脾多肽注射液联合AP方案治疗晚期肺腺癌的临床研究

Clinical study on Lienal Polypeptide Injection combined with AP chemotherapy in treatment of advanced lung adenocarcinoma

目的探讨脾多肽注射液联合AP方案(培美曲塞+顺铂)治疗晚期肺腺癌的临床疗效。方法选取2017年2月—2018年2月国药东风总医院收治的80例晚期肺腺癌患者作为研究对象,采用随机数表法将患者分为对照组和治疗组,每组各40例。对照组给予AP方案进行治疗,第1天静脉滴注注射用培美曲塞二钠500 mg/m^2,30 min滴完,第1～3天静脉滴注注射用顺铂75 mg/m^2。治疗组患者在对照组的基础上静脉滴注脾多肽注射液,6 mL/次,1次/d。14d为1个疗程,两组患者均持续治疗3个疗程。观察两组患者临床疗效,比较两组治疗前后的Karnofsky行为状态评分(KPS)、Piper疲乏量表评分(PFS)、无进展生存时间、平均生存时间、免疫功能指标和毒副反应发生率。结果治疗后,对照组总有效率(ORR)和肿瘤控制率(DCR)分别为20.0%、52.5%,分别显著低于治疗组的37.5%、87.5%,两组比较差异均有统计学意义(P<0.05)。治疗后,两组患者情感、行为、认知、感知维度评分和疲乏总分值均有所下降,KPS评分均显著上升,同组治疗前后比较差异具有统计学意义(P<0.05);治疗后,治疗组患者的PFS评分、KPS评分明显优于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组患者无进展生存时间和平均生存时间均明显长于对照组患者,两组比较差异具有统计学意义(P<0.05)。治疗组患者CD3^+、CD4^+、CD4^+/CD8^+和NK细胞水平均显著上升,同组治疗前后比较差异具有统计学意义(P<0.05);治疗后,治疗组患者免疫功能指标均明显高于对照组,两组比较差异具有统计学意义(P<0.05)。治疗后,对照组和治疗组的毒副反应发生率分别为82.5%、45.0%,两组比较差异有统计学意义(P<0.05)。结论脾多肽注射液联合AP方案治疗晚期肺腺癌具有较好的临床疗效,可有效改善患者临床症状,减轻癌因性疲乏,增强机体免疫力,降低患者的骨髓抑制发生率,具有一定的临床推广应用价值。

Objective To investigate the clinical effect of Lienal Polypeptide Injection combined with AP chemotherapy(pemetrexed and cisplatin) in treatment of advanced lung adenocarcinoma. Methods Patients(80 cases) with advanced lung adenocarcinoma in Sinopharm Dongfeng General Hospital from February 2017 to February 2018 were randomly divided into control and treatment groups, each group had 40 cases. Patients in the control group were treated with AP chemotherapy, and patients were iv administered with Pemetrexed Disodium for injection at the first day, 500 mg/m^2, dripped within 30 min. At the same time, they were iv administer with Cisplatin for injection at the first day to the third day, 75 mg/m^2. Patients in the treatment group were iv administered with Lienal Polypeptide Injection on the basis of the control group, 6 mL/time, once daily. A course of treatment had14 d, and patients in two groups were treated for 3 courses. After treatment, the clinical efficacy was evaluated, the KPS, PFS, progression-free survival time,mean survival time, immune function indexes, and toxic and side effects in two groups before and after treatment were compared.Results After treatment, the ORR and DCR in the control group were 20.0% and 52.5%, which were significantly lower than 37.5%and 87.5% in the treatment group, respectively, and there were differences between two groups(P < 0.05). After treatment, the scores of emotion, behavior, cognition, perception, and fatigue in two groups were significantly decreased, but KPS in two groups were significantly increased, and the difference was statistically significant in the same group(P < 0.05). After treatment, the KPS and PFS in the treatment group were significantly better than those in the control group, with significant difference between two groups(P <0.05). After treatment, the progression-free survival time and mean survival time in the treatment group were significantly longer than those in the control group, and there were differences between two groups(P < 0.05). After treatment, the levels of CD3^+, CD4^+,CD4^+/CD8^+, and NK cell in two groups were significantly increased, and the difference was statistically significant in the same group(P < 0.05). After treatment, the 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). After treatment, the incidence of adverse reactions in the control group and treatment group were 82.5% and 45.0%, respectively, and there were differences between two groups(P < 0.05).Conclusion Lienal Polypeptide Injection combined with AP chemotherapy has clinical curative effect in treatment of advanced lung adenocarcinoma, can effectively improve the clinical symptoms of patients, alleviate cancer-induced fatigue, and enhance the body immunity, reduce the incidence of bone marrow suppression, which has a certain clinical application value.