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From the point of the technical evaluation of the registration of medical devices, the technical evaluation focus of the disposable endoscopic injection needle registration are briefly described in the chapters of the application overview documents, risk management data, product technical requirements, research data, toxic substance residues, biocompatibility evaluation, clinical evaluation data, et al. The common terms of technical requirements are specified, risk management and research materials list the project requirements for product characteristics. So as to accurately judge the product quality, improve the review efficiency, promote the development of the industry.
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Needles , Endoscopy , Injections , Risk Management , IndustryABSTRACT
Objective:To analyze and summarize the clinical manifestations, imaging and colonoscopy characteristics, treatment and prognosis of idiopathic mesenteric phlebosclerosis(IMP), so as to raise clinicians' awareness of this rare disease.Methods:One case of IMP admitted into the Department of Gastroenterology, Beijing Hospital, was reported.The patient was admitted primarily due to abdominal pain, distension, and obstructed defecation and flatulence for 3 months, and recurrent vomiting for 2 days.Combining the patient's medical history, symptoms, physical signs, imaging and colonoscopy results, IMP was suspected to be the most likely cause for incomplete intestinal obstruction in this case.The literatures on IMP published before April 2021, including case reports, reviews and articles, were collected and analyzed.Based upon information mentioned above, the epidemiological characteristics, pathogenesis, clinical manifestations, diagnosis, treatment and prognosis of IMP were systematically reviewed.Results:A total of 206 cases of idiopathic mesenteric vein sclerosing enteritis had been reported up to April 2021 in the literature, with a male to female ratio of about 2.75∶1.Age was clearly mentioned in 111 case reports, with a median age of 59 years and 36 patients(32.4%)≥65 years old.Common clinical manifestations include abdominal pain, distension, diarrhea, hematochezia, nausea and vomiting, obstructed defecation and flatulence, among others.The lesion is usually at the right side of the colon, including the cecum, ascending colon and transverse colon, with the ascending colon as the most commonly involved site.Imaging characteristics include linear, serrated or tortuous calcification of vessels inside the involved colon segments and adjacent mesenterium, edema and thickening of the intestinal wall, and reactive hyperplasia of lymph nodes, etc.Endoscopic features include edema and thickening of the intestinal wall, discoloration of the mucosa, and tortuous and dilated submucosal vessels.Complications include intestinal obstruction, perforation and necrosis.In most cases, symptoms subside after patients stop taking herbal medicines and go through conservative treatment for microcirculation improvement, anti-inflammation, anti-coagulation, anti-infection, etc.Overall, the prognosis of IMP is satisfactory.Conclusions:IMP is a type of non-obstructive, non-thrombotic and non-inflammatory mesenteric phlebosclerosis that causes intestinal ischemia.The pathogenesis of the disease is still unclear.Combination of characteristic clinical manifestations, imaging especially CT findings, endoscopic and histopathological examinations will help the diagnosis of IMP.
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Objective:To investigate the efficacy of proximal femoral intramedullary nail antirotation fixation in the treatment of intertrochanteric fracture of the femur and its effects on Harris hip scores.Methods:Sixty-eight patients with intertrochanteric fracture of the femur who received treatment in Cixi People's Hospital from April 2018 to October 2019 were included in this study. They were randomly assigned to receive dynamic hip screw fixation (control group, n = 34) or proximal femoral intramedullary nail antirotation fixation (observation group, n = 34). Clinical efficacy, Harris score, surgical indicators, and the incidence of complications were compared between the two groups. Results:The response rate was significantly higher in the observation group than in the control group [94.12% (32/34) vs. 76.47% (26/34), χ2 = 5.81, P < 0.05]. The excellent and good rate of hip function as evaluated by Harris hip scores was significantly higher in the observation group than in the control group [91.18% (31/34) vs. 73.53% (25/34), χ2 = 6.05, P < 0.05]. The operative time, blood loss, incision length, and fracture healing time in the observation group were (51.66 ± 10.52) minutes, (120.26 ± 12.29) mL, (8.09 ± 2.62) cm, and (9.86 ± 2.67) weeks respectively, and those in the control group were (78.32 ± 12.23) minutes, (238.45 ± 17.85) mL, (12.95 ± 3.29) cm, and (13.65 ± 3.46) weeks, respectively. There were significant differences in these indices between the two groups ( t = 14.55, 14.03, 14.85, 14.60, all P < 0.05). The incidence of complications was significantly lower in the observation group than in the control group [5.88% (2/34) vs. 23.53% (8/34), χ2 = 6.51, P < 0.05]. Conclusion:Proximal femoral intramedullary nail antirotation fixation is superior to dynamic hip screw fixation in the treatment of intertrochanteric fracture of the femur. The former increases Harris hip score, decreases the incidence of complications, and is of great clinical innovation.
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To analyze the lesion distribution situations and relationship of lesions detected by gastroscopy and colonoscopy in asymptomatic population in Beijing. Data of 1 663 patients who received gastroscopy and colonoscopy in the physical examination center of Peking Union Medical College Hospital and Beijing Hospital between January 2016 and December 2018 were analyzed retrospectively. Statistical analysis was conducted on the detection rate and relationship of different lesions based on the information of gender and ages. Gastroscopy data showed that chronic non-atrophic gastritis and chronic atrophic gastritis accounted for 1 240 (74.6%)and 423 (25.4%)cases respectively. Chronic atrophic gastritis was more common in population aged over 40. Other common diseases included erosions of gastric body and/or antrum, fundic gland polyps, reflux esophagitis, duodenitis, bile regurgitation and so on. Upper gastrointestinal tumors including esophagus cancer and gastric cancer were both early lesions. Colonoscopy results showed that colonic polyps were common lesions, among which there were 382 (23.0%)cases of colonic adenoma and 217 (13.0%)hyperplastic polyps. Incidence of colonic polyps increased with age. Colorectal cancer accounted for 0.7%. Colon diverticulum and melanosis coli were more common in population aged over 40. Colon adenoma was more common in male and melanosis coli was more common in female. The positive rate of HP was 32.2%. There was no positive relationship between HP infection and fundic gland polyps( P=0.329). There was no positive relationship between fundic gland polyps and colon adenomas as well as colorectal cancer( P=0.152, P=0.616). Gastroscopy and colonoscopy play important roles in different kinds of digestive diseases, especially in the early detection of tumors. More attention should be paid to the application of endoscopy in asymptomatic population.
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Objective:To assess the future risk of bleeding events and ischemic events in a two-year follow-up of elderly patients with acute coronary syndromes(ACS)who experienced upper gastrointestinal bleeding during hospitalization, and to analyze the related factors for the recurrence.Methods:This was a retrospective case-control study.Elderly ACS patients who underwent percutaneous coronary intervention(PCI)in Beijing Hospital from January 1, 2015 to December 31, 2018 were continuously included.According to whether upper gastrointestinal bleeding occurred during hospitalization, they were divided into the bleeding group(n=51)and the control group(n=2 834). Baseline data were compared between the two groups.The incidence of major adverse cardiovascular events(MACE)and the recurrence of bleeding defined by the Bleeding Academic Research Consortium(BARC)consensus classification were monitored during the 2-year followed-up.Related factors for clinically significant bleeding events(BARC type 2, 3 and 5)were analyzed.Results:The median bleeding time in the bleeding group was 3.3 days after PCI, and the main cause was gastroduodenal ulcer(43 cases, 84.3%). Compared with the control group, patients in the bleeding group had a lower body mass index, a higher proportion of patients with a history of atrial fibrillation, chronic kidney disease, peptic ulcer, ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction, higher usage rates of ticagrelor and oral anticoagulants, a lower usage rate of proton pump inhibitor(PPI), a higher proportion of patients with coronary artery disease involving ≥ 2 vessels, higher GRACE scores, higher usage rates of tirofiban and aspiration catheters and a lower complete revascularization rate( P<0.05). Patients were followed up for(22.4±1.5)months.Compared with the control group, the incidence of MACE(19 cases or 37.3% vs.698 cases or 24.6%, HR=1.655, 95% CI: 1.026-2.673, χ 2=4.513, P<0.05)and the recurrence of clinically significant bleeding(BARC type 2, 3 and 5)(10 cases or 19.6% vs.283 cases or 10.0%, HR=2.242, 95% CI: 1.209-4.157, χ2=5.083, P<0.05)increased in the bleeding group.Logistic multivariate regression analysis showed that age ≥70 years( RR=1.813, 95% CI: 1.021-3.219), chronic kidney disease ≥ stage 2( RR=1.623, 95% CI: 1.196-2.202), history of peptic ulcer( RR=2.152, 95% CI: 1.156-4.006), ticagrelor( RR=2.014, 95% CI: 1.253-3.237), and oral anticoagulants( RR=1.352, 95% CI: 1.032-1.771)were independent risk factors for clinically significant bleeding(BARC type 2, 3 and 5), and PPI was a protective factor( RR=0.573, 95% CI: 0.345-0.952). Conclusions:A history of upper gastrointestinal bleeding in elderly patients with ACS during hospitalization can increase the recurrence risk of clinically significant bleeding and MACE events in subsequent two years.Advanced age, chronic kidney disease ≥stage 2, a history of peptic ulcer, and preoperative use of ticagrelor and oral anticoagulants are independent risk factors for the recurrence risk of clinically significant bleeding, and PPI can decrease the recurrence risk of bleeding.
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Objective:To evaluate the outcome of endoscopic submucosal dissection (ESD) of colorectal tumors, and to analyze the factors affecting the therapeutic efficacy of ESD.Methods:Clinical data of patients with colorectal tumors who were treated with ESD in Department of Gastroenterology in Beijing Hospital from November 2016 to December 2019 were reviewed. A total of 82 patients with pathologically confirmed colorectal adenoma or carcinoma of diameter ≥20 mm were included. The clinical features, ESD and pathological outcomes of the patients were analyzed.Results:All 82 lesions were single, with the mean diameter of 29.72±10.74 mm. Lesions were divided into the laterally spreading tumors (LST), mainly located in the ascending colon and ileocecal region (47.8%, 22 / 46) and the protruding colorectal tumors, mainly located in the left colon, 52.8% (19 / 36) of which were located in the sigmoid colon. The overall resection rate was 81.7%(67/82) and the curative resection rate was 72.0%(59/82). The incidences of bleeding and perforation were 2.4%(2/82) and 1.2%(1/82), respectively. The curative resection rates [91.4%(32/35), 63.6%(7/11) and 55.6%(20/36), P=0.003] and surgical operation rates [8.6%(3/35), 18.2%(2/11) and 36.1%(13/36), P=0.010] of LST-G, LST-NG and protruding colorectal tumors were significantly different. Multivariate regression analysis showed that protruding colorectal tumor ( OR=3.396, 95% CI: 1.014-11.374, P=0.047) and submucosal severe fibrosis (F2 type) ( OR=5.508, 95% CI: 2.216-13.692, P=0.001) were independent risk factors for non-curative ESD resection of colorectal tumors. Conclusion:ESD is effective and safe for colorectal tumors of diameter ≥ 20 mm. However, there are some differences in the rate of submucosal invasion and treatment outcome among different types of lesions. The risk factors for non-curative resection are protruding tumors and severe submucosal fibrosis.
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Objective:To investigate the impact of the destruction of dorsal motor nucleus of the vagus(DMV)on lower esophageal sphincter pressure in a rat model of acute esophagitis.Methods:A total of 40 male Sprague-Dawley(SD)rats were randomly divided into four groups: the control group, sham group, DMV destruction group, DMV destruction + vagal stimulation group.Two weeks after DMV destruction or sham operation, hydrochloric acid with pepsin was perfused into the esophagogastric junction of rats for 90 min, and lower esophageal sphincter pressure was measured before and after operation and 60 min after acid perfusion.Rats in the control group received assessment of lower esophageal sphincter pressure directly.Rats in the DMV destruction + vagus stimulation group were given electric current stimulation for 30 minutes before and after 15 min of esophageal acid perfusion.Rats were sacrificed after 60 min of the acid perfusion.The esophagus was prepared for hematoxylin and eosin(HE)staining, and the degree of inflammation and the expression of inflammatory cytokines were examined.Results:In the DMV destruction group, lower esophageal sphincter pressure decreased 2 weeks after DMV destruction compared with pre-destruction levels(25.9±8.8 cmH 2O vs.34.0±8.9 cmH 2O, P<0.05), and lower esophageal sphincter pressure decreased after 60 min of acid perfusion compared with pre-destruction levels(18.6±3.6 cmH 2O vs.25.9±8.8 cmH 2O, P<0.01). In the DMV destruction + vagus stimulation group, lower esophageal sphincter pressure increased after vagus nerve stimulation(22.3±2.9 cmH 2O vs.18.6±3.6 cmH 2O, P<0.05). There was no significant difference in lower esophageal sphincter pressure in the sham group before and after sham operation, while the pressure increased after acid perfusion(30.0± 9.5 cmH 2O vs.37.8±5.8 cmH 2O, P<0.05). The degree of inflammation in the lower esophagus was aggravated and the expression of tumor necrosis factor-α, interleukin(IL)-6, IL-1β and prostaglandin E2 in esophageal tissues increased in the DMV destruction group compared with the sham group( P<0.01). The inflammation degree and the expression of inflammatory factors in the lower esophagus improved after vagal nerve stimulation compared with pre-stimulation levels( P<0.01). Conclusions:DMV destruction decreases lower esophageal sphincter pressure and aggravates esophageal inflammation and injury in a rat model of acute esophagitis.Vagus nerve stimulation can strengthen the pressure of the lower esophageal sphincter and improve the inflammation of the lower esophageal segment.
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This paper briefly introduces the recent regulatory regulations issued by the European Union and the United States on the drug-device combinations. The contents include the definition of drug-device combinations, the attribute definition process, the registration requirements, the review and approval procedures, the management of production systems, and the post-marketing safety supervision. Some inspirations have been obtained from them for reference by the regulatory authorities.
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European Union , Marketing , United StatesABSTRACT
Objective To evaluate the safety of Propofol combined with Fentanyl in intravenous anesthesia for endoscopic retrograde cholangiopancreatography(ERCP)in elderly patients.Methods The clinical data of 63 elderly patients aged ≥80 years with common bile duct stones who underwent ERCP in digestive endoscopy center of our hospital were retrospectively analyzed.All the patients were divided into Propofol combined with Fentanyl anesthesia group(group A,n =41)and midazolam combined with Fentanyl anesthesia group(group B,n=22).The changes of blood pressure,heart rate and blood oxygen saturation(SpO2),and postoperative complications were compared between the two groups.Results The incidence of hypotension was higher in Propofol combined with Fentanyl anesthesia group than in midazolam combined with Fentanyl anesthesia group(24.4 ％ vs.0.0％,x2=4.683,P =0.030),but the incidence of SpO2 ＜ 90 ％ in midazolam combined with fentanyl anesthesia group was significantly increased(22.7％ vs.0.0％,x2 =7.250,P =0.007).There was no statistically significant difference in the incidence of anesthesia-related complications (39.0％ vs.36.4％,x2 =0.043,P =0.836) and postoperative complications (4.9 ％ vs.4.5 ％,x2 =0.003,P =0.953) between the two groups.Conclusions For elderly patients with common bile duct stones,intravenous anesthesia with Propofol and Fentanyl during ERCP is safe,and blood pressure changes need to be closely monitored.
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European Union (EU) medical device supervision system is more complete, has a lot of experiences and characteristics worth learning. This paper introduces a brief overview of the process of medical devices market in the EU, including three core medical device directives, process of obtaining CE mark, medical devices vigilance system and supervision after obtaining the CE mark, etc. Simultaneously, preliminary enlightenments of the EU medical devices supervision to our national medical devices' technical review process are discussed with the aim of providing reference for supervision, technical review unit and manufacturer.
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Device Approval , European Union , Product Surveillance, PostmarketingABSTRACT
Objective To evaluate the safety of intrvenous balanced propofol sedation with fentanyl in elderly patients during combined gastroscopy and colonoscopy procedures.Methods Totally 877 elderly patients aged (76.4 ± 8.5) years received intravenous propofol and fentanyl sedation during gastroscopy or/and colonoscopy procedures were assigned to groups:294 cases with only gastroscopy,257 cases with only colonoscopy and 326 cases with combined gastroscopy and colonoscopy.50 g Fentanyl and 0.5-1.0 mg/kg propofol were intravenously administered in the patients.The peripheral oxygen saturation,arterial pressure and heart rate were monitored and recorded during procedures.Results There were no procedure-related perforations and sedationassociated severe complications and mortalities,and no one need stop endoscopy procedures in all the patients.The average dosage of propofol in combined,gastroscopy and colonoscopy groups were (100.4±38.5) mg,(130.4±50.5)mg and (170.3± 60.3)mg,respectively.There were no significant differences in heart rate,arterial pressure and rate of cardiovascular events among groups (P＞0.05).The rate of respiration events in the above groups were 9 cases(3.1％),6 cases(2.3％)and 13 cases(4.0％),respectively (P＞0.05).Decrease of peripheral oxygen saturation was mainly induced by the aspiration of oral secretions and snoring.Conclusions Intravenous balanced propofol sedation provides safe and effective sedation in the elderly undergoing combined gastroscopy and colonoscopy.
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Objective To investigate the dynamic abnormality of colon and anorectum in elderly patients with chronic functional constipation(CFC). Methods Forty-two elderly patients with CFC and twenty elderly healthy controls were selected. Total and segmental colonic transit time(CTT) were assessed radiographically by using oral radiopaque markers. Eight-lead water perfusion pressure measurement system and balloon were used to test the pressure and the perception threshold values of anus and rectum. Results (1) Total colonic transit time (TCTT) and sigmoid-rectum transit time (SRTT) were (49.0±16.4) h and (20.1±13.5) h in elderly patients with CFC, which were significantly prolonged compared with the controls [(25.2±7.7) h and (7.8±4.1) h, t=6.16 and 3.97,both P<0.05]. (2) The pressure of anal canal during defecation was (39.6±15.7) mmHg in elderly patients with CFC and (17.6±9.3) mm Hg in controls (t=5.79, P<O.05). The lowest volume threshold and the maximal tolerance volume of rectal perception to balloon distention were (49.2±10.5) ml and (175.2±52.6) ml in elderly patients with CFC, which were higher than the controls[(33.6±8.5) ml and (123.4±39.1) ml, t=5.79 and 3.91, both P<0.05]. The rate of rectoanal inhibitory reflex (RAIR) was 59.5% and 85.0% in elderly patients with CFC and controls, respectively(x2 =4.03,P<O.05). Conclusions The CTT and SRTT are prolonged obviously in elderly patients with CFC. The anorectal dynamic changes include decreased sensibility of rectum, lower rate of RAIR and anorectal dyssynergia during defecation. The test of CTT and anorectal manometry provide evidence for the classification and treatment of constipation.
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Objective To evaluate the safety of conscious venous anesthesia with fentanyl and propofol in elderly patients over 70 during gastrointestinal endoscopy. Methods Clinical data of 826 elderly patients over 70, who underwent gastrointestinal endoscopy with venous anesthesia, were retrospectively analyzed. The patients were divided into 2 groups according to their ages, with 618 patients aging from 70 to 80 in group A, in which 342 received endoscopy and 276 underwent colonoscopy, and 208 patients older than 80 in group B, in which 112 underwent endoscopy and 96 had colonoscopy. Another cohort of 600 patients younger than 70, who underwent venous anesthetic endoscopy during the same time period, was randomly selected as the control group, in which 400 patients received endoscopy and 200 had colonoscopy. Blood pressure, heart rate, peripheral oxygen saturation (SpO2) and adverse reaction were monitored in each patient during the procedure and compared among different groups. Results No procedure-related perforation or sedation-related mortality was observed, and no procedure was terminated clue to sedation complication. The average dosages of propofol used in procedure of endoscopy in groups A, B and control were 54.22±21.36 mg, 40.22±12.46 mg, and 86.44±34.26 mg, respectively. The average dosages of propofol in colonoscopy were 82.56±40.64 mg, 45.36±15.44 mg and 102.23±46.32 mg, respectively. With same procedure, there was no significant difference in heart rate and blood pressure among different groups, nor was there any difference in these variables before and after the procedure in each group (P>0.05). Sedation exerted more influence on SpO<,2> in elderly patients. A total of 18 cases in groups A and B experienced SpO<,2> <90%, which was mainly due to aspiration of saliva and relieved by oxygen inhalation. Conclusion Under appropriate monitor, it is safe and feasible to give conscious sedation to elderly patients over 70 during gastroimestinal endoscopy.
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Objective To evaluate the clinical significance of phural effusion and/or ascites and their prognostic role in patients with acute pancreatitis.Methods The clinical data of 312 patients with acute pancreatitis were collected and analyzed retrospectively.Results Pieural effusion was found in 47 patients and ascites in 18.of 47 cases with pleural effusion,there were 31 cases(65.9%)of severe pancreatitis(P＜0.01)and 27 cases (57.4%)complicated by pseudocyst(P＜0.01).Among 18 cases with ascites,there were 14 cases(77.7%)of severe pancreatitis(P＜0.01).6 cases with pleural effusion and/or ascites died of multiple organs failure.Conclusion Pleural effusion and/or aseites is closely associated with severe pancreatitis.
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Numerous epidemiologic studies have shown that there is a strong inverse relationship between high-density lipoprotein cholesterol levels and artherosclerosis. The first atheroprotective mechanism of HDL is the RCT(reverse cholesterol transport). Recently,considerable pharmacological trials have focused on targeting critical proteins and enzymes in RCT including apoAⅠ, ATP binding cassette transporter A1 and cholesteryl ester transport protein etc. A number of new drugs have demonstrated conspicuous protective effects on artherosclerosis. Therefore RCT will become an attractive target for prevention and cure of dyslipidamia and artherosclerosis.