The study focuses on the concept of multifunctional traditional Chinese medicine (TCM) formulas and aims to evaluate the efficacy of the classical formula Xiaoyao San (逍遥散). Study employs the integrated evidence chain (Eff-iEC) method to organize, integrate, and evaluate its therapeutic efficacy in treating different diseases with the same therapy, and to investigate the feasibility of using Eff-iEC to evaluate the multifunctionality of TCM formulas. The evaluation covered Xiaoyao San's therapeutic effects on depression, premenstrual syndrome, chronic hepatitis, irritable bowel syndrome, dyspepsia, and menopausal syndrome. Concurrently, the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system was used for evaluation, and authoritative medical documents were incorporated to corroborate the recognition of Xiaoyao San within the medical community. Depression and menopausal syndrome received higher ratings than other conditions in the Eff-iEC, GRADE, and Medical Community Recognition assessments. The Eff-iEC evidence grade for Xiaoyao San was rated as "High" or above for chronic hepatitis, irritable bowel syndrome, dyspepsia, and menopausal syndrome. Premenstrual syndrome received a "Moderate ⁺" rating. The GRADE evidence level was "Low-〇〇⨁⨁" for depression, premenstrual syndrome, and chronic hepatitis; "Moderate-〇⨁⨁⨁" for dyspepsia and menopausal syndrome; and "Very Low-〇〇〇⨁" for irritable bowel syndrome. Depression and menopausal syndrome had the highest inclusion frequency, appearing in all 4 categories. Premenstrual syndrome, chronic hepatitis, and dyspepsia are not recommended in Western medical guidelines, but they are included in TCM guidelines, the China National Basic Medical Insurance Drug List, and the China National Essential Drug List. Irritable bowel syndrome appears only in the China National Basic Medical Insurance Drug List and China National Essential Drug List. The evaluation results obtained using the Eff-iEC method align with Medical Community Recognition, providing an objective and comprehensive assessment of Xiaoyao San's efficacy. The findings suggest that Xiaoyao San has strong evidence for treating depression and menopausal syndrome. However, further experimental and clinical trials are needed to assess its efficacy in treating premenstrual syndrome, chronic hepatitis, irritable bowel syndrome, and dyspepsia. These results support the clinical efficacy and rational use of Xiaoyao San, expand the application scope of the Eff-iEC method, and offer valuable insights and methodological references for the comparative evaluation of multifunctional TCM formulas.

In this study, the pre-market regulatory requirements for typical Class Ⅱ wound dressings, as well as the status of testing and post-market adverse events monitoring, were reviewed from the perspective of the whole lifecycle of medical devices. Additionally, the regulatory requirements for wound dressings in China, the United States, and the European Union were compared. Supplementary research was also conducted on Class Ⅰ and Ⅱ liquid and paste dressing products. Furthermore, this study analyzed the issues in the registration and application of typical Class Ⅱ wound dressings and provided regulatory recommendations, aiming to offer technical references for the review and approval, inspection and testing, and post-market supervision of wound dressing products.
Bandages/standards* ; United States ; China ; Humans ; European Union

Addressing the enduring challenge of evaluating traditional Chinese medicines (TCMs), the integrated evidence chain-based effectiveness evaluation of TCMs (Eff-iEC) has emerged. This paper explored its capacity through a demonstration study that evaluated the effectiveness evidence of six commonly used anti-hepatic fibrosis Chinese patent medicines (CPMs), including Biejiajian Pill (BP), Dahuang Zhechong Pill (DZP), Biejia Ruangan Compound (BRC), Fuzheng Huayu Capsule (FHC), Anluo Huaxian Pill (AHP), and Heluo Shugan Capsule (HSC), using both Eff-iEC and the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system. The recognition of these CPMs within the TCM academic community was also assessed through their inclusion in relevant medical documents. Results showed that the evidence of BRC and FHC received higher assessments in both Eff-iEC and GRADE system, while the assessments for others varied. Analysis of community recognition revealed that Eff-iEC more accurately reflects the clinical value of these CPMs, exhibiting superior evaluative capabilities. By breaking through the conventional pattern of TCMs effectiveness evaluation, Eff-iEC offers a novel epistemology that better aligns with the clinical realities and reasoning of TCMs, providing a coherent methodology for clinical decision-making, new drug evaluations, and health policy formulation.

ObjectiveTo investigate the effects of Tongxinluo capsules on traditional Chinese medicine （TCM） syndrome elements and major adverse cardiovascular events （MACEs） in patients with chronic coronary syndrome of Qi deficiency and blood stasis type. MethodsA multicenter and prospective cohort study was conducted. The intervention of Tongxinluo Capsules was used as the exposure factor， and the patients were divided into an exposure group （integrated traditional Chinese and western medicine treatment group） and a non-exposure group （western medicine treatment group）. The patients were followed up for one year. The TCM syndrome element scores were assessed by using a syndrome element diagnosis scale on the day of enrollment and in the third， sixth， and twelfth months， and the incidence of MACE within one year was recorded. ResultsA total of 186 patients were included， with 128 patients in the exposure group and 58 patients in the non-exposure group. There was no significant difference in baseline data between the two groups. Compared with those in the pretreatment period for each group， the Qi deficiency and blood stasis syndrome scores in the treatment and follow-up period were significantly improved （P<0.05）. Compared with the non-exposure group， the exposure group exhibited significantly decreased Qi deficiency syndrome scores in the treatment and follow-up period （P<0.01） and significantly reduced blood stasis syndrome scores in the sixth month （P<0.05）. In the remaining follow-up period， there was no statistically significant difference between the two groups. Compared with that of the non-exposure group， during the treatment period （the third month）， the difference in Qi deficiency and blood stasis syndrome scores of the exposure group was statistically significant （P<0.05， P<0.01）. At the end of the follow-up period， patients in the non-exposure group had a MACE probability of 6.90% （4/58）， higher than 3.13% in the exposure group （4/58）. Compared with patients with angina pectoris who used conventional medicine， patients administered with Tongxinluo Capsules had a relative risk（RR） of 0.45 ［95%confidence interval（95%CI） 0.12-1.75， P=0.26］. There was no significant difference in the incidence of MACE within one year between the two groups. ConclusionTongxinluo capsules can improve the degree of Qi deficiency in patients with chronic coronary syndrome in the short term， and the improvement effect of blood stasis syndrome appears in the medium and long term. They can better improve the Qi deficiency syndrome in the long term. Within one year， the incidence of MACE in the exposure group was lower than that in the non-exposure group.

ObjectiveTo investigate the effects of Tongxinluo capsules on traditional Chinese medicine （TCM） syndrome elements and major adverse cardiovascular events （MACEs） in patients with chronic coronary syndrome of Qi deficiency and blood stasis type. MethodsA multicenter and prospective cohort study was conducted. The intervention of Tongxinluo Capsules was used as the exposure factor， and the patients were divided into an exposure group （integrated traditional Chinese and western medicine treatment group） and a non-exposure group （western medicine treatment group）. The patients were followed up for one year. The TCM syndrome element scores were assessed by using a syndrome element diagnosis scale on the day of enrollment and in the third， sixth， and twelfth months， and the incidence of MACE within one year was recorded. ResultsA total of 186 patients were included， with 128 patients in the exposure group and 58 patients in the non-exposure group. There was no significant difference in baseline data between the two groups. Compared with those in the pretreatment period for each group， the Qi deficiency and blood stasis syndrome scores in the treatment and follow-up period were significantly improved （P<0.05）. Compared with the non-exposure group， the exposure group exhibited significantly decreased Qi deficiency syndrome scores in the treatment and follow-up period （P<0.01） and significantly reduced blood stasis syndrome scores in the sixth month （P<0.05）. In the remaining follow-up period， there was no statistically significant difference between the two groups. Compared with that of the non-exposure group， during the treatment period （the third month）， the difference in Qi deficiency and blood stasis syndrome scores of the exposure group was statistically significant （P<0.05， P<0.01）. At the end of the follow-up period， patients in the non-exposure group had a MACE probability of 6.90% （4/58）， higher than 3.13% in the exposure group （4/58）. Compared with patients with angina pectoris who used conventional medicine， patients administered with Tongxinluo Capsules had a relative risk（RR） of 0.45 ［95%confidence interval（95%CI） 0.12-1.75， P=0.26］. There was no significant difference in the incidence of MACE within one year between the two groups. ConclusionTongxinluo capsules can improve the degree of Qi deficiency in patients with chronic coronary syndrome in the short term， and the improvement effect of blood stasis syndrome appears in the medium and long term. They can better improve the Qi deficiency syndrome in the long term. Within one year， the incidence of MACE in the exposure group was lower than that in the non-exposure group.

Disease X refers to a new type of infectious disease that has not yet been identified or named as a poten-tial global pandemic,which poses a serious threat to human health.It is characterized by high contagiousness,rapid transmission,widespread susceptibility of the population,and the absence of effective treatment options or vaccines in the early stages.Since the World Health Organization(WHO)proposed the concept of disease X in 2018,new pathogens of disease such as the novel coronavirus and monkeypox virus X have been constantly e-merged.The pandemic of novel coronavirus infection has caused great harm to the global economy and human health,and other new pathogens may emerge in the future.It aims to reduce the harm to human beings by strengthening the knowledge about disease X and taking appropriate countermeasures.This article provides a com-prehensive overview of disease X from four aspects:the concept,characteristics,possible pathogens and counter-measures of disease X,and proposes the scientific countermeasures to disease X such as strengthening surveil-lance,improving capabilities of rapid detection,taking appropriate control measures,actively conducting vaccine research and development and treatment research,and boosting global cooperation and information sharing so as to provide bases for coping with the disease X that may occur in the future.

Disease X refers to a new type of infectious disease that has not yet been identified or named as a poten-tial global pandemic,which poses a serious threat to human health.It is characterized by high contagiousness,rapid transmission,widespread susceptibility of the population,and the absence of effective treatment options or vaccines in the early stages.Since the World Health Organization(WHO)proposed the concept of disease X in 2018,new pathogens of disease such as the novel coronavirus and monkeypox virus X have been constantly e-merged.The pandemic of novel coronavirus infection has caused great harm to the global economy and human health,and other new pathogens may emerge in the future.It aims to reduce the harm to human beings by strengthening the knowledge about disease X and taking appropriate countermeasures.This article provides a com-prehensive overview of disease X from four aspects:the concept,characteristics,possible pathogens and counter-measures of disease X,and proposes the scientific countermeasures to disease X such as strengthening surveil-lance,improving capabilities of rapid detection,taking appropriate control measures,actively conducting vaccine research and development and treatment research,and boosting global cooperation and information sharing so as to provide bases for coping with the disease X that may occur in the future.

Objective To investigate the effect of thalidomide combined with infliximab (IFX) in treatment of refractory inflammatory bowel disease (IBD) and its effects on insulin-like growth factor-1 (IGF-1) and transforming growth factor-β1 (TGF-β1). Methods A total of 120 patients with refractory IBD were randomly divided into experimental group and control group, with 60 cases in each group. The two groups were given conventional treatment (mesalazine), the control group was given IFX, and the experimental group was given IFX combined with thalidomide, continuous treatment for two months. The efficacy, intestinal flora disturbance rate, adverse reactions, Crohn's disease activity index (CDAI), Lewis score, serum IGF-1, TGF-β1 levels and nutritional status indexes[albumin (ALB), transferrin (Tf)]before and after treatment for 1 month and 2 months of the two groups were compared. Results The total effective rate of the experimental group was significantly higher than that of the control group (P < 0.05). After one month and two months of treatment, CDAI and Lewis scores of the experimental group were significantly lower than those of the control group (P < 0.05); the serum levels of IGF-1, TGF-β1 as well as ALB and Tf in the experimental group were significantly higher than those in the control group (P < 0.05). The improvement of intestinal flora disturbance rate in the experimental group was significantly better than that in the control group (P < 0.05). There was no significant difference in the incidence of oral and nasal mucosa dryness, throat discomfort, nausea and vomiting between two groups (P>0.05). Conclusion In the treatment of refractory IBD patients, thalidomide combined with IFX can regulate serum IGF-1 and TGF-β1 levels, effectively relieve clinical manifestations, inhibit inflammatory activities, and improve nutritional status and intestinal flora disorders of patients, and it has high safety.

Objective To build a comprehensive evaluation system for the operating benefit of clinical departments in cancer hospitals,so as to provide data support for the fine operation management of hospitals.Methods Literature review and semi-structured interview were used to form the index pool.Two rounds of Delphi expert consultation were used to determine the index of the evaluation system,and the analytic hierarchy process was used to determine the index weight.Finally,the weighted TOPSIS was used for empirical case analysis.Results The positive coefficient in the two rounds of Delphi expert consultation were 82.6％and 100％,the authority coefficient was 0.808,and the coordination coefficient was between 0 and 1.All indexes at all levels passed the consistency test.Finally,a comprehensive evaluation system consisting of 4 dimensions,19 indexes in surgery,16 indicators in radiotherapy and 16 indicators in internal medicine was constructed.Indicators at all levels were tested for consistency,resulting in the construction of a comprehensive evaluation system consisting of 4 dimensions,19 indicators for surgery and 16 indicators each for radiotherapy and internal medicine departments.Conclusion The comprehensive evaluation system of operating benefit of clinical departments in cancer hospitals can help hospitals and departments to find out the shortcomings of operation,build the path of operating benefit improvement,and realize the connotation improvement and high-quality development of hospitals.

Objective To build a comprehensive evaluation system for the operating benefit of clinical departments in cancer hospitals,so as to provide data support for the fine operation management of hospitals.Methods Literature review and semi-structured interview were used to form the index pool.Two rounds of Delphi expert consultation were used to determine the index of the evaluation system,and the analytic hierarchy process was used to determine the index weight.Finally,the weighted TOPSIS was used for empirical case analysis.Results The positive coefficient in the two rounds of Delphi expert consultation were 82.6％and 100％,the authority coefficient was 0.808,and the coordination coefficient was between 0 and 1.All indexes at all levels passed the consistency test.Finally,a comprehensive evaluation system consisting of 4 dimensions,19 indexes in surgery,16 indicators in radiotherapy and 16 indicators in internal medicine was constructed.Indicators at all levels were tested for consistency,resulting in the construction of a comprehensive evaluation system consisting of 4 dimensions,19 indicators for surgery and 16 indicators each for radiotherapy and internal medicine departments.Conclusion The comprehensive evaluation system of operating benefit of clinical departments in cancer hospitals can help hospitals and departments to find out the shortcomings of operation,build the path of operating benefit improvement,and realize the connotation improvement and high-quality development of hospitals.