A Randomized, Parallel-group, Controlled Trial To Evaluate The Efficacy And Safety Of Cross-linked Dextran Microspheres In The Treatment Of Primary Hepatic Cancer

Objective:To compare the clinical value of interventional efficacy of cross-linked dextran gel microsphere and ultra-liquid iodized oil embolization agents for Primary hepatic cancer(PLC) treatment, and the effectiveness and safety of cross-linked dextran gel microsphere embolization agent for PLC was evaluated. Methods:24 patients(13 males(51.8 ± 11.0 years old), 11 females(55.2 ± 9.5 years old)) were diagnosed as PLC from January 2012 to January 2013. A randomized, double-blind trial was designed and, 24 patients were divided into cross-linked dextran gel microsphere group(the experimental group, treated transcatheter arterial chemoembolization, TACE) and the ultra-liquid iodized oil group(the control group, treated ultra-liquid iodized oil). There were no significant different(P > 0.05) between the age of the two groups, tumor size and serum A-fetal protein(AFP) positive rate. The changes of tumor size, postoperative adverse reactions, blood routine, liver function, AFP level and survival rate were monitored at the end of the 45 th day after interventional therapy and, evaluated the clinic efficiency and safety of the cross-linked dextran gel microsphere for PHL therapy, combined with radiographic findings. Results:1. The change of tumor: 10 cases of patients of the experimental group(83.3%) were found with tumor necrosis zone in liquid while there were 3 cases only in the control group(25%). And the ratio of CR(complete response), PR(partial response), SD(stable disease), PD(progressive disease) in experimental group were 8.3%, 83.3%, 8.3%, 0%,compared to 0%, 41.7%, 25%, 33.3% in control group(P<0.05), respectively.2. The decrease of serum AFP: There were 10 and 9 patients’ serum AFP declined in experimental group and control group, respectively. The value of AFP declined in experimental group was significantly higher than that in control group(P < 0.05).3. Postoperative adverse reactions and complications: The average number of fever days after symptomatic treatment of experimental group was 1.67 d, significantly lower than that in control group, which was 2.91 d(P < 0.05). However, the number of fever cases of treatment group(11 cases) was significantly higher than that in the control group(7 cases), and also the number of nausea, vomiting and pain(grade П)(P <0.05).4. Laboratory tests: The blood routine and liver function were detected before and after treatment, but no significance was found between the two groups(P > 0.05).5. The survival of 180 days after embolization: The survival rate of patients in experimental group was 83.33%, and 66.67% in control group(P > 0.05). No serious adverse reactions occurred in the two groups after operation. Conclusion:Cross-linked dextran gel microsphere embolization is safe and effective, is better than ultra-liquid iodinated oil embolization agents for PLC treatment, with lighter economic burden for patients, and has better clinical value.