结核丸联合2HRZE／4HR方案治疗初患涂阳肺结核随机平行对照研究

Randomized Parallel Controlled Study on the Treatment of Initial Smear Positive Pulmonary Tuberculosis with 2HRZE/4HR combined with Tuberculosis

[目的]观察结核丸联合2HRZE/4HR方案治疗初患涂阳肺结核疗效。[方法]使用随机平行对照方法,将住院患者按病志号抽签方法简单随机分为两组。对照组55例2HRZE/4HR方案:异烟肼0.3g/次,1次/d,口服;利福平0.45g/次,1次/d,口服;乙胺丁醇0.75g/次,1次/d,口服;吡嗪酰胺0.5g/次,3次/d,口服。治疗组55例结核丸3.5g/次,2次/d,口服;2HRZE/4HR方案治疗同对照组。连续治疗6个月为1疗程。观测临床症状、痰菌、病灶、满意度、不良反应。治疗1疗程(2个月),判定疗效。随访2个月。[结果]临床症状、痰菌阴转、病灶吸收两组间无明显差异(P>0.05)。满意度治疗组优于对照组(P<0.05)。随访2个月,临床症状、痰菌阴转、病灶吸收两组间无明显差异(P>0.05)。[结论]结核丸联合2HRZE/4HR方案,与单纯西药治疗无显著差异,应进一步扩大研究样本。

[Objective] To observe the therapeutic effect of tuberculosis pill combined with 2HRZE/4HR regimen in the treatment of initial smear positive pulmonary tuberculosis. [Method] The patients were randomly divided into two groups by the method of random parallel control. The control group of 55 cases 2HRZE/4HR scheme： Isoniazid 0.3 g/times, 1 times/d; rifampiein 0.45 g/times, 1 times/d; ethambutol 0.75 g/times, 1 times/d; Pyrazinamide 0.5 g/times, 3 times/d. In the treatment group, 55 cases were treated with Jiehewan 3.5 g/times, 2 times/d, the 2HRZE/4HR regimen was given to the control group. Continuous treatment for 6 months for a course. Observation of clinical symptoms, sputum bacteria, focus, satisfaction, adverse reaction. Treatment 1 course of treatment （for 2 months）, judge curative effect. Followed up for 2 months. [Result] There was no significant difference between the two groups in clinical symptoms, sputum negative conversion and focus absorption （P〉0.05）; satisfaction with the treatment group was better than the control group （P〈0.05）. There was no significant difference between the two groups in clinical symptoms, sputum negative conversion and focus absorption （P〉0.05）. [Conclusion] There was no significant difference between the combination of 2HRZE/4HR and the western medicine in the treatment of tuberculosis pills, and the sample should be further expanded.