不同服药方式抗结核固定剂量复合剂的疗效与不良反应分析  

Study on curative effect and adverse reaction between different medication way of anti-TB fixed-dose combination

作　　者：王倪[1] 周林[1] 池俊英[2] 耿红[3] 康森[4] 杨枢敏[5] 张联英[6] 王梅引[7] 樊辰霞[8] 石峰 陈明亭[1] 

机构地区：[1]中国疾病预防控制中心结核病预防控制中心,北京102206 [2]中国卫生部-盖茨基金会结核病防治项目办公室 [3]山东省胸科医院 [4]青海省疾病预防控制中心 [5]甘肃省疾病预防控制中心 [6]河北省疾病预防控制中心 [7]四川省疾病预防控制中心 [8]内蒙古自治区结核病防治研究所 [9]宁夏回族自治区第四人民医院

出　　处：《现代预防医学》2012年第23期6275-6277,共3页Modern Preventive Medicine

基　　金：中国卫生部-盖茨基金会结核病防治项目(建立高质量FDC和二线抗结核药品供应管理系统子项目)

摘　　要：目的对不同服药方式抗结核固定剂量复合剂(FDC)进行比较,为中国抗结核FDC的推广提供政策依据。方法以中国卫生部-盖茨基金会结核病防治项目7个项目省41个项目县(区、旗)为研究现场,采取观察性研究方法,共纳入4907例初治肺结核患者,使用卡方检验比较了不同服药方式下患者不良反应发生情况和治疗转归情况。结果患者中男性占66.8%(3279/4907),农民占75.6%(3711/4907),初中及以下文化程度者占84.1%(4128/4907),平均年龄(48.49±19.08)岁,平均体重(55.93±8.74)kg。患者治疗过程中不良反应总体发生率为21.5%(1055/4907),不同服药方式下不良反应总体发生率的差异无统计学意义(χ2=1.713,P=0.190),但隔日治疗组胃肠道不良反应发生率较高(χ2=6.141,P=0.013);初治涂阳肺结核患者治愈率为94.7%(2896/3059),隔日治疗组患者治愈率较高(χ2=11.791,P=0.001),初治涂阴肺结核患者完成治疗率为95.1%(1758/1848),两组间差异无统计学意义(χ2=2.152,P=0.142)。结论每日治疗方案在治疗转归和不良反应发生率方面与隔日治疗方案相当,但由于其可以降低胃肠道不良反应,改善患者依从性,因此更适宜在中国抗结核FDC推广中使用。OBJECTIVE To facilitate the development of promotion strategies on anti-TB fixed-dose combination （FDC） . METHODS China-Gates Foundation TB Project pilot districts were adopted, 7 provinces and 41 counties were involved. Used observational study method, a total of 4 907 new TB patients were enrolled in this study. Chi-square test was used for comparing the curative effect and adverse reaction between every day treatment group and every other day treatment group. RESULTS Male accounted for 66.8% （3 279 / 4 907）, farmers accounted for 75.6% （3 711 / 4 907）, patients with junior high school education or less were 84.1% （4 128 / 4 907）, average age was 48.49±19.08 years old, and their average weight was 55.93±8.74kg. The total adverse reaction rate was 21.5% （1 055 / 4 907）, the differences between different medication ways were unnoticeable （χ2 = 1.713, P = 0.190）, but the gastrointestinal adverse reaction rate was higher in the every other day treatment group （χ2 = 6.141, P = 0.013）. The cure rate in new smear positive patients was 94.7% （2 896 / 3 059）, and the every other day treatment group performed better than the daily treatment group （χ2 = 11.791, P = 0.001）. The complete treatment rate in new smear negative patients was 95.1% （1 758 / 1 848） and there was no significant difference between different medication ways （χ2 = 2.152, P = 0.142）. CONCLUSION The curative effect and adverse reaction are similar between different medication ways but considering daily treatment can reduce the gastrointestinal side effects, improve patients’ compliance, it’s more suitable to use in the promotion of anti-TB FDC in China.

关 键 词：结核 肺 初治 固定剂量复合剂 不良反应 

分 类 号：R978.3[医药卫生—药品]