Side Effects of smallpox/mpox vaccine: A Synthesis of Findings from 2 Studies

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Original Abstract of the Article

Main Research Findings

Study 20463641 found that sirolimus and mycophenolate mofetil improved renal function, efficacy, and safety after short-term calcineurin inhibitor-based quadruple therapy in de novo renal transplant patients. 2

Study 15108768 found that sirolimus, in combination with reduced cyclosporine exposure, was safe and effective in preventing acute rejection and associated side effects in living related renal allograft recipients compared to azathioprine. 1

Reasons for Side Effects

Immunosuppressant drugs like sirolimus work by suppressing the immune system to prevent organ rejection after transplantation. However, since the immune system plays a crucial role in protecting the body from infections, immunosuppressants can increase the risk of infections.

Common Side Effects

Infections

Sirolimus can increase the risk of infections due to its immunosuppressive effects. 2 1

Hyperlipidemia

Sirolimus can cause hyperlipidemia (high cholesterol). 2

Renal dysfunction

Sirolimus can lead to renal dysfunction. 2

Hepatic dysfunction

Sirolimus can cause hepatic dysfunction. 2

Side Effect Management

Infections

To reduce the risk of infections, it is crucial to practice good hygiene, including hand washing and gargling. Regular health checkups and vaccinations when necessary are also important. 2 1

Hyperlipidemia

Dietary changes and exercise are effective in reducing the risk of hyperlipidemia. If necessary, cholesterol-lowering medications can be taken under the guidance of a doctor. 2

Renal dysfunction

Regular renal function tests are crucial to prevent the progression of renal dysfunction. It may also be necessary to adjust the sirolimus dosage under the doctor's instructions. 2

Hepatic dysfunction

Regular liver function tests are important to prevent the progression of hepatic dysfunction. It may also be necessary to adjust the sirolimus dosage under the doctor's instructions. 2

Comparison Between Studies

Commonalities

Both studies indicated that sirolimus is effective in preventing rejection after kidney transplantation. Sirolimus also has the potential to be an effective alternative to calcineurin inhibitor-based regimens.

Differences

Study 20463641 focused on renal function, efficacy, and safety after short-term calcineurin inhibitor-based quadruple therapy, while study 15108768 compared the safety and efficacy of sirolimus versus azathioprine.

Real-Life Application Notes

Sirolimus is an immunosuppressant used to prevent rejection in patients who have received kidney transplants. While sirolimus is an effective drug, it carries the risk of side effects like infections. When taking sirolimus, it is essential to follow the doctor's instructions carefully, undergo regular examinations, and address side effects promptly.

Limitations of Current Research

Further research is needed on the long-term safety and efficacy of sirolimus. Research on sirolimus dosage, administration methods, and combination with other immunosuppressants is also required.

Future Research Directions

Future research on the long-term safety and efficacy of sirolimus, optimizing sirolimus dosage and administration methods, and combinations with other immunosuppressants is necessary.

Conclusion

Sirolimus is an effective drug in preventing rejection after kidney transplantation. However, sirolimus carries the risk of side effects like infections. When taking sirolimus, it is essential to follow the doctor's instructions carefully, undergo regular examinations, and address side effects promptly.

Literature analysis of 2 papers
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Article Type
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2
1.

An open-label randomized trial of the safety and efficacy of sirolimus vs. azathioprine in living related renal allograft recipients receiving cyclosporine and prednisone combination.

Author: MachadoPaula G P, FelipeCláudia R, HanzawaNilva M, ParkSung I, GarciaRiberto, AlfieriFernando, FrancoMarcelo, SilvaHélio T, Medina-PestanaJosé O

Improved graft function
Reduced rejection
Hyperlipidemia

Sirolimus, in combination with reduced cyclosporine exposure, is effective in preventing acute rejection in renal transplant recipients. It also reduces the incidence of rejection compared to azathioprine with standard cyclosporine doses.

Clinical TrialA clinical trial is a planned study conducted on humans to evaluate the efficacy and safety of pharmaceuticals, medical devices, and treatment methods. It aims to explore the possibilities of new treatments and improve the health of patients.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.

Language : English

2.

Renal function, efficacy, and safety of sirolimus and mycophenolate mofetil after short-term calcineurin inhibitor-based quadruple therapy in de novo renal transplant patients: one-year analysis of a randomized multicenter trial.

Author: GubaMarkus, PratschkeJohann, HugoChristian, KrämerBernhard K, Nohr-WestphalConstanze, BrockmannJens, AndrassyJoachim, ReinkePetra, PressmarKatharina, HakenbergOliver, FischerederMichael, PascherAndreas, IllnerWolf-Dieter, BanasBernhard, JauchKarl-Walter,

Improved renal function
Reduced cytomegalovirus viremia
Acne
Aphtous
High rate of dropouts
Hyperlipidemia

Early conversion to a calcineurin inhibitor-free regimen with sirolimus (SRL) in combination with mycophenolate mofetil was associated with improved renal function in patients after renal transplantation. However, there was a significantly higher rate of drug discontinuation in the SRL group (36.2% vs. 19.7%) due to adverse events such as acne, aphtous ulcers, and temporary hyperlipidemia.

Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Multicenter StudyResearch conducted in collaboration with multiple research institutions. It aims to collect a wide range of data and obtain more generalizable results.
Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Language : English

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