1.Forty Cases of Therapy for Mental Retardation Associated with Agitation by Ziprasidone Mesylate
Junhui PING ; Fei PAN ; Zhaoxi ZHONG ; Lina WANG ; Jingdan ZHANG ; Yonghe CAO
Herald of Medicine 2015;(7):899-902
Objective To investigate the clinical efficacy and safety of ziprasidone mesylate injection on the acute agitation symptom in mental retardation. Methods The total of 80 patients of mental retardation with acute agitation symptoms were randomly divided into two groups:the treatment group (40 patients) were intra-muscarly given with ziprasidone mesylate injection at the initial dose of 10 mg, 20 mg 4 h later, and 30 mg once on the second day and third day. And the control group (40 patients) were treated with haloperidol injection. The volume dose of haloperidol was 20 mg everyday. Other antipsychotic drugs, antimanic drugs and benzodiazepines were not allowed to be used during the observation, neither does the prophylactic use of drugs against parkinson's disease. Before and 1, 2, 4, 6, 8, 12, 24, 48, 72 h after treatment, the positive and negative scale ( PANSS) reduction rate, the end of the clinical global impression scale ( CGI) were assessed. By the end of the treatment, the adverse reactions symptom, cale ( TESS) was assessed for the safety. Results By the end of treatment PANSS reduction rate was 46. 31% in the test group and 48. 81% in the control group, the clinical improvement rate was 80. 00% in the treatment group and 82. 50% in the control group. No statistically significant difference on efficacy was found between two groups. The side reaction rate in the treatment group was 27. 5%, that in the control group was 40. 0%, there was significant difference ( P<0. 05) between two groups, but the extrapyramidal reaction in the control group was significantly more than that in the treatment group(P<0. 05). Conclusion Ziprasidone mesylate injection is effective on treating the symptoms of mental retardation, in corresponding to the effect of haloperidol injection,and with less extrapyramidal reactions.
2.Some thoughts on compulsory licensing of pharmaceutical patents in emergency situations
Yonghe FEI ; Lijun CUI ; Jing CHEN
Journal of Pharmaceutical Practice and Service 2024;42(7):310-314
Objective To explore the conditions for compulsory licensing of pharmaceutical patents and the steps for implementing compulsory licensing of pharmaceutical patents. Methods The current situation and problem of compulsory licensing of pharmaceutical patents in China were analyzed by collecting the relevant laws and regulations in China, United States, India, and the World Trade Organization. The feasible practices of compulsory licensing of pharmaceutical patents among the other countries and organizations were compared. Results China needs to improve the system of compulsory licensing of pharmaceutical patents, clarify the implementation details, strengthen policy guidance, and encourage cooperation between government and enterprises to ensure the smooth implementation in emergency situations. Conclusion Compulsory licensing system and implementation rules in China for pharmaceutical patents should be supplemented and improved by absorbing the useful provisions of international organizations and relevant countries, so as to achieve the pharmaceutical supply in emergency situations and meet the needs of public health.
3.Analysis on the funding of pharmacy administration from National Natural Science Foundation in China from 2010 to 2021
Yonghe FEI ; Lijun CUI ; Jing CHEN
Journal of Pharmaceutical Practice 2023;41(9):572-575
Objective To summarize the project and fund of Pharmacy Administration from the NSFC during 2010 to 2021 and to provide references for the funding application. Methods The data and relevant documents which related to the projects status of Pharmacy Administration on the website of NSFC were collected and analyzed by Excel. Results There were more paths which were suitable to the Pharmacy Administration in NSFC. The direction and measure were expanded. There were more interdisciplinary researchers involved in Pharmacy Administration projects, while the funded organizations and regional distribution were concentrated. Conclusion The funding situation, research hotspots and basic information of applicants in recent years were summarized through statistical data of NSFC from 2010 to 2021, which suggest that the advantage, regional characteristics, cross-discipline and the policies should be concerned by the applicants .
4.Comparative study on pharmaceutical emergency approval systems in China and other countries
Lijun CUI ; Yanting CHEN ; Yonghe FEI ; Jing CHEN
Journal of Pharmaceutical Practice and Service 2024;42(8):359-364
Objective To explore the ideas and measures to further optimize China’s drug emergency approval system by comparing the drug emergency approval systems in China and other countries. Methods The current situation of China’s drug emergency approval system was analyzed and compared with the relevant systems of the United States, the European Union and Japan. Results The goal of drug emergency approval in other countries is clearly positioned to accelerate the review and listing of urgently needed clinical drugs for the purpose of clinical needs, forming a multi-channel, multi-mode and multi-mechanism priority review system covering the whole process, and the regulatory system is clear, complete, and operable. The corresponding approval system in China started late and is in the stage of continuous improvement, which needs to be improved in terms of system construction, government functions, personnel optimization, and post-market supervision. Conclusion Drug regulatory authorities in China should summarize their past work experience and draw on some feasible approval models and regulatory approaches in foreign countries, further improve the system and process of the drug emergency approval system and enhance the efficiency of drug approval and the ability to protect drugs in response to emergencies.