Abstract
Background
Tacrolimus is an immunosuppressant commonly used for immunosuppressive therapy after organ transplantation. However, tacrolimus has a narrow therapeutic window, and monitoring its blood concentration is crucial for adjusting treatment plans and preventing side effects. Traditional monitoring methods have complex operating procedures and time-consuming issues, so exploring new methods is necessary. Photon crystal chip detection and chemiluminescence are potential methods for monitoring tacrolimus blood concentration. This study aims to compare the advantages and limitations of these two methods and explore their potential applications in clinical practice. Through this study, scientific evidence can be provided to improve monitoring methods and provide better personalized treatment.
Methods and analysis
This study is a single-center, single-blind, diagnostic trial that compares the potential of photon crystal chip detection and chemiluminescence in monitoring tacrolimus blood concentration and exploring their value in clinical practice. The main objective is to detect the fluorescence intensity of the photon crystal chip. Secondary objectives include comparing the reliability, anti-interference ability, and optimization of experimental conditions of the photon crystal chip and chemiluminescence. The experimental flow chart is shown in Fig. 1. Participants are from the Third Medical Center of the Chinese PLA General Hospital. In order to estimate the sample size, we determined four key elements: effect size, success rate of both methods, significance level, and statistical power or sample size. The required sample size was calculated to be 80 cases using a formula. The t-test will be used to compare the differences between the tacrolimus concentration data obtained from the two detection methods to determine if there is a significant difference in concentration measurement. This study has been approved by the medical ethics committee and it is in accordance with relevant guidelines and regulations. Patients or authorized representatives will receive detailed written information before signing an informed consent form. Before signing the consent form, the attending physician or authorized representative will explain the background, purpose, participation content and process, possible benefits and risks, privacy, and other important information to the patient. Participation is voluntary and patients can withdraw at any time without giving a reason. Legally incompetent individuals will be excluded from the trial.
Discussion
This study compares the advantages and disadvantages of using the photonic crystal chip detection method and the chemiluminescence method to detect the concentration of tacrolimus in blood. The purpose is to explore new detection methods to improve monitoring efficiency and accuracy.
Ethics review approval Research ethics number (KY2022-01).
Ethics review date: January 25, 2022