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目的评估抗结核固定剂量复合剂(FDC)的临床疗效,为改进肺结核用药方案提供参考。方法选取初治涂阳肺结核患者140例,随机分为观察组和对照组各70例,2组均采用6个月短程化疗,观察组用药方案为2HRZE/4HR,药物为FDC;对照组给予国家统一标准的2H3R3Z3E3/4H3R3板式组合药,比较2组治疗效果及不良反应。结果治疗2个月及疗程结束时2组患者痰菌阴转率、病灶吸收情况、空洞变化情况,以及实验室指标比较差异均无统计学意义(P>0.05)。观察组不良反应发生率为17.14%,低于对照组的34.29%,差异有统计学意义(P<0.05)。结论 FDC治疗肺结核效果与国家标准治疗方案相似,但能够减少不良反应,具有推广价值。
Objective To evaluate the clinical efficacy of anti-tuberculosis fixed-dose combination (FDC) and provide a reference for improving the regimen of pulmonary tuberculosis. Methods A total of 140 patients with newly diagnosed smear positive pulmonary tuberculosis were randomly divided into observation group and control group with 70 cases each. The two groups were treated with 6-month short-course chemotherapy. The observation group received 2HRZE / 4HR and the drug was FDC. Unified standard 2H3R3Z3E3 / 4H3R3 plate combination of drugs, the two groups compared the therapeutic effect and adverse reactions. Results After 2 months of treatment and the end of treatment, the sputum negative conversion rate, the absorption of lesions, the cavity changes and the laboratory indexes had no significant difference (P> 0.05). The incidence of adverse reactions in the observation group was 17.14%, which was lower than that in the control group (34.29%), the difference was statistically significant (P <0.05). Conclusions The treatment effect of FDC on pulmonary tuberculosis is similar to that of the national standard treatment program, but it can reduce the adverse reaction and has the promotion value.