摘要
目的:
观察乌三颗粒(Wu San Granule,WSG)辅助治疗非小细胞肺癌(NSCLC)痰瘀兼气阴两虚证的临床疗效及安全性,并从理论和临床研究两方面探讨其作用机理。
方法:
1、选取非小细胞肺癌(NSCLC)患者60例,均为2005年4月—2007年2月间湖北省中医院肿瘤科住院和门诊的病例,中医证型为痰瘀兼气阴两虚型。按就诊先后顺序随机分为治疗组和对照组,治疗组45例,对照组15例。两组患者在年龄、性别、病程、病情严重程度及治疗前中医症状总积分方面无明显差异,具有可比性(P＞0.05)。
2、治疗组给予化疗同时口服乌三颗粒(由重庆华森制药有限公司提供。临床研究批件号:2001ZLb027生产批号:041101,规格:5g/袋。)一次5克,一日三次。而对照组化疗同时口服安慰剂,一次5克,一日三次。21天为一周期,连续两个周期。分别进行安全性检查(血尿便三大常规、心肝肾功能检查)和疗效性观察(症状和体征观察)、治疗前后中医证候积分、体重、卡氏评分及T淋巴细胞亚群(CD3、CD4、CD8、CD4/CD8)、NK细胞的变化。
3、分别比较两组治疗前后中医证候积分、体重、卡氏评分及T淋巴细胞亚群(CD3、CD4、CD8、CD4/CD8)、NK细胞的变化。
4、统计学分析方法:数据应用SPSS13.0统计软件微机进行分析。两样本均数的比较采用两组资料的t检验,根据方差齐性检验结果选择P值,治疗前后均数的比较采用配对t检验。组间比较采用单因素方差分析。
结果:
1、病例入选情况:治疗组有3例脱落,对照组有一例脱落,治疗组与对照组脱落率分别为6.67%和6.67%,无剔除病例。共有56例病人完成治疗,其中治疗组42例,对照组14例。
2、中医证候疗效:疗后6周,中医证候疗效比较,治疗组显著改善15例,部分改善19例,无改善8例,对照组显著改善1例,部分改善6例,无改善7例,两组比较有显著性差异(P＜0.05)。
3、体重变化情况:疗后6周,两组体重变化比较,治疗组增加20例,稳定15例,减少7例,对照组增加3例,稳定4例,减少7例,两组比较有显著性差异(P＜0.05).
4、生存质量疗效变化情况:按照KPS分级评定,其中治疗组提高有30例,稳定有9例,下降有3例,对照组提高有5例,稳定有5例,下降有4例,两组有显著性差异(P＜0.05)。
5、免疫功能情况:主要观察T淋巴细胞亚群(CD3、CD4、CD8、CD4/CD8)、NK细胞变化情况,其中治疗组在CD3、CD4、CD8、CD4/CD8、NK细胞的改善与对照组比较均有显著性差异(P＜0.05)。
结论:
1、乌三颗粒辅助治疗非小细胞肺癌痰瘀兼气阴两虚证患者,不仅可以保护免疫系统而拮抗化疗对免疫功能损害的毒副作用,而且可以调整和提高机体的免疫功能。
2、乌三颗粒辅助治疗非小细胞肺癌痰瘀兼气阴两虚证患者,对患者生存质量及体重的提高与单纯化疗比较,有明显优势,说明乌三颗粒能够减毒增效,提高疗效,体现了中医药的特色。
3、乌三颗粒临床安全性较好,在试验过程中未见明显与实验药物有关的不良反应,对非小细胞肺癌患者血、尿、大便常规和肝肾功能、心电图无不良影响。
Objective:
Observing Wu San Granule supporting the treatment of non-small cell lung cancer (NSCLC) of deficiency of both vital energy and yin and phlegm and blood stasis of the clinical efficacy and safety,and From the theoretical and clinical study of two areas to explore its mechanism.
Method:
1. Selecting non-small cell lung cancer (NSCLC) in 60 cases, all in April 2005 - 2007 February Chinese medicine hospital in Hubei Province cancer patient, out-patients, TCM is the type of phlegm and blood stasis and deficiency of both vital energy and yin. By order of priority were randomly divided into treatment of and control groups. Treatment group 45 cases, 15 cases with the control group. In the two groups in age, gender, disease, the severity of symptoms and treatment of Chinese medicine, and other aspects of integration there was no significant difference, comparable (P> 0.05).
2.In the treatment group were given oral chemotherapy at the same time Wu San Granule, first five grams a day three. And the control group placebo oral chemotherapy at the same time, five grams a day three times. For a period of 21 days, two consecutive cycles. Security checks were conducted (hematuria have three conventional, heart liver and kidney function tests) and the effect of the observation (signs and symptoms observed), before and after treatment TCM Syndrome points, weight,'s score card and T-lymphocyte subsets (CD3, CD4, CD8, CD4/CD8), NK cell changes
3.Comparing the two groups before and after treatment TCM Syndrome points, weight,'s score card and T-lymphocyte subsets (CD3, CD4, CD8, CD4/CD8), NK cell changes.
4. Statistical analysis: Statistical data applications SPSS13.0 computer software for analysis. Two samples of the two sets of data analyzed by the t-test, according to variance-choice test results P value, both before and after treatment figures compare to a paired t test. Group to compare the single-factor analysis of variance.
Resuits:
1.Case selected: The treatment group has lost three cases because of the loss, the control group lost one case of medical and loss, the treatment group and control group loss rates were 6.67 percent and 6.67 percent, without excluding cases. A total of 56 patients completed the treatment, the treatment group of 42 cases, 14 cases of the control group.
2.Traditional Chinese Medicine Clinical Syndrome: Six weeks after treatment, TCM Syndrome effects of the treatment group was significantly improved in 15 cases, some improvement in 19 cases, eight cases without improving the control group one case of significant improvement, improvement of the six cases, no improvement seven cases, two more significant Difference (P <0.05).
3.Changes in body weight: Treatment after six weeks, two groups of weight changes, the treatment group increased by 20 cases, 15 cases of stability, reduce the seven cases, the control group increased three cases, four cases of stability, reduce the seven cases, the two groups was significant difference (P <0.05 ).
4.Effect of changes in the quality of life: KPS to be in accordance with the classification, treatment group increase of 30 cases, nine cases of stability, have dropped three cases, the control group have increased five cases, five cases of stability, have dropped four cases, there were significant differences (P < 0.05).
5.Immune function: Mainly observed T-lymphocyte subsets (CD3, CD4, CD8, CD4/CD8), NK cell changes, including the treatment group in the CD3, CD4, CD8, CD4/CD8, NK cells to improve compared with the control group were significantly Difference (P <0.05).
Conciusion:
1.Wu San Granule adjuvant treatment of non-small cell lung cancer patients with phlegm and blood stasis and can not only deficiency of both vital energy and yin protect the immune system and the antagonism of chemotherapy on the immune function of the side effects, but can also adjust and improve the body's immune function.
2. Wu San Granule adjuvant treatment of non-small cell lung cancer patients with phlegm and blood stasis and deficiency of both vital energy and yin , the quality of life and the improvement of body weight compared with chemotherapy alone, there are clear advantages that can be attenuated Wu San Granule to improve efficiency, and improve the efficacy, reflects the characteristics of Chinese medicine.
3. Wu San Granule has a better clinical safety, in the course of the trial did not appear evident with the experimental drug-related adverse reactions, the non-small cell lung cancer patients with blood, urine, feces conventional and liver and kidney function, no adverse effects on ECG.
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