OBJECTIVE:To investigate and perfect the pilot work of medicine marketing authorization holder system in China. METHODS:The problems of medicine marketing authorization system in China and the features of medicine marketing licensing system in USA and EU were analyzed. The legal authority and content of pilot medicine marketing authorization holder system in China were summarized so as to propose related policy recommendation. RESULTS & CONCLUSIONS:There are many problems in the medicine authorization system in China which is the combination of“production license”and“marketing license”,for exam-ple,the obsolete definition of“new drugs”,the serious waste of drug resources,the insufficient research and development of new drugs. The“production license”and“marketing license”are separated in the USA and EU. There are many new drugs,high capaci-ty utilization and perfect system of drug safety,quality control and risk management. In order to ensure the effective implementa-tion of the pilot work,it is suggested to enhance and improve the quality authorization management,the pharmacovigilance system and drug injury relief related to drug safety management.

OBJECTIVE:To study the effect of canceling the maximum retail price limit on the accessibility of low-cost drugs in our hospital. METHODS:Based on the policies of canceling the maximum retail price,the low-cost drugs in the hospital man-agement system were extracted to adjust the relevant data of price,compare the drug supply changes before and after the price ad-justment and summarize the effect of canceling the maximum retail limit on the accessibility of low-cost drugs in our hospital. RE-SULTS:The price of 19 kinds of low-cost drugs in our hospital were adjusted,which were raised,for 1-4 times,the average daily cost increased to 0.06-2.51 yuan,with an increase proportion of 11%-309%. 16 varieties of order delivery rate increased,with in-crease proportion of 2%-100%,1 variety decreased,with decrease proportion of 32%,2 varieties showed the same distribution rate. CONCLUSIONS:Canceling the maximum retail price limit can promote the accessibility of low-cost drugs in our hospital.

Objective To summarize the experience of prophylaxis and treatment of acute renal failure (ARF) following orthotopic liver transplantation (OLT). Methods The clinical data of 63 cases of ARF following OLT were analyzed retrospectively. Results Preoperatively, 12 out of 63 patients had renal dysfunction to varying degrees, 28 had serious peritoneal fluid and advanced hyperbil-irubinemia. Postoperatively, complication included pulmonary infection (28 cases), MOSF (26 cases) and intraperitoneal dropsy or empyema (9 cases). Cyclosporin A, mycophenolate and tacrolimus were all used to prevent rejection. Dopamine was used in some patients to improve renal perfusion. Meanwhile, diuretic and albumin, and fresh blood plasma were used to support patients. Twelve severe cases received CRRT. Average treatment duration was 50 h. Twenty-six patients died within one month postoperatively with the mortality rate of this group being 41.27 %. Conclusions The etiology of ARF following OLT is multifactorial. It's important to evaluate renal function preoperatively and to avoid infection, apply immunosuppressant individually and improve renal perfusion postoperatively.

Objective:To understand the basic situation of pharmacy staff in the hospitals in Beijing Xicheng district. Methods:Totally 12 hospitals in Xicheng district were investigated by a questionnaire( including the age,educational degree and professional title of phama-cists) , and the obtained information was classified, gathered and counted, and the evaluation and recommendation were also performed after the combination with regulations and actual work. Results:There were 385 persons working in the pharmacies of the 12 hospitals, which accounted for 7. 56 % of the total health professionals. Among them, 67. 02% were under the age of 40, 83. 11%were undergraduates or specialists, 84. 93% had primary or intermediate titles, 3. 38% had finished standardized training, and 4. 68%were clinical pharmacists. Conclusion:The composition of pharmacy staff can not match the national requirements. It is necessary to optimize the structure of pharmacy staff, improve the level of education, and strengthen the standardized training and clinical pharma-cist training in order to promote the career competence of pharmacists.

The full-length cDNA of hTIMP-1 was obtained from a surgical patient with HCC by the method of RT-PCR. Then it was cloned into the adenoviral shuttle plasmid pAdTrack-CMV, and subsequently cotransformed into competent BJ5183 cells with the adenoviral backbone plasmid pAdEasy-1. Thereupon, a recombinant adenoviral plasmid containing full-length cDNA of hTIMP-1 was generated by homologous recombination in E. coli. The adenoviruses (AdhTIMP-1) were packaged and amplified in adenoviral packaging cells HEK 293. Then the viral titer was checked by green fluorescent protein (GFP), and the expression of hTIMP-1 was detected by the techniques of Western blot and RT-PCR. The recombinant adenovirus vector carrying human TIMP-1 was successfully constructed and expressed in vitro and may pave the way for further application in liver gene therapy.
Adenoviridae ; genetics ; metabolism ; Carcinoma, Hepatocellular ; metabolism ; Cell Line ; Cloning, Molecular ; DNA, Complementary ; genetics ; Extracellular Matrix ; metabolism ; Genetic Vectors ; Humans ; Recombinant Fusion Proteins ; biosynthesis ; genetics ; Tissue Inhibitor of Metalloproteinase-1 ; biosynthesis ; genetics