参茸方对新药联合铂类方案治疗肺癌减毒作用的临床观察
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摘要
目的：
通过前瞻性、随机(抽签法)分组的临床观察研究,观察相关的毒性与生活质量指标,评价参茸方对新药联合铂类方案治疗非小细胞肺癌的减毒作用。
方法：
拟进行各种化疗方案治疗的40例患者,治疗前用抽签法分参茸方先治疗组和参茸方后治疗组,每组各20例。
参茸方先治疗组：于第1疗程化疗周期第一天开始,每日服参茸方一剂,连续10天,同时实施化疗。第2疗程仅实施原化疗方案作自身对照。参茸方后治疗组：第1疗程仅实施化疗方案作自身对照；第2疗程化疗周期第一天开始,每日服参茸方一剂,连续10天,同时实施原化疗方案。通过随机自身前后交叉对照,采用WHO恶性肿瘤化疗毒性分级标准及生活质量量表,观察参茸方对化疗毒性及患者生活质量的影响。
结果：
共有40例患者完成本研究,2010年11月-2012年1月期间的住院病人,其中参茸方先治疗组20例,参茸方后治疗组20例。以铂类为基础的联合化疗方案主要毒副反应为血液毒性和消化道毒性。其中血液毒性主要为I-III度白细胞、中性粒细胞、血小板减少和贫血,消化道反应主要为I-III度恶心呕吐和I-II度便秘。
40例患者中,参茸方联合化疗方案的血液毒性(白细胞、中性粒细胞减少)较单纯化疗方案低(P<0.05),而血红蛋白及血小板的减少两方案无显著差异。其中参茸方先治疗组的血液毒性较单纯化疗方案低(P<0.05),参茸方后治疗组与单纯化疗方案血液毒性无显著性差异。40例患者中参茸方联合化疗方案恶心呕吐反应较单纯化疗方案轻(P<0.05)。与治疗前相比,参茸方联合化疗方案及单纯化疗方案治疗后,临床症状及生活质量均有不同程度的改善(P<0.05)；参茸方联合化疗方案较单纯化疗方案的生活质量更高(P<0.05)。
结论：
1.参茸方能减轻以顺铂为基础的化疗方案治疗非小细胞肺癌时的血液毒性和消化道毒性,缓解症状,提高生活质量,达到减毒的目的。
2.应用顺铂为基础的化疗方案治疗非小细胞肺癌时,早期联合应用参茸方,减毒作用更好。
3.参茸方对晚期非小细胞肺癌患者安全、有效,且组方简单、易于操作,值得进行进一步研究并推广应用。
Object ives
To observe the therapeutic efficacy of "ShenRong" decoction for attenuating the toxicity and improving the quality of life (QOL) of platinum-based chemotherapy in treating advanced Non-Small-Cell Lung Cancer(NSCLC).
Methods
Forty patients with NSCLC, who were scheduled to be treated by at least2cycles of chemotherapy, were enrolled. They were randomized into2groups:20cases in the "ShenRong" decoction pre-treated group and20cases in the "ShenRong" decoction post-treated group.
In the pre-treated group,"ShenRong" decoction was given on the first day of the first regimen, continued for10days. Another regimen was only given with chemotherapy. In the post-treated group, chemotherapy was given solely in the first regimen,"ShenRong" decoction was given on the first day of the second regimen for10days.
The toxicity and QOL were evaluated and compared by using WHO malignant tumor toxic chemotherapy classification standard, QLQ-C30and FACT-L.
Result
The major toxicity of platinum-based chemotherapy were hemato-toxicity and digestive toxicity. Among40patients, the hemato-toxicity (toxicity on leukocyte and neutrophil) and the digestive toxicity (represented as vomiting) of chemotherapy revealed in the treated stage (the regimen treated with "ShenRong" decoction) were all less than those in the control stage(the regimen without "ShenRong" decoction)(P<0.05).
After treatment, the QOL were better than before in both two plans (P<0.05), and the regimen treated with "ShenRong" decoction was better than chemotherapy only(P<0.05).
Conelusion
First,"ShenRong" decoction can decrease the toxicity, relieve the symptoms and improve the QOL of the patients who were treated by platinum-based chemotherapy. Second, it will be better if "ShenRong" decoction is given early. Third,"ShenRong" decoction is safe, effective and acceptable for advanced NSCLC patients, it worth further study and promotion.
通过前瞻性、随机(抽签法)分组的临床观察研究,观察相关的毒性与生活质量指标,评价参茸方对新药联合铂类方案治疗非小细胞肺癌的减毒作用。
方法：
拟进行各种化疗方案治疗的40例患者,治疗前用抽签法分参茸方先治疗组和参茸方后治疗组,每组各20例。
参茸方先治疗组：于第1疗程化疗周期第一天开始,每日服参茸方一剂,连续10天,同时实施化疗。第2疗程仅实施原化疗方案作自身对照。参茸方后治疗组：第1疗程仅实施化疗方案作自身对照；第2疗程化疗周期第一天开始,每日服参茸方一剂,连续10天,同时实施原化疗方案。通过随机自身前后交叉对照,采用WHO恶性肿瘤化疗毒性分级标准及生活质量量表,观察参茸方对化疗毒性及患者生活质量的影响。
结果：
共有40例患者完成本研究,2010年11月-2012年1月期间的住院病人,其中参茸方先治疗组20例,参茸方后治疗组20例。以铂类为基础的联合化疗方案主要毒副反应为血液毒性和消化道毒性。其中血液毒性主要为I-III度白细胞、中性粒细胞、血小板减少和贫血,消化道反应主要为I-III度恶心呕吐和I-II度便秘。
40例患者中,参茸方联合化疗方案的血液毒性(白细胞、中性粒细胞减少)较单纯化疗方案低(P<0.05),而血红蛋白及血小板的减少两方案无显著差异。其中参茸方先治疗组的血液毒性较单纯化疗方案低(P<0.05),参茸方后治疗组与单纯化疗方案血液毒性无显著性差异。40例患者中参茸方联合化疗方案恶心呕吐反应较单纯化疗方案轻(P<0.05)。与治疗前相比,参茸方联合化疗方案及单纯化疗方案治疗后,临床症状及生活质量均有不同程度的改善(P<0.05)；参茸方联合化疗方案较单纯化疗方案的生活质量更高(P<0.05)。
结论：
1.参茸方能减轻以顺铂为基础的化疗方案治疗非小细胞肺癌时的血液毒性和消化道毒性,缓解症状,提高生活质量,达到减毒的目的。
2.应用顺铂为基础的化疗方案治疗非小细胞肺癌时,早期联合应用参茸方,减毒作用更好。
3.参茸方对晚期非小细胞肺癌患者安全、有效,且组方简单、易于操作,值得进行进一步研究并推广应用。
Object ives
To observe the therapeutic efficacy of "ShenRong" decoction for attenuating the toxicity and improving the quality of life (QOL) of platinum-based chemotherapy in treating advanced Non-Small-Cell Lung Cancer(NSCLC).
Methods
Forty patients with NSCLC, who were scheduled to be treated by at least2cycles of chemotherapy, were enrolled. They were randomized into2groups:20cases in the "ShenRong" decoction pre-treated group and20cases in the "ShenRong" decoction post-treated group.
In the pre-treated group,"ShenRong" decoction was given on the first day of the first regimen, continued for10days. Another regimen was only given with chemotherapy. In the post-treated group, chemotherapy was given solely in the first regimen,"ShenRong" decoction was given on the first day of the second regimen for10days.
The toxicity and QOL were evaluated and compared by using WHO malignant tumor toxic chemotherapy classification standard, QLQ-C30and FACT-L.
Result
The major toxicity of platinum-based chemotherapy were hemato-toxicity and digestive toxicity. Among40patients, the hemato-toxicity (toxicity on leukocyte and neutrophil) and the digestive toxicity (represented as vomiting) of chemotherapy revealed in the treated stage (the regimen treated with "ShenRong" decoction) were all less than those in the control stage(the regimen without "ShenRong" decoction)(P<0.05).
After treatment, the QOL were better than before in both two plans (P<0.05), and the regimen treated with "ShenRong" decoction was better than chemotherapy only(P<0.05).
Conelusion
First,"ShenRong" decoction can decrease the toxicity, relieve the symptoms and improve the QOL of the patients who were treated by platinum-based chemotherapy. Second, it will be better if "ShenRong" decoction is given early. Third,"ShenRong" decoction is safe, effective and acceptable for advanced NSCLC patients, it worth further study and promotion.
引文
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