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.
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 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.
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.
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 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.
Objective To explore the effect of extended nursing intervention on patients with enucleation day surgery. Methods Patients who underwent monocular enucleation in the day ward of the Ophthalmology Center, Beijing Tongren Hospital, Capital Medical University between July 2020 and June 2021 were selected. They were randomly divided into control group and trial group by random number table method. The control group was given routine day-to-day nursing care, while the trial group added the extended nursing intervention measures of “forward and extended” on the basis of routine day-to-day overall nursing. The preoperative and postoperative anxiety levels, health knowledge awareness, operation shutdown rate, and nursing satisfaction were compared between the two groups of patients, and the application effect of extended nursing interventions in such patients was evaluated. Results Finally, 106 patients were included, 106 questionnaires were distributed, 106 were recovered, and the recovery rate was 100.0%. There were 53 cases in both the control group and the trial group. There was no significant difference in gender, age and education level between the two groups (P>0.05). The operation shutdown rate in the trial group was lower than that in the control group (0.0% vs. 11.3%). The preoperative and postoperative anxiety scores of the trial group were lower than those of the control group (preoperative: 50.06±5.27 vs. 58.25±5.21, postoperatively: 49.43±5.45 vs. 58.53±5.55). The score of the health knowledge awareness questionnaire in the trial group was higher than that in the control group (89.96±2.88 vs. 75.00±3.16). The degree of satisfaction in the trial group was better than that in the control group. In the trial group, 38 cases were very satisfied, 14 cases were satisfied, and 1 case was dissatisfied. In the control group, 19 cases were very satisfied, 27 cases were satisfied, and 7 cases were dissatisfied. The above differences were statistically significant (P<0.05). Conclusions Nursing intervention of “forward and extended” for patients with enucleation day surgery can effectively relieve patients’ anxiety before and after surgery, improve health knowledge awareness and nursing satisfaction, and reduce the operation shutdown rate.
