复方苦参注射液对中晚期肺癌化疗增效减毒作用的临床研究

Synergy and Attenuation of Compound Matrine Injection on Chemotherapy in Patients with Advanced Lung Cancer:A Clinic Study

目的:探讨复方苦参注射液对中晚期肺癌化疗增效减毒作用。方法:复方苦参注射液联合化疗为实验组,以顺铂为主的联合化疗为对照组,观察对比2组近期客观疗效、2组不同分期与疗效的关系、治疗后2组中医证候改善情况、2组治疗后卡氏评分变化情况以及2组治疗期间的不良反应。结果:实验组近期客观疗效CR+PR+NC 83.65%,对照组CR+PR+NC 72.50%,两组比较差异有统计学意义(P<0.01);分期与疗效:实验组Ⅱ、Ⅲ期有效率CR+PR80%,Ⅳ期有效率CR+PR 53.85%,对照组Ⅱ、Ⅲ期有效率CR+PR 55.56%,Ⅳ期有效率CR+PR 40.91%,2组比较差异有统计学意义(P<0.05);中医症候群方面除咯血外,实验组与对照组比较均具有显著性差异(P<0.01);卡氏评分改善:实验组改善56.22%稳定23.91%降低10.87%,对照组改善45.00%稳定37.50%降低17.50%,实验组与对照组比较均具有显著性差异(P<0.01);安全性观察:Hb降低发生率实验组为32.61%,对照组为40.00%。WBC降低发生率实验组为86.96%,对照组97.5%(P<0.01)。恶心呕吐发生率实验组为30.42%,对照组为45.00%(P<0.01)。其他不良反应未显示出统计学差异。结论:复方苦参注射液对中晚期肺癌化疗具有增效减毒作用,值得广泛应用。

OBJECTIVE：To evaluate the synergy and attenuation of Compound Matrine Injection on chemotherapy in patients with advanced lung cancer.METHODS： The patients enrolled were assigned to receive Compound Matrine Injection plus chemotherapy（trial group） or Cisplatin-predominated combined chemotherapy（control group）.The short-term objective curative efficacy,the relation between different stages and curative efficacy,improvement in traditional Chinese syndromes and the Karnofsky scores after treatment as well as the adverse reactions during treatment in the two groups were evaluated.RESULTS： There were significant differences in short-term objective curative efficacy（CR ＋ PR ＋ NC） between the trial group and the control group（83.65% vs.72.50%,P 0.01）.Regarding the staging and curative efficacy,the effective rate（CR ＋ PR） was 80% at stage II and III and 53.85% at stage IV for the trial group,as compared with 55.56% at stage II and III and 40.91% at stage IV for the control group,the differences between the two groups were significant（P 0.05）.In terms of traditional Chinese syndromes,the differences between the two groups in all syndromes except hemoptysis were significant（P 0.01）.With regard to Karnofsky scores,there were significant differences between the two groups（P 0.01）,with 56.22% showing improvement,23.91% stable and 10.87% decrease in the trial group as compared with 45.00% improvement,37.50% stable and 17.50% decrease in the control group.In terms of safety,the incidence rate of Hb reduction was 32.61% in the trial group as compared with 40.00% in the control group;the incidence rate of WBC reduction was 86.96% in the trial group vs.97.5% in the control group（P 0.01）,and the incidence rate of nausea and vomiting was 30.42% in the trial group as compared with 45.00% in the control group（P 0.01）.No significant differences were noted between the two groups in the other side effects.CONCLUSION： Compound Matrine Injection has synergy and attenuation action on chemotherapy in patients with advanced lung cancer,which is thus worthy of being recommended in clinical practice.