参附注射液对顺铂为基础方案治疗非小细胞肺癌的减毒作用

作者	单位
吴万垠	广州中医药大学第二临床医学院肿瘤科
龙顺钦	广州中医药大学第二临床医学院肿瘤科
柴小姝	广州中医药大学第二临床医学院肿瘤科
王斌	广州中医药大学第二临床医学院肿瘤科
邓宏	广州中医药大学第二临床医学院肿瘤科
张海波	广州中医药大学第二临床医学院肿瘤科
郑剑霄	广州中医药大学第二临床医学院肿瘤科
河文峰	广州中医药大学第二临床医学院肿瘤科
薛晓光	广州中医药大学第二临床医学院肿瘤科
刘伟胜	广州中医药大学第二临床医学院肿瘤科

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中文摘要:

目的评价参附注射液对3种新药(泰素、长春瑞滨及吉西他滨)联合顺铂方案治疗非小细胞肺癌的减毒作用。方法133例拟接受至少2个周期的新药联合顺铂方案化疗的非小细胞肺癌患者(泰素联合顺铂方案45例、长春瑞滨联合顺铂方案42例、吉西他滨联合顺铂方案46例),随机分为参附注射液先治疗组(67例)和参附注射液后治疗组(66例)。参附注射液先治疗组于第1个化疗周期的第1～3天开始,予参附注射液治疗,连续10天;同时实施化疗方案(治疗期)。第2个化疗周期仅实施相对应的化疗方案(对照期)。参附注射液后治疗组第1个化疗周期仅实施相对应的化疗方案(对照期)。第2个化疗周期的第1～3天开始,予参附注射液治疗,连续10天;同时实施化疗方案(治疗期)。通过自身前后交叉对照,观察参附注射液对3种方案毒性的影响。结果治疗期的血液学(白细胞、中性粒细胞、血红蛋白、血小板)毒副反应及消化道毒副反应(呕吐、腹泻)均较对照期低,差异有统计学意义(P<0.01);参附注射液先治疗组中,治疗期血液学毒副反应及消化道毒副反应(呕吐、便秘、腹泻)亦较对照期低,差异有统计学意义(P<0.01,P<0.05),参附注射液后治疗组中,治疗期血液学毒副反应及消化道毒副反应(呕吐、腹泻)均较对照期低,差异有统计学意义(P<0.01,P<0.05);参附注射液对气虚痰湿型患者显示出较好的减毒作用(P<0.01)。结论参附注射液能减轻3种新药联合顺铂方案治疗非小细胞肺癌时的血液学毒副反应和消化道毒副反应,对气虚痰湿型患者的减毒作用较明显。

英文摘要:

Objective To observe the effect of Shenfu Injection (SFI) for attenuating the toxicity of chemotherapy in treating non-small-cell lung cancer (NSCLC),by the regimens of combined Cisplatin (DDP) with new chemotherapeutic agents,Taxol (TXT),Vinorelbine (NVB) and Gemcitabine (GEM),respectively. Methods One hundred and thirty-three patients with NSCLC,who were scheduled to be treated by at least 2 cycles of chemotherapy,with regimen TP (45 cases),NP (42 cases) and GP (46 cases),were enrolled. They were randomized into 2 groups: 67 cases in the SFI pre-treated group and 66 cases in the SFI post-treated group,on them SFI was administered for 10 successive days on the 1st,2nd,3rd day of the 1st and the 2nd cycle,respectively. The effects of SFI on toxicity of the three regimens were observed through a self-controlled crossover design. Results The hemato-toxicity (the toxicity on leukocyte,neutrophil,hemoglobin and platelet) and the digestive toxicity (represented as vomiting,constipation or diarrhea) of chemotherapy revealed in the treated stage (the cycle treated with SFI) were all less than those in the control stage (the cycle untreated with SFI),no matter when SFI was applied,all showed statistical significance (P<0.05 or P<0.01). Besides,SFI showed a better toxicity attenuating effect on patients of qi-deficiency and phlegm-dampness type (P<0.01). Conclusion SFI can relieve the hemato-toxicity and the digestive toxicity of chemotherapy by regimen of combining DDP with TXT,NVB or GEM,and the effect is more significant on patients of qi-deficiency and phlegm-dampness type.

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