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五酯胶囊协同他克莫司治疗儿童激素耐药型肾病综合征的研究现状
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Abstract:
激素耐药型肾病综合征(Steroid-resistant nephrotic syndrome, SRNS)治疗难度大、周期长、预后相对较差。他克莫司是儿童SRNS最常用的免疫抑制剂，但存在药代动力学个体差异大、治疗窗窄及需要定期监测血药浓度的缺点。五酯胶囊在早期临床中多联合用药以减少药物性肝损害的发生。但在随访过程中逐渐发现协同用药可以提高他克莫司的血药浓度，进而降低他克莫司的用药剂量，减轻他克莫司的不良反应。本文就五酯胶囊协同他克莫司治疗儿童SRNS的研究现状进行综述。
Steroid-resistant nephrotic syndrome is difficult to treat, has a long cycle, and has a poor prognosis. Tacrolimus is the most commonly used immunosuppressant for SRNS in Pediatric patients, but has the disadvantages of large individual differences in pharmacokinetics, a narrow therapeutic window and the need for regular monitoring of blood levels. Wuzhi capsules are mostly co-administered in early clinical practice to reduce the occurrence of drug-related liver damage. However, during the follow-up process, it was gradually found that the co-administration could increase the blood concentration of tacrolimus, which in turn reduced the dose of tacrolimus and reduced the adverse effects of tacrolimus. This article provides a review of the current state of research on Wuzhi capsules in combination with tacrolimus for the treatment of SRNS in children. We review the current status of research on pentothal capsules in co-administration with tacrolimus for the treatment of SRNS in children.
| [1] | Vivarelli, M., Gibson, K., Sinha, A., et al. (2023) Childhood Nephrotic Syndrome. Lancet, 402, 809-824. https://doi.org/10.1016/S0140-6736(23)01051-6 |
| [2] | 中华医学会儿科学分会肾脏学组. 激素耐药型肾病综合征诊治循证指南(2016) [J]. 中华儿科杂志, 2017, 55(11): 805-809. |
| [3] | Trautmann, A., Vivarelli, M., Samuel, S., et al. (2020) IPNA Clinical Practice Recommendations for the Diagnosis and Management of Children with Steroid-Resistant Nephrotic Syndrome. Pediatric Nephrology, 35, 1529-1561. https://doi.org/10.1007/s00467-020-04519-1 |
| [4] | 朱月玲, 何雪, 王建炳, 等. 儿童特发性肾病综合征远期预后现状及影响因素[J]. 中华肾脏病杂志, 2023, 39(6): 473-478. |
| [5] | Rovin, B.H., Adler, S.G., Barratt, J., et al. (2021) Executive Summary of the KDIGO 2021 Guideline for the Management of Glomerular Diseases. Kidney International, 100, 753-779. https://doi.org/10.1016/j.kint.2021.05.015 |
| [6] | Choudhry, S., Bagga, A., Hari, P., et al. (2009) Efficacy and Safety of Tacrolimus versus Cyclosporine in Children with Steroid-Resistant Nephrotic Syndrome: A Randomized Controlled Trial. American Journal of Kidney Diseases, 53, 760-769. https://doi.org/10.1053/j.ajkd.2008.11.033 |
| [7] | Wang, C.B., Zhang, Y.J., Zhao, M.M. and Zhao, L.M. (2023) Population Pharmacokinetic Analyses of Tacrolimus in Non-Transplant Patients: A Systematic Review. European Journal of Clinical Pharmacology, 79, 897-913. https://doi.org/10.1007/s00228-023-03503-6 |
| [8] | 吴笑春, 辛华雯, 李罄, 等. 五酯胶囊对健康受试者他克莫司药动学的影响[J]. 中国新药杂志, 2007, 16(8): 647-650. |
| [9] | Miedziaszczyk, M., Bajon, A., Jakielska, E., et al. (2022) Controversial Interactions of Tacrolimus with Dietary Supplements, Herbs and Food. Pharmaceutics, 14, Article 2154. https://doi.org/10.3390/pharmaceutics14102154 |
| [10] | 张恩瑶, 向倩, 谢秋芬, 等. CYP3A5基因多态性的他克莫司个体化用药临床研究分析[J]. 中国临床药理学杂志, 2022, 38(8): 864-868. |
| [11] | Zong, Y.P., Wang, Z.J., Zhou, W.L., et al. (2017) Effects of CYP3A5 Polymorphisms on Tacrolimus Pharmacokinetics in Pediatric Kidney Transplantation: A Systematic Review and Meta-Analysis of Observational Studies. World Journal of Pediatrics, 13, 421-426. https://doi.org/10.1007/s12519-017-0035-4 |
| [12] | 刘杰, 徐剑, 郭江涛. 五味子活性成分及药理作用研究进展[J]. 中国实验方剂学杂志, 2019, 25(11): 206-215. |
| [13] | 廖明昊, 朱旭, 王鸣璐, 等. 五酯胶囊提高他克莫司血药浓度的耐受性研究[J]. 中国医院药学杂志, 2021, 41(8): 812-815. |
| [14] | Huang, Q., Lin, X., Wang, Y., et al. (2022) Tacrolimus Pharmacokinetics in Pediatric Nephrotic Syndrome: A Combination of Population Pharmacokinetic Modelling and Machine Learning Approaches to Improve Individual Prediction. Frontiers in Pharmacology, 13, Article 942129. https://doi.org/10.3389/fphar.2022.942129 |
| [15] | Li, J., Chen, S., Qin, X., et al. (2017) Wuzhi Tablet (Schisandra sphenanthera Extract) Is a Promising Tacrolimus-Sparing Agent for Renal Transplant Recipients Who are CYP3A5 Expressers: A Two-Phase Prospective Study. Drug Metabolism and Disposition, 45, 1114-1119. https://doi.org/10.1124/dmd.117.076737 |
| [16] | 杨燕, 辛华雯, 刘飞, 等. 五酯胶囊对他克莫司增效作用与CYP3A5*3基因多态性的相关性研究[J]. 中国药房, 2017, 28(5): 581-585. |
| [17] | 马景胜, 杨文涛, 朱红飞, 等. 五酯胶囊提升他克莫司浓度与供肝CYP3A5基因多态性的相关性[J]. 中国中西医结合消化杂志, 2022, 30(4): 271-274. |
| [18] | He, Q., Bu, F., Wang, Q., et al. (2022) Examination of the Impact of CYP3A4/5 on Drug-Drug Interaction between Schizandrol A/Schizandrol B and Tacrolimus (FK-506): A Physiologically Based Pharmacokinetic Modeling Approach. International Journal of Molecular Sciences, 23, Article 4485. https://doi.org/10.3390/ijms23094485 |
| [19] | 陈倩. 五味子对大鼠肝CYP3A酶抑制和诱导双重作用机制的探讨[D]: [硕士学位论文]. 上海: 复旦大学, 2011. |
| [20] | 翟健秀, 刘志惠, 韩娜, 等. 五味子对CYP450活性的影响及其机制探讨[J]. 世界科学技术-中医药现代化, 2015, 17(1): 52-55. |
| [21] | Zhang, F., Zhai, J., Weng, N., et al. (2022) A Comprehensive Review of the Main Lignan Components of Schisandra chinensis (North Wu Wei Zi) and Schisandra sphenanthera (South Wu Wei Zi) and the Lignan-Induced Drug-Drug Interactions Based on the Inhibition of Cytochrome P450 and P-Glycoprotein Activities. Frontiers in Pharmacology, 13, Article 816036. https://doi.org/10.3389/fphar.2022.816036 |
| [22] | 许云鹏. 五酯胶囊对难治性肾病综合征患儿他克莫司血药浓度影响[D]: [硕士学位论文]. 乌鲁木齐: 新疆医科大学, 2015. |
| [23] | Zhang, H., Bu, F., Li, L., et al. (2018) Prediction of Drug-Drug Interaction between Tacrolimus and Principal Ingredients of Wuzhi Capsule in Chinese Healthy Volunteers Using Physiologically-Based Pharmacokinetic Modelling. Basic & Clinical Pharmacology & Toxicology, 122, 331-340. https://doi.org/10.1111/bcpt.12914 |
| [24] | 朱可庆, 王莹, 葛国军, 等. 五酯胶囊对难治性肾病综合征患者他克莫司血药浓度及肝肾功能的影响[J]. 中国医药, 2020, 15(5): 726-729. |
| [25] | 杨琳. 原发性肾病综合征患者他克莫司剂量优化及预测模型研究[D]: [硕士学位论文]. 长沙: 中南大学, 2022. |
| [26] | Wei, H., Tao, X., Di, P., et al. (2013) Effects of Traditional Chinese Medicine Wuzhi Capsule on Pharmacokinetics of Tacrolimus in Rats. Drug Metabolism and Disposition, 41, 1398-1403. https://doi.org/10.1124/dmd.112.050302 |
| [27] | Trautmann, A., Schnaidt, S., Lipska-Zi？tkiewicz, B.S., et al. (2017) Long-Term Outcome of Steroid-Resistant Nephrotic Syndrome in Children. Journal of the American Society of Nephrology, 28, 3055-3065. https://doi.org/10.1681/ASN.2016101121 |
| [28] | 杨宁, 陈吉林, 刘顺芳, 等. 单用他克莫司和联合五酯胶囊治疗免疫性肾小球疾病的单中心回顾性研究[J]. 医学与哲学, 2017, 38(10): 34-36, 53. |
| [29] | 钟羚君, 胡琳璘, 何杰, 等. 3种中成药辅助他克莫司治疗肾病综合征的临床疗效分析[J]. 中国临床药理学与治疗学, 2021, 26(11): 1285-1291. |
| [30] | Cheng, F., Li, Q., Wang, J., et al. (2021) Effects and Safety Evaluation of Wuzhi Capsules Combined with Tacrolimus for the Treatment of Kidney Transplantation Recipients. Journal of Clinical Pharmacy and Therapeutics, 46, 1636-1649. https://doi.org/10.1111/jcpt.13493 |
| [31] | Qin, X.L., Bi, H.C., Wang, C.X., et al. (2010) Study of the Effect of Wuzhi Tablet (Schisandra sphenanthera Extract) on Tacrolimus Tissue Distribution in Rat by Liquid Chromatography Tandem Mass Spectrometry Method. Biomedical Chromatography, 24, 399-405. https://doi.org/10.1002/bmc.1305 |
| [32] | Chen, X., Wang, D.D., Xu, H. and Li, L.P. (2020) Optimization of Initial Dosing Scheme of Tacrolimus in Pediatric Refractory Nephrotic Syndrome Patients Based on CYP3A5 Genotype and Coadministration with Wuzhi-Capsule. Xenobiotica, 50, 606-613. https://doi.org/10.1080/00498254.2019.1669844 |
| [33] | 辛华雯, 李罄, 吴笑春, 等. 五酯胶囊与他克莫司合用对肾移植受者的成本与效果评估研究[J]. 中国临床药理学杂志, 2011, 27(4): 295-298. |
| [34] | Sun, Z., Ren, M., Wu, Q. and Du, X.Y. (2014) Co-Administration of Wuzhi Capsules and Tacrolimus in Patients with Idiopathic Membranous Nephropathy: Clinical Efficacy and Pharmacoeconomics. International Urology and Nephrology, 46, 1977-1982. https://doi.org/10.1007/s11255-014-0801-3 |
| [35] | 王硕, 黄建萍, 都娟, 等. 五酯胶囊在服用他克莫司的肾脏疾病患儿中的作用及成本效果分析[J]. 中国医刊, 2016, 51(3): 107-109, 110. |
