铁皮枫斗颗粒(胶囊)治疗肺癌放化疗患者气阴两虚证的临床研究

Clinical Study on Effects of Tiepi Fengdou Granule/Capsule Combined with Chemotherapy and/or Radiotherapy in Treating Lung Cancer with Qi-Yin Asthenia Syndrome

目的研究铁皮枫斗颗粒与胶囊治疗肺癌放化疗患者伴气阴两虚证的有效性及安全性。方法80例患者随机入组,铁皮枫斗颗粒组(32例),铁皮枫斗胶囊组(32例),生脉胶囊对照组(16例)。观察各组患者治疗30天前后气阴两虚证症状、肺癌主要症状及KPS评分、血常规变化。结果铁皮枫斗颗粒组与胶囊组气阴两虚证症状改善有效率分别为81·2%、93·3%,显著高于生脉胶囊对照组(50·0%,P<0·05,P<0·01)。铁皮枫斗胶囊组治疗后较治疗前中性粒细胞计数升高,淋巴细胞计数下降(均P<0·05)。结论铁皮枫斗颗粒及胶囊对气阴两虚证及肺癌症状改善效果显著,两种剂型之间比较差异无显著性。

Objective To study the clinical efficaly and safety of Tiepi Fengdou Granule （TFG） and Capsule （TFC） combined with chemotherapy and/or radiotherapy in treating lung cancer patients with Qi-Yin asthenia syndrome （QYAS）. Methods Eighty patients were randomly assigned into 3 groups： the TFG group （32 cases）, the TFC group （32 cases） and the Shengmai Capsule control group （16 cases）. Changes of symptoms of QYAS, main symptoms of lung cancer, Karnofsky scoring as well as the blood routine test were observed. Results The total effective rate of symptom improving in the TFG group and the TFC group was 81.2 % and 93.3% respectively, showing insignificant difference between the 2 groups （P〉0.05）, but both were higher than that in the Shengmai Capsule control group （50.0%, P〈0.05 and P〈0.01）. Additionally, as compared with those before treatment, the neutrophil count increased and the lymphocytes count obviously decreased in the TFC group after treatment （all P 〈 0.05）. Conclusion Both dose-forms of the remedies, TFC and TFG, have significant effects in treating lung cancer with QYAS, but with insignificant difference between them.