体外高频热疗联合中药治疗晚期非小细胞肺癌。
Treatment of advanced non-small cell lung cancer with extracorporeal high frequency thermotherapy combined with Chinese medicine.
机构信息
Department of Cancer, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.
出版信息
Chin J Integr Med. 2010 Oct;16(5):406-10. doi: 10.1007/s11655-010-0535-8. Epub 2010 Sep 25.
OBJECTIVE
To observe the clinical efficacy and benefit response of extracorporeal high frequency thermotherapy (EHFT) combined with Chinese medicine (CM) in the treatment of patients with advanced nonsmall cell lung cancer.
METHODS
The study adopted a prospective, small sample and randomized controlled method, and the advanced non-small cell lung cancer patients were assigned to two groups according to the table of random digits, one having the treatment of EHFT combined with CM (the treatment group), the other only with CM (the control group). The patients in the treatment group were treated with EHFT one hour once per day, together with CM differentiation decoction, 250 mL orally taken, twice daily for 14 days as one cycle, and 3-4 cycles was performed. The patients in the control group were treated only with CM differentiation decoction using the same dose as the treatment group. The efficacies were evaluated after three to four cycles of treatment. Primary endpoints were disease control rate (DCR) and time to progression (TTP). Secondary endpoints were overall survival time and 1-year survival rate.
RESULTS
Sixty-six patients accomplished the study. After the patients underwent different treatments, none of the patients got a complete response or partial response in both groups. In the treatment group, DCR was 72.2%, and 10 had progression of disease (28.8%), while the DCR of the control group was 63.3%, and 11 had progression of disease (36.7%); there was a significant statistical difference (P <0.05), suggesting that the combined regimen had superiority on the DCR. As for long-term efficacy, the median survival time (MST) of the treatment group was 7.5 months, TTP was 5.5 months, and 1-year survival rate was 21.4 %; in the control group, the results were 6.8 months, 4.5 months and 16.6% respectively. There was significant statistical difference on TTP (P <0.05), but no difference on MST or 1-year survival rate.
CONCLUSION
EHFT combined with CM differentiation has better tolerance and short-term efficacy in the treatment of patients with advanced NSCLC.
目的
观察体外高频热疗（EHFT）联合中药治疗晚期非小细胞肺癌的临床疗效和受益反应。
方法
本研究采用前瞻性、小样本、随机对照方法，根据随机数字表将晚期非小细胞肺癌患者分为两组，一组采用 EHFT 联合中药（治疗组）治疗，另一组仅采用中药（对照组）治疗。治疗组患者每天接受一次 EHFT 治疗，每次 1 小时，同时服用中药辨证汤，口服 250ml，每日两次，14 天为一个周期，进行 3-4 个周期。对照组患者仅采用与治疗组相同剂量的中药辨证汤治疗。治疗 3-4 个周期后评估疗效。主要终点是疾病控制率（DCR）和无进展生存期（TTP）。次要终点是总生存时间和 1 年生存率。
结果
66 例患者完成了研究。在不同治疗后，两组患者均无完全缓解或部分缓解。治疗组的 DCR 为 72.2%，10 例患者病情进展（28.8%），而对照组的 DCR 为 63.3%，11 例患者病情进展（36.7%）；差异有统计学意义（P <0.05），表明联合方案在 DCR 方面具有优势。长期疗效方面，治疗组的中位生存时间（MST）为 7.5 个月，TTP 为 5.5 个月，1 年生存率为 21.4%；对照组分别为 6.8 个月、4.5 个月和 16.6%。TTP 差异有统计学意义（P <0.05），而 MST 或 1 年生存率差异无统计学意义。
结论
EHFT 联合中药辨证施治对晚期 NSCLC 患者具有更好的耐受性和短期疗效。
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