奈达铂注射剂联合放疗治疗食管癌的临床研究

Clinical trial of nedaplatin injection combined with radiotherapy in the treatment of esophageal cancer

目的观察奈达铂注射剂联合放疗治疗食管癌的临床疗效和安全性。方法将56例食管癌患者随机分为对照组28例和试验组28例。对照组予以单纯放疗治疗,每周5次;试验组在对照组治疗的基础上,第1天予以90 mg·m^(-2)奈达铂,静脉滴注2 h以上,一个疗程3周。2组患者均治疗6周。比较2组患者的临床疗效和药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为82.14%(23例/28例)和57.14%(16例/28例),差异有统计学意义(P<0.05)。试验组和对照组放射性食管炎分别为21.43%和17.86%,恶心呕吐分别为32.14%和21.43%,谷丙转氨酶升高分别为10.71%和7.14%,血小板减少分别为21.43%和10.71%,血红蛋白水平下降分别为14.29%和7.14%,白细胞水平下降分别为21.43%和17.86%,差异均无统计学意义(均P>0.05)。结论奈达铂注射剂联合放疗治疗食管癌的临床疗效显著,且不增加药物不良反应的发生率。

Objective To observe the clinical efficacy and safety of nedaplatin injection combined with radiotherapy in the treatment of esophageal cancer. Methods Fifty-six patients with esophageal cancer were randomly divided into control group and treatment group with 28 cases per group. Control group was treated with radiotherapy alone,5 times a week. On the basis of control group,treatment group was given90 mg·m^（-2） nedaplatin,intravenous drip for more than 2 h on the first day,with 3 weeks per cycle. Two groups were treated for 6 weeks. The clinical efficacy and adverse drug reactions were compared between two groups. Results After treatment,the total effective rates of treatment and control group were 82. 14%（ 23 cases/28 cases） and 57. 14%（ 16 cases/28 cases） with significant difference（ P〈0. 05）. The adverse drug reactions in two groups were based on radiation esophagitis,nausea and vomiting,elevated alanine aminotransferase,thrombocytopenia,reducedhemoglobin and leukocyte levels. The incidences of adverse drug reactions in treatment and control groups were compared： radiation esophagitis were 21. 43% and 17. 86%,nausea and vomiting were32. 14% and 21. 43%,elevated alanine aminotransferase were 10. 71%and 7. 14%,thrombocytopenia were 21. 43% and 10. 71%,reduced hemoglobin level were 14. 29% and 7. 14%,reduced leukocyte levelwere 21. 43% and 17. 86%,the differences were not statistically significant（ all P〉0. 05）. Conclusion Nedaplatin injection combined with radiotherapy has a definitive clinical efficacy in the treatment of esophageal cancer,without increasing the incidence of adverse drug reactions.