康艾注射液辅助化疗治疗晚期肺癌的临床观察

Clinical Observation of Kang'ai Injection Adjuvant Chemotherapy for Advanced Lung Cancer

目的:探讨康艾注射液辅助化疗治疗晚期肺癌的临床疗效及安全性。方法:选取2013年5月-2014年4月晚期肺癌患者146例,根据入院单双号分为观察组和对照组,各73例。对照组患者给予GP(吉西他滨+顺铂)方案化疗;观察组患者在对照组基础上加用康艾注射液60 m L加入生理盐水250 m L中,qd,ivgtt,每个化疗周期连用14 d。两组患者化疗期间均采用托烷司琼5 mg预防胃肠道反应。3周为一个疗程,两组患者均治疗3个疗程。比较两组患者临床疗效及治疗前后血清炎性因子[超敏C反应蛋白(hs-CRP)、肿瘤坏死因子α(TNF-α)、干扰素γ(IFN-γ)、白细胞介素10(IL-10)]、免疫功能指标(CD3^+、CD4^+、CD8^+、CD4^+/CD8^+)、肿瘤标志物[鳞状细胞癌相关抗原(SCC-Ag)、癌胚抗原(CEA)、糖类抗原(CA)50、CA72-4]水平,并记录不良反应发生情况。结果:观察组患者的临床有效率、疾病控制率分别为39.73%、84.93%,显著高于对照组的23.29%、71.23%,差异均有统计学意义(P<0.05)。治疗前,两组患者血清炎性因子、免疫指标、肿瘤标志物水平比较,差异均无统计学意义(P>0.05);治疗后,两组患者hs-CRP、TNF-a、INF-γ水平均显著低于治疗前,IL-10显著高于治疗前,且观察组上述指标均显著优于于对照组,差异均有统计学意义(P<0.05);对照组CD4^+、CD4^+/CD8^+水平显示降低,且显著低于观察组,差异均有统计学意义(P<0.05);两组患者血清SCC-Ag、CEA、CA50、CA72-4水平均显著降低,且观察组显著低于对照组,差异均有统计学意义(P<0.05)。观察组患者血小板减少、中性粒细胞减少、肝功能异常、恶心呕吐、贫血的发生率均显著低于对照组,差异均有统计学意义(P<0.05)。结论:康艾注射液辅助化疗能有效缓解晚期肺癌患者的炎症状态,减轻毒副反应,增强免疫功能,提高近期疗效,且安全性较高。

OBJECTIVE： To investigate clinical efficacy and safety of Kang＇ ai injection adjuvant chemotherapy for advanced lung cancer. METHODS： A total of 146 patients with advanced lung cancer during May 2013-Apr. 2014 were divided into observation group and control group according to odd-even admission number, with 73 cases in each group. Control group was given GP （gemeitabine＋cisplatin） chemotherapy. Observation group was additionally given Kang＇ai injection 60 mL added into normal saline 250 mL, qd, ivgtt, for consecutive 14 d each chemotherapy cycle, on the basis of control group. Both groups were given tropise- tron 5 mg for preventing gastrointestinal reaction during chemotherapy. A treatment course lasted for 3 weeks, and both groups were treated for 3 courses. Clinical efficacies of 2 groups were compared; the levels of serum inflammatory factors （hs-CRP, TNF-α, IFN-7, IL-10）, immune function indexes （CD3＋, CD4＋, CD8＋, CD4＋/CD8＋） and tumor markers （SCC-Ag, CEA, CA50, CA72-4） were compared before and after treatment. The occurrence of ADR were recorded in 2 groups. RESULTS： The response rate and disease control rate of observation group were 39.73% and 84.93%, which were significantly higher than 23.29% and 71.23% of control group, with statistical significance （P〈0.05）. Before treatment, there was no statistical significance in the levels of serum inflammatory factors, immune function indexes or tumor markers between 2 groups （P〉0.05）. After treatment, the levels of hs-CRP, TNF-α and IFN-γ in 2 groups were significantly lower than before treatment, while the level of IL-10 was signifi- cantly higher than before treatment; above indexes of observation group were significantly better than control group, with statistical significance （P〈0.05）. The levels of CD4＋ and CD4＋/CD8＋ in control group were decreased significantly and lower than observation group, with statistical significance （P〈0.05）. Serum levels of SCC-Ag, CEA, CAS0 and CA72-4 in 2 groups were decreased significantly, and observation group was significantly lower than control group, with statistical significance （P〈0.05）. The incidence of thromboeytopenia, neutropenia, abnormal liver function, nausea and vomiting, anemia in observation group were signifi- cantly lower than control group, with statistical significance （P〈0.05）. CONCLUSIONS： Kang＇ ai injection adjuvant chemothera- py can effectively relieve inflammation symptoms of patients with advanced lung cancer, reduce toxic reactions, enhance immune function, and improve short-term therapeutic efficacy with good safety.