Objective To analyze the registered clinical trials of headache treated by TCM;To discuss the current research status;To provide reference for the optimization of subsequent clinical trial research plans.Methods All clinical trials of headache treated by TCM were retrieved from the ChiCTR and the ClinicalTrials.The retrieval time was from the database establishment to May 22,2023.The general characteristics,study types,intervention measures and outcome indicators of the trials were analyzed respectively.Results A total of 104 registered studies were included,with the number of registered studies increasing since 2004 and reaching a peak in 2020,involving 25 provincial administrative regions or countries and 69 clinical trial institutions;the funding sources were mainly scientific research funds of universities,national finance and local finance.The research type was mainly intervention research;the designing scheme was mainly randomized parallel control study;the high frequency random method was simple random method;45 registered studies used blind methods.Exploratory studies/pre-trials were the most commonly used in the phases of clinical researches.Most of the registered studies were single-center clinical trials with a total sample size of 9 648 patients.The main interventions were acupuncture and oral Chinese medicines.The high frequency outcome indicators included life quality of score,headache attack frequency,headache attack days and headache severity,etc.There were some problems in outcome indicators,such as non-standard,lack of TCM characteristic advantages,and insufficient patient participation.Conclusion The number of registered studies of headache treated by TCM has increased by year,but there are some problems in design elements,such as random method,blind method,number of research centers,sample size and the setting of outcome indicator.

The latest epidemiological data suggests that the situation of adult diabetes in China is severe, and metabolic diseases have become significant chronic illnesses that have a serious impact on public health and social development. After more than six years of practice, the National Metabolic Management Center(MMC) has developed distinctive approaches to manage metabolic patients and has achieved a series of positive outcomes, continuously advancing the standardized diagnosis and treatment model. In order to further improve the efficiency, based on the first edition, the second edition guideline was composed by incorporating experience of the past six years in conjunction with the latest international and domestic guidelines.

End-stage patients experience unbearable pain because of refractory symptoms.Palliative sedation is a form of palliative care which relieves patients' agony by lowering their consciousness.Standard palliative sedation can help patients die with dignity.It is distinct from euthanasia and does not alter the survival of patients.Sufficient palliative care is the premise of palliative sedation.Repeated and detailed clinical evaluation,as well as multidisciplinary involvement,is necessary for the standardized implementation of palliative sedation.Here,we proposed the standard process and specifications of palliative sedation in Peking Union Medical College Hospital.Furthermore,we reported a case of palliative sedation for an advanced cancer patient with refractory delirium and living pain to demonstrate its application in clinical practice.
Humans ; Anesthesia ; Pain ; Hospitals ; Palliative Care ; Universities

Chinese patent medicines(CPMs) are unique therapeutic drugs in China. Establishing and improving the evaluation criteria is an important measure to promote the high-quality development of CPMs. Based on the "evaluation criteria of high-grade CPMs with quality as the core index" established by our group in 2018, the "high-quality evaluation criteria for CPMs based on whole process control" was proposed in the present study in 2022. The scope of application and basic principles of the new criteria were clarified. A quality evaluation scoring table was established in the new criteria, including five parts: raw material selection, production process, quality control, efficacy evaluation, and brand building. The technical evaluation indexes involved have increased from 20% in the original criteria to 70% in the new criteria, and efficacy evaluation has been added in the new criteria. The subjective evaluation indicators account for a large proportion in the original criteria, which is prone to bias. The improved criteria overcome this shortcoming. It is expected that the new criteria as a basis can play a better role in the selection of high-quality products of CPMs, guide enterprises and institutions to participate actively in the evaluation and research of high-quality CPMs, and promote the high-quality development of CPMs.
Medicine, Chinese Traditional ; Drugs, Chinese Herbal/therapeutic use* ; Nonprescription Drugs ; Chlorobenzenes ; China

Three sesquiterpenoids were isolated and purified from the 95% ethanol extract of Atractylodis Macrocephalae Rhizoma by column chromatography on silica gel, Sephadex LH-20, ODS, and high-performance liquid chromatography(HPLC). Their chemical structures were identified on the basis of spectroscopic analysis and physiochemical properties as(7Z)-8β,13-diacetoxy-eudesma-4(15),7(11)-diene(1), 7-oxo-7,8-secoeudesma-4(15),11-dien-8-oic acid(2), and guai-10(14)-en-11-ol(3). Compounds 1 and 2 are new compounds and compound 3 was obtained from Compositae family for the first time. Compounds 1, 2, and 3 showed weak inhibitory activities against sterol regulatory element-binding proteins(SREBPs).
Atractylodes/chemistry* ; Drugs, Chinese Herbal/chemistry* ; Rhizome/chemistry* ; Sesquiterpenes, Eudesmane/pharmacology* ; Sterol Regulatory Element Binding Proteins/antagonists & inhibitors*

The big brand of Chinese patent medicine, Fufang Danshen Prescription(FDP), effective in promoting blood circulation, resolving blood stasis, regulating qi, and relieving pain, is wide in clinical application and diverse in dosage forms and products, but its quality and price are uneven, which causes problems for doctors and patients. To clarify the key links and weakness of quality control leading to the quality difference of FDP products, the present study carried out a comprehensive evaluation of the whole production cycle of FDP based on the "high-quality Chinese patent medicine evaluation criteria" and analyzed the advantages and disadvantages of production and quality of different FDP products according to scores. The results showed that the scores of various products in the "raw materials selection" varied greatly. The highest score(S1) and the lowest score(S2) differed by more than 3 times, indicating that different manufacturers had inconsistent requirements for the selection of raw materials, leading to fundamental differences in the quality of raw materials. The scores in the "production process" varied slightly, with an average score of 66.8%. The manufacturer S8 obtained the highest score(84.0%), which indicated the emergence of intelligent manufacturing production. The scores(with the average score of 44.0%) in the "quality control" were lower than those of the previous two items, which was attributed to the fact that most FDP products only met the "qualified" benchmark required by the 2020 edition of Chinese Pharmacopoeia, and their consistency and high quality were both uncontrollable. The scores in the "post-marketing research" were the lowest(with an average score of 28.5%), and most manufacturers were scored 0, which reflected little attention paid. Only a few brand manufacturers were scored acceptably and they were willing to carry out relevant research on post-marketing evaluation. The evaluation results demonstrated the key links and weakness leading to the production and quality differences of FDP from different manufacturers. It is expected to improve the quality of FDP, promote the formation of the "high quality and good price" mechanism, and provide information for the centralized procurement of governments.
China ; Drugs, Chinese Herbal/analysis* ; Humans ; Medicine, Chinese Traditional ; Nonprescription Drugs ; Prescriptions

Objective: On the basis of traditional experience identification,and appearance characteristics and intrinsic index components of Glycyrrhizae Radix et Rhizoma pieces,a comprehensive evaluation was carried out to explore the method of grading Glycyrrhizae Radix et Rhizoma pieces and establish grading standards. Method: Based on the investigation of 44 batches of Glycyrrhizae Radix et Rhizoma pieces,including their properties,glycyrrhizin content and ammonium glycyrrhizinate content,Glycyrrhizae Radix et Rhizoma pieces were classified according to the market grading to establish the grading standards. Result: Based on the above data,the Glycyrrhizae Radix et Rhizoma pieces were classified into four grades. First-class:average diameter>1.66 mm,average weight>0.54 g,glycyrrhizin content>1.10%,glycyrrhizic acid content>2.12%. Second-class:the average diameter is between 1.40-1.66 mm,the average weight is between 0.42-0.54 g,the content of glycyrrhizin is between 0.74%-1.10%,and the content of glycyrrhizic acid is between 1.95%-2.12%. Third-class:the average diameter is between 1.07-1.40 mm,the average weight is between 0.29-0.42 g,the content of glycyrrhizin is between 0.65%-0.74%,and the content of glycyrrhizic acid is between 1.88%-1.95%. Substandard:the average diameter<1.07 mm,average weight<0.29 g,content of glycyrrhizin<0.65%,content of glycyrrhizic acid<1.88%. Conclusion: This experiment combines the traditional experience and modern analysis method,in order to develop a scientific,reasonable and accurate classification method.

Objective:To explore the correlation between the characters and chemical constituents of Glycyrrhizae Radix et Rhizoma through the analysis of characters and main chemical constituents of Glycyrrhizae Radix et Rhizoma,and establish the grade evaluation criteria of Glycyrrhizae Radix et Rhizoma, so as to provide reference for the quality evaluation and quality control of Glycyrrhizae Radix et Rhizoma. Method:Correlation analysis,principal component analysis and cluster analysis were carried out for appearance and intrinsic indexes of Glycyrrhizae Radix et Rhizoma. Result:Class Ⅰ of Glycyrrhizae Radix et Rhizoma:the diameter of big end was more than 1.60 cm,middle circumference was more than 3.76 cm,inner core chromaticity b^* was more than13.88,outer skin chromaticity a^* was more than 37.61,glycyrrhizin content was more than 1.13%,with no worm,rot and impurity. Class Ⅱ of Glycyrrhizae Radix et Rhizoma:the diameter of big end was 1.39-1.60 cm,the middle circumference was 3.09-3.76 cm,the inner core chromaticity b^* was 10.22-13.88,the skin chromaticity a^* was 35.57-37.61,glycyrrhizin content was 0.69%-1.13%,with no worm,rot and impurity. Class Ⅲ of Glycyrrhizae Radix et Rhizoma:the diameter of the big end was 1.08-1.39 cm,the middle circumference was 2.41-3.09 cm,the inner core chromaticity b^* was 5.16-10.22,the skin chromaticity a^* was 29.19-35.57,glycyrrhizin content was 0.55%-0.69%,with no worm and rot. Substandard Glycyrrhizae Radix et Rhizoma:the diameter of the big end was lower than 1.08 cm,the central circumference was lower than 2.41 cm,the inner core color b^* was lower than 5.16,the outer skin color a^* was lower than 29.19, and glycyrrhizin content was lower than 0.55%. Conclusion:The grade evaluation standards established in this paper include appearance and intrinsic indexes, with scientific,comprehensive and practical characteristics. It can be used for the grade evaluation of Glycyrrhizae Radix et Rhizoma medicinal materials.

Modified Da-chai-hu Decoction (MDD), a traditional Chinese medicinal formulation, which was empirically generated from Da-chai-hu decoction, has been utilized to treat severe acute pancreatitis (SAP) for decades. The aim of the present study was to explore its potential organprotective mechanism in SAP. In the present study, rat SAP model was induced by retrograde injection of 3.5% sodium taurocholate into the biliopancreatic duct, MDD (23.35 g/kg body weight, twelve times the clinical dose) were orally given at 2 h before and 10 h after injection. At 12 h after model induction, blood was taken from vena cava for analysis of amylase, diamine oxidase (DAO), pulmonary surfactant protein-A (SP-A), and C-reactive protein (CRP). Histopathological change of pancreas, ileum and lung was assayed by H&E staining, myeloperoxidase (MPO) activity were determinated using colorimetric assay, and the expressions of occludin and nuclear factor-κB (NF-κB) were detected by real-time RT-PCR and western blot, respectively. In addition, the tissue concentrations of tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), and monocyte chemoattractant protein-1 (MCP-1) were measured by enzyme-linked immunosorbent assay (ELISA). The results showed that in SAP rats, MDD significantly alleviated histopathological damage, depressed the MPO activity and the concentrations of TNF-α, IL-1β, and MCP-1 of pancreas, ileum and lung, and reduced the serum levels of amylase [(3283.4 ± 585.5) U·Lvs (5626.4 ± 795.1)U·L], DAO [(1100.1 ± 334.3) U·Lvs (1666.4 ± 525.3) U·L] and CRP [(7.6 ± 1.2) μg·mLvs (17.8 ± 3.8) μg·mL]. However, the serum SP-A concentration [(106.1 ± 16.6) pg·mLvs (90.1 ± 14.9) pg·mL] was elevated when treated SAP rats with MDD. Furthermore, MDD increased the occludin expression and reduced the NF-κB expression in pancreas, ileum and lung of SAP rats. Our findings suggested that MDD administration was an effective therapeutic approach for SAP treatment. It could up-regulate occludin expression to protect intercellular tight junction and down-regulate NF-κB expression to inhibit inflammatory reaction of pancreas, ileum and lung.

OBJECTIVETo study the effects of Astragalus polysaccharide (APS), the primary effective component of the Chinese herb medicine Astragalus membranaceus (frequently used for its anti-hepatic fibrosis effects), on nanoscale mechanical properties of liver sinusoidal endothelial cells (SECs).

METHODSUsing endothelial cell medium as the control, 5 experimental groups were established utilizing different concentrations of APS, i.e. 12.5, 25, 50, 100, and 200 μg/mL. By using atomic force microscopy along with a microcantilever modified with a silicon dioxide microsphere as powerful tools, the value of Young's modulus in each group was calculated. SAS 9.1 software was applied to analyze the values of Young's modulus at the pressed depth of 300 nm. Environmental scanning electron microscopy was performed to observe the surface microtopography of the SECs.

RESULTSThe value of Young's modulus in each APS experimental group was significantly greater than that of the control group: as APS concentration increased, the value of Young's modulus presented as an increasing trend. The difference between the low-concentration (12.5 and 25 μg/mL) and high-concentration (200 μg/mL) groups was statistically significant (P<0.05), but no significant differences were observed between moderateconcentration (50 and 100 μg/mL) groups versus low- or high-concentration groups (P>0.05). Surface topography demonstrated that APS was capable of increasing the total area of fenestrae.

CONCLUSIONSThe values of Young's modulus increased along with increasing concentrations of APS, suggesting that the stiffness of SECs increases gradually as a function of APS concentration. The observed changes in SEC mechanical properties may provide a new avenue for mechanistic research of anti-hepatic fibrosis treatments in Chinese medicine.

Animals ; Astragalus Plant ; chemistry ; Biomechanical Phenomena ; drug effects ; Elastic Modulus ; Endothelial Cells ; cytology ; ultrastructure ; Liver ; cytology ; Microscopy, Atomic Force ; Microspheres ; Nanotechnology ; Polysaccharides ; pharmacology ; Rats ; Silicon Dioxide ; chemistry ; Surface Properties