1.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
2.Effectiveness of Xuanshen Yishen Decoction on Intensive Blood Pressure Control: Emulation of a Randomized Target Trial Using Real-World Data.
Xiao-Jie WANG ; Yuan-Long HU ; Jia-Ming HUAN ; Shi-Bing LIANG ; Lai-Yun XIN ; Feng JIANG ; Zhen HUA ; Zhen-Yuan WANG ; Ling-Hui KONG ; Qi-Biao WU ; Yun-Lun LI
Chinese journal of integrative medicine 2025;31(8):677-684
OBJECTIVE:
To investigate the effectiveness of Xuanshen Yishen Decoction (XYD) in the treatment of hypertension.
METHODS:
Hospital electronic medical records from 2019-2023 were utilized to emulate a randomized pragmatic clinical trial. Hypertensive participants were eligible if they were aged ⩾40 years with baseline systolic blood pressure (BP) ⩾140 mm Hg. Patients treated with XYD plus antihypertensive regimen were assigned to the treatment group, whereas those who followed only antihypertensive regimen were assigned to the control group. The primary outcome assessed was the attainment rate of intensive BP control at discharge, with the secondary outcome focusing on the 6-month all-cause readmission rate.
RESULTS:
The study included 3,302 patients, comprising 2,943 individuals in the control group and 359 in the treatment group. Compared with the control group, a higher proportion in the treatment group achieved the target BP for intensive BP control [8.09% vs. 17.5%; odds ratio (OR)=2.29, 95% confidence interval (CI)=1.68 to 3.13; P<0.001], particularly in individuals with high homocysteine levels (OR=3.13; 95% CI=1.72 to 5.71; P<0.001; P for interaction=0.041). Furthermore, the 6-month all-cause readmission rate in the treatment group was lower than in the control group (hazard ratio=0.58; 95% CI=0.36 to 0.91; P=0.019), and the robustness of the results was confirmed by sensitivity analyse.
CONCLUSIONS
XYD could be a complementary therapy for intensive BP control. Our study offers real-world evidence and guides the choice of complementary and alternative therapies. (Registration No. ChiCTR2400086589).
Adult
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Aged
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Female
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Humans
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Male
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Middle Aged
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Antihypertensive Agents/pharmacology*
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Blood Pressure/drug effects*
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Drugs, Chinese Herbal/pharmacology*
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Hypertension/physiopathology*
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Patient Readmission
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Treatment Outcome
3.Preparation of a rat model of diarrheal irritable bowel syndrome induced by an acetic acid enema combined with binding tail-clamping stress
Biyu LAI ; Mengying HONG ; Xing LI ; Yongjia HE ; Yao CHEN ; Xinwu LI ; Jia SHI ; Zihan TIAN ; Dan LI ; Jing NIE ; Chang SHE
Acta Laboratorium Animalis Scientia Sinica 2024;32(3):317-328
Objective To establish an ideal modeling method for diarrhea predominant irritable bowel syndrome(IBS-D)with anxiely and depression in rats,and to provide a basis for the clinical study of IBS-D.Methods 60 rats were used in this study.(1)At first,20 rats were randomly divided into blank,3%acetic acid enema,4%acetic acid enema,and 5%acetic acid enema groups.After the modeling and observation period,the diarrhea status and the degree of colon injury caused by different modeling concentrations were observed by diarrhea related index and colon histopathology.(2)After the optimal modeling concentration was assessed,40 rats were randomly divided into control(a),acetic acid enema(b),acetic acid+binding(c),and acetic acid+binding+tail clip(d)groups and correspondingly treated for 8 days.After the treatments,the general condition,diarrhea-related index,open field test(OFT)score,and colonic histopathology of rats were evaluated.Results(1)Compared with the blank group,the fecal trait score of 4%acetic acid enema group was increased on days 1 to 3 after intervention(P<0.001),and gradually decreased on days 4 to 7 after intervention.After 1 week,there was no significant difference between the fecal trait score and that of the blank group(P>0.05).Body weight was lower(P<0.01),fecal water content was higher(P<0.001).Compared with blank group,body weight of the 5%acetic acid enema group was decreased(P<0.001),the fecal trait score and diarrhea index were increased(P<0.01).No significant difference was found between 3%acetic acid enema and blank groups.The pathological colon tissue showed that,compared with the blank group,the mucosal structure of the 4%acetic acid enema group was complete with a small amount of inflammatory cell infiltration,and the pathological tissue score showed no significant difference(P>0.05),whereas the 5%acetic acid enema had a medium to large amount of inflammatory cell infiltration,and the pathological tissue score was increased(P<0.01).(2)Compared with group a,group b had lower body weight(P<0.001),and higher fecal trait score,fecal water content and diarrhea index(P<0.01).Compared with a and b groups,the body weight of c and d groups was lower(P<0.001),the fecal traits score,fecal water content,and diarrhea index were increased(P<0.01),and the colon running time was decreased(P<0.01).Compared with group c,Fecal water content in group D was higher(P<0.001).In the OFT score,compared with a and b groups,the OFT distance,standing times,and upright times in c and d groups were lower(P<0.05).Compared with c,the OFT distance,standing times,and upright times in d group were lower(P<0.05).The pathological tissue of colon showed that the mucosal structure of the four groups was complete,and there were different degrees of inflammatory cell infiltration.The pathological tissue scores of groups c and d were higher than those of groups a and b(P<0.05).Conclusions The 4%acetic acid concentration is appropriate for IBS-D modeling.After superposition and binding,the IBS-D diarrhea and internal hypersensitivity characteristic state can be better simulated.After superposition of a tail clip,the IBS-D model of liver stagnation and spleen deficiency can be established successfully.
4.Research on three-dimensional ordered porous carbon-based materials prepared from Acanthopanax senticosus traditional Chinese medicine residues and their drug loading performance
De-sheng WANG ; Jia-xin FAN ; Ri-qing CHENG ; Shi-kui WU ; Lai-bing WANG ; Jia-hao SHI ; Ting-ting CHEN ; Qin-fang HE ; Chang-jin XU ; Hui-qing GUO
Acta Pharmaceutica Sinica 2024;59(10):2857-2863
Three-dimensional ordered porous carbon materials exhibit potential application prospects as excellent drug supports in drug delivery systems due to their high specific surface area, tunable pore structure, and excellent biocompatibility. In this study, three-dimensional ordered porous carbon materials were prepared using
5. Prevention and inhibition of nasopharyngeal carcinoma growth by attenuated salmonella SGN1
Yun-Hao LAI ; Ting-Qi HUANG ; Shi LIU ; Yue-Rong PENG ; Fang-Hong LI ; Zheng-Gang ZHAO ; Su-Jin ZHOU ; Zi-Jian ZHAO ; Qi-Ting TAN ; Jia-Luo MAI
Chinese Pharmacological Bulletin 2023;39(10):1867-1873
Aim To study the inhibitory effect of attenuated salmonella SGN1, overexpressing methioninase, on nasopharyngeal carcinoma (NPC) and the underlying mechanism. Methods The cell proliferation, cell cycle, cell apoptosis, clony formation and migration a-bility of 5-8F, HNE-2, CNE-2 cells were measured u-sing flow cytometry assay, clone formation assay, and wound assay after the methionine restriction treatment. 5-8F, HNE-2, CNE-2 cells were infected with SGN1 at the multiplicity of infection (MOI) of 1: 100 for 5 hours, followed with the measurement of cell growth. A xenograft model was constructed by subcutaneous injection of 5-8F cells in mice to observe the inhibitory effect of SGN1 on nasopharyngeal carcinoma. Results Compared with the control group, methionine restriction significantly inhibited the proliferation, migration ability, and clone formation of nasopharyngeal carcinoma cells and blocked the G
7.Occurrence of Intracranial Hemorrhage and Associated Risk Factors in Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy:A Systematic Review and Meta-Analysis
Qi-Lun LAI ; Yin-Xi ZHANG ; Jun-Jun WANG ; Ye-Jia MO ; Li-Ying ZHUANG ; Lin CHENG ; Shi-Ting WENG ; Song QIAO ; Lu LIU
Journal of Clinical Neurology 2022;18(5):499-506
Background:
and Purpose Intracranial hemorrhage (ICH) is thought to be a rare but probably underestimated presentation of cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL). We conducted a systematic review and meta-analysis with the aim of comprehensively revealing the occurrence of ICH in patients with CADASIL.
Methods:
English-language studies published up to September 30, 2021 were searched for in the MEDLINE (PubMed), Web of Science, and Cochrane Library databases. The design, patient characteristics, occurrence rate of ICH, and associated risk factors were retrieved for each identified relevant study.
Results:
We enrolled 13 studies in the final meta-analysis, which included 1,310 patients with CADASIL. The probability of ICH occurrence in patients with CADASIL was 10.1% (95% confidence interval [CI]=5.6%–18.0%, I2 =85.1%). When stratified by geographic region, the occurrence rate of ICH was much higher in Asians (17.7%; 95% CI=11.0%–28.5%, I2 =76.3%) than in Europeans (2.0%; 95% CI=0.4%–10.8%, I2 =82.8%). A higher burden of cerebral microbleeds (CMBs) and a history of hypertension were the most commonly recorded risk factors for ICH, which were available for three and two of the included studies, respectively.
Conclusions
Our study suggests that ICH is an important clinical manifestation of CADASIL, especially in Asians. A higher burden of CMBs and the existence of hypertension were found to be associated with a higher probability of ICH occurrence in patients with CADASIL.
8.Textual Research on Nelumbinis in Famous Classical Formulas
Hui-hui LIU ; Shi-bin CHEN ; Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):42-54
The name, origin, place of origin, medicinal parts, harvesting and processing of lotus are verified by consulting ancient Chinese herbal medicines and medical books, combined with modern literature, providing a basis for the development of famous classical formulas containing lotus. According to textual research, the original base of lotus is Nelumbo nucifera since ancient times, rhizome (Nelumbinis Rhizomatis Nodus), leaf (Nelumbinis Folium), seed (Nelumbinis Semen), embryo (Nelumbinis Plumula), receptacle (Nelumbinis Receptaculum), stamen (Nelumbinis Stamen) and other medicinal parts of N. nucifera can be used as medicine and have different clinical effects. Nelumbinis Semen was originally produced in Henan, and then gradually expanded to Jiangnan. Today, it can be cultivated and planted throughout the country, with Fujian, Hunan, and Jiangxi as the authentic production areas. After combing the medicinal parts of N. nucifera and the historical evolution of its processing, it is suggested that the dried and mature fruits of N. nucifera taking in autumn and removing the shell and Nelumbinis Plumula should be used in Qingxin Lianziyin. Nelumbinis Folium in Erdongtang should be harvested in summer and autumn, and the raw products was used as medicine and processed in accordance with the provision of the 2020 edition of Chinese Pharmacopoeia.
9.Textual Research on Perillae in Famous Classical Formulas
Jin-xiu QIAN ; Wu-wei MENG ; Hui -hui LIU ; Shi-bin CHEN ; Jia-chen ZHAO ; Yi-han WANG ; Yan JIN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):55-67
Based on the ancient literature of all dynasties, this article makes a systematic textual research on the name, origin, producing area, quality, harvesting and processing of Zisu (Perillae) in the famous classical formulas, so as to clarify the information of the drug in different historical periods and provide a reference for the development and utilization of the related formulas. The main origin of Perillae in the ancient literature was Perilla frutescens var. frutescens (purple leaf type), followed by P. frutescens var. acuta (purple leaf type), but not Baisu. Modern chemical composition studies also show that there are obvious differences between Perillae and Baisu, which provides a scientific basis for distinguishing them. Although they are often treated as a species in plant classification, P. frutescens var. frutescens (purple leaf type) is recommended in the development of famous classical formulas, and Baisu should be avoided. Perillae is widely distributed, but its producing area did not record in most of the literature in the past dynasties, or the producing area is described as everywhere today. In the period of the Southern and Northern dynasties, the medicinal parts of Perillae included stems, leaves and seeds, and doctors in the Ming dynasty began to pay attention to the differentiation of different medicinal parts. The harvesting and processing methods of Perillae in the past dynasties are close to that of today. Perillae Fructus is mostly stir-fried and ground into medicine, Perillae Folium and Perillae Caulis are mainly simple cleansing. In production, we can refer to the 2020 edition of Chinese Pharmacopoeia.
10.Herbal Textual Research on Chuanxiong Rhizoma in Famous Classical Formulas
Yi-han WANG ; Jia-chen ZHAO ; Yan JIN ; Hui-hui LIU ; Shi-bin CHEN ; Wei ZHANG ; Hua-sheng PENG ; Qiu-jie CAI ; Bing LI ; Hong-jun YANG ; Hua-min ZHANG ; Zhi-lai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(10):262-274
Based on various ancient documents such as materia medica, prescription books, classics and history, combined with relevant research materials in modern times, this paper made a textual research on the name, origin, geoherbalism, harvesting time, processing methods of Chuanxiong Rhizoma, which provides a basis for the development of famous classical formulas containing this herb. According to the textual research, the original name of Chuanxiong is Xiongqiong (芎䓖), which was first recorded in Shennong Bencaojing , there are many aliases and trade names in the past dynasties. Since the Song dynasty, doctors all take Xiongqiong produced in Sichuan as the best medicine, so they take Chuanxiong as the rectification of name. In the early stage, the origin of Chuanxiong Rhizoma was relatively complicated, and the main origin was Ligusticum chuanxiong, which was a cultivated and domesticated species of Ligusticum. However, wild related plants of Ligusticum are still used as medicine. After the Ming dynasty, new cultivated varieties appeared in various places, such as Jiangxi L. sinense cv. Fuxiong, which gradually turned to self-production and self-marketing after the Republic of China. After several changes in the authentic producing area of Chuanxiong Rhizoma, Tianshui in Gansu province was highly praised in the Tang dynasty, and Dujiangyan in Sichuan province was the best place in the Song dynasty and later dynasties. Chuanxiong Rhizoma has been widely used in the past dynasties as raw products, and it has also been processed with excipients. For example, wine-processed products can enhance the effect of promoting blood circulation, promoting Qi circulation and relieving pain. There are other processing methods such as stir-frying and vinegar processing. Chuanxiong Rhizoma in the famous classical formulas can be selected according to this research conclusion.

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