解毒抑瘤汤联合西医标准方案治疗基因突变阴性晚期非小细胞肺癌的疗效观察

The efficacy of JieduYiliu decoction combined with Western medicine standard regimen in the treatment of gene mutation negative advanced non-small cell lung cancer

目的:观察基于“癌毒-气血津液”病机理论组方的解毒抑瘤汤联合西医标准方案治疗基因突变阴性晚期非小细胞肺癌(Non-small cell lung cancer,NSCLC)的疗效及毒副反应。方法:收集基因突变阴性晚期NSCLC病例共48例,采用随机数字表法分为治疗组与对照组,每组各24例,对照组采用西医标准方案治疗,治疗组在对照组基础上给予中药汤剂解毒抑瘤汤加减,以21天为1个周期,连续治疗2个周期后评价两组患者的近期疗效、中医证候疗效、生活质量、中位无进展生存期及毒副反应。结果:治疗组vs对照组:治疗有效率:54.2%vs 45.8%;疾病控制率:83.3%vs 70.8%;中医证候疗效:87.5%vs 70.8%;KPS评分:78.49±12.81分vs 69.32±13.94分;中位无进展生存期:9.8月vs 6.2月。治疗组在治疗有效率、疾病控制率、中医证候疗效、KPS评分及中位无进展生存期方面均优于对照组(P<0.05)。治疗组的恶心呕吐、便秘、纳差乏力发生率低于对照组(P<0.05),治疗组的骨髓抑制和肝肾损害发生率与对照组相比无统计学差异(P>0.05)。结论:解毒抑瘤汤能提高西医标准方案治疗基因突变阴性晚期NSCLC的近期疗效,延长患者生存时间,改善患者中医证候和生活质量,同时能减轻化疗相关部分副反应,且安全性好。

Objective:To observe the efficacy and toxicity of JieduYiliu decoction combined with Western medicine standard regimen in the treatment of gene mutation negative advanced non-small cell lung cancer(NSCLC)based on the pathogenesis theory of“cancer toxin-qi blood and body fluid”.Methods:48NSCLC cases with negative gene mutations were randomly divided into the treatment group and the control group,with 24cases in each group.The control group was treated with a standard Western medicine regimen,while the treatment group was treated with the traditional Chinese medicine JieduYiliu decoction on the basis of the control group.After two consecutive cycles of treatment,evaluate the short-term efficacy,traditional Chinese medicine syndrome efficacy,quality of life,Median progression free survival and toxic side effects.Results:Treatment group vs control group:Treatment effective rate:54.2%vs 45.8%;Disease control rate:83.3%vs 70.8%;The improvement rate of traditional Chinese medicine syndrome:87.5%vs 70.8%;KPS score:78.49±12.81points vs 69.32±13.94points;Median progression free survival time:9.8months vs 6.2months.The treatment group was superior to the control group in terms of treatment effectiveness,disease control rate,improvement rate of traditional Chinese medicine syndrome,KPS score,and median progression free survival(P<0.05).The incidence of nausea,vomiting,constipation,and anorexia in the treatment group was lower than that in the control group(P<0.05),and there was no statistically significant difference in the incidence of bone marrow suppression and liver and kidney damage between the treatment group and the control group(P>0.05).Conclusions:JieduYiliu decoction can improve the short-term efficacy of Western medicine standard regimen in treating the advanced NSCLC with negative gene mutations,prolong the survival time of patients,improve their traditional Chinese medicine syndromes and quality of life,and alleviate some chemotherapy related side effects,with good safety.