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How safe are sirolimus tablets? The clinical trial was to study the effectiveness and safety of rapamycin (sirolimus) switching treatment regimen. 93 patients who were switched to sirolimus-based immunosuppressant therapy after kidney transplantation were included in the clinical trial. There were 59 males and 34 females, aged (38±11) years old.

The treatment plan for all patients adopts a rapid conversion method, that is, calcineurin inhibitors are removed within 2 weeks, oral rapamycin (sirolimus tablets, sirolimus) is given 4 hours after oral administration of cyclosporine A or tacrolimus, with a single first loading dose of 6 mg, followed by a maintenance dose of 1.0 to 2.0 mg/d. The first sirolimus concentration is measured 5 to 7 days after taking the first dose of sirolimus, and the target mass concentration is 6 to 10 μg/L.

The results showed that after rapamycin (sirolimus) conversion treatment, the symptoms of patients with calcineurin-inhibited nephrotoxicity and hepatotoxicity improved significantly, the blood concentration was maintained at (5.1±1.2) μg/L, and the serum creatinine dropped from (297.72±150.28) μmol/L to (123.76±44.2) μmol/L. Liver function recovered after the conversion (24 cases, 92.3%). Nine cases of hyperglycemia patients returned to normal and 2 cases improved: 17 cases had a decrease in serum creatinine greater than 25% of the original creatinine level, and the effective rate was 51.5%; 10 cases of tumors occurred 6 to 43 months after kidney transplantation, and 8 cases were stable without recurrence. Three cases of acute rejection occurred within 6 months of switching treatment with rapamycin (sirolimus tablets, sirolimus). The 3-year human renal survival rates after conversion therapy were 90.9% and 75.8% respectively.

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