中医药辨证治疗亚实性肺结节的实用性随机对照研究

A Practical Randomized Controlled Study on Effectiveness of TCM Syndrome Differentiation Treatment for Subsolid Pulmonary Nodules

目的探讨中医药在亚实性肺结节(SSN)中的治疗效果。方法纳入SSN患者254例,分为中药组102例与随访组152例,随访组根据指南推荐定期复查,中药组给予中药辨证治疗24周,对比两组患者治疗前后SSN直径、数目、中医症状积分并评价总体疗效,记录不良反应发生情况及安全性指标。结果中药组治疗有效率(16.7%)显著高于随访组(2.6%)(P<0.01)。与本组治疗前相比,中药组SSN直径、数目无显著变化,乏力、小便黄赤症状积分及中医症状总分均显著降低(P<0.05);随访组SSN直径显著增大(P<0.01)、数目显著增多(P<0.01)。组间对比显示:治疗后随访组SSN直径增大程度显著高于中药组(P<0.05),乏力、情志抑郁、小便黄赤症状积分及中医症状总分显著高于中药组(P<0.05或P<0.01)。结论中医药治疗SSN临床疗效明确,能降低SSN恶性风险,改善SSN患者临床症状且安全可行,可进一步研究和应用。

Objective To explore the therapeutic effect of traditional Chinese medicine(TCM)on subsolid nodule(SSN).Methods A practical randomized controlled study method,including 254 SSN patients was adopted.The patients were divided into the TCM(102 cases)and follow-up(152 cases)groups.The follow-up group received regular check-ups in accordance with the guidelines,and the TCM group received TCM syndrome differentiation treatment for 24 weeks.The two groups were compared in terms of the changes in their SSN diameter,SSN number,TCM symptom score,and overall therapeutic effect before and after treatment.Adverse reactions and safety indicators were also recorded.Results The TCM group showed a significantly higher effective rate of treatment(16.7%)than the follow-up group(2.6%)(P<0.01).Compared with their condition before treatment,the TCM group showed no significant changes in their SSN diameter and number but presented considerably reduced fatigue,yellow and red urine symptoms,and overall TCM symptom score(P<0.05).The follow-up group exhibited significantly increased diameter and number of SSN(P<0.01).The follow-up group showed the significantly higher increase in SSN diameter after treatment than the TCM group(P<0.05).Moreover,the follow-up group showed significantly higher fatigue,depression,yellow and red urine symptom scores,and overall TCM symptom score than the TCM group(P<0.05 or P<0.01).Conclusion TCM treatment for SSN has a distinct clinical efficacy,reduces the malignant risk of SSN and improves clinical symptoms of SSN patients,and is safe and feasible.