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This paper reports a pair of siblings with congenital short-bowel syndrome (CSBS) complicated with intestinal malrotation. Case 1 was born with a birth weight of 2 550 g and a length of 48 cm. On September 10, 2017, emergency Ladd's procedure and appendectomy were performed on the infant 23 days after birth due to intestinal obstruction at the Women and Children's Hospital, School of Medicine, Xiamen University. The small intestine of the infant had a total length of 65 cm. Postoperative enteral and parenteral nutrition supports were provided for six months. Whole exome sequencing revealed a homozygous variant (NM 024769; nucleotide deletion in the exon 3-5) in the CLMP gene (chr11:122953792-122955421), with the parents being the heterozygous carriers but without phenotype. Case 2, the younger sibling of Case 1, was born in the same hospital on March 20, 2020, with a birth weight of 2 932 g and a body length of 49 cm. Prenatal single-gene sequencing on the amniotic fluid identified the same gene variation as his sister's. The baby boy received Ladd's procedure and appendectomy on the second day after birth which found the length of his small intestine was 51 cm. Full enteral nutrition was achieved six months after the operation. Both cases were followed up for 12 months. The body weight and length of Case 1 were both below the first percentile (< P1). The body weight of Case 2 was 8.03 kg ( P3- P5) and the length was 76.0 cm ( P25- P50).
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[Objective]To summarize Professor MA Lili's academic thoughts on treating chronic urticaria based on the spleen theory,providing references for clinical practice.[Methods]Through collecting and recording outpatient medical records,sorting out Professor MA's experience of treating chronic urticaria based on the spleen theory,summarizing the etiology and pathogenesis of the disease and the rule of prescription,and taking a medical case to prove it.[Results]Professor MA believes that the core pathogenesis of chronic urticaria is spleen deficiency and pathogenic invasion of human body.The chronic urticaria belongs to deficiency in origin and excess in superficislity,and the main inducement is spleen deficiency leading to disharmony between Ying-Qi and Wei-Qi,stagnation of dampness,stagnation of liver Qi.In treatment,Professor MA uses the methods of tonifying and transporting to invigorate the spleen,such as harmonizing Ying-Qi and Wei-Qi,clearing dampness by transporting the spleen,and regulating the liver Qi by tonifying the spleen.At the same time,she will use different treatments for different patients,individualized treatment is her unique experience.In this case,the patient was diagnosed as spleen deficiency and stagnation of dampness based on the patient's old age and recurrent rash.The treatment method was to remove dampness by transporting the spleen,eliminating the pathogenic factors and relieving itching,and paid attention to the deficiency in the later stage.This medication was flexible according to the change of the condition,with significant curative effect.[Conclusion]Professor MA treats chronic urticaria with a diagnosis and treatment philosophy centered around the spleen,therefore the experience derived is worthy of reference and promotion.
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From January 23, 2020 to May 29, 2021, there were 17,550 clinical research registrations on the China Clinical Trial Registry Platform. The index of clinical research on COVID-19 showed 840 registrations, accounting for 4.79% (840/17 550) of the total registrations. According to the trend chart of epidemic development, 487 clinical research projects of COVID-19 registered from January 23, 2020 to March 18, 2020 were set as the early stage of epidemic discovery in the region, the following 15 months were divided into stable initial stage, stable later stage and the later stage of the first wave of domestic epidemic every five months. The proportion of COVID-19 research projects registered in each stage was 29.80%, 5.87%, 0.76% and 1.15% of all registered projects respectively. The registration ratios of COVID-19 in each clinical stage was 57.98%, 28.81%, 5.95% and 7.26% respectively. Intervention studies were 61.60% (300/487) in the early stage of the epidemic, and most of them were in biological agent and drug therapy, which were 40.49%, 50.00% and 73.77% respectively in the later stages. Stable initial stage biological agent projects decreased. Then the vaccine research program became a focused research program. Among the 58 registration projects involving vaccines, 25 were clinical trials of vaccines in different stages, with the major research units being biopharmaceutical companies. Of the 487 clinical studies registered in the early stage, 10.23%(50/487) were withdrawn, of which 38 were intervention treatment studies, most notably drug studies (17) and blood biological products (16), but they were still registered in the stable initial stage. It is necessary to reflect on the scientific and ethical nature of early COVID-19 clinical trials or research, including whether the three core values of equal respect, help to alleviate pain and fairness can be achieved. Whether the "ethics review meeting should pay special attention to the scientificity, safety, fairness, subject protection, informed consent documents and informed consent process, avoidance of conflicts of interest, etc. of clinical trials or research" has been implemented. Competent government departments at all levels and all clinical medical research institutions should organize evaluation, and then establish an effective evaluation mechanism when new clinical trials or research projects are registered in the future.
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Objective:To study the risk factors and clinical outcomes of early pulmonary hypertension in preterm infants with gestational age(GA)≤32 w.Methods:From October 2017 to May 2021,preterm infants with GA≤ 32 w admitted to NICU of our hospital were retrospectively studied. According to their echocardiography 2 w after birth, the infants were assigned into early-onset pulmonary hypertension (ePH) group and non-PH group. SPSS 21.0 statistical software was used to analyze the general status, complications and clinical outcomes of the two groups. Multiple logistic regression was used to analyze the risk factors of early-onset PH.Results:A total of 183 cases were enrolled, including 24 in the ePH group and 159 in the non-PH group. The incidences of birth asphyxia, hemodynamically significant patent ductus arteriosus (hsPDA), FiO 2≥30% within 6 h after birth, late-onset PH, severe bronchopulmonary dysplasia(BPD) and intracranial hemorrhage(ICH) in the ePH group were significantly higher than the non-PH group( P<0.05). hsPDA was the independent risk factor for early-onset PH ( OR=11.781, 95% CI 4.192-33.108). Conclusions:Preterm infants with GA≤32 w and early-onset PH are at increased risks of ICH, late-onset PH and severe BPD, hsPDA is the independent risk factor for early-onset PH.
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Objective:To investigate the application effect of paper review combined with situational exercise in the standardized training and teaching of ophthalmology nurses.Methods:A total of 39 ophthalmology nurses who received standardized training from September 2019 to July 2020 were selected as control group, and 42 ophthalmology nurses who received standardized training from September 2020 to July 2021 were selected as study group. The nurses in the control group received traditional teaching, and those in the study group received teaching with paper review and situational exercise. The two groups were compared in terms of the scores of theoretical knowledge and operation skills, comprehensive qualities (autonomous learning ability, independent analysis and problem-solving ability, nurse-patient communication ability, organization and coordination ability, and comprehensive first aid ability) before and after teaching, and the degree of satisfaction with teaching. SPSS 26.0 was used to perform the independent samples t-test, the paired t-test, the chi-square test, and the rank sum test. Results:After standardized training, compared with the control group, the study group had significantly higher scores of theoretical knowledge (93.29±1.82 vs. 90.36±1.51, P<0.05) and operation skills (95.14±1.34 vs. 92.62±1.26, P<0.05). After standardized training, both groups had significant increases in the scores of autonomous learning ability, independent analysis and problem-solving ability, nurse-patient communication ability, organization and coordination ability, and comprehensive first aid ability, and the study group had significantly higher scores of these comprehensive qualities than the control group ( P<0.05). There was a significant difference in the distribution of the degree of satisfaction with teaching between the two groups ( P<0.05), and the study group had a significantly higher degree of satisfaction than the control group. Conclusion:Paper review combined with situational exercise can improve the specialized theoretical knowledge, technical operational level, and comprehensive qualities of ophthalmology nurses receiving standardized training and enhance the degree of satisfaction with teaching.
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Objective:To analyze the prognosis of glucose metabolism and its impacting factors at 6-12 weeks postpartum in patients with abnormal blood glucose during pregnancy.Methods:In this cross-sectional study, a total of 192 patients with abnormal blood glucose during pregnancy enrolled and delivered in the maternity clinic of Daxing Teaching Hospital of Capital Medical University from December 1, 2019 to December 31, 2020 were collected. The 75 g oral glucose tolerance test (OGTT) was applied for diabetes screening at 6-12 weeks after delivery. According to the results of postpartum blood glucose, the patients were divided into two groups: postpartum normal blood glucose group (148 cases) and abnormal blood glucose group (44 cases). Hypothesis testing was used to compare the clinical data before, during and after the pregnancy between the two groups. Multi-factor logistic regression was performed to analyze the influencing factors of postpartum abnormal blood glucose in patients with abnormal blood glucose during pregnancy.Results:Among the 192 patients with abnormal blood glucose during pregnancy, the incidence of postpartum abnormal blood glucose was 22.92% (44/192), including 6 cases of diabetes mellitus (DM) (13.64%), 38 cases of impaired glucose tolerance (IGT) (86.36%). Neck circumference, waist circumference, multiparous women and insulin use during pregnancy in postpartum abnormal blood glucose group were all significantly higher than those in postpartum normal blood glucose group [34.25(33.00, 36.00) vs 33.55 (32.00, 35.00) cm, 87.00 (82.00, 93.00) vs 84.00 (78.00, 90.00) cm, 54.55% vs 37.16%, 18.18% vs 6.76%] (all P<0.05). Neck circumference ( OR=1.315, 95% CI: 1.026-1.685), multiparous women ( OR=2.261, 95% CI: 1.057-4.836), insulin use during pregnancy ( OR=3.767, 95% CI: 1.236-11.478) were positively correlated with the occurrence of postpartum abnormal blood glucose (all P<0.05). Conclusions:The incidence of postpartum abnormal blood glucose is high at 6-12 weeks postpartum in patients with abnormal blood glucose during pregnancy. Neck circumference, waist circumference, parity and insulin use during pregnancy are important impacting factors of postpartum abnormal blood glucose.
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BACKGROUND@#Rheumatoid arthritis (RA), a chronic systemic autoimmune disease, is characterized by synovitis and progressive damage to the bone and cartilage of the joints, leading to disability and reduced quality of life. This study was a randomized clinical trial comparing the outcomes between withdrawal and dose reduction of tofacitinib in patients with RA who achieved sustained disease control.@*METHODS@#The study was designed as a multicenter, open-label, randomized controlled trial. Eligible patients who were taking tofacitinib (5 mg twice daily) and had achieved sustained RA remission or low disease activity (disease activity score in 28 joints [DAS28] ≤3.2) for at least 3 months were enrolled at six centers in Shanghai, China. Patients were randomly assigned (1:1:1) to one of three treatment groups: continuation of tofacitinib (5 mg twice daily); reduction in tofacitinib dose (5 mg daily); and withdrawal of tofacitinib. Efficacy and safety were assessed up to 6 months.@*RESULTS@#Overall, 122 eligible patients were enrolled, with 41 in the continuation group, 42 in the dose-reduction group, and 39 in the withdrawal group. After 6 months, the percentage of patients with a DAS28-erythrocyte sedimentation rate (ESR) of <3.2 was significantly lower in the withdrawal group than that in the reduction and continuation groups (20.5%, 64.3%, and 95.1%, respectively; P < 0.0001 for both comparisons). The average flare-free time was 5.8 months for the continuation group, 4.7 months for the dose reduction group, and 2.4 months for the withdrawal group.@*CONCLUSION@#Withdrawal of tofacitinib in patients with RA with stable disease control resulted in a rapid and significant loss of efficacy, while standard or reduced doses of tofacitinib maintained a favorable state.@*TRIAL REGISTRATION@#Chictr.org, ChiCTR2000039799.
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Humans , Quality of Life , China , Arthritis, Rheumatoid/drug therapy , Piperidines/therapeutic use , Treatment Outcome , Antirheumatic Agents/therapeutic use , Pyrroles/therapeutic useABSTRACT
Objective:To construct a combined radiomics model based on preoperative enhanced computed tomography (CT) examination for predicting microvascular invasion (MVI) in hepatocellular carcinoma (HCC), and provide biological explanations for the radiomics model.Methods:The retrospective cohort study was conducted. The messenger RNA (mRNA) of 424 HCC patients, the clinicopathological data of 39 HCC patients entered into the Cancer Genome Atlas database from its establishment until January 2023, and the clinicopathological data of 53 HCC patients who were admitted to the Gansu Provincial People′s Hospital from January 2020 to January 2023 were collected. The 92 HCC patients were randomly divided into a training dataset of 64 cases and a test dataset of 28 cases with a ratio of 7∶3 based on a random number table method. The CT images of patients in the arterial phase and portal venous phase as well as the corresponding clinical data were analyzed. The 3Dslicer software (version 5.0.3) was used to register the CT images in the arterial phase and portal venous phase and delineate the three-dimensional regions of interest. The original images were preprocessed and the corresponding features were extracted by the open-source software FAE (version 0.5.5). After selecting features using the Least Absolute Shrinkage and Selection Operator, the radiomics model was constructed and the radiomics score (R-score) was calculated. The nomogram was constructed by integrating clinical parameters, imaging features and R-score based on Logistic regression. The gene modules related to radiomics model were obtained and subjected to enrichment analysis by conducting weighted gene co-expression network analysis and correlation analysis. Observation indicators: (1) comparison of clinical characteristics of patients with different MVI properties; (2) establishment of MVI risk model; (3) evaluation of MVI risk model; (4) clustering of gene modules; (5) functional enrichment of feature-correlated gene modules. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the independent sample t test. Measurement data with skewed distribution were represented as M(range), and comparison between groups was conducted using the Mann-Whitney U test. Comparison of count data was conducted using the chi-square test. The intra-/inter-class correlation coefficient (ICC) was used to assess the inter-observer consistency of radiomics feature extracted by different observers. ICC >0.75 indicated a good consistency in feature extraction. The Logistic regression model was used for univariate and multivariate analyses. The receiver operating characteristic curve was drawn, and the area under curve (AUC), the decision curve and the calibration curve were used to evaluate the diagnostic efficacy and clinical practicality of the model. Results:(1) Comparison of clinical characteristics of patients with different MVI properties. Of 92 HCC patients, there were 47 cases with MVI-positive and 45 cases with MVI-negative, and there were significant differences in hepatitis, tumor diameter, peritumoral enhancement, intratumoral arteries, pseudocapsule and smoothness of tumor margin between them ( χ2=5.308, 9.977, 47.370, 32.368, 21.105, 31.711, P<0.05). (2) Establishment of MVI risk model. A total of 1 781 features were extrac-ted from arterial and portal venous phases of the intratumoral and peritumoral regions. After feature dimension reduction, 8 radiomics features were selected from arterial and portal venous phases to construct the combined model. Results of multivariate analysis showed that peritumoral enhancement, intratumoral arteries, pseudocapsule, smoothness of tumor margins, and R-score were independent risk factors for MVI in patients with HCC [ hazard ratio=0.049, 0.017, 0.017, 0.021, 2.539, 95% confidence interval ( CI) as 0.005-0.446, 0.001-0.435, 0.001-0.518, 0.001-0.473, 1.220-5.283, P<0.05]. A nomogram model was constructed incorporating peritumoral enhancement, intratumoral arteries, pseudocapsule, smoothness of tumor margins, and R-score. (3) Evaluation of the MVI risk model. The AUC of radiomics model was 0.923 (95% CI as 0.887-0.944) and 0.918 (95% CI as 0.894-0.945) in the training dataset and test dataset, respectively. The AUC of nomogram model, incorpora-ting both the R-score and radiomics features, was 0.973 (95% CI as 0.954-0.988) and 0.962 (95% CI as 0.942-0.987) in the training dataset and test dataset, respectively. Results of decision curve showed that the nomogram had better clinical utility compared to the R-score. Results of calibration curve showed good consistency between the actual observed outcomes and the nomogram or the R-score. (4) Clustering of gene module. Results of weighted gene co-expression network analysis showed that 8 gene modules were obtained. (5) Functional enrichment of feature-related gene modules. Results of correlation analysis showed 4 gene modules were significantly associated with radiomics features. The radiomics features predicting of MVI may be related to pathways such as the cell cycle, neutrophil extracellular trap formation, and PPAR signaling pathway. Conclusions:The combined radiomics model based on preoperative enhanced CT imaging can predict the MVI status of HCC. By obtaining mRNA gene expression profiles associated with radiomics features, a biological interpretation of the radiomics model is provided.
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To evaluate the clinical value of a new method of guide wire extraction and single reverse-α fixation with short nasobiliary duct for oronasal conversion and fixation, patients who underwent endoscopic nasobiliary drainage in Shanghai East Hospital, Tongji University from January to August 2022 were selected. They were randomly divided into guide wire extraction and single reverse-α fixation with short nasobiliary duct group (the observation group, n=145) and guide wire taking and reverse-α fixation group (the control group, n=71). The operation time, one-time operation success rate, adverse events, comfort and satisfaction between the two groups were compared. The operation time in the observation group was significantly shorter than that in the control group [102 ( 91, 117) s VS 136 (127, 145) s, Z=-9.639, P<0.001]. The one-time operation success rate in the observation group was significantly higher than that in the control group [88.28% (128/145) VS 67.61% (48/71), χ2=13.496], the nasopharynx stimulation score [1 (1, 2) VS 2 (1, 2), Z=-4.457] and adverse events incidence [4.14% (6/145) VS 15.49% (11/71), χ2=8.475] in the observation group were significantly lower than those in the control group ( P<0.05). During the indwelling of nasobiliary duct, the bile drainage volume (179.45±81.54 mL VS 142.89±55.69 mL, t=3.407) and nursing satisfaction score (7.72±0.99 VS 6.06±1.07, t=11.337) in the observation group were higher than those in the control group, and the comfort score (3.00±1.01 VS 4.83±0.99, t=-12.642) and incidence of adverse events [3.45% (5/145) VS 14.08% (10/71), χ2=8.344] in the observation group were lower than those in the control group ( P<0.05). The operation time of nasobiliary duct removal in the observation group was significantly shorter than that in the control group (9.00±1.14 s VS 11.93±1.36 s, t=-16.616, P<0.001). In conclusion, the guide wire extraction and single reverse-α fixation with short nasobiliary duct for nasobiliary oronasal conversion and fixation in endoscopic nasobiliary drainage has the advantages of simple operation, small irritation response and low complication incidence, which is worth of clinical promotion.
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Objective:To investigate the dignity status of lymphoma patients during perichemotherapy, and to analyze the influencing factors.Methods:The convenience sampling method was used to investigate 230 lymphoma patients during perichemotherapy in Affiliated Tumor Hospital of Xinjiang Medical University from August 2020 to February 2021 by using general data questionnaire and patient dignity scale. Dual logistic regression was used to analyze the influencing factors of dignity.Results:The dignity score of patients with malignant lymphoma during perichemotherapy was 42.1±16.8, and 30.0% (69/230) patients had obvious dignity impairment. Among 5 dimensions of patient dignity, the scores of physical and mental pain, self-cognition, social role function independence and social support were 1.8±0.8, 1.8±0.9, 1.7±0.9, 1.6±0.7 and 1.2±0.5, respectively. Each patient had an average of 4.1 dignity problems, and five items with the highest score were worrying about their future (physical and mental pain dimension) [(2.1±1.1) scores, 50.4% (116/230)], feeling uncomfortable (physical and mental pain dimension) [(2.0±1.1) scores, 56.5% (130/230)], feeling a burden to others (self-perception dimension) [(2.0±1.1) scores, 33.5% (77/230)], feeling depressed (physical and mental pain dimension) [(1.9±1.0) scores, 53.5% (123/230)], feeling like a different person (self-perception dimension) [(1.9±1.1) scores, 49.1% (113/230)]. Logistic regression analysis showed that widowed (compared with unmarried: OR = 2.108, 95% CI 1.562-3.570), barely affordable and difficult to afford (compared with fully affordable: OR = 2.163, 4.307, respectively; 95% CI 1.120-7.469, 1.374-12.807), disease acceptance and negative (compared with positive: OR = 2.003, 3.694, respectively; 95% CI 1.358-6.599, 1.221-9.061), Eastern Cooperative Oncology Group (ECOG) score 2-4 (compared with score 0: OR = 3.753, 4.720, 5.044, respectively; 95% CI 1.352-9.506, 1.514-12.793, 2.221-15.539), patients with B symptom (compared with those without B symptom: OR = 1.962, 95% CI 1.100-3.501), patients with severe chemotherapy reaction (compared with those without severe chemotherapy reaction: OR = 4.814, 95% CI 2.714-8.539) were independent risk factors for obvious dignity loss of patients during perichemotherapy (all P < 0.05), and married was an independent protective factor compared with unmarried ( OR = 0.192, 95% CI 0.036-0.807, P < 0.05). Conclusion:Patients with lymphoma have impaired dignity during perichemotherapy. Medical staff should pay attention to the influencing factors of impaired dignity and develop targeted intervention programs to reduce the impaired dignity of patients.
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Objective:To study the effects of different sizes of maternal placental chorionic hemangioma (PCH) on neonatal clinical outcome.Methods:February 2013 to December 2020, neonates whose mothers with PCH delivered in our hospital were retrospectively analyzed. According to the diameter of PCH, the neonates were assigned into giant PCH group (diameter≥4 cm) and ordinary PCH group (diameter<4 cm). Clinical characteristics and outcomes were compared between the two groups.Results:A total of 35 cases were enrolled in the study. 13 cases (37.1%) were male, 12 cases (34.3%) were Cesarean section delivered, 11 cases (31.4%) were premature infants, 12 cases (34.3%) had low birth weight and 12 cases (34.3%) were admitted to NICU, 7 cases (20.0%) had intrauterine distress, cardiac enlargement and abnormal hematological indexes, respectively, 6 cases (17.1%) needed respiratory support; 5 cases (14.2%) had increased amniotic fluid and fetal edema, respectively, 4 cases (11.4%) received blood transfusion, 3 cases (8.5%) had postnatal asphyxia, 2 cases (5.7%) had brain injury and 2 cases (5.7%) had congenital malformation. 15 cases were in the giant PCH group and 20 cases in the ordinary PCH group. Compared with the ordinary PCH group, the giant PCH group had significantly higher incidences of prematurity, low birth weight, increased amniotic fluid, intrauterine distress, NICU hospitalization, fetal edema, cardiac enlargement, respiratory support, abnormal hematological indexes, blood transfusion and mortality ( P<0.05). Conclusions:Maternal complications with giant PCH may significantly increase the risk of neonatal complications, thus perinatal monitoring should be strengthened.【 Key words】Placental chorionic hemangioma; Infant, newborn; Clinical outcome
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Objective:This study aimed to evaluate the rebleeding risk and prognosis of patients being treated after acute esophageal varices bleeding by two different treatment strategies: sclerosing agent combined with tissue glue injection, esophageal varices ligation (EVL), through comparing the therapeutic effects and securities.Methods:A total of 76 patients who underwent endoscopy and received treatment in Zhongshan Hospital Affiliated to Fudan University due to acute esophageal variceal bleeding were included retrospectively. 6 patients with active bleeding and 70 patients with thrombus in esophagus varices under gastroscopy. Among them, 21 cases were treated with sclerosing agent combined with tissue glue injection (sclerosing tissue glue group), and 55 cases were treated with EVL (EVL group). The emergency endoscopic diagnosis and treatment of the two groups were compared, and the risk factors of rebleeding 6 months after endoscopic treatment were analyzed by univariate and multivariate analysis.Results:All patients received endoscopic treatment successfully. During the follow-up period of 6 months after endoscopic treatment, rebleeding occurred in 13 cases. Kaplan Meier analysis showed that the 6-month rebleeding rate in the sclerosing tissue glue group was significantly higher than that in the EVL group (41.6% vs 12.3%, P=0.011). There were 8 deaths in total. Kaplan Meier analysis showed that there was no significant difference in 6-month mortality between the two groups (17.5% vs 10.1%, P=0.616). Multivariate analysis further showed that malignant tumor ( HR=3.700, 95% CI: 1.187-11.536, P=0.024) and treatment mode of esophageal variceal bleeding ( HR=4.834, 95% CI: 1.443-16.193, P=0.011) were independent risk factors for rebleeding 6 months after endoscopic treatment of acute esophageal variceal bleeding. Conclusions:This study found that EVL and the combining injection of lauromacrogol and cyanoacrylate could be used in emergent hemostatic treatment for acute esophageal varices bleeding. Moreover, EVL is the prioritized approach in endoscopic emergency treatment with a lower rebleeding rate and fewer complications. Sclerotherapy combined with tissue glue can be used as one of the measures of emergency treatment, which is not better than ligation.
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Takayasu′s arteritis (TAK) mainly involves the aorta and its major branches, which is characterized as a chronic, progressive and inflammatory disease. China belongs to one of the regions with a high prevalence of TAK referring to its global distribution. However, it is insufficient for the spread and update of standardized diagnosis and treatment of TAK. Based on the evidence and guidelines from China and other countries, Chinese Rheumatology Association developed the standardized diagnosis and treatment of TAK in China. The purpose is to standardize the methods for diagnosis of TAK, assessment of disease activity and disease severity, strategies of internal treatment and timing of surgical intervention, and further leading to protect the function of important organs and improve the disease prognosis.
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Objective:To investigate the safety and efficacy of endoscopic ultrasound-guided coil embolization for gastric varices.Methods:Patients with portal hypertension who received endoscopic ultrasound-guided coil embolization for the prophylaxis of gastric variceal bleeding between November 2016 and August 2020 at Zhongshan Hospital, Fudan University were included in the study. The primary evaluation index was the post-operative loss of blood flow in gastric varices, and the secondary indices included the safety of coil embolization, rebleeding rate, portal vein thrombosis changes and patient survival.Results:A total of 13 patients with isolated gastric varices and portal systemic shunt were enrolled, including 6 males and 7 females with the median age of 58 years. The median maximum diameter of the target vessel was 40 mm and the median number of coils used was 2.7. All puncture sites were in the lower part of the esophagus near the cardia, and no active bleeding occurred after deployment of coils. Flow in the gastric varices were confirmed absent by Doppler imaging. In a median follow-up period of 403 days, 2 patients had rebleeding, with the one-year rebleeding rate of 9.1%.Two patients developed portal venous thrombosis after the operation. Two patients died, and the one-year survival rate was 90.0%.Conclusion:Endoscopic ultrasound-guided coil embolization might be an effective option for the treatment of isolated gastric varices with portal systemic shunts.
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Objective:Taking into account of the current situation that domestic laws and regulations of medical technology ethics review are not perfect, we put forward practical suggestions on ethical review supervision of the clinical application of new medical technologies from the perspective of standardization.Methods:Referring to the relevant laws, regulations and specific implementation guidelines of ethical review of clinical research, combined with the practical experience of the ethics committee of the host Hospital, this paper systematically summarizes the concept and characteristics and existing problems of new clinical applied medical technology, optimizes the working steps of technology access and ethical review, and establishes an ethical continuing review model.Results:A series of measurements are proposed, which including formulate the access process, improve the management system, optimize ethical review methods, etc. At the same time, pay more attention to the annual continuing review, adverse event report review, suspension/termination of approved research, closure report review, as well as site visit to improve the initiative and efficiency of ethical review. At last, it ensures the continuing of ethical review.Conclusions:It is very important to regulate new medical technology project entry and ethical review supervision in the practice. On one hand, it can effectively make up for the possible shortcomings of current laws and regulations and promote the introduction of new regulatory requirement. On the other hand, it can effectively reduce the medical technology risks and build good medical quality management, improve the system to better safeguard people′s health rights and interests.
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From January 23, 2020 to May 29, 2021, there were 17,550 clinical research registrations on the China Clinical Trial Registry Platform. The index of clinical research on COVID-19 showed 840 registrations, accounting for 4.79% (840/17 550) of the total registrations. According to the trend chart of epidemic development, 487 clinical research projects of COVID-19 registered from January 23, 2020 to March 18, 2020 were set as the early stage of epidemic discovery in the region, the following 15 months were divided into stable initial stage, stable later stage and the later stage of the first wave of domestic epidemic every five months. The proportion of COVID-19 research projects registered in each stage was 29.80%, 5.87%, 0.76% and 1.15% of all registered projects respectively. The registration ratios of COVID-19 in each clinical stage was 57.98%, 28.81%, 5.95% and 7.26% respectively. Intervention studies were 61.60% (300/487) in the early stage of the epidemic, and most of them were in biological agent and drug therapy, which were 40.49%, 50.00% and 73.77% respectively in the later stages. Stable initial stage biological agent projects decreased. Then the vaccine research program became a focused research program. Among the 58 registration projects involving vaccines, 25 were clinical trials of vaccines in different stages, with the major research units being biopharmaceutical companies. Of the 487 clinical studies registered in the early stage, 10.23%(50/487) were withdrawn, of which 38 were intervention treatment studies, most notably drug studies (17) and blood biological products (16), but they were still registered in the stable initial stage. It is necessary to reflect on the scientific and ethical nature of early COVID-19 clinical trials or research, including whether the three core values of equal respect, help to alleviate pain and fairness can be achieved. Whether the "ethics review meeting should pay special attention to the scientificity, safety, fairness, subject protection, informed consent documents and informed consent process, avoidance of conflicts of interest, etc. of clinical trials or research" has been implemented. Competent government departments at all levels and all clinical medical research institutions should organize evaluation, and then establish an effective evaluation mechanism when new clinical trials or research projects are registered in the future.
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Objective:To speculate the effect of birth spacing on the pelvic floor type Ⅰ and Ⅱ fiber muscle strength of postpartum women with parities of two in different delivery modes.Methods:Totally 2 361 parturients who were investigated in Xuzhou Central Hospital from June 2016 to December 2020 were included in the questionnaire, clinical examination and pelvic floor surface electromyography assessment. According to the interval years between two parities and the pelvic floor typeⅠ and Ⅱ fiber muscle strength under different modes of delivery, curve fitting function equation was performed using curve regression method. The accuracy of the equation was verified by the receiver operating characteristic curve and the maximum area under the curve, and calculating the relative error rate.Results:A total of 2 357 parturients were included in the study and were divided into 4 groups based on delivery modes, women with both normal vaginal delivery were assigned to group A (589 cases); women with a first vaginal delivery and a second cesarean section were assigned to group B (480 cases); women with both cesarean deliveries were assigned to group C (1 273 cases); women with a first cesarean section and a second vaginal delivery were assigned to group D (15 cases). All of the curve fitting results were quadratic curves, and the appropriate interval years were selected when the muscle strength of type Ⅰ muscle fibers was>35 μV and that of type Ⅱ muscle fibers was>40 μV: 6-8 years in the group A, 5-10 years in the group B, and 1-11 years in the group C. The peak values of the quadratic curve were as follows: 7-8 years in the group A, 7-8 years in the group B, and 6 years in the group C. The maximum area under the curve of the function equations were all>0.6 (all P<0.05), the average relative error rate was 4.909%. Conclusions:The pelvic floor function of postpartum women with parities of two increases firstly and then decreases over time, showing a quadratic curve shape. In order to protect the pelvic floor function, the appropriate interval of birth spacing is 6-8 years.
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Objective:To analyze the characteristics of patients with Takayasu arteritis (TA) in the east China Takayasu arteritis (ECTA) cohort and their subgroups, and evaluate the disease characteristics.Methods:Patients diagnosed with TA in ECTA cohort from January 2009 to October 2019 were enrolled and their data were analyzed. The characteristics were analyzed and compared within subgroups using t-test or Wilcoxon rank sum test or Chi-square test. Results:A total of 454 patients were included, with the male to female ratio of 1∶4.75(79/375), and the main complaint were dizziness/headache, fatigue, and chest tightness/pain. The type Ⅴ and Ⅰ were the most common angiographic pattern, among which the subclavian artery and carotid artery were most vulnerable, manifested as vascular stenosis. Hypertension, tuberculosis and hepatitis B were common complications. In subgroup comparison, symptoms and inflammation index were much more evident in the active group, female group, <40 years old, and newly diagnosed group. C-reactive protein (CRP)[10(2, 33) mg/L vs 3(1, 14) mg/L, Z=-4.49, P<0.01), erythrocyte sedimentation rate (ESR) [(45±33) mm/1 h vs (25±23) mm/1 h, t=-5.82, P<0.01), in the active group were significantly higher than those in the inactive group, while the ESR in female patients was only higher than that in males, but without statistical significant difference. SAA in the young age group, ESR in the newly diagnosed group was significantly higher than that in the other subgroups [19(6, 95) mg/L vs 10(4, 39) mg/L, Z=2.06, P<0.05] [(44±34) mm/1 h vs (32±28) mm/1 h, t=3.77, P<0.01]. Conclusion:The TA patients are mainly young women, and are in active disease when first being diagnosed. The type Ⅴ and Ⅰ are the most common artery involve-ment pattern. Hypertension and tuberculosis are the most frequent complications.
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Objective:To compare the diagnostic efficacy of Chinese diagnostic model, the 1990 American College of Rheumatology (ACR) classification criteria and the 2018 ACR new classification criteria (draft) for Takayasu arteritis (TA).Methods:A total of 196 TA patients who came to our hospital from January 1, 2009 to May 31, 2019 in the TA database of the department of rheumatology and immunology, Zhongshan Hospital, Fudan University and 131 patients with other vascular diseases visited during the same period were selected. General characteristics, clinical data, laboratory tests and imaging tests of all patients were collected. Categorical variables were presented as numbers and percentages, between-group differences were analyzed using the χ2 test. Continuous variables were presented as the Mean± SD for a normal distribution or median and interquartile range (IQR) for a non-normal distribution. Between-group differences were analyzed using the Student's t-test or Mann- Whitney test, as appropriate. The sensitivity, specificity, positive predictive value, negative predictive value, accuracy and receiver operating characteristics of the above diagnostic/classification criteria area under the curve were analyzed. P<0.05 was considered significant. Results:In terms of sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and area under receiver operating characteristic curve (ROC), Chinese diagnostic models was 85.7%, 96.2%, 89.9%, 97.1%, 81.5%, 0.909, 1990 ACR criteria was 47.4%, 97.7%, 67.6%, 96.9%, 55.4%, 0.726, 2018 ACR classification criteria was 79.1%, 98.5%, 86.5%, 98.7%, 75.9%, 0.888. The difference between the Chinese diagnostic model and the 2018 ACR criteria in AUC was not statistically significant ( Z=1.186 , P>0.05). The sensitivity, accuracy and diagnostic efficiency of Chinese diagnostic model was the best, that of the 1990 ACR classification criteria was the worst, and the specificity of the 2018 ACR classification criteria was the highest. The Kappa value of the 2018 ACR classification criteria and the Chinese diagnostic model was 0.719, which had good consistency, and the Kappa value of the consistency between the 1990 ACR classification criteria and the Chinese TA diagnostic model was 0.516. Conclusion:The Chinese diagnostic model, which is based on the clinical characteristics of the Chinese TA population, has a good diagnostic efficacy for the Chinese population. The 2018 ACR classification criteria (draft) is highly consistent with the Chinese TA diagnostic model, and can be promoted and applied in practice.
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Objective:To investigate the effects of nutritional intake in the first two weeks of life on bronchopulmonary dysplasia (BPD) in preterm infants with gestational age (GA) ≤ 32 weeks.Methods:A retrospective case-control study was conducted 154 preterm infants with birth weight ≤ 1500 g and GA ≤ 32 weeks were enrolled from neonatal intensive care unit (NICU) of Affiliated Hospital of Qingdao University between January 1, 2016 and December 31, 2017. These infants were divided into BPD group or non-BPD group. All clinical and nutritional data were collected and analyzed to investigate the effects of early-life (within 2 weeks after birth) nutritional intake on BPD.Results:Among a total of 154 eligible neonates, 68 were without BPD and 86 with BPD (55.8%). Mild, moderate and severe BPD accounted for 39.5% (34/86), 58.1%(50/86)and 2.4%(2/86)of all BPD cases respectively. GA and birth-weight of BPD group were significantly lower than that of non-BPD group [(28.35 ± 1.55)weeks vs. (30.12 ± 1.23)weeks; (1050.91 ± 190.6)g vs. (1205.88 ± 195.83)g, both P = 0.000]. The duration of mechanical ventilation in BPD group was longer than that in non-BPD group [(2.65 ± 1.08)days vs. (0.47 ± 0.12)days, P < 0.05]. The incidences of complications in BPD group, including neonatal asphyxia, sepsis and patent ductus arteriosus, were all higher than those in non-BPD group( P < 0.05). The fluids and caloric intake, enteral fluids and caloric intake were significantly lower in BPD group on Day 7 and 14 of life ( P < 0.05). The macronutrient intake in BPD group was also consistently lower, reaching statistical significance for carbohydrate intake on Day 7 and 14 of life, and for protein and lipid intake on Day 14 of life ( P < 0.05). Multivariate logistic regression analysis showed that mechanical ventilation ( OR = 2.257, 95% CI: 1.143~4.456, P = 0.019) and GA ( OR = 0.325, 95% CI: 0.215~0.49, P = 0.000) were high-risk factors for BPD. The decreased odds of developing BPD were associated with higher levels of enteral calories on Day 14 of life ( OR = 0.96, 95% CI: 0.94~0.98, P = 0.000), fluids on Day 7 of life ( OR = 0.927, 95% CI: 0.876~0.981, P = 0.009) and protein intake on Day 14 of life ( OR = 0.044, 95% CI: 0.011~0.177, P = 0.000). Conclusions:GA and mechanical ventilation were independent high-risk factors for BPD. Higher intake of protein and enteral calories were protective factors. Proactive early enteral nutrition support, adequate protein intake and decreasing the duration of mechanical ventilation may reduce the risk of BPD.