1.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
3.The effect of body mass index and inferior pulmonary ligament division on the residual lung expansion after right upper lobectomy: A retrospective cohort study in a single center
Guang MU ; Wenhao ZHANG ; Hongchang WANG ; Yan GU ; Chenghao FU ; Wentao XUE ; Shiyuan XIE ; Tong WANG ; Ke WEI ; Yang XIA ; Liang CHEN ; Jun WANG
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(02):261-266
Objective To analyze the effect of releasing the lower pulmonary ligament on right residual lung expansion after right upper lobe resection under different body mass index (BMI) levels. Methods The clinical data of patients who underwent thoracoscopic right upper lobe resection in the First Affiliated Hospital with Nanjing Medical University from 2021 to 2022 were retrospectively analyzed. Patients were divided into a group A (17 kg/m2<BMI≤23 kg/m2), a group B (23 kg/m2<BMI≤29 kg/m2) and a group C (BMI>29 kg/m2) according to BMI. The presence of residual cavity was judged by chest X-ray at 7-10 days after operation, the degree of compensation change of the right main bronchus angle was measured, and the changes in lung volume were determined by CT three-dimensional reconstruction. Results A total of 157 patients who underwent thoracoscopic right upper lobe resection were included, including 71 males and 86 females, with an average age of (59.7±11.2) years. There were 50 patients in the group A, 75 patients in the group B, and 32 patients in the group C. In the group A, compared with those without releasing the lower pulmonary ligament, patients with releasing had a lower incidence of postoperative residual cavity (P=0.016), greater changes in bronchus angle (P<0.001), and smaller changes in lung volume (P<0.001). In the group B and C, there was no significant effect of releasing the lower pulmonary ligament on postoperative residual cavity, bronchus angle, and lung volume changes (P>0.05). Conclusion For patients with thin and long body shape and low BMI, releasing the lower pulmonary ligament is helpful to promote the expansion of the residual lung after right upper lobe resection and reduce the occurrence of postoperative residual cavity in patients.
4.Study on the improving mechanism of Yifei xuanfei jiangzhuo formula on vascular dementia model rats based on the GRB2/ERK/CRLS1 pathway
Guifeng ZHUO ; Wei CHEN ; Xiaomin ZHU ; Yulan FU ; Jinzhi ZHANG ; Lin WU
China Pharmacy 2026;37(7):877-882
OBJECTIVE To explore the improvine mechanism of Yifei xuanfei jiangzhuo formula (YFXF) on vascular dementia (VAD) model rats based on the growth factor receptor-bound protein 2 (GRB2)/extracellular signal-regulated kinase (ERK)/cardiolipin synthase 1 (CRLS1) pathway. METHODS VAD rat model was established by permanent bilateral common carotid artery ligation. Forty-eight successfully modeled rats were randomly divided into the model group (normal saline), donepezil hydrochloride group (positive control group, 0.2 g/kg), and YFXF low- and high-dose groups (12.18 and 24.36 g/kg, calculated based on the total amount of crude drug), respectively. In addition, a sham operation group (normal saline) was set up. There were 12 rats in each group. Daily intragastric administration of drug or normal saline was performed for 30 consecutive days. After the last administration, the spatial cognitive ability of the rats was evaluated, the pathological morphology of the hippocampus was observed, the contents of tumor necrosis factor-α (TNF-α) and interleukin-4 (IL-4) in serum were detected, the expression levels of GRB2/ERK/CRLS1 pathway-related proteins and the mRNA levels of GRB2, CRLS1, NADH dehydrogenase subunit 1(ND1), Tafazzin (TAZ), phospholipid scramblase 3(PLSCR3) and the ATP content in hippocampal tissue were measured. RESULTS Compared with the sham operation group, the escape latency of rats in the model group was significantly prolonged ( P <0.05), and the number of crossing platform was significantly reduced ( P <0.05), while the number of pyramidal cells and Nissl bodies in the hippocampus decreased sharply; the content of TNF-α in serum was significantly increased ( P <0.05), and the content of IL-4 was significantly decreased ( P <0.05); the expression levels of GRB2 and CRLS1 proteins, the phosphorylation level of ERK protein, the relative expression levels of GRB2, CRLS1,ND1, TAZ, and PLSCR3 mRNA, and the content of ATP in hippocampal tissue were significantly decreased ( P <0.05). Compared with the model group, the above pathological changes in the hippocampal tissue of each administration group were alleviated, and the quantitative indicators were significantly restored ( P <0.05). CONCLUSIONS YFXF may improve hippocampal neuron injury in VAD rats by activating the GRB2/ERK/CRLS1 pathway, maintaining cardiolipin homeostasis, and improving mitochondrial energy metabolism.
5.Expert Consensus on Clinical Application of Qidong Yixin Oral Liquid
Changkuan FU ; Xiaochang MA ; Mingjun ZHU ; Yue DENG ; Hongxu LIU ; Mingxue ZHANG ; Ying CHEN ; Yan ZHOU ; Ling ZHANG ; Jianhua FU ; Wei YANG ; Yu'er HU ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):147-158
The prescription of Qidong Yixin oral liquid is derived from the experience of national medical master Ren Jixue in treating viral myocarditis (VMC). It has the functions of tonifying Qi, nourishing the heart,calming the mind, and relieving palpitations. It is used to treat VMC and angina pectoris of coronary heart disease caused by deficiency of both Qi and Yin. However,the understanding of its efficacy evidence, advantageous aspects, dosage and administration, and medication safety remains insufficient in clinical practice. Therefore,the development of the Expert Consensus on the Clinical Application of Qidong Yixin Oral Liquid (hereinafter referred to as consensus) was initiated. Consensus strictly followed the process and methods of the expert consensus on the clinical application of Chinese patent medicines of the China Association of Chinese Medicine,successively completing multiple tasks such as the consensus project initiation,determination of clinical problems,evidence search and evaluation,formation of recommendation opinions and consensus suggestions,solicitation of opinions,peer review, submission for review and release, and so on. Consensus formed a total of 10 recommendation opinions and 12 consensus suggestions,clarifying the clinical positioning,efficacy advantages,syndrome differentiation,dosage and administration,combination therapy,timing of medication,adverse reactions,contraindications, and precautions of Qidong Yixin oral liquid,indicating that it has good clinical advantages and safety in the treatment of VMC and angina pectoris of coronary heart disease,providing norms and references for physicians to safely and rationally apply Qidong Yixin oral liquid. Consensus was reviewed and approved for release by the Standardization Office of the China Association of Chinese Medicine on December 23, 2024. Standard number:GSCACM-376-2024.
6.Differences in deltamethrin resistance and kdr gene mutation in Culex tritaeniorhynchus population in and outside the Yellow Sea wetland
Xiao-er ZHANG ; Zhi-ming WU ; Ye TIAN ; Qian CUI ; Yu-qian JI ; Huan WANG ; Shu-juan YANG ; Yi-chao ZHAO ; Yu WANG ; Hua-yu YIN ; Yu DING ; Guo-jin YAN ; Min-sen ZHAO ; Shou-gang ZHANG ; Bing-dong SONG ; Hong-na CHEN ; Jian GAO ; Wei-fang YANG ; Yu-fu ZHANG ; Hui LIU ; Hong-liang CHU
Acta Parasitologica et Medica Entomologica Sinica 2026;33(2):101-107
Objective To gain insights into the biological characteristics of different populations of Culex tritaeniorhynchus within and around the Yellow Sea wetland from the perspective of the occurrence of resistance, we investigated the levels of resistance to deltamethrin and kdr gene mutation in the wetland and its peripheral areas. Methods Specimens were collected from Cx. tritaeniorhynchus populations at two monitoring sites in the Rare Bird National Nature Reserve and Tiaozi Ni Wetland Scenic Area, and also from two populations in Yancheng City and the Liuhe District of Nanjing, and the resistance of these mosquitoes to deltamethrin was determined using the CDC biotest bottle method. For each concentration of deltamethrin assessed, a random subset of exposed specimens was selected for amplification of the kdr gene fragment, followed by Sanger sequencing to identify and analyze resistance-associated mutations. Results The LC50 levels of deltamethrin among mosquitoes from the four populations in Luhe, Yancheng, the Rare Bird National Nature Reserve and the Tiaozi Ni Wetland Scenic Area were 2.048 5, 7.798 2, 3.473 3, and 17.695 5 mg/mL, respectively, with corresponding concentrations of deltamethrin ranging from 0.005 to 5.000,0.050 to 50.000,0.050 to 25.000 and 0.050 to 50.000 mg/mL, respectively. Furthermore, the ranges of the KT50 values were 11.76-107.43, 67.05-216.30,29.77-107.43 and 28.40-329.51 min; the 1-h knockdown rates were 34.58%-99.15%, 9.52%-43.80%, 55.09%-73.01%, and 10.09%-68.07%; and the 24-h mortality rates were 12.15%-67.52%,9.52%-79.56%,13.17%-82.21%, and 11.01%-78.99%, respectively. With respect to kdr gene mutation, we assayed a total of 63,70,59, and 57 mosquitoes for the four populations, for which we detected L1014F mutation frequencies of 14.29%, 35.00%, 20.34%, and 31.58%, respectively, with a majority of these mutations being heterozygous for resistance. In addition, five adult mosquitoes were identified has having synonymous mutations at site 1011[i. e. , AAT(asparagine)mutation to AAC(asparagine)]. Conclusions Our findings revealed the clear resistance of Cx. tritaeniorhynchus to deltamethrin in the Yancheng region of the Yellow Sea wetland, and the resistance phenotype and kdr frequency of Cx. tritaeniorhynchus in the wetland environment were comparable to those of Cx. tritaeniorhynchus in the wetland environment, thereby indicating that the resistance of different populations of Cx. tritaeniorhynchus was homogeneous under the pressure of different insecticide selection within and around the wetland. However, the underlying mechanisms need to be further studied.
7.Investigations of tick habitats and potential pathogens carried in urban environments of Jiangsu Province
Zhi-ming WU ; Ye TIAN ; Wei-fang YANG ; Hong-na CHEN ; Jian GAO ; Hui LIU ; Yu-fu ZHANG ; Gan CAO ; Hong-liang CHU
Acta Parasitologica et Medica Entomologica Sinica 2026;33(3):192-197
Objective To investigate the species composition, distribution, density, and pathogen-carrying status of host-seeking ticks in urban environments of Jiangsu Province, and to provide a scientific basis for the prevention and control of tick-borne diseases in urban settings. Methods From April to September 2023, a survey on host-seeking ticks was conducted in three types of habitats (city parks, residential areas, and street greenbelts) across 54 counties (cities, districts) of 13 prefecture-level cities in Jiangsu Province by using the flagging method. RStudio 4.4.3 (Windows version) was employed to perform chi-square test analysis on the species composition of ticks across different months, and Friedman test (for multiple paired samples) was applied to analyze monthly changes in the average tick density index among different habitats. Quantitative real-time PCR was performed to detect pathogens in the captured ticks. Results A total of 863 host-seeking ticks were captured from 54 habitats in 24 counties (cities, districts) of 11 prefecture-level cities (Nanjing, Wuxi, Changzhou, Suzhou, Nantong, Huai'an, Yancheng, Yangzhou, Zhenjiang, Taizhou, and Suqian) in Jiangsu Province, whereas no ticks were captured in Xuzhou and Lianyungang. The collected ticks belonged to three species, with Haemaphysalis longicornis being the dominant species (accounting for 82.62%), followed by Haemaphysalis flava and Hae. phasiana. The average density index of ticks in positive habitats was 3.20 ticks/ (flag·100 m). In terms of tick density among prefecture-level cities, Wuxi had the highest density[13.55 ticks/(flag·100 m)], whereas Nanjing and Taizhou had the lowest[both,0.20 ticks/(flag·100 m)]. With respect to the types of positive habitats,46 positive city parks,7 positive residential areas, and 1 positive street greenbelt were found, with the average tick density index being 3.46, 1.86, and 3.60 ticks/flag · 100 m, respectively. No statistically significant differences were observed in the monthly variations in the average tick density index among different habitats (P>0.05). Pathogen detection showed no Bandavirus dabieense, Rickettsia, or Borrelia burgdorferi in the collected ticks. Conclusions Host-seeking ticks have established populations in urban environments across most prefecture-level cities in Jiangsu Province, with Hae. longicornis identified as the dominant species. City parks serve as the primary breeding habitats for these ticks. Strengthening tick surveillance and control measures in densely populated and frequently visited areas, such as city parks and residential neighborhoods, is crucial for the effective prevention and control of urban tick-borne diseases.
8.Chinese expert consensus on the clinical application of recombinant human thyroid-stimulating hormone (2025 edition)
Chentian SHEN ; Yushen GU ; Hui TAN ; Anren KUANG ; Sijin LI ; Yaming LI ; Jing WANG ; Ningyi JIANG ; Jian TAN ; Zhuoying WANG ; Shaoyan LIU ; Xiaoyi LI ; Jugao FANG ; Dingcun LUO ; Youben FAN ; Hui WANG ; Yuetao WANG ; Xuemei WANG ; Feng WANG ; Wei FU ; Feng SHI ; Xuegong LIU ; Zhongwei LÜ ; Yan XING ; Lin LI ; Hui YANG ; Jun XIN ; Yifan ZHANG ; Yue CHEN ; Yansong LIN ; Wei OUYANG ; Shuzhan YAO ; Changjiu ZHAO ; Xinming ZHAO ; Zairong GAO ; Dingde HUANG ; Qiang WEN ; Xingmin HAN ; Cen LOU ; Weibing MIAO ; Wei FAN ; Quanyong LUO ; Hongcheng SHI
Chinese Journal of Clinical Medicine 2026;33(5):932-944
The recombinant human thyroid-stimulating hormone (rhTSH) can be used for differentiated thyroid cancer (DTC) preparation before 131I therapy, and follow-up. Since its approval by the American Food and Drug Administration (FDA) in 1998, rhTSH has been clinically used in European countries, the United States, and other countries for nearly 30 years. In April 2024, China’s first independently developed rhTSH agent was approved. Based on clinical experience and evidence from domestic and international studies, an expert consensus on the application of rhTSH has been developed following thorough consultations among experts. The consensus offers evidence-based recommendations to guide the appropriate use of rhTSH in clinical practice.
9.Advances in the application of clamshell incision for complex mediastinal tumor resection
Xi CHEN ; Dong LIN ; Xiaolong LI ; Xiangnan XU ; Fu YANG ; Liang WU ; Wei HUANG ; Jiang FAN
Chinese Journal of Thoracic and Cardiovascular Surgery 2025;41(9):561-564
Clamshell incision is widely used in the surgical resection of complex mediastinal tumors, but it is also controversial. Its advantages are the full exposure of the field of vision and the huge operating space, while its disadvantages are the destruction of chest wall muscles and respiratory function impairment. At present, there is a lack of norms for the selection and application of Clamshell incisions, and the definition of complex mediastinal tumors is ambiguous and the dimensions are single. Therefore, this article reviews the literature and combines practical experience to systematically summarize the application progress of Clamshell incisions in the surgical resection of complex mediastinal tumors, with the aim of providing guidance for clinical work.
10.Progress on the relationship between small intestinal bacterial overgrowth and functional gastrointestinal disorders
Xiaoli FU ; Xuxia WEI ; Junjie XU ; Hongling CHEN ; Le ZHANG ; Ning XUE
International Journal of Pediatrics 2025;52(1):27-32
Small intestinal bacterial overgrowth(SIBO)is a clinically common but poorly recognized disease with clinical symptoms that overlap with those of functional gastrointestinal disorders(FGID). FGID is a common risk factor for the occurrence of SIBO,and its SIBO incidence rate is significantly higher than that of healthy people,and has a certain correlation. Intestinal microbiota dysbiosis(including SIBO)plays an important role in the pathophysiology of FGID. At present,the diagnosis and treatment of SIBO still face challenges,and the treatment plan of FGID is gradually introduced into the treatment of SIBO. SIBO and FGID are closely related in clinical manifestations,incidence rate,pathophysiology,treatment and other aspects,but there is little research on the relationship between them. Prospective and large-scale clinical research is still needed to improve understanding and diagnostic accuracy.This article reviews the research progress on the relationship between SIBO and FGID.


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