To standardize the clinical application of oral Chinese patent medicines （CPMs）， and address the safety issues arising from their dosage form characteristics， irrational clinical use， and the lack of targeted pharmacovigilance systems， the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines， aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China （2019 revision）， the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， led a drafting group comprising 18 institutions. After multiple rounds of expert interviews， literature retrieval， evidence screening， and extensive solicitation of opinions， the Guidelines were registered internationally. Systematic standardization focused on safety monitoring， risk identification， assessment， control， and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring， known risks， and potential risks， compared to non-oral CPMs. Then， risk control measures were proposed， including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs， the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine （TCM）， which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions， pharmaceutical manufacturers， and regulatory authorities.

To standardize the clinical application of oral Chinese patent medicines （CPMs）， and address the safety issues arising from their dosage form characteristics， irrational clinical use， and the lack of targeted pharmacovigilance systems， the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines， aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China （2019 revision）， the Institute of Basic Research in Clinical Medicine， China Academy of Chinese Medical Sciences， led a drafting group comprising 18 institutions. After multiple rounds of expert interviews， literature retrieval， evidence screening， and extensive solicitation of opinions， the Guidelines were registered internationally. Systematic standardization focused on safety monitoring， risk identification， assessment， control， and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring， known risks， and potential risks， compared to non-oral CPMs. Then， risk control measures were proposed， including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs， the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine （TCM）， which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions， pharmaceutical manufacturers， and regulatory authorities.

Background The Inner Mongolia Autonomous Region is a vast area with a wide array of ecological environments, resulting in considerable regional variations in air pollution characteristics. Current research is limited by a scarcity of systematic, region-wide studies and risk assessments. Objective To assess the health risks associated with inhalation exposure to nine heavy metal and metalloid elements in atmospheric fine particulate matter (PM_2.5) for the population of the Inner Mongolia Autonomous Region. Methods From the 10th to the 16th of each month throughout 2023, atmospheric PM_2.5 samples were collected at designated monitoring sites in 12 leagues (cities) across the Inner Mongolia Autonomous Region to analyze the characteristics and trends in concentration. The health risk assessment model developed by the United States Environmental Protection Agency was employed to evaluate both the non-carcinogenic and carcinogenic risks associated with the heavy metal elements beryllium (Be), cadmium (Cd), chromium (Cr), hydrargyrum (Hg), plumbum (Pb), manganese (Mn), and nickel (Ni) and the metalloid elements stibium (Sb) and arsenic (As). Results In 2023, a total of 1206 valid PM_2.5 samples were analyzed from the Inner Mongolia Autonomous Region. The annual average PM_2.5 concentrations in Inner Mongolia, as well as in the cities of Ordos, Wuhai, and the Alxa League, all exceeded the national limit of 35 μg·m⁻³. The PM_2.5 concentrations across the leagues (cities) exhibited a clear seasonal variation, peaking in winter, followed by spring, and reaching a minimum in summer and autumn. The median PM_2.5 concentration in Ordos throughout the year was higher than that in the other leagues (cities) of the region. Concerning health risks, the non-carcinogenic risks associated with the 9 elements detected in each league (city) were all below 1, indicating acceptable levels. However, the non-carcinogenic risk values for Mn, Cr, and As were relatively high; specifically, Ordos City displayed the highest non-carcinogenic risk values for Mn (7.74×10⁻¹) and Cr (2.97×10⁻²), while Chifeng City recorded the highest value for As (2.34×10⁻³). The carcinogenic risk values for As, Cd, Cr, and Ni fell within the range of 1×10⁻⁹ to 1×10⁻⁵, representing an acceptable level. The health risks varied with age, and the elderly residents faced the highest non-carcinogenic and carcinogenic health risks. Conclusion While the carcinogenic and non-carcinogenic risks from heavy metals and metalloids within atmospheric PM_2.5 in the Inner Mongolia Autonomous Region are generally within acceptable limits, the potential risks that Mn, As, and Cr pose to the health of elderly people warrants particular attention, and Ordos and Chifeng cities exhibit notably higher health risks among other areas. It is recommended that regular, long-term monitoring be conducted, taking into account the specific conditions at monitoring sites across each league (city), and that targeted air quality management strategies be implemented to protect public health.

OBJECTIVE: To explore the method and effectiveness of index finger proximal dorsal island flap supplied by the nutrient vessels of superficial branch of radial nerve for treatment of thumb skin and soft tissue defect. METHODS: Between August 2019 and December 2024, 12 patients with thumb skin and soft tissue defects caused by trauma accompanied by variation of the first dorsal metacarpal artery were treated. There were 8 males and 4 females, aged 19-55 years, with an average age of 32 years. The wound area ranged from 2.2 cm×2.0 cm to 5.5 cm×3.5 cm. The time from injury to operation ranged from 1.5 to 6.0 hours, with an average of 4.5 hours. After thorough debridement, the wound was repaired with a index finger proximal dorsal island flap supplied by the nutrient vessels of the superficial branch of the radial nerve. The flap area ranged from 2.4 cm×2.2 cm to 6.0 cm×4.0 cm. The donor site was repaired with free skin grafting. Regular follow-up was conducted postoperatively to observe the appearance, texture, sensory recovery of the flap, and the condition of the donor site. RESULTS: The operation time ranged from 30 to 72 minutes, with an average of 47 minutes; intraoperative blood loss ranged from 30 to 70 mL, with an average of 46 mL. After operation, partial necrosis occurred at the skin edge of the radial incision on the dorsum of the hand in 1 case, which healed after dressing changes; all other flaps survived uneventfully, with primary wound healing. The skin grafts at the donor sites all survived. All 12 patients were followed up 5-36 months, with an average of 14 months. The appearance and texture of the flaps were good. At last follow-up, the two-point discrimination of the flaps ranged from 4 to 9 mm, with an average of 5.2 mm. According to the functional evaluation criteria for upper limb issued by the Hand Surgery Society of Chinese Medical Association, the results were excellent in 11 cases and good in 1 case. No scar contracture, pain, or joint movement limitation was observed at the donor sites. CONCLUSION For patients with skin and soft tissue defects of the thumb accompanied by variation of the first dorsal metacarpal artery, the index finger proximal dorsal island flap supplied by the nutrient vessels of the superficial branch of the radial nerve can be selected. This method has advantages such as shorter operation time, less intraoperative bleeding, and good postoperative appearance and sensation of the flap.
Humans ; Male ; Adult ; Female ; Thumb/surgery* ; Soft Tissue Injuries/surgery* ; Radial Nerve/surgery* ; Middle Aged ; Surgical Flaps/innervation* ; Plastic Surgery Procedures/methods* ; Skin Transplantation/methods* ; Young Adult ; Treatment Outcome ; Fingers/surgery* ; Skin/injuries*

The Solomon four-group design， a critical method for improving internal validity in clinical research， can reduce bias and control the interference of Hawthorne effects and pretest sensitization on research results， which offers unique advantages in evaluating complex intervention outcomes. This paper systematically outlined the core framework and key points of statistical analysis of the Solomon four-group design， summarized its applications in clinical research at home and abroad， explored its advantages and limitations， and discussed the potential value in traditional Chinese medicine （TCM） clinical trials. It is believed that the Solomon four-group design can help distinguish between testing effects and intervention effects in TCM clinical studies， and reduce the bias in the evaluation of subjective indicators. Meanwhile， given the complexity of the Solomon four-group design and the particularity of TCM clinical research， it is proposed that future TCM clinical studies should focus on using psychological scales， know-ledge， attitude， and behavior measurements， and other similat evaluations as endpoints. It also advocates strengthening interdisciplinary collaboration to provide new methodological paths for TCM clinical research.

China has the highest number of smokers in the world with more than 1 million tobacco-related deaths each year.Smoking cessation is a feasible intervention to reduce the prevalence of smoking-related diseases and premature deaths.The smoking cessation therapies approved for use in China are ineffective for some tobacco dependent patients.In order to further improve the rate of smoking cessation,a combination of medications can be chosen,including varenicline combined with nicotine replacement therapy.However,there are conflicting evaluation conclusions on the effectiveness and safety of combination therapy.This article aims to review the mechanism of action,efficacy,and safety of varenicline combined with nicotine replacement therapy in the treatment of tobacco dependence,aiming to provide a basis for this combination therapy.

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.

In recent years，the incidence and prevalence of non-tuberculous mycobacterial（NTM）infections have been on the rise，posing a serious threat to public health and presenting significant challenges for disease management. Currently，the treatment outcomes for NTM disease are poor，one of the main reasons being the high resistance of NTM pathogens to various anti-mycobacterial drugs. Novel therapeutic strategies targeting the host rather than the NTM pathogens themselves may help improve cure rates and reduce mortality. This article summarizes the latest research findings on host factors related to the incidence of NTM disease，including age，pulmonary diseases，immune function，genetic factors and lifestyle，which aids in the early identification of high-risk populations and provides a theoretical basis for developing targeted prevention and treatment strategies and optimizing treatment plans.

BACKGROUND:Previous studies have found that growth arrest and DNA damage-inducible protein 45β(Gadd45b)is beneficial to the repair of acute cerebral ischemia,but the action mechanism is still unclear.OBJECTIVE:To investigate the effect and mechanism of Gadd45b on white matter demyelinating lesions in rats with chronic cerebral ischemia.METHODS:SD rats were randomly divided into four groups:sham operation group,model group,empty vector group,and Gadd45b overexpression group,with 15 rats in each group.Gadd45b-overexpressing lentivirus and no-load lentivirus were injected into the bilateral hippocampus and bilateral ventricles of rats.One week after lentivirus transfection,the rat model of chronic hypoperfusion cerebral ischemia was established by bilateral common carotid artery ligation.Three weeks after the bilateral common carotid artery ligation,the learning and cognitive functions of rats were evaluated by novel object recognition test.Luxol fast blue staining was used to observe the changes of myelin structure in the corpus callosum of rats.Hematoxylin-eosin staining and Nissl staining were used to observe the damage of the rat corpus callosum.Immunofluorescence staining was used to detect the expression of myelin basic protein and neurofilament protein 200 in the corpus callosum of rats.Immunofluorescence double staining was used to detect the expression of astrocyte markers GFAP/C3d and GFAP/S100A10 in rat brain tissue.ELISA was used to detect the levels of tumor necrosis factor-α and interleukin-6 in the supernatant of brain tissue.RESULTS AND CONCLUSION:(1)Gadd45b overexpression could significantly improve the learning and cognitive function of rats with chronic cerebral ischemia,and improve demyelination and pathological damage in the rat corpus callosum.(2)The results of immunofluorescence showed that Gadd45b overexpression significantly increased the expression levels of myelin basic protein and neurofilament protein 200 in the brain tissue of rats with chronic cerebral ischemia.(3)Gadd45b overexpression reduced GFAP/C3d double positive cells and increased GFAP/S100A10 double positive cells in the brain tissue of rats with chronic cerebral ischemia.(4)Gadd45b overexpression reduced the levels of tumor necrosis factor-α and interleukin-6 in the brain tissue of rats with chronic cerebral ischemia.It is concluded that Gadd45b overexpression improves cognitive dysfunction by promoting the A2 phenotype transformation of astrocytes,alleviating white matter myelin structure damage and neuroinflammation in rats with chronic cerebral ischemia.

Objective To examine the expression levels of inflammatory factors,including IL-6,IL-10,MMP-9,IL-17A,and LDH,in the cerebrospinal fluid(CSF)of patients with spontaneous intracerebral hemor-rhage(sICH),and to investigate their associations with disease severity and clinical outcomes.Methods A total of 168 patients with sICH admitted to Tangshan GongRen Hospital between January 2023 and January 2025 were prospectively enrolled as the study group,while 30 non-sICH patients who underwent lumbar puncture during the same period served as the control group.Levels of inflammatory factors in CSF were compared between the two groups.Spearman's rank correlation analysis was performed to assess the association between inflammatory factor levels and clinical severity in sICH patients.Binary logistic regression analysis was conducted to identify independent predictors of sICH prognosis.Receiver operating characteristic(ROC)curve analysis was employed to evaluate the prognostic value of these inflammatory factors in sICH.Results The levels of IL-6,IL-10,MMP-9,IL-17A,and LDH in the CSF of patients with sICH were significantly higher than those in non-sICH patients(all P<0.05).Furthermore,among sICH patients,these biomarker levels exhibited a graded increase according to disease severity:severe>moderate>mild(all P<0.05).Spearman correlation analysis revealed significant positive correlations between CSF levels of IL-6,IL-10,MMP-9,IL-17A,and LDH and the NIHSS scores,with correlation coefficients(r)of 0.686,0.553,0.685,0.593,and 0.695,respectively(all P<0.05).When comparing the prognoses of sICH patients,hematoma size,NIHSS score,and CSF levels of IL-6,IL-10,MMP-9,IL-17A,and LDH were significantly higher in the deceased group than in the survival group(P<0.05),whereas ApoA1 levels were lower in the deceased group(P<0.05).Logistic regression analysis revealed that hematoma size,NIHSS score,and elevated CSF levels of IL-6,IL-10,MMP-9,IL-17A,and LDH were independent risk factors for mortality in sICH patients(P<0.05).ROC curve analysis showed that the AUC values for CSF IL-6,IL-10,MMP-9,IL-17A,and LDH in predicting sICH prognosis were 0.794,0.754,0.670,0.717,and 0.683,respectively.Notably,the combination of CSF inflammatory markers with hematoma size and NIHSS score yielded an AUC of 0.993,demonstrating significantly greater predictive accuracy than CSF inflammatory markers alone(P<0.05).Conclusions The levels of inflammatory factors in the CSF,including IL-6,IL-10,MMP-9,IL-17A,and LDH,were elevated in patients with sICH and positively correlated with disease severity.Combining CSF inflammatory markers with the NIHSS score and hematoma size improved the predictive accuracy for sICH prognosis.