OBJECTIVE To construct the research questions and topic selection evaluation index system of the Guideline for Topic Selection for Comprehensive Clinical Evaluation of Drugs （hereinafter referred to as the Guideline）， so as to provide the basis for the formulation of the Guideline. METHODS Through literature research， an expert questionnaire on the research questions and evaluation index system of the Guideline was initially constructed. Experts were selected according to relevant requirements of the guideline formulation and Delphi method； the research questions and evaluation indicators of the Guideline were screened by electronic questionnaire communication， and the weights of evaluation index system of topic selection were assigned by the analytic hierarchy process. RESULTS Five research questions of the Guideline were constructed， including the organization and management of theme selection， evaluation process， evaluation methods， evaluation index system， and index weight assignment. And a theme selection and evaluation index system， including 5 primary indexes， 9 secondary indexes and 17 tertiary indexes， was constructed. Kendall coefficients of the research questions and all indexes were ＞0.4， and the P values of χ2 test were＜0.05， which meant the evaluation results were consistent. The weights of all levels of the evaluation index system were assigned by analytic hierarchy process with consistency ratio of 0.007 6 （＜0.1）， and the model matrix passed the consistency test. CONCLUSIONS The research questions and topic selection evaluation index system of the Guideline established in this study are highly authoritative， scientific and reliable， which lay a foundation for the standardization of the Guideline.

OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs， and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization （WHO）， strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States， and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions； research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center， and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions， including topic selection， evaluation implementation， evidence evaluation， and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs， which can effectively guide the high-quality and high-efficient development of this work， enhance the standardized output and transformation application value of evaluation evidence， and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.

Objective　To understand the situation of plague host vectors, indicator animals and residents infected with plague bacteria in Cangyuan County, Yunnan Province, China-Myanmar border region, and to explore the risk of plague epidemic, so as to provide reference basis for supplementary plague data and prevention and control in this area. Methods　A plague survey was carried out in three townships in Cangyuan County in 2023. The collected host animals organs and body surface parasitic fleas were bacterial cultured. Serum collected from border residents, indicator animals, and host animals was tested for plague F1 antibodies using indirect hemagglutination assay (IHA). The positive samples were rejudged by IHA, immune colloidal gold assay(GICA) and up-converting phosphor technology(UPT). Results　Totally 294 serum samples were collected from border residents, with an average age of (48.48±14.27) years old, with more females than males. Three were positive for F1 antibody against Yersinia pestis, with a positive rate of 1.02%. And 65 samples of indicator animal serum and 31 samples of Rattus tanezumi serum were collected, and the detection of plague F1 antibody was negative. And 198 rodents belonging to 3 orders, 5 families, 11 genus and 14 species were captured, with a total capture rate of 7.93%, with Rattus tanezumi (46.97%) and Rattus andamanensis (19.19%) as the dominant species. The capture rate in residential indoor areas was 3.72%, and Rattus tanezumi was the absolutely dominant species (100.00%). The capture rate in farming areas was 10.26%, the dominant species were Rattus tanezumi (36.36%), Rattus andamanensis (23.03%), Mus pahari (10.30%) and Hylomys suillus (10.30%). And 60 fleas belonging to 3 families, 5 genera and 6 species were seized, the average infection rate of fleas was 11.62%, and the total flea index was 0.30. The dominant species were Xenopsylla cheopis (28.34%), Palaeopsylla remota (23.33%), Ctenophthalmus quadratus (18.33%), Stivalius aporus (15.00%) and Palaeopsylla incurua (11.67%). A total of 198 murine organ samples were isolated and cultured, and 24 groups of flea samples were obtained, no Yersinia pestis was isolated. Conclusion　The investigation has not found any recent infection with Yersinia pestis in rodents, body surface parasitic fleas and indicator animals; however, it is found that there is still a certain proportion of positive population of plague F1 antibody in the serum of residents. Rattus tanezumi and Xenopsylla cheopis are the first dominant species of host and vector in the county, the indoor density of Rattus flavipectus exceeds 3%, reaching the animal pestis IV early warning, and there is a risk of recurrence in the plague foci.

OBJECTIVE To analyze the medication needs of parents of pediatric children in our hospital regarding drug instructions， and explore improvement strategies， thereby providing a basis for clinically guiding the rational use of drugs in pediatric patients. METHODS A self-designed questionnaire was used to randomly select the parents of pediatric patients in the pediatric outpatient and emergency departments of our hospital from July 1st to September 30th， 2024. A randomized face-to-face survey was conducted regarding their willingness to read drug instructions， their current understanding status， and their needs. The survey results were then statistically analyzed. RESULTS A total of 300 questionnaires were distributed in this survey， and 299 valid questionnaires were recovered， with an effective recovery rate of 99.7%. Before medication， the parents who “always” and “often” read the drug instructions in detail accounted for 39.1% （117 respondents） and 35.1% （105 respondents）， respectively. Statistically significant differences were observed in the willingness to read drug instructions among respondents with varying educational levels and occupations （P＜0.05）. Among the 299 respondents， only 48 people （16.1%）“ fully understood” the drug instructions， and the average understanding score of all the respondents was （3.77±0.83） points. The stronger the respondents’ willingness to read drug instructions， the higher their understanding scores of drug instructions （P＜0.05）. A total of 256 respondents thought that drug instructions were of great help to themselves， and the average helpfulness rating score of all the respondents was （4.28±0.78） points. Under the conditions of varying ages， educational levels， occupations， and willingness to read drug instructions， statistically significant differences were observed in the scores representing the degree of helpfulness of drug instructions to the respondents （P＜0.05）. Respondents paid the most attention to content in drug instructions such as “dosage and administration method”，“ adverse reactions”， and “indications and therapeutic categories”. The most difficult sections for them to understand included “chemical structure and properties”， “pharmacological and toxicological effects” ， and “pharmacokinetics”， etc. The demographic characteristics of the respondents were not significantly associated with the content areas of drug instructions they most desired to see improved （P＞0.05）. Most respondents （86.0%） hoped to improve the instructions mainly by “simplifying professional terms to make them more accessible”. Others included “highlighting key information” （60.5%） and “providing more detailed medication guidance” （49.2%）， etc. CONCLUSIONS Parents of pediatric patients in our hospital have a high demand for drug instructions but low comprehension. The pharmacy department should make targeted improvements to drug instructions based on parents’ actual needs， helping them accurately obtain medication knowledge and reduce potential medication safety risks.

In order to standardize the workflow for the clinical comprehensive evaluation of drugs， enhance the assessment of research evidence， and improve the application value of research outcomes in translational practice， the Chinese Pharmaceutical Association issued the Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs （T/CLPA 5-2025） in June 2025. The core points include clarifying the concept of clinical comprehensive evaluation of drugs and standardizing the main work processes and technical essentials. This article provides a detailed interpretation of the technical methods for standard formulation， the operational logic of the four core processes （theme selection， evaluation implementation， evidence evaluation， result application transformation）， and the key points of core technologies. The aim is to assist medical institution technicians， policymakers and researchers in accurately grasping the connotation of the standards， resolving practical concerns such as process connection and technology application， and enhancing the quality and homogenization of evaluation work. It provides support for the scientific decision-making of healthcare and health， and the rational clinical medication.

To analyze potential adverse drug events(ADEs) associated with ustekinumab and upadacitinib in the treatment of inflammatory bowel disease(IBD) based on an international authoritative database, thereby providing evidence for clinical medication safety.

OBJECTIVE To mine the adverse drug event （ADE） signals of sacituzumab govitecan and provide a reference for its clinical safety application. METHODS The data of sacituzumab govitecan-related ADE reports were collected from the FDA Adverse Event Reporting System （FAERS） database from April 1， 2020 to April 30， 2024. The reporting odds ratio（ROR） method， the United Kingdom Medicines and Healthcare Products Regulatory Agency comprehensive standard method （MHRA） and Bayesian confidence propagation neural network （BCPNN） method were used for data mining. Systematic organ classification （SOC） and preferred term （PT） in the ADE terminology set of version 27.0 of the Medical Dictionary for Regulatory Activities （MedDRA） were used for data classification and statistics. RESULTS A total of 753 ADE reports were obtained for sacituzumab govitecan， including 46 ADE signals， involving 12 SOCs， and 13 new suspicious ADE signals not recorded in the instructions. Top 5 PTs in terms of occurrence frequency were disease progression， death， diarrhea， off label use and inappropriate schedule of product administration. Top 5 PTs in terms of signal strength were febrile bone marrow aplasia， neutropenic colitis， disease progression， pulmonary sepsis， general physical condition abnormal. New ADE not recorded in the drug instructions included neutropenic sepsis， hepatic cytolysis， meningitis， aplasia， etc. CONCLUSIONS When using sacituzumab govitecan in clinical practice， special attention should be paid to ADE with highly reported cases and strong signal intensity， such as febrile neutropenia， febrile bone marrow aplasia， weight fluctuations， colitis. We should also be alert to new suspected ADE such as neutropenic sepsis， hepatic cytolysis， meningitis， and aplasia to ensure patient medication safety.

OBJECTIVE To investigate the effects of formononetin （FMN） on the apoptosis of intestinal epithelial cells in inflammatory bowel disease （IBD） rats and its possible mechanism. METHODS IBD rat model was constructed by using trinitrobenzene sulfonic acid （TNBS） induction. Forty-eight rats with successful modeling were divided into model group （normal saline）， low-dose and high-dose FMN groups （20 and 40 mg/kg FMN）， and high-dose FMN+YAP inhibitor Verteporfin （VTPF） group （40 mg/kg FMN+10 mg/kg VTPF）， with 12 rats in each group. Another 12 rats were set as the normal group （normal saline）. They were given drug/normal saline， once a day， for 7 consecutive days. After the last administration， the disease activity index （DAI） of rats was calculated， and the colon length of rats in each group was measured. The pathological changes in the colon tissue of rats were observed. The levels of tumor necrosis factor-α （TNF-α）， interleukin-6 （IL-6） and IL-10 in serum were detected， and the apoptosis of intestinal epithelial cells was detected. The expressions of Yes associated protein （YAP）， cleaved cysteine-containing aspartate proteolytic enzyme 3 （cleaved-caspase-3）， B-cell lymphoma-2 （Bcl-2） and Bcl-2 associated X protein （Bax） were detected in colon tissue of rats. RESULTS Compared with the normal group， DAI score， the levels of TNF-α and IL- 6， the apoptotic rate of intestinal epithelial cells， and the expressions of cleaved-caspase-3 and Bax protein in the model group were increased greatly （P＜0.05）； the length of the colon was greatly decreased （P＜0.05）， and the serum level of IL-10 and the protein expressions of YAP and Bcl-2 were greatly reduced （P＜0.05）. The cell morphology of colon tissue was abnormal， with disordered arrangement and inflammatory cell infiltration. Compared with IBD group， the above indexes of rats were improved significantly in low-dose and high-dose FMN groups （P＜0.05）， in dose-dependent manner （P＜0.05）. VTPF significantly alleviated the effects of FMN on the above indexes of IBD rats （P＜0.05）. CONCLUSIONS FMN may promote the expression of YAP by inhibiting the Hippo/YAP signaling pathway， thereby inhibiting apoptosis of intestinal epithelial cells in IBD rats.

OBJECTIVE To explore the mechanism of Taohong siwu decoction （THD） improving peripheral nerve injury induced by paclitaxel （PTX） in rats. METHODS The effects of THD （1 g/mL drug-containing serum） and PTX （0.1 μmol/L） alone or in combination on the proliferation rate of Schwann cells line RSC96 as well as the expressions of lysosomal-associated membrane protein-2 （LAMP2）， autophagy marker protein yeast Atg 6 homolog （Beclin1）， phosphatidylinositol 3-kinase （PI3K）， protein kinase B （Akt）， and mammalian target of rapamycin （mTOR） were investigated， and then compared with autophagy promoter rapamycin and autophagy inhibitor 3-methyladenine （3-MA）. The effects of high-dose and low-dose THD on the expressions of myelin basic protein （MBP） and myelin protein zero （MPZ）， S100 calcium-binding protein （S100）， LAMP2， Beclin1， PI3K， Akt and mTOR were tested at the end of the experiment. RESULTS After treatment of THD+PTX， the proliferation rate of RSC96 cells was significantly higher than those treated with PTX alone. After treatment of THD+PTX or THD+ 3-MA， the protein expressions of LAMP2 and Beclin1 in RSC96 cells were significantly higher than those treated with PTX or 3- MA alone， while the protein expressions of PI3K， Akt and mTOR were significantly lower than those treated with PTX or 3-MA alone （P＜0.05）. Compared with model group， the protein expressions of MBP， MPZ， S100， LAMP2 and Beclin1 in sciatic nerve of rats were increased significantly in THD high-dose and low-dose groups， while the protein expressions of PI3K， Akt and mTOR were significantly decreased （P＜0.05）. CONCLUSIONS THD may activate Schwann cell autophagy by inhibiting the PI3K/Akt/ mTOR signaling pathway， thereby improving peripheral nerve injury caused by PTX.

Objective:To compare the efficacy and safety of endoscopic sclerotherapy with polycinnamol solution and foam in the treatment of grade II hemorrhagic internal hemorrhoids.Methods:From September 2020 to June 2021, 81 patients with grade II hemorrhagic internal hemorrhoids were collected from the Department of Gastroenterology, the First Affiliated Hospital of University of Science and Technology of China. They were randomly divided into an observation group and a control group. The observation group was injected with polycinnamol solution, and the control group was injected with polycinnamol foam. All of them were treated with endoscopic sclerotherapy. The clinical data of the two groups were compared and analyzed. The operation time, immediate hemostasis rate, incidence of postoperative complications (such as fever, pain, bleeding and Urinary retention), recurrence and rebleeding rate of the two groups were observed, and the efficacy and safety of the two groups in the treatment of grade II hemorrhagic internal hemorrhoids were compared.Results:There was no statistically significant difference in basic data between the two groups of patients (all P>0.05), indicating comparability. The surgical operation time of the observation group patients [(7.40±1.18)min] was shorter than that of the control group [(13.88±0.95)min] ( P<0.05); The injection dose of polycinnamol [(5.79±1.61)ml] in the observation group was higher than that in the control group [(4.38±1.92)ml] ( P<0.05). The immediate postoperative hemostasis rate in the observation group was the same as that in the control group (100%). The incidence of postoperative fever (7.32%), perianal pain (4.88%), bleeding (7.32%), and urinary retention (4.88%) complications in the observation group had no significant difference from that in the control group [postoperative fever (5.00%), anal pain (7.50%), bleeding (7.50%), and urinary retention (2.50%)] (all P>0.05). Two months after surgery, the rebleeding rate in the observation group (4.88%) was not significantly different from that in the control group (7.50%) ( P>0.05), but the rebleeding score in the observation group (1.21±0.63) was lower than that in the control group (2.62±0.71), with a statistically significant difference ( P<0.05). The rebleeding rate (2.44%) and the rebleeding score (2.33±1.51) in the observation group were lower than those in the control group [the rebleeding rate (12.50%) and the rebleeding score (5.54±2.42)] at 12 months after follow-up, and the differences were statistically significant ( P<0.05). Conclusions:Endoscopic sclerotherapy is effective in the treatment of grade II hemorrhagic internal hemorrhoids. There is no significant difference in the immediate and short-term hemostasis rate and the incidence of complications between two different dosage forms of sclerotherapy, namely, polycinnamol solution and foam, but the operation of the solution injection is more time-saving and the long-term recurrence rate is lower, which is worthy of clinical application.