消癌平注射液联合TP方案治疗晚期非小细胞肺癌痰湿瘀阻证的疗效观察

  目的  观察比较消癌平注射液联合TP化疗及单纯化疗两种治疗方式对ⅢB~ Ⅳ期非小细胞肺癌患者的临床疗效。  方法  采用前瞻性队列研究方法, 纳入ⅢB~Ⅳ期非小细胞肺癌痰湿瘀阻证患者，治疗组及对照组各53例。对照组给予TP化疗, 治疗组为TP方案联合消癌平注射液治疗。比较2组治疗2个疗程后的客观有效率(RR)和疾病控制率(DCR)、中医证候量表积分、欧洲生活质量协作组癌症核心(QLQ-C30)量表积分。比较治疗前后肿瘤标记物、凝血指标及炎症因子水平，并评估治疗过程中不良事件的发生情况。  结果  2个疗程后治疗组RR为41.5%(22/53)，DCR为71.7%(38/53)，对照组分别为35.8%(19/53)和62.3%(33/53)。治疗组患者中医证候量表积分低于对照组(P＜0.05)，QLQ-C30量表疲乏和总体健康状况改善明显(均P＜0.05)。治疗组肿瘤标记物CEA、细胞角蛋白19片段低于对照组(均P＜0.05)；治疗组活化部分凝血活酶时间高于对照组、D-二聚体低于对照组(均P＜0.05)；治疗组炎症因子PCT低于对照组(P＜0.05)。治疗组不良事件中血小板降低发生率低于对照组(P＜0.05)。  结论  消癌平注射液联合TP方案在改善中医临床症状、提高生命质量方面有优势，能预防血小板下降的发生，综合提高晚期非小细胞肺癌痰湿瘀阻证的疗效。 

Clinical observation of Xiaoaiping Injection combined with TP regimen in the treatment of advanced non-small cell lung cancer with phlegm-damp-stasis syndrome

  Objective  This study aims to observe and compare the clinical efficacy of Xiaoaiping Injection combined with TP chemotherapy and chemotherapy alone in patients with non-small cell lung cancer with phlegm dampness stasis syndrome.  Methods  A prospective cohort study was used to enroll patients with stage ⅢB-Ⅳ non-small cell lung cancer with phlegm dampness stasis syndrome, There were 53 cases in the treatment group and 53 cases in the control group. The control group was treated with TP chemotherapy, while the treatment group was treated with TP regimen combined with Xiaoaiping Injection. The objective response rate (RR), disease control rate (DCR), TCM syndrome scale score, and the European Quality of Life Collaboration Cancer Core (QLQ-C30) scale score were evaluated and compared between the 2 groups after 2 courses of treatment. The levels of tumor markers, coagulation indicators and inflammatory factors before and after treatment were compared, and the adverse events during treatment were evaluated.  Results  The objective RR and DCR in the treatment group were 41.5% (22/53) and 71.7% (38/53), after 2 courses of treatment, while those in the control group were 35.8% (19/53) and 62.3% (33/53) respectively. The integral of TCM syndrome scale in the treatment group were lower than those in the control group (P < 0.05), and the QLQ-C30 scale had significant advantages in fatigue improvement and overall health sub items (both P < 0.05). The tumor markers CEA and cytokeratin 19 fragment in the treatment group were lower than those in the control group (all P < 0.05). The activated partial thromboplastin time in the treatment group was higher than that in the control group, and D-dimer was lower than that in the control group (all P < 0.05). The inflammatory factor PCT in the treatment group was lower than that in the control group (P < 0.05). The incidence of thrombocytopenia amongst adverse events in the treatment group was lower than that in the control group (P < 0.05).  Conclusion  Xiaoaiping Injection combined with TP regimen has advantages in improving TCM clinical symptoms and quality of life. It can prevent the occurrence of thrombocytopenia, and comprehensively improve the treatment effect of advanced non-small cell lung cancer with phlegm damp blood stasis syndrome.