表柔比星壳聚糖微球联合奥沙利铂注射剂治疗原发性肝癌的临床研究

Clinical trial of epirubicin chitosan microspheres combined with oxaliplatin injection in the treatment of primary hepatic carcinoma

目的观察表柔比星壳聚糖微球联合奥沙利铂注射剂治疗原发性肝癌的临床疗效及安全性。方法将70例原发性肝癌患者随机分为对照组和试验组,每组35例。对照组予以130 mg·m^(-2)奥沙利铂,每周1次,缓慢灌注;试验组在对照组治疗的基础上,予以表柔比星壳聚糖微球每次30 mg,每周1次,灌注。2组患者1个疗程均为4周,均治疗2个疗程。比较2组患者的临床疗效、肝功能、甲胎蛋白、糖蛋白抗原199、谷氨酸转移酶(GGT)水平,以及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77.14%(27例/35例)和54.29%(19例/35例),差异有统计学意义(P<0.05)。治疗后,对照组和试验组的谷丙转氨酶分别为(51.49±5.79)和(33.26±4.43)U·L^(-1),谷草转氨酶分别为(56.17±6.72)和(41.39±4.63)U·L^(-1),甲胎蛋白分别为(139.20±16.04)和(112.15±13.32)ng·m L^(-1),糖蛋白抗原199分别为(63.49±8.05)和(48.93±6.46)U·L^(-1),GGT分别为(120.83±14.31)和(103.49±12.18)U·L^(-1),差异均有统计学意义(均P<0.05)。试验组发生的药物不良反应有消化道反应、低热和转氨酶增高,对照组发生的药物不良反应有消化道反应、低热、上腹疼痛和黄疸。试验组和对照组的总药物不良反应发生率分别为8.57%和31.42%,差异有统计学意义(P<0.05)。结论表柔比星壳聚糖微球联合奥沙利铂注射剂治疗原发性肝癌的临床疗效确切,且安全性高。

Objective To observe the clinical efficacy and safety of epirubicin chitosan microspheres combined with oxaliplatin injection in the treatment of primary hepatic carcinoma. Methods Seventy patients with primary hepatic carcinoma were randomly divided into control and treatment groups with 35 cases per group. Control group was given 130 mg·m-2oxaliplatin,once a week,slow perfusion. Treatment group was treated with epirubicin chitosan microspheres 30 mg per time,once a week,perfusion on the basis of control group. Two groups were treated for 2 cycles with 4 weeks per cycle. The clinical efficacy,liver function,alpha fetal protein, glycoprotein antigen 199, glutamate transferase(GGT）,and adverse drug reactions were compared between two groups.Results After treatment,the total effective rates of treatment and control groups were 77. 14%(27 cases/35 cases） and 54. 29%(19 cases/35 cases） with significant difference(P〈0. 05）. After treatment,themain indexes in control and treatment groups were compared： alanine transaminase were(51. 49 ± 5. 79） and(33. 26 ± 4. 43） U·L-1,aspartate aminotransferase were(56. 17 ± 6. 72） and(41. 39 ± 4. 63） U·L-1,alpha fetal protein were(139. 20 ± 16. 04） and(112. 15 ± 13. 32） ng·m L-1,glycoprotein antigen 199 were(63. 49 ± 8. 05）and(48. 93 ± 6. 46） U·L-1,GGT were(120. 83 ± 14. 31） and(103. 49 ± 12. 18） U·L-1,the differences were statistically significant(all P〈0. 05）. The adverse drug reactions of treatment group were digestive response,low-grade fever and transaminase raise,which in control group were digestive response,low-grade fever,abdomen ache and jaundice. The total incidences of adverse drug reactions in treatment and control groups were 8. 57% and 31. 42% with significant difference(P〈0. 05）. Conclusion Epirubicin chitosan microspheres combined with oxaliplatin injection have a definitive clinical and safety in the treatment of primary hepatic carcinoma