| Objective To evaluate the clinical efficacy and safety of thermochemotherapy infusion combinedwith chemoembolization in the treatment of hepatic carcinoma. Methods Ninety-six patients with hepaticcarcinoma, were randomly divided into two groups. Each group had forty-eight patients. In the study group,the patients underwent thermochemotherapy infusion combined with chemoembolization. In the contrastgroup, chemotherapy infusion was followed by chemoembolization. Before the treatment, the patients un-derwent the basic blood examination and other necessary examination, including liver function, renal func-tion, routine analysis of blood, clotting mechanism, immune function, electrocardiogram and score of KPS.At the same time, each patient was performed with enhanced CT scaning, which could describe the tumortype, volumes and numbers. In all patients of the two groups the treatment was applied and was repeated2to4courses. In the study group, forty-eight cases were treated by HGC-3000, which was the hyperthermiamachine for interventional oncology, and made in China. At first,1000mg gemcitabine were dissolved insaline and then were infused into the hyperthermia machine, which could warm the solution to50-55℃before infusioning into the hepatic arteries. The rate of fluid was set to0.5-1.0ml/s. The time was set to10-37minutes. After transhepatic arterial infusion of warmed chemotherapeutic, superselective transcathe-ter arterial chemoembolization was performed with the mixture of200mg gemcitabine,200mg carboplatinand lipiodol. While in the control group,1000mg gemcitabine were dissolved in saline in room temperature,and then the solution were infused into hepatic arteries directly by the rate of fluid of0.5-1.0ml/s. After that,superselective transcatheter arterial chemoembolization was performed with the mixture of200mg gemci-tabine,200mg carboplatin and lipiodol. The dosage of lipiodol was according to the volumes of tumours.Repeated treatment was given after30-40days and continued for two or three times. Examination wereperformed, including the liver function, renal function, routine analysis of blood, clotting mechanism andimmune function, three days and one month after treatment. The volumes of tumor were measured on CTimages, and toxicity were recorded and the patients survival periods were observed. Results Two groups ofalanine aminotransferase (ALT) and aspartate aminotransferase (AST) were higher than pre-treatment after 3days(P<0.05), but there were no changes after30days. No significant difference of renal function be-tween pre-treatment and post-treatment were found in the both groups. In the study group, the levels ofalanine aminotransferase (ALT) were (43±5) U/L, three days after treatment, the levels increased to (84±12)U/L (P=0.000), but thirty days after treatment it showed no difference with pre-treatment (P=0.710). In thecontrol group, the levels of ALT were (41±3) U/L, it was (175±10) U/L three days after treatment, and itwere (40±5) U/L thirty days after treatment. There was significant difference between pre-treatment andpost-treatment in the control group. In the study group, the levels of aspartate aminotransferase (AST) were(44±2) U/L, the levels increased to (94±11) U/L three days after treatment (P=0.000). But thirty days aftertreatment there was no difference with pre-treatment (P=0.202). In the control group, the levels of ASTwere (42±1) U/L, it were (173±13) U/L three days after treatment, and it were (41±3) U/L thirty days aftertreatment. There was significant difference between pre-treatment and post-treatment in the control group.The result of our study indicated as following: CR zero case, PR thirty six cases, SD seven cases, PD fivecases, with the total efficiency being75%(36/48); and that of the control group showed that: CR zero case,PR ninteen cases, SD eighteen cases, PD eleven cases, with the total efficiency being39.58%(19/48).Allof above data showed statistically significant difference in two groups (P=0.000). As to the study group,the mark of Karnofsky had improved for thirty-nine cases, accounting for81.25%(39/48), showed statisti-cally significant difference in two groups also (P=0.003); compared with that of the control group fortwenty four cases, accounting for50%(24/48). In the study group,the immunity state of patients were im-proved after treatment, however, There was no significant difference between pre-treatment andpost-treatment in the control group. In the study group, the CD3was (69.35±6.88)%before treatment, andit was (72.23±6.84)%after treatment,(P=0.005). The CD4was (40.67±6.75)%before treatment, and itwas (40.89±8.19)%, after treatment (P=0.849), The CD8was (24.18±1.85)%before treatment, and it was(23.56±6.66)%, after treatment,(P=0.028). The ratio of CD4/CD8was (1.82±0.67) before treatment,and it was (1.85±0.57) after treatment,(P=0.194). The NK cells were (12.69±4.98)%before treatment,and it was (11.41±4.43)%after treatment,(P=0.291). The Regulatory T cells were (11.83±4.09)%beforetreatment, and it were (14.17±3.92)%after treatment,(P=0.002). In the control group, the CD3was (68.89±5.45)%before treatment and it was (68.67±5.35)%after treatment (P=0.172). The CD4was (39.89± 5.78)%before treatment and it was (40.01±5.68)%after treatment (P=0.570). The CD8was (23.08±1.75)%before treatment and it was (23.10±1.70)%after treatment,(P=0.854). The ratio of CD4/CD8was(1.86±0.56) before treatment and it was (1.87±0.61) after treatment (P=0.206). The NK cells were (11.70±5.78)%before treatment and it was (11.80±5.25)%after treatment (P=0.851). The Regulatory T cellswere (11.61±3.08)%before treatment and it were (11.59±3.07)%after treatment (P=0.724). There wasno significant difference between pre-treatment and post-treatment in the control group. However, in thestudy group, the immunity state of patients were improved after treatment. In the study group, the mediansurvival was24months [95%confidence interval(CI):20-29]. In the control group, the median survival was18.9months [95%confidence interval(CI):18-20]. No significant difference was found in side effect be-tween two groups. Conclusion The transcatheter arterial heated chemotherapy combined with transcatheterarterial chemoembolization for Hepatocellular Carcinoma was better than the transcatheter arterial chemo-therapy combined with transcatheter arterial chemoembolization. |
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