摘要
目的 对针剂甘氨双唑钠 (CMNa)的放射治疗增敏作用及临床安全性进行随机、双盲Ⅱ期临床研究。方法 共有 2 18例患者入组 ,病种包括头颈部肿瘤、非小细胞肺癌及食管癌。患者随机分为放射治疗加CMNa组 (A组 ,10 0例 )及放射治疗加安慰剂组 (B组 ,98例 )。放射治疗为 1.8～ 2 .0Gy/次 ,5次 /周 ,总剂量为 6 0～ 70Gy ,6～ 7周完成。A组用CMNa 80 0mg/m2 ,3次 /周 (星期一、三、五用药 ) ;CMNa溶于 10 0ml生理盐水中 ,30min内滴完 ;放射治疗在输液结束后 30～ 6 0min内进行。B组用安慰剂加生理盐水 ,方法同A组。结果 共有 2 0 5例患者可评价疗效 ,其中 199例评价了原发灶疗效 ,A、B两组有效 (CR +PR)率分别为 91.2 % (93/ 10 2 )、78.4 % (76 / 97) (P <0 .0 5 ) ,完全缓解 (CR)率分别为 5 5 .9% (5 7/ 10 2 )、30 .9% (30 / 97) (P <0 .0 1)。10 7例评价了转移灶疗效 ,A、B两组CR +PR率分别为 91.1% (5 1/ 5 6 )、92 .2 % (47/ 5 1) (P >0 .0 5 ) ,CR率分别为 5 7.1% (32 / 5 6 )、4 3.1% (2 2 / 5 1) (P >0 .0 5 )。未出现严重不良反应 ,所有患者对CMNa均有很好的耐受性。结论 CMNa对原发灶有良好的放射治疗增敏作用 ,且耐受性好 ,远期效果及安全性有待进一步的随诊观察。
Objective To investigate the radiosensitizing effect and clinical safety of sodium glycididazole (CMNa) in a randomized double blind clinical Phase Ⅱ study. Methods From May 1995 to March 2000, a total of 218 patients with head and neck cancer, non-small cell lung cancer (NSCLC) or esophageal carcinoma were randomized into radiotherapy plus CMNa (group A) or radiotherapy plus placebo (group B) group. Radiotherapy was given by conventional schedule: 1.8-2.0?Gy per fraction, 5 times per week to a total dose of 60-70?Gy/6-7w. CMNa was given 800?mg/m 2 3 times a week (Monday, Thursday, Friday) in solution of 100?ml normal saline, iv drip within 30 minutes. Radiotherapy was started 30-60 minutes after completion of infusion. B group patients received placebo and normal saline. Results A total of 205 patients were evaluated including 199 primary sites and 107 metastatic sites. The response rate (CR+PR) of primary site was 91.2%(93/102) in group A and 78.4% (76/97) in group B(P< 0.05 ).The CR of primary site was 55.9%(57/102) and 30.9%(30/97) in group A and group B(P<0.01). The response rate (CR+PR) of metastatic site was 91.1%(51/56)、in group A and 92.2%(47/51) in group B(P> 0.05 ).The CR of metastatic site was 57.1%(32/56) and 43.1%(22/51)(P> 0.05 ) in group A and group B(P<0.01).There were no serious side-effects, notably the neuropathy. All patients tolerated CMNa infusion well. Conclusions CMNa increased the radiotherapeutic effect in the primary site. CMNa given with radiotherapy was also well tolerated. Further study on its sensitizing effect and safety is warranted.
出处
《中华放射肿瘤学杂志》
CSCD
北大核心
2003年第4期254-258,共5页
Chinese Journal of Radiation Oncology
基金
国家 10 3 5工程资助项目 (96 90 1 0 1 49)
关键词
针剂
甘氨双唑钠
放射治疗
增敏
临床试验
肿瘤
Neoplasms/radiotherapy
Sodium glycididazole
Radiation-sensitizing agent
