目的 评价肺通口服液治疗气阴两虚兼痰瘀交阻型特发性肺纤维化的有效性及安全性。方法 试验采用随机、双盲双模拟、阳性药平行对照、多中心、非劣性的临床试验方法，共纳入253例受试者，随机分为肺通大剂量组(84例)、小剂量组(85例)和对照组(84例)，疗程12周，观察肺通口服液治疗特发性肺纤维化的疗效及安全性。结果 在疾病疗效比较中，肺通大剂量组非劣效于对照组；肺通大剂量组患者生活质量明显优于对照组(P < 0.05)；6 min步行距离、血气分析(动脉血氧分压、动脉血氧饱和度、肺泡动脉氧分压差)及肺功能(肺总量、一氧化碳弥散能力)等指标比较，肺通大剂量组有优于对照组及肺通小剂量组的趋势，但差异无显著性意义。肺通大、小剂量组不良反应发生率明显低于对照组。结论 肺通口服液治疗特发性肺纤维化(气阴两虚兼痰瘀交阻型)安全有效。

Objective To evaluate the efficacy and safety of Feitong oral liquid(FOL) in treating qi-yin deficiency idiopathic pulmonary fibrosis accompanied with phlegm and blood stasis. Methods A multicenter，randomized，double blind，double dummy，controlled trial was conducted. A total of 253 patients with idiopathic pulmonary fibrosis were randomly divided into three groups. Large-dose FOL group(84 patients) were treated with large-dose FOL and prednisone acetate analogue，small-dose FOL group(85 patients) were treated with low-dose FOL and prednisone acetate analogue，and the control group(84 patients) were treated with prednisone acetate and FOL analogue. The therapeutic course of all the groups was 12 weeks. After treatment，the efficacy and safety were evaluated. Results The large-dose FOL group obtained non-inferior effect to control group in curative effect rate. The large-dose FOL group obtained better effect than control group in the quality of life(P < 0.05). Compared with the small-dose FOL group and the control group，large-dose Fol group showed a trend on improving six-minute walking distance，blood gas analysis parameters (PaO₂，SaO₂，P(A-a)O₂) and pulmonary function(total lung capacity and diffusing capacity of the lung for carbon moNO_xide)，but there was no significant difference among the three groups. The incidence of adverse reaction was lower in FOL groups than that in the control group. Conclusion Feitong oral liquid is effective and safe in treating qi-yin deficiency idiopathic pulmonary fibrosis accompanied with phlegm and blood stasis.

R285.6

国家自然科学基金资助项目(30901948)；中国中医科学院西苑医院课题(WYKY-mp-05)。