参芪扶正注射液联合化疗治疗中晚期非小细胞肺癌(气虚)随机平行对照研究

Randomized Parallel Study of Shenqi Fuzheng Injection combined with Chemotherapy in the Treatment of Moderate and Advanced Non-small Cell Lung Cancer(Qi Deficiency)

[目的]观察参芪扶正注射液联合化疗治疗中晚期非小细胞肺癌疗效。[方法]使用随机平行对照方法,将61例住院患者按随机数字表方法随机分为两组。对照组30例TC方案,第1d,紫杉醇135mg/m^2+0.9%氯化钠500mL,静滴,>3h;第1~3d,顺铂(DDP)25mg/m^2静脉注射,同时抗过敏治疗。治疗组31例,化疗前3d,参芪扶正注射液250mL+0.9%氯化钠250mL静滴;TC方案治疗同对照组。连续治疗21d为1疗程。观测临床症状、生活质量评分、不良反应(骨髓抑制)。连续治疗2疗程(42d),判定疗效。[结果]治疗组CR2例,PR11例,SD3例,PD15例,总有效率51.61%;对照组CR1例,PR7例,SD4例,PD18例,总有效率40.00%;两组总有效率无显著差异(P>0.05)。生活治疗改善治疗组优于对照组(P<0.01),生活质量下降人数治疗组少于对照组(P<0.05),生活质量稳定人数两组无显著差异(P>0.05)。骨髓抑制率治疗组低于对照组(P<0.05)。[结论]参芪扶正注射液联合化疗治疗中晚期非小细胞肺癌具有增效减毒作用,提高了患者对化疗的耐受程度和治疗信心,值得进一步研究。

[Objective] To observe the therapeutic effect of Shenqi Fuzheng injection combined with chemotherapy on advanced non-small cell lung cancer. [Methods] Using random parallel control method,61 patients were randomly divided into two groups according to random number table. The control group consisted of 30 patients with TC, 1 d, paclitaxel, 135 mg/m^2＋0.9%, sodium chloride, 500 mL, intravenous drip,3 h, 1～3 d, cisplatin（DDP） 25 mg/m^2 intravenous injection, and anti allergy treatment. In the treatment group, 31 cases were treated with 3 d, Shenqi Injection, 250 mL＋0.9% sodium chloride, 250 mL intravenous drip before chemotherapy, and the TC regimen was used to treat the same group. Continuous treatment with 21 d was the 1 course of treatment. The clinical symptoms, the quality of life score and the adverse reactions（myelosuppression） were observed. Continuous treatment for 2 courses（42 d）, to determine the efficacy.[Results] The treatment group CR2 cases, PR11 cases, SD3 cases, PD15 cases, the total effective rate was51.61%; the control group CR1 cases, PR7 cases, SD4 cases, PD18 cases, the total effective rate was 40%; the total effective rate of the two groups was not significantly different（P〈0.05）. The life therapy improvement group was better than the control group（P〈0.01）, the quality of life decreased, the treatment group was less than the control group（P〈0.05）, the quality of life was stable, there was no significant difference between the two groups（P〈0.05）. The bone marrow suppression rate in the treatment group was lower than that in the control group（P〈0.05）. [Conclusion] Shenqi Fuzheng Injection combined with chemotherapy has the effect of increasing toxicity and reducing toxicity in the treatment of moderate and advanced non-small cell lung cancer, and it can improve the patient＇s tolerance to chemotherapy and the confidence of treatment, and deserves further study.