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中国防痨杂志 ›› 2010, Vol. 32 ›› Issue (5): 21-25.

• 论著 • 上一篇    下一篇

在DOTS管理下应用国产4药固定剂量复合剂治疗初治菌阳肺结核的可行性研究

马丽萍1, 吴晓光1, 初乃慧1, 朱莉贞1, 陕斌2, 王敏3, 王燕6, 张文书5, 李会军4, 候栋7   

  1. 1.北京胸科医院;2. 四川省都江堰市疾病预防控制中心;3. 四川省彭州市疾病预防控制中心;4. 四川省龙泉驿区疾病预防控制中心; 5.山东省苍山县结防所; 6.山东省临邑结防所; 7.山东省郓城县结防所;
  • 出版日期:2010-05-20 发布日期:2010-05-20

Feasibility study of domestic four-drug fixed-dose combination under DOTS as initial treatment in ptients with smear positive pulmonary tuberculosis

Ma Liping1; Wu Xiaoguang1; Chu Naihui1; Zhu Lizhen1; Shan Bin2; Wang Min3; Wang Yan6; Zhang Wenshu5; Li Huijun4; Hou Dong7   

  1. 1.Beijing chest hospital; Beijing 101149; China; 2.Dujiangyan CDC of sichuan province; Dujiangyan 611800; 3.Pengzhou CDC of sichuan province; Pengzhou 611930; 4.Longquanyi CDC of sichuan province; Longquanyi 610100; 5.Cangshan TB control institute of Shandong province; Cangshan 277700; 6.Linyi TB control institute of Shandong province; Linyi 251500; 7.Yuncheng TB control institu...;
  • Online:2010-05-20 Published:2010-05-20
  • Contact: Zhu Lizhen E-mail:zhulizhen@hotmail.com

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摘要： 目的 评价在DOTS管理下应用4药（HRZE）固定剂量复合剂（FDC），和2药（HR）的抗结核疗效及不良反应。 方法 将225例初治涂阳肺结核患者，随机分为治疗组（2个月4药FDC/4个月2药FDC）和对照组（2HRZE/4HR），观察近期痰菌阴转率、X线病变改变情况及不良反应。 结果治疗组和对照组2个月痰菌阴转率分别为94.6%、93.8%；满疗程痰菌阴转率分别为99.1%、96.5%；胸部X线明显改善，治疗组和对照组病灶吸收率分别为98.2%和97.4%；2组空洞闭合率分别为72.2%和56.4%；治疗组和对照组各有4例和3例肝功异常。 结论 国产4药固定剂量复合剂是一种安全、高效、易被患者接受的抗结核药物制剂。且有很好的依从性，适于在国内广泛推广应用。

关键词: 结核, 肺/药物疗法, 抗结核药, 固定剂量复合剂

Abstract: Objective To assess antituberculosis efficacy and adverse events of domestic four-drug fixed-dose combination in smear positive pulmonary tuberculosis under the management of directly observed treatment short-course (DOTS).  Method Two hundreds and twenty-five new patients with smear positive pulmonary tuberculosis were randomly divided into a treatment group (2yinuonikang/4yifu capsule) and a control group (2HRZE/4HR) to observe rates of sputum negative conversion in short time, chest X-ray improvement and advert events.  Result The sputum negative conversion rates in the treatment group and the control were 94.6% and 93.8% at the 2nd month, and 99.1% and 96.5% at the end of treatment. Chest radiography showed remarkable improvement of lesions. The foci absorption rate in the treatment group and the controls were 98.2% and 97.4%, respectively, and the cavity closure rates were 72.2% in the treatment group and 56.4% in the controls. Hepatic dysfunction was seen among 4 cases in the treatment group and 3 cases in the controls.  Conclusion Domestic four-drug fixed-dose combination shows an excellent therapeutic efficacy, safety and good compliance in antituberculous chemotherapy which could be recommended widely in tuberculosis control in China.

Key words: tuberculosis, pulmonary/ drug therapy, antitubercular agents, fixed-dose combination

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