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目的 观察人参皂苷Rh2联合同步放化疗治疗鼻咽癌的临床疗效和安全性.方法 将123例中晚期(Ⅲ～Ⅳa期)未角化性未分化鼻咽癌患者分为试验组63例和对照组60例.对照组给予同期放化疗和常规对症支持治疗,6MVX放射线,原发灶照射剂量66 ～76 Gy,转移淋巴结照射剂量60～70 Gy,颈部预防照射剂量56～60 Gy,每周5次;静脉滴注顺铂30 mg·m-2,每周1次.试验组在对照组的基础上口服人参皂苷Rh2支持治疗,每次250 mg,早晚各1次,2组疗程均为6周.参照实体瘤评价标准(RECIST)评价近期疗效,跟踪随访2年的生存率,根据世界卫生组织(WHO)抗癌药物不良反应评价标准进行安全性评价.结果 治疗后,试验组客观缓解率为95.24％(60例/63例),对照组为78.33％(14例/60例),差异有统计学意义(P、0.05).试验组疾病控制率为98.41％(62例/63例),对照组为93.33％(56例/60例),差异无统计学意义(P＞0.05);试验组2年总生存率为90.48％(57例/63例),对照组为76.67％(46例/60例),差异有统计学意义(P＜0.05).试验组总体Ⅲ～Ⅳ级药物不良反应发生率(39.68％)与对照组(58.33％)相比,差异有统计学意义(P＜0.05).结论 人参皂苷Rh2联合同步放化疗治疗鼻咽癌,临床疗效和安全性均优于单纯同步放化疗.“,”Objective To evaluate the clinical efficacy and safety of ginsenoside Rh2 combined with concurrent radiotherapy and chemotherapy in the treatment of nasopharyngeal carcinoma.Methods A total of 123 cases of non-keratinized undifferentiated nasopharyngeal carcinoma (stage Ⅲ-Ⅳ A) were divided into treatment group (n =63 cases) and control group (n =60 cases).Control group was received concurrent radiotherapy and chemotherapy and conventional symptomatic support therapy,6MV X radiation,the original lesion dose of 66-76 Gy,lymph node metastasis treated with 60-70 Gy,56-60 Gy of neck prevention,5 times a week;intravenous infusion of cisplatin 30 mg · m-2,once a week.Treatment group was orally administration of ginsenoside Rh2 250 mg on the basis of control group.The two groups were treated for 6 weeks.The short-term efficacy was evaluated by reference to the sohd tumor evaluation criteria (RECIST).The overall survival rate was followed for 2 years.The safety evaluation was conducted according to the World Health Organization (WHO) evaluation criteria for adverse drug resistance.Results After treatment,the objective response rates in treatment group and control group were 95.24％ (60 cases/63 cases),78.33％ (14 cases/60 cases),with significant difference (P ＜0.05).The disease control rates in treatment group and control group were 98.41％ (62 cases/63 cases),93.33％ (56 cases/60 cases),with significant difference (P＜0.05).The overall survival rates in treatment group and control group were 90.48％ (57 cases/63 cases),76.67％ (46 cases/60 cases),with significant difference (P ＜0.05).The incidences of adverse reactions in treatment group and control group were 39.68％,58.33％,with significant difference (P ＜ 0.05).Conclusion The clinical efficacy and safety of ginsenoside Rh2 combined with concurrent radiotherapy and chemotherapy in the treatment of nasopharyngeal carcinoma were better than those of simple concurrent radiotherapy and chemotherapy.