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目的评价重组人p53基因腺病毒注射液(rAd-p53)瘤内注射联合~(125)I粒子组织间植入治疗肝癌的安全性。方法 49例经过TACE及物理消融治疗后的肝癌患者。20例(33个病灶)进行rAd-p53瘤内注射联合~(125)I粒子植入治疗(联合组);29例(47个病灶)进行单独的~(125)I粒子植入术(对照组)。观察术后3d、1周和2周的不良反应,及1个月后的短期疗效。结果联合组术后3 d的不良反应主要是寒战、发热、乏力、肌肉、关节轻度疼痛,发生率明显高于对照组;其他不良反应包括:恶心、呕吐、腹痛,但与对照组比较无统计学差异。术后1周,联合组仅有1例发热,其他不良反应缓解;术后2周,所有不良反应均消失。所有患者观察期内均未见大出血、胆汁瘘、胆囊炎及肠瘘等严重并发症;未见白细胞减低及肝肾功能损害;体力状况(Kamofsky评分)无明显降低。短期疗效显示,联合组和对照组的有效率(CR+PR)分别为90.9%和76.6%,但无统计学差异。结论 rAd-p53瘤内注射联合~(125)I粒子植入是一种较安全的肝癌治疗方式。
Objective To evaluate the safety of rAd-p53 injection combined with 125 I seed implantation in the treatment of liver cancer. Methods Totally 49 patients with hepatocellular carcinoma after TACE and physical ablation were treated. Twenty (33 lesions) were treated with rAd-p53 intratumoral injection combined with (125) I seed implantation (combination group); 29 (47 lesions) were treated with 125 I seed implantation alone group). Adverse reactions were observed at 3d, 1 and 2 weeks after operation, and short-term effects were observed after 1 month. Results The adverse reaction was mainly chills, fever, fatigue, mild muscle and joint pain in the combined group at 3 days after operation. The incidence rate was significantly higher than that of the control group. Other adverse reactions included nausea, vomiting and abdominal pain, but no significant difference compared with the control group Statistical differences. One week after operation, only 1 patient in the combined group had fever and other adverse reactions were relieved. All the adverse reactions disappeared 2 weeks after the operation. No severe bleeding, biliary fistula, cholecystitis and intestinal fistula were found in all the patients during the observation period. No leukopenia and liver and kidney dysfunction were found. There was no significant difference in physical condition (Kamofsky score). Short-term efficacy showed that the combined group and control group, the effective rate (CR + PR) were 90.9% and 76.6%, but no significant difference. Conclusion Intratumor injection of rAd-p53 combined with ~ (125) I particle implantation is a safer treatment for liver cancer.