Efficacy and eligibility of high-dose moxifloxacin short-course regimen for rifampicin-resistant pulmonary tuberculosis

doi:10.19982/j.issn.1000-6621.20220297

Abstract

Abstract:

Objective: To analyze the efficacy and safety of high-dose moxifloxacin short-course regimen in patients with rifampicin-resistant pulmonary tuberculosis (RR-PTB), as well as the factors restricting the clinical application. Methods: A retrospective cohort study was conducted in 272 RR-PTB patients admitted to Xi’an Chest Hospital and had treatment outcome from January 2020 to June 2021. The observation group included 27 patients who was treated with high-dose moxifloxacin short course regimen, while the other 127 patients treated with long course regimen were in the control group. The treatment outcomes and the occurrence of adverse events were compared between the two groups, and the causes 245 patients not using short-course regimen were also analyzed. Results: In the observation group, 15 patients were cured, and 6 patients completed the treatment. There was no significant difference between the treatment success rate in observation group and in control group (77.8% (21/27) vs.71.7% (91/127); χ²=0.421, P=0.516). The occurrence of adverse events in observation group and adverse events at grade 3 or above were significantly higher than those in the control group (88.9% (24/27) vs. 50.4% (64/127), χ²=13.473, P<0.001; and 40.7% (11/27) vs. 21.3% (27/127),χ²=4.546, P=0.033, respectively). The top 4 reasons for 245 patients high-dosenot using high-dose moxifloxacin short-course regimen were fluoroquinolone resistance (n=87, 35.5%), the second-line anti-tuberculosis drugs had been used for more than 1 month (n=52, 21.2%), combined tracheobronchial tuberculosis (n=40, 16.3%), and uncontrolled diabetes (n=20, 8.1%). Conclusion: High-dose moxifloxacin short-course regimens for RR-PTB patients could obtain a high success rate, while the incidence of adverse events was higher and the proportion of eligible patients was lower. We should pay more attention to the adverse events of short-course regimen and applicability studies should be carried out based on the actual conditions of Chinese patients.

Key words: Tuberculosis, pulmonary, Multi-drug resistance, Drug therapy, Regimens evaluation, Feasibility studies

CLC Number:

Ren Fei, Ma Jinbao, Li Rong, Yang Han, Yang Hong, Wu Yanqin, Yang Xinjun, Dang Liyun. Efficacy and eligibility of high-dose moxifloxacin short-course regimen for rifampicin-resistant pulmonary tuberculosis[J]. Chinese Journal of Antituberculosis, 2023, 45(1): 52-59. doi: 10.19982/j.issn.1000-6621.20220297

Figures/Tables 2

References 26

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类别	观察组(27例)	对照组(127例)	统计检验值	P值
年龄	33.0(29.0,37.0)	34.0(27.0,53.0)	Z=-0.815	0.415
体质量指数	19.6(18.4,21.4)	20.1(18.1,22.5)	Z=-0.415	0.818
性别			χ²=0.056	0.813
男性	17(63.0)	83(65.4)
女性	10(37.0)	44(34.6)
痰抗酸杆菌镜检			χ²=0.011	0.914
阴性	12(44.4)	55(43.3)
阳性	15(55.6)	72(56.7)
类别	观察组(27例)	对照组(127例)	统计检验值	P值
病灶侵犯肺野数			χ²=0.359	0.549
单肺	17(63.0)	72(56.7)
双肺	10(37.0)	55(43.3)
空洞			χ²=0.102	0.750
有	11(40.7)	56(44.1)
无	16(59.3)	71(55.9)
气管结核			χ²=2.994	0.084
有	11(40.7)	31(24.4)
无	16(59.3)	96(75.6)
淋巴结结核			χ²=0.041	0.839
有	6(22.2)	26(20.5)
无	21(77.8)	101(79.5)
糖尿病			χ²=0.187	0.665
有	2(7.4)	16(12.6)
无	25(92.6)	111(87.4)
疾病类型			χ²=17.180	<0.001
初治	27(100.0)	74(58.3)
复治	0(0.0)	53(41.7)
氟喹诺酮类			χ²=9.989	0.002
耐药	0(0.0)	36(28.3)
敏感	27(100.0)	91(71.7)
阿米卡星			χ²=0.547	0.459
耐药	0(0.0)	7(5.5)
敏感	27(100.0)	120(94.5)
乙胺丁醇			χ²=0.005	0.945
耐药	6(22.2)	29(22.8)
敏感	21(77.8)	98(77.2)
异烟肼			χ²=2.769	0.096
耐药	19(70.4)	109(85.8)
敏感	8(29.6)	18(14.2)
丙硫异烟胺			χ²=0.365	0.546
耐药	0(0.0)	6(4.7)
敏感	27(100.0)	121(95.3)
氯法齐明			-	1.000^a
耐药	0(0.0)	1(0.8)
敏感	27(100.0)	126(99.2)

不良事件类型	观察组(27例)	对照组(127例)	χ²值	P值
QT间期延长	14(51.9)	8(6.3)	34.104	<0.001
胃肠道不良反应	14(51.9)	13(10.2)	23.870	<0.001
肝功能损伤	10(37.0)	22(17.3)	5.257	0.022
痛风/关节疼痛	2(7.4)	10(7.9)	0.098	0.754
神经系统损伤	1(3.7)	28(22.0)	4.902	0.027
血液系统损伤	1(3.7)	3(2.4)	-	0.541^a
血糖异常	1(3.7)	0(0.0)	-	0.175^a
甲状腺功能紊乱	0(0.0)	5(3.9)	-	0.587^a
肾功能损伤	0(0.0)	4(3.1)	-	1.000^a
精神异常	0(0.0)	3(2.4)	-	1.000^a
过敏反应	0(0.0)	2(1.6)	-	1.000^a
合计	24(88.9)	64(50.4)	13.473	<0.001