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目的观察补肺通络丸联合甲氨蝶呤治疗早期类风湿关节炎肺间质病变(RA-ILD)的临床疗效及安全性。方法选择符合纳入标准的患者64例,随机分为治疗组和对照组各32例,治疗组在甲氨蝶呤基础上口服补肺通络丸,对照组继续单用甲氨蝶呤,治疗6个月后比较两组患者肺功能指标及高分辨率CT(HRCT)治疗前后的变化。结果治疗后治疗组的肺总量(TLC)、一氧化碳弥散量(DLCO)较治疗前明显改善(P<0.01),其HRCT评分较治疗前减小(P<0.05),两组治疗后的TLC、DLCO、HRCT结果比较差异有统计学意义(P<0.01或P<0.05)。结论补肺通络丸联合甲氨蝶呤治疗早期RA-ILD能明显改善肺功能,缩小肺间质病变面积,疗效确切,安全性好。
Objective To observe the clinical efficacy and safety of Bufei Tongluo Pill combined with methotrexate in the treatment of early rheumatoid arthritis (RA-ILD). Methods Sixty-four patients who met the inclusion criteria were randomly divided into treatment group (n = 32) and control group (n = 32). The treatment group received Bufei Tongluo Pill on the basis of methotrexate, while the control group continued methotrexate alone. A month later, the pulmonary function indexes and the changes of high resolution CT (HRCT) before and after treatment were compared between the two groups. Results After treatment, the total amount of pulmonary function (TLC) and diffusing capacity of carbon monoxide (DLCO) in the treatment group were significantly improved (P <0.01), and the HRCT score of the treatment group was significantly lower than that before treatment (P <0.05) There was significant difference between DLCO and HRCT (P <0.01 or P <0.05). Conclusion Bufei Tongluo Pills combined with methotrexate early RA-ILD can significantly improve lung function, reduce interstitial lung disease area, the exact effect, good safety.