The Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines （hereinafter referred to as the Guidelines） is first specialized in the field of drug safety for oral Chinese patent medicines （OCPMs） in China. Rooted in China's healthcare context， the Guidelines address the unique usage patterns and risk characteristics of OCPMs， filling a regulatory gap in the pharmacovigilance framework specific to this category. To facilitate accurate understanding and effective implementation of the Guidelines， and to promote the standardized development of pharmacovigilance practices for OCPMs， this study offered a systematic interpretation based on its three core components. In the domain of risk monitoring and reporting， the paper analyzed the rationale for multi-source information integration and clarified the criteria for identifying key products and target populations for intensive monitoring. Regarding risk assessment， the Guidelines were examined from three dimensions of formulation components， medication behaviors， and population to address complex safety issues arising from medicinal constituents， irrational use， and individual susceptibility. In the area of risk control， the analysis focused on context-based interventions and dynamic closed-loop management strategies， exploring practical pathways to shift from passive response to proactive risk mitigation. Furthermore， this paper evaluated the applied value of the Guidelines and identified implementation challenges， such as insufficient capacity at the primary-care level and limited digital infrastructure. In response， the study proposed optimization strategies including establishing a dynamic updating mechanism， strengthening training at the grassroots level， and incorporating artificial intelligence to enhance pharmacovigilance capacity. This interpretation aims to provide actionable insights for marketing authorization holders （including manufacturers）， pharmaceutical distributors， healthcare institutions， and research organizations， ultimately supporting the establishment and refinement of a full lifecycle pharmacovigilance system for OCPMs.

The prescription of Qidong Yixin oral liquid is derived from the experience of national medical master Ren Jixue in treating viral myocarditis （VMC）. It has the functions of tonifying Qi， nourishing the heart，calming the mind， and relieving palpitations. It is used to treat VMC and angina pectoris of coronary heart disease caused by deficiency of both Qi and Yin. However，the understanding of its efficacy evidence， advantageous aspects， dosage and administration， and medication safety remains insufficient in clinical practice. Therefore，the development of the Expert Consensus on the Clinical Application of Qidong Yixin Oral Liquid （hereinafter referred to as consensus） was initiated. Consensus strictly followed the process and methods of the expert consensus on the clinical application of Chinese patent medicines of the China Association of Chinese Medicine，successively completing multiple tasks such as the consensus project initiation，determination of clinical problems，evidence search and evaluation，formation of recommendation opinions and consensus suggestions，solicitation of opinions，peer review， submission for review and release， and so on. Consensus formed a total of 10 recommendation opinions and 12 consensus suggestions，clarifying the clinical positioning，efficacy advantages，syndrome differentiation，dosage and administration，combination therapy，timing of medication，adverse reactions，contraindications， and precautions of Qidong Yixin oral liquid，indicating that it has good clinical advantages and safety in the treatment of VMC and angina pectoris of coronary heart disease，providing norms and references for physicians to safely and rationally apply Qidong Yixin oral liquid. Consensus was reviewed and approved for release by the Standardization Office of the China Association of Chinese Medicine on December 23， 2024. Standard number：GSCACM-376-2024.

ObjectiveThis paper aims to analyze the variety characteristics and prescription patterns of marketed traditional Chinese patent medicines for treating abortion and provide references for new medicine development and clinical application. MethodsRelevant information of traditional Chinese patent medicines for treating abortion was systematically retrieved and collected. Microsoft Excel 2021 software was used to sort and statistically analyze the medicine syndrome types， quantity， market situation， and status of package inserts. Based on the Ancient and Modern Medical Case Cloud Platform （V2.3.9）， the medicine properties， flavors， meridian tropism， and medication characteristics of standardized prescriptions were analyzed. ResultsA total of 39 marketed traditional Chinese patent medicines for treating abortion in China were included. According to disease type， these medicines were categorized as therapeutic medicines for threatened abortion and recurrent spontaneous abortion. According to clinical function， they were categorized into three groups： fetus stabilization， blood nourishment， and adjunctive conditioning. They were also categorized into pre-pregnancy conditioning and post-pregnancy fetal maintenance by clinical intervention stage. Post-marketing research showed that only three products had undergone safety evaluations and one involved pharmacoeconomic research， indicating a general lack of standardized evidence-based data. Dosage forms were mainly pills and granules. Package insert analysis revealed that 15 products listed "contraindications"， while 28 included "precautions". Based on prescription inclusion and exclusion criteria， 25 products were selected for further analysis. Their therapeutic effects were mainly concentrated on "tonifying the kidney and spleen， replenishing Qi， and nourishing blood"， with core medicines including Paeoniae Radix Alba， Angelicae Sinensis Radix， and Atractylodis Macrocephalae Rhizoma. Most medicines were warm or neutral in nature， predominantly sweet and pungent in flavor， and mainly entered the spleen， liver， and kidney meridians. ConclusionTraditional Chinese patent medicines for treating abortion demonstrate clear clinical value. However， shortcomings remain， including insufficient post-marketing research， prescription homogeneity， and incomplete package inserts. Future efforts should establish a clinically value-oriented modern development pathway， strengthen safety surveillance and evidence evaluation， improve package inserts， and promote precision use to further enhance clinical value.

ObjectiveTo investigate whether there are differences in the efficacy of Gegen Qinliantang with different contents of Puerariae Lobatae Radix on the acute enteritis （AE） model mice and provide a scientific basis for the interpretation of Gegen Qinliantang in the treatment of "Xie Re Li". MethodsA total of 112 male BALB/c mice were randomly divided into a blank group，model group，single Puerariae Lobatae Radix group，non-Puerariae Lobatae Radix group，regular dose Gegen Qinliantang group （regular dose group），half-dose Puerariae Lobatae Radix group，and doubled-dose Puerariae Lobatae Radix group， with 16 mice in each group. Hematoxylin-eosin （HE） staining was used to observe the pathological changes of the colon tissue. Western blot was employed to detect the expression of ZO-1 （a protein in the tight junction） and Occludin in the colon tissue， as well as the changes of tumor necrosis factor-α （TNF-α） and interleukin-1β （IL-1β）. ResultsCompared with the blank group，the DAI scores of the mice in the model group were significantly higher （P<0.05），and the histopathological sections of their colon tissues showed mucosal damage，glandular atrophy，disordered arrangement，and a large number of inflammatory cells infiltration，and the expression of ZO-1 and Occludin proteins in their colon tissues was significantly down-regulated （P<0.05，P<0.01）. The expression of inflammatory factors TNF-α and IL-1β was significantly up-regulated （P<0.05，P<0.01）. Compared with the model group，the DAI scores of mice in all dosing groups decreased significantly （P<0.05），with the most significant effect in the regular dose group. After 7 d of drug administration，the regular dose group had the best impact on the repair of colonic mucosa in the AE mouse model. The regular dose group significantly down-regulated the expression of TNF-α （P<0.05） and significantly up-regulated the expression of ZO-1 protein （P<0.05）. The doubled-dose Puerariae Lobatae Radix group significantly down-regulated the expression of IL-1β protein （P<0.01），and there was no significant difference between all dosing groups and the model group in terms of the expression of Occludin protein. After 14 d of drug administration，the best effect on the repair of colonic mucosa in the AE mouse model was observed in the doubled dose Puerariae Lobatae Radix group. All groups except the non-Puerariae Lobatae Radix group significantly down-regulated the expression of TNF-α （P<0.01）. Meanwhile，the regular dose group and doubled-dose Puerariae Lobatae Radix group significantly elevated the expression level of Occludin protein （P<0.01）. The doubled-dose Puerariae Lobatae Radix group also significantly inhibited the expression of IL-1β protein （P<0.05） and up-regulated ZO-1 protein expression （P<0.05）. ConclusionGegen Qinliantang can reduce the pathological damage of colon tissue， protect the barrier function and structure of intestinal epithelial cells， and reduce the expression of inflammatory factors， so as to achieve the therapeutic effect of AE model mice. When comparing the therapeutic efficacy of Gegen Qinliantang containing different Gegen contents， Gegen Qinliantang with the proportion of the original formula of Zhongjing was the most effective in AE model mice.

ObjectiveTo investigate whether there are differences in the efficacy of Gegen Qinliantang with different contents of Puerariae Lobatae Radix on the acute enteritis （AE） model mice and provide a scientific basis for the interpretation of Gegen Qinliantang in the treatment of "Xie Re Li". MethodsA total of 112 male BALB/c mice were randomly divided into a blank group，model group，single Puerariae Lobatae Radix group，non-Puerariae Lobatae Radix group，regular dose Gegen Qinliantang group （regular dose group），half-dose Puerariae Lobatae Radix group，and doubled-dose Puerariae Lobatae Radix group， with 16 mice in each group. Hematoxylin-eosin （HE） staining was used to observe the pathological changes of the colon tissue. Western blot was employed to detect the expression of ZO-1 （a protein in the tight junction） and Occludin in the colon tissue， as well as the changes of tumor necrosis factor-α （TNF-α） and interleukin-1β （IL-1β）. ResultsCompared with the blank group，the DAI scores of the mice in the model group were significantly higher （P<0.05），and the histopathological sections of their colon tissues showed mucosal damage，glandular atrophy，disordered arrangement，and a large number of inflammatory cells infiltration，and the expression of ZO-1 and Occludin proteins in their colon tissues was significantly down-regulated （P<0.05，P<0.01）. The expression of inflammatory factors TNF-α and IL-1β was significantly up-regulated （P<0.05，P<0.01）. Compared with the model group，the DAI scores of mice in all dosing groups decreased significantly （P<0.05），with the most significant effect in the regular dose group. After 7 d of drug administration，the regular dose group had the best impact on the repair of colonic mucosa in the AE mouse model. The regular dose group significantly down-regulated the expression of TNF-α （P<0.05） and significantly up-regulated the expression of ZO-1 protein （P<0.05）. The doubled-dose Puerariae Lobatae Radix group significantly down-regulated the expression of IL-1β protein （P<0.01），and there was no significant difference between all dosing groups and the model group in terms of the expression of Occludin protein. After 14 d of drug administration，the best effect on the repair of colonic mucosa in the AE mouse model was observed in the doubled dose Puerariae Lobatae Radix group. All groups except the non-Puerariae Lobatae Radix group significantly down-regulated the expression of TNF-α （P<0.01）. Meanwhile，the regular dose group and doubled-dose Puerariae Lobatae Radix group significantly elevated the expression level of Occludin protein （P<0.01）. The doubled-dose Puerariae Lobatae Radix group also significantly inhibited the expression of IL-1β protein （P<0.05） and up-regulated ZO-1 protein expression （P<0.05）. ConclusionGegen Qinliantang can reduce the pathological damage of colon tissue， protect the barrier function and structure of intestinal epithelial cells， and reduce the expression of inflammatory factors， so as to achieve the therapeutic effect of AE model mice. When comparing the therapeutic efficacy of Gegen Qinliantang containing different Gegen contents， Gegen Qinliantang with the proportion of the original formula of Zhongjing was the most effective in AE model mice.

ObjectiveTo investigate the protective effects and mechanisms of Bushen Zhuyun prescription （BSZY） on abortion rats with kidney deficiency-corpus luteum inhibition syndrome. MethodsAn abortion rat model with kidney deficiency-corpus luteum inhibition syndrome was constructed. Pregnant mice aged 8-10 weeks were randomly divided into a control group （Control）， a model group （Model）， low-dose BSZY （BSZY-L）， medium-dose BSZY （BSZY-M）， and high-dose BSZY （BSZY-H） groups （2.57， 5.14， 10.28 g·kg^-¹）， and a Zishen Yutai Pill （ZSYT） group （1.575 g·kg^-¹）. Hematoxylin-eosin （HE） staining was used to evaluate histopathological changes in ovarian and decidual tissue of rats in each group. Enzyme-linked immunosorbent assay （ELISA） was employed to measure levels of estrogen （E₂）， progesterone （P）， luteinizing hormone （LH）， prolactin （PRL）， and follicle-stimulating hormone （FSH） in serum. The candidate targets of BSZY were obtained from the Traditional Chinese Medicine System Pharmacology Platform （TCMSP） and Integrative Pharmacology-based Research Platform of Traditional Chinese Medicine （TCMIP） v2.0 databases， while disease targets for recurrent spontaneous abortion （RSA） were retrieved from GeneCards， DrugBank， Online Mendelian Inheritance in Man （OMIM）， and Therapeutic Target Database （TTD）. The intersection targets were identified by the Venny 2.1.0 platform. Pathway enrichment analysis was conducted based on the Metascape database to predict the potential mechanisms of BSZY. Additionally. Western blot was used to verify the effects of BSZY on the expression of estrogen receptor （ERα）， phosphatidylinositol 3-kinase （PI3K）， and protein kinase B （Akt） and explore its protective mechanism on RSA rats. ResultsCompared with the control group， the model group exhibited significantly decreased uterine， ovarian， and embryonic wet weights （P<0.05， P<0.01）， with an abortion rate of 57.18%. The ovarian tissue showed varying degrees of reduction in primordial follicles， primary follicles， mature follicles， and corpora lutea， along with a large number of atretic follicles. The endometrium was thinner， and decidual tissue exhibited cellular edema and disorganized arrangement. In contrast， compared with the model group， the BSZY groups at all doses and the ZSYT group demonstrated increased uterine， ovarian， and embryonic wet weights， along with a reduced abortion rate. The number of primordial follicles， primary follicles， mature follicles， and corpora lutea increased， while atretic follicles decreased. The endometrium thickened， and decidual tissue displayed normal cellular structure with tight arrangement. Additionally， the model group showed significantly decreased levels of E₂， P， PRL， and FSH in serum （P<0.05， P<0.01）， along with a decreasing trend in LH level. In contrast， the BSZY groups at all doses exhibited significantly elevated levels of E₂， P， LH， PRL， and FSH in serum （P<0.05， P<0.01）. Network pharmacology predictions suggested that BSZY may exert protective effects against abortion in rats by activating the ERα/PI3K/Akt signaling pathway. Western blot results confirmed that BSZY significantly upregulated the expression of ERα， PI3K， and p-Akt proteins （P<0.05， P<0.01）. ConclusionBSZY has a protective effect on the abortion rats with kidney deficiency-corpus luteum inhibition syndrome， possibly by activating the ERα/PI3K/Akt signaling pathway to reduce ovarian apoptosis and regulate endocrine function， thereby lowering the abortion rate.

To systematically construct a guideline to provide a methodological guide for researchers to develop patient decision aids.

To systematically construct a guideline to provide a methodological guide for researchers to develop patient decision aids.

Objective:The purpose of this study was to explore the critical values of monitored indexes of perioperative major adverse cardiac events(MACE), so as to take effective prevention and treatment measures in time to maintain the stability of perioperative cardiac function to further improve the perioperative safety of elderly patients with biliary diseases.Methods:The clinical data of 246 elderly patients with biliary diseases in our hospital from May 2016 to February 2022 were collected.According to whether MACE occurred during the perioperative period, they were divided into the MACE group and the non-MACE group.The differences of clinical data, the monitoring indexes of postoperative cardiac function, and the coagulation function between the two groups were compared and analyzed.Logistic regression was used to analyze the independent risk factors of perioperative MACE, the cut-off value of the receiver operating characteristic(ROC)curve was calculated, and the Logistic multivariate prediction model was established.Results:In the MACE compared with the non-MACE group, age, postoperative complications and mortality, postoperative hospital stay, and the levels of postoperative high sensitivity troponin-I(Hs-TnI), creatine kinase isoenzyme(CK-MB), myoglobin(MYO), B-type natriuretic peptide(BNP), and D-dimer(D-D)were significantly increased(all P<0.05). Multivariate Logistic regression showed that postoperative BNP and D-D were two independent risk factors for perioperative MACE, and their cut-off values in the ROC curve were 382.65 pg/mL and 0.975mg/L respectively.The Logistic multivariate prediction model established by the Logistic regression equation was P= ex/(1+ ex), X=-5.710+ 0.003X 1+ 0.811X 2, where X 1 was the postoperative BNP level and X 2 was the postoperative D-D level.The accuracy, specificity and sensitivity of this prediction model for predicting perioperative MACE were 96.3%(237/246), 100.0%(235/235), and 18.2%(2/11). Conclusions:The Logistic multivariate prediction model established in this study can effectively predict the occurrence of perioperative MACE in elderly patients.Postoperative BNP and D-D were two independent risk factors for perioperative MACE.The cut-off values of BNP and D-D in the ROC curve could be used as critical values for monitoring perioperative MACE.Therefore, it is of great clinical significance to take effective prevention and treatment measures in time to maintain the stability of perioperative cardiac function, and further improve the perioperative safety of elderly patients with biliary diseases.

OBJECTIVE: To observe the efficacy and safety of Guihuang Formula (GHF) in treating patients with type III prostatitis and Chinese medicine syndrome of dampness-heat and blood stasis. METHODS: Sixty-six patients diagnosed with type III prostatitis with dampness-heat and blood stasis syndrome were randomly divided into the treatment group (GHF) and the control group (tamsulosin) using a random number table, with 33 cases each group. The treatment group received GHF twice a day, and the control group received tamsulosin 0.2 mg once daily before bedtime. Patients in both groups received treatment for 6 weeks and was followed up for 2 weeks. The outcomes included the National Institute of Health Chronic Prostatitis Symptom Index (NIH-CPSI) score, Chinese Medicine Symptoms Score (CMSS), expressed prostatic secretions (EPS) and adverse events (AEs). RESULTS: After treatment, the NIH-CPSI total score and domain scores of pain discomfort, urination and quality of life decreased significantly from the baseline in both groups (P<0.05). The CMSS score decreased in both groups (P<0.05). The WBC count decreased and lecithin body count increased in both groups (P<0.05). GHF showed a more obvious advantage in reducing the pain discomfort and quality of life domain scores of NIH-CPSI, reducing the CMSS score, increasing the improvement rate of the WBC and lecithin body counts, compared with the control group (P<0.05). There were no significant differences in decreasing urination domain score of NIH-CPSI between two groups (P>0.05). In addition, no serious AEs were observed. CONCLUSION GHF is effective in treating type III prostatitis patients with dampness-heat and blood stasis syndrome without serious AEs. (Registration No. ChiCTR1900026966).
Chronic Disease ; Hot Temperature ; Humans ; Lecithins ; Male ; Pain ; Prostatitis/drug therapy* ; Quality of Life ; Tamsulosin