1.Formulation and interpretation of the Guidelines for the Pharmacist-managed Clinics Service and Document Writing and Usage(Reference)
Lijuan YANG ; Quanzhi LI ; Kejing WANG ; Xiaofen YE ; Zining WANG ; Xuelian YAN ; Liang HUANG ; Juan LI ; Jiancun ZHEN
China Pharmacy 2025;36(11):1301-1305
The writing of pharmacist-managed clinics documents (hereinafter referred to as “outpatient medication record”) is a necessary part of pharmacist-managed clinics service. Outpatient medication record is an important carrier to reflect the quality of pharmacist-managed clinics service. The Chinese Hospital Association Pharmaceutical Specialized Committee was entrusted by the Pharmaceutical Administration Department of the National Health Commission to lead the formulation of the Guidelines for the Pharmacist-managed Clinics Service and Document Writing and Usage (Reference) (hereinafter referred to as Guidelines) according to the compilation method of group standards and the technical route of “documentation combing→framework establishment→draft writing→opinion collection→Guidelines formation”. The Guidelines standardizes the basic requirements of pharmacist-managed clinics record management and the basic content of record, and provides a general template and two specialized templates including pregnant and lactating pharmacist-managed clinics record template and cough and asthma pharmacist-managed clinics record template, which provides a reference for medical institutions to write pharmacist-managed clinics record. This paper introduces the formulation process of Guidelines and analyzes the key contents of Guidelines, which is helpful for the application practice of Guidelines and further improves the quality of pharmacist-managed clinics work.
2.Clinicopathological Characteristics of HER2-Positive Breast Cancer Patients with BRCA1/2 Pathogenic Variants and Their Response to Neoadjuvant Targeted Therapy
Xingyu LIAO ; Huimin LIU ; Jie SUN ; Li HU ; Juan ZHANG ; Lu YAO ; Ye XU ; Yuntao XIE
Cancer Research on Prevention and Treatment 2025;52(6):491-495
Objective To analyze the proportion and clinicopathological characteristics of HER2-positive breast cancer patients with BRCA1/2 pathogenic variants, and their response to neoadjuvant anti-HER2 targeted therapy. Methods The clinicopathological data of 531 breast cancer patients with germline BRCA1/2 pathogenic variants (201 with BRCA1 variants and 330 with BRCA2 variants) were analyzed. Results Among the 201 BRCA1 and 330 BRCA2 variants, 17 (8.5%) and 42 (12.7%) HER2-positive breast cancer cases were identified, respectively, accounting for 11.1% of all BRCA1/2-mutated breast cancers. Compared with BRCA1/2-mutated HR-positive/HER2-negative patients, HER2-positive patients did not present any significant differences in clinicopathological features; however, compared with triple-negative breast cancer patients, HER2-positive patients had a later onset age and lower tumor grade. Among the 17 patients who received neoadjuvant anti-HER2 targeted therapy, 10 cases achieved pCR (58.8%), whereas 7 cases did not (41.2%). Conclusion HER2-positive breast cancer accounts for more than 10% of BRCA1/2-mutated patients. Approximately 40% of these patients fail to achieve pCR after neoadjuvant targeted therapy. This phenomenon highlights the possibility of combining anti-HER2 targeted agents with poly (adenosine diphosphate-ribose) polymerase inhibitors.
3.Effect of Atractylodes macrocephala Koidz. extract on regulating immune function in mice
YAO Jiali ; ZHANG Juan ; YE Kang ; HUANG Jingjing ; SUN Jian ; JIN Zuhan ; ZHOU Danying
Journal of Preventive Medicine 2025;37(9):968-972
Objective:
To analyze the regulatory effect of Atractylodes macrocephala Koidz. extract on the immune function of mice, so as to provide a reference for the study of the mechanism of Atractylodes macrocephala Koidz. regulating immune function.
Methods:
Forty-eight SPF healthy male ICR mice were randomly divided into control group and low (0.5 g/kg), medium (2.0 g/kg), and high (4.0 g/kg) dose groups, with 12 mice in each group. The mice in control group were given the pure water by gavage once a day, while the mice in each dose group were given the corresponding dose of Atractylodes macrocephala Koidz. extract by gavage once a day. The delayed allergy test was performed for 28 consecutive days. Sixty SPF healthy male ICR mice were randomly divided into a control group, polyinosinic acid injection group (model group), and low, medium, and high dose groups, with 12 mice in each group. The mice in control group were given the pure water by gavage once a day, while the mice in each dose group were given the corresponding dose of Atractylodes macrocephala Koidz. extract by gavage once a day for 14 consecutive days. On days 13 and 14 of administration, the mice in the model group and each dose group were intraperitoneally injected with sterile polyinosinic acid solution to perform the immunosuppressive experiment induced by polyinosinic acid. The mouse ear pieces were weighed, and the thymus and spleen of the mice were weighed and stained with HE to calculate the pathological scores. Peripheral blood was collected for blood cell detection and T cell classification.
Results:
Mice in each group had normal feeding, activity, and growth status, and no abnormality was observed. In the delayed allergy test, compared with the control group, the degree and rate of ear swelling in the low, medium and high dose groups were higher, the white blood cell count in the medium dose group was higher, and the absolute values of lymphocytes in the low and medium dose groups were higher (all P<0.05). Compared with the control group, the pathological scores of the thymus and spleen in the model group were higher (both P<0.05). In the immunosuppressive experiments in mice induced by polyinosinic acid, compared with the model group, the pathological score of the thymus in the high dose group was lower (P<0.05), and the boundary between the thymus cortex and medulla was improved.
Conclusions
Atractylodes macrocephala Koidz. extract can increase the degree of ear swelling and peripheral blood white blood cell count in mice. High dose of Atractylodes macrocephala Koidz. extract can improve the thymus injury induced by polyinosinic acid, and has an immunomodulatory effect.
4.Study on insulin resistance induced by supernatant of bone marrow mesenchymal stem cells derived from diabetic mice
Bao-Juan LI ; Ke-Chun ZHOU ; ABUDOULA·Mi-re-he-mai-ti ; ZULIHUMA·Re-he-man ; Yu-Meng YE ; Yan-Zhi ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(14):2033-2037
Objective To investigate the role of bone marrow mesenchymal stem cells derived from diabetic mice and their paracrine roles in inducing insulin resistance(IR).Methods The mouse model of diabetes mellitus was established,bone marrow mesenchymal stem cells(BMSC)were extracted and cultured,and the culture supernatant(M-BMSC-CS)was collected.(1)Cell experiment:HepG2 hepatocytes were divided into normal low-glycemic culture group[cultured with low-glycemic DMEM(5.55 mmol·L-1)],M-BMSC-CS experimental group(M-BMSC-CS 75 μL),and high-glycemic and high-lipid control group(given 25 mmol·L-1 high-glycemic DMEM+0.25 mmol·L-1 palmitic acid);(2)Animal experiments:Mice were divided into normal mice group(0.9%NaCl by intraperitoneal injection)and M-BMSC-CS-m group(M-BMSC-CS by intraperitoneal injection of normal mice(injection dose 0.2 mL/10 g)].Glucose intake was measured by glucose oxidase method.The fluorescence intensity of Glut2 protein was detected by immunofluorescence.The expression of insulin signaling pathway protein was detected by Western blot.Test oral glucose tolerance(OGTT)and insulin tolerance(ITT).Results The glucose intakes of the normal low-glucose culture group,the M-BMSC-CS experimental group and the high-glucose and high-lipid control group were(2.96±0.05),(1.64±0.28)and(1.42±0.32)mmol·L-1,respectively;the fluorescence expressions of glucose transporter 2(Glut2)were 53.21±2.70,30.95±3.39 and 34.96±7.60,respectively;the protein expression levels of phosphorylated insulin receptor substrate 1-ser307(p-IRS-1ser307)were 0.46±0.21,1.09±0.24 and 0.91±0.16,respectively;phosphorylated protein kinase(p-AKT)protein expression levels were 0.94±0.05,0.59±0.06 and 0.53±0.05;Glut2 protein expression levels were 1.08±0.14,0.58±0.14 and 0.62±0.09,respectively.The above indexes in M-BMSC-CS experimental group were statistically significant compared with those in normal low-glycemic culture group(all P<0.05).Fasting blood glucose levels in the normal group and M-BMSC-CS-m group were(5.23±0.57)and(9.30±1.14)mmol·L-1;p-AKT protein expression level were 1.27±0.21 and 0.51±0.19;Glut2 protein expression level were 1.17±0.17 and 0.79±0.09,respectively.The above indexes in M-BMSC-CS-m group were significantly different from those in normal mouse group(P<0.05).Conclusion BMSC culture supernatant from diabetic mice induced insulin resistance of normal HepG2 hepatocytes in vitro and normal mice in vivo.
5.Pharmacokinetics of JS026 and JS026-JS016 for single intravenous administration in healthy volunteers
Yan TIAN ; Hui-Jing YE ; Jing-Jing WANG ; Nan-Yang LI ; Juan MA ; Xi TAN ; Fan WU ; Jie WANG ; Shu-Yan YU ; Xiao-Jie WU ; Jin-Jie HE ; Jing ZHANG ; Wen-Hong ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(15):2251-2255
Objective To evaluate tolerability,safety and pharmacokinetics of JS026 and JS026-JS016 single dose intravenous infusion in healthy adults.Methods This phase 1,randomized,double-blind,placebo-controlled,dose-escalation study totally included 48 participants:32 healthy subjects were enrolled in JS026 single intravenous infusion groups and 16 healthy subjects were enrolled in JS026-JS016 groups.JS026 was sequentially administered from low dose to high dose(30-1 000 mg),with intravenous infusion of JS026 or placebo in JS026 single-dose groups,and intravenous infusion of JS026-JS016 or placebo in the combination drug groups.Blood was collected according to the time point designed for trial.Serum concentrations of JS026 and JS016 were determined by enzyme linked immunosorbnent assay(ELISA),and pharmacokinetics parameters were calculated by WinNonlin 8.2.The power model method was used to evaluate the linear analysis of dose and drug exposure.Results 47 subjects completed trial and 1 subject lost to follow-up.After a single intravenous injection of JS026 of 30 mg,100 mg,300 mg,600 mg,and 1 000 mg,mean Cmax were(9.47±1.53),(33.20±4.95),(96.10±13.70),(177.00±22.20)and(353.00±56.70)μg·mL-1,respectively;mean AUC0-∞ were(4 225.00±607.00),(1.78 × 104±3 268.00),(5.83 × 104±1 038.00),(1.07 × 105±152.00),(1.66 × 105±327.00)μg·h·mL-1,respectively;mean t1/2 of JS026 were 563-709 h.The Cmax and AUC0-∞ of JS026 were basically similar alone or in combination with JS016.The results of Power model showed that Cmax and AUC0-∞ increased approximately linearly with the increasing dose of JS026.Treatment emergent adverse event was not increasing when dose increased and most of adverse event associated with drugs were abnormal on laboratory tests and haematuria,thus JS026 and JS016 was well tolerated in all groups.Conclusion The single intravenous infusion of JS026 can almost be thought to be a linear relationship between the doses and drug serum exposure.JS016 had no significant effect on serum concentration of JS026 and JS026 was well tolerated and safe in healthy subjects within 30-1 000 mg.
6.The taste correction process of ibuprofen oral solution based on the combination of electronic tongue technology and artificial taste comprehensive evaluation
Rui YUAN ; Yun-ping QU ; Yan WANG ; Ya-xuan ZHANG ; Wan-ling ZHONG ; Xiao-yu FAN ; Hui-juan SHEN ; Yun-nan MA ; Jin-hong YE ; Jie BAI ; Shou-ying DU
Acta Pharmaceutica Sinica 2024;59(8):2404-2411
This experiment aims to study the taste-masking effects of different kinds of corrigent used individually and in combination on ibuprofen oral solution, in order to optimize the taste-masking formulation. Firstly, a wide range of corrigent and the mass fractions were extensively screened using electronic tongue technology. Subsequently, a combination of sensory evaluation, analytic hierarchy process (AHP)-fuzzy mathematics evaluation, and Box-Behnken experimental design were employed to comprehensively assess the taste-masking effects of different combinations of corrigent on ibuprofen oral solution, optimize the taste-masking formulation, and validate the results. The study received ethical approval from the Review Committee of the Beijing University of Chinese Medicine (ethical code: 2024BZYLL0102). The results showed that corrigent fractions and types were screened separately through single-factor experiments. Subsequently, a Box-Behnken response surface design combined with AHP and fuzzy mathematics evaluation was used to fit a functional model:
7.Huaiqihuang Granules Affect Differentiation of Th17 Cells in IgA Vasculitis Nephritis Mice by Regulating AMPK/ACC Pathway
Xinglan YE ; Keying LI ; Jiaxuan LI ; Juan BAI ; Wencheng XU ; Hong LIU ; Xue XUE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(11):78-86
ObjectiveTo observe the intervention effect of Huaiqihuang granules (HQH) on immunoglobulin A vasculitis nephritis (IgAVN) mice and explore the underlying therapeutic mechanism. MethodFifty SPF-grade male Kunming mice were randomly divided into a normal group, an IgAVN model group, a dexamethasone group (2.5 mg·kg-1·d-1), a low-dose HQH group (4 g·kg-1·d-1), and a high-dose HQH group (8 g·kg-1·d-1). The mouse model was established using oral administration of gliadin combined with intravenous injection of India ink. After successful modeling, the mice were euthanized after 4 weeks of gastric gavage according to groups. The 24 h urinary total protein (24 h UTP), urine β2-microglobulin (β2-MG), serum total protein, albumin, IgA, etc. were detected in each group. Flow cytometry was used to determine the proportion of T helper 17 (Th17) cells in spleen cell suspension. Western blot was employed to detect the expression of adenosine 5'-monophosphate-activated protein kinase α (AMPKα), phosphorylated AMPKα (p-AMPKα), acetyl-CoA carboxylase 1 (ACC1), and phosphorylated ACC1 (p-ACC1) in Th17 cells. Pathological changes in the spleen and kidneys were observed. ResultCompared with the normal group, the IgAVN model group showed significant increases in 24 h UTP, urine β2-MG, total cholesterol (P<0.05), serum interleukin-17 (IL-17), IgA, Th17 proportion in the spleen cell suspension, and IL-17 expression in the spleen tissue (P<0.01), and significantly decreased serum total protein, albumin, p-AMPKα/AMPKα, and p-ACC1/ACC1 expression of Th17 cells (P<0.01). Compared with the IgAVN model group, in the 4th week, the 24 h UTP, urine β2-MG, serum IL-17, IgA levels, and renal IgA deposition were significantly reduced in each treatment group (P<0.01), and the Th17 proportion and IL-17 expression in spleen tissue were significantly decreased (P<0.05, P<0.01). Serum albumin levels significantly increased (P<0.05). Compared with the IgAVN model group, the dexamethasone group and the high-dose HQH group showed increases in serum total protein (P<0.01), p-AMPKα/AMPKα, and p-ACC1/ACC1 expression of Th17 cells (P<0.05, P<0.01). The high-dose HQH group showed a significant decrease in total cholesterol level (P<0.05). Various treatment groups showed different degrees of improvement in spleen and kidney pathological changes. ConclusionHQH may affect Th17 cell differentiation by regulating the AMPK/ACC pathway, correcting immune inflammatory disorders, and exerting therapeutic effects on IgAVN.
8.Efficacy observation of ZR2 regimen for treatment of elderly patients with diffuse large B-cell lymphoma
Chunmei YE ; Hui XU ; Juan LI ; Peimin SHI ; Jun LI
Journal of Leukemia & Lymphoma 2024;33(1):52-54
Objective:To investigate the clinical efficacy and safety of ZR2 (zevalin + lenalidomide + rituximab) regimen in the treatment of elderly patients with diffuse large B-cell lymphoma (DLBCL).Methods:A retrospective case series study was conducted. The clinical data of 16 elderly (>65 years old) non-germinal center B-cell-like DLBCL patients treated with ZR2 regimen at the Taixing People's Hospital from January 2021 to March 2023 were retrospectively analyzed. The efficacy, adverse reactions and prognosis of patients were observed.Results:Of the 16 patients, 11 were male and 5 were female, with the age [ M ( Q1, Q3)] of 76 years old (70 years old, 78 years old), and 10 cases were Ann Arbor stage Ⅲ-Ⅳ. Among the 16 patients, 9 achieved complete remission, 4 patients achieved partial remission. All 16 patients experienced varying degrees of reversible bone marrow suppression, grade Ⅲ-Ⅳ hematologic adverse reactions included neutropenia (7 cases) and thrombocytopenia (2 cases), and the bone marrow hematopoiesis recovered after treatment with granulocyte colony-stimulating factor and thrombopoietin. The main ≥grade Ⅱ non-hematologic adverse reactions were gastrointestinal reactions (5 cases), liver function abnormalities (3 cases) and peripheral neuropathy (2 cases), which were improved after the appropriate treatment. Two patients discontinued the treatment of this regimen due to disease progression, and 1 patient died from complications after 2 cycles of treatment. No deep vein thrombosis, cardiac toxicity or renal toxicity occurred during the treatment process. Conclusions:The ZR2 regimen is effective in the treatment of elderly DLBCL patients with tolerable adverse reactions.
9.Status of exposure to television advertising of sugar sweetened beverages among children and adolescents in Beijing
CUI Jia, LEI Nan, TANG Yuxiang, YE Lihong, LIANG Kaipeng, XIANG Lin, ZHANG Juan
Chinese Journal of School Health 2024;45(5):654-658
Objective:
To investigate the exposure to television advertising of sugar sweetened beverages and the use of persuasive marketing techniques among children and adolescents in Beijing, so as to provide evidence for reduing childrens intake of sugar sweetened beverages.
Methods:
From October 19, 2020 to November 16, 2021, 32 days were randomly selected. The top four popular channels of children and adolescents aged 3-18 years were defined. Each channel was monitored from 6:00:00 to 23:59:59 for each date. A total of 2 304 h was recorded. Advertisements involving sugar sweetened beverages broadcast before, during or after the program were included. The frequency and the use of persuasive marketing techniques were analyzed.
Results:
A total of 1 237 advertisements for sugar sweetened beverages were included, of which 50.93% were dairy beverages, 28.38% were teabased beverages, and 19.48% were vegetable protein beverages. The average frequency of sugar sweetened beverages advertisements on every channel was (0.62±1.29)piece/h. The frequency of sugar sweetened beverages advertisements on every local channel [(1.04±1.35)piece/h] and childrens channel [(1.11±1.61)piece/h] was separately higher than every national channel [(0.48±1.24)piece/h] and general channel [(0.12±0.48)piece/h] (t=-14.05, 31.64, P<0.01). There were seasonal differences in television advertising of sugar sweetened beverages, and were more frequent during lunch and dinner times. The most frequently used persuasive marketing techniques were "images of children" (74.54%), "nutritional message" (61.76%), "product composition details" (58.61%), "nutrition claim" (57.24%), and "nutrition function claim or other function claim" (53.11%).
Conclusions
Children and adolescents are often exposed to television advertisement of sugar sweetened beverages on childrens channels and during meal times. There is an urgent need to formulate relevant policies to regulate the marketing of sugar sweetened beverages advertisement and reduce children and adolescents intake.
10.Clinical phenotype and genetic analysis of a rare case with 6p duplication and terminal deletion syndrome
Yanhong YU ; Jian LU ; Hong LI ; Yingying GAO ; Xia YE ; Xuzhuo ZHANG ; Jingtian LU ; Juan QIU
Chinese Journal of Medical Genetics 2024;41(9):1117-1123
Objective:To explore the genetic basis for a child with developmental delay and intellectual deficit (DD/ID).Methods:A child who was admitted to the Maternal and Child Health Care Hospital of Longhua District of Shenzhen City on June 3, 2023 due to DD/ID, craniofacial malformations, and recurrent infections of upper respiratory tract was selected as the study subject. G-banded chromosomal karyotyping was carried out for the child and her parents. Low-depth genome-wide copy number variation sequencing (CNV-seq) and chromosomal microarray analysis (CMA) were used to screen for genome-wide copy number variation (CNV), and fluorescence in situ hybridization (FISH) was used to verify the origin of candidate CNV. This study was approved by the Maternal and Child Health Care Hospital of Longhua District of Shenzhen City(Ethics No. 2023052504). Results:The child, an 8-year-old girl, had featured unexplained growth and intellectual development delay, multiple craniofacial malformations, and recurrent infections of the upper respiratory tract. She was found to have a karyotype of 46, XX, der(6)add(6)(q23), while both of her parents were normal. Both CNV-seq and CMA showed that the child has harbored a 21.38 Mb interstitial duplication at 6p25.3p22.3 and a 0.78 Mb terminal deletion at 6p25. FISH verified that both the duplication and deletion had occurred de novo. Conclusion:The abnormal phenotype of the child may be attributed to the 6p duplication and terminal deletion.


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