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2026, 02, v.39 151-157
利福喷丁短程方案治疗毕节地区活动性药物敏感结核病的疗效及安全性评价
基金项目(Foundation): 毕节市科学技术项目(毕科合[2023]44号); 广东省自然基金(粤基金字[2023]2号;2023A1515010461)
邮箱(Email): zhoufeiyin@163.com;
DOI:
发布时间: 2026-04-30
出版时间: 2026-04-30
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摘要:

目的 探讨利福喷丁在短程方案治疗活动性药物敏感结核病患者的临床疗效、安全性,并重点分析其对血常规、肝肾生化指标的特定影响。方法 选取2023年7月至2024年11月毕节市第三人民医院收治的120例活动性药物敏感结核病患者,随机分为标准组和利福喷丁组,每组各60例,标准组给予6个月标准治疗,利福喷丁组给予4个月短程治疗,比较并分析两组临床疗效、病原学转阴率、症状改善、病灶吸收率、不良反应发生率以及血常规、肝功能和肾功能各指标。结果 疗效评估结果显示,利福喷丁组总有效率(93.33%)与标准组(90.00%)相当,两组在病原学转阴率、病灶吸收率及症状改善方面比较,差异均无统计学意义(P>0.05)。安全性分析显示,两组不良反应总发生率比较差异无统计学意义(P>0.05)。进一步分析显示,两组血常规指标治疗前后均无异常波动;肝功能指标中,利福喷丁组治疗后总胆红素和直接胆红素水平较治疗前显著升高(P<0.01),但谷氨酸氨基转移酶和天门冬氨酸氨基转移酶水平未见明显异常;肾功能指标中,利福喷丁组治疗后肌酐水平较治疗前呈统计学显著下降(P<0.01),尿酸水平无明显变化。标准组肝肾各项生化指标治疗前后均保持平稳。结论 利福喷丁4个月短程方案治疗活动性药物敏感结核病的疗效非劣效于标准6个月方案,虽可能引起胆红素代谢的轻度波动,但未造成实质性肝肾损伤,整体耐受性良好,具有缩短疗程的临床应用价值。

Abstract:

Objective To investigate the clinical efficacy and safety of a rifapentine-based short-course regimen in patients with active drug-sensitive tuberculosis, with a specific focus on analyzing its impact on blood routine, hepatic and renal biochemical indicators. Methods A total of 120 patients with active drug-sensitive tuberculosis admitted to The Third People's Hospital of Bijie City between July 2023 and November 2024 were selected and randomly assigned to a standard group and a rifapentine group, with 60 patients in each group. The standard group received a 6-month standard treatment regimen, while the rifapentine group received a 4-month short-course regimen. Clinical efficacy, pathogen negative conversion rate, symptom improvement, lesion absorption rate, incidence of adverse reactions, as well as blood routine, liver function, and renal function indicators were compared and analyzed between the 2 groups. Results The efficacy evaluation showed that the total effective rate in the rifapentine group(93.33%) was comparable to that in the standard group(90.00%). No statistically significant differences were observed between the 2 groups in terms of pathogen negative conversion rate, lesion absorption rate, or symptom improvement(P>0.05). Safety analysis indicated no significant difference in the total incidence of adverse reactions between the groups(P>0.05). Further analysis revealed no abnormal fluctuations in blood routine indicators for either group before and after treatment. Regarding liver function indicators, levels of total bilirubin(TBIL) and direct bilirubin(DBIL) in the rifapentine group significantly increased after treatment compared to baseline(P<0.01), whereas alanine aminotransferase(ALT) and aspartate aminotransferase(AST) showed no obvious abnormalities. Regarding renal function indicators, serum creatinine levels in the rifapentine group decreased significantly after treatment compared to baseline(P<0.01), while uric acid levels showed no significant change. All hepatic and renal biochemical indicators in the standard group remained stable throughout the treatment. Conclusion The efficacy of the 4-month rifapentine short-course regimen for active drug-sensitive tuberculosis is non-inferior to the standard 6-month regimen. Although the regimen may induce mild fluctuations in bilirubin metabolism, it does not cause substantial hepatic or renal injury. It exhibits favorable overall tolerability and clinical value in shortening the treatment course.

参考文献

[1]彭涛,房珂,宋维维,等.活动性肺结核免疫耗竭及免疫治疗的研究进展[J].传染病信息,2022,35(1):5. DOI:10.3969/j.issn.1007-8134.2022.01.013.

[2]袁媛,卢水华.《世界卫生组织结核病整合指南模块4:药物敏感结核病的治疗》解读[J].中国防痨杂志,2022,44(11):1122-1125.DOI:10.19982/j.issn.1000-6621.20220330.

[3]梁晨,于佳佳,唐神结.世界卫生组织《全球结核病报告2022》解读[J].诊断学理论与实践,2023,22(1):21-30. DOI:10.16150/j.1671-2870.2023.01.004

[4]Pettit AC, Phillips PPJ, Kurbatova E, et al. Rifapentine with and without moxifloxacin for pulmonary tuberculosis in people with human immunodeficiency virus(S31/A5349)[J]. Clin Infect Dis, 2023,76(3):e580-e589. DOI:10.1093/cid/ciac707.

[5]Dorman SE, Nahid P, Kurbatova EV, et al. High-dose rifapentine with or without moxifloxacin for shortening treatment of pulmonary tuberculosis:Study protocol for TBTC study 31/ACTG A5349 phase3 clinical trial[J]. Contemp Clin Trials, 2020, 90(1):105938. DOI:10.1016/j.cct.2020.105938.

[6]Goletti D, Meintjes G, Andrade BB, et al. Insights from the 2024WHO global tuberculosis report-More comprehensive action,innovation, and investments required for achieving WHO end TB goals[J]. Int J Infect Dis, 2025, 150(1):107325. DOI:10.1016/j.ijid.2024.107325.

[7]徐莉娟,刘华.肺结核耐药情况及影响因素分析[J].传染病信息,2018,31(3):258-260. DOI:10.3969/j.issn.1007-8134.2018.03.014.

[8]Dorman SE, Nahid P, Kurbatova EV, et al. Four-month rifapentine regimens with or without moxifloxacin for tuberculosis[J]. N Engl J Med, 2021, 384(18):1705-1718. DOI:10.1056/NEJMoa2033400.

[9]Jindani A, Harrison TS, Nunn AJ, et al. High-dose rifapentine with moxifloxacin for pulmonary tuberculosis[J]. N Engl J Med, 2014,371(17):1599-1608. DOI:10.1056/NEJMoa1314210.

[10]Sterling TR, Njie G, Zenner D, et al. Guidelines for the treatment of latent tuberculosis infection:Recommendations from the National Tuberculosis Controllers Association and CDC, 2020[J]. MMWR Recomm Rep, 2020, 69(1):1-11. DOI:10.15585/mmwr.rr6901a1.

[11]Merle CS, Fielding K, Sow OB, et al. A four-month gatifloxacin-containing regimen for treating tuberculosis[J]. N Engl J Med, 2014,371(17):1588-1598. DOI:10.1056/NEJMx150015.

[12]Imperial MZ, Nahid P, Phillips PPJ, et al. A patient-level pooled analysis of treatment-shortening regimens for drug-susceptible pulmonary tuberculosis[J]. Nat Med, 2018, 24(11):1708-1715. DOI:10.1038/s41591-018-0224-2.

[13]Savic RM, Weiner M, Mackenzie WR, et al. Defining the optimal dose of rifapentine for pulmonary tuberculosis:Exposure-response relations from two phase II clinical trials[J]. Clin Pharmacol Ther,2017, 102(2):321-331. DOI:10.1002/cpt.634.

[14]Nunn AJ, Phillips PPJ, Meredith SK, et al. A trial of a shorter regimen for rifampin-resistant tuberculosis[J]. N Engl J Med, 2019,380(13):1201-1213. DOI:10.1056/NEJMoa1811867.

[15]Dorman SE, Johnson JL, Goldberg S, et al. Substitution of moxifloxacin for isoniazid during intensive phase treatment of pulmonary tuberculosis[J]. Am J Respir Crit Care Med, 2009, 180(3):273-280. DOI:10.1164/rccm.200901-0078OC.

[16]Wallis RS, Wang C, Meyer D, et al. Month 2 culture status and treatment duration as predictors of tuberculosis relapse risk in a meta-regression model[J]. PLoS One, 2013, 8(8):e71116. DOI:10.1371/journal.pone.0071116.

[17]Savic RM, Lu Y, Bliven-Sizemore E, et al. Population pharmacokinetics of rifapentine and desacetyl rifapentine in healthy volunteers:nonlinearities in clearance and bioavailability[J]. Antimicrob Agents Chemother, 2014, 58(6):3035-3042. DOI:10.1128/AAC.01918-13.

[18]Franklin JM, Schneeweiss S. When and how can real world data analyses substitute for randomized controlled trials?[J]. Clin Pharmacol Ther, 2017, 102(6):924-933. DOI:10.1002/cpt.857.

[19]Sathekge M, Maes A, van de Wiele C. FDG-PET imaging in HIV infection and tuberculosis[J]. Semin Nucl Med, 2013, 43(5):349-366.DOI:10.1053/j.semnuclmed.2013.04.008.

[20]王飞,王晓君,金倩,等.有肺结核史非结核分枝杆菌肺病临床特征[J].中华医院感染学杂志,2025,35(10):349-366. DOI:10.11816/cn.ni.2025-241684.

[21]Dheda K, Schwander SK, Zhu B, et al. The immunology of tuberculosis:from bench to bedside[J]. Respirology, 2010, 15(3):433-450.DOI:10.1111/j.1440-1843.2010.01739.x.

[22]Forget EJ, Menzies D. Adverse reactions to first-line antituberculosis drugs[J]. Expert Opin Drug Saf, 2006, 5(2):231-249. DOI:10.1517/14740338.5.2.231.

[23]Sterling TR, Villarino ME, Borisov AS, et al. Three months of rifapentine and isoniazid for latent tuberculosis infection[J]. N Engl J Med, 2011, 365(23):2155-2166. DOI:10.1056/NEJMoa1104875.

[24]李梅梅.利福喷丁胶囊联合盐酸乙胺丁醇治疗肺结核的临床疗效分析[J].中文科技期刊数据库(引文版)医药卫生,2023,34(3):417-419. DOI:10.19381/j.issn.1001-7585.2021.03.024.

[25]杨晓明,陈海兰,杨艳杰,等.甘草酸制剂治疗抗结核药物性肝损伤的疗效和安全性的Meta分析[J].传染病信息,2025,38(4):326-332. DOI:10.3969/j.issn.1007-8134.2025.04.004.

[26]Tostmann A, Boeree MJ, Aarnoutse RE, et al. Antituberculosis drug-induced hepatotoxicity:concise up-to-date review[J]. J Gastroenterol Hepatol, 2008, 23(2):192-202. DOI:10.1111/j.1440-1746.2007.05207.x.

[27]Yew WW, Leung CC. Antituberculosis drugs and hepatotoxicity[J]. Respirology, 2006, 11(6):699-707. DOI:10.1111/j.1440-1843.2006.00941.x.

[28]Dorman SE, Goldberg S, Stout JE, et al. Substitution of rifapentine for rifampin during intensive phase treatment of pulmonary tuberculosis:study 29 of the tuberculosis trials consortium[J]. J Infect Dis,2012, 206(7):1030-1040. DOI:10.1093/infdis/jis461.

[29]Chang CH, Chen YF, Wu VC, et al. Acute kidney injury due to anti-tuberculosis drugs:a five-year experience in an aging population[J].BMC Infect Dis, 2014, 14(1):23. DOI:10.1186/1471-2334-14-23.

[30]Weiner M, Burman W, Vernon A, et al. Low isoniazid concentrations and outcome of tuberculosis treatment with once-weekly isoniazid and rifapentine[J]. Am J Respir Crit Care Med, 2003, 167(10):1341-1347. DOI:10.1164/rccm.200208-951OC.

基本信息:

中图分类号:R52

引用信息:

[1]林丽娟,耿成亮,代梅,等.利福喷丁短程方案治疗毕节地区活动性药物敏感结核病的疗效及安全性评价[J].传染病信息,2026,39(02):151-157.

基金信息:

毕节市科学技术项目(毕科合[2023]44号); 广东省自然基金(粤基金字[2023]2号;2023A1515010461)

发布时间:

2026-04-30

出版时间:

2026-04-30

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