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OBJECTIVE To understand the future development trend of dispensing and use for preparations of medical institutions,and to provide countermeasures and suggestions for promoting the high-quality development of application and dispensing use for preparations of medical institutions . METHODS The development history of dispensing and use for preparations of medical institutions of China was reviewed as a whole ,and then the differences of domestic dispensing and use institutions for preparations of medical institutions over the years were compared from different perspectives ;and the differences between domestic institutions and Japan ’s hospital preparation dispensing and use institutions were compared. The development trend of dispensing and use for preparations of medical institutions of China was summarized to put forward countermeasures and suggestions. RESULTS & CONCLUSIONS The development process of dispensing and use for preparations of medical institutions of China could be roughly divided into the initial stage (2001-2004),the forming stage (2005-2018) and the development stage (2019-present). Year by year ,the dispensing and use institutions of preparations of medical institutions had shown that the scope of dispensing and use had been expanded ;the approval process had been accelerated ,and the responsibilities of all parties had been clearly defined. Compared with Japan ,regulatory model for preparations of medical institutions was relatively simple in China. In the future ,the large-scale promotion and application of preparations of medical institutions will be normalized ,the time limit for dispensing approval will be shortened ,the approval process will be simplified ,the access threshold for dispensing and use will be gradually lowered ,and the supervision of dispensing and use will be strengthened during and after the event. It is recommended to strictly control the quality and safety of preparations of medical institutions ,implement classified management of use for preparations of medical institutions ,and further improve the supervision mechanism during and after the event.
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OBJECTIVE:To know about the current situation and trend of encouraged generic drug catalogue policy in China , and to put forward countermeasures and suggestions for the better implementation of the policy. METHODS :The evolution of encouraged generic drug catalogue policy in China ,the characteristics of 2 batches of included types in encouraged generic drug catalogue,the implementation effect of the first batch of encouraged generic drug catalogue ,the development trend and existing problems of encouraged generic drug catalogue policy were analyzed to put forward corresponding suggestions. RESULTS & CONCLUSIONS:The evolution of encouraged generic drug catalogue policy in China can be roughly divided into embryonic stage,policy design stage and policy implementation and adjustment stage. The first batch of included types in encouraged generic drug catalogue are mainly drugs whose patents are about to expire and the competition is insufficient ,drugs with clinical necessity , definite curative effect and short supply ,and varieties for special clinical purposes such as the prevention and treatment of major infectious diseases and rare diseases ,and children ’s use. The second batch of included types in encouraged generic drug catalogue are mainly those with expired patents (about to expired )and insufficient competition ,and also those with special clinical uses. Among the types of the first batch of encouraged generic drug catalogue ,the number of abbreviated new drug application (ADNA) increased by 18,involving a total of 8 varieties;only 3 ADNA were included in the priority review ,accounting for 16.67%. In 2019 and 2020,218 and 119 varieties were newly included in the medical insurance catalogue ,and 3 varieties were newly included in the encouraged generic drugs catalogue (accounting for 1.4% and 2.5% respectively). At present ,encouraged generic drug catalogue policy in China has the trend and characteristics of patent oriented regression ,lack of priority review and approval system,and enhanced linkage with the medical insurance catalogue. It is suggested to adhere to the original intention of the Opinions of the State Council on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Drugs and Medical Devices in 2017,continue to adhere to the patent orientation of encouraged generic drug catalogue ,and improve the priority review system of generic drugs in the catalogue ,explore the “first imitation market monopoly period ”system in line with the characteristics of encouraged generic drug catalogue policy in China with reference to the U.S. FDA competitive imitation therapy guidelines ,and further strengthen the cooperation between government departments in the implementation of the encouraged generic drug catalogue policy.
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Objective To assess the clinical manifestation, management and outcome of abdominal aortic aneurysm (AAA) in young adult Methods Retrospective study was made on young AAA patients (
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Objective To assess the results of surgical intervention on patients with medullary thyroid carcinoma(MTC), and determine the value of measuring plasma calcitonin concentration postoperatively. Methods The diagnosis and treatment of 14 patients with MTC from January 1992 to December 1998 were analysed retrospectively. Results The diagnosis of MTC in the 14 patients was confirmed by pathology. Of them, 64.3% of patients had lymph node metastases. According to AJCC staging system, 1 patient was in stage Ⅰ, 7 in stage Ⅱ, 5 in stage Ⅲ and 1 in stage Ⅳ. Of nine patients measured plasma calcitoinin after initial operation, 4 had persisted hypercalcitoninemia. In the 4 patients, MTC in residual thyroid and enarged lymph node were comfirmed by B mode ultrasounography. After re operation, the calcitonin level returned to normal in 3 cases, but one remained in higher level. Postoperative follow up ranged from 2 to 8 years, 2 patients died of the disease. Twelve patients still lived, 6 of them survived more than 5 years. Conclusions The clinical stage of MTC at the time of diagnosis is an important prognostic factor. An aggressive surgical approach at the initial operation is essential to achieve a curative effect in patient with MTC. Measuring plasma calcitonin postoperatively helps to detect residuled MTC or recurrent MTC.
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Objective To introduce the experience in endovascular stent graft repair (EVSGR) of thoracoabdominal aortic dissecting aneurysm (TAADA). Methods Retrospective analysis was made on the management of 6 patients with TAADA from October 2000 to June 2001. Results There were six male patients aged 42~72 in this series. Of them, 5 patients with Stanford type B TAADA and one with Stanford A TAADA. Of the 6 patients, The fissures were sealed and the dissections were disappeared completely in 5 cases; one case shifted to open surgery for abdominal aortic fenestration, Rupture of the iliac dissection occurred in 1 case 3 days after EVSGR, then the abdominal aortic fenestration and graft replacement of distal abdominal aorta were performed. One patient died of heart infarction on the third day postoperatively. Five cases were followed-up for 1~9 months, they all were alive and well. Conclusions Endovascular stent graft technique is safe and simple in repairing of TAADA, and abdominal aortic fenestration is an adjuvant procedure.