| 夏广荣,刘桂梅,靳国华.甘氨双唑钠放射增敏作用的临床研究[J].中华放射医学与防护杂志,2006,26(5):470-472 |
| 甘氨双唑钠放射增敏作用的临床研究 |
| Clinical study on tumor radiosensitizer CMNa |
| 投稿时间：2006-01-17 |
| DOI： |
| 中文关键词: 放射治疗 甘氨双唑钠 放射增敏剂 |
| 英文关键词:Radiotherapy CMNa Radiosensitizer |
| 基金项目: |
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| 中文摘要: |
| 目的 观察甘氨双唑钠(CMNa)放射增敏作用。方法 对55例经病理学和(或)细胞学证实的肺癌、食管癌采用随机双盲对照法分为A组(放疗+CMNa组)和B组(放疗+安慰剂组)。A组CMNa按800mg/m2于放疗前1h内静脉滴注,3次/周滴注至放疗结束。B组用同样剂量的安慰剂。静脉滴注后30～60min内进行放疗,直至疗程结束。放疗总剂量60～70Gy,2Gy/次,5次/周,共6～7周。结果 治疗组2例肺癌患者因过敏反应(皮疹)退组未参与疗效评价。肺癌A组和B组的有效率分别为42%和53%(P=0.516),食管癌中A组和B组有效率分别为100%和43%(P=0.015),A组和B组总有效率分别为62%和50%(P=0.378)。中位生存期A组为11个月,B组为10个月。1、3、5年总生存率A组分别为31%、13%、10%,B组分别为25%、15%、6%(P=0.475)。1、3、5年局部控制率A组分别为32%、18%、16%,B组分别为28%、19%、13%(P=0.518)。除偶见皮疹,两组毒副反应相似。结论 CMNa对食管癌有放射增敏作用,而对肺癌疗效不明显,其毒副作用轻微。CMNa配合放疗远期疗效不明显,仍需追踪观察和扩大病例试验。 |
| 英文摘要: |
| Objective To verify the role of glycodidazolum natrium (CMNa) in enhancing radiosensitivity of tumors. Methods A double-blind randomized clinical trial was performed. Fifty-five cancer cases of the lungs or esophagus were randomly classified into two groups, one group (Group A) was treated with radiotherapy plus CMNa, and the control group (Group B) with radiotherapy plus placebo. Radiotherapy was administered by conventional schedule: 2 Gy per fraction, 5 fractions per week, 60～70 Gy in total during 6～7 weeks. CMNa was given by intravenous drip at a dose of 800 mg/m2 on day 1,3,and 5 per week throughout the course of treatment. Radiotherapy was started 30-60 minutes after completion of CMNa infusion. Results Among the patients of lung cancer, the CR+PR rate was 42% in Group A and 53% in Group B, respectively (P=0.516). Among the patients of esophageal carcinoma, the CR+PR rate was 100% in Group A and 43% in Group B, respectively (P=0.015). The mean survival time in Group A was 11 months, and 10 months in Group B. The 1-, 3-, and 5-year local control rates were 32%, 18%, 16% in Group A, and 28%, 19%, 13% in Group B, respectively; and the difference of local control rates between the two groups were not statistically significant (P=0.518). The 1-, 3-, and 5-year survival rates were 31%, 13% and 10% in Group A and 25%, 15% and 6% in Group B (P=0.475). There was no serious side-effect. Conclusions CMNa increased the radiotherapeutic effect in the treatment of esophageal carcinoma, but almost no effect for lung cancer. CMNa administered with radiotherapy was also well-tolerated. Long-term effect was not satisfactory. Further study with large sample-size is needed. |
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