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Article(id=1200024246148755505, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1200024241572770746, articleNumber=null, orderNo=null, doi=10.11855/j.issn.0577-7402.1102.2023.0120, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=research-article, receivedDate=1652371200000, receivedDateStr=2022-05-13, revisedDate=null, revisedDateStr=null, acceptedDate=1661616000000, acceptedDateStr=2022-08-28, onlineDate=1764037675654, onlineDateStr=2025-11-25, pubDate=1695830400000, pubDateStr=2023-09-28, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1764037675654, onlineIssueDateStr=2025-11-25, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1764037675654, creator=13701087609, updateTime=1764037675654, updator=13701087609, issue=Issue{id=1200024241572770746, tenantId=1146029695717560320, journalId=1189873630562394117, year='2023', volume='48', issue='9', pageStart='993', pageEnd='1112', issueExtLink='null', onlineDate='null', pubDate='null', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1764037674563, creator=13701087609, updateTime=1764038723302, updator=13701087609, preIssue=null, nextIssue=null, ext={EN=IssueExt(id=1200028640353288193, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1200024241572770746, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1200028640353288194, tenantId=1146029695717560320, journalId=1189873630562394117, issueId=1200024241572770746, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null}, startPage=1040, endPage=1047, ext={EN=ArticleExt(id=1200024246442356811, articleId=1200024246148755505, tenantId=1146029695717560320, journalId=1189873630562394117, language=EN, title=Analysis of treatment outcomes and influencing factors of multidrug-resistant pulmonary tuberculosis patients, columnId=1190310109000602400, journalTitle=Medical Journal of Chinese People’s Liberation Army, columnName=Clinical Research, runingTitle=null, highlight=null, articleAbstract=

Objective To evaluate the risk factors of treatment outcomes in MDR-PTB patients with long-term treatment regimen in China. Methods 332 patients with MDR-PTB were recruited from 22 sentinel hospitals and 1 tertiary general hospital in 23 Provinces in China from January 2013 to December 2017. The treatment outcomes were investigated retrospectively, and the influencing factors of treatment outcomes were collected and analyzed. Results For the 332 patients, 196 cases were successful (59.04%), 76 cases failed (22.89%), 33 cases lost follow-up (9.94%), 12 cases died (3.61%), and 15 cases were transferred out (4.52%). The main factors affecting the outcome of treatment included age ≥50 years (OR=0.342, 95%CI 0.169-0.690), course of MDR-PTB ≥1 year (OR=0.297, 95%CI 0.108-0.815), irregular treatment (OR=0.429, 95%CI 0.197-0.934), cavities before treatment (OR=0.073, 95%CI 0.026-0.207) and positive sputum culture month 3 (OR=0.161, 95%CI 0.072-0.358), and cavity closure month 6 (OR=15.723, 95%CI 5.690-43.444) is predictor of success. Conclusions The result of this study indicated that age, course of MDR-PTB, irregular treatment, sputum culture in month 3, cavity before treatment and cavity closure in month 6 were the influencing factors of MDR-PTB outcome. In the initial stage of treatment of MDR-PTB patients, sputum culture results in month 3 and CT images have important predictive value for the treatment results of MDR-PTB patients.

, correspAuthors=Zhen-Hui Lu, authorNote=null, correspAuthorsNote=
E-mail:
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目的 评估耐多药肺结核(MDR-PTB)标准长疗程方案治疗结果的影响因素。方法 选取2013年1月-2017年12月在我国23个省(市)的22个结核病哨点医院和1个三级综合医院接受标准长疗程方案治疗的332例MDR-PTB患者，对其治疗转归情况进行回顾性调查并分析其影响因素。结果 332例MDR-PTB患者中，治疗成功196例(59.04%)，失败76例(22.89%)，失访33例(9.94%)，死亡12例(3.61%)，转诊15例(4.52%)。多因素logistic回归分析结果显示，年龄≥50岁(OR=0.342，95%CI 0.169~0.690)、MDR-PTB病程≥1年(OR=0.297，95%CI 0.108~0.815)、不规则治疗(OR=0.429，95%CI 0.197~0.934)、治疗前有空洞(OR=0.073，95%CI 0.026~0.207)、第3个月末痰培养阳性(OR=0.161，95%CI 0.072~0.358)是治疗失败的预测因素，第6个月末空洞闭合(OR=15.723，95%CI 5.690~43.444)是治疗成功的预测因素。结论 年龄、MDR-PTB病程、不规则治疗、第3个月末痰培养结果、治疗前有无空洞、第6个月末空洞闭合是MDR-PTB转归的影响因素。在MDR-PTB的治疗初期，第3个月末痰培养结果、CT影像特征等对治疗结果有重要预测价值。

, correspAuthors=鹿振辉, authorNote=null, correspAuthorsNote=
鹿振辉，E-mail：
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潘辰慧，硕士研究生，主要从事呼吸系统疾病方面的研究

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潘辰慧，硕士研究生，主要从事呼吸系统疾病方面的研究

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潘辰慧，硕士研究生，主要从事呼吸系统疾病方面的研究

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articleId=1200024246148755505, language=EN, label=Fig.2, caption=ROC curves of MDR-PTB treatment outcome predictive model, figureFileSmall=d7cdQi3ydXdNSUZN7HyI6A==, figureFileBig=igDuhEGQFY0s0+tv4IcAjQ==, tableContent=null), ArticleFig(id=1200066181961970548, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200024246148755505, language=CN, label=图2, caption=MDR-PTB治疗结局预测的ROC曲线

MDR-PTB. 耐多药肺结核

, figureFileSmall=d7cdQi3ydXdNSUZN7HyI6A==, figureFileBig=igDuhEGQFY0s0+tv4IcAjQ==, tableContent=null), ArticleFig(id=1200066182037468023, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200024246148755505, language=EN, label=Tab.1, caption=

Univariate analysis of prognostic factors in MDR-PTB patients [n(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
变量 治疗失败(n=76) 治疗成功(n=196) χ2 P OR(95%CI)
社会人口学特征
年龄≥50岁 36(47.4) 47(24.0) 14.129 <0.001 0.350(0.201~0.612)
女性 22(28.9) 64(32.7) 0.348 0.555 1.190(0.667~2.123)
体重≥ 60 kg 23(30.3) 92(46.9) 6.240 0.012 2.038(1.160~3.583)
体重正常(18.5 kg/m2<BMI<24.0 kg/m2) 21(27.6) 44(22.4) 0.809 0.368 1.319(0.721~2.414)
居住城市 35(46.1) 75(38.3) 1.379 0.240 0.726(0.425~1.240)
住院病例 17(22.4) 39(19.9) 0.204 0.651 0.862(0.453~1.641)
已婚 57(75.0) 136(69.4) 0.837 0.360 0.756(0.414~1.379)
农民 36(47.7) 74(37.8) 2.101 0.147 0.674(0.395~1.151)
有医疗保险 74(97.4) 192(98.0) 0.089 0.766 1.297(0.233~7.233)
教育水平高中及以上 28(36.8) 80(40.8) 0.361 0.548 1.182(0.685~2.041)
吸烟 29(38.2) 75(38.3) 0.001 0.987 1.005(0.582~1.733)
饮酒 37(48.7) 87(44.4) 0.408 0.523 0.841(0.495~1.430)
吸毒 0 3(1.5) 1.176 0.278 0.717(0.666~0.773)
结核病史
TB病程≥1年 52(68.4) 101(51.5) 6.349 0.012 0.491(0.281~0.858)
MDR-PTB病程<1年 61(80.3) 184(93.9) 11.353 0.001 0.265(0.118~0.598)
MDR-PTB伴肺外结核 15(19.7) 22(11.2) 3.377 0.066 0.514(0.251~1.054)
不规则治疗 31(40.8) 28(14.3) 22.648 <0.001 0.242(0.132~0.444)
复治 45(59.2) 77(39.3) 8.790 0.003 0.446(0.260~0.765)
并发症
糖尿病 6(7.9) 8(4.1) 1.631 0.202 0.496(0.166~1.482)
高血压病 14(18.4) 29(14.8) 0.541 0.462 0.769(0.381~1.551)
慢性阻塞性肺疾病 6(7.9) 13(6.6) 0.134 0.714 0.829(0.303~2.266)
恶性肿瘤 1(1.3) 1(0.5) 0.487 0.485 0.385(0.024~6.228)
HIV感染 0 0 - - -
咯血 11(14.5) 20(10.2) 0.989 0.320 0.671(0.305~1.478)
严重不良反应 13(17.1) 23(11.7) 1.376 0.241 0.644(0.308~1.349)
肝保护性药物 29(38.2) 61(31.1) 1.224 0.269 0.732(0.421~1.273)
临床指标
谷丙转氨酶升高 10(13.2) 20(10.2) 0.487 0.485 0.750(0.334~1.686)
谷草转氨酶升高 5(6.6) 16(8.2) 0.193 0.660 1.262(0.446~3.575)
总胆红素升高 4(5.3) 21(10.7) 1.950 0.163 2.160(0.716~6.514)
治疗前痰涂片菌浓度≥+++ 34(44.7) 63(32.1) 3.786 0.052 0.585(0.340~1.007)
治疗前有空洞 51(71.1) 105(53.6) 4.398 0.009 0.470(0.266~0.831)
治疗前空洞数量≥3个 19(25.0) 28(14.3) 4.398 0.036 0.500(0.260~0.963)
第1个月末痰培养阳性 65(85.5) 163(83.2) 0.226 0.635 0.836(0.399~1.753)
第2个月末痰培养阳性 65(85.5) 135(68.9) 7.799 0.005 0.375(0.185~0.759)
第3个月末痰培养阳性 63(82.9) 83(42.3) 36.212 <0.001 0.151(0.078~0.294)
第6个月末痰培养阳性 50(65.8) 695(35.2) 20.817 <0.001 0.283(0.162~0.493)
第9个月末痰培养阳性 29(38.2) 46(23.5) 5.917 0.015 0.497(0.281~0.878)
第12个月末痰培养阳性 27(35.5) 39(19.9) 7.279 0.007 0.451(0.251~0.810)
第6个月末病灶吸收 35(46.1) 115(58.7) 3.527 0.060 1.663(0.976~2.835)
第12个月末病灶吸收 42(55.3) 119(60.7) 0.674 0.412 1.251(0.732~2.137)
第6个月末空洞闭合 22(28.9) 97(49.5) 9.391 0.002 2.405(1.361~4.250)
第12个月末空洞闭合 35(46.1) 97(49.5) 0.259 0.611 1.148(0.675~1.952)
), ArticleFig(id=1200066182112965497, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200024246148755505, language=CN, label=表1, caption=

MDR-PTB患者治疗结果影响因素的单因素分析[例(%)]

, figureFileSmall=null, figureFileBig=null, tableContent=
变量 治疗失败(n=76) 治疗成功(n=196) χ2 P OR(95%CI)
社会人口学特征
年龄≥50岁 36(47.4) 47(24.0) 14.129 <0.001 0.350(0.201~0.612)
女性 22(28.9) 64(32.7) 0.348 0.555 1.190(0.667~2.123)
体重≥ 60 kg 23(30.3) 92(46.9) 6.240 0.012 2.038(1.160~3.583)
体重正常(18.5 kg/m2<BMI<24.0 kg/m2) 21(27.6) 44(22.4) 0.809 0.368 1.319(0.721~2.414)
居住城市 35(46.1) 75(38.3) 1.379 0.240 0.726(0.425~1.240)
住院病例 17(22.4) 39(19.9) 0.204 0.651 0.862(0.453~1.641)
已婚 57(75.0) 136(69.4) 0.837 0.360 0.756(0.414~1.379)
农民 36(47.7) 74(37.8) 2.101 0.147 0.674(0.395~1.151)
有医疗保险 74(97.4) 192(98.0) 0.089 0.766 1.297(0.233~7.233)
教育水平高中及以上 28(36.8) 80(40.8) 0.361 0.548 1.182(0.685~2.041)
吸烟 29(38.2) 75(38.3) 0.001 0.987 1.005(0.582~1.733)
饮酒 37(48.7) 87(44.4) 0.408 0.523 0.841(0.495~1.430)
吸毒 0 3(1.5) 1.176 0.278 0.717(0.666~0.773)
结核病史
TB病程≥1年 52(68.4) 101(51.5) 6.349 0.012 0.491(0.281~0.858)
MDR-PTB病程<1年 61(80.3) 184(93.9) 11.353 0.001 0.265(0.118~0.598)
MDR-PTB伴肺外结核 15(19.7) 22(11.2) 3.377 0.066 0.514(0.251~1.054)
不规则治疗 31(40.8) 28(14.3) 22.648 <0.001 0.242(0.132~0.444)
复治 45(59.2) 77(39.3) 8.790 0.003 0.446(0.260~0.765)
并发症
糖尿病 6(7.9) 8(4.1) 1.631 0.202 0.496(0.166~1.482)
高血压病 14(18.4) 29(14.8) 0.541 0.462 0.769(0.381~1.551)
慢性阻塞性肺疾病 6(7.9) 13(6.6) 0.134 0.714 0.829(0.303~2.266)
恶性肿瘤 1(1.3) 1(0.5) 0.487 0.485 0.385(0.024~6.228)
HIV感染 0 0 - - -
咯血 11(14.5) 20(10.2) 0.989 0.320 0.671(0.305~1.478)
严重不良反应 13(17.1) 23(11.7) 1.376 0.241 0.644(0.308~1.349)
肝保护性药物 29(38.2) 61(31.1) 1.224 0.269 0.732(0.421~1.273)
临床指标
谷丙转氨酶升高 10(13.2) 20(10.2) 0.487 0.485 0.750(0.334~1.686)
谷草转氨酶升高 5(6.6) 16(8.2) 0.193 0.660 1.262(0.446~3.575)
总胆红素升高 4(5.3) 21(10.7) 1.950 0.163 2.160(0.716~6.514)
治疗前痰涂片菌浓度≥+++ 34(44.7) 63(32.1) 3.786 0.052 0.585(0.340~1.007)
治疗前有空洞 51(71.1) 105(53.6) 4.398 0.009 0.470(0.266~0.831)
治疗前空洞数量≥3个 19(25.0) 28(14.3) 4.398 0.036 0.500(0.260~0.963)
第1个月末痰培养阳性 65(85.5) 163(83.2) 0.226 0.635 0.836(0.399~1.753)
第2个月末痰培养阳性 65(85.5) 135(68.9) 7.799 0.005 0.375(0.185~0.759)
第3个月末痰培养阳性 63(82.9) 83(42.3) 36.212 <0.001 0.151(0.078~0.294)
第6个月末痰培养阳性 50(65.8) 695(35.2) 20.817 <0.001 0.283(0.162~0.493)
第9个月末痰培养阳性 29(38.2) 46(23.5) 5.917 0.015 0.497(0.281~0.878)
第12个月末痰培养阳性 27(35.5) 39(19.9) 7.279 0.007 0.451(0.251~0.810)
第6个月末病灶吸收 35(46.1) 115(58.7) 3.527 0.060 1.663(0.976~2.835)
第12个月末病灶吸收 42(55.3) 119(60.7) 0.674 0.412 1.251(0.732~2.137)
第6个月末空洞闭合 22(28.9) 97(49.5) 9.391 0.002 2.405(1.361~4.250)
第12个月末空洞闭合 35(46.1) 97(49.5) 0.259 0.611 1.148(0.675~1.952)
), ArticleFig(id=1200066182192657275, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200024246148755505, language=EN, label=Tab.2, caption=

Multifactorial assignment table of prognostic factors in MDR-PTB patients

, figureFileSmall=null, figureFileBig=null, tableContent=
变量 赋值方法
X1 年龄 <50岁=1，≥50岁=2
X2 MDR-PTB病程 <1年=1，≥1年=2
X3 不规则治疗 否=1，是=2
X4 治疗前有无空洞 无=1，有=2
X5 第3个月末痰培养 阴性=1，阳性=2
X6 第6个月末空洞闭合 未改善=1，改善=2
Y 治疗结局 治疗失败=1，治疗成功=2
), ArticleFig(id=1200066182280737661, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200024246148755505, language=CN, label=表2, caption=

MDR-PTB患者治疗结果影响因素的多因素分析赋值

, figureFileSmall=null, figureFileBig=null, tableContent=
变量 赋值方法
X1 年龄 <50岁=1，≥50岁=2
X2 MDR-PTB病程 <1年=1，≥1年=2
X3 不规则治疗 否=1，是=2
X4 治疗前有无空洞 无=1，有=2
X5 第3个月末痰培养 阴性=1，阳性=2
X6 第6个月末空洞闭合 未改善=1，改善=2
Y 治疗结局 治疗失败=1，治疗成功=2
), ArticleFig(id=1200066182427538305, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200024246148755505, language=EN, label=Tab.3, caption=

Multivariate logistic regression analysis of prognostic factors in MDR-PTB patients

, figureFileSmall=null, figureFileBig=null, tableContent=
变量 B SE Wald χ2 P OR(95%CI)
年龄 -1.073 0.358 8.983 0.003 0.342(0.169~0.690)
MDR-PTB病程 -1.215 0.516 5.554 0.018 0.297(0.108~0.815)
不规则治疗 -0.846 0.397 4.549 0.033 0.429(0.197~0.934)
治疗前有无空洞 -2.618 0.531 24.277 0.001 0.073(0.026~0.207)
第3个月末痰培养 -1.828 0.408 20.033 <0.001 0.161(0.072~0.358)
第6个月末空洞闭合 2.755 0.519 28.227 <0.001 15.723(5.690~43.444)
常数项 4.366 0.674 42.002 <0.001 -
), ArticleFig(id=1200066183165735812, tenantId=1146029695717560320, journalId=1189873630562394117, articleId=1200024246148755505, language=CN, label=表3, caption=

MDR-PTB患者治疗结果影响因素的多因素logistic回归分析

, figureFileSmall=null, figureFileBig=null, tableContent=
变量 B SE Wald χ2 P OR(95%CI)
年龄 -1.073 0.358 8.983 0.003 0.342(0.169~0.690)
MDR-PTB病程 -1.215 0.516 5.554 0.018 0.297(0.108~0.815)
不规则治疗 -0.846 0.397 4.549 0.033 0.429(0.197~0.934)
治疗前有无空洞 -2.618 0.531 24.277 0.001 0.073(0.026~0.207)
第3个月末痰培养 -1.828 0.408 20.033 <0.001 0.161(0.072~0.358)
第6个月末空洞闭合 2.755 0.519 28.227 <0.001 15.723(5.690~43.444)
常数项 4.366 0.674 42.002 <0.001 -
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耐多药肺结核治疗转归的影响因素分析
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潘辰慧 1 , 张顺先 1 , 张少言 1 , 邱磊 1 , 周伟 1 , 吴显伟 1 , 吴定中 1 , 张惠勇 1 , 肖和平 2 , 鹿振辉 1, *
解放军医学杂志 | 临床研究 2023,48(9): 1040-1047
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解放军医学杂志 | 临床研究 2023, 48(9): 1040-1047
耐多药肺结核治疗转归的影响因素分析
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潘辰慧1, 张顺先1, 张少言1, 邱磊1, 周伟1, 吴显伟1, 吴定中1, 张惠勇1, 肖和平2, 鹿振辉1, *
作者信息
  • 1上海中医药大学附属龙华医院呼吸疾病研究所，上海 200032
  • 2同济大学附属上海市肺科医院结核科，上海 200433

    • 潘辰慧，硕士研究生，主要从事呼吸系统疾病方面的研究

通讯作者:

鹿振辉，E-mail：
Analysis of treatment outcomes and influencing factors of multidrug-resistant pulmonary tuberculosis patients
Chen-Hui Pan1, Shun-Xian Zhang1, Shao-Yan Zhang1, Lei Qiu1, Wei Zhou1, Xian-Wei Wu1, Ding-Zhong Wu1, Hui-Yong Zhang1, He-Ping Xiao2, Zhen-Hui Lu1, *
Affiliations
  • 1Department of Respiratory Medicine, Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai 200032,China
  • 2Department of Tuberculosis, Shanghai Pulmonary Hospital Affiliated to Tongji University,Shanghai 200433, China
出版时间: 2023-09-28 doi: 10.11855/j.issn.0577-7402.1102.2023.0120
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摘要
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目的 评估耐多药肺结核(MDR-PTB)标准长疗程方案治疗结果的影响因素。方法 选取2013年1月-2017年12月在我国23个省(市)的22个结核病哨点医院和1个三级综合医院接受标准长疗程方案治疗的332例MDR-PTB患者，对其治疗转归情况进行回顾性调查并分析其影响因素。结果 332例MDR-PTB患者中，治疗成功196例(59.04%)，失败76例(22.89%)，失访33例(9.94%)，死亡12例(3.61%)，转诊15例(4.52%)。多因素logistic回归分析结果显示，年龄≥50岁(OR=0.342，95%CI 0.169~0.690)、MDR-PTB病程≥1年(OR=0.297，95%CI 0.108~0.815)、不规则治疗(OR=0.429，95%CI 0.197~0.934)、治疗前有空洞(OR=0.073，95%CI 0.026~0.207)、第3个月末痰培养阳性(OR=0.161，95%CI 0.072~0.358)是治疗失败的预测因素，第6个月末空洞闭合(OR=15.723，95%CI 5.690~43.444)是治疗成功的预测因素。结论 年龄、MDR-PTB病程、不规则治疗、第3个月末痰培养结果、治疗前有无空洞、第6个月末空洞闭合是MDR-PTB转归的影响因素。在MDR-PTB的治疗初期，第3个月末痰培养结果、CT影像特征等对治疗结果有重要预测价值。

结核，肺  /  分枝杆菌，结核，耐多药  /  治疗结果  /  危险因素

Objective To evaluate the risk factors of treatment outcomes in MDR-PTB patients with long-term treatment regimen in China. Methods 332 patients with MDR-PTB were recruited from 22 sentinel hospitals and 1 tertiary general hospital in 23 Provinces in China from January 2013 to December 2017. The treatment outcomes were investigated retrospectively, and the influencing factors of treatment outcomes were collected and analyzed. Results For the 332 patients, 196 cases were successful (59.04%), 76 cases failed (22.89%), 33 cases lost follow-up (9.94%), 12 cases died (3.61%), and 15 cases were transferred out (4.52%). The main factors affecting the outcome of treatment included age ≥50 years (OR=0.342, 95%CI 0.169-0.690), course of MDR-PTB ≥1 year (OR=0.297, 95%CI 0.108-0.815), irregular treatment (OR=0.429, 95%CI 0.197-0.934), cavities before treatment (OR=0.073, 95%CI 0.026-0.207) and positive sputum culture month 3 (OR=0.161, 95%CI 0.072-0.358), and cavity closure month 6 (OR=15.723, 95%CI 5.690-43.444) is predictor of success. Conclusions The result of this study indicated that age, course of MDR-PTB, irregular treatment, sputum culture in month 3, cavity before treatment and cavity closure in month 6 were the influencing factors of MDR-PTB outcome. In the initial stage of treatment of MDR-PTB patients, sputum culture results in month 3 and CT images have important predictive value for the treatment results of MDR-PTB patients.

Tuberculosis, pulmonary  /  Mycobacterium tuberculosis, multidrug-resistant  /  treatment outcome  /  risk factors
潘辰慧, 张顺先, 张少言, 邱磊, 周伟, 吴显伟, 吴定中, 张惠勇, 肖和平, 鹿振辉. 耐多药肺结核治疗转归的影响因素分析. 解放军医学杂志, 2023 , 48 (9) : 1040 -1047 . DOI: 10.11855/j.issn.0577-7402.1102.2023.0120
Chen-Hui Pan, Shun-Xian Zhang, Shao-Yan Zhang, Lei Qiu, Wei Zhou, Xian-Wei Wu, Ding-Zhong Wu, Hui-Yong Zhang, He-Ping Xiao, Zhen-Hui Lu. Analysis of treatment outcomes and influencing factors of multidrug-resistant pulmonary tuberculosis patients[J]. Medical Journal of Chinese People’s Liberation Army, 2023 , 48 (9) : 1040 -1047 . DOI: 10.11855/j.issn.0577-7402.1102.2023.0120
正文
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耐多药肺结核(multi-drug resistant pulmonary tuberculosis，MDR-PTB)已成为全球性的公共卫生问题，严重威胁2035年“终止结核病流行”目标的实现[1]。2020年世界卫生组织(world health organization，WHO)报告全球新增肺结核病患者580万例，其中6.3%为MDR-PTB或利福平耐药肺结核(rifampicin resistant tuberculosis，RR-PTB)[1]。2020年我国新增耐药结核病1.63万例，其中约77%的RR-PTB病例为MDR-PTB[2]。MDR-PTB存在诊断率低、诊断延迟、疗程长、治疗费用高、药物不良反应多、患者依从性差等诸多临床难题[3-6]，严重影响治疗结果，导致其治疗失败率较高，病死率达12.60%~15.13%[7-10]。2020年全球MDR-PTB患者中接受治疗者仅占32%，且平均治愈率仅为50%~75%[7-9,11-13]，而我国治疗成功率为49.5%~68%[14-16]。虽然近年来结核病的快速诊断和新药研究均取得了显著进展[17]，但仅少数国家MDR-PTB患者治疗成功率显著提高。我国是MDR-PTB的高负担国家之一，疫情形势较为严峻，MDR-PTB的广泛传播给我国结核病防控工作带来了巨大挑战。评估影响MDR-PTB治疗结局的危险因素，有助于临床医师早期识别预后较差的MDR-PTB患者，尽早改进治疗方案，促进其治愈率和生活质量的提高。
1 资料与方法
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1.1 研究对象
选取2013年1月-2017年12月就诊于全国23个省(市)的22个结核病哨点医院(重庆市公共卫生医疗救治中心、丽水市中医院、云南省传染病医院、新疆维吾尔自治区胸科医院、天津海河医院、西南医科大学附属医院、上海中医药大学附属龙华医院、陕西省结核病防治研究所、潍坊市呼吸疾病医院、内蒙古第四人民医院、沈阳市胸科医院、江西省胸科医院、南京市第二人民医院、吉林省结核病医院、长沙市中心医院、武汉市肺科医院、新乡医科大学第一附属医院、河北省胸科医院、贵阳市公共卫生救治中心、福州市肺科医院、北京市胸科医院、合肥市传染病医院)和1个三级综合医院(深圳市人民医院)并被确诊为MDR-PTB的患者332例进行回顾性队列分析。332例患者中男226例，女106例，年龄(39.0±14.0)岁。MDR-PTB的诊断标准参照《耐药结核病化学治疗指南(2009)》[18]。本研究方案经上海中医药大学附属龙华医院医学伦理委员会审查批准(批准文号：2012LCSY033)。纳入研究的MDR-PTB患者均签署知情同意书。
1.2 纳入与排除标准
(1)纳入标准：①入组时痰结核分枝杆菌培养阳性；②痰结核分枝杆菌药敏试验(drug sensitivity test，DST)结果显示对异烟肼、利福平同时耐药；③年龄18~70岁，性别不限；④对本研究方案知情同意。(2)排除标准：①体外药敏试验结果为单一耐药(利福平或异烟肼)、前广泛耐药肺结核或广泛耐药肺结核；②患精神疾病不能配合治疗；③妊娠期、准备妊娠或哺乳期女性；④因其他疾病存在生存风险，不能完成治疗；⑤病例资料不全，合规性差；⑥拒绝签署知情同意书。
1.3 方法
1.3.1 结核杆菌培养及体外药敏试验
以实验室痰涂片和结核分枝杆菌培养检测结果作为主要诊断依据及分组指标。参照《WHO耐药结核病规划管理指南——2008年紧急修订版》[19]，采用罗氏培养法筛选受试者，培养阳性者进行菌种鉴定，鉴定为结核分枝杆菌复合群者使用比例法DST进行体外药物敏感性试验，明确对异烟肼(isoniazid，INH)、利福平(rifampicin，R)同时耐药，同时检测其对乙胺丁醇(ethambutol，EMB)、链霉素(streptomycin，SM)、卡那霉素(kanamycin，Km)、氧氟沙星(ofoxacin，Ofx)、对氨基水杨酸(P-aminosalicylic acid，PAS)、吡嗪酰胺(pyrazinamide，PZA)等药物的敏感性。收集研究对象治疗前(第0个月)及治疗第1、2、3、6、9、12个月末的痰涂片和痰培养(罗氏培养法)检测结果。
1.3.2 痰标本
在医务人员指导下留取痰标本，为患者深呼吸后由肺部深处咳出的分泌物，标本量为3~5 ml。痰标本的质量界定参照《中国结核病防治规划实施工作指南(2008版)》[20]。痰涂片操作参考《中国结核病防治规划·痰涂片镜检标准化操作及质量保证手册》[21]，采用萋尔-尼尔逊抗酸染色法。痰涂片菌浓度分级标准如下：(1)抗酸杆菌阴性，连续观察300个不同视野，未发现抗酸杆菌；(2)抗酸杆菌阳性，抗酸杆菌数为1~8条/300个视野；(3)抗酸杆菌阳性(+)，3~9条/100个视野，连续观察300个视野；(4)抗酸杆菌阳性(++)，1~9条/10个视野，连续观察100个视野；(5)抗酸杆菌阳性(+++)，每个视野1~9条；(6)抗酸杆菌阳性(++++)，每个视野≥10条。
1.3.3 治疗方案
参考《WHO耐药结核病规划管理指南——2008年紧急修订版》[19]制定治疗方案(6Am-Lfx-P-Z-Pto，18Lfx-P-Z-Pto)，服用剂量、频次等参考指南要求；部分患者因为严重不良反应等原因，可适当调整药品剂量。标准长疗程方案治疗完成后进行为期2年的随访。
1.3.4 药物不良反应监测
收集患者的严重药物不良反应事件，治疗过程中每个月行血常规、肝肾功能、尿常规等检查。
1.3.5 CT图像分析评估
MDR-PTB患者在治疗前(第0个月)及治疗第6、12个月各进行1次CT检查随访，连续观察肺内病变的转归和进展趋势。采用递进读片法(主要观察吸收好转病变)和倒溯性读片法(主要观察不可逆损伤病变)相结合的方法，了解诸病灶的演变特点。由3名副高级或以上职称的放射科医师集中阅片，意见不一致时，以多数意见作为最终判定结论。影像学观察内容：病变范围、空洞(包括空洞数量、空洞累及肺叶数、空洞壁最大厚度、空洞最大内径、空洞壁类型、空洞累及单侧肺还是双侧肺、空洞内壁是否光滑、空洞是否伴液平、空洞壁是否有钙化、空洞周围是否有卫星病灶)、支气管病变(包括支气管是否有扩张、支气管管壁有无增厚、管腔有无狭窄、支气管有无闭塞)、肺实变、肺不张、毁损肺、树芽征、肺门及纵隔淋巴结肿大、肺气肿、胸腔积液、胸膜增厚、肺内钙化灶。
1.3.6 治疗转归评估
在疗程末MDR-PTB的定义和患者的治疗转归(治愈、完成治疗、成功治疗、丢失、死亡)参照WHO发布的《结核病定义和报告框架——2013年修订版》[22]的标准。(1)初治患者：指从未使用过抗结核药物或使用抗结核药物不超过1个月或首次行标准化疗方案规律用药而未满疗程，且从未登记过的肺结核患者。(2)复治患者：指使用抗结核药物治疗≥1个月或初治失败和复发的患者，包括复发、初治失败、复治失败、初治2个月末痰涂片阳性和其他(指由于既往治疗情况不明，不能归属到上述复发等5个类别中的患者)。(3)治愈：按照国家指南完成治疗疗程，不存在治疗失败的证据，且强化期后间隔至少30 d连续3次或3次以上培养阴性。(4)完成治疗：按照国家指南完成治疗疗程，不存在治疗失败的证据，但没有证据显示强化期后间隔至少30 d连续3次或者3次以上培养阴性。(5)治疗失败：由于以下原因终止治疗或需要永久性地更改治疗方案中至少2种抗结核药物，包括强化期结束后没有出现阴转，或阴转后又发生细菌学检测结果逆转，或证据显示对氟喹诺酮类药物或二线注射剂产生获得性耐药，或产生药物不良反应。(6)死亡：治疗过程中因为任何原因死亡。(7)失访：治疗中断连续2个月或以上。(8)转诊：患者转诊到其他医疗机构或不知治疗转归。(9)治疗成功：包括治愈和完成治疗。
1.4 数据收集
由经过培训的专业研究人员从MDR-PTB患者的CRF表中详细收集临床和微生物学数据，包括患者基本情况［如年龄、性别、身高、体重指数(body mass index，BMI)、职业、教育水平、吸烟史、饮酒史、婚姻状况、居住地、病例来源等］、病史资料[基础疾病(包括糖尿病、高血压、慢性阻塞性肺疾病等呼吸系统疾病、恶性肿瘤等)，有无吸毒史，是否感染HIV/AIDS，是否出现谷丙转氨酶、谷草转氨酶等异常，是否出现严重不良反应，是否出现咯血等]、影像学资料(包括是否有空洞及病变范围、是否累及双肺、空洞数量及大小、是否合并肺外结核等)、微生物学资料(痰培养是否转阴、痰涂片菌浓度)和治疗相关资料(包括治疗是否为复治、既往是否有过不规则治疗、治疗结局等)。
1.5 统计学处理
采用Excel 2020 软件建立数据库，采用SPSS 28.0软件对数据进行统计分析。计量资料符合正态分布时以$\bar{x}±s$表示，组间比较采用t检验；计量资料为偏态分布时则以M(Q1，Q3)表示，组间比较采用Wilcoxon秩和检验。计数资料采用构成比或率(%)表示，组间比较采用χ2检验。使用非条件多因素 logistic 回归模型分析MDR-PTB治疗结局的影响因素，变量选择采用逐步法，剔除和入选的标准均为α=0.05。P<0.05为差异有统计学意义。
2 结果
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2.1 MDR-PTB患者的一般情况和治疗结果
332例MDR-PTB患者的身高为(168.4±7.8) cm，体重为(57.9±10.1) kg，吸烟126例(38.0%)，居住地区为农村192例(57.8%)，已婚234例(70.5%)，教育水平为初中及以下203例(61.1%)；结核病(tuberculosis，TB)病程(从TB初诊到接受MDR-PTB治疗的时间)为440.5(131.0，1515.0) d，MDR-PTB病程(从MDR-PTB初诊到治疗的时间)为35.5(17.3，82.8) d；初治185例(55.7%)，不规则治疗69例(20.8%)；合并糖尿病15例(4.5%)，合并慢性阻塞性肺疾病25例(7.5%)，合并恶性肿瘤3例(0.9%)；痰涂片菌浓度≥+++者116例(34.9%)；入组治疗前肺部有空洞者195例(58.7%)，其中空洞数量≥3个者56例(16.9%)。
332例MDR-PTB中，治愈188例(56.63%)，治疗完成8例(2.41%)，治疗失败76例(22.89%)，失访33例(9.94%)，死亡12例(3.61%)，转诊15例(4.52%)。最终治疗成功196例(59.04%，图1)。
2.2 MDR-PTB预后的影响因素分析
纳入MDR-PTB患者的社会人口学特征、生活习惯、疾病相关情况、临床表现等42个变量，单因素分析结果显示，与MDR-PTB治疗结局有关联(P<0.05)的变量包括年龄(χ2=14.129，P<0.001)、体重(χ2=6.24，P=0.012)、TB病程(从TB初诊到接受MDR-PTB治疗的时间间隔)(χ2=6.349，P=0.012)、MDR-PTB病程(从MDR-PTB初诊到治疗的时间间隔)(χ2=11.353，P=0.001)、不规则治疗(χ2=22.648，P<0.001)、复治(χ2=8.79，P=0.003)、第2个月末痰培养(χ2=7.799，P=0.005)、第3个月末痰培养(χ2=36.212，P<0.001)、第6个月末痰培养(χ2=20.817，P<0.001)、第9个月末痰培养(χ2=5.917，P=0.015)、第12个月末痰培养(χ2=7.279，P=0.007)、治疗前空洞数量≥3个(χ2=4.398，P=0.036)、第6个月末空洞闭合(χ2=9.391，P=0.002)(表1)。
将上述单因素分析结果中P<0.05的变量纳入多因素分析，包括年龄、体重、TB病程、MDR-PTB病程、不规则治疗、复治、治疗前空洞数量≥3个、第2个月末痰培养、第3个月末痰培养、第6个月末痰培养、第9个月末痰培养、第12个月末痰培养、第6个月末空洞闭合。变量赋值见表2。
多因素logistic 回归分析结果显示，年龄、MDR-PTB病程、不规则治疗、治疗前空洞、第3个月末痰培养、第6个月末空洞闭合情况是影响MDR-PTB患者治疗结局的重要因素(P<0.05，表3)；其中年龄≥50岁、MDR-PTB病程≥1年、不规则治疗、治疗前有空洞、第3个月末痰培养阳性是MDR-PTB患者治疗失败的预测因素，第6个月末空洞闭合是MDR-PTB患者治疗成功的预测因素。
整体多因素分析判断MDR-PTB患者预后的受试者工作曲线下面积为0.866(95%CI 0.818~0.914)。各预测因素的曲线下面积分别为：年龄0.617(95%CI 0.540~0.694)，MDR-PTB病程0.568(95%CI 0.489~0.647)，不规则治疗0.633(95%CI 0.555~0.710)，治疗前有无空洞0.587(95%CI 0.513~0.661)，第3个月末痰培养0.703(95%CI 0.637~0.769)，第6个月空洞闭合0.603(95%CI 0.529~0.676，图2)。
3 讨论
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MDR-PTB是我国结核病防控工作中面临的艰巨挑战，对公众健康危害较大。本研究通过评估MDR-PTB患者治疗转归的影响因素，建立基于多个变量的预测模型，准确率可达85%以上，具有一定的应用价值。本研究结果显示，治疗期间痰培养转阴延迟是早期识别MDR-PTB患者预后不良的关键指标之一；此外，胸部CT动态征象变化显示，在治疗第6个月末空洞未闭合是治疗失败的重要预测因素。
本研究结果显示，第3个月末痰培养阴转预测MDR-PTB患者治疗结局的准确度较高。目前，病原学检查是MDR-PTB诊断及治疗转归、疾病复发评价的主要手段[23]，在MDR-PTB的监测中发挥着重要作用，痰菌转阴被认为是失去传染性的一个可靠指标；患者治疗随访过程中的痰菌改变是预测治疗转归的重要指标，定期的痰培养监测对于早期发现治疗失败的MDR-PTB患者至关重要[24]。Gadallah等[25]报道痰培养延迟转化时间为2个月或更长时间是治疗失败的预测因素。本研究结果还显示，痰培养的预测能力高于痰涂片，提示痰培养法检出耐药结核分枝杆菌的能力高于痰涂片法；在MDR-PTB患者开始用药后，耐药结核分枝杆菌的活性降低，此时容易出现痰培养阴性而痰涂片阳性的现象，这往往预示良好的治疗结局。
影像学检查在评价肺结核病变范围、严重程度等方面可发挥重要作用。本研究显示CT征象可在一定程度上预测MDR-PTB的治疗结局，治疗前有无空洞和第6个月末空洞闭合程度都能预测MDR-PTB的结局，提示初筛时和第6个月末是影像学评价MDR-PTB患者治疗转归较好时间节点，这也提示CT检查对MDR-PTB患者治疗结果具有重要预测价值，与其他研究结果基本一致[26]。有研究显示MDR-PTB患者治愈组与治疗失败组的CT征象评分在疗程第2个月开始出现差异，且在此后的所有治疗阶段均有差异[27]。本研究显示，第6个月末时未闭合空洞多属于厚壁空洞，而厚壁空洞患者更容易治疗失败，其机制可能为厚壁有屏障作用，可显著减少抗结核药物的渗透，同时空洞周围血管少，缺乏血供，通过血流向空洞内渗透的抗结核药物量更少，空洞壁血药浓度维持在较低水平，难以有效抑菌及杀菌。空洞内大量隐匿的MTB得以存活，从而使空洞内反复持续排菌，导致MDR-PTB患者的疗程增加，复发率、耐药性和治疗失败率增高[27]。但也有研究显示，MDR-PTB患者是否获得治愈与初始影像学特征并无关联，这可能是由于化疗效果与化疗方案、依从性、耐受性以及是否伴有喹诺酮类或氨基糖苷类药物耐药有关；同时，随着抗结核新药如贝达喹啉、德拉马尼、利奈唑胺等应用于临床，治疗成败更取决于患者对这些药物的耐受性、依从性及是否耐药等因素[27]。
MDR-PTB患者治疗转归的影响因素在不同地区的研究报道中存在较大差异。我国学者Liu等[28]报道吸烟、饮酒或痰涂片级别是MDR-PTB治疗效果的影响因素。本研究显示，年龄较大、不规则治疗、从MDR-PTB初诊到治疗的时间间隔等是影响MDR-PTB治疗转归的因素。印度的一项回顾性队列研究显示，影响MDR-PTB治疗效果的危险因素有药物不良反应、BMI<18 kg/m2、强化期与持续期的不规则用药、肺空洞、更长的持续时间等；一些社会经济因素也与MDR-PTB治疗失败有关，如受教育水平低、收入低、酗酒、失业和缺乏医疗保险[26]。Alemu等[7]报道，HIV状态、是否存在非HIV并发症或合并感染、临床并发症、肺外受累、BMI<18.5 kg/m2、贫血、治疗延迟是治疗结果不良的预测因素。
本研究存在一定局限性：(1)为观察性研究，收集到的研究对象信息和实际情况可能存在偏差，导致结果出现偏倚；(2)亚组分析时由于某些亚组的样本量较少，导致异质性较高，结果可能存在偏倚。未来将继续扩大样本量，以减少偏倚，使所得结果更加准确，为临床提供可靠性更高的循证依据。
综上所述，本研究结果显示，年龄、MDR-PTB患者确诊后到纳入治疗的时间、第3个月末痰培养结果、治疗前有无空洞等是MDR-PTB治疗转归的主要影响因素，临床医师可据此早期鉴别并采取有针对性的个体化措施，促进精准治疗，提升患者的治愈率，为MDR-PTB的防控提供技术支撑。
基金
收起
  • 国家“十三五”传染病科技重大专项(2018ZX10725-509)
  • 上海市“科技创新行动计划”医学创新研究专项(21Y11922500)
  • 上海市促进市级医院临床技能与临床创新能力三年行动计划(SHDC2022CRS039)
  • 上海中医药大学附属龙华医院人才基金(LH001.007)
文献
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2023年第48卷第9期
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doi: 10.11855/j.issn.0577-7402.1102.2023.0120
  • 接收时间：2022-05-13
  • 首发时间：2025-11-25
  • 出版时间：2023-09-28
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  • 收稿日期：2022-05-13
  • 录用日期：2022-08-28
基金
Fund of the 13th Five-Year Plan National Science and Technology Major Project for Infectious Diseases(2018ZX10725-509)
国家“十三五”传染病科技重大专项(2018ZX10725-509)
Medical Innovation Research Special Project "Science and Technology Innovation Action Plan" of Shanghai(21Y11922500)
上海市“科技创新行动计划”医学创新研究专项(21Y11922500)
Three-Year Action Plan for Promoting Clinical Skills and Innovation Ability of Municipal Hospitals of Shanghai(SHDC2022CRS039)
上海市促进市级医院临床技能与临床创新能力三年行动计划(SHDC2022CRS039)
Talent Fund of Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine(LH001.007)
上海中医药大学附属龙华医院人才基金(LH001.007)
作者信息
    1上海中医药大学附属龙华医院呼吸疾病研究所，上海 200032
    2同济大学附属上海市肺科医院结核科，上海 200433

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