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目的评价复方苦参注射液联合多西他赛每周方案治疗老年非小细胞肺癌(NSCLC)的疗效及安全性。方法将68例老年Ⅲa~Ⅳ期NSCLC患者随机分为治疗组33例和对照组35例。两组均给予多西他赛35mg/m2,溶于250ml生理盐水中静脉滴注1h,分别于第1、8天给药。对照组在给予多西他赛前1天开始口服地塞米松片4mg,每天2次,共3天;治疗组在化疗的同时静脉滴注复方苦参注射液10ml,每天1次,连用14天,休息7天,21天为1个周期。两组疗程均以3周为1个周期,重复2个周期。治疗结束后观察两组患者肿瘤疗效、Karnofsky评分、体重及不良反应(包括白细胞减少、恶心呕吐、乏力、肝肾功能损害、便秘)。结果近期总有效率治疗组24.24%,对照组22.86%,两组比较差异无统计学意义(P>0.05);疾病控制率治疗组69.70%,对照组57.14%,两组比较差异有统计学意义(P<0.05)。治疗组治疗后Karnofsky评分降低和体重下降均少于对照组(P<0.05)。两组患者在恶心呕吐、白细胞减少、乏力和肝肾功能损害、便秘等方面比较差异有统计学意义(P<0.05),治疗组的不良反应小于对照组。结论复方苦参注射液联合多西他赛每周方案化疗治疗老年NSCLC患者安全有效,复方苦参注射液有一定的减毒增效作用。
Objective To evaluate the efficacy and safety of compound Kushen injection combined with weekly docetaxel in the treatment of elderly non-small cell lung cancer (NSCLC). Methods Sixty-eight elderly patients with stage Ⅲa-Ⅳ NSCLC were randomly divided into treatment group (n = 33) and control group (n = 35). Both groups were given docetaxel 35mg / m2, dissolved in 250ml normal saline intravenous infusion 1h, respectively, in the first and eighth days of administration. The control group received oral administration of dexamethasone 4mg once daily for 3 days before given docetaxel. The treatment group received intravenous infusion of compound Kushen injection 10ml once daily for 14 days , Rest 7 days, 21 days for a cycle. Two groups of treatment are 3 weeks for a cycle, repeat 2 cycles. Tumor efficacy, Karnofsky score, weight and adverse reactions (including leukopenia, nausea and vomiting, fatigue, liver and kidney dysfunction, constipation) were observed after treatment. Results The total effective rate was 24.24% in the treatment group and 22.86% in the control group. There was no significant difference between the two groups (P> 0.05). The disease control rate was 69.70% in the treatment group and 57.14% in the control group. There was significant difference between the two groups (P <0.05). Karnofsky score and weight loss in the treatment group after treatment were less than the control group (P <0.05). The two groups of patients in the nausea and vomiting, leukopenia, fatigue and liver and kidney dysfunction, constipation and other aspects of the difference was statistically significant (P <0.05), adverse reactions in the treatment group was less than the control group. Conclusion Compound Kushen injection combined with weekly docetaxel chemotherapy in the treatment of elderly patients with NSCLC safe and effective compound Fufang Kushen injection has some attenuated synergistic effect.