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目的观察食道通结方辅助化疗治疗中晚期食管癌鳞癌的临床疗效及安全性。方法纳入中晚期食管癌鳞癌患者71例,随机分为对照组36例与治疗组35例。对照组给予紫杉醇加卡铂化疗方案治疗;治疗组同时配合食道通结方内服,每日1剂,化疗结束后服用中药4个月。观察患者3年生存率及化疗结束4个月的行为状况、免疫指标及中医证候疗效,并观察不良反应。结果治疗组三年生存率为48.6%,高于对照组的25.0%(P<0.05);治疗组中医证候疗效总有效率为80.0%,高于对照组的58.3%(P<0.05);化疗4个月后,治疗组呕吐痰涎、反酸、大便稀溏、乏力症状积分较化疗前明显降低,且显著低于对照组(P<0.05);治疗组行为状况总有效率为71.4%,明显高于对照组的41.7%(P<0.05);治疗组治疗后CD4+/CD8+、自然杀伤(NK)细胞较治疗前显著提高,且明显高于对照组(P<0.05)。治疗组各抗癌药物毒副反应发生率较对照组低,但差异无统计学意义(P>0.05)。结论食道通结方辅助化疗治疗中晚期食管癌鳞癌患者,可以改善临床症状,减轻毒副反应,提高生活质量,改善机体的免疫功能。
Objective To observe the clinical efficacy and safety of esophageal Tongluo Recipe in the treatment of advanced esophageal squamous cell carcinoma. Methods Totally 71 patients with advanced esophageal squamous cell carcinoma were divided into control group (36 cases) and treatment group (35 cases). The control group was treated with paclitaxel plus carboplatin chemotherapy. The treatment group also took orally Tongluo recipe orally, one day a day, after taking chemotherapy for 4 months. Observe the patients 3-year survival rate and the end of chemotherapy for 4 months of behavioral status, immune indicators and TCM syndrome efficacy, and observed adverse reactions. Results The three - year survival rate of the treatment group was 48.6%, which was higher than that of the control group (25.0%, P <0.05). The total effective rate of TCM syndromes in the treatment group was 80.0%, which was higher than that in the control group (58.3%, P <0.05). After 4 months of chemotherapy, vomiting and salivary spit, acid reflux, stool thinning and weakness symptom scores in the treatment group were significantly lower than those before chemotherapy (P <0.05), and the total effective rate in the treatment group was 71.4% , Which was significantly higher than that of the control group (41.7%, P <0.05). The CD4 + / CD8 + and NK cells in the treatment group were significantly higher than those in the control group after treatment (P <0.05). The incidence of side effects of anticancer drugs in the treatment group was lower than that in the control group, but the difference was not statistically significant (P> 0.05). Conclusion Esophageal Tongfang adjuvant chemotherapy for advanced esophageal squamous cell carcinoma patients can improve clinical symptoms, reduce side effects, improve quality of life and improve the body’s immune function.