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目的:观察参附注射液联合吉西他滨加顺铂方案(GP方案)治疗气虚型晚期非小细胞肺癌(NSCLC)患者的临床疗效。方法:将192例中医辨证为气虚型的晚期NSCLC患者,随机分为治疗组(96例)和对照组(96例)。治疗组选用参附注射液联合GP方案治疗,对照组仅采用GP方案治疗。比较两组的生活质量、毒副反应、近期疗效、生存期。结果:化疗结束后,治疗组体力状态评分(PS评分)低于对照组,差异具有统计学意义(P<0.05)。两组中医症候总有效率分别为81.25%、15.62%,治疗组明显优于对照组(P<0.05)。与对照组相比,治疗组的血液学毒性及非血液学毒性均降低,差异具有统计学意义(P<0.05)。治疗组与对照组的有效率分别为20.45%、11.24%,两组比较差异无统计学意义;疾病控制率(DCR)分别为57.95%、41.57%,差异有统计学意义(P<0.05)。治疗组中位PFS和OS分别为4.6个月、7.9个月,对照组中位PFS和OS为4.1个月、7.0个月,两组相比差异均无统计学意义(P>0.05)。结论:参附注射液联合GP方案治疗气虚型晚期NSCLC患者,能改善患者的生活质量,改善中医症状,减轻化疗引起的毒副反应,提高疾病控制率,但不能提高GP方案治疗晚期NSCLC患者的远期疗效。
Objective: To observe the clinical effect of Shenfu injection combined with gemcitabine plus cisplatin (GP regimen) in the treatment of patients with advanced non-small cell lung cancer (NSCLC). Methods: A total of 192 patients with advanced NSCLC with syndrome differentiation of qi deficiency were randomly divided into treatment group (96 cases) and control group (96 cases). The treatment group was treated with Shenfu injection combined with GP regimen and the control group with GP regimen alone. The quality of life, adverse reactions, short-term curative effect and survival period were compared between the two groups. Results: At the end of chemotherapy, the score of physical status (PS score) of the treatment group was lower than that of the control group, with statistical significance (P <0.05). The total effective rate of TCM syndrome in the two groups was 81.25% and 15.62% respectively, which was significantly better in the treatment group than in the control group (P <0.05). Compared with the control group, the treatment group hematological toxicity and non-hematological toxicity were reduced, the difference was statistically significant (P <0.05). The effective rates of the treatment group and the control group were 20.45% and 11.24%, respectively. There was no significant difference between the two groups. The disease control rates (DCR) were 57.95% and 41.57%, respectively. The difference was statistically significant (P <0.05). The median PFS and OS of the treatment group were 4.6 months and 7.9 months respectively. The median PFS and OS of the control group were 4.1 months and 7.0 months, respectively. There was no significant difference between the two groups (P> 0.05). Conclusion: Shenfu injection combined with GP regimen in treatment of advanced NSCLC patients with qi deficiency can improve the quality of life of patients, improve symptoms of traditional Chinese medicine, reduce chemotherapy-induced side effects and improve disease control rate, but can not improve GP regimen in patients with advanced NSCLC Long-term efficacy.