80例耐多药/利福平耐药肺结核患者全口服标准化短程治疗疗效观察

doi:10.19983/j.issn.2096-8493.20250141

结核与肺部疾病杂志 ›› 2025, Vol. 6 ›› Issue (6): 731-737.doi: 10.19983/j.issn.2096-8493.20250141

80例耐多药/利福平耐药肺结核患者全口服标准化短程治疗疗效观察

苏伟¹, 刘胤杉², 罗旭善², 古丽孜拜尔·赛麦尔², 吐尔洪·吾守尔², 帕尔哈提·沙拉衣丁², 戚海波², 亚森·吐尔逊², 古丽米热·依明², 麦维兰江·阿不力米提², 周临军²(), 黄飞¹()

¹中国疾病预防控制中心(中国预防医学科学院)结核病预防控制中心,北京 102206
²新疆维吾尔自治区喀什地区结核病防治所,喀什 844099

收稿日期:2025-09-08 出版日期:2025-12-20 发布日期:2025-12-08
通信作者: 周临军,Email:1149306215@qq.com;黄飞,Email:huangfei@chinacdc.cn
基金资助:
结核病预防控制项目(2528);新疆维吾尔自治区喀什地区科技局项目(KS20220408);新疆维吾尔自治区天山英才项目(2024TSYCJC0061)

Observation on the efficacy of all-oral standardized short-course treatment for 80 cases of multidrug/rifampicin-resistant pulmonary tuberculosis

Su Wei¹, Liu Yinshan², Luo Xushan², Gulizibaier·Saimaier ², Turhong·Wushouer ², Paerhati·Shalayiding ², Qi Haibo², Yasen·Tuerxun ², Gulmira·Imin ², Maiwelanjiang·Abulimiti ², Zhou Linjun²(), Huang Fei¹()

¹National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention (Chinese Academy of Preventive Medicine), Beijing 102206, China
²Kashgar Prefecture Institute for Tuberculosis Control and Prevention, Xinjiang Uygur Autonomous Region, Kashgar 844099, China

Received:2025-09-08 Online:2025-12-20 Published:2025-12-08
Contact: Zhou Linjun, Email: 1149306215@qq.com;Huang Fei, Email: huangfei@chinacdc.cn
Supported by:
Tuberculosis Prevention and Control Project(2528);Project of the Bureau of Science and Technology of Kashgar Prefecture, Xinjiang Uygur Autonomous Region(KS20220408);Tianshan Talent Project of Xinjiang Uygur Autonomous Region(2024TSYCJC0061)

摘要/Abstract

摘要：

目的: 验证在结核病防治规划条件下,应用9~11个月全口服标准化短程方案(简称“短程方案”)治疗耐多药/利福平耐药结核病(multidrug/rifampicin-resistant tuberculosis, MDR/RR-TB)患者的有效性、安全性及可行性。方法: 采用前瞻性研究方法,选取2022年3月至2024年3月在新疆维吾尔自治区喀什地区肺科医院确诊为利福平耐药、氟喹诺酮类药物敏感的耐多药/利福平耐药肺结核(MDR/RR-PTB)患者,参照短程方案入组标准将符合患者纳入短程方案治疗组(短程组),其余患者纳入18~20个月长程治疗组(长程组)。观察、评价两组完成治疗患者的治疗结局和费用,分析短程组不良反应和治疗结局的特征。结果: 研究共纳入242例符合入组标准且完成治疗的MDR/RR-PTB患者,总成功治疗率为54.13%(131/242)。其中,短程方案治疗的80例患者和长程方案治疗的162例患者的成功治疗率分别为76.25%(61/80)和43.21%(70/162)。短程组患者中,复治患者的成功治疗率[44.26%(27/61)]明显低于初治患者[55.74%(34/61)],差异有统计学意义(χ²=6.989,P=0.008)。短程组肝功能异常、胃肠道反应和尿酸偏高的发生率分别为21.25%(17/80)、16.25%(13/80)和3.75%(3/80),仅1例患者因重度肝功能异常停药2周,无患者因药物不良反应停止短程治疗。短程组患者的治疗费用较长程组例均约少6.1万元,且以药品费为主(5.9万元)。结论: 9~11个月全口服标准化短程方案治疗特定MDR/RR-TB患者的成功治疗率较高,与现有文献研究基本一致,且安全性良好、医疗成本明显降低,可在具备利福平和氟喹诺酮类药物快速诊断能力的地区推广应用。

关键词: 结核,抗多种药物性, 药物疗法,联合, 临床方案, 治疗应用, 评价研究, 因素分析,统计学

Abstract:

Objective: To verify the feasibility, safety and efficacy of a 9-11-month all-oral, short-course standardized treatment regimen (abbreviated “short-term plan”) for multidrug/rifampicin-resistant tuberculosis (MDR/RR-TB) patients under the framework of tuberculosis control programs. Methods: A prospective study was conducted from March 2022 to March 2024, patients with MDR/RR-PTB who were diagnosed with rifampicin resistance and fluoroquinolone susceptibility at Kashgar Prefectural Pulmonary Hospital, Xinjiang Uygur Autonomous Region. Patients were enrolled in the short-course treatment group (short-course group) based on the inclusion criteria. The remaining MDR/RR-PTB patients were assigned to the 18-20-month long-course treatment group (long-course group). The treatment outcomes and costs of the two groups of completed patients were observed and evaluated, and to analyze the characteristics of adverse reactions and treatment outcomes in the short-term group. Results: A total of 242 MDR/RR-PTB patients who met the inclusion criteria and completed treatment were enrolled. The overall treatment success rate was 54.13% (131/242). Among them, the treatment success rates were 76.25% (61/80) for the 80 patients treated with the short-course regimen and 43.21% (70/162) for the 162 patients treated with the long-course regimen, respectively. In the short-course group, the treatment success rate of retreated patients (44.26% (27/61)) was significantly lower than that of new patients (55.74% (34/61)), with a statistically significant difference (χ²=6.989, P=0.008); the incidences of liver function abnormalities, gastrointestinal reactions and high uric acid were 21.25% (17/80), 16.25% (13/80) and 3.75% (3/80), respectively. Only one patient discontinued the drug for 2 weeks due to severe liver dysfunction, none of the remaining patients discontinued treatment due to adverse drug reactions. The average treatment cost per patient in the short-course group was 61000 yuan less than that in the long-course group, with drug costs being the main component (59000 yuan). Conclusion: The 9-11-month all-oral standardized short-course treatment achieves a relatively high treatment success rate and exhibits favorable safety profiles in eligible MDR/RR-TB patients, which is generally consistent with existing literatures. It can also reduce medical costs and is suitable for application in regions equipped with rapid diagnostic capabilities for rifampicin and fluoroquinolone resistance.

Key words: Tuberculosis, multidrug-resistant, Combination drug therapy, Clinical protocols, Therapeutic uses, Evaluation studies, Factor analysis, statistical

中图分类号:

苏伟, 刘胤杉, 罗旭善, 古丽孜拜尔·赛麦尔, 吐尔洪·吾守尔, 帕尔哈提·沙拉衣丁, 戚海波, 亚森·吐尔逊, 古丽米热·依明, 麦维兰江·阿不力米提, 周临军, 黄飞. 80例耐多药/利福平耐药肺结核患者全口服标准化短程治疗疗效观察[J]. 结核与肺部疾病杂志, 2025, 6(6): 731-737. doi: 10.19983/j.issn.2096-8493.20250141

Su Wei, Liu Yinshan, Luo Xushan, Gulizibaier·Saimaier , Turhong·Wushouer , Paerhati·Shalayiding , Qi Haibo, Yasen·Tuerxun , Gulmira·Imin , Maiwelanjiang·Abulimiti , Zhou Linjun, Huang Fei. Observation on the efficacy of all-oral standardized short-course treatment for 80 cases of multidrug/rifampicin-resistant pulmonary tuberculosis[J]. Journal of Tuberculosis and Lung Disease, 2025, 6(6): 731-737. doi: 10.19983/j.issn.2096-8493.20250141

图/表 3

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参考文献 20

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特征	合计(242例)	短程组(80例)	长程组(162例)	χ²值	P值
性别				1.705	0.192
男性	140(57.85)	51(63.75)	89(54.94)
女性	102(42.15)	29(36.25)	73(45.06)
年龄组(岁)				-	0.001^a
<20	6(2.48)	4(5.00)	2(1.24)
20~39	31(12.81)	14(17.50)	17(10.49)
40~59	73(30.17)	32(40.00)	41(25.31)
60~83	132(54.54)	30(37.50)	102(62.96)
职业				2.813	0.094
农民	217(89.67)	68(85.00)	149(91.98)
其他	25(10.33)	12(15.00)	13(8.02)
民族				-	1.000^a
维吾尔族	236(97.52)	78(97.50)	158(97.53)
汉族	6(2.48)	2(2.50)	4(2.47)
患者类型				8.033	0.005
初治	85(35.12)	38(47.50)	47(29.01)
复治	157(64.88)	42(52.50)	115(70.99)
耐药类型				0.697	0.404
耐多药	82(33.88)	30(37.50)	52(32.10)
利福平耐药	160(66.12)	50(62.50)	110(69.90)

治疗转归结果	合计(242例)		短程组(80例)		长程组(162例)
治疗转归结果	例数	成功率(%)	例数	成功率(%)	例数	成功率(%)
治疗成功	131	54.13	61	76.25	70	43.21
治愈	90	37.19	45	56.25	45	27.78
完成治疗	41	16.94	16	20.00	25	15.43
死亡	65	26.86	6	7.50	59	36.42
失败	14	5.78	4	5.00	10	6.17
丢失及未评估	32	13.22	9	11.25	23	14.20

因素	治疗成功 (61例)	未治疗成功 (19例)	χ²值	P值	因素	治疗成功 (61例)	未治疗成功 (19例)	χ²值	P值
性别			2.894	0.089	体质量指数(kg/m²)			-	0.529^a
男性	42(68.85)	9(47.37)			<18.5	8(13.11)	2(10.53)
女性	19(31.15)	10(53.63)			18.5~	36(59.02)	9(47.37)
年龄组(岁)			-	0.351^a	≥24	17(27.87)	8(42.10)
<20	3(4.92)	1(5.26)			患者分类			6.989	0.008
20~39	13(21.31)	1(5.26)			初治	34(55.74)	4(21.05)
40~59	22(36.07)	10(52.63)			复治	27(44.26)	15(78.95)
60~75	23(37.70)	7(36.84)			耐药类型			2.434	0.119
民族			-	0.054^a	利福平耐药	41(67.21)	9(47.37)
维吾尔族	61(100.00)	17(89.47)			耐多药	20(32.79)	10(52.63)
汉族	0(0.00)	2(10.53)			肺部空洞
教育程度			-	0.522^a	是	36(59.02)	12(63.16)	0.104	0.748
小学及以下	44(72.13)	12(63.16)			否	25(40.98)	7(36.84)
初中	13(21.31)	4(21.05)			居住县(市)			-	0.241^a
高中/中专及以上	4(6.56)	3(15.79)			麦盖提	2(3.28)	3(15.79)
职业			-	0.507^a	疏勒县	7(11.48)	2(10.53)
农民	52(85.24)	16(84.21)			伽师县	4(6.56)	1(5.26)
无业	4(6.56)	0(0.00)			叶城	5(8.20)	0(0.00)
学生	2(3.28)	1(5.26)			泽普	0(0.00)	1(5.26)
其他	3(4.92)	2(10.53)			莎车县	13(21.31)	3(15.79)
患者来源			-	0.648^a	英吉沙	9(14.75)	4(21.05)
健康体检	13(21.31)	5(26.31)			巴楚县	9(14.75)	1(5.26)
因症就诊	4(6.56)	2(10.53)			疏附县	1(1.64)	0(0.00)
转诊	26(42.62)	9(47.37)			喀什市	11(18.03)	3(15.79)
追踪	18(29.51)	3(15.79)			岳普湖	0(0.00)	1(5.26)

80例耐多药/利福平耐药肺结核患者全口服标准化短程治疗疗效观察

Observation on the efficacy of all-oral standardized short-course treatment for 80 cases of multidrug/rifampicin-resistant pulmonary tuberculosis

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