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1.
Article in Chinese | WPRIM | ID: wpr-1024653

ABSTRACT

Objective:To evaluate the simulation effect of the placebo in a clinical trial of whole nutrition formula, and to inform the preparation of placebo in the clinical trial of foods for special medical purposes.Methods:Evaluators assessed the appearance, color, smell, and taste, and made the distinction between the placebo and the experimental product independently. The similarity and consistency between the placebo and experimental product were also assessed using a manual scoring method.Results:In the group assessing experimental product, 40% evaluators made the correct judgment while 50% did not. In the group assessing placebo, 10% evaluators made the correct judgment while 70% did not. Compared with the reference product, the experimental product and placebo were scored 9.75±0.79 vs. 6.63±3.73 for appearance, 9.75±0.79 vs. 7.25±3.99 for color, 8.75±3.17 vs. 8.50±3.16 for smell, and 9.00±1.29 vs. 7.75±2.99 for taste. The intra-evaluator consistency rate for the appearance, color, smell and taste of different products was 80%, 80%, 90%, and 90%, respectively. Conclusions:The blinding effect of placebo was relatively satisfactory in the trial we assessed. The placebo was comparable with the experimental product in terms of color, smell, and taste, but not appearance. The approaches for preparing and evaluating placebo in this clinical trial could give some clues for similar trials involving foods for special medical purposes.

2.
Article in Chinese | WPRIM | ID: wpr-1038354

ABSTRACT

Objective @#To investigate the effects of luteolin on invasion and migration of endometriosis stromal cells and whether its mechanism is related to the regulation of 15-hydroxyprostaglandin dehydrogenase (HPGD) expres- sion.@*Methods @#The endometrial stromal cells HEM15A were divided into control group (cells were cultured in nor- mal medium) ,luteolin group ( cells were treated with different concentrations of luteolin) ,si-HPGD group ( cells were transfected with si-HPGD) ,si-NC group ( cells were transfected with si-NC ) ,luteolin + si-HPGD Group (cells were transfected with si-HPGD and treated with 20 μmol / L luteolin) ,Luteolin + si-NC Group ( cells were transfected with si-NC and treated with 20 μmol / L luteolin) . Real-time quantitative PCR was used to detect mRNA level of HPGD.Cell proliferation was detected by CCK-8 assay,Transwell and scratch assays were used to detect cell invasion and migration.The protein expression of proliferating cell nuclear antigen (PCNA) ,matrix metallopro- teinase (MMP-2) ,MMP-9 and HPGD were detected by Western blot,and the level of prostaglandin E2 ( PGE2) was detected by ELISA. @*Results @#Compared with 0 μmol / L luteolin,luteolin at 20,50 and 100 μmol / L significantly inhibited the proliferation activity of hEM15A cells,and reduced PCNA expression ( all P<0. 05) .Compared with the control group,20 μmol / L of luteolin significantly inhibited cell invasion and migration (P <0. 05) ,decreased the expressions of MMP-2 and MMP-9 (P<0. 05) ,and up-regulated the mRNA and protein levels of HPGD (P < 0. 05) ,while inhibited cellular PGE2 level (P<0. 05) .Compared with the luteolin group,the luteolin + si-HPGD group increased cell invasion and migration (P <0. 05 ) ,increased the expressions of MMP-2 and MMP-9 (P < 0. 05) .@*Conclusion @#Luteolin regulates HPGD / PGE2 signaling pathway to inhibit the invasion and migration of en- dometrial stromal cells.

3.
Article in Chinese | WPRIM | ID: wpr-991891

ABSTRACT

Objective:To analyze the clinical application effect of otoendoscopic myringoplasty with tragus perichondrium.Methods:The clinical data of 20 patients with tympanic membrane perforation who received treatment in Suixian Traditional Chinese Medicine Hospital from March 2019 to March 2020 were retrospectively analyzed. Among the 20 patients, 6 patients had traumatic tympanic membrane perforation, and 14 patients had tympanic membrane perforation caused by chronic suppurative otitis media (stationary phase). All patients underwent otoendoscopic myringoplasty with tragus perichondrium. After surgery, the healing of tympanic membrane perforation and the improvement of hearing were evaluated.Results:After surgery, all patients were followed up for 12 months. Traumatic tympanic membrane perforation healed in six patients. The tympanic membrane grafts survived in 12 patients with tympanic membrane perforation caused by chronic suppurative otitis media (stationary phase). One patient had poor postoperative healing and the remaining small perforation healed after secondary treatment under local anesthesia. Healing from tympanic membrane perforation was not achieved in one patient because of perforation caused by otitis media. The healing rate of tympanic membrane perforation caused by chronic suppurative otitis media was 95%. Before surgery, the air conduction pure tone hearing threshold was (42 ± 11) dBHL, and it was (25 ± 10) dBHL 12 months after surgery. There was a significant difference in air conduction pure tone hearing threshold between before and after surgery ( t = 4.00, P < 0.05). No complications such as tragus cartilage infection, skin flap necrosis of external auditory meatus, peripheral facial paralysis, hearing loss, or tinnitus occurred in 20 patients with tympanic membrane perforation. Conclusion:Otoendoscopic myringoplasty with tragus perichondrium leads to a high perforation healing rate, improves healing greatly, has no serious complications, produces minimal trauma, and contributes to a rapid recovery from tympanic membrane perforation.

4.
Article in Chinese | WPRIM | ID: wpr-993210

ABSTRACT

Objective:To evaluate the practicability of dose volume histogram (DVH) prediction model for organ at risk (OAR) of radiotherapy plan by minimizing the cost function based on equivalent uniform dose (EUD).Methods:A total of 66 nasopharyngeal carcinoma (NPC) patients received volume rotational intensity modulated arc therapy (VMAT) at Cancer Hospital & Shenzhen Hospital, Chinese Academy of Medical Sciences from 2020 to 2021 were retrospectively selected for this study. Among them, 50 patients were used to train the recurrent neutral network (RNN) model and the remaining 16 cases were used to test the model. DVH prediction model was constructed based on RNN. A three-dimensional equal-weighted 9-field conformal plan was designed for each patient. For each OAR, the DVHs of individual fields were acquired as the model input, and the DVH of VMAT plan was regarded as the expected output. The prediction error obtained by minimizing EUD-based cost function was employed to train the model. The prediction accuracy was characterized by the mean and standard deviation between predicted and true values. The plan was re-optimized for the test cases based on the DVH prediction results, and the consistency and variability of the EUD and DVH parameters of interest (e.g., maximum dose for serial organs such as the spinal cord) were compared between the re-optimized plan and the original plan of OAR by the Wilcoxon paired test and box line plots.Results:The neural network obtained by training the cost function based on EUD was able to obtain better DVH prediction results. The new plan guided by the predicted DVH was in good agreement with the original plan: in most cases, the D 98% in the planning target volume (PTV) was greater than 95% of the prescribed dose for both plans, and there was no significant difference in the maximum dose and EUD in the brainstem, spinal cord and lens (all P>0.05). Compared with the original plan, the average reduction of optic chiasm, optic nerves and eyes in the new plans reached more than 1.56 Gy for the maximum doses and more than 1.22 Gy for EUD, and the average increment of temporal lobes reached 0.60 Gy for the maximum dose and 0.30 Gy for EUD. Conclusion:The EUD-based loss function improves the accuracy of DVH prediction, ensuring appropriate dose targets for treatment plan optimization and better consistency in the plan quality.

5.
Chin. med. j ; Chin. med. j;(24): 2156-2165, 2023.
Article in English | WPRIM | ID: wpr-1007648

ABSTRACT

BACKGROUND@#Immune checkpoint inhibitors (ICIs) are standard treatments for advanced non-small cell lung cancer (NSCLC); however, evidence regarding their relative efficacy and safety is lacking. This study compared the efficacy and safety of all currently available ICI treatments in patients with advanced NSCLC to identify optimal treatment regimens.@*METHODS@#PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, and Embase databases were systematically searched for randomized controlled trials (RCTs) published up to August 8, 2022. The primary outcomes were overall survival (OS) and progression-free survival (PFS). Secondary outcomes included objective response rate (ORR) and adverse events (AEs).@*RESULTS@#Forty RCTs involving 22,526 patients were selected, and a total of 26 treatment regimens were identified. Treatment with anti-programmed cell death protein-1 (anti-PD-1) provided superior OS compared with anti-programmed death ligand 1 (anti-PD-L1) treatment. ICIs plus platinum-based chemotherapy (PBC) were superior to ICIs treatment alone, although the addition of PBC increased treatment toxicity. Cemiplimab ranked first for OS and lowest for any-grade AEs in advanced NSCLC patients without PD-L1 selection. Regarding grade ≥3 AEs, the toxicity of ICI monotherapy or ICI-ICI combination was consistently lower than that of the other treatments. For patients without PD-L1 selection, cemiplimab showed the best OS, pembrolizumab plus docetaxel (Pem-DXT) showed the best PFS, and atezolizumab plus bevacizumab and PBC (Atezo-Beva-PBC) showed the best ORR. Pembrolizumab plus PBC and Atezo-Beva-PBC were the most likely optimal treatments for OS and PFS in patients with PD-L1 expression <1%, respectively. In patients with PD-L1 expression ≥1%, treatment regimens containing anti-PD-1 provided superior OS benefits compared with those of anti-PD-L1 treatment, and sintilimab plus PBC (Sint-PBC) provided the best OS benefit; as for PFS, ICI plus PBC consistently showed greater PFS benefits than ICI or PBC alone. For patients with anti-PD-L1 expression of 1-49%, camrelizumab plus PBC provided the best benefit for OS and PFS among included treatment. Durvalumab-tremelimumab-PBC and Atezo-Beva-PBC respectively presented the highest OS and PFS for patients with PD-L1 expression ≥50%. Moreover, cemiplimab and Atezo-Beva-PBC yielded the best OS and PFS benefits as first-line treatments for patients with advanced NSCLC, respectively.@*CONCLUSIONS@#Although ICI plus PBC likely resulted in superior survival outcomes compared to ICI treatment alone, it did increase toxicity. Cemiplimab presented a well-balanced efficacy and safety profile in advanced NSCLC treatment. Our findings with the current ICIs comparisons will aid future trials for cancer immunotherapy.@*REGISTRATION@#PROSPERO, https://www.crd.york.ac.uk/PROSPERO/ , CRD42022323879.


Subject(s)
Humans , Immune Checkpoint Inhibitors/adverse effects , Carcinoma, Non-Small-Cell Lung/drug therapy , Network Meta-Analysis , Lung Neoplasms/drug therapy
6.
Article in English | WPRIM | ID: wpr-1010578

ABSTRACT

This study aims to investigate the impact of hepatocyte nuclear factor 1β (HNF1b) on macrophage sortilin-mediated lipid metabolism and aortic atherosclerosis and explore the role of the flavone of Polygonatum odoratum (PAOA-flavone)-promoted small ubiquitin-related modifier (SUMO) modification in the atheroprotective efficacy of HNF1b. HNF1b was predicted to be a transcriptional regulator of sortilin expression via bioinformatics, dual-luciferase reporter gene assay, and chromatin immunoprecipitation. HNF1b overexpression decreased sortilin expression and cellular lipid contents in THP-1 macrophages, leading to a depression in atherosclerotic plaque formation in low-density lipoprotein (LDL) receptor-deficient (LDLR-/-) mice. Multiple SUMO1-modified sites were identified on the HNF1b protein and co-immunoprecipitation confirmed its SUMO1 modification. The SUMOylation of HNF1b protein enhanced the HNF1b-inhibited effect on sortilin expression and reduced lipid contents in macrophages. PAOA-flavone treatment promoted SUMO-activating enzyme subunit 1 (SAE1) expression and SAE1-catalyzed SUMOylation of the HNF1b protein, which prevented sortilin-mediated lipid accumulation in macrophages and the formation of atherosclerotic plaques in apolipoprotein E-deficient (ApoE-/-) mice. Interference with SAE1 abrogated the improvement in lipid metabolism in macrophage cells and atheroprotective efficacy in vivo upon PAOA-flavone administration. In summary, HNF1b transcriptionally suppressed sortilin expression and macrophage lipid accumulation to inhibit aortic lipid deposition and the development of atherosclerosis. This anti-atherosclerotic effect was enhanced by PAOA-flavone-facilitated, SAE1-catalyzed SUMOylation of the HNF1b protein.


Subject(s)
Mice , Animals , Polygonatum/metabolism , Sumoylation , Hepatocyte Nuclear Factor 1-beta/metabolism , Atherosclerosis/metabolism , Flavones , Lipids
7.
Zhongguo fei'ai zazhi (Online) ; Zhongguo fei'ai zazhi (Online);(12): 429-438, 2023.
Article in Chinese | WPRIM | ID: wpr-982175

ABSTRACT

BACKGROUND@#Studies have shown that the incidence and severity of corona virus disease 2019 (COVID-19) in patients with lung cancer are higher than those in healthy people. At present, the main anti-tumor treatments for lung cancer include surgery, immunotherapy, chemotherapy, radiotherapy, targeted therapy and anti-angiogenesis therapy. While the effects of different anti-tumor treatments on the occurrence and severity of COVID-19 pneumonia are not uniform. Therefore, we aimed to describe clinical characteristics and antitumor therapy of patients with lung cancer and COVID-19 pneumonia, and examined risk factors for severity in this population.@*METHODS@#From December 1, 2022 to February 15, 2023, a retrospective study was conducted in 217 patients diagnosed with COVID-19 and pathologically confirmed lung cancer in the Jinling Hospital. We collected data about patients' clinical features, antitumor treatment regimen within 6 months, and the diagnosis and treatment of COVID-19. Risk factors for occurrence and severity of COVID-19 pneumonia were identified by univariable and multivariable Logistic regression models.@*RESULTS@#(1) Among the 217 patients included, 51 (23.5%) developed COVID-19 pneumonia, of which 42 (82.4%) were classified as medium and 9 (17.6%) were classified as severe; (2) Univariate and multivariate analysis revealed overweight (OR=2.405, 95%CI: 1.095-5.286) and intrapulmonary focal radiotherapy (OR=2.977, 95%CI: 1.071-8.274) are risk factors for increasing occurrence of COVID-19 pneumonia, while other therapies are not; (3) Chronic obstructive pulmonary disease (COPD) history (OR=7.600, 95%CI: 1.430-40.387) was more likely to develop severe pneumonia and anti-tumor therapies such as intrapulmonary focal radiotherapy, chemotherapy, targeted therapy and immunotherapy did not increase severity.@*CONCLUSIONS@#Intrapulmonary focal radiation therapy within 6 months increased the incidence of COVID-19 pneumonia, but did not increase the severity. However, there was no safety concern for chemotherapy, targeted therapy, surgery and immunotherapy.


Subject(s)
Humans , COVID-19 , Retrospective Studies , Lung Neoplasms/drug therapy , Incidence , Pneumonia/etiology
8.
Article in Chinese | WPRIM | ID: wpr-930311

ABSTRACT

Objective:To investigate the relationship between dosimetric parameters and tumor volume change after 125I implantation for thyroid cancer and obtain better dosimetric parameters that predict the curative effect more accurately. Methods:A total of 22 consecutive patients with thyroid cancer (23 targets) who received 125I interstitial brachytherapy in Department of Oncology, Hebei General Hospital were retrospectively analyzed. All the patients received post-operative dose verification, and the D 90 (Minimum dose received by 90% target volume) was calculated. After a regular follow-up, the tumor volume reduction ratio after t months (R t) , actual absorbed dose (D 1m) , efficacy corrected absorbed dose (D 1e) , and sensitivity corrected absorbed dose (D 1s) of the first month were calculated according to the actual follow-up CT images. The statistical test was carried out by SPSS21.0. The Spearman linear analysis was applied to analyze the relationship between D 90, D 1m, D 1e, D 1s and R t, and the curve fitting was also completed. Results:The post-operative D 90, D 1m, D 1e, D 1s and R t were (129.73±14.22) Gy, (36.95±7.35) Gy, (43.45±11.32) Gy, (41.78±13.39) Gy, and (32.00±19.00) %, respectively. And the correlation coefficient were 0.692, 0.551, 0.728, and 0.858, respectively, which showed significant positive relevance between dosimetric parameters and tumor volume change ( P<0.01) , the curve fitting presented cubic function. Conclusion:The post-operative D 90, D 1m, D 1e, and D 1s can be predictors for curative effect, and D 1s is the best predictor.

9.
Article in Chinese | WPRIM | ID: wpr-931742

ABSTRACT

DECIDE-Diet trial was taken as a case to introduce the methods of blinding and blinding assessment for feeding trials, report the details of blinding, conduct a blinding survey and calculate Jame's BI and Bang's BI. Jame's BI was 0.683 (95% CI: 0.593~0.772). The Bang's BI for the intervention group was 0.340 (95% CI: 0.199~0.481), and for the control group was 0.086 (95% CI: -0.060~0.231). The blinding of the DECIDE)-Diet was generally successful, but the intervention group may infer their group to a certain extent. Feeding trials should report the details of blinding and consider blinding assessment.

10.
Journal of Preventive Medicine ; (12): 340-345, 2022.
Article in Chinese | WPRIM | ID: wpr-923323

ABSTRACT

Objective@#To examine the relationship between interpregnancy interval (IPI) and neurodevelopment among 6-month-old infants, so as to provide insights into the prevention of neurodevelopmental abnormalities among infants.@*Methods@#Puerparas with full-term delivery at Anhui Province Maternity and Child Health Hospital from April 2017 to July 2018 and their babies were recruited. The demographic features, behaviors during pregnancy, IPI and birth outcomes were collected through questionnaires and medical records. The neurodevelopment was evaluated using the Ages and Stages Questionnaire (third edition) among infants at 6 months of age. The association between IPI and neurodevelopment was examined using multivariable logistic regression analysis.@*Results @#Totally 485 maternal-newborn pairs were investigated, and the puerparas had a mean age of ( 29.43±4.40 ) years. There were 330 puerparas ( 68.04% ) with normal pre-pregnancy body mass index, 325 puerparas ( 67.01% ) with eutocia, 233 puerparas (48.04%) with the first delivery, 44 puerparas ( 9.07% ) with IPI of less than one year and 208 puerparas ( 42.89% ) with IPI of one year and greater. There were 246 male babies ( 50.72% ) and 437 babies ( 90.10% ) with normal birth weight. A total of 148 newborns were diagnosed with neurodevelopmental abnormalities, with a detection rate of 30.52%. Of all newborns with neurodevelopmental abnormalities, there were 45 babies with communication abnormalities ( 9.28% ), 87 babies with gross motor abnormalities ( 17.94% ), 73 babies with fine motor abnormalities ( 15.05% ), 68 babies with abnormalities of solving problems ( 14.02% ) and 60 babies with personal-social abnormalities ( 12.37% ). Multivariable logistic regression analysis showed a reduced risk of infant's communication abnormalities ( OR=0.273, 95%CI: 0.090-0.833 ), gross motor abnormalities ( OR=0.340, 95%CI: 0.150-0.770 ), fine motor abnormalities ( OR=0.266, 95%CI: 0.106-0.670 ), personal-social abnormalities ( OR=0.321, 95%CI: 0.121-0.851 ) and neurodevelopmental abnormalities ( OR=0.353, 95%CI: 0.171-0.730 ) among puerparas with IPI of one year and greater as compared to those with IPI of less than one year, and no significant difference was seen in infant's neurodevelopmental abnormalities between puerparas with the first delivery and with IPI of less than one year.@*Conclusion@#IPI is associated with neurodevelopmental abnormalities among 6-month-old infants.

11.
Article in Chinese | WPRIM | ID: wpr-910894

ABSTRACT

Objective:To analyze the clinical features of tuberculous peritonitis (TBP).Methods:The clinical data of 252 TBP patients admitted to three hospitals in Wuhu area from January 2014 to June 2020 were retrospectively analyzed, and the clinical characteristics of TBP patients of different genders and ages were compared. SPSS 26.0 software was used to analyze the data.Results:Among 252 TBP patients, 130 were males (51.6%) and 122 were females (48.4%). History of abdominal surgery, abdominal masses, reproductive disorders, genital tuberculosis, and delay in diagnosis were more common in female patients (all P<0.01); while fever, cough/sputum expectoration, intestinal tuberculosis and active tuberculosis were more common in male patients (all P<0.01). The proportion of adenosine deaminase in ascites (ADA) ≥35 U/L, strong positive tuberculin test or T-cell spot test in middle-aged and elderly patients was lower than that in young patients ( P<0.01), but there was no significant difference between different genders. Compared with young patients, middle-aged and elderly patients had a low complete response rate, a high proportion of irregular medications, a high incidence of gastrointestinal reactions, liver damage and overall adverse reactions (all P<0.05). Conclusion:Female patients with TBP have fewer symptoms of systemic tuberculosis and high rate of delay in diagnosis, and are prone to complicated with reproductive tuberculosis. In middle-aged and elderly patients with TBP, the sensitivity of ADA and tuberculosis tests is decreased, and the anti-tuberculosis therapy is less effective. The study indicates that the clinical diagnosis and treatment of TBP should be optimized based on the gender and age of patients.

12.
Article in Chinese | WPRIM | ID: wpr-912586

ABSTRACT

Objective:To summarize the experiences of clinical study project management in Peking University Clinical Research Institute, REDCap (Research Electronic Data Capture) data management system was proposed to improve the follow-up process management.Methods:Current clinical study follow-up process management situation were analyzed and methods for utilizing REDCap in follow-up management was proposed.Results:Using REDCap through " direct management" and " system management" data management can improve the follow-up quality and standard level of management in clinical study, at the same time, secured better protection of participants′ privacy and rights during the process.Conclusions:REDCap plays crucial roles in securing follow-up data quality from the source, timely tracking and standardization of follow-up management, it can be adopted more widely in assisting clinical study follow-up management.

13.
Article in Chinese | WPRIM | ID: wpr-907949

ABSTRACT

Objective:To investigate the clinical characteristics, diagnosis and treatment status, and existing problems of early infantile epileptic encephalopathy type 2 (EIEE2) caused by de novoa mutation of cyclin-dependent kinase-like 5 gene (CDKL5).Methods:The medical history, auxiliary examination and diagnosis and treatment characteristics of 1 case with EIEE2 caused by de novoa mutation of CDKL5 gene in neonatal department of Children′s Hospital of Nanjing Medical University on August 12, 2019 were retrospectively analyzed.Combined with relevant literatures, the clinical diagnosis and treatment ideas and future prospects of this disease were summarized.Results:The patient was a female child with the age of 13 days and 23 hours.The main clinical manifestation was recurrent convulsion which was not alleviated significantly after using antiepileptic drug.The second-generation sequencing detected c. 119C>T/ p. A40V heterozygous mutation of CDKL5 gene, which was de novo mutation.Conclusions:EIEE2 caused by de novoa mutation of CDKL5 gene is a rare disease worthy of attention.Early detection and genetic diagnosis are the key to improve the diagnosis and treatment rate.

14.
Article in Chinese | WPRIM | ID: wpr-933937

ABSTRACT

Objective:To evaluate the reliability and validity of the Chinese version of the Ohkuma questionnaire.Methods:The Ohkuma questionnaire was translated and revised, before it was used to investigate 70 elderly patients. Cronbach′s alpha coefficient, Cohen′s kappa coefficient and Pearson correlation were used to evaluate the scale′s internal reliability, sub-item retest reliability and total score retest reliability. KMO and Bartlett tests were used to evaluate the validity. The correlation between the Chinese version of the Ohkuma questionnaire and ratings from video fluoroscopy before and after treatment was used to evaluate the scale′s discrimination ability.Results:The Cronbach′s alpha of the Chinese version of Ohkuma questionnaire was 0.831, with 0.814 in the initial evaluation and 0.808 in a second evaluation. The Cohen′s kappas of the 15 sub-items ranged from 0.728 to 1.000. The Pearson correlation coefficient of the total score was 0.914. The scale′s KMO value was 0.701. A t-test of the Ohkuma scores before and after treatment showed a statistically significant difference.Conclusion:The revised Chinese Ohkuma questionnaire has good reliability, validity and discriminatory power. It can be used to screen for dysphagia among the elderly.

15.
Article in Chinese | WPRIM | ID: wpr-934412

ABSTRACT

Objective:Proposed suggestions to improve the quality of investigator-initiated trials follow-up management under the normalization of COVID-19.Methods:Analyzed current status and challenges of follow-up management in China investigator initiated trial through a combination of literature review and previous work reflection, in the context of normalization of COVID-19.Results:Follow-up management of investigator initiated trial had shown variations in follow-up contents, methods, personnel and auxiliary tools. The insufficient research funding and lacking of professional clinical research team support have led to the challenges of low follow-up visits, insufficient follow-up personnel, lack of electronic follow-up platforms, and unknown follow-up time windows for investigator-initiated trials, which became more prominent in the context of COVID-19.Conclusions:In order to improve the quality of follow-up management during the normalization of COVID-19, appropriate amendment of the investigator-initiated trials follow up should be carefully considered. For instance, taking into account of the characteristics of the research disease, the main research endpoints, the content of the key indicators of the research key follow-up, follow-up methods, follow-up frequency, and follow-up tools to make sure the scientific validity and feasibility, as well as the mandate of clinical research related laws, regulations and ethical requirement. The possible amendments may include follow content, method, mode, frequency, time window. At the same time, re-consent or sufficient disclosure of information should be carried out with compliance of the updated protocols to assure the quality of clinical research follow up.

16.
Article in Chinese | WPRIM | ID: wpr-864712

ABSTRACT

Objective:To summarize the nursing experience of a puerperal woman with cryptococcal meningitis complicated with intracranial venous sinus thrombosis.Methods:Before the surgery, the patient′s consciousness, pupil, headache and other symptoms of cranial hypertension closely were observed. And the prodromal stage of cerebral hernia was timely detected and the emergency rescue measures if needed was implemented. The cause of intracranial venous sinus thrombosis was analyzed and the risk intervention was carried out. At the same time, the blood potassium concentration was closely monitored, the hypokalemia was effectively controlled, and the anticoagulant observation and nursing was performed. Cooperated with doctors for intracranial venous sinus angiography+ balloon dilatation. The postoperative complications were prevented and patients′ health and psychology was remodeled.Results:The patient recovered well physically and psychologically after the operation.Conclusions:Effective clinical observation, symptom management, risk intervention and prevention of complications can promote patient recovery.

17.
Article in Chinese | WPRIM | ID: wpr-864798

ABSTRACT

Objective:To evaluate the effect of early screening and multidisciplinary management for elderly patients with dysphagia.Methods:All of the elderly patients who were hospitalized during January 2018 to December 2019, were divided into control group ( n=16 273) and intervention group ( n=18 853) according to the order of inpatient. Patients in control group received routine care, and those in intervention group received early screening and multidisciplinary management. The difference of detection, rehabilitation, indwelling, pneumonia and the professional level of nurses were compared between two groups. Results:The positive rate of intervention group was 14.10% (2 659/18 853), which was higher than 10.81% (1 759/16 273) of control group ( χ2 value was 66.11, P<0.01). The rehabilitation rate was increase from 67.08% (1 180/1 759) to 78.68% (2 092/2 659) ( χ2 value was 17.88, P<0.01) . The rate of indwelling nasogastric tube was decreased from 21.49% (378/1 759) to 19.33% (514/2 659) ( χ2 value was 8.52, P<0.01). The incidence of pneumonia was decreased from 10.18% (179/1 759) to 4.25% (113/2 659) ( χ2 value was 37.27, P<0.01). And dysphagia related knowledge ( t value was 7.549, P<0.01) and skills ( t value was 7.413, P<0.01) of the nurses were improved. Conclusion:Implementation of early screening and hierarchical management based on the form of multidisciplinary cooperation for dysphagia in elderly inpatients can enhance the positive outcome of patient and improve dysphagia related knowledge and skills of nurse.

18.
Article in Chinese | WPRIM | ID: wpr-872016

ABSTRACT

Objective To establish the quality control system of the Capital's Funds for Health(CFH),strengthen the process management,and improve the clinical research capacity.Methods The framework,contents and implementation method of the quality control system were developed with comprehensively adopting methodologies of literature analysis,expert discussion,summaries of policy and practice experiences.Results This quality control system of the Capital's Funds for Health is comprised of three tiers.The first tier is self-assessment,the principle investigator takes the responsibility;the second tier is the sponsor verification,the sponsor organization takes the responsibility;the third tier is the independent audit,the CFH office takes the responsibility.The contents of quality control focus on the compliance with ethical approval and informed consent,data authenticity,protocol deviation,progress of project,and quality assurance methods taken during the project implementation.Conclusions This three-tier quality control system of the Capital's Funds for Health provides a new idea and scheme for the quality control of clinical research projects supported by funding agencies in China,and its impacts will be evaluated in next implementation practices.

19.
Chinese Journal of Nephrology ; (12): 247-252, 2019.
Article in Chinese | WPRIM | ID: wpr-745968

ABSTRACT

Objective To assess the influencing factors of interdialysis blood pressure variability (BPV) in maintenance hemodialysis (MHD) patients from Pearl River Delta,and provide clinically useful information for the prevention and treatment of BPV.Methods MHD patients in 10 hemodialysis centers from Pearl River Delta were enrolled and analyzed retrospectively.According to the quartile of interdialysis systolic blood pressure-coefficient of variation (SBP-CV),patients were divided into four groups,and clinical data,biochemical indicators and drug use were compared among 4 groups.Binary logistic regression analysis was used to analyze the associated factors of interdialysis BPV.Results A total of 1010 MHD patients (612 males and 398 females) with the age of (56.3±13.9) years were enrolled in this study.Their dialysis duration was (48.4±36.1) months,and the median of interdialysis SBP-CV was 8.07% (5.72%,11.34%).According to the quartile of SBP-CV,the patients were divided into four groups:low BPV group (SBP-CV≤5.72%,253 cases),middle BPV group (5.72% < SBP-CV≤8.07%,252 cases),high BPV group (8.07% < SBP-CV≤11.34%,253 cases) and extremely high BPV group (SBP-CV > 11.34%,252 cases),and the dialysis duration,diabetes,ultrafiltration,interdialysis weight gain rate (IDWGR),serum calcium and the proportion of calcium channel antagonist used in the 4 groups were significantly different (all P < 0.05).Logistic multiple regression analysis showed that high IDWGR (OR=1.216,95%CI 1.108-1.435,P < 0.001) was an independent risk factors for interdialysis BPV in MHD patients,while high ultrafiltration volume (OR=0.436,95%CI 0.330-0.575,P < 0.001) and calcium channel antagonists used (OR=0.686,95%CI 0.477-0.986,P=0.042) were independent protective factors.Conclusion High IDWGR is an independent risk factor for interdialysis BPV in MHD patients,while high ultrafiltration volume and calcium channel antagonists used are protective factors for interdialysis BPV in MHD patients.

20.
Article in Chinese | WPRIM | ID: wpr-746297

ABSTRACT

Objective The management of medical projects of the National Key Research and Development Program of China is difficult.Thus this article aims to analyze the common problems and summarize the preparatory work before the project initiation.Methods Comprehensively adopted the methodologies of literature analysis,survey investigation to analyze the common problems before the project initiation,and then particularly summarize the preparatory works for biomedical research,especially for clinical research,from the perspective of investigators.Results Proposed several aspects that should take into consideration before the initiation of the projects..clarify the organizational management framework,play the role of kick-off meeting,organize tailored training on financial management,prepare research protocol and related documents,seek Institutional Review Board approval and conduct clinical research registration,normalize document managment,formulate project management plan,and prepare research facilities timely.Conclusions Investigators should develop a detailed project management plan before initiation of the project,preparation work should focus on personnel,financial resources,facilities,research progress,quality,data,etc.

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