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.
Objective To establish standards, methods and processes for evidence-based evaluation and selection of essential medicine that meet the needs of the 8 pilot township health centers in China. Methods A descriptive analysis was conducted to compare the similarities/differences and the advantages/disadvantages of the standards, methods and processes between the World Health Organization (WHO) essential medicines evaluation and selection, and the GRADE evidence quality and recommend intensity. In combination with the former outcomes of this series of study, the standards, methods and processes of evidence-based evaluation and selection of essential medicines in the domestic pilot township health centers were optimized, restructured and improved. Softwares such as GRADEprofiler were used to assess the quality of evidence. Results a) Localized standards, methods and processes for evidence-based evaluation and selection of essential medicine were established, and the evaluation tool was ascertained; and b) Disease and drug names, guidelines and searching processes for evaluation and selection of essential medicine were developed with standardized, systematic and transparent approaches. Conclusion a) Standards, methods and processes for searching, evaluating and recommending the best evidence are preliminarily established, through comparative analysis on the effectiveness, safety, cost-effectiveness and applicability of the candidate medicines for diagnosing, treating and preventing diseases in township health centers in China; b) Following the principle of “utilizing the best existing evidences and developing the urgently-needed but lacking evidence”, a good exploration was done for the localization, standardization and transparency of the standards, methods and processes of evidence-based evaluation and selection of essential medicine for pilot township health centers.
Objectives To assess the effectiveness and safety of carnitine in the treatment of idiopathic asthenozoospermia. Methods The Cochrane Library, MEDLINE, EMbase, and CNKI were searched between Jan 1995 and Dec 2006. Both English and Chinese studies were included in the review if they were randomized controlled trials (RCTs) involving men with idopathic asthenozoospermia who were treated with carnitine. Trial screening, data extraction, and quality assessment of included trials were conducted by method recommended by Cochrane Collaboration. Statistical analysis was conducted using RevMan 4.2.10 software. Results Five RCTs involving 346 patients met the inclusion criteria, and 307 patients were included in the meta-analysis. The results showed that: after being treated with carnitine for 3 and 6 months, the difference of the patients’ partners’ spontaneous pregnancy rate between treatment group and control group was statistically significant with RR2.46 and 95% CI1.12 to 5.43 (Z=2.23, P=0.03). After being treated with carnitine for 3 and 6 months, the difference of forward motile sperm per ejaculate between treatment group and control group was not statistically significant with WMD 9.16 and 95%CI 0.14 to 18.18 (Z=1.99, P=0.05) and WMD 5.28 and 95%CI –4.45 to 15.01 (Z=1.06, P=0.29). After being treated with carnitine for 3 and 6 months, the difference of percentage of forward sperm motility between treatment group and control group was not statistically significant with WMD 14.56 and 95%CI –4.49 to 33.61( Z=1.50 ,P=0.13), and WMD 7.34 and 95%CI –5.93 to 20.61 (Z=1.08, P=0.28). After being treated with carnitine for 3 and 6 months, the difference of total motile sperm per ejaculate between treatment group and control group was not statistically significant with WMD 15.32 and 95%CI –1.34 to 31.98 (Z=1.80, P=0.07) and WMD 6.20, 95%CI –3.00 to 15.39 (Z=1.32, P=0.19).After being treated with carnitine for 3 and 6 months, the difference of percentage of total sperm motility between treatment group and control group was not statistically significant with WMD 2.97 and 95%CI –5.75 to 11.69 (Z=0.67, P=0.50) and WMD 4.48 and 95%CI-9.17 to18.14 (Z=0.64, P=0.52). After being treated with carnitine for 3 and 6 months, the difference of semen volume between treatment group and control group was not statistically significant with WMD –0.12 and 95%CI –0.55 to 0.30 (Z=0.57, P=0.57) and WMD 0.03 and 95%CI –0.38 to 0.45 (Z=0.16, P=0.87). After being treated with carnitine for 3 and 6 months, the difference of sperm concentration between treatment group and control group was not statistically significant with WMD 7.92 and 95%CI – 2.85 to18.68 (Z=1.44, P=0.15), and WMD 1.02 and 95%CI –5.09 to 7.14 (Z=0.33, P=0.74). Three RCTs reported that there were no serious side effects of carnitine during the treatment period. Conclusions The available evidence indicates that spontaneous pregnancy rate would increase with carnitine therapy, while it is short of improvement of semen parameters. There is no serious side effect of carnitine. Because of lack of evidence, we cannot conclude that carnitine is effective in improving the prognosis of infertile patients with idiopathic asthenozoospermia. More high quality trials with large sample are proposed.
目前,新型农村合作医疗正在我国300多个县(市)开展试点工作.然而,在农村总体经济实力不强又面临市场经济冲击的大形势下,建立新型农村合作医疗制度将是一项十分艰难、复杂的工程.本文讨论了新型农村合作医疗制度产生的历史背景及如何增强农民对新型农村合作医疗制度的信心问题.
Objective To analyze the withdrawal reason of natalizumab in depth based on the serious adverse reaction reports and approval channel, and to provide decision references for more safe and effective report method of other biologicals. Methods We searched MEDLINE, EMbase, and the official websites of Food and Drug Administration (FDA) for case reports, approval channel, and the relevant information of drug marketing or withdrawal. Results Four case reports and fourteen official reports were included. Three cases of progressive multifocal leukoencephalopathy (PML) were reported in the clinical trials after natalizumab’s initially approval with two dead and one disabled, which could be retrieved by hemodialysis (2 cases hitherto). Consequently, multiple sclerosis (MS) patients were willing to bear the risk. Two cases of natalizumab-related PML (0.06‰) were confirmed in 32 000 patients without death report after two years of its remarketing, in July 2008. Another PML patient was reported in October 2008. Because of its non-substitutability for treating MS and Crohn disease (CD), FDA announced that patients could still use natalizumab under the close monitoring. Conclusion (1) The most serious adverse reaction of treating MS and CD with natalizumab is PML, but it can be preventable and curable now. The monitoring findings of efficacy and adverse reaction during the postmarketing indicate that the review system is perfect and practicable relatively, and can give references for other high-risk drugs on the fast or standard approval channel, for example, Chinese medicine injection can draw lessons from it. (2) The remarketing of natalizumab not only provide significant risk management precedent for other drug-development firms, but also brings hope to the remarketing or relaunching clinical trials for the suspected sideeffect drugs. (3) Because of the fast-track reviewing of natalizumab and the overlap between the research of Good Clinical Practice (GCP) and the post-marketing evaluation, we should continue to track the information and provide new evidence.