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In this study, a novel quality control strategy was proposed, aiming to establish a multivariate specification for the processing step by exploring the correlation between colors, chemical components, and hemostatic effects of the carbonized Typhae pollen (CTP) using multivariate statistical analysis. The CTP samples were stir-fried at different durations. Afterward, the colorimeter and LC-MS techniques were applied to characterize the CTP samples, followed by the determination of bleeding time and clotting time using mice to evaluate their hemostatic effect. Then, principal component analysis, hierarchical cluster analysis, and multi-block partial least squares were used for data analysis on colors, chemical components, and their correlation with the hemostatic effect. Consequently, 13 critical quality attributes (CQAs) of CTP were identified via multivariate statistical analysis-L*, a*, b*, 3,4-dihydroxybenzoic acid, 4-hydroxybenzoic acid, 3-hydroxybenzoic acid, quercetin-3-O-glucoside, azelaic acid, kaempferol-3-O-glucoside, quercetin, naringenin, kaempferol, and isorhamnetin. The multivariate specification method involving the 13 CQAs was developed and visualized in the latent variable space of the partial least squares model, indicating that the proposed method was successfully applied to assess the quality of CTP and the degree of carbonization. Most importantly, this study offers a novel insight into the control of processing for carbonized Chinese herbal medicines.
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Pólen , Controle de Qualidade , Typhaceae , Animais , Pólen/química , Análise Multivariada , Camundongos , Typhaceae/química , Espectrometria de Massas/métodos , Cromatografia Líquida/métodos , Masculino , Medicamentos de Ervas Chinesas/química , Medicamentos de Ervas Chinesas/análise , Espectrometria de Massa com Cromatografia LíquidaRESUMO
Objective:To analyze the risk factors of secondary epileptic seizures in children with febrile seizures and to construct a nomogram prediction model.Methods:A total of 235 children with febrile seizures who were admitted to Enshi State Hospital for Nationalities from August 2018 to September 2021 were selected. According to whether the children had secondary epileptic seizures during the 6-month follow-up, the children were divided into the seizure group (62 cases) and no-seizure group (173 cases). The best cut-off value of each factor were obtained by the receiver operating characteristic (ROC). Multivariate Cox regression analysis was used to analyze the independent risk factors of secondary seizures in children with febrile seizures. The R software "rms" package was constructed to predict secondary seizures in children with febrile seizures. High-risk nomogram models, calibration curves was used for internal validation of nomogram models, and decision curves to assess the predictive power of nomogram models.Results:The age of the patients in the seizure group was lower than that in the no-seizure group: (14.45 ± 1.54) months vs. (21.47 ± 2.18) months; and the proportion of family history of epilepsy, the proportion of perinatal (abnormal), the proportion of seizure type (comprehensive), the proportion of electroencephalogram (EEG) (abnormal), the number of seizures, the duration of seizure, the tumor necrosis factor-alpha (TNF-α) level in the seizure group were higher than those in the no-seizure group: 56.45%(35/62) vs. 35.84%(62/173), 59.68% (37/62) vs. 15.61%(27/173), 70.97%(44/62) vs. 36.99% (64/173), 74.19% (46/62) vs. 20.81% (36/173), (5.45 ± 2.32) times vs. (2.04 ± 1.02) times, (18.89 ± 4.29) min vs. (12.62 ± 2.34) min, (25.65 ± 5.32) ng/L vs.(18.21 ± 2.29) ng/L, there were statistical differences ( P<0.05). The area under the curve (ACU) of age, number of convulsions, duration of convulsion, and TNF-α were 0.906, 0.913, 0.899, and 0.890, respectively; the best cut-off values were 3 years, 4 times, 15 min, 21 ng/L; age (≤3 years), family history of epilepsy (yes), type of seizures (generalized), perinatal period (abnormal), number of seizures (≥4 times), duration of seizures (≥15 min) were febrile seizures independent risk factors for secondary epileptic seizures in children ( P<0.05), the C-index of this nomogram prediction model was 0.744 (0.567-0.932); the decision curve showed that when the risk threshold was greater than 0.11, the clinical net benefit provided by this prediction model. The benefits were all higher than individual independent risk factors and provided a significant additional net clinical benefit in predicting a high risk of seizures secondary to febrile seizures in children with febrile seizures. Conclusions:This study constructed a nomogram model of the risk of secondary seizures in children with febrile seizures based on age, family history of epilepsy, type of seizures, perinatal period, number of seizures, and duration of seizures. Important strategic guidance.
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Ablation of ventricular arrhythmia originating from the epicardial and intramural sites tends to be challenging in clinical practice.As the reflux system of cardiac blood flow,tributaries of the coronary venous system widely covers the surface and the myocardium tissue of the heart,which could serve as alternative access route for auxiliary mapping and ablation.This review updated the research progress on the novel ablation methods via the coronary venous system.
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Objective To explore the protein expression levels of serum neurite outgrowth inhibitor-A(Nogo-A),energy balance related protein(Adropin),zonula occludens-1(ZO-1)and angiopoietin-like protein 4(ANGPTL4)in patients with acute cerebral hemorrhage and their predictive efficacy for prognosis.Methods A total of 148 patients with acute cerebral hemorrhage treated in the hospital from April 2020 to May 2022 were selected as the study group,and another 150 healthy people who came to the hospital for gen-eral physical examination during the same period were selected as the control group,and a retrospective analy-sis was conducted.The protein expression levels of Nogo-A,Adropin,ZO-1 and ANGPTL4 in serum of the two groups were detected by enzyme-linked immunosorbent assay(ELISA)and compared.Spearman correla-tion coefficient was used to analyze the correlation between serum Nogo-A,Adropin,ZO-1,ANGPTL4 protein expression levels and the occurrence of acute cerebral hemorrhage.Receiver operating characteristic(ROC)curve was drawn to analyze the diagnostic efficacy of the combined detection of the above four indicators for a-cute cerebral hemorrhage.In addition,patients in the study group were followed up for 6 months,and were di-vided into good group(91 cases)and poor group(57 cases)according to the prognosis.Serum protein expres-sion levels of Nogo-A,Adropin,ZO-1 and ANGPTL4 were compared between the two groups.ROC curve was used to verify the predictive efficacy of the combined detection for the prognosis of these patients.Results Compared with the control group,the protein expression levels of Nogo-A,ZO-1 and ANGPTL4 in the study group were significantly increased,while the protein expression level of Adropin was significantly decreased(all P<0.05).Spearman correlation coefficient analysis showed that serum Nogo-A,ZO-1,ANGPTL4 pro-tein expression levels were positively correlated with the incidence rate of acute cerebral hemorrhage,while Adropin protein expression level was negatively correlated with the incidence rate of acute cerebral hemor-rhage(all P<0.05).ROC curve verification showed that the combined detection of Nogo-A,Adropin,ZO-1 and ANGPTL4 protein expression levels had high diagnostic efficacy in the evaluation of acute cerebral hemor-rhage,with the sensitivity and the specificity of 92.57%and 90.67%,respectively.Compared with good group,the protein expression levels of Nogo-A,ZO-1 and ANGPTL4 in poor group were significantly higher,while the protein expression level of Adropin was significantly decreased(all P<0.05).ROC curve showed that compared to single detections,the area under the curve of the combined detection of protein expression levels of Nogo-A,Adropin,ZO-1 and ANGPTL4 was larger(P<0.05),with the sensitivity of 84.21%and the specificity of 89.01%.Conclusion The protein expression levels of Nogo-A,Adropin,ZO-1 and AN-GPTL4 are abnormal in patients with acute cerebral hemorrhage,and the protein expression levels of Nogo-A,Adropin,ZO-1 and ANGPTL4 are closely related to the development of acute cerebral hemorrhage.The com-bined detection of the four indicators could not only assist clinical accurate judgment of acute cerebral hemor-rhage,but also have important clinical value in predicting the prognosis of patients.
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Objective To explore the characteristics and diagnostic significance of ultrasound signs in the diagnosis of acute appendicitis in children.Methods This study focused on 81 children with acute appendicitis and divided them into two groups based on pathological examination results:34 children with severe progressive appendicitis(41.98%)and 47 children with simple appendicitis(58.02%).By analyzing the indirect and direct signs of ultrasound detection,as well as pathological examination data,and using ROC curve analysis to analyze the area under the curve(area under curve,AUC)of ultrasound signs combined,a comprehensive analysis is conducted to score the ultrasound examination results of children.Results The detection rates of wall continuity interruption/low-level clarity,intraluminal fluid accumulation,periappendiceal or abdominal fluid accumulation,periappendiceal hyperechogenicity,cecal and ileal wall thickening in the advanced group were higher than those in the simple group(P<0.05);The scores of indirect,direct,and combined ultrasound signs in the progressive group were higher than those in the simple group(P<0.05);Under the ROC curve,the sensitivity,specificity,positive predictive value,and negative predictive value of combined signs were 98.77%,97.53%,98.77%,and 96.30%,respectively,higher than those of indirect signs and direct signs.The AUC was 0.835,higher than those of indirect signs and direct signs(P<0.05).Conclusion The combined diagnosis of ultrasound examination signs can provide objective evidence for the early diagnosis of acute appendicitis in children,and can also achieve dynamic monitoring of the disease,which is conducive to the formulation of clinical treatment plans.
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ObjectiveThe purpose of this study was to investigate the effects of transcutaneous electrical acupoint stimulation (TEAS) on cognitive function of vascular dementia (VD) rats and its mechanism. MethodsVD rat model was established by modified two-vessel occlusion (2-VO). After modeling, TEAS and electroacupuncture (EA) were used to stimulate Baihui and Zusanli points of rats respectively for 14 d. After treatment, novel object recognition test, Morris water maze test, and Y maze test were used to evaluate the spatial memory and learning ability of rats. Hematoxylin and eosin staining was used to observe the morphology of hippocampal neurons. Transmission electron microscopy was used to observe the ultrastructure of hippocampal mitochondria. Enzyme-linked immunosorbent assay kits were used to detected the levels of SOD, CAT, GSH-Px, MDA and ROS in serum of rats. Western blot was used to detect the expression of PGC-1α, TFAM, HO-1, NQO1 proteins in the hippocampus, Keap1 protein in the cytoplasm and Nrf2, NRF1 proteins in the nucleus. ResultsAfter treatment for 14 d, compared to the model group, the escape latency of VD rats decreased, while the discrimination index, the times of rats crossing the original platform area, the residence time in the original platform quadrant, and the percentage of alternation increased. TEAS can improve the structure of hippocampal neurons and mitochondria of VD rats, showing that neurons were arranged more regularly and distributed more evenly, nuclear membrane and nucleoli were clearer, and mitochondrial swelling were reduced, mitochondrial matrix density were increased, and mitochondrial cristae were more obvious. The levels of SOD, GSH-Px and CAT in serum increased significantly, while the concentration of MDA and ROS decreased. TEAS also up-regulated the expression levels of PGC-1α TFAM, NQO1 and HO-1 proteins in the hippocampus and Nrf2, NRF1 proteins in the nucleus, but down-regulated the Keap1 protein in the cytoplasm. ConclusionTEAS can improve cognition, hippocampal neurons and mitochondrial structure of VD rats, and the effect is better than EA. The mechanism may be the activation of PGC-1α mediated mitochondrial biogenesis and antioxidant stress, which also provides a potential therapeutic technology and experimental basis for the treatment of VD.
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Objective To study the application effect of quality control circle(QCC)in reducing the dissatisfaction rate of physical examination clients in health management center.Methods To establish QCC,selected the health check-up popula-tion in our hospital in September-2019 and March-2020,through the questionnaire investigation and analysis,compare the dis-satisfaction of the clients before and after the quality control circle.Results After carrying out QCC activities,the dissatisfaction of physical examination clients was significantly lower than that before QCC,and the difference was statistically significant(P<0.05).Conclusion The activities of QCC in the health management center can effectively improve the quality of the physical examination work and reduce the dissatisfaction of the customers in the physical examination.It is of great significance to the health management.
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Objective To design an assisted patient conveying and vibration damping system to solve the problems of operator fatigue and patient bump during casualty evacuation.Methods The assisted patient conveying and vibration damping system was composed of several conveying straps and a vibration damping mechanism.The conveying straps were made up of a waist strap,two shoulder straps,a chest strap,adhesive straps and joint components,and the joint components included adjusting buckles,big buckles,small buckles,connecting buckles and hook mechanisms;the vibration damping mechanism adopted the technical form of extension handle combined with vibration absorber,in which the extension handle was made of rigid material and the vibration absorber was equipped with a scissor guiding mechanism.Tests were carried out on the system to record the operating time of the operators and to analyze the system's vibration damping characteristics.Results The system developed extended the operating time of the stretcher conveyers while reduced the vibration during casualty transport,with a maximum vibration reduction of 71.73%.Conclusion The system developed gains advantages in low vibration and low workload,and can be used for casualty conveying in poor road conditions.[Chinese Medical Equipment Journal,2024,45(1):15-24]
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Objective:To explore the changes of left ventricular remodeling after artificial chordae implantation and its effect on the recurrence of mitral regurgitation(MR).Methods:Clinical data of 141 patients with severe mitral regurgitation(Carpentier type Ⅱ) repaired by artificial chordae technique in our hospital from January 2010 to December 2019 were retrospectively analyzed. Patients were divided into significant regurgitation group(15 cases) and non- significant regurgitation group(126 cases) according to the presence or absence of moderate regurgitation by follow-up echocardiography. To observe the effect of left ventricular reverse remodeling(LVRR) on the recurrence of MR after artificial chordae implantation and analyze the risk factors.Results:All patients successfully underwent mitral valvuloplasty with artificial chordae. In the early postoperative period(30 days after operation), LVRR appeared in both groups(LVEDD and LVESD were significantly smaller than those before operation, P<0.05); LVRR was further enhanced(LVEDD and LVESD were further reduced, P<0.05) in non- significant regurgitation group at 1 year after operation, but left ventricular remodeling reoccurred in significant regurgitation group at 1 year after operation(LVEDD and LVESD increased compared with the early postoperative period, P<0.05). After 12-132 months’ follow-up, 15 patients had more than moderate MR. In the early postoperative period, 13 patients had more than mild MR, 8 of which evolved to more than moderate MR during follow-up. Cox regression showed that LVEDD≥65 mm( HR=5.573) and more than mild MR in the early postoperative period( HR=8.801) were the risk factors for the recurrence of MR after artificial chordae implantation. Conclusion:LVRR appeared in the early postoperative period, and the degree of LVRR further increased at 1 year after operation, but the patients with significant MR would reappear left ventricular remodeling. Early postoperative LVRR had a bad effect on the recurrence of MR after artificial chordae implantation, while further enhanced LVRR at 1 year after operation had little effect on the recurrence MR.
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Laboratory animals are the foundational conditions and indispensable technical support in life science research and biomedical industry development. The scientific development of animal models of diseases is of great significance to biomedical research and industrial development. In light of the booming development of multiple emerging in vitro modelling technologies over the past decade, in 2022, the U.S. Senate unanimously passed the bill FDA Modernization Act 2.0. This bill rescinded the requirement for animal testing in investigating the safety and effectiveness of a drug—a federal mandate since 1938, and highlighted the potential of various in vitro disease modeling approaches in future biomedical fields. This paper provides a comprehensive review of the latest advances and applications of in vitro disease modeling approaches in academia and industry followed by an interpretation of the FDA bill, namely cell culture, organoid, organ-on-a-chip, 3D bio-printing model and computer-based model. The paper next introduces the crossed applications of various disease models and discusses the advantages and disadvantages of each system, thereby providing insights into future trends in the use of animal disease models in China.
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OBJECTIVE To investigate the types and differences of allergens in patients with allergic rhinitis(AR)in Kashgar,Xinjiang,and to provide a research basis for its treatment and prevention.METHODS A retrospective analysis was conducted on the data of AR patients diagnosed in the First People's Hospital of Kashgar from July 2015 to December 2020.The specific IgE(sIgE)results of peripheral venous blood and the types of allergens were analyzed.The patients were grouped according to gender,ethnicity and age,and the differences in allergens among the groups were further analyzed.RESULTS Among the sIgE test results of 528 AR patients,the highest positive rate was for dust mites(246 cases,46.6%),followed by egg,Alternaria alternata/Aspergillus fumigatus/Cladosporium herbarum and so on.There was a statistically significant difference in the dog epithelium allergen positive rate between males and females(P<0.05),and a statistically significant difference in the positive rate of tomato allergen detection among different age groups,while there was no statistically significant difference in the allergen positive rate among different ethnic groups.CONCLUSION Dust mites,egg,and Alternaria alternata/Aspergillus fumigatus/Cladosporium herbarum are the most common allergens in patients with AR in Kashgar.
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Objective:To explore the value of transapical catheter of mitral valve repair (MVR) with Memoclip device in the management of moderate to severe and severe mitral regurgitation (MR) guided by transesophageal echocardiography (TEE).Methods:Fifteen patients with moderate to severe and severe MR in Hefei High-tech Cardiovascular Hospital from December 2021 to October 2022 were prospectively selected. Mitral valve morphology and length, regurgitation severity, left ventricular ejection fraction and pulmonary venous Doppler spectra were carefully evaluated before MVR by TEE.Intraprocedural TEE was performed to guide the MVR including transseptal catheterization, alignment of the clip delivery system, assessment of leaflet capture, clip deployment, post-clip deployment assessment, and withdrawal of the clip delivery system. The position and coaptation length of the clips, the mitral orifice morphology, residual mitral valve regurgitation and pressure gradient were evaluated after MVR.Meanwhile, the complications were monitored throughout the procedure.Results:Among the 15 patients, 12 were implanted with 1 clip and 3 were implanted with 2 clips, respectively. No complications occurred. There were 13 patients with mild regurgitation and 2 showed to moderate mitral regurgitation 1 month later after MVR, and 13 remained mild and 2 maintained moderate regurgitation 3 months later. Significant differences were found in maximal MR area (MRA-max), maximal and mean mitral valve pressure gradient (MVPG-max, MVPG-mean) and mitral valve area (MVA) among the 5 observation time points (all P<0.05). MRA-max, MVA and MVPG-mean were significantly decreased immediately and 3 months after the procedure ( P<0.001). No significant stenosis was found in mitral valve after MVR. Conclusions:MVR with Memoclip is safe, effective, easy to operate in treating patients with moderate to severe and severe MR. TEE plays a key role in perioperative MVR with Memoclip through apical catheterization.
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Objective:To evaluate the efficacy and safety of Osimertinib in the second-line and above treatment of elderly patients with advanced lung adenocarcinoma with epidermal grouth factor receptor(EGFR)mutation.Methods:A retrospective analysis of 51 elderly patients with advanced lung adenocarcinoma aged 65 years and over was performed.EGFR gene mutations were detected at baseline.The patients were treated with Osimertinib as second or later-line treatment after disease progression on prior epidermal growth factor receptor tyrosine kinase inhibitor(EGFR-TKI)therapy.Results:The median age of the patients was 72 years old, and the median progression-free survival(PFS)with Osimertinib was 13 months(95% CI: 10.8-15.2 months). Patients with exon 19 deletion(19del)treated with Osimertinib had longer PFS than patients with EGFR 21 exon L858R mutation(12 vs.24 month, P=0.028). In patients with EGFR resistance mutation T790M(T790M-positive), the PFS of patients with 19del combined with T790M(19del / T790M-positive)was better than that of patients with L858R combined with T790M(L858R / T790M-positive)(10 vs.28 months, P=0.029). After Osimertinib treatment, 43.8% of patients had brain or meningeal progression.The most commonly used agents for treatment after resistance to Osimertinib are antiangiogenic drugs.The common adverse reactions of Osimertinib were diarrhea(31.4 %), followed by dry skin with itching(29.4%)and rash(25.5 %). Most adverse reactions were grade 1 to 2, and one patient discontinued the drug intermittently due to grade 3 hematological adverse reactions. Conclusions:Osimertinib is effective and well tolerated in elderly patients with advanced EGFR-mutant lung adenocarcinoma.
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@#Objective To investigate the left ventricular reverse remodeling (LVRR) in patients with aortic valve insufficiency with reduced ejection fraction (AIrEF) and aortic valve insufficiency with preserved ejection fraction (AIpEF) after transcatheter aortic valve replacement (TAVR). Methods The clinical and follow-up data of patients who underwent TAVR in the Department of Cardiothoracic Surgery, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine from 2018 to 2021 were retrospectively analyzed. According to the guideline, the patients with left ventricular ejection fraction<55% were allocated to an AIrEF group, and the patients with left ventricular ejection fraction≥55% were allocated to an AIpEF group. Results A total of 50 patients were enrolled. There were 19 patients in the AIrEF group, including 15 males and 4 females with a mean age of 74.5±7.1 years. There were 31 patients in the AIpEF group, including 19 males and 12 females with a mean age of 72.0±4.8 years. All patients underwent TAVR successfully. Echocardiographic results showed that TAVR significantly promoted LVRR in the patients. Significant LVRR occurred in the early postoperative period (the first day after the surgery) in both groups. It remained relatively stable after the LVRR in the early postoperative period (the first day after surgery) in the AIpEF patients, while it continued to occur in the early postoperative period (the first day after surgery) to three months after the surgery in the AIrEF patients, and then remained relatively stable. Compared to preoperative values, AIrEF patients had a reduction in the average left ventricular end-diastolic volume index and left ventricular end-systolic volume index by 16.8 mL/m2 (P=0.003) and 8.6 mL/m2 (P=0.005), respectively, and the average left ventricular end-diastolic diameter index and end-systolic diameter index decreased by 2.5 mm/m2 (P=0.003) and 1.9 mm/m2 (P=0.003), respectively on the first day after the surgery. In comparison to the first day after the surgery, AIrEF patients experienced an average increase of 12.1% in the left ventricular ejection fraction three months after the surgery (P<0.001). Conclusion TAVR has achieved good therapeutic effects in patients with aortic valve insufficiency, significantly promoting the LVRR in patients, and has better curative effects in AIrEF patients.
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Objective:To investigate the surgical efficacy and prognosis influencing factors of hilar cholangiocarcinoma based on multidisciplinary diagnosis and treatment.Methods:The retrospective cohort study was conducted. The clinicopathological data of 91 patients with hilar cholangiocarcinoma who underwent surgery in Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School from April 2004 to April 2021 were collected. There were 59 males and 32 females, aged (61±10)years. Patients who were admitted from April 2004 to March 2014 underwent traditional surgical diagnosis and treatment, and patients who were admitted from April 2014 to April 2021 underwent multidisciplinary diagnosis and treatment. Observation indica-tors: (1) surgical situations; (2) postoperative situations; (3) postoperative pathological examina-tions; (4) postoperative prognosis analysis; (5) influencing factors of postoperative prognosis. Follow-up was conducted using telephone interview and outpatient examination. Patients were followed up once every 6 months after surgery to detect survival. The follow-up was up to April 2023. Measure-ment 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 ordinal data was conducted using the rank sum test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher exact probability. The Kaplan-Meier method was used to draw survival curve and calculate survival rate. The Log-Rank test was used for survival analysis. Univariate and multivariate analyses were conducted using the COX proportional hazard model. Results:(1) Surgical situations. Of the 91 patients, there were 65 cases receiving hemi- or expanded hemi-hepatectomy, 13 cases receiving tri-hepatectomy, 9 cases receiving partial hepatectomy, 4 cases receiving extrahepatic bile duct resection. There were 24 cases receiving combined vein resection and reconstruction, 8 cases receiving combined pancreaticoduodenectomy, 6 cases receiving com-bined hepatic artery resection and reconstruction, including 24 cases receiving extended radical surgery (tri-hepatectomy, hepatic artery resection and reconstruction, hepatopancreaticoduodenec-tomy). The operation time, volume of intraoperative blood loss and intraoperative blood transfusion rate of 91 patients was (590±124)minutes, 800(range, 500?1 200)mL and 75.8%(69/91), respectively. Of the 91 patients, cases receiving extended radical surgery, the volume of intraoperative blood loss were 4, 650(range, 300?1 000)mL in the 31 patients who were admitted from April 2004 to March 2014, versus 20, 875 (range, 500?1 375)mL in the 60 patients who were admitted from April 2014 to April 2021, showing significant differences between them ( χ2=4.39, Z=0.31, P<0.05). (2) Post-operative situations. The postoperative duration of hospital stay and cases with postoperative infectious complications were (27±17)days and 50 in the 91 patients. Cases with abdominal infection, cases with infection of incision, cases with bacteremia and cases with pulmonary infection were 43, 7, 5, 8 in the 91 patients. One patient might have multiple infectious complications. Cases with bile leakage, cases with delayed gastric emptying, cases with chylous leakage, cases with liver failure, cases with pancreatic fistula, cases with intraperitoneal hemorrhage, cases with reoperation, cases dead during the postoperative 90 days were 30, 9, 9, 6, 5, 3, 6, 3 in the 91 patients. Cases with abdominal infection was 10 in the 31 patients who were admitted from April 2004 to March 2014, versus 33 in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( χ2=4.24, P<0.05). Cases dead during the postoperative 90 days was 3 in the 31 patients who were admitted from April 2004 to March 2014, versus 0 in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( P<0.05). (3) Post-operative pathological examinations. Of the 91 patients, cases with Bismuth type as type Ⅰ?Ⅱ, type Ⅲ, type Ⅳ, cases with T staging as Tis stage, T1 stage, T2a?2b stage, T3 stage, T4 stage, cases with N staging as N0 stage, N1 stage, N2 stage, cases with M staging as M0 stage, M1 stage, cases with TNM staging as 0 stage, Ⅰ stage, Ⅱ stage, Ⅲ stage, ⅣA stage, ⅣB stage, cases with R 0 radical resection, cases with R 1 or R 2 resection were 15, 46, 30, 1, 9, 25, 30, 26, 49, 36, 6, 85, 6, 1, 7, 13, 58, 6, 6, 63, 28. Cases with R 0 radical resection, cases with R 1 or R 2 resection were 15, 16 in the 31 patients who were admitted from April 2004 to March 2014, versus 48, 12 in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( χ2=9.59, P<0.05). (4) Postoperative prognosis analysis. Of the 91 patients, 3 cases who died within 90 days after surgery were excluded, and the 5-year overall survival rate and median overall survival time of the rest of 88 cases were 44.7% and 55 months. The 5-year overall survival rate was 33.5% in the 28 patients who were admitted from April 2004 to March 2014, versus 50.4% in the 60 patients who were admitted from April 2014 to April 2021, showing a significant difference between them ( χ2=5.31, P<0.05). Results of further analysis showed that the corresponding 5-year overall survival rate of cases without lymph node metastasis was 43.8% in the 16 patients who were admitted from April 2004 to March 2014, versus 61.6% in the 31 patients who were admitted from April 2014 to April 2021. There was a significant difference in the 5-year overall survival rate between these patients without lymph node metastasis ( χ2=3.98, P<0.05). The corresponding 5-year overall survival rate of cases with lymph node metastasis was 18.5% in the 12 patients who were admitted from April 2004 to March 2014, versus 37.7% in the 29 patients who were admitted from April 2014 to April 2021. There was no significant difference in the 5-year overall survival rate between these patients with lymph node metastasis ( χ2=2.25, P>0.05). (5) Influencing factors of postoperative prognosis. Results of multivariate analysis showed that poorly differentiated tumor and R 1 or R 2 resection were inde-pendent risk factors influencing prognosis after surgical treatment of hilar cholangiocarcinoma ( hazard ratio=2.62, 2.71, 95% confidence interval as 1.30?5.29, 1.30?5.69, P<0.05). Conclusions:Compared with traditional surgical diagnosis and treatment, treatment of hilar cholangiocarcinoma based on multidisciplinary diagnosis and treatment can expand surgical indications, reduce proportion of dead patients within 90 days after surgery, improve proportation of radical resection and long-term survival rate. Poorly differentiated tumor and R 1 or R 2 resection are independent risk factors influencing prognosis after surgical treatment of hilar cholangiocarcinoma.
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Objective:To investigate the clinical efficacy of radical resection of pancreatic cancer after neoadjuvant conversion therapy.Methods:The retrospective and descriptive study was conducted. The clinicopathological data of 23 patients who underwent radical resection of pancreatic cancer after neoadjuvant conversion therapy in Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School from January 2019 to May 2022 were collected. There were 17 males and 6 females, aged 58(range, 33-73)years. After neoadjuvant conversion therapy, the three-dimensional (3D) visualization was used to evaluate and classify tumor vascular invasion, and surgical plan was planned and implemented. Observation indicators: (1) situations of neoadjuvant conversion therapy; (2) surgical situations; (3) postoperative histopathological examination; (4) postoperative recovery; (5) follow-up. Measurement data with normal distribution were represen-ted as Mean± SD, and measurement data with skewed distribution were represented as M(range) or M( Q1, Q3). Count data were described as absolute numbers. Results:(1) Situations of neoadjuvant conversion therapy. All 23 patients received the AG combination chemotherapy (albumin-paclitaxel+gemcitabine), including 14 patients combined with stereotactic body radiation therapy. Of the 23 patients, 22 cases achieved partial response, and 1 case showed stable disease. The CA19-9 of the 23 patients was 85.06(29.74,634.5)U/mL and 13.96(9.74,25.02)U/mL before and after neoadjuvant conversion therapy, respectively. (2) Surgical situations. According to the results of preoperative 3D visualization of tumor vascular invasion, 7 of the 23 patients were evaluated as arterial invasion, 8 cases were evaluated as venous invasion, 5 cases were evaluated as arterial and venous invasion, and there were 3 cases showing negative of vascular invasion. Of the 23 patients, 12 cases underwent pancreaticoduodenectomy, 4 cases underwent radical antegrade modular pancreatosplenectomy, 7 cases underwent total pancreaticoduodenectomy. For vascular reconstruction, there were 10 patients without vascular reconstruction, and there were 13 patients undergoing artificial vascular vein reconstruction. The operation time and volume of intraoperative blood loss of the 23 patients was (524±171)minutes and 1 000(400,1 600)mL, respectively. (3) Postoperative histopathological exami-nation. Results of postoperative histopathological examination in 23 patients showed that there were 2 cases with moderate-well differentiated tumor, 10 cases with moderate differentiated tumor, 7 cases with moderate-poorly differentiated tumor, 2 cases with poorly differentiated tumor, and 2 cases negative of tumor. The number of lymph node dissected in 23 patients was 16±7. There were 5 cases with lymph node metastasis and 18 cases without lymph node metastasis. There were 17 cases with nerve invasion and 6 cases without nerve invasion. All 23 patients were negative of vascular invasion. Of the 23 patients, there were 21 cases with R 0 resection and 2 cases with R 1 resection. For pathological TNM staging, there were 2 cases with 0 stage, 13 cases with Ⅰ stage, 7 cases with Ⅱ stage, and 1 case with Ⅳ stage. For postoperative pathological scoring, there were 2 cases achieved 0 point (complete pathological remission), 16 cases achieved 2 points (partial remission), and 5 cases achieved 3 points (no significant effect). (4) Postoperative recovery. The postoperative duration of hospital stay of 23 patients was 19(14,31)days. There were 17 of 23 patients underwent postoperative complications, including 11 cases with Clavien-Dindo Ⅱ stage complications, 3 cases with Clavien-Dindo Ⅲa stage complications, 1 case with Clavien-Dindo Ⅲb stage complication, 1 case with Clavien-Dindo Ⅳ stage complication, and 1 case with Clavien-Dindo Ⅴ stage complica-tion. (5) Follow-up. There were 22 patients underwent follow-up, with follow-up time as 12(9,23)months. There were 9 patients underwent postoperative recurrence and metastasis, with recurrence and metastasis time as 7.8(range, 6.0-12.0)months. During the follow-up, 15 of the 22 patients survived. Conclusion:Radical resection of pancreatic cancer after neoadjuvant conversion therapy is feasible.
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The human use experience of traditional Chinese medicine(TCM) is of great significance for the development of new traditional Chinese medicine. In 2023, the National Medical Products Administration(NMPA) issued the Special Regulations on Registration Management of Traditional Chinese Medicine, which explicitly encouraged the conduct of high-quality human use experience research on TCM clinical practice to obtain sufficient evidence for registration support. It also required that human use experience research should comply with relevant requirements and undergo registration verification. The quality of human use experience research on TCM directly determines the reliability of the evidence. This article discussed the quality requirements for human use experience research on TCM from the perspectives of basic requirements, organizational management, key pharmaceutical information, scientific research, risk management, ethical compliance, and study implementation and proposed differential treatment in quality requirements and registration verification focus based on different research purposes, stages, and types of studies. While ensuring the authenticity of data, retrospective studies should pay particular attention to the integrity of the data, and prospective studies should focus on the normativity of the data, which may affect the research conclusions. Human use experience research, as part of drug registration materials, falls within the scope of relevant regulatory oversight. Researchers should have a strong awareness of regulations to avoid serious quality issues. The standardized conduct of human use experience research on TCM requires joint efforts from regulatory authorities, applicants, research institutions, and researchers to establish a research quality management system based on the clinical characteristics of TCM.
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Humanos , Medicina Tradicional Chinesa , Estudos Prospectivos , Reprodutibilidade dos Testes , Estudos Retrospectivos , Preparações Farmacêuticas , Medicamentos de Ervas Chinesas/uso terapêuticoRESUMO
Evidence-based medicine plays an important role in promoting the scientific nature of clinical decision-making. Howe-ver, there is a problem where evidence derived from clinical research may not necessarily be applicable to individual patients. Evidence-based medicine has been introduced into the field of traditional Chinese medicine(TCM) for over 20 years, and although certain achievements have been made, the overall level of clinical research evidence based on the principles of evidence-based medicine in TCM is not high. The acceptance of TCM diagnosis and treatment guidelines developed based on evidence-based medicine methods is generally low. As revealed by the analysis of the problems in the application of evidence-based medicine in the field of TCM, it is found that there is a structural contradiction between clinical randomized controlled trial(RCT) of TCM and the characteristics of TCM clinical practice. They cannot comprehensively, objectively, and truthfully reflect the clinical efficacy and safety of TCM. Conducting clinical RCTs of TCM in pursuit of "evidence" actually means giving up the advantages of TCM in clinical treatment based on syndrome differentiation, prescription changes along with syndromes, and treatment in accordance with three categories of disease cause, which leads to sacrificing some clinical effectiveness of TCM. Based on the concept of evidence-based medicine, this article proposed the construction of "clinical syndrome-based medicine" based on the optimal clinical experience, which was suitable for the characteristics of TCM clinical practice. The key to clinical syndrome-based medicine is the optimal clinical experience, and the core elements of the optimal clinical experience are regularity and reproducibility. Real-world research methods are recommended as a reference for obtaining the optimal clinical experience. Clinical syndrome-based medicine, combining the characteristics of TCM clinical practice and incorporating the concept of evidence-based medicine, is the product of integrating TCM into evidence-based medicine. It is dedicated to improving the clinical efficacy of TCM along with evidence-based medicine.
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Humanos , Reprodutibilidade dos Testes , Medicina Tradicional Chinesa , Resultado do Tratamento , Medicina Baseada em Evidências , Síndrome , Medicamentos de Ervas Chinesas/uso terapêuticoRESUMO
Esfenvalerate is a kind of commonly used highly effective pyrethroid insecticide. It is common for people who are poisoned by contact or misuse, but rarely reported for people who are poisoned by intramuscular injection. This paper reports a case of intramuscular injection of esfenvalerate in the Department of Infection, West China Hospital of Sichuan University in November 2021. The patient was intramuscularly injected with about 20 ml of esfenvalerate, inducing the sense of swelling and tingling, degeneration and necrosis of striated muscle tissue at the injection site, also liver function damage and other manifestations. The patient was discharged from hospital after rehydration, accelerating poison metabolism, anti-infection, liver protection and local puncture.
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Humanos , Inseticidas , Injeções Intramusculares , Piretrinas , Nitrilas/metabolismoRESUMO
【Objective】 To analyze the causes of the failure of previous operations in female patients with stress urinary incontinence (SUI), and to evaluate the efficacy and safety of modified transobturator outside-in tape (TOT). 【Methods】 A total of 42 female SUI patients who had failed in previous anti-incontinence surgery during Aug.2016 and Jul.2022 were enrolled. The causes of failure were analyzed. All patients were treated with modified TOT, and the operation time, estimated blood loss, duration of catheterization, symptom improvement and complications were observed. The outcomes were evaluated with the International Consultation on Incontinence Questionnaire Short Form (ICI-Q-SF), pad test and urodynamic study. 【Results】 All operations were technically successful. The average operation time was (32.4±18.6) min, and estimated blood loss was (54.2±34.5) mL. There were no obvious complications. After operation, the ICI-Q-SF score significantly decreased (P0.05). The overall effective rate was 88.1%. 【Conclusion】 Modified TOT can be used for the treatment of patients with failed anti-SUI surgery, which is simple and easy to perform, with a low complication rate and satisfactory postoperative results.