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雷帕鸣上市没?

Author: Medicalhalo
Release time: 2025-10-19 11:44:20

Is Rapaming on the market? Sirolimus tablets are imported drugs produced by Pfizer Ireland Pharmaceuticals. In September 1999, the US FDA approved them for use in patients undergoing kidney transplantation to prevent organ rejection. In 2003, sirolimus tablets were launched in China. On May 28, 2015, they were approved for the treatment of a rare lung disease, lymphangioleiomyomatosis (LAM).

Sirolimus is a lipophilic triene nitrogen-containing macrolide antibiotic compound produced by Streptomyces hygroscopicus isolated from soil samples of Easier Island in the Pacific in 1975 by Vezina and others at Ayerst Laboratory in Canada. Initially used as an antifungal drug with low toxicity, it was found to have immunosuppressive effects in 1977. In 1989, RAPA began to be tried out as a new drug to treat rejection of organ transplants. It is a new immunosuppressant with good efficacy, low toxicity and no nephrotoxicity.

Rapamin (sirolimus tablets) is a substrate of CYP3A4 and P-gp. The mean blood/plasma ratio of sirolimus after rapamycin administration was 36 ± 18, indicating that rapamycin is widely distributed into the formed components of the blood.

Clinical trials explore the clinical efficacy and safety of sirolimus (sirolimus) in kidney transplantation. A total of 23 kidney transplant patients were selected and given triple immunosuppressive therapy with this product combined with cyclosporine and glucocorticoids. Start taking this product within 48 hours after transplantation, with a loading dose of 6 mg and a maintenance dose of 2 mg. Results: 22 patients completed 6-12 months of follow-up. The incidence rates of acute rejection (AR) at 6 and 12 months were 13.6% (3 cases/22 cases) and 15.8% (3 cases/19 cases) respectively. AR patients were reversed after pulse treatment with methylprednisolone and continued to be followed up for more than half a year. No recurrence of AR was found.

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