OBJECTIVE To standardize the prophylactic use of antibiotics for pregnant women during peripartum and reduce the irrational use of antibiotics. METHODS Initiated by the Chinese Eugenics Science Association， and led by the First Affiliated Hospital of the Army Military Medical University， clinical， pharmaceutical and evidence-based medicine experts from some domestic medical institutions jointly developed a tiered program of prophylactic use of antibiotics during the peripartum period aiming at the characteristics of pregnant women during the peripartum period by collecting relevant issues， combining national guiding documents， guidelines， expert consensus and literature. RESULTS & CONCLUSIONS A total of 13 consensus opinions were formed on antibiotic regimens for prophylactic use before， during and after delivery for vaginal delivery， cesarean delivery and for pregnant women with related complications or comorbidities（such as obesity， abnormal glucose metabolism， combined autoimmune diseases， etc.）. However， to reduce the overall risk of infection in pregnant women， prophylactic use of antibiotics is just one of the measures. Medical staff must still pay attention to strict disinfection and standard sterilization， and strictly implement balanced nutrition， reasonable control of blood sugar of pregnant women and other comprehensive measures.

OBJECTIVE To promote the industrialization process and modernization of traditional knowledge of Chinese medicine under the framework of the Regional Comprehensive Economic Partnership Agreement. METHODS It was done firstly， to sort out the framework for the protection of traditional knowledge in the international area； and secondly， to respond in the following two paths， one was the explicitization of traditional knowledge， and the other was the standardization of its carriers. RESULTS & CONCLUSIONS The goal of protecting traditional knowledge is to facilitate its modernization and accelerate its industrial utilization at the international level. As one of the countries of origin of traditional knowledge， our response is， to improve the registration provisions in the Regulations on the Protection of Traditional Knowledge of Chinese Medicine （Draft for Public Comments）， promote the synchronization of both the patent and the standard application of Chinese medicine， and strengthen the integration of Chinese standardization system with the international one， which will promote the compliance application of traditional knowledge of Chinese medicine.

OBJECTIVE To sort out the evaluation mechanism and methodology of published cases of comprehensive clinical evaluation of drugs in China， and provide a reference for promoting standardized comprehensive clinical evaluation of drugs and strengthening policy transformation in China. METHODS Clinical comprehensive evaluation cases of drugs published in China from CNKI， Wanfang Data， PubMed and Web of Science were systematically searched， and the retrieval time was from the inception to December 31st， 2023. The summary and analysis were performed from the aspects of theme selection， indicator system construction， evaluation methods， comprehensive decision-making， quality control， etc. RESULTS A total of 143 pieces of literature were ultimately included from 2014 to 2023. The number of publications has shown a rapid upward trend since 2019. The subjects of the evaluation cases were mainly pediatric drugs， Chinese patent medicines， cardiovascular drugs and anti-tumor drugs. The evaluation dimensions were between 3-8， all involving safety and effectiveness dimensions. Most cases adopted rapid evaluation methods based on literature review and expert interviews/questionnaire surveys with less emphasis on real-world research. Most cases did not involve comprehensive decision-making， quality control， or policy transformation. CONCLUSIONS The clinical comprehensive evaluation of drugs in China has made rapid progress under the guidance of national policies. However， there are still issues and challenges such as incomplete evaluation methods and standards， few cases of evaluation results being converted into decision-making， and a lack of quality control mechanisms. It is suggested that standardized evaluation paths and quality control mechanisms should be explored； when the evidence-based basis is insufficient， real-world research should be conducted as much as possible， so as to accelerate the policy transformation of evaluation results.

OBJECTIVE To observe the effects of Modified shaoyao gancao decoction on intestinal transit function， intestinal flora and the contents of metabolites [γ aminobutyric acid （GABA） and 5-hydroxytryptamine （5-HT）] in slow transit constipation （STC） rats. METHODS SD rats were randomly divided into blank group （10 rats） and modeling group （30 rats）， with half male and half female. The STC model was established by intragastric administration of Compound diphenoxylate tablets in the modeling group. The successfully modeled rats were randomly divided into model group， Modified shaoyao gancao decoction group [56 g/（kg·d）， calculated by crude drug] and positive control group [lactulose 2.09 g/（kg·d）]， with 10 rats in each group. Each administration group was given relevant medicine intragastrically， the blank group and model group received an equivalent volume of normal saline， once a day， for 14 consecutive days. During the experiment， the general situation of rats was observed in each group. After the last medication， the body weight was measured， and the Bristol score was used to evaluate the fecal characteristics. The fecal moisture content， intestinal propulsion rate， and the contents of GABA and 5-HT in intestinal content were detected； the diversity of intestinal flora in intestinal contents was investigated， and the correlation between the contents of GABA， 5-HT and relative abundance of microbiota was analyzed. RESULTS Compared with the model group， general conditions such as small body shape， sparse and rough fur， and slow movement were all improved in Modified shaoyao gancao decoction body weight， Bristol score， fecal moisture content，intestinal propulsion rate， 5-HT content， Chao1 index and Shannon index were increased significantly， while GABA content and Simpson index were decreased significantly （P＜0.05）. The intestinal flora of rats in the Modified shaoyao gancao decoction group could be classified as the same as the blank group， but was far from the model group； the relative abundances of Desulfobacterota， Firmicutes and Bacteroidota in this group showed a tendency of pull back， but the differences were not statistically significant compared to model group （P＞0.05）. Desulfobacterota was an intergroup differential factor （P＜0.05）. The content of GABA was negatively correlated with the relative abundance of Bacteroidota， Cyanobacteria， Patescibacteria and Actinobacteriota （P＜0.05）. The content of 5-HT was positively correlated with the relative abundance of Campilobacterota （P＜0.05）. CONCLUSIONS Modified shaoyao gancao decoction can improve the fecal properties and intestinal motility of STC rats. Its mechanism may be related to improving intestinal flora and then affecting the contents of GABA and 5-HT in intestinal contents. In addition， the contents of GABA and 5-HT may be significantly correlated with the relative abundance of specific bacterial phyla such as Bacteroidota and Campilobacterota.

OBJECTIVE To investigate the effects and potential mechanism of Qiangxin decoction on mitochondrion of rats with chronic heart failure （CHF）. METHODS The CHF model was established by ligating the left anterior descending branch of the coronary artery. Modeled rats were divided into model group， Qiangxin decoction low-dose and high-dose groups （12.25， 24.50 g/kg， calculated by crude drug）， and chemical medicine group （Sacubitril valsartan sodium tablets， 10.42 mg/kg）， with 10 rats in each group； control group was set up without treatment. Each group of rats was orally administered with the corresponding medication or normal saline twice a day for 28 consecutive days. After the last medication， the contents of N-terminal pro-brain natriuretic peptide （NT-proBNP） and adenosine triphosphate （ATP） in serum and phosphatidic acid （PA） and cardiolipin （CL） in myocardial tissue were all detected； the pathological damage and collagen fibrosis of rat myocardial tissue were observed； the apoptosis of myocardial cells was determined； the ultrastructure of myocardial tissue was observed； the protein expressions of mitofusin 1 （Mfn1）， Mfn2， optic atrophy protein 1 （OPA1） and dynamin-related protein 1 （Drp1） were all detected in myocardial tissue. RESULTS Compared with control group，the serum content of NT-proBNP， apoptotic rate of myocardial cells， and relative expressions of S-OPA1 and Drp1 proteins were all increased significantly； serum content of ATP，contents of PA and CL， and relative expressions of Mfn1， Mfn2 and L-OPA1 proteins were all significantly reduced （P＜0.05）. There were abnormal membrane tissue structure in various layers of myocardial tissue， degeneration and necrosis of myocardial cells， and severe fibrosis； the mitochondria were swollen， with reduced or absent cristae， and uneven matrix density. After intervention with Qiangxin decoction， the levels of the aforementioned quantitative indicators in serum and myocardial tissue of rats （excluding CL content in the Qiangxin decoction low- dose group） were significantly reversed （P＜0.05）； the pathological damage of myocardial tissue had significantly improved， fibrosis had significantly reduced， mitochondrial morphology tended to be normal， cristae had increased， and matrix density was uniform. CONCLUSIONS Qiangxin decoction can regulate myocardial mitochondrial function and structural integrity of CHF rats， thereby improving myocardial energy metabolism and antagonizing myocardial fibrosis， the mechanism of which may be associated with activating PA/Mfn/CL signaling pathway.

OBJECTIVE To investigate the effects and mechanism of asperuloside （Asp） on the pyroptosis of intestinal epithelial cells in rats with ulcerative colitis （UC）. METHODS The male SD rats were randomly divided into Control group， model group （UC group）， ASP low-dose and high-dose groups [Asp-L， Asp-H groups， Asp 35， 70 mg/（kg·d）]， ASP high-dose group+AMPK inhibitor Compound C group [Asp-H+Compound C group， Asp 70 mg/（kg·d）+Compound C 0.2 mg/（kg·d）]， with 12 rats in each group. Except for Control group， the other groups were injected with 50% ethanol （0.25 mL）+5% 2，4， 6- trinitrobenzene sulfonic acid solution （2 mL/kg） into the intestinal cavity to construct UC model. After modeling， the rats in each drug group were given corresponding drug solution by gavage or （and） tail vein injection， once a day， for 14 consecutive days. After the last administration， the weight of rats in each group was measured， and the length of their colons was measured； disease activity index （DAI） score and colonic mucosal damage index （CMDI） score were performed， and the serum levels of inflammatory factors （interleukin-18， -1β， -6） were detected. The pathological changes of the colon tissue were observed. The expressions of pyroptosis-related proteins [caspase-1， gasdermin D （GSDMD）] in colon tissue， and pathway-related proteins such as adenosine monophosphate-activated protein kinase （AMPK）， thioredoxin-interacting protein （TXNIP）， NOD-like receptor protein 3 （NLRP3） and apoptosis-associated speck-like protein containing a CARD （ASC） were all detected. RESULTS Compared with Control group， the colon tissue structure of rats in UC group was damaged， with obvious infiltration of inflammatory cells and edema. Their body weight， colon length and phosphorylation level of AMPK protein were significantly reduced or shortened； DAI and CMDI scores， serum levels of inflammatory factors， and the protein expressions of caspase-1， GSDMD， TXNIP， NLRP3 and ASC in colon tissue were increased or upregulated significantly （P＜0.05）. Compared with UC group， the pathological damage of colon tissue in rats was relieved in Asp-L and Asp-H groups， and all quantitative indicators were significantly improved （P＜0.05）； the improvement effect of Asp-H group was more significant （P＜0.05）. Compound C could significantly reverse the improvement effect of high-dose of Asp on the above indicators in UC rats （P＜0.05）. CONCLUSIONS Asp can improve inflammatory damage in colon tissue and inhibit pyroptosis of intestinal epithelial cells in UC rats， which is associated with the activation of AMPK and inhibition of TXNIP/NLRP3 signaling pathway.

OBJECTIVE To explore the effect and mechanism of Prunus mume against hepatic fibrosis （HF）. METHODS Male SD rats were randomly divided into normal control group （n＝10） and modeling group （n＝50）. The modeling group established HF model using carbon tetrachloride. The modeled rats were randomly divided into model group （normal saline）， positive control group [colchicine， 0.09 mg/（kg·d）]， and P. mume low-dose， medium-dose and high-dose groups [1.35， 2.70， 5.40 g/（kg·d）]， with 9 rats in each group. They were given the corresponding drug/normal saline intragastrically， once a day， for 8 consecutive weeks. After the last medication， the liver index was calculated， while liver function indexes， liver fiber indexes， oxidative stress indicators and inflammatory factors of rats were measured. HE staining was used to observe the pathological changes in liver tissue of rats； Masson staining was used to observe the degree of HF in liver tissue of rats； transmission electron microscopy was used to observe the ultrastructure of liver tissue in rats； TUNEL staining was used to detect liver cell apoptosis in each group of rats. Western blot method was used to detect the protein expressions of transforming growth factor-β1 （TGF-β1） and platelet-derived growth factor （PDGF） in liver tissue of rats. RESULTS Compared with normal control group， the levels of alanine transaminase， alkaline phosphatase， aspartate transaminase， total bilirubin， malondialdehyde， procollagen type Ⅲ protein， Ⅳ-type pre collagenase， laminin， hyaluronic acid， interleukin-6， tumor necrosis factor-α， as well as the protein expressions of TGF-β1 and PDGF in model group were increased significantly， while the levels of superoxide dismutase and glutathione peroxidase were significantly reduced （P＜0.01）； the HE， Masson staining and transmission electron microscopy observation results showed obvious HF characteristics in rats of model group. Compared with model group， varying degrees of improvement in above indexes were observed in P. mume groups， and the above 2021BSZR011） indicators of rats in P. mume medium-dose and high-dose groups were reversed significantly （P＜0.05 or P＜0.01）. CONCLUSIONS P. mume has an anti-HF effect， which may be achieved through mechanisms such as antioxidation， anti-inflammation， reduction of collagen production， inhibition of PDGF protein expression， and regulation of TGF- β1 signaling pathway.

OBJECTIVE To investigate the effects of clopidogrel on the pharmacokinetics and pharmacodynamics of ciprofol in rats. METHODS Eighteen male SD rats were randomly divided into control group， clopidogrel normal-dose group and clopidogrel high-dose group， with 6 rats in each group. Among them， rats in the normal-dose group and high-dose group were given 7.5 mg/kg and 15 mg/kg clopidogrel by gavage， respectively， and rats in the control group were given the same volume of 0.5% sodium carboxymethyl cellulose solution， once a day， for 14 consecutive days. Afterward， 2.4 mg/kg ciprofol was injected by tailvein and blood samples were collected from the inner canthus of the eye at 2， 4， 8， 12， 16， 20， 30， 45 and 60 min after the end of the administration. During this period， the duration of the loss of righting reflex （LORR） in rats was counted. After the proteins were precipitated by acetonitrile， the rat plasma sample was analyzed by LC-MS/MS using deuterated ciprofol as the internal standard， Symmetry C18 as the chromatographic column， and acetonitrile-0.01% ammonia solution containing 5 mmol/L ammonium acetate （gradient elution） as the mobile phase to detect the concentration of ciprofol in the plasma. The pharmacokinetic parameters in rats were calculated by using DAS 2.0 software. RESULTS Compared with control group， area under the drug concentration-time curve and mean residence time of ciprofol increased or prolonged significantly， while plasma clearance decreased significantly in clopidogrel normal-dose and high-dose groups； the duration of LORR in rats was prolonged by 19.5% and 23.9%， with statistical difference （P＜0.05）. However， there was no statistically significant difference in the pharmacokinetic parameters or LORR duration of ciprofol between the different dose groups of clopidogrel （P＞0.05）. CONCLUSIONS Clopidogrel could inhibit the metabolism of ciprofol in rats and prolong the duration of LORR.

OBJECTIVE To investigate the effects of medicated serum of Siwutang on autophagy of ovarian granulosa cells （KGN cells） in polycystic ovarian syndrome （PCOS） and its underlying mechanism. METHODS Blank serum and different- concentration medicated serum of Siwutang were prepared by intragastric administration of normal saline and different doses of Siwutang [0.52， 1.04， 2.08 g/（kg·d）] in 3-month-old female SD rats. After screening the intervention concentration of Siwutang medicated serum， KGN cells were divided into control group （without any treatment）， dehydroepiandrosterone （DHEA） group （treated with 50 μmol/L DHEA for 48 h）， blank serum group （treated with 50 μmol/L DHEA for 48 h and with 10% blank serum for 72 h） and medium-concentration of Siwutang medicated serum group （treated with 50 μmol/L DHEA for 48 h and with 10% medium-concentration Siwutang medicated serum for 72 h）. The number of autophagosomes was observed in each group， and protein expressions of pathway-related proteins [fructose-1， 6-bisphosphatase 1 （FBP1），mammalian target of rapamycin （mTOR）， phosphorylated mTOR （p-mTOR）]， autophagy-related proteins [p62， microtubule-associated protein 1 light chain 3 （LC3）] and mRNA expression of FBP1 were also detected. The （transfected） cells were further divided into Siwutang group （treated with 10% medium dose of Siwutang medicated serum for 72 h after 48 h intervention with 50 μmol/L DHEA）， Siwutang+si-NC group [negative control small interfering RNA （siRNA） transfected cells treated with 50 μmol/L DHEA for 48 h， and then with 10% medium-concentration of Siwutang medicated serum for 72 h] and Siwutang+si-FBP1 group （FBP1 siRNA transfected cells treated with 50 μmol/L DHEA for 48 h， and then with 10% medium-concentration Siwutang medicated serum for 72 h）. The effects of knocking down FBP1 on the above-mentioned effects of Siwutang were detected. RESULTS Compared with control group， DHEA group exhibited an increase in the number of autophagosomes， an elevated LC3-Ⅱ/LC3-Ⅰ and p-mTOR/mTOR， as well as increases in protein and mRNA expressions of FBP1， and decreased protein expression of p62 （P＜0.05）. Compared to both DHEA group and blank serum group， the medium-concentration of Siwutang medicated serum group showed a decrease in the number of autophagosomes， a decrease in LC3-Ⅱ/LC3-Ⅰ， and increases in p-mTOR/mTOR， protein expression of p62， protein and mRNA expressions of FBP1 （P＜0.05）. After knocking down FBP1， compared with Siwutang+si-NC group， Siwutang+si-FBP1 group showed a significant decrease in cell viability， protein expression of p62 ， protein and mRNA expressions of FBP1 as well as p-mTOR/mTOR， and an increase in LC3-Ⅱ/LC3-Ⅰ （P＜0.05）. CONCLUSIONS Siwutang can promote the phosphorylation of mTOR protein by up- regulating the protein and mRNA expressions of FBP1 in KGN cells， thus inhibiting autophagy of KGN cells.

OBJECTIVE To investigate the effects of imperatorin （IMP-SD） on malignant biological behavior of gastric cancer （GC） cells by regulating zinc finger and BTB domain 7B （ThPOK）. METHODS Human GC cells MKN-7 were used as the research object and then divided into control group （no treatment）， IMP-SD low-， medium- and high-concentration groups （40， 80 and 160 μmol/L IMP-SD）， si-ThPOK and si-NC group [treated with 160 μmol/L IMP-SD and then transfected with ThPOK small interfering RNA （si-ThPOK） or its negative control （si-NC）]. After treatment， cell clone formation， migration and invasion abilities and apoptosis of MKN-7 cells were detected； the killing activity of NK cells， T cells classification， the protein expressions of ThPOK， programmed death-1 （PD-1） and programmed death-ligand 1 （PD-L1） were all determined. RESULTS Compared with the control group， the number of cell clones， migration number， invasion number， and the protein expressions of PD-1 and PD-L1 were decreased or down-regulated significantly in IMP-SD groups， while the cell apoptotic rate， NK cell killing activity， CD4+ T proportion， the ratio of CD4+ T proportion and CD8+ T proportion （CD4+ T/CD8+ T）， and the protein expression of ThPOK were increased or up-regulated significantly， in a concentration-dependent manner （P＜0.05）. Compared with IMP-SD high-concentration group and si-NC group， the number of cell clones， migration number， invasion number， and the protein expressions of PD-1 and PD-L1 were increased or up-regulated significantly in si-ThPOK group， while the cell apoptotic rate， NK cell killing activity， CD4+ T proportion， CD4+ T/CD8+ T， and the protein expression of ThPOK were decreased or down-regulated significantly （P＜0.05）. CONCLUSIONS IMP-SD may reduce the clonal formation， migration and invasion abilities of GC cells， promote their apoptosis and inhibit their immune escape by promoting ThPOK expression.