汉防己甲素联合GP方案治疗晚期非小细胞肺癌的随机对照临床研究

Randomized controlled clinical trial on tetrandrine combined with GP regimen in the treatment of advanced non-small cell lung cancer

目的:评价汉防己甲素注射液联合吉西他滨(gemcitabine,G)、顺铂(cisplatin,P)方案治疗晚期非小细胞肺癌(a-NSCLC)的临床疗效、不良作用。方法:240例a-NSCLC患者随机分为汉防己甲素联合GP方案组和单纯GP方案组。吉西他滨1000mg/m2于第1、8天静滴,顺铂75mg/m2于第1天静滴,治疗组同时加用汉防己甲素注射液150mg/d静滴,第1-10天连续给药,对照组单纯化疗,每21天为1个周期。按照RE-CIST标准评价近期疗效,参照Karnofsky评分及体重变化评价生活质量,按照NCICTC3.0版标准评价毒性反应。结果:219例患者可评价疗效。治疗组近期客观有效率36.1%,对照组为24.3%,P=0.057;治疗组近期疾病控制率63.9%,对照组为52.3%,P=0.081;1年生存率两组分别为45.7%、31.3%,P=0.059;治疗后两组KPS评分提高率分别为49.1%、32.4%,P=0.012;体重增加率分别为28.7%、16.2%,P=0.027。治疗组的2-4度白细胞、血小板减少及恶心、呕吐等发生率分别为38.0%、19.4%、46.3%、16.7%,均低于对照组53.2%、34.2%、63.0%、27.9%,均P<0.05,而局部刺激为2.8%,略高于对照组0.0%,P>0.05;上述不良反应均可耐受及预防。结论:汉防己甲素可能具有提高a-NSCLC患者化疗的近期疗效、延长生存期的作用,无明显不良作用,同时可减轻化疗不良反应、改善患者的生活质量,在一定程度上提高机体对化疗的耐受性,是a-NSCLC综合治疗的较好选择。

Objective：To evaluate the curative effect and side - effect of tetrandrine （Tet） injection combined with GP（gemcitabine/cisplatin） regimen in the treatment of advanced non -small cell lung cancer（ a -NSCLC）. Meth- ods： Total of 240 patients with a - NSCLC were randomized assigned to two groups. Patients in the treatment group re- ceived Tet combined with chemotherapy of GP regimen, otherwise with chemotherapy alone. The regimen was repeated every 21 days. We evaluated the curative effect according to RECIST criteria, quality of life（QOL） according to Karnofsky scores, and side - effect according to NCI CTC 3.0 version criteria. Results： Among 240 patients 219 cases were evaluable. No significant difference was found between the two groups in response rate（36.1% versus 24.3% ,P =0.057） ,disease control rate（63.9% versus 52.3% ,P = 0. 081 ） and one - year survival rate（45.7% ver- sus 31.3% ,P = 0. 059）. Significant difference was shown in KPS improving rate （49.1% versus 32.4% ,P = 0. 012） and body weight score raising up rate（28.7% versus 16.2% ,P = 0. 027 ）. The incidence of G2 - 4 neutropenia, thromboeytopenia, nausea and vomiting in treatment group were 38.0%, 19.4% ,46.3% and 16.7%, respectively, were significantly lower than that of control group （53.2% , 34.2% , 63.0% and 27.9%, respectively）, P 〈 0.05. Meanwhile, the rate of local venous toxicity （2.8%） was a little higher than the control group （0.0%） , P 〉 0.05. All of the side - effects above were acceptable and preventable. Conclusion： As a complementary treatment of a - NSCLC chemotherapy,Tet injection, with no obvious side- effects, could improve response rate, prolong survival period, re- duce chemotherapy side - effects and improve patients＂ QOL. Tet combined with GP regimen is a better choice for comprehensive treatment of a - NSCLC.