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.

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.

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.

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.

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.