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.
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 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.
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.
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 investigate the prevalence of cognitive impairment and identify its influencing factors among lung cancer patients undergoing chemotherapy, providing a scientific basis for targeted interventions. Methods A convenience sample of lung cancer patients receiving chemotherapy at West China Hospital, Sichuan University between April and October 2024 was enrolled. Data were collected using a general information questionnaire, the Mini-Mental State Examination, Nutritional Risk Screening 2002, Hospital Anxiety and Depression Scale, Barthel index, and FRAIL scale. Univariate analyses and multivariate logistic regression were performed to determine factors associated with cognitive impairment. Results A total of 380 patients undergoing chemotherapy for lung cancer were enrolled, and 205 (53.9%) of them had cognitive impairment. Univariate analyses revealed that there were statistically significant differences between the cognitively normal group and the cognitive impairment group in age, educational level, work status, nutritional status, Barthel index, and FRAIL scale score (P<0.05). Multivariate logistic regression showed that advanced age [odds ratio (OR)=1.045, 95% confidence interval (CI) (1.015, 1.075), P=0.002] and FRAIL scale score [OR=1.369, 95%CI (1.165, 1.609), P<0.001] were identified as independent risk factors for cognitive impairment, whereas higher educational attainment served as a protective factor, compared with patients with primary school education or below, patients with junior high school, high school/secondary vocational school, college, or undergraduate education and above had a lower risk of cognitive impairment [OR=0.437, 0.258, 0.243, 0.120, P<0.05]. Conclusions Cognitive impairment is highly prevalent among lung cancer patients undergoing chemotherapy and is significantly influenced by age, educational level, and frailty. Healthcare providers should develop targeted interventions based on these factors to reduce the prevalence of cognitive impairment.
Objective To systematically review the efficacy of preoperative administration of oral carbohydrates in patients undergoing elective hip replacement surgery. Methods PubMed, EMbase, The Cochrane Library, CBM, WanFang Data and CNKI databases were electronically searched to collect randomized controlled trials (RCTs) about preoperative oral carbohydrate treatment in patients undergoing elective hip arthroplasty from inception to January, 2017. Two reviewers independently screened literature, extracted data and assessed the risk of bias of included studies. Meta-analysis was performed by using RevMan 5.3 software. Results A total of 10 RCTs were included. The results of meta-analysis showed that: compared with the placebo group, the preoperative oral carbohydrate group had no significant differences in postoperative insulin resistance (SMD=5.14, 95%CI –1.05 to 11.33, P=0.10), length of hospital stay (MD=–0.26, 95%CI –1.11 to 0.58, P=0.54), rate of complications (OR=1.46, 95%CI 0.53 to 4.07, P=0.47), postoperative glucose and insulin level. Conclusion Current evidence shows that preoperative oral carbohydrate can not mediate postoperative insulin resistance. It also does not reduce length of hospital stay, postoperative glucose and insulin level. Due to limited quality and quantity of the included studies, more high quality studies are needed to verify above conclusion.
目的 观察对比卒中单元早期康复护理对卒中偏瘫患者肢体功能恢复的效果。 方法 将2011年6月－12月期间住院的脑卒中偏瘫患者88例，按照发病时间分为试验组和对照组，发病5 d以内急性期入院者为试验组，5 d以上入院的超过急性期者为对照组。在规范治疗基础上予以相同的康复护理干预，对其日常生活活动能力采用改良的Rakin量表MRS评分来进行功能评定。 结果 试验组和对照组生活能自理人数分别占25%、13.6%，能部分自理的人数分别占56.8%、40.9%，试验组肢体功能恢复明显高于对照组（P＜0.05）。 结论 卒中单元早期康复护理对脑卒中偏瘫患者肢体功能恢复有重要意义。
ObjectiveTo estimate the prognosis of duodenum-preserving resection of pancreatic head (DPRPH) in the treatment of space occupying with extensive calcification of pancreatic head, and to summarize the key points of surgery.MethodsThe clinical data of a middle-aged woman with rare space occupying with extensive calcification of pancreatic head who underwent surgery in Department of Pancreatic Surgery of West China Hospital in May. 2016 was collected and analyzed.ResultsThe DPRPH operation was successfully completed, with the operative time was 207 min, the intraoperative blood loss was 130 mL, and the hospital stay was 12 d. Removing time of the gastric tube and off-bed activity were on the 3rd day after operation, and the volume of peritoneal drainage per day was decreasing from 30 mL to 10 mL until 7th day after operation. We made examination of serum amylase and fluid amylase for the patient every 2 days, and the examination indexes were within normal level. After removing the peritoneal drainage tube, the pain was obviously relieved on the 12th day after operation, then the patient made hospital discharge. There was no observable pancreatic fistula, duodenal fistula, biliary fistula, delay gastric emptying, peritoneal effusion, pleural effusion, abdominal infection, and abdominal bleeding, neither nor any special discomfort. During the follow-up period of 18 months, we got a good prognosis without any symptom of relapse or discomfort according to the result of CT scans and other examinations.ConclusionDPRPH can make a satisfied prognosis in the treatment of rare space occupying with extensive calcification of pancreatic head.
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.