| 微卡免疫干预辅助治疗初治涂阴肺结核4个月治疗方案的疗效研究 |
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| 引用本文： | 刘礼亲,徐祖辉,黄移生,姚其能,谭云洪,周林,夏愔愔,刘二勇,黄国军,白丽琼,成诗明. 微卡免疫干预辅助治疗初治涂阴肺结核4个月治疗方案的疗效研究[J]. 中国防痨杂志, 2022, 44(2): 125-130. DOI: 10.19982/j.issn.1000-6621.20210563 |
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| 作者姓名： | 刘礼亲 徐祖辉 黄移生 姚其能 谭云洪 周林 夏愔愔 刘二勇 黄国军 白丽琼 成诗明 |
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| 作者单位： | 1.湖南省结核病防治所/湖南省胸科医院,长沙 410013;2.中南大学湘雅公共卫生学院流行病与卫生统计学系在职博士研究生,长沙 410078;3.中国疾病预防控制中心结核病预防控制中心,北京,102206;4.中国防痨协会,北京 100710 |
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| 基金项目： | “十二五”国家“艾滋病和病毒性肝炎等重大传染病防治”科技重大专项(2014ZX10003001-002-003)。 |
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| 摘 要： | 目的: 评价微卡(注射用母牛分枝杆菌菌苗)免疫干预辅助治疗涂阴肺结核4个月治疗方案的临床疗效、药物不良反应及随访1年和2年复发情况,为缩短涂阴肺结核患者的疗程提供依据。 方法: 以2014年11月至2016年4月在湖南省邵东县和岳阳县结核病定点医疗机构诊断为初治涂阴肺结核的连续病例为研究对象,按纳入顺序在“德派(DAP)流行病学研究系统”进行登记录入,由系统随机分配到观察组(微卡免疫辅助方案组)和对照组(标准方案组),其中观察组184例,采用2H-R-Z-E/2H-R联用微卡治疗方案,对照组180例,采用2H-R-Z-E/4H-R治疗方案。比较两组患者治疗强化期末、疗程末的临床疗效和药物不良反应,以及疗程结束后随访1年和2年的复发情况。 结果: 共纳入患者364例,其中男性292例(80.2%),女性72例(19.8%),平均年龄(54±17)岁;在强化期末和疗程末,观察组的症状改善率分别为86.1%(130/151)和96.0%(145/151);对照组分别为86.5%(128/148)和95.3%(141/148),两组差异均无统计学意义(χ2值分别为0.010,0.103;P值分别为0.921,0.749)。观察组的胸部X线摄片病灶吸收率分别为19.0%(35/184)和41.3%(76/184),对照组分别为18.9%(34/180)和41.7%(75/180),两组差异无统计学意义(χ2值分别为0.100,0.005;P值分别为0.920,0.944)。观察组强化期末和疗程末的CD4+T淋巴细胞计数分别为(643.3±207.1)个/μl和(698.5±208.9)个/μl;对照组分别为(600.5±183.2)个/μl和(625.2±177.9)个/μl,两组差异均无统计学意义(t值分别为1.023,1.766;P值分别为0.309,0.081)。疗程末两组的成功治疗率均为100.0%(184/184,180/180)。疗程结束后观察组病例随访1年累计复发率0.6%(1/174),两年累计复发率1.2%(2/167);对照组随访1年累计复发率1.2%(2/172),两年累计复发率1.8%(3/164),差异均无统计学意义(Fisher精确概率法,P值分别为0.621和0.683)。疗程中观察组和对照组药物不良反应发生率分别为19.6%(36/184)和28.3%(51/180),差异有统计学意义(χ2=3.846,P<0.05)。 结论: 微卡免疫干预辅助治疗初治涂阴肺结核4个月治疗方案的临床疗效不劣于6个月标准治疗方案,且药物不良反应发生率低。
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| 关 键 词： | 微卡 结核 肺 超短程化疗 临床特征 |
| 收稿时间： | 2021-09-22 |
Study on the clinical efficacy of a 4-month treatment program for the initial treatment of smear-negative pulmonary tuberculosis with Mycobacterium vaccae Vaccine immune intervention |
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| LIU Li-qin,XU Zu-hui,HUANG Yi-sheng,YAO Qi-neng,TAN Yun-hong,ZHOU Lin,XIA Yin-yin,LIU Er-yong,HUANG Guo-jun,BAI Li-qiong,CHENG Shi-ming. Study on the clinical efficacy of a 4-month treatment program for the initial treatment of smear-negative pulmonary tuberculosis with Mycobacterium vaccae Vaccine immune intervention[J]. The Journal of The Chinese Antituberculosis Association, 2022, 44(2): 125-130. DOI: 10.19982/j.issn.1000-6621.20210563 |
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| Authors: | LIU Li-qin XU Zu-hui HUANG Yi-sheng YAO Qi-neng TAN Yun-hong ZHOU Lin XIA Yin-yin LIU Er-yong HUANG Guo-jun BAI Li-qiong CHENG Shi-ming |
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| Affiliation: | 1.Tuberculosis Control Department of Hunan Institute For Tuberculosis Control/Hunan Chest Hospital, Changsha 410013, China;2.On-job postgraduate of the Department of Epidemiology and Health Statistics, Xiangya School of Public Health,Changsha 410078, China;3.National Center for Tuberculosis Control and Prevention,China CDC, Beijing, 102206;4.Chinese Antituberculosis Association, Beijing 100710, China |
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| Abstract: | Objective: To evaluate the clinical efficacy, adverse drug reactions, and 1-year and 2-year follow-up recurrence for the 4-month treatment program with Mycobacterium vaccae Vaccine immune intervention in the smear-negative pulmonary tuberculosis treatment, and provide a basis for shortening the course of treatment. Methods: The consecutive cases diagnosed as smear negative pulmonary tuberculosis in Shaodong County and Yueyang County of Hunan province from November 2014 to April 2016 were enrolled in the study. They were enrolled in the ‘DAP epidemiological research system’ according to the inclusion order. They were randomly assigned to the observation group and the control group. Among them, 184 cases in the observation group were treated with 2H-R-Z-E/2H-R combined with Mycobacterium vaccae Vaccine, and 180 cases in the control group were treated with 2H-R-Z-E/4H-R. The clinical efficacy and adverse drug reactions at the end of the intensive treatment and the end of the treatment course were compared between the two groups, as well as the recurrence after 1 and 2 years of follow-up. Results: A total of 364 patients were enrolled, including 292 males (80.2%) and 72 females (19.8%), with an average age of (54±17) years. At the end of the intensive period and the end of the course of treatment, the symptom improvement rates of the observation group were 86.1% (130/151) and 96.0% (145/151), respectively; the control group were 86.5% (128/148) and 95.3% (141/148), respectively. There was no significant difference between the two groups (χ 2=0.010, P=0.921; χ 2=0.103, P=0.749). The absorption rates of chest X-ray lesions in the observation group were 19.0% (35/184) and 41.3% (76/184), respectively; in the control group, they were 18.9% (34/180) and 41.7% (75/180) respectively, and the difference was not statistically significant (χ 2=0.100, P=0.920; χ 2=0.005, P=0.944). The CD4 + T lymphocyte counts of the observation group were (643.3±207.1) cells/μl and (698.5±208.9) cells/μl; the control group were (600.5±183.2) cells/μl and (625.2±177.9) cells/μl, there was no statistically significant difference between the two groups (t=1.023, P=0.309; t=1.766, P=0.081). At the end of the course of treatment, the successful treatment rate of both groups was 100.0% (184/184,180/180). After the course of treatment, the 1-year and 2-year follow-up cumulative recurrence rate in the observation group was 0.6% (1/174) and 1.2% (2/167); the control group was 1.2% (2/172) and 1.8% (3/164) respectively, the difference was not statistically significant (Fisher exact Probability method, P values were 0.621 and 0.683 respectively). During the course of treatment, the incidence of adverse drug reactions in the two groups were 19.6% (36/184) and 28.3% (51/180) respectively, and the difference was statistically significant (χ2=3.846, P<0.05). Conclusion: The clinical efficacy of the 4-month regimen combined with Mycobacterium vaccae Vaccine immunotherapy was not inferior to the 6-month standard regimen in patients with smear-negative pulmonary tuberculosis. And the incidence of adverse drug reactions is low. |
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| Keywords: | Mycobacterium vaccae Vaccine Pulmonary tuberculosis Ultra-short course chemotherapy Clinical features |
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