1.Driving innovation and fostering collaboration to advance the development and clinical research of next-generation human serum albumin
Journal of Clinical Hepatology 2025;41(3):401-403
Albumin is the most abundant protein in human plasma, and in addition to the function of maintaining plasma colloid osmotic pressure, it also has the functions of material transport, detoxification, maintaining vascular integrity, antioxidation, anti-inflammation, and immune modulation. In the field of liver disease, albumin is mainly used to prevent circulatory dysfunction after large-volume paracentesis and treat cirrhotic hypoalbuminemia and ascites, spontaneous bacterial peritonitis, and hepatorenal syndrome. The development of recombinant human serum albumin helps to reduce the potential biosafety risks of human serum albumin products and the disadvantages of relying heavily on import. Due to the lack of reference to the results of pivotal clinical trials of marketed human albumin products, there are still various challenges in the design, implementation, and evaluation of clinical trials of human albumin. Therefore, experts in pharmaceutical enterprises, clinical medicine, methodology, and evaluation/supervision are needed to be pragmatic, innovative and collaborative.
2.Update on the treatment navigation for functional cure of chronic hepatitis B: Expert consensus 2.0
Di WU ; Jia-Horng KAO ; Teerha PIRATVISUTH ; Xiaojing WANG ; Patrick T.F. KENNEDY ; Motoyuki OTSUKA ; Sang Hoon AHN ; Yasuhito TANAKA ; Guiqiang WANG ; Zhenghong YUAN ; Wenhui LI ; Young-Suk LIM ; Junqi NIU ; Fengmin LU ; Wenhong ZHANG ; Zhiliang GAO ; Apichat KAEWDECH ; Meifang HAN ; Weiming YAN ; Hong REN ; Peng HU ; Sainan SHU ; Paul Yien KWO ; Fu-sheng WANG ; Man-Fung YUEN ; Qin NING
Clinical and Molecular Hepatology 2025;31(Suppl):S134-S164
As new evidence emerges, treatment strategies toward the functional cure of chronic hepatitis B are evolving. In 2019, a panel of national hepatologists published a Consensus Statement on the functional cure of chronic hepatitis B. Currently, an international group of hepatologists has been assembled to evaluate research since the publication of the original consensus, and to collaboratively develop the updated statements. The 2.0 Consensus was aimed to update the original consensus with the latest available studies, and provide a comprehensive overview of the current relevant scientific literatures regarding functional cure of hepatitis B, with a particular focus on issues that are not yet fully clarified. These cover the definition of functional cure of hepatitis B, its mechanisms and barriers, the effective strategies and treatment roadmap to achieve this endpoint, in particular new surrogate biomarkers used to measure efficacy or to predict response, and the appropriate approach to pursuing a functional cure in special populations, the development of emerging antivirals and immunomodulators with potential for curing hepatitis B. The statements are primarily intended to offer international guidance for clinicians in their practice to enhance the functional cure rate of chronic hepatitis B.
3.Update on the treatment navigation for functional cure of chronic hepatitis B: Expert consensus 2.0
Di WU ; Jia-Horng KAO ; Teerha PIRATVISUTH ; Xiaojing WANG ; Patrick T.F. KENNEDY ; Motoyuki OTSUKA ; Sang Hoon AHN ; Yasuhito TANAKA ; Guiqiang WANG ; Zhenghong YUAN ; Wenhui LI ; Young-Suk LIM ; Junqi NIU ; Fengmin LU ; Wenhong ZHANG ; Zhiliang GAO ; Apichat KAEWDECH ; Meifang HAN ; Weiming YAN ; Hong REN ; Peng HU ; Sainan SHU ; Paul Yien KWO ; Fu-sheng WANG ; Man-Fung YUEN ; Qin NING
Clinical and Molecular Hepatology 2025;31(Suppl):S134-S164
As new evidence emerges, treatment strategies toward the functional cure of chronic hepatitis B are evolving. In 2019, a panel of national hepatologists published a Consensus Statement on the functional cure of chronic hepatitis B. Currently, an international group of hepatologists has been assembled to evaluate research since the publication of the original consensus, and to collaboratively develop the updated statements. The 2.0 Consensus was aimed to update the original consensus with the latest available studies, and provide a comprehensive overview of the current relevant scientific literatures regarding functional cure of hepatitis B, with a particular focus on issues that are not yet fully clarified. These cover the definition of functional cure of hepatitis B, its mechanisms and barriers, the effective strategies and treatment roadmap to achieve this endpoint, in particular new surrogate biomarkers used to measure efficacy or to predict response, and the appropriate approach to pursuing a functional cure in special populations, the development of emerging antivirals and immunomodulators with potential for curing hepatitis B. The statements are primarily intended to offer international guidance for clinicians in their practice to enhance the functional cure rate of chronic hepatitis B.
4.Update on the treatment navigation for functional cure of chronic hepatitis B: Expert consensus 2.0
Di WU ; Jia-Horng KAO ; Teerha PIRATVISUTH ; Xiaojing WANG ; Patrick T.F. KENNEDY ; Motoyuki OTSUKA ; Sang Hoon AHN ; Yasuhito TANAKA ; Guiqiang WANG ; Zhenghong YUAN ; Wenhui LI ; Young-Suk LIM ; Junqi NIU ; Fengmin LU ; Wenhong ZHANG ; Zhiliang GAO ; Apichat KAEWDECH ; Meifang HAN ; Weiming YAN ; Hong REN ; Peng HU ; Sainan SHU ; Paul Yien KWO ; Fu-sheng WANG ; Man-Fung YUEN ; Qin NING
Clinical and Molecular Hepatology 2025;31(Suppl):S134-S164
As new evidence emerges, treatment strategies toward the functional cure of chronic hepatitis B are evolving. In 2019, a panel of national hepatologists published a Consensus Statement on the functional cure of chronic hepatitis B. Currently, an international group of hepatologists has been assembled to evaluate research since the publication of the original consensus, and to collaboratively develop the updated statements. The 2.0 Consensus was aimed to update the original consensus with the latest available studies, and provide a comprehensive overview of the current relevant scientific literatures regarding functional cure of hepatitis B, with a particular focus on issues that are not yet fully clarified. These cover the definition of functional cure of hepatitis B, its mechanisms and barriers, the effective strategies and treatment roadmap to achieve this endpoint, in particular new surrogate biomarkers used to measure efficacy or to predict response, and the appropriate approach to pursuing a functional cure in special populations, the development of emerging antivirals and immunomodulators with potential for curing hepatitis B. The statements are primarily intended to offer international guidance for clinicians in their practice to enhance the functional cure rate of chronic hepatitis B.
5.Key Information Research and Modern Clinical Application of Famous Classical Formula Yanghetang
Weilu NIU ; Mengjie YANG ; Chengqi LYU ; Shunxi WANG ; Ziwen WANG ; Huangchao JIA ; Liyun WANG ; Xuewei LIU ; Mingsan MIAO ; Xiaomeng WANG ; Yawei YAN ; Chunyong LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(15):238-246
Through data collection and collation combined with bibliometrics, this study conducted a series of textual research on Yanghetang, such as the name and origin, the evolution of prescription composition and modern clinical application. Yanghetang was first recorded in Bencao Yidu of WANG Ang in the Qing dynasty. In addition to Yanghetang, there were 3 bynames of Jiawei Yanghetang, Quanshengji Yanghetang and Zhenjun Yanghetang. Regarding the composition of the formula, a total of 4 versions of Yanghetang were collected. The first version is the 5 medicines version of Cervi Cornus Colla, Rehmanniae Radix Praeparata, Cinnamomi Cortex, Zingiberis Rhizoma and Ephedrae Herba in Bencao Yidu. The second version is the 7 medicines version of Waike Zhengzhi Quanshengji, changing Zingiberis Rhizoma to Zingiberis Rhizoma Praeparatum Carbonisata(ZRPC) and adding Sinapis Semen and Glycyrrhizae Radix et Rhizoma(GRR) on the basis of Bencao Yidu, and most of the Yanghetang is of this version. The third version is the 6 medicines version of Wushi Yifang Huibian, that is, on the basis of Bencao Yidu, Zingiberis Rhizoma is changed into ZRPC, and Sinapis Semen is added. The fourth version is the 6 medicines version in Yifang Jiedu, that is, on the basis of Bencao Yidu, Zingiberis Rhizoma is changed into Zingiberis Rhizoma Praeparatum, and GRR Praeparata cum Melle is added. Regarding the dose of Yanghetang, the doses of the medicines in Waike Zhengzhi Quanshengji was converted into the modern doses as follows:37.3 g of Rehmanniae Radix Praeparata, 1.87 g of Ephedrae Herba, 11.19 g of Cervi Cornus Colla, 7.46 g of Sinapis Semen, 3.73 g of Cinnamomi Cortex, 3.73 g of GRR, and 1.87 g of ZRPC. The origins of the above medicines are consistent with the 2020 edition of Chinese Pharmacopoeia. The processing specification of Rehmanniae Radix Praeparata is steaming method, ZRPC is ginger charcoal, Sinapis Semen is the fried products, and the rest of the medicines are raw products. The decoction method was verified by the decoction method in Chonglou Yuyao, which is similar in the time, and it is recommended that the above medicines should be added with 600 mL of water, decocted to 100 mL, and taken warmly 30 min after meal. For each dose, it is recommended to use 1-3 doses per day according to the doctor's advice in combination with clinical practice. The diseases involved in the ancient applications involved 42 diseases in 11 departments, including orthopedics, dermatology and gynecology, which were dominated by Yin-cold syndrome. However, the diseases involved in modern research also include 148 related diseases in 10 departments, such as orthopedics, obstetrics and gynecology, which is consistent with the ancient books. In recent years, the research hotspots of Yanghetang have focused on more than 10 fields, including osteoblasts, malignant tumors, wound healing, traditional Chinese medicine fumigation and so on, which are widely used. It is suitable for comprehensive research and development because of its rational formula composition, clear origin, processing and decoction method, and wide clinical application.
6.Historical Evolution and Modern Clinical Application of Huoxiang Zhengqisan
Weilu NIU ; Mengjie YANG ; Chengqi LYU ; Cuicui SHEN ; Congcong LI ; Huangchao JIA ; Liyun WANG ; Xuewei LIU ; Mingsan MIAO ; Xiaomeng WANG ; Yawei YAN ; Chunyong LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):156-167
In this study, bibliometric methods were used to systematically investigate the name and origin, the evolution of prescription composition, dose evolution, origin and processing method, decoction method, ancient application, modified application, modern application and other information of Huoxiang Zhengqisan. After research, Huoxiang Zhengqisan, also known as Huoxiang Zhengqitang, was first recorded in Taiping Huimin Hejijufang. The original formula is composed of 41.3 g of Arecae Pericarpium, 41.3 g of Angelicae Dahuricae Radix, 41.3 g of Perilla frutescens(actually Perillae Folium), 41.3 g of Poria, 82.6 g of Pinelliae Rhizoma, 82.6 g of Atractylodis Macrocephalae Rhizoma, 82.6 g of Citri Reticulatae Pericarpium(actually Citri Exocarpium Rubbum), 82.6 g of Magnoliae Officinalis Cortex, 82.6 g of Platycodonis Radix, 123.9 g of Pogostemonis Herba, and 103.25 g of Glycyrrhizae Radix et Rhizoma. In this formula, Magnoliae Officinalis Cortex is processed according to the specifications for ginger-processed products, Glycyrrhizae Radix et Rhizoma is processed according to the specifications for stir-fried products, and other herbs are used in their raw products. The botanical sources of the herbs are consistent with the 2020 edition of Pharmacopoeia of the People's Republic of China. The above herbs are ground into a fine powder with a particle size passing through a No. 5 sieve. For each dose, take 8.26 g of the powdered formula, add 300 mL of water, along with 3 g of Zingiberis Rhizoma Recens and 3 g of Jujubae Fructus, and decoct until reduced to 140 mL. The decoction should be administered hot, with three times daily. To induce sweating, the patient should be kept warm under a quilt, and an additional dose should be prepared and taken if needed. This formula is traditionally used to relieve the exterior and resolve dampness, regulate Qi and harmonize the middle, which is mainly used to treat a series of diseases of digestive and respiratory systems. However, potential adverse reactions, including allergies, purpura and disulfiram-like reactions, should be considered during clinical use. Huoxiang Zhengqisan features a rational composition, extensive clinical application, and strong potential for further research and development.
7.Historical Evolution and Modern Clinical Application of Huoxiang Zhengqisan
Weilu NIU ; Mengjie YANG ; Chengqi LYU ; Cuicui SHEN ; Congcong LI ; Huangchao JIA ; Liyun WANG ; Xuewei LIU ; Mingsan MIAO ; Xiaomeng WANG ; Yawei YAN ; Chunyong LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):156-167
In this study, bibliometric methods were used to systematically investigate the name and origin, the evolution of prescription composition, dose evolution, origin and processing method, decoction method, ancient application, modified application, modern application and other information of Huoxiang Zhengqisan. After research, Huoxiang Zhengqisan, also known as Huoxiang Zhengqitang, was first recorded in Taiping Huimin Hejijufang. The original formula is composed of 41.3 g of Arecae Pericarpium, 41.3 g of Angelicae Dahuricae Radix, 41.3 g of Perilla frutescens(actually Perillae Folium), 41.3 g of Poria, 82.6 g of Pinelliae Rhizoma, 82.6 g of Atractylodis Macrocephalae Rhizoma, 82.6 g of Citri Reticulatae Pericarpium(actually Citri Exocarpium Rubbum), 82.6 g of Magnoliae Officinalis Cortex, 82.6 g of Platycodonis Radix, 123.9 g of Pogostemonis Herba, and 103.25 g of Glycyrrhizae Radix et Rhizoma. In this formula, Magnoliae Officinalis Cortex is processed according to the specifications for ginger-processed products, Glycyrrhizae Radix et Rhizoma is processed according to the specifications for stir-fried products, and other herbs are used in their raw products. The botanical sources of the herbs are consistent with the 2020 edition of Pharmacopoeia of the People's Republic of China. The above herbs are ground into a fine powder with a particle size passing through a No. 5 sieve. For each dose, take 8.26 g of the powdered formula, add 300 mL of water, along with 3 g of Zingiberis Rhizoma Recens and 3 g of Jujubae Fructus, and decoct until reduced to 140 mL. The decoction should be administered hot, with three times daily. To induce sweating, the patient should be kept warm under a quilt, and an additional dose should be prepared and taken if needed. This formula is traditionally used to relieve the exterior and resolve dampness, regulate Qi and harmonize the middle, which is mainly used to treat a series of diseases of digestive and respiratory systems. However, potential adverse reactions, including allergies, purpura and disulfiram-like reactions, should be considered during clinical use. Huoxiang Zhengqisan features a rational composition, extensive clinical application, and strong potential for further research and development.
8.Textual Research on Lianggesan from Ancient Literature and Its Modern Clinical Application
Weilu NIU ; Chengqi LYU ; Mengjie YANG ; Shunxi WANG ; Jingkang QIAO ; Huangchao JIA ; Liyun WANG ; Xuewei LIU ; Mingsan MIAO ; Jianwei LI ; Gang WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(22):223-234
Lianggesan was first recorded in Taiping Huimin Heji Jufang, which was composed of Rhei Radix et Rhizoma, Natrii Sulfas, Gardeniae Fructus, Forsythiae Fructus, Scutellariae Radix, Glycyrrhizae Radix et Rhizoma(GRR), Menthae Haplocalycis Herba, Lophatheri Herba and Mel. It was clinically applied to treat fire-heat syndrome in the upper and middle Jiao, and the curative effect was positive. In this study, the bibliometric method was used to conduct a detailed textual research on the formula name, medicinal composition, dosage evolution, origin and processing, functional indications and other aspects of Lianggesan. Research revealed that Lianggesan has six other names, such as Lianqiao Yinzi, Lianqiao Jiedusan, Jufang Lianggesan, Jiegu Lianggesan, Hejian Lianggesan and Qingji Lianggesan. Based on the edition of Taiping Huimin Heji Jufang, an analysis of the evolution of its formula composition revealed that the missing Chinese medicines were predominantly bamboo leaves and honey, while the added Chinese medicines were primarily supplements introduced to address changes in disease manifestations. After textual research, the dosage for one dose of Lianggesan from Taiping Huimin Heji Jufang was as follows:826 g of Rhei Radix et Rhizoma, 826 g of Natrii Sulfas, 826 g of GRR, 413 g of Gardeniae Fructus, 413 g of Menthae Haplocalycis Herba, 413 g of Scutellariae Radix, and 1652 g of Forsythiae Fructus. Decocting method was as following:Grinding the Chinese medicines into coarse powder(2-4 mm), taking 8.16 g per dose, adding 300 mL of water, along with 2 g of Lophatheri Herba and 5 g of Mel, and decocting to 140 mL. The residue was removed and taken warmly 30 min after meals. It was recommended to take it three times daily until improvement was achieved. The origins of the 9 Chinese medicines were consistent with the 2020 edition of Pharmacopoeia of the People's Republic of China. Except for GRR, which required single frying(stir-frying), the remaining medicines were all raw products. The description of the function of this formula in ancient books was summarized as purging fire and promoting bowel movements, clearing heat from the upper body and purging the lower body, and the main syndromes included facial redness, tongue swelling, red eyes, etc. In modern applications, the formula is primarily used for respiratory and digestive system diseases, including acute lung injury, chronic obstructive pulmonary disease, herpetic angina and aphthous stomatitis, covering 142 types of diseases. In summary, this paper can provide a basis for further research and development of Lianggesan through the literature review and key information combing.
9.Application value of the Status Epilepticus in Pediatric Severity Score and PEDSS in assessing the short-term prognosis of children with status epilepticus
Jiechao NIU ; Yu ZHANG ; Jiandong WANG ; Haiying LI ; Mengjiao ZHANG ; Huiqiong LIU ; Peisheng JIA ; Erhu WEI ; Huaili WANG
Chinese Journal of Applied Clinical Pediatrics 2024;39(1):54-58
Objective:To validate and compare the value of the Status Epilepticus in Pediatric Severity Score (STEPSS) versus PEDSS in assessing the short-term prognosis of children with status epilepticus (SE).Methods:Clinical data of 152 children with SE hospitalized at the First Affiliated Hospital of Zhengzhou University from January 2020 to December 2022 were retrospectively analyzed.According to the STEPSS and PEDSS scores, children with SE were scored and their prognosis was predicted.Receiver operating characteristic (ROC) curves of the 2 scales in assessing the short-term prognosis of SE in children were plotted, and the area under the curve (AUC), optimal cut-off, sensitivity and specificity were calculated, thus validating and comparing the value of the STEPSS versus PEDSS in assessing the short-term prognosis of children with SE.Results:Of the 152 children with SE, 90 were male and 62 were female, with the age of (5.8±3.9) years (1 month to 15 years). There were 112 cases with good prognosis and 40 cases with poor prognosis, involving 13 deaths.The AUC of STEPSS and PEDSS scores in predicting the death in children with SE were 0.908(95% CI: 0.848-0.967) and 0.887(95% CI: 0.831-0.942), respectively, both with the optimal cut-off value of 4.The sensitivity of STEPSS and PEDSS scores in predicting the death in children with SE were 0.740 and 0.846, respectively, and the specificity were 0.745 and 0.835, respectively.There was no significant difference in predicting the death in children with SE between the 2 scales ( P>0.05). In predicting adverse outcomes, the AUC of the STEPSS and PEDSS scores were 0.869(95% CI: 0.800-0.937) and 0.926(95% CI: 0.873-0.979), respectively, both with the optimal cut-off value of 3.The sensitivity of STEPSS and PEDSS scores in predicting adverse outcomes in children with SE were 0.827 and 0.900, respectively, and the specificity were 0.732 and 0.866, respectively.There was significant difference in predicting the adverse outcomes in children with SE between the 2 scales ( P<0.05). Conclusions:Compared with the STEPSS, the PEDSS has a higher application in predicting the short-term treatment outcome of children with SE, which can be used as a routine method to assess the prognosis of children with SE.
10.Limit test for 5-hydroxymethylfurfural in Yueju Baohe pills
NIU Chenjin ; AN Jie ; QIU Shuowen ; QU Jia
Drug Standards of China 2024;25(1):055-061
Objective: To establish an HPLC method to detect the limit of 5-hydroxymethylfurfural in Yueju Baohe pills.
Methods: A Zafex Acutfex PW-C18 column(4.6 mm×250 mm, 5 μm) was adopted with mobile phase consisted of acetonitrile-0.1% formic acid aqueous solution(2:98)at the flow rate of 1.0 mL·min-1. The column temperature was 40 ℃ and the detective wavelength was set at 284 nm.
Results: The linear range of 5-hydroxymethylfurfural was 0.491 9-122.98 μg·mL-1 (r=1.000). The average recovery(n=6) was 97.99% with RSD 0.61%. All of the RSDs for precision,repeatability and stability met the methodological requirements. According to the proposed limit, 17 of the 65 batches of samples did not meet the requirements, and the failure rate was 26.15%.
Conclusion: The established method is suitable for the limit test of 5-hydroxymethylfurfural in Yueju Baohe pills.There was a significant difference in the content of 65 batches of samples. It is necessary to investigate the limit of 5-hydroxymethylfurfural in Yueju Baohe pills.

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