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目的通过中西医结合治疗693例初治继发性肺结核肺阴虚证临床观察评价该方案对减轻抗结核化疗药物毒副作用、促进空洞闭合、痰菌阴转、改善症状及提高生活质量等方面的疗效和安全性。方法对全国不同地域的693例初期继发性肺结核患者采用随机、单盲、阳性药平行对照、多中心临床试验,观察其安全性及有效性。试验组和对照组均采用2HREZ/4HR化疗方案治疗,试验组在化疗方案的基础上加用对症的中药治疗,每月检查血尿常规、肝功能、肾功能、痰涂片等指标,隔月复查胸片、T细胞亚群并进行中医证候评分,疗程为6个月。结果痰菌涂片阴转率,两组比较无统计学意义;X线疗效评价、中医证候疗效评价、生活质量评价及不良反应评价,两组比较均有统计学意义,试验组优于对照组;药物依从性分析,两组比较无统计学意义。结论本研究通过应用滋阴润肺免煎颗粒联合西药抗痨药物治疗初治继发性肺结核肺阴虚证疗效显著,能有效的减轻抗结核化疗药物毒副作用、促进空洞闭合、痰菌阴转、改善症状及提高生活质量,从而明显提高患者的治愈率,降低患者的复发率和耐药率。
Objective To observe the clinical observation of 693 cases of newly diagnosed lung-yin deficiency syndrome of pulmonary tuberculosis treated by integrated traditional Chinese and western medicine in the aspects of reducing the toxic and side effects of anti-TB chemotherapy drugs, promoting empty closure, sputum negative conversion, improving symptoms and improving quality of life Efficacy and safety. Methods A total of 693 patients with initial secondary pulmonary tuberculosis in different regions of China were randomly divided into two groups: randomized, single-blind and positive drug-controlled, multicenter clinical trial to observe the safety and efficacy. Experimental group and control group were treated with 2HREZ / 4HR chemotherapy, the experimental group on the basis of chemotherapy plus symptomatic Chinese medicine treatment, monthly examination of hematuria, liver function, renal function, sputum smear and other indicators, review the chest every other month Films, T cell subsets and TCM syndrome score, treatment for 6 months. Results The negative conversion rate of sputum smear was no significant difference between the two groups. The evaluation of X-ray efficacy, TCM syndrome curative effect, quality of life and adverse reactions were statistically significant, the experimental group was better than the control group Group; drug compliance analysis, no significant difference between the two groups. Conclusion In this study, the application of Ziyin Runfei Granule combined with western medicine anti-tuberculosis drugs in the treatment of primary pulmonary tuberculosis yin deficiency syndrome significant effect, can effectively reduce the side effects of anti-TB chemotherapy drugs to promote empty closure, sputum negative conversion , Improve symptoms and improve quality of life, thus significantly improve the cure rate of patients, reduce the patient’s recurrence rate and drug resistance.