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OBJECTIVE To analyze the implementation experience of France’s additional list system for innovative medical products， and to provide reference for China to support medical institutions to use innovative medical products. METHODS Taking France as a case study， using policy analysis method， this paper systematically studied the practice of establishing additional list system to compensate for innovative medical products in France under diagnosis-related group （DRG） payment， including the establishment background， selection procedure and implementation effect. The suggestions were provided on the medical insurance payment methods for innovative medical products in China. RESULTS & CONCLUSIONS The additional list system established a compensation and payment system for innovative medical products with significant clinical efficacy but high treatment cost， covering four stages： application， evaluation， payment and adjustment， which effectively reduced the drug burden on medical institutions， promoted the use of innovative pharmaceutical products by medical institutions， and stimulated the innovation drive of the pharmaceutical industry， but at the same time brought payment pressure to the medical insurance fund. With the rapid spread of our DRG/diagnosis-intervention packet payment reform of China， some regions have also explored the establishment of a compensation and payment mechanism for innovative medical products， but there are still imperfections. We can refer to the implementation experience of the French additional list system and establish an effective compensation and payment system for innovative medical products starting from the establishment of selection criteria， the selection of compensation mode and the implementation of dynamic adjustment.
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Objective:The effect of antiviral therapy for hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) after radical hepatectomy was assessed. Methods:A total of 478 HBV-HCC patients treated by radical hepatectomy were retrospectively col-lected. Patients in the treatment group (n=141) received postoperative lamivudine therapy (100 mg/d), whereas patients in the control group (n=337) did not. Recurrence-free survival rates, overall survival rates, treatments for recurrent HCC and cause of death were com-pared between the two groups. Propensity score matching was also conducted to reduce confounding bias between the groups. Results:The one-, three-, and five-year recurrence-free survival rates didn't significantly differ between the two groups (P=0.778);however, the one-, three-, and five-year overall survival rates in the treatment group were significantly higher than those in the control group (P=0.002). Similar results were observed in the matched data. Subgroup analysis showed that antiviral treatment conferred a significant sur-vival benefit for Barcelona Clinical Liver Cancer stage A/B patients. Following HCC recurrence, more people in the treatment group were able to choose curative treatments than those in the control group (P=0.031). For cause of death, fewer people in the treatment group died of liver failure than those in the control group (P=0.041). Conclusion:Postoperative antiviral therapy increases chances of receiving curative treatments for recurrent HCC and prevents death because of liver failure, thereby significantly prolonging overall sur-vival, especially in early-or intermedian-stage tumors.
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Objective To investigate the efficacy of laparoscopic hepatectomy for the treatment of hepatocellular carcinoma (HCC).Methods The clinical data of 30 HCC patients who were admitted to the Affiliated Cancer Hospital of Guangxi Medical University from January 2011 to December 2011 were retrospectively analyzed.All patients were divided into the laparoscopic hepatectomy (LH) group (10 patients) and open hepatectomy (OH) group (20 patients) according to the operation patterns and at the ratio of 1 ∶ 2.The degree of cirrhosis,size and location of tumor of the 2 groups were analyzed using the covariance analysis.The student t test was used for analysing the difference of the 2 groups.Results In the LH group,7 patients received laparoscopic nonanatomical liver resection,3 received anatomical resection of the left lateral lobe,no patient was converted to the hand assisted laparoscopic surgery or open surgery.In the OH group,14 patients received non-anatomical liver resection,and 6 received anatomical liver resection.The volume of blood loss of the LH group was (247 ± 235) ml,which was significantly lower than (408 ± 191)ml of the OH group (t =2.199,P ＜ 0.05).The mean postoperative fasting time,postoperative abdominal drainage time and duration of hospital stay of the LH group were (1.9 ±0.6) days,(3.2 ± 1.2) days and (8.9 ± 2.3) days,which were significantly shorter than (3.0 ± 1.6) days,(4.9±1.6)daysand (11.5±2.3)days of the OH group (t=2.149,2.917,2.921,P＜0.05).The levels of alanine aminotransferase (ALT) of the LH group at day 1,3,5 were (228 ± 100)U/L,(143 ± 51)U/L,(85 ±24) U/L,and the levels of aspartate aminotransferase (AST) of the LH group at day 1,3,5 were (196 ± 67)U/L,(90 ± 35) U/L,(46 ± 10) U/L.The levels of ALT of the OH group at day 1,3,5 were (557 ± 401) U/L,(414 ±397)U/L,(217 ± 199)U/L,and the levels of AST of the OH group at day 1,3,5 were (506 ±317)U/L,(178 ± 122) U/L,(71 ± 33) U/L.The time for hepatic function recovery of the LH group was significantly shorter than that of the OH group (t =3.675,3.001,2.073 ; 4.196,2.223,2.272,P ＜ 0.05).All the 30 patients were followed up for 3-15 months.The level of alpha fetoprotein of 1 patient in the LH group was increased at postoperative month 4,and the results of computed tomography showed multiple intrahepatic lesions.The patient was cured by intervention treatment.One patient of the OH group was diagnosed as with tumor recurrence at the resection margins and adjacent hepatic segments.The patient was cured by radiofrequency ablation,with no tumor recurrence.No tumor recurrence or metastasis was observed in the other patients.Conclusion Laparoscopic hepatectomy is a feasible,safe and minimally invasive approach for patients with HCC.
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Objective To identify potential serum biomarkers specific for hepatocellular carcinoma (HCC).Methods Eighty-one patients wilh hepatitis B-related HCC and 80 healthy controls were randomly divided into a training set (48 HCC,47 controls) and a testing set (33 HCC,33 controls).Serum proteomic profiles were measured using surface-enhanced laser desorption/ionization time-offlight mass spectroscopy (SELDI-TOF-MS).A classification tree was established by the Biomarker Pattern Software.Candidate biomarkcrs were separated by HPLC and identified by MA1DI-MS/MS and database searching.Forty-eight patients with HCC,54 cirrhotic patients and 42 healthy subjects were clinically validated using candidate biomarkers by SELDI-Immunoassay.Real-time reverse transcriptase-polymerase chain reaction was performed to observe GRO-1 and Thrombin in 55 HCC tissues and 13 normal hepatolage tissues.Results Two up-regulated protein peaks were automatically chosen as a classification tree in the training set.These biomarkers were identified as thrombin light chain and CXC chemokines ligand 1 (GRO-1).The sensitivity and specificity of this classification tree were 89.6％.The multivariate model using the two biomarkers and alpha-fetoprotein (AFP) resulted in a sensitivity of 91.7％ and specificity of 92.7％,which was significantly better than AFP alone.The mRNA expression of GRO-1 and Thrombin were found in all HCC tissues.There were significant associations between GRO-1 gene expression and some clinical and pathological findings such as metastasis and recurrence (P＜0.05).Significant differences of 5-year survival rates wee observed among subgroups according to the expression of GRO-1 (P＜0.05).There were significant associations between Thrombin gene expression and some clinical and pathological findings such as recurrence and AFP (P＜0.05).Significant differences of 5-year survival rates were observed among the subgroups according to the expression of THROMBIN (P＜0.05).A positive correlation was found between GRO-1 and Thrombin (r=0.73,P＜0.01).Conclusion Thrombin light chain and GRO-1 are potential biomarkers of HCC.The expression of GRO-1 in HCC tissues was a valuable indicator in estimating metastasis and recurrence in HCC patients.