艾迪注射液联合化疗治疗晚期非小细胞肺癌疗效的随机临床研究
[A randomized clinical study on efficacy of Aidi injection combined with chemotherapy in the treatment of advanced non-small cell lung cancer].
作者信息
Wang Dijin, Chen Yinglan, Ren Jian, Cai Yun, Liu Minzhi, Zhan Qinyuan
机构信息
Department of Chemotherapy, Jiangxi Tumor Hospital, Nanchang, Jiangxi 330029, P.R.China.
出版信息
Zhongguo Fei Ai Za Zhi. 2004 Jun 20;7(3):247-9. doi: 10.3779/j.issn.1009-3419.2004.03.16.
BACKGROUND
To compare the therapeutic effect, adverse reaction and effect on immunity of chemotherapy combined Aidi injection (AI) with those of chemotherapy alone in the treatment of advanced non small cell lung cancer (NSCLC).
METHODS
Ninety eight cases of advanced NSCLC were randomly divided into two groups, trial group and control group. In the trial group, NP plus AI (60 80 ml) were given intravenously by dissolving in 400 ml of normal saline per day for 8-10 days, while in the control group, only NP chemotherapy was given. Navelbine (25 mg/m², d1, 8) and cisplastin (40 mg/m², d1-3) were chosen in the chemotherapy. Each patient received at least two cycles of treatment.
RESULTS
The effective rate in the trial group and the control group was 53.1% and 44.9% respectively, without significant difference between the two groups ( P > 0.05). But the rate of progression, adverse reactions in bone marrow and digestive tract, and change of immunity in the trial group were all lower than those in the control group ( P < 0.05), and the improvement in Karnofsky score in the trial group was higher than that in the control group ( P < 0.05).
CONCLUSIONS
Chemotherapy of NP combined with AI shows benefit in the treatment of advanced NSCLC. AI could decrease the influence on immunity and adverse reaction of chemotherapy, and improve the quality of life in patients with NSCLC.
背景
比较化疗联合艾迪注射液（AI）与单纯化疗治疗晚期非小细胞肺癌（NSCLC）的疗效、不良反应及对免疫功能的影响。
方法
将98例晚期NSCLC患者随机分为两组，试验组和对照组。试验组采用NP方案加AI（60 - 80 ml），加入400 ml生理盐水中静脉滴注，每日1次，共8 - 10天；对照组仅采用NP方案化疗。化疗方案选用长春瑞滨（25 mg/m²，第1、8天）和顺铂（40 mg/m²，第1 - 3天）。每位患者至少接受两个周期的治疗。
结果
试验组和对照组的有效率分别为53.1%和44.9%，两组间差异无统计学意义（P > 0.05）。但试验组的疾病进展率、骨髓及消化道不良反应发生率和免疫功能变化均低于对照组（P < 0.05），试验组卡氏评分的改善情况高于对照组（P < 0.05）。
结论
NP方案联合AI化疗对晚期NSCLC治疗有益。AI可减轻化疗对免疫功能的影响及不良反应，提高NSCLC患者的生活质量。
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