中西医结合治疗非小细胞肺癌近期疗效观察

Analysis of Short-term Therapeutic Efficacy of Integrated Traditional and Western Medicine in Treating Non-small Cell Lung Cancer

目的观察中西医治疗Ⅲ、Ⅳ期非小细胞肺癌的近期疗效。方法采用前瞻性、多中心、随机、对照的临床研究方法,将纳入的病例324例按1∶1∶1比例分成中医组、中西医组以及西医组,除去剔除或脱落病例,最后纳入研究的病例为294例,分别为中医组99例,中西医组103例,西医组92例,各组剔除或脱落病例分别依次为10例、6例和14例。临床试验在6家医院进行。治疗期3个月,主要观察指标为瘤体大小、卡氏评分、体重、不良反应等。结果3组瘤体大小变化有效率分别为4.0%、26.2%、14.1%,稳定率分别为66.7%、81.6%、76.1%,3组有效率比较,差异有显著性(χ2=21.72,P=0.000<0.017);稳定率比较差异无显著性(χ2=6.052,P=0.049>0.017);治疗90天后中医组与中西医组卡氏评分值上升,西医组卡氏评分值下降,经配对t检验,中西医组与本组治疗前比较,差异有显著性(P<0.05);3组比较,差异有显著性(H=10.572,P=0.000<0.05)。治疗后体重均有下降,中医组和中西医组下降低于西医组(P<0.05);中医组及西医组与治疗前比较差异有显著性(P<0.05)。在咳嗽、气促、胃纳、乏力等肿瘤主要相关症状改善方面,中西医组和中医组优于西医组。不良反应观察,中医组、中西医组比西医组较少出现Ⅲ、Ⅳ度血液毒性,在白细胞、粒细胞、血小板及血红蛋白等方面3组差异亦有显著性(P<0.01)。结论中西医结合治疗中晚期非小细胞肺癌近期疗效优于单纯化疗组和中医组,显示了中西医结合治疗优势,可作为晚期非小细胞肺癌的有效、低毒的治疗方案。

Objective To observe the short-term therapeutic efficacy of integrated traditional and Western medicine （ITWM） in treating non-small cell lung cancer （NSCLC） in Ⅲ and Ⅳ phase. Methods Adopting the prospective, multi-centered, randomized and controlled method for clinical research, 324 patients who conformed to the enrolling standard were divided by ratio of 1 ： 1 ： 1 into the Chinese medicine （CM）group （n=99）, the ITWM group （n = 103） and the Western medicine （WM） （n = 92） group. The excluded or dropping off cases were 10 in CM, 6 in ITWM and 14 in WM. Clinical trials were conducted in 6 hospitals and 3 months of treatment was taken as one therapeutic course. The main observation indexes were tumor size, Karnofsky scores, body weight, adverse reaction, etc. Results The total effective rate of tumor remission in the 3 groups was 4.0%, 26.2%, and 14.1%, respectively, statistical significance was shown in the difference among them （χ^2=21.72,P=0.000〈0.017）. The total tumor stabilization rate was 66.7%, 81.6%, and 76.1% , respectively, by rectification test, no significance was shown in difference among them （χ^2= 6. 052, P = 0.049〉0.017）. Karnofsky scoring showed that after 90 days of treatment, Karnofsky score raised in the CM and ITWM group, but lowered in the WM group, paired t-test showed significant difference in the ITWM group before and after treatment. The Karnofsky score in IWTM was higher than that in CM and WM with significant difference （H = 10.572, P-0.000〈 0.05）. The patients＇ body weight in the 3 groups were all reduced. The reduction in the CM and ITWM group was lower than that in WM group, among which, significant difference was shown in CM and WM group when compared with the same group before treatment （P 〈 0.05）. The effect in the ITWM and CM group was better than that in WM group in aspects of improving such tumor related symptoms as cough, short breath, anorexia, fatigue, etc. Observation of adverse reaction showed that lesser hemotoxicity of Ⅲ and Ⅳ grade appeared in the CM and ITWM group than that in the WM group, and significant difference was shown in counts of white blood cells, granulocytes, platelets hemoglobin, etc. among the 3 groups （P 〈 0.01 ）. Conclusion ITWM therapy showed better short-term efficacy in treating patients with NSCLC than CM or WM alone, showing the superiority of ITWM therapy. It can be adopted as an effective therapeutic program with low-toxicity.