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 study the effects and adverse reaction of imatinib mesylate used to prevent the recurrence of gastrointestinal stromal tumor (GIST) after resection. Methods 22 patients with primary gastrointestinal stromal tumor were included in the First Affiliated Hospital of Chongqing Medical University from January, 2007 to November, 2009 who received resection and were imageologically diagnosed as no residual tumor by enhanced CT or enhanced MRI after resection. They were all given imatinib mesylate 400 mg for oral use daily after resection (median-risk GIST: more than 1 year; high-risk GIST: more than 2 years). Patients’ 1-year and 2-year relapse-free survival (RFS) and adverse reaction were recorded during follow-up. Results Among 22 patients, there were 13 males and 9 females, with median age of 57.4 years, and 9 high-risk cases were included. The median follow-up lasted 34 months (24 to 48 months). Patients’ 1-year and 2-year RFS was 100% and 94.5%, respectively. Adverse reaction mainly included edema, nausea, abdominal pain, muscle or bone pain, thrombocytopenia, weakness, skin rashes, etc., most of which were mild or moderate and could be alleviated after treating symptoms. Conclusion Imatinib mesylate therapy given after resection is a safe and reliable method which could prolong RFS and prevent or delay the recurrence of GIST. However, further high-quality randomized controlled trial was required to verify its curative effects, since no control group has been set in our study.
ObjectiveTo summarize the recent advancements in the researches on the pathogenesis of postoperative ileus and explain the clinical significances of postoperative ileus mechanisms for the diagnosis, treatment, and prevention. MethodsRelevant literatures about the postoperative ileus mechanism published recently were collected and reviewed. ResultsThe occurrence of postoperative ileus were related to postoperative nerve reflex inhibition, inflammatory response, effects of drugs, and other factors, it was a variety of mechanisms modulating each other. ConclusionThe gastrointestinal motility of postoperative ileus is mainly regulated by neural reflexes, inflammatory reactions, and drug interactions, three of which act differently but as a whole in different time segments while the inflammatory response play a key role of postoperative ileus persistence.
Objective To investigate the expression of granulysin ( GNLY) in lung of rats with acute lung injury ( ALI) stimulated with lipopolysaccharide ( LPS) . Methods Thirty-six healthy adult Wistar rats were randomly divided into a normal control group and a LPS group, with 18 rats in each group. LPS ( 4 mg/kg) was given intraperitoneally in the LPS group to induce ALI. The same amount of normal saline was given in the control group. The rats were randomly assigned to three subgroups ( n = 6) to be sacrificed respectively at 6, 18, and 30 hours after intraperitoneal injection. Wet/dry lung weight ratio ( W/D) and pathological changes of the lung were observed. The expression of GNLY in lung tissue was assayed by immunohistochemistry. Results In the LPS group, the W/D ratio was higher than that of the control group at each time point ( P lt;0. 05) and there were a large number of inflammatory cells infiltration and edema in interstitial spaces which suggested ALI. Compared with the control group, the expression of GNLY in the LPS group was significantly increased at all time points ( P lt;0. 05) . Conclusion GNLY may participate in ALI inflammatory process, which might play a role in preventing infection induced ALI.
Objectives To compare the differences of the medical charity donations between at home and abroad in West China Hospital of Sichuan University, so as to provide the evidence for the management and development of medical charity in West China Hospital and China. Methods A cross-sectional study was conducted to investigate and analyze the current situation and problems of the medical charity donations at home and abroad in West China Hospital from January 2005 to December 2006. Results The total amount of the charity funds at home and abroad was 2.043 mill ion and 14.6 mill ion, respectively. The main target diseases of domestic donation were tumor, hematologic disease, dangerous and severe diseases and congenital heart disease, which accounted for 43.3%, 35.9%, 15.8% and 1.0%, respectivley. While the main targeted interventions and diseases of overseas donation were hearing rehabilitation, prosthetic replacement, cataract and congenital heart disease, which took up 52.1%, 27.4%, 13.7% and 6.8%, respectively. Conclusions There are differences in the amount of charity funds, target diseases, behavioral motivations, organizations, objectives and criteria of the charity donation between the donations at home and abroad. It would probably cause the problems in recruitment, distribution and monitoring of the charity funds. It is suggested that the hospital management committee of charity funds and the related law to regulate the charity behaviors should be developed.
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.
Economic evaluation used alongside clinical trials has become a hot spot in the development of clinical studies. The definition and classification of the cost were introduced in this article. The ways to conduct cost analysis in clinical trials were introduced systematically, including the identification, collection and analysis of the data of costs, and the concern of the analysis.
摘要:目的: 评价机械通气对胸腔内脉搏氧饱和度的影响。 方法 :以食道、气管和降主动脉作为胸腔内脉搏氧饱和度的监测位点,将改制后的氧饱和度探头分别固定于上述部位,并连接于同一监护仪上。纯氧通气,待上述氧饱和度容积波波形和读数稳定,停止机械通气30s。以录像的方式记录机械通气停止前后30 s内食道、气管和降主动脉SpO2容积波和读数的变化。同时记录舌SpO2。 结果 :机械通气时,食道、气管和降主动脉三个监测位点均可获得异常高大的SpO2容积波;停止通气时,异常高大的氧饱和度波形消失。食道、气管和降主动脉脉搏容积波变异率分别为112%,74%,302%。降主动脉脉搏容积波的变异率明显高于食道和气管( 〖WTBX〗P ＜005)。机械通气停止前后30s内食道、气管和降主动脉的SpO2读数变化无显著差异(〖WTBX〗P ＞005)。 结论 :机械通气对胸腔内食道、气管和降主动脉氧饱和度读数无影响,主要影响是脉搏容积波。且各位点间脉搏氧容积波受呼吸的影响不同。Abstract: Objective: To investigate the impact of mechanical ventilation on pulse oximetry in thoracic cavity. Methods : After dogs anesthesia induction and thoracotomy, pulse oximeters were simultaneously placed at esophagus, trachea, and descending aorta, and connected with the same monitor for SpO2 monitoring. During ventilation with 100% oxygen, the mechanical ventilator was temporarily switched off for 30 seconds after high quality PPG waveforms and SpO2 readings were obtained. SpO2 signals and readings from esophagus (SeO2), trachea (StraO2), descending aorta (SDAO2) shown on the monitoring screen were recorded by the SONY video before and after stopventilation. And StonO2 were also recorded. Results : Abnormally largeamplitude PPG waves were found in normal waves at monitoring sites of esophagus, trachea, and descending aorta in all animals during ventilation; however, they disappeared without ventilator. The variation rate in ventilationinduced PPG amplitude were 112%, 74%, 302% at esophagus, trachea and descending aorta respectively. The PPG amplitude variation rate from SDAO2 was higher than that from SeO2 and StraO2 (〖WTBX〗P ＜005). However, the SpO2 readings obtained from pulse oximetries in all sites were no significantly statistical difference within 30s before and after temporarily stopventilation (〖WTBX〗P ＞005). Conclusion : Abnormally amplitude PPG waveforms from oximetry probe placed at esophagus, trachea, and descending aorta were induced by ventilation. The Variation rate in ventilationinduced PPG amplitude was various at different monitoring sites. The SpO2 readings from esophagus, trachea, and descending aorta were not significantly contaminated by ventilation.
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.
ObjectivesTo systematically review the efficacy and safety of fast track surgery in perioperative patients with adrenalectomy.MethodsPubMed, EMbase, Web of Science, CNKI, WanFang Data and VIP databases were electronically searched to collect randomized controlled trials (RCTs) on the efficacy and safety of fast track surgery in perioperative patients with adrenalectomy from inception to January 2019. Two reviewers independently screened literature, extracted data and assessed risk of bias of included studies. Then, meta-analysis was performed by using RevMan 5.3 software.ResultsA total of 11 RCTs involving 1 034 patients were included. The results of meta-analysis showed that: fast track surgery in perioperative patients with adrenalectomy could shorten first exhaust time (MD=−17.16, 95%CI −21.86 to −12.46, P<0.000 01), postoperative catheter indwelling time (MD=−43.44, 95%CI −46.65 to −40.23, P<0.000 01) and drainage tube indwelling time (MD=−39.91, 95%CI −57.58 to −22.23, P<0.000 01), and reduce the incidence of complications after adrenalectomy (OR=0.26, 95%CI 0.1 to 0.39, P<0.000 01). There were no statistically differences in operation time (MD=−1.18, 95%CI −3.22 to 0.86, P=0.26) and blood loss (MD=0.25, 95%CI −2.84 to 3.34, P=0.88) between two groups.ConclusionsCurrent evidence shows that, compared with the conventional rehabilitation group, fast track surgery can promote postoperative recovery of patients with adrenalectomy more safely and effectively, which has clinical promotion value. Due to limited quality and quantity of the included studies, more high quality studies are required to verify the above conclusion.