中西医结合疗法治疗初治继发性肺结核病的临床疗效及安全性评价

Therapeutic Effect and Safety of Integrated Therapy of Chinese Medicine and Chemical Drugs on Initial Treatment of Pulmonary Tuberculosis

目的评价中西医结合疗法治疗初治继发性肺结核的临床疗效及安全性。方法临床选择1404例符合西医初治继发性肺结核和中医肺痨(肺阴亏虚、气阴两虚、阴虚火旺证候)诊断标准的患者,进行随机、对照、单盲、多中心临床试验。试验组口服西药+中药,对照组单纯口服西药,疗程6个月。观察2组不良反应发生率和临床症状改善情况,评价其临床疗效及安全性。结果试验组可减少治疗中因药物引起的肝损伤及其他不良反应,不良反应发生率组间比较差异有统计学意义(P<0.001)。肺阴虚证治疗2、4、6个月后,阴虚火旺证治疗6个月后,气阴两虚证治疗4、6个月后症状总积分组间比较差异有统计学意义(P<0.001)。中医证候疗效组间比较差异有统计学意义(P<0.001)。安全性评价分层分析组间比较差异有统计学意义(P<0.001)。结论采用中西医结合方法治疗初治继发性肺结核可减少单纯西药治疗引起的不良反应,减轻临床症状,提高临床疗效和安全性。

Objective To observe the effect of integrated therapy of Chinese medicine and chemical drugs on adverse reaction and curative effect of initial treatment of secondary pulmonary tuberculosis. Methods Totally 1404 patients with secondary pulmonary tuberculosis and TCM lung consumption diagnostic criteria （syndrome of lung yin deficiency, qi-yin deficiency, yin-deficiency caused excessive fire） were chosen for single blind, rarldomized, controlled, multicenter clinical trials. Trial group was given 2HRZE/4HR, 1 time/day with Chinese medicine 2 or 3 times/day, and control group was given 2HRZE/4HR only for six months. The adverse reactions and clinical symptoms were observed to evaluate clinical efficacy and safety. Results In terms of reducing liver damage and other adverse reactions, the ratio of trial group had statistical difference with that of control group （P 〈0.001）. In symptom scores of lung yin deficiency syndrome treated for 2, 4, 6 months, yin-deficiency caused excessive fire syndrome treated for 6 months, qi-yin deficiency syndrome treated for 4, 6 months, the differences between the two groups were significant （P〈0.001）. TCM syndrome curative effect between the two groups was statistical different （P〈 0.001）. Safety evaluation result between the two groups was statistical different by tratified analysis （P〈 0.001）. Conclusion Integrated therapy of Chinese medicine and chemical drugs can improve the symptoms and reduce adverse reactions caused by chemical drugs. It can enhance the curative effect and safety.