OBJECTIVE:To guarantee the quality of the clinical drug trial and to ensure the interests of the subjects.ME- THODS:The basic principles,procedures and methods of ISO9001quality management standards were applied in the whole construction of clinical drug trial institution.RESULTS&CONCLUSION:The construction of clinical drug trial institution based on the ISO9001quality management standards was in conformity with the principle of Good Clinical Practice,which was helpful for the guarantee of the quality of clinical drug trial and the interests the subjects.

Objective:To obtain purified recombinant Litopenaeus vannamei allergen protein Lit v 1.2.Methods: The target gene of Lit v 1.2 was inserted into clone vector pGEM-T and then ligated to the expression vector pET 44a.The pET44a-Liv 1.2 was transformed into Rosetta and screened by ampicillin resistance .The recombinant protein was expressed by IPTG induction .The protein was purified by 6-His tag affinity chromatography and the purification was analyzed by SDS-PAGE gel electrophoresis .Results:The ex-pression plasmid pET44a-Lit v 1.2 was constructed.SDS-PAGE showed that expressed Lit v 1.2 was efficient and soluble in E.coli Rosetta.The protein molecular weight was consistent with the theoretical value .The highly purified target protein was obtained.Conclusion:In this study ,we successfully gained highly purified recombinant allergen protein Lit v 1.2 which was expressed in prokaryotic system and purified by affinity chromatography column .The purified Lit v 1.2 protein will facilitate us to further study its role in immunological responses .

Objective To evaluate the safety and clinical efficacy of stent implantation using a rapid artificial cardiac pacing technique on ostial lesions of left anterior descending artery (LAD).Methods From Jun 2008 to Nov 2010,38 patients with ostial lesions of LAD were recruited and randomly divided into two groups:patients with stent implantation using a rapid artificial cardiac pacing technique (pacing group,n =19 ) and patients with direct stent implantation (no-pacing group,n =19 ).Post-stenting examination was performed.Patients were followed-up for 9 months and coronary angiography was reviewed.The immediate success rate,major adverse cardiac events including death,reinfarction and target vessel revascularization,late lumen loss,sent thmmbosisin,rent-restenosis were compared between these two groups.Results There were no significant differences in the baseline values,disease characteristics and instant response to surgery between pacing and no-pacing groups(P ＞ 0.05 ).The time cost for stent placement was significantly shorter in the pacing group than that in the no-pacing group ( [ 16.5 ± 0.5 ] s vs.[46.6 ± 1.4 ] s,t =88.256,P =0.004 ).After surgery,there was no acute or subacute thrombosis,in-stent restenosis or occlusion for patients in the pacing group.In the no-pacing group,one patient developed acute thrombosis.The symptoms disappeared after thrombus aspiration and balloon dilatation by emergency percutaneous coronary intervention.Patients were followed up for 270 -275 days,and patients in the pacing group received post-stenting coronary angiography 9 months after stent implantation using a rapid artificial cardiac pacing technique,and no in-stent re-stenosis was found.During this period,nobody had adverse events such as death,myocardial infarction or target lesion revascularization,while five cases with in-stent restenosis (50％ -60％ )were found in the no-pacing group,without further target lesion reconstruction due to symptomless.Conclusion Compared with previous positioning technique,stent implantation using a rapid artificial cardiac pacing technique on treatment of ostial lesions of LAD is safer,and more effective.It is a favorable method for accurate positioning of bracket and can improve the prognosis,reduce the occurrence of acute thrombosis and in-stent restenosis.

Objective:To analyze the commonalities and differences of " Internet plus healthcare" related policies in the eastern, central and western regions of China before and after the COVID-19 pandemic and to provide references for further improving China′s " Internet plus healthcare" policy.Methods:Collecting the policies of " Internet plus healthcare" promulgated by 31 provinces(autonomous regions, municipalities)in China from April 2018 to December 2020 on the websites of various government departments, extracting keywords based on content analysis methods, and calculating degree centralities using UCINET 6 software. A comparison of the policies of the eastern, central and western regions between the pre epidemic stage(April 2018 to December 2019)and the COVID-19 pandemic stage(January 2020 to December 2020)was carried out.Results:In the pre epidemic stage, Internet diagnosis and treatment, " Internet plus medical service price" and quality supervision were the focus of attention in all regions. But the eastern region paid more attention to the policy planning of Internet hospital operation and Internet medical application, the central region focused on the transformation and efficiency improvement of medical service process by Internet technology, and the western region paid more attention to encourage the application of telemedicine to solve the difficulty of seeing a doctor. In the pandemic stage, the " Internet plus service price" was the policy focus in all regions, mostly in medical insurance payment, and the policy difference was not obvious among the eastern, central and western regions.Conclusions:Before and after the COVID-19 pandemic, the policy of " Internet plus healthcare " promulgated by the local governments in eastern, central and western regions had different emphasis and different characteristics. Our suggestion was to improve the policy system, standardize industry supervision, strengthen information security, orderly interconnect medical insurance, and actively promote the exchange of policy experiences among the provinces.

Vaccination is the most effective and feasible way to contain the Coronavirus disease 2019 (COVID-19) pandemic. The rapid development of effective COVID-19 vaccines is an extraordinary achievement. This study reviewed the efficacy/effectiveness, immunogenicity, and safety profile of the 12 most progressed COVID-19 vaccines and discussed the challenges and prospects of the vaccine-based approaches in a global crisis. Overall, most of the current vaccines have shown safety and efficacy/effectiveness during actual clinical trials or in the real-world studies, indicating a development of pandemic control. However, many challenges are faced by pandemic control in terms of maximizing the effect of vaccines, such as rapid vaccine coverage, strategies to address variants with immune escape capability, and surveillance of vaccine safety in the medium- and long-terms.
COVID-19/prevention & control* ; COVID-19 Vaccines/adverse effects* ; Humans ; Pandemics/prevention & control* ; SARS-CoV-2 ; Vaccination