康莱特注射液联合GP方案对晚期非小细胞肺癌患者免疫功能的改善作用

Improvement Effect of Kanglaite Injection Combined with GP Program on the Immunity of Patients with Non-Small-Cell Lung Cancer at Advanced Stage

目的:观察康莱特注射液联合GP方案对晚期非小细胞肺癌(non-small-cell lung cancer,NSCLC)患者免疫功能的改善作用。方法:将85例晚期NSCLC患者随机分为对照组42例和观察组43例,两组均给予GP方案化疗,观察组在对照组的治疗基础上从化疗第1天开始加用康莱特注射液,比较两组患者临床疗效,血清免疫球蛋白IgA、IgG、IgM水平,以及外周血T细胞亚群CD3^+、CD4^+、CD8^+百分比和CD4^+/CD8^+。结果:观察组有效率(RR)及疾病控制率(DCR)有优于对照组的趋势,但两组差异无统计学意义(P>0.05)。治疗后两组CD3^+、CD4^+、CD4^+/CD8^+均较治疗前显著降低(P<0.05,P<0.01),对照组CD8^+较治疗前显著升高(P<0.01),观察组升高不明显(P>0.05),且治疗后两组间各指标差异均有统计学意义(P<0.01)。治疗后观察组IgM、IgA、IgG水平较治疗前有所降低,但差异无统计学意义(P>0.05),对照组各指标水平均较治疗前显著降低(P<0.05或P<0.01),且治疗后两组间各指标差异均有统计学意义(P<0.05)。观察组2~4级血小板减少、血红蛋白减少和恶心呕吐的发生率显著低于对照组(P<0.05)。结论:与单纯应用GP方案比较,联合康莱特注射液治疗晚期NSCLC患者可在一定程度上提高RR和DCR,显著减轻化疗对机体免疫功能的损伤,并降低毒副作用的发生率。

Objective： To observe the improvement effect of Kanglaite Injection combined with GP program on the immunity of pa- tients with non-small-cell lung cancer （NSCLC） at advanced stage. Methods： Totally 85 cases with NSCLC at advanced stage were randomized into control group （42 cases） and observation group （43 cases）. Both groups were given chemotherapy of GP program while observation group were additionally given Kanglaite Injection from the first day of chemotherapy. The clinical effects, the levels of serum immune globulin IgA, IgM and IgG, and the percentage of T cell subset of CD3 ＋ , CD4 ＋ , CD8＋ and CD4＋/CD8＋ were compared between the two groups. Results： The RR, DCR in observation group were better than these in con- trol group, but the difference was no significance ＇（ P 〉 0.05）. The levels of CD3 ＋ , CD4＋ , and CD4 ＋/CD8＋ declined markedly in both groups （P 〈 0.05 or P 〈 0.01 ）. The level of CD8＋ in control group increased significantly after the treatment （P 〈 0.01 ）, but the rise in obvious group was not apparent （P 〉 0.05）. And the difference of each indicator between the two groups had sta- tistical significance （P 〈 0.01 ）. The levels of IgA ,IgM and IgG in observation group decreased in observation group after treat- ment, but the difference had no statistical significance （ P 〉 0.05 ）. Each indicator in control group obviously declined after the treatment （P 〈0.05 or P 〈0.01 ） ,and the difference between the two groups had statistical significance （P 〈0, 05）. The level 2-4thrombocytopenia, hemoglobin decline and occurrence rate of nausea and vomiting in observation group were greatly lower than these in control group （P 〈 0.05 ）. Conclusion： Compared with pure application of GP program, the combined Kanglaite Injection can enhance the RR and DCR to a certain degree, remarkably reduce the impairment of the immunity due to chemotherapy and the toxic and side effects.