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目的:观察食道通结方联合化疗治疗中晚期食管癌术后患者的临床疗效。方法:纳入痰气阻膈型中晚期食管癌术后患者128例,随机分为治疗组64例和对照组64例。对照组采用多西紫杉醇加顺铂的化疗方案治疗,治疗组在化疗同时配合食道通结方内服。观察两组患者的1年、3年无进展生存率及化疗的毒副反应,评价两组的中医证候疗效及主要临床症状改善情况。结果:对照组1年无进展生存率为50.0%,3年无进展生存率为18.8%,中位复发时间为10个月;治疗组1年无进展生存率为70.3%,3年无进展生存率为45.3%,中位复发时间为31个月。两组的3年无进展生存率及中位复发时间比较,差异有统计学意义(P<0.05)。化疗后,治疗组患者的恶心呕吐、腹泻情况优于对照组(P<0.05)。治疗组中医证候改善的总有效率为60.9%,对照组为35.9%,两组比较差异有统计学意义(P<0.05);化疗后,治疗组患者的胸膈痞满、泛吐痰涎、便溏症状积分较化疗前明显降低(P<0.05),且显著低于对照组(P<0.05)。结论:食道通结方联合化疗治疗中晚期食管癌术后患者,可提高患者的3年无进展生存率,减少化疗毒副反应,改善患者的临床症状。
Objective: To observe the clinical efficacy of esophageal Tongluo combined with chemotherapy in the treatment of advanced esophageal cancer patients. Methods: One hundred and eighty-eight patients with moderate and advanced esophageal cancer with phlegm blocking were randomly divided into treatment group (64 cases) and control group (64 cases). The control group was treated with docetaxel plus cisplatin chemotherapy, while the treatment group was treated with chemotherapy combined with esophagus Tongluo recipe. The 1-year, 3-year progression-free survival rates and the toxicities and side effects of chemotherapy were observed in both groups, and the curative effect of traditional Chinese medicine and the improvement of the main clinical symptoms were evaluated. Results: The 1-year progression-free survival rate was 50.0% in control group, the 3-year progression-free survival rate was 18.8%, and the median time to relapse was 10 months. The 1-year progression-free survival rate was 70.3% in treatment group and 3 years in progression-free survival The rate was 45.3% and the median time to recurrence was 31 months. The difference of 3-year progression-free survival and median time to recurrence between the two groups was statistically significant (P <0.05). After chemotherapy, nausea, vomiting and diarrhea were better in the treatment group than in the control group (P <0.05). The total effective rate of TCM syndromes improvement was 60.9% in the treatment group and 35.9% in the control group, with significant difference between the two groups (P <0.05). After chemotherapy, the patients in the treatment group had pleural-phrenic fullness and pancreas spit , And the scores of stool symptoms were significantly lower than those before chemotherapy (P <0.05), and were significantly lower than those of the control group (P <0.05). Conclusion: Esophageal Tongluo combined with chemotherapy for patients with advanced esophageal cancer patients can improve the 3-year progression-free survival rate, reduce chemotherapy side effects, and improve the clinical symptoms of patients.