抗结核固定剂量复合剂与板式组合药治疗肺结核效果对比分析

摘要/Abstract

摘要： 目的研究国产抗结核FDC的有效性和安全性,探索适合深圳市结核病防治用药。方法从深圳市罗湖区和南山区登记的全部初治涂阳病例中随机抽取200例,其中FDC组、对照组(板式组合药)各100例,均采用全程督导的方式。对两组病人的用药剂量、临床表现、治疗效果、不良反应进行分析比较。结果(1)FDC组与对照组患者1、2、3、6个月末相关临床症状(如盗汗、发热、咳嗽、咯血、胸痛、呼吸困难、乏力)的出现率均逐渐下降,两组无显著性差异(P<0.05);(2)FDC组与对照组2个月末痰菌阴转率分别为88%、84%,6个月末痰菌阴转率提高到98%、97%,两组6个月末结核空洞闭合率分别为58.3%、48.6%,痰菌阴转率X线胸片吸收率和空洞闭合率均无显著性差异(P<0.05);(3)FDC组与对照组临床不良反应率分别为25%和18%,WBC异常率分别为18%和11%,AST异常率分别为16%和9%,TBIL异常率分别为19%和15%,临床和实验室检测的结果均无显著性差异(P<0.05);(4)FDC中利福平(R)的体质量与剂量相关系数为0.804,高于组合药中利福平(R)的体质量与剂量相关系数(0.781)。FDC组异烟肼(H)、利福平(R)、吡嗪酰胺(Z)、乙胺丁醇(E)的用药剂量低于对照组,有显著性差异(P<0.05)。结论国产FDC与板式组合药的治疗效果相同,不良反应率相近,但FDC药物的用药剂量低,具有一定的推广应用前景。

关键词: 固定剂量复合剂, 结核,肺/药物疗法

Abstract: Objective To study the effects and safety of fixed-dose combinations(FDC) in treatment of tuberculosis,and to explore good medication and measure which is fitted for anti-tuberculosis chemotherapy in Shenzhen. Methods Two hundred new smear-positive pulmonary tuberculosis patients(PTB) randomly selected from Luohu district and Nanshan district were allocated into two groups with 100 into FDC treatment group and 100 into controlled group.DOT was adopted in both groups.The following issues were compared between the two groups including drug dosage,clinical manifestation,treatment outcome and adverse reaction. Results (1) The incidence of clinic symptoms such as night sweating,fever,cough,emptysis,chest pain,dyspnea and fatigue were gradually declined at the end of 1st,2nd,3rd and 6th month in both groups,but there was no significant difference between the two groups(P<0.05).(2) The negative conversion rates of sputum at the end of 2nd month were 88% and 84% in the FDC group and the control group and 98% and 97% at the end of 6th month.Chest radiography showed remarkable improvement.The cavity closure rates at the end of 6th month were 58.3% in the FDC group and 48.6% in the control group.No significant difference was found between them(P<0.05).(3) In FDC group and control group,the rate of adverse reactions was 25% and 18%,abnormity rate of WBC was 18% and 11%,abnormity rate of was 16% and 9% and abnormity rate of BIL was 19% and 15%.There was no significant difference between the two groups.(4) The relation efficient between weight and dosage of RFP in the FDC group and the control group were 0.804 and 0.781 respectively.The per dose/kg of INH,RFP,PZA and EMB in FDC group was lower than those in the control group and there was significant difference between them(P<0.05). Conclusion The treatment outcome and adverse reaction FDC are similar as blister pack drug in treating smear-positive TB.While the dosage of FDC is lower than blister pack,the expanded use of FDC is promising.

Key words: Fixed-dose combination, Pulmonary tuberculosis/drug therapy

谭卫国,杨应周,吴清芳,张玉华,管红云,钟球,王甦民,傅瑜,. 抗结核固定剂量复合剂与板式组合药治疗肺结核效果对比分析[J]. 中国防痨杂志, 2007, 29(2): 117-121.

Tan Weiguo¹,Yang Yingzhou,Wu Qingfang,et al.. Comparison analysis on Fixed-dose Combination and blister pack drug in treating tuberculosis patients[J]. Chinese Journal of Antituberculosis, 2007, 29(2): 117-121.

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