消癌平片联合PC方案治疗晚期非小细胞肺癌的临床研究

目的探讨消癌平片联合PC方案(培美曲塞+顺铂)治疗晚期非小细胞肺癌的临床疗效。方法选取2014年5月—2015年5月许昌市中心医院收治的86例晚期非小细胞肺癌患者作为研究对象,采用随机数字表法将患者分为对照组和治疗组,每组43例。对照组患者给予PC方案治疗,在第1天静脉滴注注射用培美曲塞二钠,500 mg/m~2溶于100 mL生理盐水中,滴注时间为30 min,并在静注结束后30 min静脉滴注注射用顺铂(冻干型),75 mg/m~2溶于500 mL生理盐水中,且滴注时间为200 min。治疗组在对照组治疗的基础上口服消癌平片,8片/次,3次/d。21 d为1个周期,两组患者均治疗1个周期。观察两组患者的近期疗效,比较两组的免疫功能指标、毒副作用和远期疗效。结果治疗后,对照组和治疗组的疾病控制率分别为74.4%、90.7%,客观缓解率分别为60.5%、83.7%,两组近期临床疗效比较差异有统计学意义(P0.05)。治疗后,对照组T淋巴细胞亚群CD3~+、CD4~+、免疫球蛋白A(IgA)、免疫球蛋白G(IgG)和免疫球蛋白M(IgM)均明显降低,而治疗组明显升高,同组治疗前后比较差异具有统计学意义(P0.05);治疗后,治疗组免疫功能指标明显高于对照组,两组比较差异具有统计学意义(P0.05)。治疗期间,治疗组胃肠道反应、心脏毒性、神经毒性、骨髓抑制、肾功能异常、肝功能异常、口腔黏膜炎和皮疹发生率均明显低于对照组,两组毒副作用发生率比较差异具有统计学意义(P0.05)。治疗后,治疗组1年生存率、3年生存率、无进展生存期(PFS)和总生存时间(OS)均明显高于对照组,两组比较差异具有统计学意义(P0.05)。结论消癌平片联合PC方案治疗晚期非小细胞肺癌的疗效较好,可明显改善患者免疫功能,降低化疗所致毒副作用,延长患者生存时间,具有一定的临床推广应用价值。

Clinical study on Xiao'aiping Tablets combined with PC regimen in treatment of advanced non-small cell lung cancer

Objective To investigate the clinical effect of Xiao''aiping Tablets combined with PC regimen (pemetrexed + cisplatin) in treatment of advanced non-small cell lung cancer. Methods Patients (86 cases) with advanced non-small cell lung cancer in Xuchang Central Hospital from May 2014 to May 2015 were randomly divided into control and treatment groups, and each group had 43 cases. Patients in the control group were given PC regimen, and iv administered with Pemetrexed Disodium for injection at the first day, 500 mg/m² added into normal saline 100 mL, the infusion time was 30 min. And Cisplatin for injection was infused intravenously 30 min after the end of Pemetrexed Disodium for injection infusion, 75 mg/m² was added into 500 mL normal saline, the infusion time was 200 min. Patients in the treatment group were po administered with Xiao''aiping Tablets on the basis of the control group, 8 tablets/time, three times daily. A course had 21 days, and patients in two groups were treated for one course. After treatment, the short-term effects were evaluated, and immune function indexes, toxic and side effects, and long-term effects in two groups were compared. Results After treatment, the DCR in the control and treatment groups were 74.4% and 90.7%, respectively, and ORR in the control and treatment groups were 60.5% and 83.7%, respectively, and there was difference between two groups (P<0.05). After treatment, the levels of CD3⁺, CD4⁺, IgA, IgG, and IgM in the control group were significantly decreased, while those in the treatment group were significantly increased, and the difference was statistically significant in the same group (P<0.05). After treatment, immune function indexes in the treatment group were significantly higher than those in the control group, with significant difference between two groups (P<0.05). During the treatment, the incidence of gastrointestinal reaction, cardiotoxicity, neurotoxicity, myelosuppression, renal dysfunction, liver dysfunction, oral mucositis and rash in the treatment group were significantly lower than those in the control group, and there was difference between two groups (P<0.05). After treatment, the 1-year survival rate, 3-year survival rate, PFS, and OS in the treatment group were significantly higher than those in the control group, and there was difference between two groups (P<0.05). Conclusion Xiao''aiping Tablets combined with PC regimen has good curative effect in treatment of advanced non-small cell lung cancer, can significantly improve the immune function, reduce the toxic and side effects caused by chemotherapy, prolong the survival time of patients, which has a certain clinical application value.