Interpretation and reflection of Traditional Chinese Medicine registration evidence system in Canada / 国际中医中药杂志

Traditional Chinese Medicine (TCM) products could be registered as natural health products (NHPs) in Canada. Its registration process could be mainly divided into simple-application, traditional-application and non-traditional application. By analyzingi the TCM registration evidence system and its safety, effectiveness and quality required by different registration categories in Canada, we found that "simple-application" procesure needs to submit evidence based on the parameters of a component in the monograph. As for "traditional application", TCM products need to be used at least 50 years with, traditional material or Pharmacopoeia can be used as evidence; As for non-traditional application, TCM products need to provide evidence according to the disease risk level, and most of them need to provide scientific experiment evidence. Therefore, from the experience of TCM registration evidence system in Canada, the registration of TCM products should pay attention to improve the its classification method, refining its evidence requirements and data types, promoting the formulation of monograph of TCM, realizing the scientific evaluation and rapid review of classic famous prescriptions, and promoting the inheritance and innovative development of TCM in China.

Introduction and analysis of the registration process of Traditional Chinese Medicine as a natural health product in Canada / 国际中医中药杂志

At present, the registration process of Traditional Chinese Medicine (TCM) in Canada is refering to the requirements of Natural Health Products (NHPs). In terms of registration material, both NHPs and TCM include plants, animals and minerals with medicinal components, but the fundamental difference between them is that TCM is guided by the basic theory of TCM. As for the registration classification of TCM in Canada, first of all, judge whether the product to be applied for is NHPs; Secondly, we should clarify the types and ways of registration, mainly including simple application, traditional application and non-traditional application, and provide application forms, label texts, summary reports, evidence, animal tissue forms, finished product specifications and other materials according to different requirements. At present, the successful registration experience of TCM products in Canada mainly mainly includes applying for superior varieties, selecting appropriate application channels, communicating with local health management units and providing sufficient scientific evidence and good clinical application records. The regulations on the registration of NHPs in Canada have not fully considered the particularity of TCM and the registration of TCM products is still facing some difficulties. In the future, we can learn from the registration process and requirements of the Health Canada, promote the interconnection and mutual recognition of the Pharmacopoeia of the People's Republic of China and the NNHPD monographs in Canada, reduce the obstacles to the local application for registration of TCM, and promote the further improvement of the international standards of TCM.

Analysis of Traditional Chinese Medicine regulation in Canada / 国际中医中药杂志

This paper analyzes the laws, regulations and concre measures of Traditional Chinese Medicine (TCM) in Canada, so as to provide reference for TCM products to enter Canada, and for the establishment of TCM regulation system and the improvement of its detailed rules in China. The regulation of TCM in Canadian, on the one hand, supervision is to provide guidance for the protection of consumers' rights and interests, including the guidance of rational drug use and rational purchase for consumers; on the other hand, it is to supervise enterprises, including the safety, effectiveness and quality certification of TCM products, labeling and packaging requirements, as well as the site certification of product manufacturing, packaging, labeling and import. The Ministry of health of Canada takes evidence as the core of evaluation, and ensures the safe and effective use of TCM products in Canada through product and site licensing evaluation. In the supervision of TCM, relevant departments in China should further strengthen the protection of consumers' drug rights and interests, strengthen the construction of TCM registration evidence system, and pay attention to the risk management of drug production quality.

Analysis of simplified registration of traditional herbal medicinal products in European Union / 国际中医中药杂志

Europe occupies an important position in the world herbal medicine market. The registration of Traditional Chinese Medicine (TCM) in EU is of great significance to the internationalization of TCM. The European Medicines Agency (EMA) has designed a relatively complete management system and regulatory guidelines for the registration and supervision of herbal medicinal products. The promulgation of the DIRECTIVE 2004/24/EC (2004 / 24 / EC) indicates that TCM could enter the EU market through simplified registration. Based on the registration conditions, registration authority and document guideines of Traditional Herbal Medicinal Products (THMPs) in EU, this paper analyzes the application requirements of simple registration of traditional herbal products in EU, and provides suggestions for the simplified registration of TCM in EU according to the registration requirements of medicinal history, quality requirements and application data format.

Construction of the pharmacoeconomic evaluation system of Chinese patent medicine in the prevention and treatment of major chronic diseases / 中国药房

OB JECTIVE To explore the construction of system of pharmacoeconomic evaluation fo r Chinese patent medicine in preventing and treating major chronic diseases. METHODS The problems in pharmacoeconomic evaluation of Chinese patent medicine for preventing and treating major chronic diseases were analyzed. Based on the problem ，the pharmacoeconomic theory ， tools and methods that can be used to systematically evaluate the prevention and treatment of major chronic diseases by Chinese patent medicine were explored to build the relevant pharmacoeconomic evaluation system. RESULTS & CONCLUSIONS Traditional Chinese medicine shows the advantages in the prevention and treatment of major chronic diseases. This unique advantage needed to be explored ，reflected and proved in the pharmacoeconomic evaluation. The pharmacoeconomic evaluation of Chinese patent medicine had made some progress in recent years. However ，there were still deficiencies of theory and methodology in the pharmacoeconomic evaluation for the advantages of Chinese patent medicine in preventing and treating major chronic diseases. It was difficult to truly and comprehensively reflect the value of Chinese patent medicine by simply applying the economic evaluation indicators and technologies of chemical medicine. It is necessary to focus on the unique pharmacoeconomic attributes of Chinese patent medicine ，excavate the economic value indicators of Chinese patent medicine for “preventive treatment of disease ” and playing the self-regulation role of human body ，comprehensively consider the pharmacoeconomic particularity of Chinese patent medicine in respects of research design ，research angle ，target population ，intervention measures and control selection ，research time limit and evaluation method ，etc. Through the use of system modeling ，real-world research and the establishment of Chinese medicinal quality of life scale that reflects the characteristics of TCM ，the economic value of Chinese patent medicine in the prevention and treatmen t of major chronic diseases is reflected comprehensively，so as to reflect the advantage of Chinese patent medicine in preventing and treating major chronic diseases.

Current Situation and Improvement Suggestion of Traditional Chinese Medicine Policy in Guangdong-Hong Kong-Macao Greater Bay Area / 中国药房

OBJECTIVE：To study the current situation of traditional Chinese medicine （TCM）industry policy in Guangdong- Hong Kong-Macao greater bay area ，and to provide suggestions for the follow-up planning and layout. METHODS ：The content analysis method was used to code and measure the policy text of TCM industry in Guangdong-Hong Kong-Macao greater bay area issued by the central government and local government as of April 2020 from the perspective of policy tools. The current development focus and existing problems of the industry were summarized to put forward reasonable suggestion. RESULTS & CONCLUSIONS：A total of 34 relevant policy texts were retrieved ，including 9 at the central government level and 25 at the local government level. In respective of essential policy tool ，the supply-oriented ，demand-oriented and environmental policy tools of TCM industry in Guangdong-Hong Kong-Macao greater bay area accounted for 58.10％，22.86％ and 19.05％，respectively. Among supply-oriented policy tools ，hardware construction accounted for 40.98％，internal communication for 26.23％，quality construction for 22.95％，and international exchange for 9.84％；there was no specific implementation rules and programs for policy tools ，which affect their operability. The demand-oriented policy tools included health service （75.00％），international trade （16.67％），service outsourcing （4.17％）and government subsidies （4.17％）；the use of the latter three approaches limited the openness of the industrial market. The environmental policy tools included target planning （40.00％），access rules （25.00％）， intellectual property （30.00％）and financing support （5.00％），but needed to improve the support of laws and regulations and relevant measures. In respective of the value chain of TCM industry ，34 policy texts showed 4 contents，including platform construction（36.19％），scientific and technological innovation （19.05％），market expansion （23.81％），exchange and cooperation （20.95％）；the lack of scientific and technological innovation and exchange and cooperation limited the standardization ， modernization and internationalization of TCM. It suggested to optimize the supply-oriented policy tools ，improve the operability of policies； pay attention to the demand-oriented and environmental policy tools ， highlight the role of marketization and standardization；pay attention to the integration of basic policy tools and industrial value chain ，and achieve the standardization ， modernization and international development of TCM in Guangdong-Hong Kong-Macao greater bay area.

The mediating effect of coping style between self-esteem and negative emotions among college students with left-behind experience / 中华行为医学与脑科学杂志

Objective To explore mediating effect of coping style on the relationship between self-esteem and negative emotions among college students with left-behind experience. Methods The investiga-tion was carried out among 663 college students with left-behind experience by multistage sampling method, using coping style scale, self-esteem scale, self-rating anxiety scale and Beck depression inventory. Re-sults Scores of all scales were shown as follows: self-esteem (3. 09±0. 51),anxiety (34. 94±7. 90),de-pression (8. 80±8. 72),solving problem coping (9. 03±2. 57),help-seeking coping (5. 70±2. 24),self-bla-ming coping (3. 54±2. 24),fantasy coping (4. 56±2. 35),avoidance coping (4. 74±2. 02),rationalizing coping (4. 67±2. 32). Anxiety and depression had significantly negative correlations with self-esteem(r=-0. 46,-0. 50,P<0. 01) ,solving problem coping( r=-0. 29,-0. 30,P<0. 01) and help-seeking coping( r=-0. 08,-0. 18,P<0. 01) ,and significantly positive correlations with rationalizing coping( r=0. 32,0. 28,P<0. 01),self-blaming coping(r=0. 45,0. 43,P<0. 01),fantasy coping(r=0. 33,0. 23,P<0. 01) and avoid-ance coping(r=0. 26,0. 23,P<0. 01). There were partially significant mediating effects of solving problem coping(-0. 09,95％CI:-0. 06--0. 13),rationalizing coping(-0. 03,95％CI:-0. 01--0. 05),self-blaming coping(-0. 11,95％CI:-0. 06--0. 15) ,fantasy coping(-0. 02,95％CI:-0. 01--0. 04) ,and non-significant effects of help-seeking coping and avoidance coping in the relationship between self-esteem and negative e-motions. Conclusion Solving problem coping,rationalizing coping,self-blaming coping and fantasy coping play a partial mediating role in the relationship between self-esteem and negative emotions,while the media-ting effect of help-seeking coping and avoidance coping are not significant.

Role and treatment strategy of hypoxia in the pathogenesis of multiple myeloma / 国际肿瘤学杂志

Hypoxia environment plays an important role in the pathogenesis of multiple myeloma such as stimulating angiogenesis,increasing bone destructiong,epithelial-mesenchymal transition and drug resis-tance.Thus,there are many therapeutic strategies targeting the hypoxic environment of multiple myeloma,such as hypoxia-activated prodrug and molecular targeting inhibitors.Targeting the hypoxic environment is a promis-ing therapy for multiple myeloma in the future.

Inhibition of RPMI-8226 myeloma cell xenografted tumor angiogenesis by down-regulation of Notch1 / 国际肿瘤学杂志

Objective To investigate the effects of Notch1 siRNA on VEGF and angiogenesis of myeloma cell line RPMI-8226 in vitro and in vivo.Methods In vitro,Notch siRNA was transfected into RPMI-8226 cells,and then cell supernatant VEGF secretion was detected using ELISA method.Expression levels of Notch1 and VEGF proteins were assayed by Western blotting.RPMI-8226 cells were subcutaneously transplanted in NOD/SCID mice,and then the tumor mice were divided into three groups randomly:NS group (Notch1 siRNA-transfected group),CS group (Control siRNA-transfected group) and UN group (Untransfected group),and the changes of tumor volume were observed.Immunohistochemical staining was used to detect the changes in expression levels of Notch1,VEGF and CD34.Results Notch1 and VEGF proteins expressions of RPMI-8226 cells were significantly decreased by Notch1 siRNA.At 48 h and 72 h,VEGF secretion level in NS group was significantly different with CS group [(120 ± 25) ng/L ∶ (175 ± 15) ng/L,t =3.27,P ＜ 0.05;(145 ± 24)ng/L ∶ (295 ± 17)ng/L,t =8.83,P＜0.01].At 13 d,17 d and 21 d,tumor volume in NS group was significantly reduced,that was significantly different with CS group [(1 548 ± 218) mm3 ∶ (1 820 ± 64) mm3,t =2.68,P ＜0.05;(1 200 ±75)mm3 ∶ (2 180 ±84)mm3,t =19.46,P＜0.01;(1 150 ±88)mm3 ∶ (2 250 ± 145)mm3,t =14.50,P ＜0.01].The expression levels of Notch1 and VEGF protein were decreased by Notch1 siRNA.The expression levels of Notchl and VEGF in NS group were different with CS group [(16.33 ±2.52)％∶ (75.33 ±2.52)％,t=28.71,P＜0.01;(5.00±1.00)％∶29.67±2.08 ％,t=18.50,P ＜ 0.01].Notch1 siRNA reduced the number of transplanted tumor neovascularization in NS group.Microvascular density in NS group was significantly less than that in CS group [(14.67 ± 2.52) ∶ (30.00 ± 5.00),t =4.74,P ＜ 0.01].Conclusion In vitro,Notch siRNA reduces human myeloma cell RPMI-8226 cell supernatant VEGF secretion.In vivo,Notch siRNA can reduce tumor volume and the number of new blood vessels in transplanted-multiple myeloma mice.Thus,Notchl is an effective molecular target for anti-angiogenesis in myeloma.

Changes of oral flora within 6 months after fixed metal orthodontic treatment / 中国组织工程研究

BACKGROUND:Currently, there are a lot of studies addressing oral microflora variation in patients wearing fixed orthodontic appliance. OBJECTIVE:To determine the changes in Streptococcus mutans, Lactobacil us and oral health in teenagers wearing metal orthodontic appliances. METHODS:Twenty-three who were subjected to fixed metal orthodontic appliances as testing group and 18 adolescent volunteers with no oral diseases served as controls. We col ected saliva samples from al the participants immediately, 90 days and 180 days after fixed metal orthodontic treatment to detect changes in Streptococcus mutans and Lactobacil us, which can lead to dental caries, and other oral parameters, including gingival index and oral hygiene index. RESULTS AND CONCLUSION:In the control group, there were no difference in Streptococcus mutans, Lactobacil us, gingival index and oral hygiene index at three time points. In the testing group, the hazard levels of Streptococcus mutans and Lactobacil us were significantly increased at 90 and 180 days than immediately after fixed metal orthodontic treatment (P<0.05), as wel as the gingival index at 90 days and oral hygiene index at 180 days became worse (P<0.05). At 180 days after fixed metal orthodontic treatment, the hazard levels of Streptococcus mutans and Lactobacil us, gingival index and oral hygiene index were severer in the testing group than the control group (P<0.05). These findings indicate that the fixed metal orthodontic appliance could lead to increasing of Streptococcus mutans and Lactobacil us, and reduce oral health status badly.

Cognitive behavioral intervention in the nursing care for chronic obstructive pulmonary disease / 中华医院管理杂志

Objective To explore the application effect of cognitive behavioral intervention on chronic obstructive pulmonary disease nursing care.Methods 80 patients with chronic obstructive pulmonary disease were randomly divided into an experimental group and a control group(n=40).Both groups were given medical treatment and conventional nursing care,and the control group was given the cognitive behavioral intervention nursing care additionally.The average days of stay,the ratio of readmission,the treatment adherence,and smoking cessation rate in one year were recorded.Moreover,the life quality of the two groups was analyzed with a CAT assessment test.Results Compared with the control group,the experimental group achieved shorter average days of stay,higher medication adherence and smoking cessation rate,lower readmission rate and admission rate.The experimental group achieved better life quality with lower CAT value than the control group.Conclusion Cognitive behavioral intervention can obviously improve the treatment effectiveness of patients with chronic obstructive pulmonarv disease.

Roles of hypoxia and Notch1 in multiple myeloma / 国际肿瘤学杂志

Recently numerous studies have demonstrated that Notch signaling pathway plays a critical role in regulating cell proliferation and differentiation in hematopoietic microenvironment,which is associated with MM occurrence and the drug resistance.The latest researches show that there are close relations between hypoxia and Notch signaling pathway in tumor occurrence and progression.Exploring the interactions of microenvironment of hypoxia,HIF-1α and Notch signaling pathway will provide theoretical basis for MM targeted therapy.

Experimental study on phosphatidylinositol 3 kinase signal transduction pathway in Barrett esophagus genesis / 中华消化杂志

Objective To explore the relationship between phosphatidylinositol 3 kinase (PI3K)/protein kinase B (Akt)/mammals target protein rapamycin (mTOR) signal transduction pathway and Barrett esophagus genesis.Methods A total of 140 rats were divided into sham operated group (n=10),iron group (n =10),esophageal duodenal side anastomosis group (n =30),esophageal duodenal side anastomosis plus iron group (n-30),esophageal gastric duodenal side anastomosis group (n=30) and esophageal gastric duodenal anastomosis plus iron group (n=30).In the end,10 normal esophagus tissue specimens,62 reflux esophagitis tissue specimens and 34 Barrett's esophagus tissue specimens were obtained.The expression levels of epidermal growth factor receptor (EGFR),Akt,phospho Akt (p-Akt),phospho-mTOR (p-mTOR) protein were detected by immunohistochemistry.Single factor analysis of variance,SNK between two groups and nonparametric correlation analysis were performed for statistical analysis.Results The protein expression levels of EGFR,Akt,p-Akt,p-mTOR in Barret(s esophagus tissues were higher than those in reflux esophagitis tissues and normal esophagus tissues (EGFR 0.1799±0.0367 vs 0.0438±0.0025 and 0.0277±0.0069,q=6.79,4.13; Akt 0.1874±0.0250 vs 0.0986±0.0093 and 0.0383±0.0048,q=6.51,3.56; p-Akt 0.1418±0.0130 vs 0.0592±0.0027 and 0.0281 ±0.0017,q=7.68,3.99; p-mTOR 0.1591±0.0275 vs 0.0674 ±0.0059 and 0.0112±0.0017,q=5.62,4.11; all P＜0.05).The protein expression levels of EGFR,Akt,p-Akt,and p-mTORin reflux esophagitis tissues were higher than those in normal esophagus tissues(q=4.67,4.29,4.27,4.03; all P＜0.05).Conclusion PI3K/Akt/mTOR signal transduction pathway were activated in reflux esophagitis and Barrett's esophagus,which provided theoretical basis for clinical multi-target treatment for diseases.

Notch signal pathway and the pathogenesis of multiple myeloma / 国际肿瘤学杂志

Notch signal pathway can regulate the morphogenesis,apoptosis and cellular proliferation of normal tissues and organs,which plays an important role in regulating hematopoietic cells proliferation and differentiation in bone marrow microenvironment.The occurrence and development of multiple myeloma(MM)are closely related to the bone marrow microenvironment in which many signal pathways are involved.Recent studies show that Notch signal pathway promotes the development and progression of many cancers including MM,which plays key roles in tumor invasion and drug resistance.This review focus on the recent findings on Notch signal pathway in MM,and reveals that Notch signal pathway will be identified as a potential new therapeutic target in MM.

Clinical Features and Diagnosis of Kennedy's Disease / 中国康复理论与实践

@#ObjectiveTo explore the clinical features and diagnosis of one Kennedy's disease.MethodsOne patient was clinically diagnosed as Kennedy's disease on the basis of the clinical features including slowing progression of disease, symptoms, nervous system signs, electromyography and nerve conduction velocity results and family history. His CAG number from the repetitive CAG sequence in the first exon of androgen receptor gene was determined using PCR.ResultsThe progression of Kennedy's disease is usually much slower. The CPK and testosterone levels increased in patient. EMG revealed neurogenic injury. The numbers of CAG region of the first exon of androgen receptor gene were 51 in the patient.ConclusionDespite its relatively typical manifestations, the definite diagnosis of Kennedy's disease should be made by detecting the number of CAG from the repetitive CAG region in the first exon of androgen receptor gene.

Texture analysis of SPIO-enhanced MR imaging in rat models of hepatocellular carcinoma and hepatocirrhosis based on gray level co-occurrence matrix / 中国医学影像技术

Objective To analyze the texture features of SPIO-enhanced MR imaging in rat models of hepatocellular carcinoma (HCC) and hepatocirrhosis with gray level co-occurrence matrix (GLCM). Methods HCC and hepatocirrhosis models were established in rats. SPIO-enhanced MR images were obtained. A total of 161 regions of interests (ROIs, 81 of HCC and 80 of hepatocirrhosis) were selected manually. Feature values as angular second moment, contrast, correlation, inverse difference moment, entropy, variance were extracted based on GLCM. The differences of feature values between two groups were statistically analyzed. Results In SPIO-enhanced MR images, hypointense signal changes were found in hepatocirrhosis, as well as hyperintensity in HCC nodules and intermixed intensity in larger HCC nodules. Correlation and entropy values of HCC group were higher than that of hepatocirrhosis group, while the angular second moment, contrast, inverse difference moment, and variance values were lower than hepatocirrhosis group. Conclusion The feature values based on GLCM could be used for the further computer aided diagnosis of SPIO-enhanced MR images in rat models of HCC and hepatocirrhosis.

The arthroscopic exhibition of 310 knee joints of 223 rheumatoid arthritis / 中华风湿病学杂志

Objective To investigate the arthroscopic presentations of knee joint of rheumatoid arthritis (RA). Methods During December 2005 to February 2008,223 patients with RA in our department underwent knee arthroscopy examination. The arthroscopic presentations of 310 knee joints were analyzed retrospectively. Results Synovial hyperplasia were observed in 305 knees (98.4% ) out of 310 ones. The medial part (88.4%), intercondylar fossa (86.1%) and lateral space (83.2%) were the most frequent localization of synovial hyperplasia, which was less common in the suprapatellar bursa. Hyperplastic synovium of 296 knees had coralloid or cotton-wool like presentation, with central nourishing vessels. Nine knees were lichen-like hyperplasia, without nourishing vessels. Different degrees of pathological changes or defect could be seen in 301 knees, including merely cartilage degeneration in 63 knees, cartilage degeneration plus cartilage damage or defect in femoral medial condyle or lateral condyle in 124, 163 knees, in which 53, 45 with the damage deep to the cancellous bone. Most anterior or posterior cruciate ligament (in 274 knees) were covered with hyperplastic synovium, anterior cruciate ligament of 51 knees were partial ruptured, 5 ones were completely ruptured,while 23 and 1 case had these presentations in the posterior cruciate ligament.. Meniscus damage was commonly seen under arthroscope. 234 and 38 knees had medial meniscus torn or disappeared completely, while 214 and 45 in the lateral meniscus. Conclusion Synovial hyperplasia is commonly seen in knee joints of RA and most commonly seen in the intercondylar fossa, medial space and lateral space, but less common in the suprapatellar bursa. The hyperplastic synovium appears most often in the coralloid or cotton-wool like form, Cartilage damage is commonly seen in knee joints of RA. The most serious damage of the cartilage is seen in the femoral medial condyle or lateral condyle. Partial or complete anterior cruciate ligament rupture can be seen in one proportion of knees. In most knees of RA, meniscus are torn or disappeared mostly or completely.

Seasonal Distribution and Breeding Conditions of Acaroid Mites / 环境与健康杂志

Objective To investigate the breeding densities and the seasonal distribution of Tyrophagus putrescentiae, Acarus siro, Lepidoglyphus destructor, and Dermatophagoides farinae in Bengbu City, 4 common storage acaroid mites during Feb.2006-Jan.2007. Methods The samples were collected and isolated by Waterflotation and Tullgren, then counted and identified the four acaroid mites from 20 different habitats. Results 4 species of acaroid mites had high breeding density in ham, wheat, seed and house dust. The number of the mite increased from Apr. or May, and to the peak during July and Aug. and declined from Sep. or Oct.. Seasonal distribution of the individual acaroid mites might be different. Conclusion 4 species of acaroid mites are widely distributed in Bengbu city with distinctive seasonal distribution.

Study on Drug Safety of Emergent Public Health Events / 中国药房

OBJECTIVE: To provide references for the improvement of drug safety of emergent public health events.METHODS: The characteristics of drug demands in emergent public health events were analyzed to guarantee the characteristics of drug safety so as to explore effective safeguard strategy.RESULTS & CONCLUSIONS: Special system and countermeasure are required to guarantee drug safety of emergent public health events.The strategy includes three aspects,i.e.adequate plan in advance,rapid response and timely consummation after the event.

Analysis of the Structural Convergence of Regional Pharmaceutical Idustry / 中国药房

OBJECTIVE: To discuss about the acceptability of the structural convergence of regional pharmaceutical indus- try. METHODS: According to the calculation of LQ and LQS2, the regional distributing structure of pharmaceutical industry was judged. RESULTS & CONCLUSION: The results showed that the regional distribution of pharmaceutical industry in China assumed characteristics of regional convergence. Because advanced technology and large scale are very important to pharmaceutical industry, the structural convergence of regional pharmaceutical industry is not acceptable.