Efficacy and safety of 6-month short-course regimen B-Pa-L/M versus 18-month long-course regimen for treating rifampicin-resistant pulmonary tuberculosis

doi:10.19982/j.issn.1000-6621.20260361

Abstract

Abstract:

Objective: To evaluate clinical effectiveness and safety of 6-month B-Pa-L/M short-course regimen compared with 18-month long-course all-oral regimen containing bedaquiline (Bdq) on patients with rifampicin-resistant pulmonary tuberculosis (RR-PTB), to provide real-world evidence for the application of 6B-Pa-L/M short-course regimen. Methods: A retrospective study was conducted, enrolling 142 patients with RR-PTB from Anhui Province and Xinjiang Uygur Autonomous Region. Among them, 66 received 6B-Pa-L/M short-course regimen (B-Pa-L/M group), and 76 received 18-month all-oral long-course regimen containing Bdq (long-course group). The efficacy and safety of the two regimens was assessed by sputum culture conversion rate, comprehensive clinical effectiveness, and adverse drug reactions during treatment. Results: The treatment success rate of B-Pa-L/M group (96.97%, 64/66) was significantly higher than that of the long-course group (82.89%, 63/76; χ²=7.407, P=0.006). Among the 92 patients with positive baseline sputum cultures, the sputum conversion rates of B-Pa-L/M group at 4, 8, 12, and 16 weeks were significantly higher than those of the long-course group (4 weeks: 59.09% (26/44) vs. 27.08% (13/48), χ²=9.630, P=0.002; 8 weeks: 84.09% (37/44) vs. 43.75% (21/48), χ²=16.035, P<0.001; 12 weeks: 93.18% (41/44) vs. 70.83% (34/48), χ²=7.611, P=0.006; 16 weeks: 95.45% (42/44) vs. 79.17% (38/48), χ²=5.370, P=0.020). Kaplan-Meier analysis showed that the median time to sputum culture conversion of B-Pa-L/M group (4 (4, 8) weeks) was significantly shorter than that of the long-course group (12 (4, 16) weeks; log-rank χ²=12.936, P<0.001). In terms of safety, the overall incidence of adverse reactions, gastrointestinal adverse reactions, and psychiatric symptoms of B-Pa-L/M group (specifically 45.45% (30/66), 7.58% (5/66), and 0 (0/66), respectively) were significantly lower than those of long-course group (specifically 68.42% (52/76), 21.05% (16/76), and 14.47% (11/76), respectively), all differences were statistically significant (χ²=7.636, P=0.006; χ²=5.091, P=0.024; Fisher’s exact test, P=0.001). However, compared with that in the long-term group, the difference in the incidence of adverse events rated as grade 3 or higher (6.06% (4/66) vs. 10.53% (8/76)) was not statistically significant (χ²=0.905, P=0.341). Conclusion: The B-Pa-L/M short-course regimen achieves faster sputum culture conversion in the treatment of RR-PTB. The treatment success rate is higher than that of the long-course all-oral regimen containing Bdq, and the regimen demonstrated a favorable safety profile.

Key words: Tuberculosis, pulmonary, Drug resistance, Comparative study, Program evaluation, Pretomanid, Bedaquiline

CLC Number:

R521

Huang Pengfei, Xiao Yu, Peng Yi, Xiong Yanjun, Guo Shanshan, Nadila Abulizi, Malipati Aierkenjiang, Wang Hua, Rukeyamu Abudushalamu. Efficacy and safety of 6-month short-course regimen B-Pa-L/M versus 18-month long-course regimen for treating rifampicin-resistant pulmonary tuberculosis[J]. Chinese Journal of Antituberculosis, 2026, 48(10): 1506-1514. doi: 10.19982/j.issn.1000-6621.20260361

Figures/Tables 6

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药物	体质量
药物	<50kg	≥50kg
利奈唑胺(Lzd)	600mg,1次/d
贝达喹啉(Bdq)	400mg,1次/d,前2周;200mg,3次/周
左氧氟沙星(Lfx)	600mg,1次/d	800mg,1次/d
莫西沙星(Mfx)	400mg,1次/d
氯法齐明(Cfz)	100mg,1次/d
环丝氨酸(Cs)	早250mg,晚250mg	早250mg,晚500mg
普托马尼(Pa)	200mg,1次/d
乙胺丁醇(E)	750mg,1次/d	1000mg,1次/d
吡嗪酰胺(Z)	500mg,3次/d
丙硫异烟胺(Pto)	200mg,3次/d
对氨基水杨酸(PAS)	2000mg,4次/d

特征	B-Pa-L/M组(66例)	长程组(76例)	统计检验值	P值
年龄[岁,M(Q₁,Q₃)]	41(25,63)	33(26,57)	Z=1.133	0.260
性别[例(构成比,%)]			χ²=1.210	0.271
女性	33(50.00)	31(40.79)
男性	33(50.00)	45(59.21)
BMI[例(构成比,%)]			χ²=0.136	0.934
<18.5kg/m²	17(25.76)	21(27.63)
18.5~24kg/m²	40(60.61)	46(60.53)
>24kg/m²	9(13.63)	9(11.84)
耐药类型[例(构成比,%)]			χ²=0.328	0.826
RR-TB	3(4.55)	2(2.63)
MDR-TB	39(59.10)	46(60.52)
pre-XDR-TB	24(36.35)	28(36.85)
病灶累及数[例(构成比,%)]			χ²=0.211	0.646
1~2个	50(75.76)	55(72.39)
≥3个	16(24.24)	21(27.61)
空洞[例(构成比,%)]			χ²=0.007	0.932
无	36(54.55)	42(55.26)
有	30(45.45)	34(44.74)
肺外结核[例(发生率,%)]			-	0.658
结核性胸膜炎	3(4.55)	2(2.63)
淋巴结结核	2(3.03)	1(1.32)
结核性心包炎	0(0.00)	1(1.32)
疾病类型[例(构成比,%)]			χ²=0.000	1.000
初治	33(50.00)	38(50.00)
复治	33(50.00)	38(50.00)
吸烟史[例(构成比,%)]			χ²=0.312	0.577
无	60(90.91)	71(93.42)
有	6(9.09)	5(6.58)
饮酒史[例(构成比,%)]			-	0.663
无	63(95.45)	74(97.37)
有	3(4.55)	2(2.63)
合并症[例(发生率,%)]
高血压	8(12.12)	3(3.95)	χ²=3.302	0.069
糖尿病	9(13.64)	9(11.84)	χ²=0.103	0.749
乙型病毒性肝炎	4(6.06)	3(3.95)	-	0.704
支气管扩张	3(4.55)	2(2.63)	-	0.663
长期服用免疫抑制剂	1(1.52)	0(0.00)	-	0.465
恶性肿瘤	1(1.52)	1(1.32)	-	1.000
痰培养[例(构成比,%)]			χ²=0.191	0.662
阳性	44(66.67)	48(63.16)
阴性	22(33.33)	28(36.84)
痰涂片[例(构成比,%)]			χ²=0.018	0.894
阳性	32(48.48)	36(47.37)
阴性	34(51.52)	40(52.63)

治疗时间	B-Pa-L/M组 (66例)	长程组 (76例)	χ²值	P值	治疗时间	B-Pa-L/M组 (66例)	长程组 (76例)	χ²值	P值
4周			9.630	0.002	16周			5.370	0.020
阴性	26(59.09)	13(27.08)			阴性	42(95.45)	38(79.17)
阳性	18(40.91)	35(72.92)			阳性	2(4.55)	10(20.83)
8周			16.035	<0.001	20周			-	0.093
阴性	37(84.09)	21(43.75)			阴性	42(95.45)	40(83.33)
阳性	7(15.91)	27(56.25)			阳性	2(4.55)	8(16.67)
12周			7.611	0.006	24周			-	0.093
阴性	41(93.18)	34(70.83)			阴性	42(95.45)	40(83.33)
阳性	3(6.82)	14(29.17)			阳性	2(4.55)	8(16.67)

不良反应	B-Pa-L/M组 (66例)	长程组 (76例)	χ²值	P值	不良反应	B-Pa-L/M组 (66例)	长程组 (76例)	χ²值	P值
骨髓抑制			1.117	0.291	胃肠道反应			5.091	0.024
有	14(21.21)	22(28.95)			有	5(7.58)	16(21.05)
无	52(78.79)	54(71.05)			无	61(92.42)	60(78.95)
周围神经炎			0.449	0.503	QTcF延长			0.370	0.543
有	15(22.73)	21(27.63)			有	5(7.58)	8(10.53)
无	51(77.27)	55(72.37)			无	61(92.42)	68(89.47)
视神经炎			-	0.632	精神症状			10.355	0.001
有	1(1.52)	3(3.95)			有	0(0.00)	11(14.47)
无	65(98.48)	73(96.05)			无	66(100.00)	65(85.53)
肝功能损伤			0.345	0.557	总体不良反应			7.636	0.006
有	11(16.67)	10(13.16)			有	30(45.45)	52(68.42)
无	55(83.33)	66(86.84)			无	36(54.55)	24(31.58)
肾功能损伤			-	1.000	≥3级不良事件			0.905	0.341
有	4(6.06)	4(5.26)			有	4(6.06)	8(10.53)
无	62(93.94)	72(94.74)			无	62(93.94)	66(89.47)