中医综合治疗方案治疗原发性中晚期肝癌的前瞻、随机、对照研究

目的：观察中医综合治疗方案治疗原发性中晚期肝癌的疗效。方法：采用前瞻性、随机、平行对照实验的设计方法，97例患者分别用中医综合洽疗—中药鸦胆子油介入治疗＋内服肝积方＋外敷癌理通（实验组，共49例）和西医治疗—化疗药物灌注＋碘油栓塞＋西药镇痛（对照组，共48例）治疗，观察两组患者的近远期疗效、毒副作用、镇痛起效时间、镇痛维持时间及患者生活质量变化。结果：两组疾病控制率的差异无统计学意义（P〉0.05）；与对照组比较，实验组毒副作用发生率明显降低（P〈0.05）；两组镇痛起效时间无显著性差异（P〉0.05），镇痛维持时间分别为（10.37±2.18）h和（7.78±1.95）h。实验组明显优于对照组（P〈0.01）；治疗后实验组卡氏评分优于对照组（P〈0.05）；实验组中患者治疗后躯体功能改善、症状减轻、总的生活质量较前提高，优于对照片组（P〈0.05）；治疗后3个月生存率两组比较差异无显著意义（P〉0．05），但0.5、1年生存率，实验组分别为65.9％、38.6％，对照组分别为42．5％、18．1％，实验组优于西药对照组（P〈0．05）。两组患者的中位生存期分别为8.9个月和5.3个月。结论：中医综合治疗方案副作用低，并可延长镇痛维持时间，提高患者生活质量，改善远期生存,是治疗中晚期原发性肝癌的有效方法。

Prospective randomized controlled study on complex treatment of traditional chinese medicine to advanced primary hepatocarcinoma

Objective： To observe the effects of complex treatment with traditional chinese medicine on advanced primary hepatocarcinoma. Methods： 97 patient with advanced primary hepatocarcinoma were randomly and parallelly divided into experimental group and control group. Patients in experimental group were treated by complex treatment with traditional chinese medicine, and patients in control group were treated by western medicine. Then the curative effect of near term and long term, the side effect and toxicity, the onset time and duration of analgesia as well as the quantity of life （QOL） were determined. Results： No significant difference of disease control rate was shown between the two groups. The rate of side effect and toxicity in experimental group was lower than that in control group （P〈0.05）. The mean duration of analgesia of experimental group was （10.37±2.18） b, which was higher than that in control group （P〈0.05）, but no considerable difference of the onset time of analgesia was shown between the two groups. Karnofsky scores of experimental group was higher than that in control group after treatment（P〈0.05）. After the treatment, the patients in experimental group showed an enhanced body function, alleviated symptom and improved total QOL compared with patients in control group （P〈0.05）. No marked difference of 3-month survival rate was shown between the two groups （P〉0.05）. The 0.5- and 1-year survival rate in exper imental group were 65.9% and 38.6% respectively, superior to those in control group （42.5% and 18.1% repectively）（P〈0.05）. The median survival times in the experimental and control group were 8.9 and 5.3 months respectively （P〈0.05）. Conclusion： Complex treatment of traditional chinese medicine has lower side effect and toxicity and can prolong the duration of anslgesia, improve the QOL and raise the long-term survival rate. It is an effective method of treating the patients with advanced primary hepatocarcinoma.