扶正为主辨治晚期非小细胞肺癌的疗效研究

目的：观察扶正为主辨证论治对晚期非小细胞肺癌（NSCLC）的疗效。方法：采用前瞻性、随机设计研究方法。选取晚期NSCLC一线治疗后疾病无进展的患者，随机分为治疗组和对照组各29例，治疗组以扶正为主辨证论治进行巩固治疗，对照组不进行中药抗肿瘤治疗。每月随访1次，治疗直至疾病进展或患者拒绝治疗为止。观察扶正为主辨证论治对晚期NSCLC一线化疗后疾病控制患者巩固治疗的临床疗效。观察指标包括疾病进展时间（Time to Progression，TTP）、中医症状改善情况、体重变化、生活质量（Quality of Life，QOL）。结果：（1）治疗组中位TTP为89d，对照组中位TTP为70d，差异有统计学意义（P〈0．05）；（2）治疗组患者中医症状积分明显改善，总有效率86．21％较对照组的17．24％，差异有统计学意义（P〈0．05）；（3）治疗组体重稳定率79．31％较对照组的44．83％，差异有统计学意义（P〈0．05）；（4）扶正为主辨证论治能明显改善晚期NSCLC患者的生活质量，EORTCQLQ—LC43中的躯体、角色、情绪、社会功能领域，总健康状况，疲倦、恶心呕吐、气促、失眠、食欲丧失、便秘、咳嗽、口腔渍疡、脱发的症状领域方面较对照组都有明显改善，差异均有统计学意义（P〈0．05）。结论：（1）中医巩固治疗对晚期非小细胞肺癌一线化疗疾病控制后患者能延长疾病进展时间；（2）中医巩固治疗能明显改善晚期非小细胞肺癌患者一线化疗后中医症状和稳定体重；（3）中医巩固治疗能提高晚期非小细胞肺癌患者一线化疗后生活质量。

Clinical Research on Therapeutic Effect of Strengthening Body Resistance TCM Consolidated Therapy for Advanced Non-Small-Cell Lung Cancer

Objective： To observe the therapeutic effect of strengthening the body resistance consolidated therapy for advanced non-small-cell lung cancer. Methods： The study was a prospective, multicenter and randomized clinical trial. Non-progressive （ CR/ PR/SD） patiants with advanced non-small-cell lung cancer who responded to first-line therapy were radomized into the treatment group and the control group. All patients were divieded with the sealed envelope method in the ratio. There are twenty nine cases in each group. The treatment group was treated with TCM consolidated therapy. The control group was not treated with TCM antineoplastic thera- py. All cases were follow up once a month. Treatment were not over until the appearances of disease progression or rejection of pa-tients. To oberserve the therapeutic effect of TCM consolidated therapy for the disease control patients with advanced non-small-cell lung cancer. The observe gauge including Time to Progression （TTP） , TCM symptoms integral improvement, weight, and Quality of Life （QOL） . Results： （1） The middle TIP in the treatment group was prolonged for 19 days when compared with that of the control group, the difference was statistically significant （89 days versus 70 days, P 〈 0. 05 ） . （2） The TCM symptoms integral of the treatment group patients obviously improved, with the total effective rate was 86.21%. The total effective rate of the control group was 17.24%. The difference was statistically significant （P 〈0.05） . （3） The weight stability rate of the treatment group patients was 79. 31% better than 44. 83% that of the control group, traditional Chinese medicine can obviously improve the weight stability rate of patients （P 〈0.05） . （4） TCM can obviously improve the QOL of the NSCLC patients. The scores of the treatment group in EORTC QLQ-LC43 were better than that of the contrl group with statisticallly significant difference （P 〈 0. 05）, including the role, mood, social areas, total health, fatigue, nausea and vomiting, shortness of breath, insomnia, loss of appetite, constipation, cough, oral ulcer, the symptoms of hair loss. Conclusion： （ 1 ） TCM consolidated treatment can extend TIP of the disease control patients with advanced non-small-cell lung cancer. （2） TCM consolidated treatment can improve the TCM symptoms and stabilize weight of the dis- ease control patients with advanced non-small-cell lung cancer. （3） TCM consolidated treatment can improve the quality of life of the disease control patients with advanced non-small-cell lung cancer.