial 2) while taking cyclosporine and corticosteroids. Trial 1 was conducted at 38 research sites in the United States, with 719 patients participating.

After transplantation, 284 patients received Rapamune 2 mg/d, 274 patients received Rapamune 5 mg/d, and 161 patients received azathioprine 2-3 mg/kg/d. Trial 2 was conducted at 34 research units in Australia, Canada, Europe and the United States, with 576 patients participating. Before transplantation, 227 patients received Rapamune 2 mg/d, 219 patients received Rapamune 5 mg/d, and 130 patients received placebo. In both trials, antilymphocyte antibody induction therapy was contraindicated. In both trials, the primary efficacy endpoint was the rate of treatment failure within the first 6 months after transplantation. Treatment failure was defined as the first episode of acute rejection (confirmed by biopsy), graft loss, or death.

Compared with azathioprine and placebo, (Rapamune) 2 mg/d and 5 mg/d dose levels significantly reduced the incidence of treatment failure 6 months after transplantation.