Objective To investigate the impact of edaravone on serum reactive oxygen species during the perioperative period of off-pump coronary artery bypass grafting （OPCAB）. Methods A total of 40 patients who underwent selective OPCAB in the First Hospital of Hebei Medical University between June 2011 and November 2012 were prospectively enrolled in this study. All the patients were randomly divided into a trial group and a control group by a random digitaltable method with 20 patients in each group. There were 13 males and 7 females in the trial group with their age of 40-67（51.8±11.5） years， and 9 males and 11 females in the control group with their age of 42-70 （53.5±13.1） years. Afteranesthesia induction， patients in the trial group received continuous intravenous infusion of edaravone 60 mg （diluted in 100 ml saline）， while patients in the control group received continuous intravenous infusion of saline 100 ml， both of whichwere finished within 30 minutes. Venous blood samples were taken 24 hours preoperatively （T1）， 1 hour after skin incision（T2）， at the end of the surgery （T3） and 24 hours postoperatively （T4） to examine the concentration of superoxide dismutase（SOD） and malondialdehyde （MDA）. The data of the two groups were compared. Results All the patients successfully underwent their surgery and were included in the analysis. At the T2， T3 and T4 time point， SOD concentration was 80.3±21.3 U/ml， 78.5±17.4 U/ml and 81.4±17.5 U/ml， and MDA concentration was 10.2±1.8 nmol/ml， 11.3±1.9 nmol/ml，14.8±2.1 nmol/ml respectively in the control group；SOD concentration was 92.8±18.4 U/ml，90.0±18.1 U/ml，and 88.7±18.7 U/ml，and MDA concentration was 7.2±1.7 nmol/ml，8.2±1.2 nmol/ml，10.2±1.3 nmol/ml respectively in the trial group. At each above time point， SOD activity was significantly higher in the trial group than the control group （F=2.90，P=0.003；F=2.80，P=0.003；F=2.80，P=0.001）， and MDA concentration was significantly lower in the trial group than the control group （F=2.79，P=0.001；F=2.80，P=0.001；F=2.90，P=0.000）. Conclusion Edaravone can decrease serum reactive oxygen species caused by OPCAB and reduce myocardial injury.
Based on the principles and methods of systematic review of randomized controlled clinical trials,
systematic review of economic analyses can integrate information from multiple economic studies which focus on the
same clinical questions. It can also provide important insights by systematically examining how differences among studies
lead to different results. Generally, there are seven steps to conduct such a review: 1) formulating questions; 2) establishing
eligibility criteria; 3) searching and selecting eligible economic analyses; 4) assessing the validity of economic analyses;
5) acquiring data; 6) analyzing and synthesizing data; and 7) presenting results. Owing to the specificity of economic
analyses, many methodological challenges exist, including the varieties of economic models, analytic perspectives, time
horizons, and uncertainty and sensitivity analysis among different economic analyses. This may cause difficulties for
critical assessment of the economic analyses.
Objective To investigate the regulations and implementation effect for high-risk drugs of the FDA and MHRA on the basis of natalizumab, and to provide references for the risk regulation of the innovative drugs and high-risk drugs of China. Methods We searched MEDLINE, EMBASE.com, the official website of Food and Drug Administration (FDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for the marketing/withdrawal and risk regulation information of natalizumab as well as the relevant information of drug marketing/withdrawal and approval track. Results (1) Natalizumab was initially approved by the FDA through accelerated approval in November, 2004 with the phase three clinical trial still being conducted. But in February 2005, it was withdrawn after 3 patients developed PML. FDA resumed its marketing under a specially restricted distribution program called the Touch Prescribing Program in March, 2006. (2) Natalizumab was marketed in the European Union in April 2006. No cases of PML have been reported in the UK for this drug. (3) To speed the development of drugs that treat serious diseases, the FDA developed 3 distinct and successful approaches to make such drugs available as rapidly as possible: Priority Review, Accelerated Approval, and Fast Track. The proportion of new molecular entity and new biologic approved by fast tract were 45% and 74%, respectively between 2002 and 2009. (4) Drug regulation of MHRA contained: Yellow Card Scheme, Black Triangle products, Download Drug Analysis Prints (DAPs), and Defective Medicines Report Centre (DMRC). Self-reporting and monitoring system were fairly perfect, thus they can fulfill the close monitoring for high-risk drugs under the existing conditions and then realize the risk-minimization. Conclusion (1) The risk-minimization program of FDA for high-risk drugs is effective, and plays a role in the policy support for the researching and marketing of irreplaceable innovative drugs. (2) The risk regulation for high-risk drugs of MHRA is integrated into drug regulation program and enforces hierarchical management, and acquires risk-minimization effect. (3) We should learn from the policy and operational experience for the international new molecular entity and new biologic on the re-evaluation for innovative drugs and high-risk drugs. Combined with drug specific characteristics, evaluation indicators and criteria are developed base on evidence, risk management system and mechanism for innovative drugs are established and improved, and policy and administration security for the safety application of innovative drugs and high-risk drugs are provided.
Objective To compare and assess the efficacy of ventral/dorsal onlay graft urethroplasty in the treatment of urethral stricture. Methods We searched pertinent English literature via MEDLINE (1966 to 2007), EMBASE (1977 to 2007) and The Cochrane Library (Issue 4, 2007) for the use of ventral/dorsal graft urethroplasty in the reconstruction of urethral defect associated with urethral stricture. Data were extracted by two reviewers independently and analyzed by SPSS 13.0 software. Results A total of 50 studies involving 1 264 patients were included. Ventral onlay graft urethroplasty was used in 751 patients with a success rate of 82.6%, while dorsal onlay graft urethroplasty was used in 513 patients with a success rate of 86.9% (ventral vs. dorsal, χ2=4.432, P=0.035). Oral mucosa graft had the highest success rate (88.1%) of all grafts, and the success rate of free skin graft onlay urethroplasty was associated with the location of graft placement (ventral vs. dorsal, P=0.016). Concerning the location of stricture, urethroplasty for bulbar urethral stricture achieved the best results, with a success rate of 87.7%, which was also associated with the location of graft placement (ventral vs. dorsal, P=0.025). Conclusion Dorsal onlay graft urethroplasty is better than ventral onlay. It is better to place the free skin graft in the dorsal part of urethra. Bulbar urethral stricture is more suitable for graft onlay urethroplasty than penile urethral stricture.
