健脾化痰祛湿方联合DP方案治疗脾虚痰湿型晚期非小细胞肺癌的临床研究

发布时间：2019-04-11 18:19

【摘要】：目的通过规范化随机对照临床试验研究,重点研究自拟健脾化痰祛湿方联合DP方案化疗和单纯DP方案化疗对晚期非小细胞肺癌患者生活质量的影响,评估健脾化痰祛湿方在晚期非小细胞肺癌治疗中的疗效及优势,为健脾化痰祛湿方广泛应用于肺癌及其他恶性肿瘤提供临床依据,能够客观真实地评价中医药治疗肺癌的临床疗效,最大限度地展示中医药治疗肺癌的特色和优势。方法将60例晚期非小细胞肺癌患者随机分为2组,治疗组30例接受健脾化痰祛湿方联合DP方案化疗治疗,对照组30例单纯接受DP方案化疗,共观察2个疗程。采用EORTCQLQ-LC43国际生存质量量表作为测定工具,并结合传统的临床疗效评价指标(如中医证候疗效、肿瘤客观疗效、行为状况疗效、肿瘤指标等)作为参照。结果1.近期客观疗效比较:治疗组患者30例,其中完全缓解1例,部分缓解15例,稳定12例,进展2例,有效率为53.3%,疾病控制率为93.3%;对照组病人30例,无完全缓解病例,部分缓解8例,稳定13例,进展9例,有效率为26.7%,疾病控制率为70%,2组之间差异有统计学意义(P0.05)。2.中医证候疗效比较:治疗组中30例患者中医证候疗效显效8例,有效20例,无效2例,有效率93.3%;对照组30例患者中显效2例,有效19例,无效9例,有效率70%,2组之间差异有统计学意义(P0.05)。3.KPS评分比较:治疗组的KPS评分由治疗前的72.33±4.30升为79.33±7.39,对照组的KPS评分由之前的74.33±5.04升为75.33±6.81,2组患者治疗前的卡氏评分无统计学差异意义(P0.05),但在治疗后有统计学意义(P0.05)。4.肿瘤指标 CEA 比较:治疗组 CEA 值由(68.73±54.81)ng/ml 降至(27.98±22.70)ng/ml,统计学有意义(P0.05);对照组患者CEA值由(74.92±53.80)ng/ml降至(50.88±39.73)ng/ml,统计学无意义(P0.05);治疗后2组对比统计学有差异(P0.05)。5.不良反应比较:2组在出现恶心呕吐、腹泻、便秘方面对比统计学有差异(P0.05)。6.生活质量评分比较:2组治疗后躯体、角色、社会功能、总体健康状况量表和疲倦、失眠、食欲丧失、便秘症状及肺癌特异性子量表评分比较具有统计学意义(P0.05)。结论运用健脾化痰祛湿方联合DP方案,可改善晚期非小细胞肺癌患者生存质量,提高肿瘤近期客观疗效,缓解临床症状和体征,改善体力状态,无明显毒副反应,值得临床推广。
[Abstract]:Objective to study the effect of self-made prescription of invigorating spleen and eliminating phlegm and eliminating dampness on the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by standardized randomized controlled clinical trial study, combined with DP regimen chemotherapy and DP regimen chemotherapy alone. To evaluate the curative effect and advantage of Jianpi Huatan Qushi recipe in the treatment of advanced non-small cell lung cancer, and to provide clinical basis for the extensive application of Jianpi Huatan Qushi recipe in lung cancer and other malignant tumors. It can objectively and truly evaluate the clinical efficacy of traditional Chinese medicine in the treatment of lung cancer, and maximize the characteristics and advantages of traditional Chinese medicine in the treatment of lung cancer. Methods Sixty patients with advanced non-small cell lung cancer were randomly divided into two groups. The treatment group (30 cases) was treated with Jianpi Huatan Qushi decoction combined with DP regimen, while the control group (30 cases) was treated with DP regimen alone. Two courses of treatment were observed. EORTCQLQ-LC43 International quality of Life scale (IQOL) was used as a measurement tool, and combined with the traditional clinical efficacy evaluation indexes (such as TCM syndrome effect, objective curative effect of tumor, therapeutic effect of behavior condition, tumor index, etc.). Outcome 1. Short-term objective curative effect comparison: the treatment group 30 cases, the complete remission 1 case, the partial remission 15 cases, the stability 12 cases, the progress 2 cases, the effective rate is 53.3%, the disease control rate is 93.3%; In the control group, there were 30 cases with no complete remission, 8 cases with partial remission, 13 cases with stability, 9 cases with progress, the effective rate was 26.7%, the rate of disease control was 70%, the difference was statistically significant between the two groups (P0.05). Comparison of TCM syndrome curative effect: in the treatment group, the curative effect of TCM syndrome was obvious in 8 cases, effective in 20 cases, ineffective in 2 cases, the effective rate was 93.3%; In the control group, 2 cases were effective, 19 cases were effective, 9 cases were ineffective, and the effective rate was 70%. There was a significant difference between the two groups (P0.05) .3.KPS score in the treatment group increased from 72.33 卤4.30 before treatment to 79.33 卤7.39 in the treatment group, KPS score increased from 72.33 卤4.30 before treatment to 79.33 卤7.39 in the treatment group. The KPS score of the control group increased from 74.33 卤5.04 to 75.33 卤6.81. There was no significant difference between the two groups before treatment (P0.05), but there was statistical significance after treatment (P0.05). CEA: the value of CEA decreased from (68.73 卤54.81) ng/ml to (27.98 卤22.70) ng/ml, in the treatment group (P0.05). There was no significant difference in CEA value between control group and control group from (74.92 卤53.80) ng/ml to (50.88 卤39.73) ng/ml, (P0.05), and there was significant difference between the two groups after treatment (P0.05). Side effects: there were significant differences in nausea and vomiting, diarrhea and constipation between the two groups (P0.05). Comparison of body, role, social function, general health status scale and fatigue, insomnia, loss of appetite, constipation symptom and lung cancer specific sub-scale scores in two groups after treatment were statistically significant (P0.05). Conclusion the combination of Jianpi Huatan Qushi recipe and DP regimen can improve the quality of life of patients with advanced non-small cell lung cancer, improve the short-term objective curative effect of the tumor, relieve the clinical symptoms and signs, improve the physical state, and have no obvious toxic and side effects. It is worthy of clinical popularization.
【学位授予单位】：南京中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R734.2

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