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To systematically explore the correlation between serum tacrolimus trough concentration (C0) and the efficacy in patients with systemic lupus erythematosus (SLE), and to obtain the effective concentration threshold of tacrolimus in such patients, so as to provide reference for the safety and efficacy of clinical medication.
The clinical and laboratory data of SLE patients treated with tacrolimus in our hospital from January 2016 to December 2021 were collected retrospectively, including demographic information (sex, age, height, and weight), course of disease, results of laboratory test, medication, monitoring data on blood concentration and clinical response, and efficacy and safety were evaluated. The correlation between C0 and efficacy was analyzed, and the threshold of effective concentration of tacrolimus was determined by receiver operating characteristic curve (ROC).
A total of 72 patients who met the criteria were included in this study, and 176 monitoring data of C0 (0.1~10.3 ng·mL-1) were collected. There was a weak correlation between daily dose of tacrolimus and C0 (r=0.326). With the prolonging of time of tacrolimus treatment, there was no significant change in C0, and there was significant difference in complement C3 among different blood concentration groups (P<0.05). There was no significant difference in other biochemical indexes. In the effective concentration study, 124 monitoring results of blood concentration in 59 patients with long-term of tacrolimus treatment (tacrolimus >3 months) were analyzed. They were divided into effective group (76 cases) and ineffective group (48 cases) according to clinical manifestations and biochemical indexes. Binary logistics regression analysis showed that C0 had a significant effect on the curative effect of the patients (P<0.001). The area under ROC curve (AUC) is 0.763 (P<0.001, 95%CI: 0.674~0.851).
This study showed that the drug dose affected the blood concentration of tacrolimus in patients with SLE, and there was a correlation between the plasma concentration of tacrolimus and the curative effect. The threshold of its effective concentration was determined by ROC curve analysis, which is 1.55 ng·mL-1.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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