肺结核病人对抗结核FDC制剂治疗可接受性的研究  

Investigation into the accptibility of tuberculosis patients to treatment with anti-TB preparation

作　　者：赵梅桂[1] 赵安贵[1] 龙卫军[1] 林仕平[2] 钟云辉[1] 潘海宏[1] 文善适[1] 

机构地区：[1]深圳市宝安区慢性病防治院,广东深圳518133 [2]深圳市慢性病防治院,广东深圳518020

出　　处：《中国热带医学》2006年第7期1154-1156,共3页China Tropical Medicine

基　　金：深圳市科学技术委员会资助项目(项目编号为200304209)

摘　　要：目的评价肺结核病人对抗结核FDC制剂治疗可接受性的情况。方法对373例新发涂阳肺结核病例,随机分为FDC制剂组和广泛使用的组合药组。在治疗期间对病人的耐受性、副反应和实验室检查结果进行监测。结果与组合药组病人相比,更多的FDC组病人认为服药方式可以接受,药片大小合适,药片数适中(P<0.05);但药片吞咽情况、药片苦不苦、药片是否粘喉等问题上两组病人回答结果接近(P>0.05);FDC组病人强化治疗期流感综合症的出现率略高于组合药组(P<0.05),其余副反应(包括消化道症状、皮肤反应、神经系统症状以及视听神经症状)的出现情况两种药物之间差异无显著性意义(P>0.05);实验室检查,FDC组AST异常率高于组合药组,但TBIL异常率低于组合药(P<0.05),两组肝功能异常者ALT、AST、TBIL的分布一致(P>0.05)。结论相对于传统组合药,病人对FDC制剂的接受性改善,但FDC组流感综合症和AST异常率高于组合药组。Objective To evaluate the acceptability of tuberculosis patients to anti - tuberculosis therapy with fixed - dose combination （FDC） in China. Methods 374 cases diagnosed as new smear positive pulmonary tuberculosis patients were allocated into two groups： FDC group consisted of 232 cases and a control group consited of 141 cases .The side effect were strictly supervised by the investigator. Results 1 ） Compared with control group, most of the cases in FDC group could accept the therapeutic procedure, the size and number of pills （ P 〈 0.05） ; 2）the incidence of influenza syndrome in the FDC group during the first two months of anti - tuberculosis treatment was a little higher than that in the control group , but no significant difference could be observed on the adverse reactions in the two groups （ P 〈 0.05） ; 3）laberatory test result showed that Abnormal rate of AST was higher and TBIL was lower in FDC group as compared with the control one （ P 〈 0.05） . The distribution of ALT, AST, TBIL in those with abnormal liver function patients of the two groups were similar. Conclusion FDC can improve acceptability of patients to anti - tuberculosis therapy, but the incidence rate of flu syndrome and abnormity rate of AST were higher in FDC group than in control group, but the mechanism remains to be explored.

关 键 词：结核 治疗 FDC 可接受性 

分 类 号：R521[医药卫生—内科学]