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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。
Objective To study the short-term curative effect and safety of quadruple anti-tuberculosis fixed-dose combination. Methods 540 patients with newly diagnosed smear positive pulmonary tuberculosis registered in 6 counties of Zhanjiang City of Guangdong Province were divided into study group and control group. The clinical symptoms, treatment effects and adverse reactions of the two groups were compared by the comparative study. Results (1) The cure rate was 94.4% in the study group and 92.2% in the control group. There was no significant difference in the cure rate between the two groups (χ2 = 1.071, P = 0.301). (2) The clinical symptoms Cough, chest pain, fatigue, night sweats, fever and hemoptysis) in the two groups were significantly improved (P> 0.05). (3) The sputum negative conversion rates in the study group at the end of two and three months were 90.7% 94.1% in the control group and 89.6%, 91.9% in the control group, respectively. There was no significant difference between the two groups (P> 0.05). In the X-ray examination, the empty cavity closure rate was 78.2% in the study group and 61.2% Study group than the control group. (4) Adverse reactions in study group and control group were 21.5% and 20.0%, respectively, with no significant difference (P> 0.05). The incidence of gastrointestinal adverse reactions in the control group was significantly higher than that in the study group (P <0.05). The blood routine and the rate of abnormal liver function in two groups were close. The withdrawal rate in study group was higher than that in control group (P <0.05). Conclusions Quadruple FDC has the same anti-tuberculosis efficacy as plate-type combination drug with similar incidence of adverse reactions, and shows great advantages in treatment management. It is recommended to be applied in the prevention and control program of tuberculosis in our country.