复方苦参注射液联合放疗治疗局部晚期非小细胞肺癌

Combined treatment with composite radix sophora flavescentis injection plus radiotherapy for local advanced non-small cell lung cancer

目的:观察复方苦参注射液联合放疗治疗局部晚期非小细胞肺癌的疗效与减毒作用。方法:128例确诊的Ⅲa/Ⅲb期非小细胞肺癌患者,随机分为治疗组(复方苦参注射液联合放疗组)和对照组(单纯放疗组),观察比较近期疗效和毒副反应。结果:治疗组完全缓解15例,部分缓解37例,疾病稳定9例,疾病进展3例,总的有效率81.3%;对照组完全缓解15例,部分缓解34例,疾病稳定10例,疾病进展5例,总的有效率76.6%。近期疗效比较无显著性差异(P>0.05)。2度以上的急性放射性肺炎发生率,治疗组12.5%(8/64例),对照组26.6%(17/64例);2度以上的急性放射性食管炎发生率,治疗组20.3%(13/64例),对照组43.8%(28/64例);2度以上骨髓抑制发生率,治疗组6.3%(4/64例),对照组18.8%(12/64例)。两组不良反应比较,治疗组均低于对照组(P值分别为0.045,0.004和0.033)。结论:复方苦参注射液联合放疗治疗晚期非小细胞肺癌有显著的减毒作用,值得进一步研究。

Objective：To observe the therapeutic effect and toxicity of composite radix sophora flavescentis injection plus radiotherapy in the treatment of patients with local advanced non-small cell lung cancer.Methods：One hundred and twenty-eight cases of histologically confirmed stage Ⅲa/Ⅲb non-small cell lung cancer were randomized into therapeutic group and control group.The patients in the therapeutic group were treated with composite radix sophora flavescentis injection combined with radiotherapy,while the patients in the control group were treated with single radiotherapy.Short-term efficacy and side-effects of the two regimens were observed and compared.Results：There were 15 CR cases,37 PR cases,9 SD cases and 3 PD cases in the therapeutic group with ORR of 81.3%.There were 15 CR cases,34 PR cases,10 SD cases and 5 PD cases in the control group with ORR of 76.6%.No significant differences were noted between the two groups in regard to the short-term therapeutic efficacy.Eight patients（12.5%） in the therapeutic group and 17 patients（26.6%） in the control group developed Grade 2 radiation pneumonitis.Thirteen patients（20.3%） in the therapeutic group and 28 patients（43.8%） in the control group developed Grade 2 radiation esophagitis.Four patients（6.3%） in the therapeutic group and 12 patients（18.8%） in the control group developed Grade 2 myelosuppression.The toxicity was milder in the therapeutic group than in the control group（P=0.045,0.004 and 0.033,respectively）.Conclusion：Composite radix sophora flavescentis injection plus radiotherapy can decrease the radiation-related side effects for local advanced non-small cell lung cancer.Whether it can improve the therapeutic efficacy needs further studies.