扶正祛瘀消癥方联合TP方案治疗气虚毒瘀型晚期非小细胞肺癌临床研究

Clinical Study on Fuzheng Quyu Xiaozheng Prescription Combined with TP Regimen for Advanced Non-small Cell Lung Cancer of Qi Deficiency and Toxin Stasis Type

目的:观察扶正祛瘀消癥方联合TP方案治疗气虚毒瘀型晚期非小细胞肺癌(NSCLC)的临床疗效。方法:选取98例气虚毒瘀型晚期NSCLC患者,按随机数字表法分为观察组与对照组各49例。对照组予TP (紫杉醇+顺铂)方案化疗,观察组在此基础上加服扶正祛瘀消癥方。比较2组临床疗效及严重不良反应发生情况,观察患者治疗前后疼痛介质包括前列腺素(PG)E2、5-羟色胺(5-HT)、内皮素(ET)-1)浓度及中医证候积分的变化。结果:客观缓解率观察组30.6%,对照组18.4%,2组比较,差异无统计学意义(P> 0.05)。观察组临床获益率71.4%,高于对照组的40.8%,差异有统计学意义(P <0.01)。观察组严重不良反应发生率18.4%,低于对照组的36.7%,差异有统计学意义(P <0.05)。治疗后,2组PGE2、5-HT、ET-1浓度均较治疗前降低(P <0.05);观察组3项疼痛介质浓度均比对照组下降更明显(P <0.05)。治疗后,2组中医主、次症积分及总积分均较治疗前均下降(P <0.05);观察组上述各项中医证候积分均比对照组下降更明显(P <0.05)。结论:晚期NSCLC气虚毒瘀证患者应用扶正祛瘀消癥方联合TP方案治疗可提高临床疗效,有效改善患者的中医证候,减轻不良反应,下调疼痛介质水平。

Objective:To observe the clinical effect of Fuzheng Quyu Xiaozheng prescription combined with TP regimen for advanced non-small cell lung cancer(NSCLC)of qi deficiency and toxin stasis type. Methods: A total of 98 patients with advanced NSCLC of qi deficiency and toxin stasis were selected and divided into the observation group and the control group according to the random number table method, 49 cases in each group. The control group was treated with TP regimen(paclitaxel+cisplatin),and the observation group was additionally treated with Fuzheng Quyu Xiaozheng prescription based on the treatment of the control group. The clinical effect and the occurrence of severe adverse reactions in the two groups were compared, and the changes in the concentrations of pain mediators including prostaglandin(PG)E2, 5-hydroxytryptamine(5-HT)and endothelin(ET-1), and Chinese medicine syndrome scores before and after treatment were observed. Results:Objective remission rate was 30.6% in the observation group and 18.4% in the control group, there being no significant difference(P > 0.05). The clinical benefit rate in the observation group was 71.4%, higher than that of 40.8% in the control group, the difference being significant(P < 0.01). The incidence of severe adverse reactions in the observation group was18.4%,lower than that of 36.7% in the control group,the difference being significant(P<0.05). After treatment,the concentrations of PGE2,5-HT and ET-1 in the two groups were decreased when compared with those before treatment(P< 0.05);the above three indexes in the observation group were decreased more obviously than those in the control group(P < 0.05). After treatment,the scores of main and secondary symptoms and the total scores in the two groups were all decreased compared with those before treatment(P < 0.05);the decrease of the above scores was more significant than that in the control group(P < 0.05). Conclusion: The therapy of Fuzheng Quyu Xiaozheng prescription combined with TP regimen for NSCLC can improve the clinical effect, effectively improve Chinese medicine syndrome, lessen adverse reactions, and reduce the levels of pain mediators.