1.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
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.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
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.
3.Clinical efficacy of sulbactam-durlobactam in treating patients with carbapenem-resistant Acinetobacter baumannii pulmonary infection and drug concentration surveillance
Yue CHEN ; Lin QIAO ; Zhongyao XIE ; Wenqian CHEN ; Dongjie GUO ; Pengmei LI
Chinese Journal of Nosocomiology 2025;35(20):3105-3109
OBJECTIVE To evaluate the efficacy of sulbactam-durlobactam combined with meropenem in treating carbapenem-resistant Acinetobacter baumannii(CRAB)pulmonary infection.METHODS A total of 16 patients treated at China-Japan Friendship Hospital from Jan.1,2025 to Jun.1,2025 were included.Retrospective analy-sis was conducted on patients'basic situation,preliminary treatment regimens,infection-related diagnoses,etiolo-gy and clinical outcomes.Therapeutic drug monitoring(TDM)for sulbactam was also performed.RESULTS By the end of the treatment course,13 patients achieved etiological eradication of CRAB and clinical improvement,while 1 patient experienced CRAB recurrence within one month.Three patients showed treatment failure.TDM for sulbactam was performed in 13 patients.Except for one slightly lower,all achieved trough plasma concentra-tions above the minimum inhibitory concentration(MIC)(100%T>MIC,MIC=4 mg/L based on clinical breakpoints).Dosage adjustments based on plasma concentrations were made for 4 patients,with 3 receiving re-duced doses and 1 receiving an increased dose.CONCLUSIONS Sulbactam-durlobactam combined with meropenem demonstrates superior efficacy in treating CRAB compared to other regimens.Under the recommended dosage,all patients can achieve the PK/PD target for sulbactam.
4.Echocardiographic evaluation of pediatric mitral valve replacement:a single-center study
Linyue ZHANG ; Yuji XIE ; Zhaoli REN ; He LI ; Wenqian WU ; Li ZHANG ; Yuman LI ; Mingxing XIE
Chinese Journal of Ultrasonography 2025;34(1):17-25
Objective:To explore the application value of echocardiography in the management of pediatric mitral valve replacement.Methods:Thirty-three children who underwent mitral valve replacement at Union Hospital Tongji Medical College Huazhong University of Science and Technology from January 2009 to June 2023 were retrospectively analyzed. Clinical data and preoperative and postoperative echocardiographic data were collected. The differences in ultrasound parameters among preoperative,1-week postoperative,1-month postoperative and 1-year postoperative were compared.Results:Of the 33 children,there were 4 cases(12.12%)of mitral stenosis,33 cases(100%)of mitral regurgitation and 4 cases(12.12%)of mitral stenosis combined with regurgitation. Mechanical valve replacement was performed in 30 cases(90.91%)and bioprosthetic valve replacement in 3 cases(9.09%). Compared with the preoperative period,the left atrial internal diameter and left ventricular end-diastolic internal diameter were significantly reduced at 1-week postoperatively,1-month postoperatively,and 1-year postoperatively,respectively(all P <0.05).The left ventricular mass was significantly reduced and the left ventricular end-diastolic sphericity index was significantly increased(both P < 0.05)at 1-month postoperatively compared with preoperatively. The left ventricular ejection fraction was significantly higher at 1-year postoperatively compared with 1-week postoperatively( P <0.05). Conclusions:After pediatric mitral valve replacement,the left ventricular dimensions decrease,and cardiac function progressively recovers. Echocardiography is an essential tool for accurate preoperative assessment and postoperative follow-up in pediatric mitral valve replacement.
5.Research progress of novel three-dimensional echocardiographic rendering tools in structural heart disease
Alimu TEZHI ; Yuman LI ; Lin HE ; He LI ; Wenqian WU ; Yun YANG ; Huan WANG ; Mingxing XIE ; Lingyun FANG
Chinese Journal of Ultrasonography 2025;34(2):173-179
Recently developed three-dimensional echocardiography rendering technology,which includes transillumination imaging and tissue transparency imaging,is based on powerful artificial intelligence algorithm and employs unique visualization methods. This novel technology enables intuitive and realistic visualization of the heart's three-dimensional structure and blood flow images,providing richer and more accurate imaging information for evaluating cardiac anatomy and function. They demonstrate unique value in the diagnosis and treatment of structural heart diseases. This article reviews the applications and prospects of three-dimensional echocardiographic rendering techniques in structural heart disease.
6.Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults (version 2025)
Bobin MI ; Faqi CAO ; Weixian HU ; Wu ZHOU ; Chenchen YAN ; Hui LI ; Yun SUN ; Yuan XIONG ; Jinmi ZHAO ; Qikai HUA ; Xinbao WU ; Xieyuan JIANG ; Dianying ZHANG ; Zhongguo FU ; Dankai WU ; Guangyao LIU ; Guodong LIU ; Tengbo YU ; Jinhai TAN ; Xi CHEN ; Fengfei LIN ; Zhangyuan LIN ; Dongfa LIAO ; Aiguo WANG ; Shiwu DONG ; Gaoxing LUO ; Zhao XIE ; Dong SUN ; Dehao FU ; Yunfeng CHEN ; Changqing ZHANG ; Kun LIU ; Deye SONG ; Yongjun RUI ; Fei WU ; Ximing LIU ; Junwen WANG ; Meng ZHAO ; Biao CHE ; Bing HU ; Chengjian HE ; Guanglin WANG ; Xiao CHEN ; Guandong DAI ; Shiyuan FANG ; Wenchao SONG ; Ming CHEN ; Guanghua GUO ; Yongqing XU ; Lei YANG ; Wenqian ZHANG ; Kun ZHANG ; Xin TANG ; Hua CHEN ; Weiguo XU ; Shuquan GUO ; Yong LIU ; Xiaodong GUO ; Zhewei YE ; Liming XIONG ; Tian XIA ; Hongbin WU ; Qisheng ZHOU ; Mengfei LIU ; Yiqiang HU ; Yanjiu HAN ; Hang XUE ; Kangkang ZHA ; Wei CHEN ; Zhiyong HOU ; Bin YU ; Jiacan SU ; Peifu TANG ; Baoguo JIANG ; Guohui LIU
Chinese Journal of Trauma 2025;41(5):421-432
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.
7.Clinical efficacy of sulbactam-durlobactam in treating patients with carbapenem-resistant Acinetobacter baumannii pulmonary infection and drug concentration surveillance
Yue CHEN ; Lin QIAO ; Zhongyao XIE ; Wenqian CHEN ; Dongjie GUO ; Pengmei LI
Chinese Journal of Nosocomiology 2025;35(20):3105-3109
OBJECTIVE To evaluate the efficacy of sulbactam-durlobactam combined with meropenem in treating carbapenem-resistant Acinetobacter baumannii(CRAB)pulmonary infection.METHODS A total of 16 patients treated at China-Japan Friendship Hospital from Jan.1,2025 to Jun.1,2025 were included.Retrospective analy-sis was conducted on patients'basic situation,preliminary treatment regimens,infection-related diagnoses,etiolo-gy and clinical outcomes.Therapeutic drug monitoring(TDM)for sulbactam was also performed.RESULTS By the end of the treatment course,13 patients achieved etiological eradication of CRAB and clinical improvement,while 1 patient experienced CRAB recurrence within one month.Three patients showed treatment failure.TDM for sulbactam was performed in 13 patients.Except for one slightly lower,all achieved trough plasma concentra-tions above the minimum inhibitory concentration(MIC)(100%T>MIC,MIC=4 mg/L based on clinical breakpoints).Dosage adjustments based on plasma concentrations were made for 4 patients,with 3 receiving re-duced doses and 1 receiving an increased dose.CONCLUSIONS Sulbactam-durlobactam combined with meropenem demonstrates superior efficacy in treating CRAB compared to other regimens.Under the recommended dosage,all patients can achieve the PK/PD target for sulbactam.
8.Guideline for diagnosis and treatment of infection after internal fixation of closed lower limb fractures in adults (version 2025)
Bobin MI ; Faqi CAO ; Weixian HU ; Wu ZHOU ; Chenchen YAN ; Hui LI ; Yun SUN ; Yuan XIONG ; Jinmi ZHAO ; Qikai HUA ; Xinbao WU ; Xieyuan JIANG ; Dianying ZHANG ; Zhongguo FU ; Dankai WU ; Guangyao LIU ; Guodong LIU ; Tengbo YU ; Jinhai TAN ; Xi CHEN ; Fengfei LIN ; Zhangyuan LIN ; Dongfa LIAO ; Aiguo WANG ; Shiwu DONG ; Gaoxing LUO ; Zhao XIE ; Dong SUN ; Dehao FU ; Yunfeng CHEN ; Changqing ZHANG ; Kun LIU ; Deye SONG ; Yongjun RUI ; Fei WU ; Ximing LIU ; Junwen WANG ; Meng ZHAO ; Biao CHE ; Bing HU ; Chengjian HE ; Guanglin WANG ; Xiao CHEN ; Guandong DAI ; Shiyuan FANG ; Wenchao SONG ; Ming CHEN ; Guanghua GUO ; Yongqing XU ; Lei YANG ; Wenqian ZHANG ; Kun ZHANG ; Xin TANG ; Hua CHEN ; Weiguo XU ; Shuquan GUO ; Yong LIU ; Xiaodong GUO ; Zhewei YE ; Liming XIONG ; Tian XIA ; Hongbin WU ; Qisheng ZHOU ; Mengfei LIU ; Yiqiang HU ; Yanjiu HAN ; Hang XUE ; Kangkang ZHA ; Wei CHEN ; Zhiyong HOU ; Bin YU ; Jiacan SU ; Peifu TANG ; Baoguo JIANG ; Guohui LIU
Chinese Journal of Trauma 2025;41(5):421-432
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.
9.Research progress of novel three-dimensional echocardiographic rendering tools in structural heart disease
Alimu TEZHI ; Yuman LI ; Lin HE ; He LI ; Wenqian WU ; Yun YANG ; Huan WANG ; Mingxing XIE ; Lingyun FANG
Chinese Journal of Ultrasonography 2025;34(2):173-179
Recently developed three-dimensional echocardiography rendering technology,which includes transillumination imaging and tissue transparency imaging,is based on powerful artificial intelligence algorithm and employs unique visualization methods. This novel technology enables intuitive and realistic visualization of the heart's three-dimensional structure and blood flow images,providing richer and more accurate imaging information for evaluating cardiac anatomy and function. They demonstrate unique value in the diagnosis and treatment of structural heart diseases. This article reviews the applications and prospects of three-dimensional echocardiographic rendering techniques in structural heart disease.
10.Echocardiographic evaluation of pediatric mitral valve replacement:a single-center study
Linyue ZHANG ; Yuji XIE ; Zhaoli REN ; He LI ; Wenqian WU ; Li ZHANG ; Yuman LI ; Mingxing XIE
Chinese Journal of Ultrasonography 2025;34(1):17-25
Objective:To explore the application value of echocardiography in the management of pediatric mitral valve replacement.Methods:Thirty-three children who underwent mitral valve replacement at Union Hospital Tongji Medical College Huazhong University of Science and Technology from January 2009 to June 2023 were retrospectively analyzed. Clinical data and preoperative and postoperative echocardiographic data were collected. The differences in ultrasound parameters among preoperative,1-week postoperative,1-month postoperative and 1-year postoperative were compared.Results:Of the 33 children,there were 4 cases(12.12%)of mitral stenosis,33 cases(100%)of mitral regurgitation and 4 cases(12.12%)of mitral stenosis combined with regurgitation. Mechanical valve replacement was performed in 30 cases(90.91%)and bioprosthetic valve replacement in 3 cases(9.09%). Compared with the preoperative period,the left atrial internal diameter and left ventricular end-diastolic internal diameter were significantly reduced at 1-week postoperatively,1-month postoperatively,and 1-year postoperatively,respectively(all P <0.05).The left ventricular mass was significantly reduced and the left ventricular end-diastolic sphericity index was significantly increased(both P < 0.05)at 1-month postoperatively compared with preoperatively. The left ventricular ejection fraction was significantly higher at 1-year postoperatively compared with 1-week postoperatively( P <0.05). Conclusions:After pediatric mitral valve replacement,the left ventricular dimensions decrease,and cardiac function progressively recovers. Echocardiography is an essential tool for accurate preoperative assessment and postoperative follow-up in pediatric mitral valve replacement.

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