1.Effects of subanesthetic dose of esketamine on postoperative anxiety and recovery in patients undergoing laparo-scopic cholecystectomy
Zhangzhen ZHONG ; Xian ZHENG ; Ting XU ; Jie WANG ; Hui CAO ; Xinggen ZHOU ; Hui LI ; Jiacheng ZHAO ; Hui LIU ; Chao ZHANG
China Pharmacy 2026;37(2):204-209
OBJECTIVE To investigate the effects of subanesthetic dose of esketamine on postoperative anxiety and recovery in patients undergoing laparoscopic cholecystectomy. METHODS A total of 200 patients scheduled for laparoscopic cholecystectomy at Suzhou Ninth Hospital Affiliated to Soochow University from January 2023 to December 2024 were randomly assigned to control group (n=100) and observation group (n=100). One minute before the initiation of anesthesia, patients in the control group received intravenous injections of Propofol emulsion injection, Sufentanil citrate injection, and Succinylcholine chloride injection. On this basis, patients in the observation group received an intravenous injection of Esketamine hydrochloride injection. The anxiety status of patients in both groups was compared, along with their general intraoperative conditions (including sufentanil dosage, duration of pneumoperitoneum, operative time, anesthesia time, and extubation time), postoperative recovery, incidence of adverse reactions, and the need for dezocine rescue analgesia. Heart rate and mean arterial pressure, entropy index (state entropy and response entropy), inflammatory marker levels [interleukin-6 (IL-6) and C-reactive protein (CRP)], numerical rating scale (NRS) for pain intensity were compared between the two groups at different time points. RESULTS No significant differences were found between the two groups in pneumoperitoneum duration, operative time, anesthesia time,extubation time, incidence of postoperative dry mouth, entropy index or length of stay in the post-anesthesia care unit (P>0.05). Compared with the control group, the observation group showed significantly lower postoperative STAI-S scores, reduced intraoperative sufentanil consumption, decreased incidence of postoperative nausea, vomiting, and shivering, the need for dezocine rescue analgesia, as well as lower plasma IL-6 and CRP levels at 24 h after surgery, and NRS (P<0.05). The heart rate and mean arterial pressure of patients in the observation group at the start of surgery, end of surgery, and during extubation were all significantly higher than those in the control group (P<0.05). CONCLUSIONS Subanesthetic dose of esketamine can effectively alleviate postoperative anxiety, reduce intraoperative opioid consumption, suppress postoperative inflammatory response, relieve postoperative pain, and promote recovery in patients undergoing laparoscopic cholecystectomy.
2.Reporting Status of Clinical Practice Guideline Protocols: A Systematic Analysis
Huayu ZHANG ; Xufei LUO ; Hui LIU ; Qi ZHOU ; Yishan QIN ; Ye WANG ; Yuanyuan YAO ; Haodong LI ; Xiaohui WANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2026;17(1):255-262
To systematically analyzed the reporting status of core elements in publicly available clinical practice guideline(hereafter referred to as "guideline") protocols published domestically and internationally over the past decade, identified existing problems, and provided evidence to inform the standardized writing and publication of future guideline protocols. A systematic search was conducted in Chinese and English databases for clinical practice guideline protocols published during the past ten years. The basic characteristics and reporting of core elements—including registration information, conflict of interest management, evidence grading, development process and timeline planning, as well as dissemination and implementation—were extracted and analyzed. Chi-square tests were performed to explore associations between protocol characteristics and the reporting of core elements. A total of 94 guideline protocols were included, of which 67 were in Chinese(71.28%) and 27 were in English(28.72%). Overall, 82.98% of the guideline protocols were registered, 92.55% reported management of conflicts of interest, 97.87% reported evidence searching, 88.30% reported evidence grading, and 89.36% described dissemination and implementation strategies. However, only 55.32% reported the guideline development process, and merely 23.40% reported timeline planning. Further analysis indicated that the reporting of registration, evidence searching, development process, and timeline planning was associated with year of publication. Differences were observed between domestic and international guidelines in reporting registration, conflict of interest management, development process, time planning, and dissemination and implementation. Guidelines intended for development exhibited higher reporting rates for registration, development process, and dissemination and implementation compared to those planned for updating or adaptation. Although current guideline protocols demonstrate relatively adequate reporting of methodological elements, deficiencies remain in development process and timeline planning. Future efforts should focus on promoting the publication and standardized reporting of guideline protocols, enhancing the international recognition of registration platforms, and strengthening the development process and timeline planning to advance the scientific rigor and transparency of guideline development.
3.Standardization Challenges in Outcome Evaluation Systems of Animal Experiments and Considerations for Core Outcome Set Construction Strategies
Qingyong ZHENG ; Yongjia ZHOU ; Tengfei LI ; Jianguo XU ; Chen TIAN ; Hui LIU ; Min TIAN ; Ziyu ZHOU ; Caihua XU ; Yating CUI ; Junfei WANG ; Jinhui TIAN
Laboratory Animal and Comparative Medicine 2026;46(1):138-148
Animal experimentation constitutes a critical link between basic research and clinical application, making its research quality and translational efficiency paramount. Although considerable progress has been made in standardizing operational procedures and ethical guidelines, the standardization of outcome evaluation systems has significantly lagged, creating a key bottleneck that constrains the quality of biomedical research and evidence synthesis. This deficiency is manifested by pronounced heterogeneity in outcome selection across similar studies, incomplete methodological reporting, and disparate criteria for result interpretation, which severely impairs the comparability of findings and the evidence integration. To cope with this challenge, this paper systematically introduces a mature methodological tool from clinical research–the core outcome set (COS)–and explores its construction strategies and application potential in the field of animal experimentation. Given the extensive diversity of animal experiments, a pragmatic strategy of "focusing on key areas, implementing phased pilots, and promoting gradual expansion" should be adopted. This approach prioritizes the development of domain-specific COS for disease areas characterized by high research volume, urgent translational needs, and well-established animal models. A multi-source integration pathway for COS development is detailed, comprising systematic literature searches, methodological appraisals, and expert consensus, with the feasibility of leveraging artificial intelligence (AI) to enhance efficiency also being examined. The development and promotion of such COS are not intended to restrict scientific exploration; rather, they aim to establish a new, tiered evaluation paradigm consisting of "core outcomes" (mandatory), "recommended outcomes" (encouraged), and "exploratory outcomes" (optional). This framework is expected not only to enhance research quality through standardization and to adhere to the "3R" principles but also to accelerate the accumulation of high-quality evidence. This, in turn, provides a solid foundation for higher-level evidence synthesis, ultimately facilitating the effective translation of basic research findings into clinical practice and providing an essential methodological framework for scientific advancement in relevant disciplines.
4.Mechanisms of Liuwei Buqi Prescription in Regulating Macrophage Efferocytosis for Treatment of Lung-kidney Qi Deficiency Syndrome in COPD Based on Nrf2/MARCO Signaling Pathway
Jiankang JIANG ; Hui WANG ; Lu ZHANG ; Zegeng LI ; Jiabing TONG ; Fan WU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(7):222-229
ObjectiveTo investigate the mechanisms by which Liuwei Buqi prescription (LWBQ) regulates alveolar macrophage efferocytosis and improves inflammatory responses in rats with chronic obstructive pulmonary disease (COPD) characterized by lung-kidney Qi deficiency based on the nuclear factor erythroid 2-related factor 2 (Nrf2)/macrophage receptor with collagenous structure (MARCO) pathway. MethodsSuccessfully modeled rats were randomly divided into a model group, low-dose LWBQ group (LWBQ-L, 2.25 g·kg-1·d-1), medium-dose LWBQ group (LWBQ-M, 4.5 g·kg-1·d-1), high-dose LWBQ group (LWBQ-H, 9 g·kg-1·d-1), and aminophylline group (AMIN, 50 mg·kg-1·d-1), with 8 rats in each group. Another 8 healthy rats were included as the blank group. Except for the blank group, rats in the remaining groups were subjected to smoke exposure combined with forced swimming, intratracheal lipopolysaccharide (LPS) instillation, and subcutaneous hydrocortisone injection to establish a COPD model with lung-kidney Qi deficiency. After successful modeling, rats were administered different doses of LWBQ or AMIN by gavage. Body weight, fur condition, and oral secretions were observed. Pulmonary function was measured using an animal lung function analyzer. Enzyme-linked immunosorbent assay (ELISA) was used to detect the expression levels of interferon-γ (IFN-γ), interleukin-6 (IL-6), interleukin-1 (IL-1), and tumor necrosis factor-α (TNF-α) in bronchoalveolar lavage fluid (BALF) and serum (SER). Hematoxylin-eosin (HE) staining was used to examine pathological changes in lung tissue. Giemsa staining was performed to detect eosinophils, basophils, and neutrophils in BALF. Terminal deoxynucleotidyl transferase-mediated dUTP nick-end labeling (TUNEL) was used to detect apoptosis in lung tissue. Western blot and real-time polymerase chain reaction (Real-time PCR) were employed to determine the protein and mRNA expression levels of efferocytosis-related proteins growth arrest-specific gene 6 (GAS6), milk fat globule-epidermal growth factor 8 (MFG-E8), and pathway-related proteins Nrf2 and MARCO in lung tissue. ResultsCompared with the blank group, the model group showed reduced food intake, nasal and oral secretions with sputum, and decreased body weight (P<0.01), decreased peak expiratory flow (PEF) (P<0.01), increased forced vital capacity (FVC) (P<0.01), and decreased forced expiratory volume in 0.3 s/forced vital capacity [FEV0.3/FVC (%)] (P<0.01). The expression levels of IFN-γ, IL-6, IL-1, and TNF-α in BALF and SER were increased (P<0.01). Lung tissue exhibited structural destruction, hyperplasia, inflammatory exudation, increased apoptotic cells, and increased mean optical density (P<0.01). The protein and mRNA expression levels of GAS6, MFG-E8, and MARCO, as well as Nrf2 mRNA expression, were increased (P<0.01). Compared with the model group, the LWBQ groups showed increased food intake, reduced nasal and oral secretions with sputum, and increased body weight (P<0.05, P<0.01). PEF was increased (P<0.01). FVC was increased in rats treated with low- and medium-dose LWBQ (P<0.01), and FEV0.3/FVC (%) was increased in rats treated with medium- and high-dose LWBQ (P<0.05, P<0.01). The expression levels of IFN-γ, IL-6, IL-1, and TNF-α in BALF and SER were decreased (P<0.01). Lung tissue structure was relatively intact, with improvement in hyperplasia and inflammatory exudation. The number of apoptotic cells in lung tissue was reduced, and mean optical density was decreased (P<0.05, P<0.01). The protein and mRNA expression levels of efferocytosis-related proteins GAS6 and MFG-E8 and pathway-related proteins Nrf2 and MARCO were increased (P<0.01). ConclusionLWBQ can alleviate pulmonary and systemic inflammation, improve lung function, and reduce lung tissue damage in rats with COPD characterized by lung-kidney Qi deficiency. The mechanism may be related to enhancement of alveolar macrophage efferocytosis through regulation of the Nrf2/MARCO pathway.
5.Volatile Component Differences in Xihuangwan Prepared with Natural and Artificial Musk Based on Non-targeted and Targeted Metabolomics
Jing WANG ; Fangzhu XU ; Li MENG ; Qizhen ZHU ; Huanjun ZHAO ; Caina YU ; Xuelian CHEN ; Hui GAO ; Zimin YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):194-201
ObjectiveHeadspace solid-phase microextraction-gas chromatography-mass spectrometry(HS-SPME-GC-MS) and GC-triple quadrupole MS(GC-QqQ-MS) in combination with non-targeted and targeted metabolomics were employed to systematically analyze the chemical composition differences of Xihuangwan prepared with natural musk and artificial musk, and establish an identification system for them. MethodsThe volatile components of 9 batches of Xihuangwan samples from 8 manufacturers were analyzed by HS-SPME-GC-MS non-targeted metabolomics, and identified by comparing their MS data with the National Institute of Standards and Technology(NIST) spectral library. Orthogonal partial least squares-discriminant analysis(OPLS-DA) was used to identify differential volatile components of Xihuangwan prepared with natural musk and artificial musk. Additionally, GC-QqQ-MS targeted metabolomics was applied to quantify the levels of α-pinene, β-elemene, muscone, dehydroepiandrosterone, bornyl acetate, and octyl acetate in 27 batches of samples from 9 manufacturers. Cluster analysis, principal component analysis(PCA), and partial least squares-discriminant analysis(PLS-DA) were conducted to further explore the differences in volatile components between Xihuangwan samples prepared with natural musk and artificial musk. ResultsNon-targeted metabolomics identified 291 volatile compounds in Xihuangwan, including alkanes, esters, alkanes, alcohols, ketones, naphthalenes and others. OPLS-DA analysis revealed distinct separation between Xihuangwan samples containing artificial musk(A1, C1, D1, E1, F1, G1, I1) and those containing natural musk(H1, H3). A total of 30 differential metabolites were identified. The relative contents of these 30 differential metabolites were visualized using a radar chart, revealing significant differences in the levels of octanol, borneol acetate and muscone. Cluster analysis and PCA results from targeted metabolomics indicated that Xihuangwan could be classified into two distinct groups:one composed of natural musk(H1, H3) and the other of artificial musk, sample H2. PLS-DA identified muscone, octyl acetate, and dehydroepiandrosterone as key differential volatile components. Although no significant difference was observed in the content of octyl acetate between the two groups, statistically significant differences were found for muscone and dehydroepiandrosterone(P<0.05). ConclusionMuscone and dehydroepiandrosterone can be used for the differentiation of Xihuangwan samples containing natural musk from those containing artificial musk. This study systematically and comprehensively analyzed the differences in the types and contents of major volatile components in Xihuangwan prepared with natural musk and artificial musk, providing a scientific basis for quality evaluation and control of Xihuangwan.
6.Volatile Component Differences in Xihuangwan Prepared with Natural and Artificial Musk Based on Non-targeted and Targeted Metabolomics
Jing WANG ; Fangzhu XU ; Li MENG ; Qizhen ZHU ; Huanjun ZHAO ; Caina YU ; Xuelian CHEN ; Hui GAO ; Zimin YUAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):194-201
ObjectiveHeadspace solid-phase microextraction-gas chromatography-mass spectrometry(HS-SPME-GC-MS) and GC-triple quadrupole MS(GC-QqQ-MS) in combination with non-targeted and targeted metabolomics were employed to systematically analyze the chemical composition differences of Xihuangwan prepared with natural musk and artificial musk, and establish an identification system for them. MethodsThe volatile components of 9 batches of Xihuangwan samples from 8 manufacturers were analyzed by HS-SPME-GC-MS non-targeted metabolomics, and identified by comparing their MS data with the National Institute of Standards and Technology(NIST) spectral library. Orthogonal partial least squares-discriminant analysis(OPLS-DA) was used to identify differential volatile components of Xihuangwan prepared with natural musk and artificial musk. Additionally, GC-QqQ-MS targeted metabolomics was applied to quantify the levels of α-pinene, β-elemene, muscone, dehydroepiandrosterone, bornyl acetate, and octyl acetate in 27 batches of samples from 9 manufacturers. Cluster analysis, principal component analysis(PCA), and partial least squares-discriminant analysis(PLS-DA) were conducted to further explore the differences in volatile components between Xihuangwan samples prepared with natural musk and artificial musk. ResultsNon-targeted metabolomics identified 291 volatile compounds in Xihuangwan, including alkanes, esters, alkanes, alcohols, ketones, naphthalenes and others. OPLS-DA analysis revealed distinct separation between Xihuangwan samples containing artificial musk(A1, C1, D1, E1, F1, G1, I1) and those containing natural musk(H1, H3). A total of 30 differential metabolites were identified. The relative contents of these 30 differential metabolites were visualized using a radar chart, revealing significant differences in the levels of octanol, borneol acetate and muscone. Cluster analysis and PCA results from targeted metabolomics indicated that Xihuangwan could be classified into two distinct groups:one composed of natural musk(H1, H3) and the other of artificial musk, sample H2. PLS-DA identified muscone, octyl acetate, and dehydroepiandrosterone as key differential volatile components. Although no significant difference was observed in the content of octyl acetate between the two groups, statistically significant differences were found for muscone and dehydroepiandrosterone(P<0.05). ConclusionMuscone and dehydroepiandrosterone can be used for the differentiation of Xihuangwan samples containing natural musk from those containing artificial musk. This study systematically and comprehensively analyzed the differences in the types and contents of major volatile components in Xihuangwan prepared with natural musk and artificial musk, providing a scientific basis for quality evaluation and control of Xihuangwan.
7.Mechanism of Zuogui Jiangtang Jieyu Prescription Against Damage to Hippocampal Synaptic Microenvironment via Suppressing GluR2/Parkin Signal-mediated Mitophagy in Rats with Diabetes-related Depression
Jian LIU ; Lin LIU ; Xiaoyuan LIN ; Wei LI ; Yuhong WANG ; Hui YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(1):104-112
ObjectiveTo reveal the mechanism of Zuogui Jiangtang Jieyu prescription against damage to hippocampal synaptic microenvironment via suppressing glutamate receptor 2 (GluR2)/Parkin signal-mediated mitophagy in rats with diabetes-related depression (DD). MethodsEighty male SD rats underwent adaptive feeding for 5 days before the study. Ten rats were randomly assigned to the normal group. The model of DD rats was established with the rest by 2-week high-fat diet + streptozotocin (STZ) tail intravenous injection + 28 days of chronic unpredictable mild stress (CUMS) combined with isolation. The rats were randomly divided into a normal group, a model group, a GluR2 blocker group (5 μg·kg-1), a GluR2 agonist group (10 μg·kg-1), a metformin + fluoxetine group (0.18 g·kg-1 metformin + 1.8 mg·kg-1 fluoxetine), and high- and low-dose Zuogui Jiangtang Jieyu prescription groups (20.52 and 10.26 g·kg-1, respectively). The rats in the GluR2 blocker group and the GluR2 agonist group were continuously injected with CNQX and Cl-HIBO in the dentate gyrus of the hippocampus once a week starting from stress modeling, respectively, while the metformin + fluoxetine group and the high- and low-dose Zuogui Jiangtang Jieyu prescription groups were continuously given intragastric administration for 28 d at the same time of stress modeling. Depression-like behavior was evaluated by open field and forced swimming experiments. The levels of serum insulin and adenosine triphosphate (ATP) in hippocampus were detected by biochemical analysis. The levels of 5-hydroxytryptamine (5-HT) and dopamine (DA) in hippocampus were detected by enzyme-linked immunosorbent assay (ELISA). The autophagosomes of hippocampal neurons were observed by transmission electron microscopy. The morphology and structure of dendrites and spines of hippocampal neurons were evaluated by Golgi staining. Western blot detected the expression levels of GluR2 and Parkin proteins in hippocampus. The expression levels of GluR2, Parkin, regulating synaptic membrane exocytosis protein 3 (RIMS3), and postsynaptic density protein 95 (PSD95) in the dentate gyrus of the hippocampus were detected by immunofluorescence. ResultsCompared with the normal group, the model group exhibited reduced total activity distance in the open field and increased immobility time in forced swimming (P<0.01), lowered levels of serum insulin and ATP, 5-HT, and DA in hippocampus (P<0.01), increased autophagosomes of hippocampal neurons, significantly damaged morphology and structure of dendrites and spines of hippocampal neurons, decreased expression levels of GluR2, RIMS3, and PSD95 in hippocampus, and an increased Parkin expression level (P<0.05, P<0.01). Compared with the model group, the GluR2 blocker group and the GluR2 agonist group showed aggravation and alleviation of the above abnormal changes, respectively (P<0.05, P<0.01). The above depression-like behavior was significantly improved in the high- and low-dose Zuogui Jiangtang Jieyu prescription groups to different degrees. Specifically, the two groups saw elevated levels of serum insulin and ATP, 5-HT, and DA in hippocampus (P<0.05, P<0.01), restrained increase in autophagosomes and damage to morphology and structure of dendrites and spines of hippocampal neurons, up-regulated protein expression levels of GluR2, RIMS3, and PSD95, and down-regulated Parkin expression level (P<0.05, P<0.01). ConclusionZuogui Jiangtong Jieyu prescription can ameliorate the mitophagy-mediated damage to hippocampal synaptic microenvironment in DD rats, the mechanism of which might be related to the regulation of GluR2/Parkin signaling pathway.
8.Evaluation of Effect of Tongnaoyin on Blood-brain Barrier Injury in Acute Ischemic Stroke Patients Based on Dynamic Contrast-enhanced Magnetic Resonance Imaging
Yangjingyi XIA ; Shanshan LI ; Li LI ; Xiaogang TANG ; Xintong WANG ; Qing ZHU ; Hui JIANG ; Cuiping YUAN ; Yongkang LIU ; Zhaoyao CHEN ; Wenlei LI ; Yuan ZHU ; Minghua WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):140-146
ObjectiveTo evaluate the effects of Tongnaoyin on the blood-brain barrier status and neurological impairment in acute ischemic stroke (AIS) patients with the syndrome of phlegm-stasis blocking collaterals by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). MethodsA total of 63 patients diagnosed with AIS in the Jiangsu Province Hospital of Chinese Medicine from October 2022 to December 2023 were enrolled in this study. According to random number table method,the patients were assigned into a control group (32 cases) and an observation group (31 cases). The control group received conventional Western medical treatment,and the observation group took 200 mL Tongnaoyin after meals,twice a day from day 2 of admission on the basis of the treatment in the control group. After 7 days of treatment,the patients were examined by DCE-MRI. The baseline data for two groups of patients before treatment were compared. The National Institute of Health Stroke Scale (NIHSS) score and modified Rankin Scale (mRS) score were recorded before treatment and after 90 days of treatment for both groups. The rKtrans,rKep,and rVe values were obtained from the region of interest (ROI) of the infarct zone/mirror area and compared between the two groups. ResultsThere was no significant difference in the NIHSS or mRS score between the two groups before treatment. After 90 days of treatment,the NIHSS and mRS scores declined in both groups,and the observation group had lower scores than the control group (P<0.05). After treatment,the rKtrans and rVe in the observation group were lower than those in the control group (P<0.01). ConclusionCompared with conventional Western medical treatment alone,conventional Western medical treatment combined with Tongnaoyin accelerates the repair of the blood-brain barrier in AIS patients,thereby ameliorating neurological impairment after AIS to improve the prognosis.
9.Clinical Evidence Profile of Eleven Expensive Chinese Patent Medicines: A Scoping Analysis
Yajing LI ; Miaomiao LI ; Le ZHANG ; Wenya WANG ; Hui ZHAO ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):227-238
ObjectiveThis study employed the scoping review method to systematically retrieve and analyze the basic information and clinical research evidence of expensive Chinese patent medicines (CPMs), aiming to provide a basis for future related research and clinical applications. MethodsEight Chinese and English databases were systematically searched for the clinical research evidence on expensive CPMs. ResultsEleven expensive CPMs (Angong Niuhuang Wan, Jufang Zhibao Wan, Suhexiang Wan, Pien Tze Huang, Niuhuang Qingxin Wan, Qinggong Shoutao Wan, Compound Realgar Natural Indigo Tablets, Xihuang Wan, Dingkun Wan, Babao Wan, and Guilingji Capsules) were selected. A total of 365 related studies were included in this review, comprising 331 clinical studies (of which 291 were randomized controlled trials), 30 systematic reviews and Meta-analyses, 3 expert consensus, and 1 rapid health technology assessment. Among the 11 CPMs, 2(Angong Niuhuang Wan and Jufang Zhibao Wan) had a daily price over 500 yuan. The famous and precious Chinese medicinal materials involved included Moschus (frequency of 7), Bovisc Alculus (7), and Borneol (5). The dosage forms included pills, capsules, oral liquid, tablets, and lozenges. The diseases treated by these CPMs mainly included malignant tumors, cerebrovascular diseases, gynecological diseases, and hepatobiliary system diseases. The sample sizes of the clinical studies were mainly concentrated within the range of 51-100 cases, and the main control form was CPM + basic Western medicine treatment vs. basic Western medicine treatment. The 331 clinical studies reported a total of 44 adverse events occurred, of which 36 were determined to be adverse reactions. ConclusionThe scarcity of raw materials leads to the high prices of expensive CPMs. The difficulty of conducting clinical research and the critical and severe cases treated lead to a lack of clinical research evidence with large sample sizes. The uneven distribution of existing studies, incomplete information on medicine package, and non-standard clinical research designs remain to be addressed in the future.
10.Herbal Textual Research on Dioscoreae Hypoglaucae Rhizoma, Dioscoreae Spongiosae Rhizoma, Smilacis Chinae Rhizoma and Smilacis Glabrae Rhizoma in Famous Classical Formulas
Li LU ; Yichen YANG ; Erhuan WANG ; Hui CHANG ; Li AN ; Shibao WANG ; Cunde MA ; Zhilai ZHAN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):218-247
This article systematically reviews and verifies the medicinal materials of Dioscoreae Hypoglaucae Rhizoma(DHR), Dioscoreae Spongiosae Rhizoma(DSR), Smilacis Chinae Rhizoma(SCR) and Smilacis Glabrae Rhizoma(SGR) from the aspects of name, origin, producing area, quality, harvesting, processing and efficacy by consulting historical literature, in order to provide reference for the development and utilization of famous classical formulas containing the four medicinal materials. DHR, DSR, SCR and SGR have a long history of application as medicinal materials. However, due to their similar growth environment and medicinal properties, as well as their functions of promoting dampness, dispelling wind and removing numbness, there have been instances of homonymous foreign objects and homonymous synonyms throughout history, resulting in confusion of the origin. Therefore, it is necessary to conduct comparative analysis and systematic research for clarifying the historical development and changes of the four, in order to provide a basis for safe and effective medication. According to research, Bixie was first recorded in Shennong Bencaojing and has been historically known as Baizhi, Chijie, Zhumu, and other aliases. From ancient times to the mid-20th century, there has always been a situation where the rhizomes of Dioscorea plants and Smilax plants, and even the rhizomes of Heterosmilax plants, were mixed together to be used as medicinal herbs for Bixie. However, since the Tang dynasty, it has been clearly advocated that the rhizomes of Dioscorea plants have excellent quality and have been the mainstream throughout history. The 2020 edition of Chinese Pharmacopoeia categorized it into two types of medicinal herbs(DHR and DSR). Among them, the origin of DHR is the dry rhizomes of Dioscorea hypoglauca, and the origins of DSR are the dry rhizomes of D. spongiosa and D. futschauensis. In ancient times, due to different types, the corresponding production areas of DHR and DSR were also different. Nowadays, They are mainly produced in the southern region of the Yangtze River. Since the Tang dynasty, the quality of Bixie has been characterized by its white color and soft nature. In modern times, it has been summarized that those with white color, large and thin pieces, powdery texture, tough and elastic texture, and neat and unbreakable are the best. The harvesting times of DHR and DSR are in spring or autumn, with the best quality harvested in autumn. The mainstream processing methods of them are slicing and then using the raw products or wine-processed products. SCR was first recorded in Mingyi Bielu and has been known as Jinganggen, Tielingjiao, Tieshuazi, and other aliases in history. The mainstream source is the dry rhizomes of Smilax china in the past dynasties, with the best quality being those that are tough and rich in powder. The harvesting time is from the late autumn to the following spring, and the main processing method throughout history has been slicing for raw use. SGR was first recorded under the item of Yuyuliang in Variorum of Shennong's Classic of Materia Medica. It was listed as an independent medicinal material from Bencao Gangmu. In history, there were such aliases as Cao Yuyuliang, Lengfantuan, Xianyiliang, Tubixie, etc. The main source of the past dynasties was dry rhizomes of S. glabra. In history, there have also been instances of multiple plants belonging to the same genus, and even cases of mixing the rhizomes of plants in the genus Heterosmilax. It is mainly produced in Guangdong, Hunan, Hubei, Zhejiang, Sichuan, Anhui and other regions, its quality has been summarized as large in size, powdery in texture, with few veins, and light brown in cross-section since modern times. The harvesting time is in spring or autumn, and the main processing method throughout history has been slicing for raw use. DHR, DSR, SCR and SGR all have the effects of promoting dampness, dispelling wind, relieving rheumatism and detoxifying. However, their detoxification abilities are ranked as follows:SGR>SCR>Bixie(DHR and DSR). Especially for the treatment of limb spasms, arthralgia and myalgia, scrofula, and scabies caused by syphilis and mercury poisoning, SGR has a unique effect. Based on the research results, DHR is recommended to develop the famous classical formulas containing Bixie as the first choice for medicinal herbs. It should be harvested in autumn, sliced thinly while fresh, and processed according to the requirements of the famous classical formulas, without any requirements for raw use. Selecting the rhizomes of S. china, harvested in late autumn, and thinly sliced while fresh. If there are no special processing requirements in the formulas, use it raw. Selecting the rhizomes of S. glabra, it is harvested in autumn and thinly sliced while fresh. If there are no special processing requirements in the formulas, raw products can be used.

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