Email Alert | RSS    帮助

中国防痨杂志 ›› 2010, Vol. 32 ›› Issue (3): 162-167.

• 论著 • 上一篇    下一篇

四联抗结核固定剂量复合剂的临床疗效研究

钟球, 高翠南, 方兰君, 陈瑜晖, 李建伟, 莫卓鼎   

  1. 广东省结核病防治研究所； 广州市胸科医院； 广东省湛江市结核病防治所；
  • 出版日期:2010-03-20 发布日期:2010-03-20

Study on clinical efficacy of four-drug fixed-dose combinations in tuberculosis treatment

Zhong Qiu，Gao Cuinan,Fang Lanjun,Cheng Yuhui,Li Jianwei,Mo Zhuoding   

  1. 1.Tuberculosis research institute of Guangdong province,Guangzhou 510630,China;2.Guangzhou chest hospital,Guangzhou,510095,China;3.Zhanjiang City Dispensary for Tuberculosis Treatment and Prevention,Zhanjiang,524008,China
  • Online:2010-03-20 Published:2010-03-20
  • Contact: Zhong Qiu E-mail:zhongqiu@vip.163.com

PDF (PC)

794

摘要： 目的 研究四联抗结核固定剂量复合剂的近期疗效及安全性。 方法 将广东省湛江市6个县区登记的540例初治涂阳肺结核病人分为研究组和对照组,用对照研究方法 对2组病例的临床症状、治疗效果和不良反应等进行对比研究。 结果(1)研究组治愈率为94.4%，对照组为92.2%，2组的治愈率比较差异无统计学意义（χ2=1.071, P=0.301）；(2)2组患者相关临床症状（如咳嗽、胸痛、乏力、盗汗、低热、咯血）逐渐得到改善，2组比较差异无统计学意义(P>0.05)；(3)2、3个月末研究组痰菌阴转率分别为90.7%、94.1%，对照组分别为89.6%，91.9%，比较差异无统计学意义（P>0.05）；X线胸片显示空洞愈合方面，研究组的空洞闭合率为78.2%，对照组为61.2%，研究组比对照组高。(4)研究组与对照组的不良反应发生率分别为21.5%和20.0%，比较差异无统计学意义（P>0.05）；强化期对照组的消化道不良反应发生率明显大于研究组（P<0.05）；2组血常规、肝功能异常率接近；研究组因不良反应停药率高于对照组（P<0.05）。 结论 四联FDC与板式组合药具有同等的抗结核疗效，不良反应发生率相近，并且在治疗管理方面显示出较大的优势，建议推荐在我国结核病防治规划中应用。

关键词: 固定剂量复合剂, 结核, 肺;抗结核药

Abstract: Objective To study the short-term efficacy and safety of four-drug fixed-dose combinations (FDC) in tuberculosis treatment.  Methods 540 registered smear positive pulmonary tuberculosis cases in six countiesof Zhanjiang citywere divided into 2 groups,with the case group takingFDC and control group taking the blister pack. The clinical manifestation, treatment outcome and adverse reaction were compared between two groups.   Results (1) the cure rates for FDC group and control group were 94.4% and 92.2% respectively. There was no significant difference between two groups（χ2=1.071, P=0.301）. (2) Related clinical symptoms (such as cough, chest pain, fatigue, night sweats, fever, hemoptysis) both gradually improved, no significant difference between the two groups (P>0.05); (3) The sputum conversion rates at the end of 2nd and 3rd month were 90.7% and 94.1% in the FDC group and 89.6% and91.9% in the control group, and no significant difference between two groups(P>0.05). Chest radiography showed that the cavity closure rate at the end of treatment in the FDC group was 78.2%, higher than that in the control group (61.2%).(4) In the FDC group and the control group, the rate of adverse reactions was 21.5% and 20.0% respectively, with no significant difference between the two groups (P>0.05). In the intensive phase, gastrointestinal adverse reactions in the control group were significantly greater than the FDC group (P<0.05). The abnormal rate of blood routine and liver function was similar in the two groups. The discontinuation rate due to adverse reactions in FDC group was higher than control group.   Conclusion Four-drug FDCs and blister pack drug have equal efficacy in TB treatment, and similar incidence of adverse reactions. FDCs showed great advantages in TB patients management. Therefore, it is recommended to apply FDCs in National TB Program.

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

版权所有 © 2021 中国防痨协会　　　京ICP备11029069号-1   京公网安备11010202007215号
ip访问总数:  ip当日访问总数:  当前在线人数:
本作品遵循Creative Commons Attribution 3.0 License授权许可