注射用黄芪多糖联合CIK细胞治疗中晚期气虚型非小细胞肺癌的临床观察

Clinical observation on Astragalus Polysaccharide Injection combined with CIK cells treating NSCLC patients with qi deficiency syndrome

目的探究注射用黄芪多糖联合细胞因子诱导的杀伤细胞(cytokine-induced killer cells,CIK)治疗中晚期气虚型非小细胞肺癌的协同作用,并观察其安全性。方法选择天津中医药大学第一附属医院75例经明确诊断为中晚期气虚型非小细胞肺癌住院患者,分为两组,对照组给予CIK细胞静脉回输(每次100 mL,每周一、三、五回输,共计5次,细胞总数>1×10^(10)/mL),联合治疗组加用注射用黄芪多糖(每天250 mg,静脉滴注至回输最后1 d,共计10 d),10 d为1个周期,间隔1个月后行第2周期治疗,共治疗2个周期。结果联合治疗组治疗后疾病控制率为69.4%,高于对照组36.1%,差异显著(P<0.05);两组卡氏评分(KPS)有效率分别为77.8%与55.6%,差异显著(P<0.05);联合治疗组患者治疗后较治疗前外周血中CD3^+和CD4^+T淋巴细胞比例显著增加(P<0.05);治疗后联合治疗组在气短、神疲、乏力、自汗、懒言方面均有改善,其中在神疲、乏力、自汗、懒言方面改善明显,差异显著(P<0.05);两组在治疗过程中未出现严重的血液学毒性及肝肾毒性。结论注射用黄芪多糖联合CIK细胞治疗可控制中晚期非小细胞肺癌患者肿瘤病灶进展,提高患者免疫功能,改善气虚证症状,提高机体功能状态,且安全性良好。

Objective To explore the synergetic effect and observe the safety of Astragalus Polysaccharide Injection combined with cytokine-induced killer cells（CIK cells） in the treatment of advanced NSCLC patients with qi deficiency syndrome. Methods A total of 75 advanced NSCLC patients with qi deficiency syndrome in oncology department of First Teaching Hospital of Tianjin University of TCM enrolled in the study were randomized into two groups： the control group（CIK cells group） and the combined group（Astragalus Polysaccharide Injection ＋ CIK cells group） by the random number table method. The control group： CIK cells were transfused in vein（100 mL each time, once every Monday, Wednesday, and Friday, five times in total, the total number of cells 1 × 10-（10）/mL）. The combined group： CIK cells treatment combined with astragalus polysaccharide injection intravenous drip（250 mg Qd, 10 d）. Ten days is one cycle, both groups were received the second cycle treatment in a month later. Results The combined group＇s disease control rate（DCR = CR ＋ PR ＋ SD） was 69.4%, higher than that of control group＇s（36.1%）, and the difference was statistically significant（P〈0.05）.The KPS of combined group＇s effective rate was 77.8%, higher than 55.6% in the control group, the difference was statistically significant（P〈0.05）. After treatment, shortness of breath, spiritlessness, hypodynamia, spontaneous perspiration and speaking reluctantly had taken a turn for the better in combined group, especially in spiritlessness, hypodynamia, spontaneous perspiration, gospeaking reluctantlyt to improve obviously, and the difference was statistical significance（P〈0.05）. The haematologic toxicity inⅡ, Ⅲ, Ⅳ degree and hepatic and renal toxicity in Ⅲ, Ⅳ degree did not appear in two groups. Conclusion The Astragalus Polysaccharide Injection combined with CIK cells could control tumor lesion＇s progress, and improve the patient＇s immune function, the symptom of qi deficiency syndrome, and body functional status due to itsbetter security.