金康化积方二线治疗晚期非小细胞肺癌临床观察

Clinical observation of second-line therapy with Jinkang Huaji Decoction in advanced non-small cell lung cancer

目的观察金康化积方二线辨证治疗晚期非小细胞肺癌的临床疗效和不良反应。方法将符合入组标准的86例患者随机分为中药组41例和化疗组45例。中药组服用自拟金康化积方,4周为1个治疗周期;化疗组予第三代化疗药单药或联合铂类方案化疗,3周为1个治疗周期,最多不超4个治疗周期。2组每治疗2个周期后评价疗效,观察记录治疗前后肺癌相关症状缓解情况、KPS评分及不良反应发生情况,同时检测T细胞亚群,并对2组进行生存分析。结果治疗后中药组咳嗽、咳痰、咯血、发热等肺癌相关症状的缓解率优于化疗组(P均<0.05);中药组疾病控制率为60.00%,化疗组为58.14%,2组比较差异无统计学意义(P>0.05);2组中位PFS、中位OS及1年生存率比较差异无统计学意义(P均>0.05);中药组KPS评分提高率+稳定率为85.00%,化疗组为62.78%,2组比较差异有统计学意义(P<0.05);中药组治疗后CD3+、CD4+、CD4+/CD8+均明显高于治疗前及同期化疗组(P均<0.05);中药组贫血、乏力、粒细胞减少、血小板减少、消化道反应及脱发发生率均明显低于化疗组(P均<0.05)。结论中药金康化积方辨证施治在晚期非小细胞肺癌二线治疗中疗效满意,不良反应较轻,值得临床推广。

Objective It is to observe the clinical effects and adverse reactions of second-line therapy with Jinkang Huaji Decoction（ JKHJD） in advanced non-small cell lung cancer. Methods 86 patients were divided into Chinese medicine group with 41 cases and chemotherapy group with 45 cases. The patients in the Chinses medicine group were treated with JKHJD,4weeks for a treatment cycle; and the patients in the chemotherapy group were treated with chemotherapy scheme of the 3rd generation chemotherapy drugs single or combined with platinum in the chemotherapy group,3 weeks for a treatment cycle,most of the 4 treatment cycles. The curative effect was evaluated once every 2 treatment cycles,the relief conditions of lung cancer symptoms,KPS scores,and the adverse reaction were recorded,and T- cell Subgroups were detected at the same time,and the survival analysis was performed. Results The response rates of the Chinese medicine group were significantly higher than the chemotherapy group in chogh,fever,expectoration,hemoptysis related lung cancer（ all P 0. 05）. The disease control rates was 60. 00% in the Chinese medicine group and 58. 14% in the chemotherapy group,there was no significant differences between the two groups（ P 0. 05）. There was no significant difference in median PFS,median OS and survival rates between the two groups（ all P 0. 05）. The rate of KPS score in improvement and stability was 85. 00% in Chinese medicine group and 62. 78% in chemotherapy group,there was significant difference（ P 0. 05）. The value of CD3＋,CD4＋and CD4＋/CD8＋in the Chinese group after treatment were obviously increase than before treatment and the chemotherapy group（ all P 0. 05）. The incidences of anemia,feeble,granulocytopenia,thrombocytopenia,digestive tract reaction and calvities of Chinese medicine group were significantly higher than these of the chemotherapy group（ all P 0. 05）. Conclusion The curative effect of JKHJD is satisfactory in second-line therapy of advanced non-small cell lung cancer,and the adverse reaction is small.