经药盒动脉序贯输注p53基因治疗晚期肝癌的临床观察

Clinical Therapeutic Effect of p53 Gene Sequential Infusion via Hepatic Artery on Advanced Hepatocellular Carcinoma

目的:观察经皮下药盒动脉输注p53基因治疗晚期肝癌的疗效。方法:晚期肝癌48例,治疗组30例,对照组18例。经右髂外动脉入路皮下埋植药盒系统,根据造影表现决定灌注药物的靶动脉。治疗组在靶动脉注入p53基因(今又生,深圳赛百诺公司),每次用1012VP,加羟基喜树碱20rag,每周1次,连用3周为l疗程,30例患者分别接受1～8疗程的治疗。对照组给予羟基喜树碱20mg肝动脉灌注。观察治疗前后患者的AFP、卡氏评分、病灶的变化和生存期等。结果:治疗组所有病例治疗后都有不同程度的发热,2例出现口角湿疹,未观察到恶心、呕吐、腹泻和骨髓抑制等表现。治疗组14例腹水患者,9例明显吸收好转,对照组无一例好转。治疗组生存期最小14d,最长405d,平均199.6±111.8d。对照组生存期最小18d,最长182d,平均83.0±50.2d 两者相比较,P<0.05,有显著差异。治疗组治疗前AFP是(45064.1±42 349.8)ng/L,治疗后AFP是(33 994.7±34 750.8)ng/L,两者相比较,P<0.05,有显著差异。对照组治疗前AFP是(47 573.9±39 734.8)ng/L,治疗后AFP是(49 042.5±37 285.4)ng/L,两者相比较,P>0.05,无显著差异。治疗组治疗前KPS是58.8+-14.8,治疗后:KPS是66.8+8.4,两者相比较,P<0.05,有显著差异,,对照组治疗前KPS是59.2±14.4,治疗后KPS是58.3±13.9,两者相比较,P>0.05,无显著差异。结论:经肝动脉序贯输注p53基因治疗晚期肝癌有一定的疗效。

Objective： To investigate the therapeutic effect of hepatic arterial perfusion of p53 gene via port catheter system （PCS） on advanced hepatocellular carcinoma. Methods： A total of 48 cases of advanced hepatocellular carcinoma were divided into the experimental group （30） and the control group （18）. Transiliaca external artery PCS implantation was performed in all cases, p53 gene was perfused into target artery confirmed by angiography. In the experimental group, 1012VP of p53 gene and 20mg OPT were employed every week as a course for 21 days. One to 4 courses were performed. In the control group, only 20 mg OPT was used. KPS, AFP and the survival period were analyzed. Results： In the experimental group, all cases had fervescence and 2 cases had eczema at the corner of the mouth. Nausea, vomiting, diarrhea and bone marrow depression were not observed. In the experimental group, 14 cases had ascites. However, ascites was not observed in the control group. The survival period was 14 to 405 days in the experimental group and 18 to 182 days in the control group, with a significant difference between the two groups （P〈0.05）. AFP level was 45064.1±42349.8ng/L before therapy and 33994.7±34750.8ng/L after therapy in the experimental group, with a significant difference （P〈0.05）. AFP level was 47573.9 ± 39734.8ng/L before therapy and 49042.5 ± 37285.4ng/L after therapy in the control group, with no significant difference （P〉0.05）. The KPS was 58.8± 14.8 before therapy and 66.8±8.4 after therapy in the experimental group, with a significant difference （P〈 0.05）. The KPS was 59.2±14.4 before therapy and 58.3±13.9 after therapy in the control group, with no significant difference （P〉0.05）. Conclusion： p53 gene sequential infusion via hepatic artery is effective for advanced hepatocellular carcinoma.