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2.
Braz. j. otorhinolaryngol. (Impr.) ; 89(2): 271-278, March-Apr. 2023. tab, graf
Article in English | LILACS-Express | LILACS | ID: biblio-1439720

ABSTRACT

Abstract Objective: Bilateral Vocal Fold Paralysis (BVFP) is a rare but significant resource of respiratory distress in neonates and infants. The objective of this study was to evaluate the efficacy and functional outcomes of Endoscopic Percutaneous Suture Lateralization (EPSL) for the treatment of BVFP in neonates and infants. Methods: A case series study of nine patients undergoing EPSL for BVFP between January 2019 and June 2021 was conducted. All patients were candidates for tracheostomy prior to EPSL. Demographic features including gender, age at diagnosis and surgery, main symptoms, airway comorbidities, airway support, and etiology were collected preoperatively. Patients were evaluated for breathing, swallowing and phonation postoperatively. Surgical success was defined as the ability to avoid tracheostomy. Functional Endoscopic Evaluation of Swallowing (FEES) was conducted to identify aspiration. Voice evaluation was based on clinical observation. Results: Nine patients underwent ten EPSL procedures (one in the left vocal fold, and nine in the right vocal fold). Eight patients (8/9) were able to successfully avoid tracheostomy and feed orally without aspiration after the procedure. One patient experienced clinical improvement in respiratory support requirements and underwent laparoscopic nissen and gastrostomy tube placement. At the last follow-up, two patients regained normal voice, two patients had mild dysphonia, and five patients had moderate dysphonia. Five patients showed partial return of the contralateral vocal fold function. Conclusion: EPSL is an effective and safe treatment for neonatal and infantal BVFP, which enables patients free from tracheostomy without significant impact on swallowing function or phonation. Level of evidence: Level 4.

3.
Chinese Journal of Preventive Medicine ; (12): 641-648, 2023.
Article in Chinese | WPRIM | ID: wpr-985456

ABSTRACT

Objective: To investigate the association of mixed exposure to greenness and nitrogen dioxide(NO2) and hypertension among the older adults aged 65 years and over in China. Methods: The study subjects were from the Chinese Longitudinal Healthy Longevity Survey from 2017 to 2018. A total of 15 423 older adults aged 65 years and over meeting the criteria were finally included in the study. A questionnaire survey was used to collect information on demographic characteristics, lifestyle habits and self-reported prevalence of hypertension. Blood pressure values were obtained through physical examination. The level of normalized difference vegetation index(NDVI) was measured by the Medium-resolution Imaging Spectral Radiator(MODIS) of the National Aeronautics and Space Administration(NASA). The concentration of NO2 was from China's surface air pollutant data set. Meteorological data was from NASA MERRA-2. The exposure to NDVI and NO2 for each study subject was calculated based on the area within a 1 km radius around their residence. The association between mixed exposure of NDVI and NO2 as well as their interaction and hypertension in older adults was analyzed by using the multivariate logistic regression model. The restrictive cubic spline(RCS) function was used to explore the exposure-response relationship between greenness and NO2 and the risk of hypertension in study subjects. Results: The mean age of 15 423 older adults were (85.6±11.6). Women accounted for 56.3%(8 685/15 423) and 55.6%(8 578/15 423) lived in urban areas. The mean time of residence was (60.9±28.5) years. 59.8% of participants were with hypertension. The mean NDVI level was 0.41±0.13, and the mean NO2 concentration was (32.18±10.36) μg/cm3. The results of multivariate logistic regression analysis showed that NDVI was inversely and linearly associated with the hypertension in older adults, with the OR(95%CI) value of 0.959(0.928-0.992). Compared with the T1 group of NDVI, the risk of hypertension was lower in the T3 group, with the OR(95%CI) value of 0.852(0.769-0.944), and the trend test was statistically significant(P<0.05). Compared with the T1 group of NO2, the risk of hypertension was higher in the T2 and T3 groups, with OR(95%CI) values of 1.160(1.055-1.275) and 1.244(1.111-1.393), and the trend test was statistically significant (P<0.05). The result of the RCS showed that NDVI was inversely and linearly associated with hypertension in older adults. NO2 was nonlinearly associated with hypertension in older adults. The interaction analysis showed that NDVI and NO2 had a negative multiplicative interaction on the risk of hypertension, with OR(95%CI) value of 0.995(0.992-0.997). Conclusion: Exposure to greenness and NO2 are associated with hypertension in older adults.


Subject(s)
Aged , Humans , Female , Nitrogen Dioxide , Air Pollution , Prevalence , Hypertension/epidemiology , China/epidemiology , Particulate Matter/analysis
4.
China Journal of Chinese Materia Medica ; (24): 811-822, 2023.
Article in Chinese | WPRIM | ID: wpr-970551

ABSTRACT

Children's fever is often accompanied by food accumulation. Traditional Chinese medicine believes that removing food stagnation while clearing heat of children can effectively avoid heat damage. To systematically evaluate the efficacy of Xiaoer Chiqiao Qingre Granules(XRCQ) in clearing heat and removing food accumulation and explore its potential mechanism, this study combined suckling SD rats fed with high-sugar and high-fat diet with injection of carrageenan to induce rat model of fever and food accumulation. This study provided references for the study on the pharmacodynamics and mechanism of XRCQ. The results showed that XRCQ effectively reduced the rectal temperature of suckling rats, improved the inflammatory environment such as the content of interleukin-1β(IL-1β), interleukin-2(IL-2), interferon-γ(IFN-γ), white blood cells, and monocytes. XRCQ also effectively repaired intestinal injury and enhanced intestinal propulsion function. According to the confirmation of its efficacy of clearing heat, the thermolytic mechanism of XRCQ was further explored by non-targeted and targeted metabolomics methods based on LTQ-Orbitrap MS/MS and UPLC-QQQ-MS/MS. Non-target metabolomics analysis of brain tissue samples was performed by QI software combined with SIMCA-P software, and 22 endogenous metabolites that could be significantly regulated were screened out. MetaboAnalyst pathway enrichment results showed that the intervention mechanism was mainly focused on tyrosine metabolism, tricarboxylic acid cycle, inositol phosphate metabolism, and other pathways. At the same time, the results of targeted metabolomics of brain tissue samples showed that XRCQ changed the vitality of digestive system, and inhibited abnormal energy metabolism and inflammatory response, playing a role in clearing heat and removing food stagnation from multiple levels.


Subject(s)
Animals , Rats , Rats, Sprague-Dawley , Hot Temperature , Tandem Mass Spectrometry , Metabolomics , Food , Fever , Interferon-gamma
5.
Chinese Journal of Preventive Medicine ; (12): 86-92, 2023.
Article in Chinese | WPRIM | ID: wpr-969890

ABSTRACT

Objective: To examine the association of greenness exposure with waist circumference (WC) and central obesity in older adults in China. Methods: Based on the cross-sectional data from the Chinese Longitudinal Healthy Longevity Survey in 2017-2018, 14 056 participants aged 65 years and over were included. Demographic characteristics, lifestyle, WC, and other information were collected through a questionnaire and physical examination. Based on the satellite monitoring data of moderate-resolution imaging spectroradiometer (MODIS) provided by NASA, the annual mean of normalized difference vegetation index (NDVI) within a radius of 1 000 meters was obtained as the measurement value of greenness exposure. Multivariate linear regression model, multivariate logistic regression model, and restricted cubic splines (RCS) model were used to analyze the association and dose-response relationship between greenness exposure and WC and central obesity in older adults in China. Results: A total of 14 056 participants were enrolled with a median age of 84.0 years [IQR: 75.0-94.0 years]. About 45.0% (6 330) of them were male and 48.6% (5 853) were illiterate. There were 10 964 (78.0%) participants from rural. The mean of WC was (84.4±10.8) cm. Central obesity accounted for 60.2% (8 465), and the NDVI range was (-0.06, 0.78). After adjusting for confounding factors, the multivariate linear regression model showed that the change value of WC in the urban group [β (95%CI):-0.49 (-0.93, -0.06)] was smaller than that in the rural [-0.78 (-0.98, -0.58)] for every 0.1 unit increase in NDVI (Pinteraction=0.022). Compared with the Q1 group in NDVI, WC of Q2 and Q3 groups in rural decreased, and the β (95%CI) values were-1.74 (-2.5, -0.98) and-2.78 (-3.55, -2.00), respectively. The multivariate logistic regression model showed that after adjusting for confounding factors, the risk of central obesity decreased for urban and rural older adults with an increase of 0.1 unit in NDVI, and the OR (95%CI) values were 0.87 (0.80, 0.95) and 0.86 (0.82, 0.89), respectively (Pinteraction=0.284). Compared with the Q1 group in NDVI, the risk of central obesity in the Q2 and Q3 groups in rural was lower, and the OR (95%CI) values were 0.68 (0.58, 0.80) and 0.57 (0.49, 0.68), respectively. The results of the multivariate regression model with RCS showed that there was a non-linear association of NDVI with WC (Pnonlinear=0.006) and central obesity (Pnonlinear=0.025). Conclusion: Greenness exposure is negatively associated with WC and central obesity in older adults in China.

6.
China Journal of Orthopaedics and Traumatology ; (12): 440-444, 2023.
Article in Chinese | WPRIM | ID: wpr-981712

ABSTRACT

OBJECTIVE@#To compare the clinical efficacy of micro steel plate and Kirschner needle oblique and transverse internal fixation of adjacent metacarpal bone in the treatment of metacarpal diaphyseal oblique fracture.@*METHODS@#Fifty-nine patients with metacarpal diaphyseal oblique fractures admitted between January 2018 and September 2021 were selected as the study subjects and divided into the observation group (29 cases) and the control group (30 cases) based on different internal fixation methods. The observation group was treated with Kirschner wire oblique and transverse internal fixation of adjacent metacarpal bones, while the control group was treated with micro steel plate internal fixation. Postoperative complications, operation time, incision length, fracture healing time, treatment cost, and metacarpophalangeal function were compared between the two groups.@*RESULTS@#No incision or Kirschner wire infections occurred in the 59 patients, except for one in the observation group. No fixation loosening, rupture, or loss of fracture reduction occurred in any of the patients. The operation time and incision length in the observation group were (20.5±4.2) min and (1.6±0.2) cm, respectively, which were significantly shorter than those in the control group (30.8±5.6) min and (4.3±0.8) cm (P<0.05). The treatment cost and fracture healing time in the observation group were (3 804.5±300.8) yuan and (7.2±1.1) weeks, respectively, which were significantly lower than those in the control group (9 906.9±860.6) yuan and (9.3±1.7) weeks (P<0.05). The excellent and good rate of metacarpophalangeal joint function in the observation group was significantly higher than that in the control group at 1, 2, and 3 months after operation (P<0.05), but there was no significant difference between the two groups at 6 months after operation (P>0.05).@*CONCLUSION@#Micro steel plate internal fixation and Kirschner wire oblique and transverse internal fixation of adjacent metacarpal bones are both viable surgical methods for treating metacarpal diaphyseal oblique fractures. However, the latter has the advantages of causing less surgical trauma, shorter operation time, better fracture healing, lower cost of fixation materials, and no need for secondary incision and removal of internal fixation.


Subject(s)
Humans , Metacarpal Bones/injuries , Fractures, Bone/surgery , Fracture Fixation, Internal/methods , Bone Wires , Bone Plates , Treatment Outcome
7.
Journal of Sun Yat-sen University(Medical Sciences) ; (6): 150-158, 2023.
Article in Chinese | WPRIM | ID: wpr-961842

ABSTRACT

ObjectiveTo further study the pathogenic role of different types of Chlamydia trachomatis (CT) proteins in tubal factor infertility, evaluate the clinical detection value of Chlamydia trachomatis protein antibody in predicting tubal factor infertility. MethodsA total of 58 cases of tubal factor infertility (TFI), 41 cases of fertile controls (FC) and 18 cases of infertile controls (IFC) were included. For serum detection, first, CT-IgG ELISA kit was used to detect the expression of CT-IgG in serum of three groups of people; then, 6 kinds of Chlamydia trachomatis proteins were expressed and purified in the early stage to establish the antibody test for these proteins, and ELISA detection method was used to detect the expression of their antibodies in the serum of TFI group, FC group and IFC group, respectively; and finally, the antibody OD value of the 6 kinds of Chlamydia trachomatis proteins in the three groups of subjects were statistically described, and CT-IgG was used as the reference standard to draw the receiver operating characteristic curve (ROC curve) of each CT antibody. The Youden Index determines the cutoff value for each antibody. Taking TFI as the reference class, two disordered multiple classification logistic regression models were established with the FC and IFC groups, respectively; and the reference class was used to explore the value of various antibodies and age in predicting TFI, FC and IFC of Chlamydia trachomatis. The back-off method was used to screen the variables. ResultsThe OD value of CT376 antibody in the TFI group was higher than that in the FC group (0.86 vs. 0.60, P=0.026). The CT376 antibody OD value in the TFI group was higher than that in the IFC group (0.86 vs. 0.64, P=0.026). The CT443 antibody OD value in the IFC group was higher than that in the TFI group (0.59 vs. 0.34, P=0.036) and higher than that in the FC group (0.59 vs. 0.30, P=0.02). The multiple classification logistic regression analysis established between TFI and FC showed that CT-IgG [P<0.001, OR=0.084, 95%CI (0.025, 0.284)], CT376 antibody [P=0.068, OR=0.359, 95%CI (0.120, 1.078)]. CT-IgG is an independent risk factor for tubal infertility, and CT376 antibody cannot be an independent risk factor for tubal infertility. The multiple classification logistic regression analysis established between TFI and IFC showed that among infertile patients, CT-IgG [P<0.05, OR=0.194, 95%CI (0.046, 0.817)], CT376 antibody [P<0.05, OR=0.176, 95%CI (0.038, 0.818)] and CT381 antibody [P<0.05, OR=0.112, 95%CI ( 0.016, 0.796)] were independent risk factors for tubal infertility. ConclusionThe expression of CT376 antibody in tubal infertility patients is higher than that in fertile and infertile controls, suggesting that CT-induced tubal factor infertility may be related to CT376. CT-IgG, and CT376 antibodies are meaningful in predicting CT-induced tubal factor infertility.

8.
Journal of Peking University(Health Sciences) ; (6): 8-12, 2023.
Article in Chinese | WPRIM | ID: wpr-971267

ABSTRACT

Sialolithiasis occurs in approximately 0.45% to 1.20% of the general population. The typical clinical symptom manifests as a painful swelling of the affected glands after a meal or upon salivary stimulation, which extremely affects the life quality of the patients. With the development of sialendoscopy and lithotripsy, most sialoliths can be successfully removed with preservation of the gland. However, sialoliths in the deep hilar-parenchymal submandibular ducts and impacted parotid stones located in the proximal ducts continue to pose great challenges. Our research center for salivary gland diseases (in Peking University School and Hospital of Stomatology) has used sialendoscopy for 17 years and treated >2 000 patients with salivary gland calculi. The success rate was approximately 92% for submandibular gland calculi and 95% for parotid calculi. A variety of minimally invasive surgical techniques have been applied and developed, which add substantial improvements in the treatment of refractory sialolithiasis. Further, the radiographic positioning criteria and treatment strategy are proposed for these intractable stones. Most of the hilar-parenchymal submandibular stones are successfully removed by a transoral approach, including transoral duct slitting and intraductal basket grasping, while a small portion of superficial stones can be removed by a mini-incision in submandibular area. Impacted stones located in the distal third of parotid gland ducts are removed via "peri-ostium incision", which is applied to avoid a cicatricial stenosis from a direct ostium incision. Impacted parotid stones located in the middle and proximal third of the Stensen's duct are removed via a direct mini-incision or a peri-auricular flap. A direct transcutaneous mini-incision is commonly performed under local anesthesia with an imperceptible scar, and is indicated for most of impacted stones located in the middle third, hilum and intraglandular ducts. By contrast, a peri-auricular flap is performed under general anesthesia with relatively larger operational injury of the gland parenchyma, and should be best reserved for deeper intraglandular stones. Laser lithotripsy has been applied in the treatment of sialolithiasis in the past decade, and holmium ∶YAG laser is reported to have the best therapeutic effects. During the past 3 years, our research group has performed laser lithotripsy for a few cases with intractable salivary stones. From our experiences, withdrawal of the endoscopic tip 0.5-1.0 cm away from the extremity of the laser fiber, consistent saline irrigation, and careful monitoring of gland swelling are of vital importance for avoidance of injuries of the ductal wall and the vulnerable endoscope lens during lithotripsy. Larger calculi require multiple treatment procedures. The risk of ductal stenosis can be alleviated by endoscopic dilation. In summary, appropriate use of various endoscopy-assisted lithotomy helps preserve the gland function in most of the patients with refractory sialolithiasis. Further studies are needed in the following aspects: Transcervical removal of intraglandular submandibular stones, intraductal laser lithotripsy of impacted parotid stones and deep submandibular stones, evaluation of long-term postoperative function of the affected gland, et al.


Subject(s)
Humans , Salivary Gland Calculi/surgery , Constriction, Pathologic , Endoscopy , Salivary Ducts/surgery , Lithotripsy , Treatment Outcome
9.
China Occupational Medicine ; (6): 640-644, 2022.
Article in Chinese | WPRIM | ID: wpr-976090

ABSTRACT

@#Objective - ( )- ( ) To observe the effects of renin angiotensin Ang aldosterone system RAAS in workers exposed to Methods - - occupational noise. Forty five workers with suspected occupational noise induced deafness were selected as noise , , exposure group using convenient sampling method. According to their tinnitus symptom noise exposure intensity and work age - , , they were divided into no tinnitus and tinnitus subgroups <90 dB and ≥90 dB subgroups work years <10 years and ≥10 years subgroups. Another 45 workers with no occupational noise exposure history were selected as control group. The levels of plasma ( ), , , renin activity PRA AngⅠ AngⅡ and aldosterone of the two groups were detected and the aldosterone to renin activity Results ratio was calculated. The diastolic blood pressure of the noise exposure group was higher than that of the control group [( )vs( ) ,P ] , 80±7 76±8 mmHg <0.05 . However there was no significant difference in systolic blood pressure between the two (P ) ( : groups >0.05 . The level of plasma AngⅡ in the noise exposure group was higher than that in the control group median vs ,P ) ( P ) 100.98 65.43 μg/L <0.05 . There was no statistical significance in other indexes between the two groups all >0.05 . The ( : plasma AngⅡ level in < 90 dB subgroup in the noise exposure group was higher than that of the control group median 123.16 vs ,P ) 65.43 μg/L <0.05 . There was no statistical significance in other indexes among the two subgroups of tinnitus symptom or ( P ) work age in the noise exposure group and the control group all >0.05 . There were no significant differences in the abnormal , ( P ) rates of PRA AngⅡ and aldosterone in plasma between the noise exposure group and the control group all >0.05 . Conclusion Occupational noise exposure may affect RAAS and lead to increased plasma AngⅡ levels in the workers. - Tinnitus and work age may not affect RAAS in occupational noise exposure workers.

10.
China Occupational Medicine ; (6): 640-644, 2022.
Article in Chinese | WPRIM | ID: wpr-976089

ABSTRACT

@#Objective - ( )- ( ) To observe the effects of renin angiotensin Ang aldosterone system RAAS in workers exposed to Methods - - occupational noise. Forty five workers with suspected occupational noise induced deafness were selected as noise , , exposure group using convenient sampling method. According to their tinnitus symptom noise exposure intensity and work age - , , they were divided into no tinnitus and tinnitus subgroups <90 dB and ≥90 dB subgroups work years <10 years and ≥10 years subgroups. Another 45 workers with no occupational noise exposure history were selected as control group. The levels of plasma ( ), , , renin activity PRA AngⅠ AngⅡ and aldosterone of the two groups were detected and the aldosterone to renin activity Results ratio was calculated. The diastolic blood pressure of the noise exposure group was higher than that of the control group [( )vs( ) ,P ] , 80±7 76±8 mmHg <0.05 . However there was no significant difference in systolic blood pressure between the two (P ) ( : groups >0.05 . The level of plasma AngⅡ in the noise exposure group was higher than that in the control group median vs ,P ) ( P ) 100.98 65.43 μg/L <0.05 . There was no statistical significance in other indexes between the two groups all >0.05 . The ( : plasma AngⅡ level in < 90 dB subgroup in the noise exposure group was higher than that of the control group median 123.16 vs ,P ) 65.43 μg/L <0.05 . There was no statistical significance in other indexes among the two subgroups of tinnitus symptom or ( P ) work age in the noise exposure group and the control group all >0.05 . There were no significant differences in the abnormal , ( P ) rates of PRA AngⅡ and aldosterone in plasma between the noise exposure group and the control group all >0.05 . Conclusion Occupational noise exposure may affect RAAS and lead to increased plasma AngⅡ levels in the workers. - Tinnitus and work age may not affect RAAS in occupational noise exposure workers.

11.
Journal of Experimental Hematology ; (6): 222-226, 2022.
Article in Chinese | WPRIM | ID: wpr-928697

ABSTRACT

OBJECTIVE@#To establish a stable mouse model of acquired aplastic anemia.@*METHODS@#Female BALB/C mice aged 6 months were intraperitoneally injected with cyclophosphamide and cyclosporine for 14 days. The number of peripheral blood cells, the concentration of hemoglobin, the number of bone marrow nucleated cells, bone marrow smear, bone marrow pathological sections and other indexes were observed.@*RESULTS@#In BALB/C mice injected intraperitoneally with cyclophosphamide and cyclosporine, the number of peripheral blood cells and the concentration of hemoglobin were significantly decreased, especially the white blood cells and platelets. Bone marrow smear showed a significant decrease in the number of nucleated cells and bone marrow hyperplasia. Bone marrow pathology showed decreased hematopoietic cells and increased non-hematopoietic cells such as adipocytes.@*CONCLUSION@#The mouse model with intraperitoneal injection of cyclophosphamide and cyclosporine can meet the diagnostic criteria of acquired aplastic anemia, which can be used as a mouse model for the study of the pathogenesis and treatment of acquired aplastic anemia.


Subject(s)
Animals , Female , Mice , Anemia, Aplastic , Bone Marrow , Cyclophosphamide , Cyclosporine , Mice, Inbred BALB C
12.
Chinese Journal of Surgery ; (12): 169-173, 2022.
Article in Chinese | WPRIM | ID: wpr-935597

ABSTRACT

Objective: To examine the clinical effect of simple muscle packing through transnasal sphenoid approach in the treatment of intrasellar arachnoid cyst. Methods: The clinical data of 11 patients with intrasellar arachnoid cyst treated by transnasal sphenoidal approach with simple muscle packing at the Neurosurgery Department of the First Affiliated Hospital of Zhengzhou University from January 2014 to February 2020 were retrospectively analyzed. There were 5 males and 6 females, with a median age of 48 years (range: 23 to 75 years). The clinical manifestations included headache in 6 cases, dizziness in 4 cases, hypo-libido in 1 case, disturbance of consciousness in 1 case, visual impairment in 7 cases and mixed pituitary dysfunction in 5 cases. The enlargement of the sellar fossa was seen in the preoperative MRI images. The enhanced MRI images showed that the cyst wall of the intrasellar arachnoid cyst was not enhanced, and the compression and thinning of the sellar base was seen in the CT images. In 9 cases, the cyst extended suprasellar and the sellar septum was "arched". In 7 cases, the cyst compressed the optic chiasm upward. The cyst walls of all patients were incised through the nasal sphenoid approach under the endoscope, and the muscle was packed after sufficient drainage. The postoperative symptoms, pituitary endocrine function and recurrence of patients were followed up. Results: MRI images of the sellar region in all patients showed significant reduction or disappearance of cysts. Intracranial infection occurred in 1 case and electrolyte disorder in 2 cases, which were relieved after symptomatic treatment. No cerebrospinal fluid rhinorrhea occurred. Postoperative clinical symptoms were completely relieved in 6 cases and partially relieved in 5 cases. Pituitary endocrine function recovered completely in 2 cases and improved significantly in 4 cases. All patients were followed up for 10 to 40 months. One patient found to have a partial recurrence of the cyst 3 months after surgery. Because there were no new symptoms appeared, the follow-up was continued without second operation. Conclusion: Transnasal sphenoidal approach is a feasible method for the treatment of intrasellar arachnoid cyst.


Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Young Adult , Arachnoid Cysts/surgery , Endoscopy , Magnetic Resonance Imaging , Muscles , Retrospective Studies , Sella Turcica
13.
Chinese Journal of Oncology ; (12): 587-592, 2022.
Article in Chinese | WPRIM | ID: wpr-940927

ABSTRACT

Single-arm trial refers to a clinical trial design that does not set up parallel control group, adopts open design, and does not involve randomization and blind method. These features, on the one hand, speed up the process of clinical trials, significantly shorten the time to market and meet the needs of patients with advanced malignancies, but also lead to the uncertainty of single-arm clinical trials themselves. Recently, the US Food and Drug Administration held a meeting of the oncologic drug advisory committee to discuss six tumor indications that have been accelerated approved, which once again triggered the discussion of single-arm trials. The basis of accelerated approval by single-arm trial is actually a compromise on the level of evidence-based medical evidence requirements after assessing the benefit risk. Therefore, the sponsor should strictly grasp the applicable conditions of single-arm trial in anti-tumor drugs and conduct single-arm trial scientifically. Post-marketing clinical trial should be implement as early as possible to ensure the benefit of patients. Based on the characteristics of single-arm trial, combined with two guidance relevant to single-arm trial issued by National Medical Products Administration recently, this article is supposed to propose and summarize the strategy of single-arm trial supporting the marketing of anti-tumor drugs.


Subject(s)
Humans , Antineoplastic Agents/therapeutic use , Clinical Trials as Topic , Marketing , Neoplasms/drug therapy , Research Design , United States , United States Food and Drug Administration
14.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 130-137, 2022.
Article in Chinese | WPRIM | ID: wpr-940527

ABSTRACT

ObjectiveA feedforward control model for dry granulation of polysaccharide components was established to guide the adjustment and optimization of critical process parameters (CPPs) in the design space, so as to reduce the impact of fluctuations in raw materials properties on the quality of medicines. MethodTaking Astragali Radix extract powder as the model drug, the design space of dry granulation CPPs was determined by Box-Behnken design. Astragali Radix mixed powder with different powder properties were prepared by mixture design, the variance inflation factor (VIF) was used to diagnose the multicollinearity of the powder properties, and principal component analysis (PCA) was used to extract the characteristic data of the model. Radial basis function neural network (RBFNN) was used to establish a feedforward control model for reflecting the relationship between the powder properties of polysaccharide components, dry granulation CPPs and one-time molding rate. ResultThe design space for dry granulation CPPs of polysaccharide components was 16-35 Hz for feeding speed, 10-23 Hz for roller speed, and 10-46 kg·cm-2 for roller pressure. The established RBFNN feedforward control model had a good predictive effect on the one-time molding rate of dry granulation of polysaccharide components, which could be used to guide the adjustment and optimization of CPPs in the design space, the relative error was 0.38%-6.73%, and the average relative error was 3.42%. ConclusionThe established feedforward control model can well reflect the relationship between the powder properties of the polysaccharide components, the dry granulation CPPs and the one-time molding rate of the granules, which can be used to guide the adjustment and optimization of CPPs in the design space, reduce the impact of material property fluctuation on product quality, and provide ideas for promoting the quality of traditional Chinese medicine from passive control to active control.

15.
China Journal of Chinese Materia Medica ; (24): 324-333, 2022.
Article in Chinese | WPRIM | ID: wpr-927974

ABSTRACT

To clarify the key quality attributes of substance benchmarks in Danggui Buxue Decoction(DBD), this study prepared 21 batches of DBD substance benchmarks, and established two methods for detecting their fingerprints, followed by the identification of peak attribution and similarity range as well as the determination of extract and transfer rate ranges and contents of index components ferulic acid, calycosin-7-O-β-D-glucoside, and astragaloside Ⅳ. The mass fractions and transfer rates of DBD substance benchmarks from different batches were calculated as follows: ferulic acid(index component in Angelicae Sinensis Radix): 0.037%-0.084% and 31.41%-98.88%; astragaloside Ⅳ(index component in Astragali Radix): 0.021%-0.059% and 32.18%-118.57%; calycosin-7-O-β-D-glucoside: 0.002%-0.023% and 11.51%-45.65%, with the extract rate being 18.4%-36.1%. The similarity of fingerprints among 21 batches of DBD substance benchmarks was all higher than 0.9. The quality control method for DBD substance benchmarks was preliminarily established based on the HPLC fingerprint analysis and index component determination, which has provided a basis for the subsequent development of DBD and the quality control of novel related preparations.


Subject(s)
Chromatography, High Pressure Liquid/methods , Drugs, Chinese Herbal/standards , Quality Control
16.
Chinese Journal of Orthopaedics ; (12): 33-42, 2021.
Article in Chinese | WPRIM | ID: wpr-884683

ABSTRACT

Objective:To investigate the effects of curcumin on apoptosis and radiosensitivity of human chordoma cell line CM-319 and its mechanism.Methods:CM-319 cells were cultured in vitro and divided into curcumin 0 μmol/L group, curcumin 5 μmol/L group, curcumin 10 μmol/L group, curcumin 20 μmol/L group, si-NC group, si-UHRF1 group, curcumin+pcDNA group, curcumin+pcDNA-UHRF1 group.Flow cytometry was usedtodetect cell apoptosis, Western Blot was used to detectthe protein expression of Bcl-2, Bax, Cleaved Caspase-3 and UHRF1, qRT-PCR was used to detect the expression of UHRF1 mRNA, and clone formationexperiment was used to detect the sensitivity of CM-319 cells to radiation.Results:Compared with the curcumin 0 μmol/L group, the apoptosis rate of CM-319 cellsinthe curcumin 5 μmol/L group, curcumin 10 μmol/L group and curcumin 20 μmol/L groupincreased 12.61%±1.57%, 18.42%±1.54%, 29.37%±2.65% vs 7.24%±0.73% ( t=9.305, 19.680, 24.153; all P<0.05), and the protein expression of Bcl-2 decreased 0.62±0.06, 0.51±0.05, 0.33±0.03 vs 0.76±0.07 ( t=4.556, 8.719, 16.939; all P<0.05), while the protein expression of Bax 0.41±0.04, 0.55±0.05, 0.69±0.06 vs 0.26±0.03 ( t=9.000, 14.920, 19.230; all P<0.05) and Cleaved Caspase-3 0.37±0.04, 0.49±0.05, 0.62±0.06 vs 0.24±0.03 ( t=7.800, 12.862, 16.994; all P<0.05) increased, and the expression of UHRF1 mRNA decreased 0.82±0.08, 0.67±0.07, 0.42±0.04 vs 1.01±0.09 ( t=4.734, 8.946, 17.972; all P<0.05), the protein expression of UHRF1 decreased 0.61±0.06, 0.48±0.05, 0.31±0.03 vs 0.83±0.08 ( t=6.600, 11.130, 18.258; all P<0.05), and were dose-dependent, and the sensitization ratios were 1.433, 1.708, and 2.183, respectively. Compared with the si-NC group, the protein expression of UHRF1in CM-319 cells in the si-UHRF1 group decreased 0.35±0.04 vs 0.79±0.08 ( t=14.758, P<0.05), the apoptosis rate of CM-319 cells increased 21.49%±2.11% vs 8.24%±0.83% ( t=17.531, P<0.05), the protein expression of Bcl-2 decreased 0.34±0.03 vs 0.71±0.07 ( t=14.575, P<0.05), while the protein expression of Bax 0.62±0.06 vs 0.25±0.03 ( t=16.547, P<0.05) and Cleaved Caspase-3 0.58±0.05 vs 0.23±0.03 ( t=18.007, P<0.05) increased, and the sensitization ratio was 1.727. Compared with the curcumin+pcDNA group, the apoptosis rate of CM-319 cells in the curcumin+pcDNA-UHRF1 groupreduced 13.59%±1.25% vs 28.31%±3.01% ( t=13.549, P<0.05), the protein expression of Bcl-2 increased 0.63±0.06 vs 0.31±0.03 ( t=14.311, P<0.05), while the protein expression of Bax 0.42±0.04 vs 0.71±0.07 ( t=10.791, P<0.05) and Cleaved Caspase-3 0.38±0.04 vs 0.65±0.05 ( t=12.650, P<0.05) decreased, and the sensitization ratio was 0.539. Conclusion:Curcumin can induce apoptosis of CM-319 cells and enhance the radiosensitivity of CM-319 cells, , and the mechanism is related to the down-regulation of UHRF1 expression.

17.
Singapore medical journal ; : 476-481, 2021.
Article in English | WPRIM | ID: wpr-920921

ABSTRACT

INTRODUCTION@#Stroke is a leading cause of death and disability, with the administration of recombinant transcriptase-plasminogen activator (rtPA) improving outcomes in a time-dependent manner. Only 52.3% of eligible stroke patients at our institution received rtPA within 60 minutes of arrival. We aimed to improve the percentage of acute stroke patients receiving rtPA within 60 minutes of arrival at the emergency department (ED).@*METHODS@#This study presents results from the first year of a clinical practice improvement project that implemented quality improvement interventions. The primary outcome measure was percentage of acute ischaemic stroke patients receiving rtPA within 60 minutes of arrival at the ED. Secondary outcome measures included components of total door-to-needle (DTN) time and factors for delay to thrombolysis. Interventions were establishment of standardised acute stroke activation guidelines, screening question at ED registration, prehospital notification of stroke activation, public education, scripting for thrombolysis consent and easy access to equipment.@*RESULTS@#The percentage of patients thrombolysed within 60 minutes increased to 60.6% (p = 0.27), and DTN time decreased from 59 minutes to 54.5 minutes (p = 0.15). This was attributable to reduced door-to-physician time, door-to-imaging time and decision time, although the results were not significant. There was no significant increase in symptomatic intracranial haemorrhage or mortality secondary to stroke. Length of stay was significantly reduced by 1.5 days (p < 0.048).@*CONCLUSION@#The interventions resulted in an increasing but non-significant trend of acute stroke patients receiving thrombolysis within 60 minutes. Outcomes will be monitored for a longer duration to demonstrate trends and sustainability.

18.
Singapore medical journal ; : 482-485, 2021.
Article in English | WPRIM | ID: wpr-920920

ABSTRACT

INTRODUCTION@#With Singapore's ageing population, there are increasing numbers of elderly cyclists and motorcyclists. Compared to younger riders, this cohort sustains more injuries and has poorer outcomes. This study aimed to describe and compare patient demographics, injury patterns and outcomes among elderly cyclists and motorcyclists at a Level 1 trauma centre.@*METHODS@#Data of all cyclists, motorcyclists and pillion riders aged 65 years and above who presented to the emergency department after accidents from 1 January 2013 to 31 December 2017 was extracted from the hospital's trauma registry and reviewed.@*RESULTS@#Cyclists and motorcyclists formed 42.0% and 58.0%, respectively, of 157 recruited patients. At the time of the accident, 40.8% of the patients were employed. The mean age of the patients was 71.6 ± 5.8 years. Extremities and pelvic girdle injuries (61.1%) were the most frequent, followed by chest injuries (48.4%), and head and neck injuries (40.1%). Among severe injuries (defined as Abbreviated Injury Scale score ≥ 3), chest injuries (39.5%) were the most common, followed by head and neck injuries (36.3%). The overall mortality rate was 9.6%, with cyclists at nearly three times the risk compared to motorcyclists. More cyclists than motorcyclists (18.2% vs. 11.0%) required intensive care. There were no significant differences in the length of hospital stay between cyclists and motorcyclists.@*CONCLUSION@#Elderly riders have unique injury patterns and consume significant healthcare resources. Trauma systems need to acknowledge this changing injury epidemiology and equip trauma centres with the necessary resources targeted at elderly patients. Future work should focus on strategies to minimise extremity and chest injuries.

19.
Chinese Journal of Experimental Traditional Medical Formulae ; (24): 83-88, 2021.
Article in Chinese | WPRIM | ID: wpr-906426

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Objective:To investigate the effect and mechanism of saikosaponin A (SSA) on the reversal of cisplatin (DDP) resistance in human lung cancer cell line A549/DDP. Methods:The resistance of A549 and A549/DDP cells to DDP and the inhibitory effects of SSA against the proliferation of A549 and A549/DDP cells were detected using cell counting kit-8 (CCK-8). The apoptosis rates of A549/DDP cells treated with SSA or DDP or SSA combined with DDP and the changes in reactive oxygen species (ROS) were determined by flow cytometry. The mRNA expression levels of C-myc, B-cell lymphoma 2 (Bcl-2) and cysteinyl aspartate-specific protease-3 (Caspase-3) were detected by real-time polymerase chain reaction (Real-time PCR), followed by the determination of <italic>β</italic>-catenin transcriptional activity using the TopFish dual-luciferase reporter assay system and the measurement of <italic>β</italic>-catenin protein expression in A549/DDP cells by Western blot. Results:The results of CCK-8 assay showed that the DDP resistance of A549/DDP cells was 12.82 times that of A549 cells (<italic>P</italic><0.05). SSA inhibited the viability of A549 cells with the half maximal inhibitory concentration (IC<sub>50</sub>) being 34.9 μmol·L<sup>-1</sup>, and also suppressed the viability of A549/DDP cells in a concentration-dependent manner. Since the inhibition rate of 20 μmol/L SSA against A549/DDP cells was less than 10%, the reversal concentration was set at 20 μmol/L. Flow cytometry revealed that compared with the control, DDP alone increased the apoptosis rate of A549/DDP cells (<italic>P</italic><0.05), stimulated the accumulation of intracellular ROS (<italic>P</italic><0.05), down-regulated the mRNA expression levels of C-myc and Bcl-2 in A549/DDP cells, up-regulated Caspase-3 mRNA expression, and reduced the transcriptional activity of <italic>β</italic>-catenin (<italic>P</italic><0.05). Compared with the DDP group, the SSA+DDP group exhibited obviously increased apoptosis of A549/DDP cells, enhanced accumulation of intracellular ROS, down-regulated C-myc and Bcl-2 mRNA expression, up-regulated Caspase-3 mRNA expression (<italic>P</italic><0.05), and weakened <italic>β</italic>-catenin transcription (<italic>P</italic><0.05). DDP combined with SSA better decreased the <italic>β</italic>-catenin protein expression in contrast to that of control or DDP (<italic>P</italic><0.05). Conclusions:SSA enhances the sensitivity of A549/DDP cells to DDP possibly by inhibiting the activation of Wnt/<italic>β</italic>-catenin pathway.

20.
Chinese Journal of Rehabilitation Theory and Practice ; (12): 341-348, 2021.
Article in Chinese | WPRIM | ID: wpr-905283

ABSTRACT

Objective:To construct the competency model of physical therapists in China. Methods:A set of physical therapists' competency elements was established based on literature review and expert interviews. A questionnaire was designed based on the set, and 641 rehabilitation practitioners were investigated (521 valid questionnaires returned) with the questionnaire. Exploration factor analysis was used to construct the competency model of physical therapists, and confirmatory factor analysis was used to confirmed. Results:The set of physical therapists' competency elements included 74 elements in four dimensions. There were 44 competency elements in the competency model of physical therapists, including five dimensions that were Professionalism and Moral Conduct, Knowledge and Skills of Evaluation and Intervention, Abilities of Educational-Research and Advocate, Abilities of Cooperation and Management, and Basic Knowledge of Discipline, covering 74.41% of the total variance. The Cronbach's α coefficient of the whole questionnaire and each dimension was more than 0.8. Model fitness indexes of confirmatory factor analysis were as follow: χ2/df = 2.340, Root Mean Square Error of Approximation = 0.060, Goodness of Fit Index = 0.746, Normed Fit Index = 0.811, Incremental Fit Index = 0.850, Comparative Fit Index = 0.850. Conclusion:The competency model can provide a basis for physical therapists to become independent occupation, as well as for the education, selection, evaluation of physical therapists in China.

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