1.Interpretation and reflection on the Measures for the Administration of Standards for Medicinal Products
Mengxia ZHAO ; Lina SUN ; Dan XU ; Wen CHAI ; Xuekong JIANG ; Zhihai MAO ; Shengliang HE
China Pharmacy 2024;35(7):783-786
In July 2023, the National Medical Products Administration issued the Measures for the Administration of Standards for Medicinal Products (hereinafter referred to as the Measures). This article interprets the main content of the Measures, and analyzes its shortcomings as unclear definition of the drug standard code and the goals of drug standard information construction. It is recommended that the national drug regulatory department promptly apply to the standardization authority for the confirmation of the drug standard code “YB” letter, and the drug standard code and numbering rules would be included in the next round of amendments to the Measures. It is necessary to clarify the construction goals of the information system for drug standards at the same time, and build a national drug standard data-sharing platform based on the basic framework of user interface layer, computing processing layer, and data storage layer. Digital drug standards will be free, and access and download services for the public will be provided.
2.Discussion on TCM Connotation and Pathogenesis of Gastroesophageal Reflux Related Cough Based on the Theory of"Relevance of Lung and Stomach"
Yunyun HE ; Cong HE ; Xiao WANG ; Gaofan XU ; Yuyang LIU ; Yue WU ; Yi WANG ; Shengliang ZHU ; Bingduo ZHOU
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(10):14-18
Gastroesophageal reflux related cough is located in the lung and stomach.The basic pathogenesis is the inversion of stomach qi and the lung loss propagating and descending.In view of the above,based on the theory of"relevance of lung and stomach",this article analyzed the modern mechanism of"relevance of lung and stomach"in gastroesophageal reflux related cough,which included"microinhalation"theory,"esophagus-bronchial reflex"theory,and"airway neurogenic inflammation"theory.This article also put forward the TCM disease name of"gastric cough",and the treatment methods of"simultaneous treatment of lung and stomach"and"treatment of cough from stomach",which would provide new ideas for the theoretical and mechanism research of TCM treatment of gastroesophageal reflux related cough.
3.Stress Distributions of Hip Cartilage During Gait Cycle and its Effects in Curved Periacetabular Osteotomy
Shengliang BAO ; Ping XU ; Ning LU ; Ruichang WANG ; Hao TIAN ; Jinhai PENG
Journal of Medical Biomechanics 2022;37(4):E612-E617
Objective To study stress distributions of the cartilage around the hip joint in stress environment of complete gait cycle, and explore the optimal correction angle of bone block in curved periacetabular osteotomy (CPO), so as to provide theoretical references for clinical operation. Methods Based on CT scans from a healthy volunteer and a patient with development dysplasia of hip (DDH), the three-dimensional (3D) model including pelvis and proximal femur was reconstructed. The cortical bone and cancellous bone were distinguished by dividing the masks, and the material attributes were assigned to the finite element model. A total of 100 different postoperative models were obtained by simulating CPO in DDH model, by adjusting lateral center edge angle (LCEA) and anterior center edge angle (ACEA). According to hip joint stresses in complete gait cycle, the model was loaded respectively, and stress changes of normal, preoperative and postoperative acetabular cartilage were analyzed and compared. ResultsThe minimum peak contact stresses of acetabular cartilage of DDH patient at heel landing phase, start phase of single leg support, mid phase of single leg support, end phase of single leg support and double support phase after simulated CPO operation were 5.273, 6.128, 7.463, 6.347, 6.582 MPa, which were decreased by 2.159, 2.724, 2.249, 2.164, 2.119 MPa,respectively, compared with those before operation. The contact area between femoral head and acetabulum was significantly increased after operation, but it was still smaller than that of normal volunteers. Conclusions The optimal correction angle of LCEA and ACEA can be obtained by using finite element method, and the simulation of CPO surgery on different patients is of great significance to improve surgical accuracy and efficiency.
4.Preoperative Planning of Acetabular Arc Osteotomy Using Finite Element Method
Ruichang WANG ; Ping XU ; Ning LU ; Hao TIAN ; Jinhai PENG ; Shengliang BAO
Journal of Medical Biomechanics 2021;36(3):E377-E383
Objective In order to simulate different angles of acetabular blocks that need to be adjusted during operation, the optimal angle was determined through analyzing the contact stress and contact area of cartilage around the hip joint, so as to provide an individual scheme for acetabular osteotomy. Methods The finite element models for development dysplasia of hip (DDH) and normal pelvis were established to investigate morphological characteristics of the acetabulum and the causes of stress concentration. To simulate osteotomy for the DDH model, a total of 20 postoperative osteotomy models were obtained through the combination of different angles for anterior rotation and lateral rotation of acetabular blocks, and the differences in optimal results of the models during simulated one legged-standing were compared and analyzed. Results The maximum contact pressure of acetabular cartilage in normal model was 7.85 MPa. The maximum contact pressure of acetabular cartilage in DDH model was 13.42 MPa. The optimal contact pressure after simulated osteotomy decreased to 8.49 MPa, and the contact distribution was improved more significantly. Conclusions Changing the anterior rotation angle can significantly improve the contact pressure distribution and size, as well as stay away from the preoperative lesion area, which has a positive impact on postoperative outcomes. Personalized osteotomy plan based on actual situation of each patient before the operation is crucial for the surgical effect.
5.Effect of residual sex hormones in sex-differentiated human IgG samples on DC secretion of inflammation-related factors
Jixuan XU ; Wei ZHANG ; Shengliang YE ; Xi DU ; Liyuan ZHU ; Li MA ; Changqing LI
Chinese Journal of Blood Transfusion 2021;34(5):465-471
【Objective】 Tostudy the effect of sex-differentiated human IgG samples on Dendritic cells (DC) secretion of inflammation-related factors and explore the effect of residual sex hormones in IgG products (such as IVIg) on the secretion of IL-6 by DC. 【Methods】 According to the standard IVIg production process, the company was entrustedto prepare sex-differentiated plasma purified IgG samples, and two sex-differentiated IgG samples with different sex ratios (male to female ratio1: 0, 0: 1) were obtained. The samples and referenceswere treated with human DC (induced by THP-1 cells) respectively. After 24 h of culture, the chemokines (CCL2, CCL3, CCL4), adhesion molecule (ICAM-1) and inflammatory cytokines (IL-1, IL-6, IL-10, IL-12p70, IFN-) in the cell supernatant were detected, The effects of different samples on the secretion of inflammation-related factors by DC were compared. The effect of sex hormone residues on the anti-inflammatory ability of IgG products was preliminarily explored uing sex hormones and sex hormone receptor blockers. 【Results】 The samples in each group significantly inhibitedthe secretion of chemokines (CCL2, CCL3, CCL4) and the adhesion molecule (ICAM-1) by mature DC (compared with the PBS group, P<0.05), but significantly promoted the secretion of inflammatory cytokines (IL-1a/b, IL-6, IL-10, IL-12p70), compared with the PBS group(P<0.05). The results of sex hormone residues showed that therewere residues of estradiol (E2) and testosterone (TSTO) in sex-differentiated IgG samples and IVIg products. The experimental results of IVIg and sex hormone/sex hormone receptor blockers showed that residual E2 may promote the secretion of IL-6 by DC, which may be achieved through the E2 receptor ERb. 【Conclusion】 There are differences in the effect of IgG samples prepared from combined plasma with different sex ratios on the secretion of cytokines by DC, which may be related to the residual E2 in the products. The residual sex hormones in IVIg may promote the production and secretion of IL-6 through the sex hormone receptor ERb expressed in DC, and TSTO may have a collaboration effect to enhance the secretion-promoting effect of IL-6 by E2. This study provides a theoretical basis for whether sex hormone residues need to be considered in the quality control indicators of IVIg products.
6.The Effect of Pelvic Modeling on Outcome in Preoperative Planning for Bernese Acetabular Osteotomy
Hao TIAN ; Ping XU ; Ning LU ; Jinhai PENG ; Ruichang WANG ; Shengliang BAO
Journal of Medical Biomechanics 2020;35(6):E712-E717
Objective To explore the influence of different model scopes on acetabular stress distribution and optimal osteotomy result in preoperative planning of Bernese acetabular osteotomy. Methods Two patients with hip dysplasia were established according to different model ranges. Model 1 included the affected hip and femur, and Model 2 included the complete pelvis and affected femur. Compare and analyze the acetabular cartilage contact pressure, area and distribution of the two models under single-leg standing conditions, and simulate osteotomy. Results Compared with Model 1 before surgery, Model 2 had higher contact pressure, smaller contact area and closer distribution to the meniscus edge of acetabulum. Compared with 11 postoperative plans, the variation amplitude of contact pressure and the optimal osteotomy angle for Model 1 were all smaller than those of Model 2. Conclusions The preoperative analysis result of the model with affected hip bone and femur would underestimate the degree of stress concentration and misjudge the location of stress concentration, and the obtained optimal osteotomy rotation angle would be relatively small. The research findings provide certain theoretical basis for preoperative planning and modeling of osteotomy.
7.Investigation on rural environmental sanitation and summer diarrhea among rural residents in Zhejiang Province
Yuan CHEN ; Lizhi WU ; Peiwei XU ; Weizhong CHEN ; Shengliang HE ; Zhijian CHEN
Journal of Preventive Medicine 2019;31(2):109-112
Objective :
To understand the status of rural environmental sanitation and summer diarrhea among rural residents in Zhejiang Province,and to provide evidence for improvement of rural environmental sanitation and prevention and control of summer diarrhea.
Methods :
The stratified random sampling method was used. Five or six counties each were selected from the east,middle and west of Zhejiang Province;five townships(excluded Chengguan Town)were selected from each selected county;four villages were selected as field survey points from each township;five households were selected from each survey point;one family member(householder or housewife)was selected from each selected household. The information about the environmental sanitation status and prevalence of summer diarrhea were obtained by literature review,interviews,questionnaire suvey,field investigation and laboratory tests. Logistic regression model was used to analyze the influencing factors for occurrence of summer diarrhea among rural residents.
Results :
There were 2 000 households surveyed. In the past two weeks,108 households had families with diarrhea and the prevalence of diarrhea was 5.40%. A total of 1 828 households disposed the household waste in the garbage bins or pools,accounting for 91.40%. There were 1 926 households with organized sewage discharge,accounting for 96.30%. There were 768 households with nymphs found in the kitchen,accounting for 38.40%;404 households with live egg sheaths found,accounting for 20.20%;592 households with cockroach traces found,accounting for 29.60%;564 households with rat traces found,accounting for 28.20%;and 1 206 households with flies found,accounted for 60.30%. There were 1 314 households with disease vectors around the house,accounting for 65.70%. There were 1 944 household with sanitary toilets,accounting for 97.20%. A total of 1 915 households had habits of drinking boiled water,accounting for 96.57%. The results of multivariate logistic regression analysis showed that rat traces found in the kitchen(OR=2.026,95%CI: 1.362-3.013)were a risk factor for summer diarrhea in rural residents,while drinking boiled water(OR=0.272,95%CI: 0.091-0.811)was a protective factor.
Conclusion
The sanitary environment and family health habits of rural residents were related to the prevalence of diarrhea in summer. Paying attention to kitchen hygiene and drinking boiled water could prevent summer diarrhea.
8.Disinfection effect and its influencing factors of rural drinking water in Zhejiang Province
Yuan CHEN ; Lizhi WU ; Peiwei XU ; Weizhong CHEN ; Shengliang HE ; Dandan XU ; Zhijian CHEN ; Li WANG
Journal of Preventive Medicine 2019;31(10):992-997
Objective:
To learn the disinfection effect and its influencing factors of drinking water in rural areas of Zhejiang Province,so as to provide scientific basis for the control of microbial pollution in drinking water and prevention of waterborne diseases.
Methods:
A total of 5 299 samples from 879 rural water plants Zhejiang Province were collected by stratified sampling method in 2017. The disinfection effect of water samples was assessed quality according to GB 5749-2006 Hygienic Standards for Drinking Water. Logistic regression models were used to analyze the influencing factors for disinfection effect of rural drinking water.
Results:
There were 540 rural water plants in Zhejiang Province adopting routine process for water purification,accounting for 61.43%;771 ones using surface water,accounting for 87.72%. About 4 458 samples(84.13%)were disinfected and the qualified rate was 86.05%,22.32% of which were disinfected by chlorine dioxide and the qualified rate was 100.00%. The results of multivariate logistic regression analysis showed that scale of water plant,disinfectant residue,use frequency of disinfection equipment,disinfection,season and source water turbidity were the influencing factors for the disinfection effect of rural drinking water(P<0.05);disinfection,disinfectant residue,use frequency of disinfection equipment and source water turbidity were the influencing factors for the disinfection effect of finished water(P<0.05);disinfection,disinfectant residue,use frequency of disinfection equipment,source water turbidity and scale of water plant were the influencing factors for the disinfection effect of tap water(P<0.05);disinfectant residue,use frequency of disinfection equipment,source water turbidity and scale of water plant were the influencing factors forthe disinfection effect of surface water(P<0.05);disinfectant residue,use frequency of disinfection equipment,source water turbidity and pH were the influencing factors for the disinfection effect of groundwater(P<0.05).
Conclusion
The disinfection effect of drinking water in rural areas of Zhejiang Province is associated with source water quality,scale of plants,water purification technique and so on. The disinfection process should be improved,the management of water plants should be strengthened to reduce the risk of microbial contamination.
9.Evalution of the combination of dexmedetomidine and fentanyl in sedation during awake nasotracheal intu-bation
Shengliang PENG ; Dan HUANG ; Fan XIAO ; LUJun ; ZHOUBin ; Haijun HU ; Guohai XU ; Zhenzhong LUO
The Journal of Practical Medicine 2018;34(12):2061-2064,2069
Objective To evalute the combination of dexmedetomidine and fentanyl in sedation during awake nasotracheal fiberoptic intubation. Methods One hundred and twenty ASAⅠ or Ⅱ patients scheduled to receive general anesthesia were randomly divided into 3 groups (n = 40 in each group). Patients in group L received an infusion of 1 μg/kg dexmedetomidine,patients in group H received an infusion of 2 μg/kg dexmedeto-midine ,and patients in group DF received an infusion of 1 μ g/kg dexmedetomidine added to 1 μ g/kg fentanyl. Nasotracheal intubation was performed after complete topical anesthesia. HR and MAP were recorded before anes-thesia(baseline,T0),before intubation(T1)and immediately after intubation(T2),respectively. The intubation score(vocal cord movement,coughing and limb movement),fiberoptic intubation score,nasotracheal intubation score and airway obstraction score were assessed in all aptients. On the first post-operative day,recall,adverse events and satisfaction score were also assessed. Results HR and MAP at T1 in three groups were significantly lower than those at T0(P < 0.05,respectively ). HR and MAP at T2 in group L were significantly higher than those in group H and DF(P<0.05,respectively). More incidence of vocal cord closed,severe cough,severe limb movement,heavy grimacing,defensive movement of head and hands after nasotracheal intubation were observed in group L than those in the other two groups. The incidence of airway obstraction and bradycardia in group H were higher than those in group L and DF. Patients in group L had lower postoperative satisfaction scores. Conclusion Adding 1 μg/kg fentanyl to 1 μg/kg dexmedetomidine is a good method for awake nasotracheal fiberoptic intuba-tion,which can prevent the risk of airway obstruction associated with the increase of dexmedetomidine dose,with the achievement of the same favorable sedation.
10.Effect of ganglioside combined with hyperbaric oxygen on mild to moderate craniocerebral trauma and its influence on serum NSE and MBP levels
Yankai XU ; Cheng LUO ; Shaoling MA ; Shengliang XU ; Jin WU
Chinese Journal of Primary Medicine and Pharmacy 2018;25(2):225-228
Objective To study the effect of ganglioside combined with hyperbaric oxygen on mild to moderate craniocerebral trauma , and its effect on serum neuron specific enolase ( NSE ) and myelin basic protein ( MBP) levels.Methods Following the random number table method ,110 patients with mild and moderate cranioce-rebral trauma were randomly divided into the observation group and the control group ,55 cases in each group.The observation group was treated with ganglioside combined with hyperbaric oxygen therapy ,while the control group was treated with hyperbaric oxygen alone .The clinical efficacy ,the Glasgow Coma Scale ( GCS) ,the levels of serum NSE and MBP before and after treatment were compared between the two groups .Results The effective rate of the observation group was 94.55%,which was significantly higher than 81.82% of the control group,the difference was statistically significant(χ2 =4.274,P<0.05).The D-value of GCS before and after treatment in the observation group was (2.97 ±0.59)points,which was significantly higher than that of control group (t=17.601,P<0.05). The levels of serum NSE and MBP of the observation group were significantly lower than those of the control group ( t=14.674,10.450,all P<0.05).Conclusion Ganglioside combined with hyperbaric oxygen can promote the recovery of neurological function ,has significant effect and high safety in the treatment of mild to moderate craniocerebral trauma .


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