In recent years, the reform of the registration, evaluation, and approval system for traditional Chinese medicine(TCM) has been promoted at the national level, with establishment of an evaluation evidence system for TCM registration that combines TCM theory, human use experience, and clinical trials(known as the "three-combined" evaluation evidence system). This system, which aligns with the characteristics of TCM clinical practice and the laws of TCM research and development, recognizes the unique value of human use experience in medicine and returns to the essence of medicine as an applied science, thus receiving widespread recognition from both academia and industry. However, it meanwhile poses new and higher challenges. This article delves into the value and challenges faced by the "three-combined" evaluation evidence system from three perspectives: registration management, medical institutions, and the TCM industry. Furthermore, it discusses how the China Association of Chinese Medicine, leveraging its academic platform advantages and leading roles, has made exploratory and practical efforts to facilitate the research and development of new TCM drugs and the implementation of the "three-combined" evaluation evidence system.
Drugs, Chinese Herbal/standards* ; Humans ; Medicine, Chinese Traditional/standards* ; China ; Drug Development

In order to solve the problems of difficult test, high cost and long cycle in the development of large-scale airborne negative pressure isolation system, the simulation analysis of negative pressure response characteristics is carried out around various aviation conditions such as aircraft ascending, leveling and descending, especially rapid decompression, based on the computational fluid dynamics (CFD) method. The results showed that the isolation cabin could achieve -50 Pa pressure difference environment and form a certain pressure gradient. The exhaust air volume reached the maximum value in the early stage of the aircraft's ascent, and gradually decreased with the increase of altitude until it was level flying. In the process of aircraft descent, the exhaust fan could theoretically maintain a pressure difference far below -50 Pa without working; Under the special condition of rapid pressure loss, it was difficult to deal with the rapid change of low pressure only by the exhaust fan, so it was necessary to design safety valve and other anti-leakage measures in the isolation cabin structure. Therefore, the initial stage of aircraft ascent is the key stage for the adjustment and control of the negative pressure isolation system. By controlling the exhaust air volume and adjusting parameters, it can adapt to the change of low pressure under normal flight conditions, form a relatively stable negative pressure environment, and meet the needs of biological control, isolation and transport.
Aircraft ; Computer Simulation ; Aviation/instrumentation* ; Humans ; Hydrodynamics ; Air Pressure ; Equipment Design ; Pressure

To evaluate the therapeutic effect of a modified Devine procedure with a subcutaneous sliding fixation method for the treatment of congenital concealed penis, we retrospectively selected 45 patients with congenital concealed penises who were admitted to General Hospital of Ningxia Medical University (Yinchuan, China) between September 2020 and November 2023. In all cases, the penis was observed to be short, and retracting the skin at the base revealed a normal penile body, which immediately returned to its original position upon release. All patients underwent the modified Devine procedure with subcutaneous sliding fixation and completed a 12-week postoperative follow-up. A statistically significant increase in penile length was observed postoperatively, with the median length increasing from 4.0 (interquartile range [IQR]: 3.5-4.8; 95% confidence interval [CI]: 3.9-4.4) cm to 8.0 (IQR: 7.8-8.0; 95% CI: 7.7-7.9) cm, with P < 0.001. The parents were satisfied with the outcomes, including increased penile length, improved hygiene, and enhanced esthetics. Except for mild foreskin edema in all cases, no complications (such as infections, skin necrosis, or penile retraction) were observed. The edema was resolved within 4 weeks after the operation. This study demonstrates that the modified Devine procedure utilizing the subcutaneous sliding fixation method yields excellent outcomes with minimal postoperative complications, reduced penile retraction, and high satisfaction rates among patients and their families.
Humans ; Male ; Penis/abnormalities* ; Retrospective Studies ; Urologic Surgical Procedures, Male/methods* ; Treatment Outcome ; Child ; Plastic Surgery Procedures/methods*

OBJECTIVE: To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents. METHODS: This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs). RESULTS: This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed. CONCLUSION STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans ; Double-Blind Method ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Middle Aged ; Angina, Stable/physiopathology* ; Aged ; Syndrome ; Treatment Outcome ; Placebos ; Tablets

Postoperative infection of internal fixation of closed fractures the lower limbs in adults represents a devastating complication, characterized by diagnostic challenges, prolonged treatment duration and high disability rates. Current management of these infections faces multiple challenges, such as difficulties in early accurate diagnosis, and various controversies about the treatment plan, leading to poor overall diagnosis and treatment results. To address these issues, based on evidence-based medicine and principles with emphasis on scientific rigor, clinical applicability and innovation, the Trauma Branch of the Chinese Medical Association, Orthopedic Branch of the Chinese Medical Doctor Association, Orthopedics Branch of the Chinese Medical Association, and Trauma Orthopedics and Polytrauma Group of the Resuscitation and Emergency Committee of the Chinese Medical Doctor Association have collaboratively organized a panel of relevant experts to develop the Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults ( version 2025). The guideline proposed 10 recommendations, aiming to provide a foundation for standardized diagnosis and treatment of postoperative infection in adults with closed lower limb fractures.

Objective: To explore the key factors affecting the selection and effectiveness of bladder management modalities in patients with spinal cord injury，so as to provide reference for the optimization of individualized bladder management strategies. Methods: The clinical and follow-up data of 78 patients with spinal cord injury treated in our hospital during Jan.1,2013 and Dec.31,2022 were retrospectively analyzed.The distribution of bladder management modalities among different grades of injuries was analyzed. Bowker symmetry test was used to evaluate the difference between bladder management modalities at discharge and at the end of follow-up. Multiple linear regression was used to explore the influencing factors of bladder management effects. Plotting Kaplan-Meier survival curves were adopted to calculate the median time of changes in bladder management. Results: At discharge，there were 9 cases of self-catheterization，19 cases of intermittent catheterization，22 cases of reflexive voiding，26 cases of long-term catheterization，and 2 cases using urinary collector.At the end of follow-up，there were 15 cases of self-catheterization，8 cases of intermittent catheterization，34 cases of reflexive voiding，14 cases of long-term catheterization，and 7 cases using urinary collector.There was a significant difference between the modalities of bladder management at discharge and at the end of follow-up (χ =21.43，P=0.018).Multiple linear regression showed a significant decrease of 8.60 in the total neurogenic bladder symptom score (NBSS) for grade D injuries compared with grade A injuries (P=0.026). The median time to bladder management change was 7.93 months (95%CI:5.44-9.44), with approximately 50% of patients experiencing a change in bladder management within 8 months after discharge. Conclusion: The modalities of bladder management changed significantly after discharge.The grade of injury was a key factor affecting the effectiveness of bladder management.Higher grade was associated with worse effectiveness of bladder management.

Objective:To discuss the protective effect of TUG-891 on ischemic stoke(IS)induced by ischemia-hypoxia,and to clarify its potential mechanism.Methods:A total of 60 healthy male C57BL/6 mice were randomly divided into sham operation group(n=20),model group[distal middle cerebral artery occlusion(dMCAO)group,n=20],and model+TUG-891 group(dMCAO+TUG-891 group,n=20).After modeling,the mice were intraperitoneally injected with TUG-891 solution(35 mg·kg?1·d?1)for 3 consecutive days.Modified neurological severity score(mNSS)and rotarod test were used to evaluate the neurological function of the mice in various groups;2,3,5-triphenyltetrazolium chloride(TTC)staining was used to observe the cerebral infarction volumes of the mice in various groups;biochemical method was used to detect the malondialdehyde(MDA)level and superoxide dismutase(SOD)activity in the supernatant of brain tissue of the mice in various groups;Hematoxylin-Eosin(HE)and NISSL staining were used to observe the pathomerphology of brain tissue of the mice in various groups;terminal deoxynucleotidyl transferase dUTP nick-end labeling(TUNEL)staining was used to detect the apoptotic indexes of neuronal cells in brain tissue of the mice in various groups;Western blotting method was used to detect the expression levels of glucose-regulated protein 78(GRP78),protein kinase R-like endoplasmic reticulum kinase(PERK),phosphorylated PERK(p-PERK),and C/EBP homologous protein(CHOP)proteins in brain tissue of the mice in various groups.Results:The mNSS and rotarod test results shoued that compared with sham operation group,the mNSS of the mice in dMCAO group was significantly increased(P<0.01),and the time on the rod was significantly decreased(P<0.01);compared with dMCAO group,the mNSS of the mice in dMCAO+TUG-891 group was decreased(P<0.05),and the time on the rod was increased(P<0.05).The TTC staining results shoued that compared with sham operation group,the volume of white infarct foci in the cerebral cortex of the mice in dMCAO group was increased(P<0.01);compared with dMCAO group,the cerebral infarction volume of the mice in dMCAO+TUG-891 group was significantly decreased(P<0.01).The HE staining results showed that compared with sham operation group,the cortex of the mice in dMCAO group was severely damaged,manifested by disordered arrangement of neuronal cells and obvious nuclear pyknosis in the infarct area,and the morphology of cortical infarct area of the mice in dMCAO+TUG-891 group was improved;the NISSL staining results showed that the Nissl bodies in the cortical infarct area of the mice in dMCAO group became thinner,elongated,and lost more.The pathological damage of brain tissue of the mice in dMCAO+TUG-891 group was significantly improved.Compared with sham operation group,the MDA level in brain tissue of the mice in model group was significantly increased(P<0.01),and the SOD activity was decreased(P<0.01);compared with model group,the MDA level in brain tissue of the mice in TUG-891 group was significantly decreased(P<0.01),and the SOD activity was significantly increased(P<0.01).The TUNEL staining results showed that compared with sham operation group,the apoptotic index of neuronal cells in brain tissue of the mice in dMCAO group was increased(P<0.01);compared with dMCAO group,the apoptotic index of neuronal cells in brain tissue of the mice in dMCAO+TUG-891 group was decreased(P<0.01).Compared with sham operation group,the expression levels of GRP78,p-PERK,and CHOP proteins in brain tissue of the mice in dMCAO group were increased(P<0.05);compared with dMCAO group,the expression levels of GRP78,p-PERK,and CHOP proteins in brain tissue of the mice in dMCAO+TUG-891 group were decreased(P<0.05).Conclusion:TUG-891 can alleviate neurological injury caused by ischemic stroke,and its mechanism may be related to the inhibition of endoplasmic reticulum stress and apoptosis.

Objective To explore the efficacy and safety of conversion therapy for advanced hepatocellular carcinoma(HCC)with macrovascular invasion.Methods A total of 149 patients with advanced HCC with macrovascular invasion who were treated at our hospital from Jul.2019 to Jun.2021 were enrolled.All patients received systemic therapy combined with local therapy,and were assigned to conversion therapy group(n=42)and non-conversion therapy group(n=107)according to whether they ultimately underwent surgical treatment.The long-term prognosis and adverse reactions of these patients after conversion therapy were analyzed.Results The median event-free survival of 149 patients was 15.5 months,and the median overall survival had not been reached.The median event-free survival in the conversion therapy and non-conversion therapy groups were 19.8 months and 10.7 months,respectively,with the median overall survival being not reached and 28.2 months,respectively.Multifactor Cox regression analysis showed that conversion therapy was a protective factor for overall survival(hazard ratio[HR]=0.125,95％confidence interval[CI]0.016-0.966),but not for event-free survival.The 1-year and 2-year overall survival rates of the conversion therapy and non-conversion therapy groups were 100.0％,96.4％and 72.1％,53.4％,respectively,and the difference in survival curves between the 2 groups was statistically significant(P=0.003).The 1-year and 2-year event-free survival rates were 77.5％,33.8％and 47.3％,31.5％,respectively.There was no significant difference in survival curves between the 2 groups(P=0.070).The differences of the overall incidences of targeted and immunotherapy-related adverse reactions in the conversion therapy group and non-conversion therapy group(66.7％[28/42]vs 72.0％[77/107],P=0.524)and the incidences of grade Ⅲ to Ⅳ adverse reactions(23.8％[10/42]vs 27.1％[29/107],P=0.681),were not statistically significant.Conclusion For patients with advanced HCC with macrovascular invasion,conversion therapy can significantly improve the prognosis without serious adverse reactions.

Under the background of forensic medicine becoming a first-level discipline,the opportuni-ties and challenges of discipline development coexist.Starting from the actual situation and characteris-tics of local medical colleges and universities,this paper discusses the problems and solutions for the development of forensic medicine discipline from the perspective of building a regional high-level medical university.Combined with the experiences of carrying out forensic medicine education in our college,this paper supplies our thoughts and practices on improving the discipline system,enhancing the ability to serve society,perfecting the talent cultivation model and promoting forensic culture,to provide reference and inspiration for the development of forensic medicine in other universities,jointly promote the advancement of forensic medicine in China to a new stage,and contribute the wisdom and strength of forensic medical experts to the construction of a law-based China,a safe China and a healthy China.