Specification for Quality Control in Traditional Chinese Medicine Clinical Trials（GB/T 47336-2026） is the first national standard in the field of clinical research on traditional Chinese medicine （TCM）， aims to address the core issue that the quality shortcomings of current TCM clinical research restrict the transformation of achievements and international recognition. Through the interpretation of the core contents of this standard， including its scope of application， graded quality control system， TCM-specific quality control requirements， implementation and responsible entities， responsibilities of quality control personnel， formulation of quality control plans， critical nodes of quality control， and quality control archive management， it is believed that the promotion and implementation of this standard are of great significance for improving the standard system of TCM clinical research， enhancing research quality， optimizing the quality management model， and promoting the internationalization process of TCM. Meanwhile， the implementation paths for the standard are discussed， including carrying out pilot applications in institutions， establishing publicity， implementation， and training mechanisms， encouraging multi-party collaborative supervision， and setting up implementation feedback mechanisms. On this basis， the challenges that may be encountered during implementation， such as resource input pressure， difficulties in implementing TCM-specific quality control， and a relative shortage of interdisciplinary composite talents， are sorted out， and corresponding strategies are proposed， which can provide references for relevant researchers and practitioners.

Objective:To measure and analyze upper lip morphology variation before and after the cross-arch fixed restoration of the maxillary implant-supported prostheses using cone- beam CT (CBCT) to provide an esthetic objective reference for maxillary edentulous patients.Methods:There were 32 maxillary edentulous patients selected in the Department of Dental Implantology, The Affiliated Stomatological Hospital of Nanjing Medical University from January 2010 to December 2023. The CBCT data of patients with maxillary full-arch implant-supported fixed prostheses were retrospectively collected before implantation (T0), at the time of radio-guide insertion (T1), and after final repair (T2). The length and thickness of the upper lip were measured and analyzed at each time point, and the correlation between the upper lip contour data and facial esthetic parameters was analyzed.Results:After the final prosthodontic treatment, the length of the upper lip was significantly increased from (21.72±2.84) mm to (24.98±2.93) mm ( t=-8.13, P<0.001) compared with that before implant treatment. The widths of the middle and vermilion of the upper lip (Sm-Hm/Ls-UP), were reduced from (13.24±1.41), (12.81±1.67) mm to (11.36±1.67), (10.21±1.69) mm, with significant differences ( t=7.79, P<0001; t=9.37, P<0.001). The lower face height (Sn-Gn) was increased from (54.52±4.95) mm to (58.70±4.42) mm, with significant differences ( t=-11.05, P<0.001). However, the nasolabial angle reduced significantly from 95.35°± 7.70°to 90.53°±7.28°( t=7.68, P<0.001). The width of the middle of the upper lip with a radiation guide was (10.94±1.24) mm, and it increased significantly compared with that after the final prosthesis treatment ( t=-0.76, P<0.05). The proportion of straight upper lip profiles accounted for 59% (19/32), and the proportion of concave upper lip profiles accounted for 41% (13/32) after the final prosthesis treatment. In addition, the results of correlation analysis showed that the nasolabial angle variation was weak and negatively correlated with residual bone height ( r=-0.37, P=0.490). Conclusions:After the treatment of the maxillary full-arch implant-supported fixed prosthesis, the length of the upper lip increases, and the thickness of the upper lip becomes significantly thin. The maxillary full-arch implant-supported fixed prostheses support upper lips to improve the patients′ side appearances.

Frailty is a clinical condition associated with aging, encompassing deficiencies in physical performance, nutritional status, mental health, and cognition.Physical exercise has proven to be an effective strategy for maintaining functional abilities and alleviating frailty symptoms in older adults.Exercise helps in preserving or enhancing bone density, muscle mass, strength, and overall function.In recent years, there has been increasing attention on the impact of resistance exercise on the prognosis of frailty in the elderly population.This article explores the mechanisms of resistance exercise in preventing and treating frailty, examines the effects of different types of resistance exercise on age-related weakness, and reviews related research on the use of resistance exercise for preventing and treating frailty.The findings of this study provide valuable insights for developing precise exercise prescriptions that incorporate multiple modes of exercise for frail older patients.

Objective:To explore the effect of different calcium intakes on metabolism in healthy adults with traditional Chinese dietary pattern.Methods:A total of 64 college students (32 males and 32 females) were recruited from the School of Public Health, Harbin Medical University from September to October 2015. A prospective, randomized, double-blind, placebo-controlled trial design (RCT trial) was used to strictly control the diet of the volunteers through meal preparation, so that the background of the experimental and the control group was exactly the same. In our study, 64 healthy adults were randomly divided into two groups (calcium supplementation and control). The two groups were given the same diet every day. One group was given 400 mg/d of calcium supplementation, which was close to the recommended intake in China (800 mg/d); the other group was given pacebo, the average calcium intake was close to the average intake of Chinese (400 mg/d), calcium intervention lasted for 35 days. Serum and urine samples from pre-intervention, mid-intervention, and post-intervention were collected for metabolomics studies and detection of serum hormone levels and biochemical indicators. PCA and PLS-DA were used to compare the differences in serum and urine metabolites. After adjusting for age and BMI, the differences of hormones [parathyroid hormone, 1, 25(OH) 2D 3] and biochemical indicators were compared by repeated measurement variance analysis. Results:The 64 subjects were aged 23-28 years, including 32 males and 32 females. The baseline characteristics of the calcium supplementation group and the control group were balanced. The results showed that there were no significant differences in blood and urine metabolites, metabolic hormone [parathyroid hormone, 1, 25(OH) 2D 3] levels and biochemical indicators(serum Ca, serum P, glycolipid metabolism and hepatorenal function indicators)between the calcium supplementation group and control group at each time point throughout the trail ( P>0.05). Conclusion:No health hazards associated with calcium deficiency was observed in healthy adults in the short term at current calcium intake level (300-400 mg/d).

Objective:To explore the effect of different calcium intakes on metabolism in healthy adults with traditional Chinese dietary pattern.Methods:A total of 64 college students (32 males and 32 females) were recruited from the School of Public Health, Harbin Medical University from September to October 2015. A prospective, randomized, double-blind, placebo-controlled trial design (RCT trial) was used to strictly control the diet of the volunteers through meal preparation, so that the background of the experimental and the control group was exactly the same. In our study, 64 healthy adults were randomly divided into two groups (calcium supplementation and control). The two groups were given the same diet every day. One group was given 400 mg/d of calcium supplementation, which was close to the recommended intake in China (800 mg/d); the other group was given pacebo, the average calcium intake was close to the average intake of Chinese (400 mg/d), calcium intervention lasted for 35 days. Serum and urine samples from pre-intervention, mid-intervention, and post-intervention were collected for metabolomics studies and detection of serum hormone levels and biochemical indicators. PCA and PLS-DA were used to compare the differences in serum and urine metabolites. After adjusting for age and BMI, the differences of hormones [parathyroid hormone, 1, 25(OH) 2D 3] and biochemical indicators were compared by repeated measurement variance analysis. Results:The 64 subjects were aged 23-28 years, including 32 males and 32 females. The baseline characteristics of the calcium supplementation group and the control group were balanced. The results showed that there were no significant differences in blood and urine metabolites, metabolic hormone [parathyroid hormone, 1, 25(OH) 2D 3] levels and biochemical indicators(serum Ca, serum P, glycolipid metabolism and hepatorenal function indicators)between the calcium supplementation group and control group at each time point throughout the trail ( P>0.05). Conclusion:No health hazards associated with calcium deficiency was observed in healthy adults in the short term at current calcium intake level (300-400 mg/d).

Objective To investigate the clinical characteristics and prognosis of patients with acute aortic dissection (AAD) and hypertension,and explore other related prognostic factors in AAD.Methods The present study enrolled consecutive patients diagnosed with AAD who were admitted to Peking University People's Hospital between January 2000 to December 2015.Patients diagnosed with AAD by CT angiography,aortography or magnetic resonance imaging within 14 days of onset were included.Patients with infectious diseases,haematological diseases,malignancies,autoimmune diseases and patients without clearly clinical diagnosis or incomplete data were excluded.The patients were initially divided into two groups based on their history of hypertension,and their clinical characteristics were compared and analyzed.We further divided AAD patients into survival group and death group according to their in-patient outcomes,and factors related to their prognoses were analyzed.Logistic regression analysis was applied to analyze the independent risk factors related to hospital death in AAD patients with P＜0.05 as the significant value.Results The hypertensive group contained 237/346 cases included (68.45％),patients in this group were generally older than their non-hypertensive counterparts,accompanied by increased prevalence of comorbidities (coronary heart diseases or diabetes) and a statistical significant elevated admission blood pressures (systolic and diastolic,P＜0.05).No significant difference were found between the groups in terms of white blood cell and platelet count,D-dimer,neutrophil to lymphocyte ratio(NLR),fibrinogen,serum creatinine and serum lipid profiles (P＞0.05).Hypertensive patients were less likely to receive surgical treatment compared with those without hypertension(P＜0.05),with increased risk of in-hospital mortality (P＞0.05).Further logistic regression analysis revealed the presence of hypertension did not independently predict in-hospital mortality of AAD patients.Factors such as age,Stanford classification of the AAD,NLR and platelet counts were found to have independent predictive values for in-hospital mortality (P＜0.05).Conclusion AAD patients with hypertension are generally older,have more comorbidities such as coronary heart diseases and diabetes.The presence of hypertension itself is not directly associated with in-hospital mortality in AAD patients,while the Stanford classification,age,NLR and platelet counts are independent risk predictors.

Objective: To investigate the clinical characteristics, coagulation function and associated prognostic factors of acute aortic dissection. Methods: The clinical data of 119 patients with acute aortic dissection (AAD) admitted to Beijing University People's Hospital from November 2008 to January 2016 were analyzed. All the participants were confirmed by computed tomography angiography, and the onset time was less than 14 days. Data of blood routine test, coagulation function at the first admission were collected, and surgical intervention and prognosis were recorded. All the patients, according to the prognosis, or whether disseminated intravascular coagulation (DIC) occurred, were divided into two groups, and the differences between the two groups were compared. Logistic regression analysis was applied to analyze independent risk factors related to in-hospital death in AAD patients. Results: In 119 patients with AAD, the average age was (52.9±14.2) years, with a male/female ratio of 5.3:1. Pain was the most common clinical manifestation in patients with AAD, accounting for more than 90.0%. The nature of pain was mostly expansible and/or transitive pain. Dominant DIC occurred in 13 cases (10.9%), and 7 patients died (53.8%). There were significant differences between the DIC group and non-DIC group in neutrophil/lymphocyte ratio (NLR), platelet count, fibrinogen, D-dimer, FDP, PT, APTT and mortality rate (P<0.05). All the 16 patients in the death group were type A AAD, among which, 7 patients (43.8%) developed with DIC. There were significant differences between the death group and survival group in NLR, platelet count, fibrinogen, D-dimer, FDP, PT, APTT, DIC proportion and surgical operation rate (P<0.05).Logistic regression analysis showed that NLR and platelet count were independent risk factors of in-hospital death (P<0.05). Conclusions D-dimer has a high diagnostic and prognosis value for AAD. The mortality increased with the activation and depletion of platelet. Once DIC occurs, the prognosis is extremely poor. NLR and platelet count are independent risk factors for in-hospital death in patients with AAD.

Objective To investigate the clinical characteristics and associated prognostic factors of the acute aortic syndrome. Methods The clinical data of 391 patients with acute aortic syndrome (AAS) admitted to Beijing University People's Hospital from January 2000 to December 2015 were analyzed. Results In 391 patients with AAS, the average age was (52.7 ±13.3) with a male/female ratio of 4.3:1, and 73.4％ patients had hypertension. The most common clinical manifestation of patients with AAS was pain accounting for more than 90.0％, and the nature of pain was expansible and/or transitive pain. The level of D-dimer was elevated in 91.1％ of patients with AAS (ELISA), and significantly higher in type A patients than type B patients. Ultrasound/echocardiography was used to diagnose AAS with a sensitivity of 88.4％, of which the sensitivity of type A patients was 99.1％; the mortality of type A patients was significantly higher than type B patients (34.3％ vs. 0.9％, P <0.01). The mortality was declined obviously (11.7％ vs. 28.0％, P <0.01) when patients were treated with stent. Compared with the in-hospital surviving group, the in-hospital mortality group had decreased platelet counts and FIB, higher level of D-dimer, FDP and NLR (neutrophil to lymphocyte ratio). Conclusions Transitive and(or) expansible pains were the characteristic clinical manifestations of acute aortic syndrome,which usually happened suddenly or tearing;D - dimer and ultrasound were valueble and simple methods in AAS patients; Compared with In-hospital surviving group,the In-hospital mortality group had decreased platelet counts and FIB,higher level of D-dimer, FDP and NLR.The mortality of type A was significantly higher than type B,operation can lower the mortality of AAS patients obviously.

Frailty is a geriatric syndrome that has been implicated as a causative and prognostic factor for cardiovascular disease (CVD).Frailty and CVD are often concurrent and mutually promotive.The prevalence of frailty ranges from 10％ to 60％ in patients with CVD,depending on different tools and cutoffs chosen to define frailty.Short-and long-term prognosis of CVD are both affected by frailty.The presence of frailty is correlated with an increase in complications,outpatient and emergency department visits,hospital admissions and stays,and mortality in patients with CVD.Early prevention and clinical intervention can delay or even reverse the development of frailty,thus improving the prognosis for CVD.

With the aging of the global population,frailty is now considered a unique old age syndrome,has become an important worldwide public health problems.The elderly people is at increased risk of falls,hip fractures,disability,death and other risks.Motor system disease as an independent risk factor participates in frailty progress and interacts with each other.This article reviews recent studies on frailty and motor system diseases.