1.Practice and analysis of implementing drug traceability code management in outpatient pharmacy
Liwen LIAO ; Yuqi WANG ; Yuzi WANG ; Kang CHEN ; Shuxia LI ; Kejing TANG ; Wei YANG
China Pharmacy 2025;36(7):858-862
OBJECTIVE To explore optimization pathways for the drug traceability code management model in outpatient pharmacy workflows, providing practical evidence for enhancing the efficiency of pharmaceutical service. METHODS Taking the outpatient pharmacy of the First Affiliated Hospital of Sun Yat-sen University as the research subject, a comprehensive drug traceability system was established through three key interventions: upgrading the information system architecture [including integration of the hospital information system (HIS) with the traceability platform], workflow optimization (reorganizing the inventory-dispensing-verification tripartite process), and designing a dual-mode traceability data collection mechanism (primary data capture at dispensing stations and supplementary capture at verification stations). Operational efficiency differences before and after implementation were analyzed using the medical insurance data and service timeliness metrics in September 2024. RESULTS After the implementation of drug traceability code management, in terms of data collection: Mode Ⅰ (verification-stage capture) uploaded 26 144 records, while Mode Ⅲ (inventory-as-sales capture) uploaded 443 061 records, totaling 469 205 entries; in terms of time efficiency: average drug dispensing time increased from 28.74 s to 43.37 s (enhanced by 51%). Through dynamic staffing adjustments, patient wait time only extended from 8.04 min to 8.67 min (enhanced by 8%). CONCLUSIONS Drug traceability code management can be effectively implemented via a “system reconstruction-process reengineering-human-machine collaboration” trinity strategy, leveraging informatization (e.g., dual-mode data capture) to offset manual operation delays, which validates the feasibility of balancing national traceability demands with service efficiency in outpatient pharmacies.
2.Preparation of a dual-specific antibody targeting human CD123 and exploration of its anti-acute myeloid leukemia effects
Tong ZHOU ; Manling CHEN ; Chuyue ZHANG ; Xiaoyu LIU ; Zhenzhen WANG ; Haiyan XING ; Kejing TANG ; Zheng TIAN ; Qing RAO ; Min WANG ; Jianxiang WANG
Chinese Journal of Hematology 2024;45(3):225-232
Objective:To construct a novel dual-specific antibody targeting human CD123 (CD123 DuAb) and study its effects in acute myeloid leukemia (AML) .Methods:Based on the variable region of the CD123 monoclonal antibody independently developed at our institution, the CD123 DuAb expression plasmid was constructed by molecular cloning and transfected into ExpiCHO-S cells to prepare the antibody protein. Through a series of in vitro experiments, its activation and proliferation effect on T cells, as well as the effect of promoting T-cell killing of AML cells, were verified.Results:① A novel CD123 DuAb plasmid targeting CD123 was successfully constructed and expressed in the Expi-CHO eukaryotic system. ②The CD123 DuAb could bind both CD3 on T cells and CD123 on CD123 + tumor cells. ③When T cells were co-cultured with MV4-11 cells with addition of the CD123 DuAb at a concentration of 1 nmol/L, the positive expression rates of CD69 and CD25 on T cells were 68.0% and 44.3%, respectively, which were significantly higher than those of the control group ( P<0.05). ④Co-culture with CD123 DuAb at 1 nmol/L promoted T-cell proliferation, and the absolute T-cell count increased from 5×10 5/ml to 3.2×10 6/ml on day 9, and CFSE fluorescence intensity decreased significantly. ⑤ With the increase in CD123 DuAb concentration in the culture system, T-cell exhaustion and apoptosis increased. When the CD123 DuAb was added at a concentration of 1 nmol/L to the culture system, the proportion of CD8 + PD-1 + LAG-3 + T cells was 10.90%, and the proportion of propidium iodide (PI) - Annexin Ⅴ + T cells and PI + Annexin Ⅴ + T cells was 18.27% and 11.43%, respectively, which were significantly higher than those in the control group ( P<0.05). ⑥ The CD123 DuAb significantly activated T cells, and the activation intensity was positively correlated with its concentration. The expression rate of CD107a on T cells reached 16.05% with 1 nmol/L CD123 DuAb, which was significantly higher than that of the control group ( P<0.05). ⑦The CD123 DuAb promoted cytokine secretion by T cells at a concentration of 1 nmol/L, and the concentration of IFN-γ and TNF-α in the supernatant of the co-culture system reached 193.8 pg/ml and 169.8 pg/ml, respectively, which was significantly higher than that of the control group ( P<0.05). ⑧When CD123 DuAb was added at a concentration of 1 nmol/L to the co-culture system of T cells and CD123 + tumor cells, the killing intensity of T cells significantly increased, and the residual rates of CD123 + MV4-11 cells, CD123 + Molm13 cells, and CD123 + THP-1 cells were 7.4%, 6.7%, and 14.6% on day 3, respectively, which were significantly lower than those in the control group ( P<0.05) . Conclusion:In this study, a novel CD123 DuAb was constructed and expressed. In vitro experiments verified that the DuAb binds to CD123 + tumor cells and T cells simultaneously, promotes T-cell activation and proliferation, and facilitates their anti-leukemia effect, which provides a basis for further clinical research.
3.Clinical Pharmacy Services for Paternal Drug Exposure Based on A Pregnancy Drug Registry Platform
Dan ZHENG ; Kejing WANG ; Zongjie LYU ; Xiaohong CHEN ; Lin CHEN
Herald of Medicine 2024;43(10):1668-1671
Objective To communicate the paternal medication behaviors and patterns during the peri-pregnant period in China and to explore the types of pharmaceutical care services that clinical pharmacists can provide.Methods Focusing on patients exposed to paternal medication during the perinatal period,the clinical practice model of our hospital's clinical pharmacists consultation for paternal drug exposure was introduced.Furtherly,a retrospective survey on the information of consultants was conducted and the characteristics of drug exposure were analysed in this population,and a comparation made with data from foreign teratogenic information service centers.Results From October 2017 to September 2022,leveraging our hospital's Pregnancy Registration Platform for Medication,clinical pharmacists provided pharmaceutical consultation services for 404 outpatient cases of paternal exposure,and established a standardized consultation flow.Paternal exposure counseling accounted for 3.6% of cases,with medication use during an unplanned pregnancy being the most common situation(79.2% ).The average number of exposed drugs was(2.6±1.7).The top five types of drugs consulted were antimicrobials,Chinese traditional patent medicine,cardiovascular system drugs,digestive system drugs and endocrine system drugs.The five most frequently used drugs were cephalosporins,sartans,entecavir,levofloxacin and metformin.Effective follow-up was conducted on 261 cases,with a follow-up rate of 81.6%,and no congenital abnormal signals were indicated after exposure to the father's medication.Conclusion Pateral drug exposure in China has received little attention,with very limited research evidence available.Clinical pharmacists providing evidence-based drug risk assessment and medication advice to the public and healthcare professionals,along with conducting observational studies based on cases,are of significant importance in promoting the the safe use of paternal medications.
4.Risk factors of new-onset hypertriglyceridemia in kidney transplant recipients: a single-center analysis
Yuan XU ; Bo YANG ; Chengxin CHEN ; Kejing ZHU ; Yulin NIU ; Haiyang LI
Organ Transplantation 2023;14(5):691-699
Objective To identify the risk factors of new-onset hypertriglyceridemia (HTG) in kidney transplant recipients. Methods Clinical data of 149 kidney transplant recipients were retrospectively analyzed. According to serum triglyceride (TG) level after operation, they were divided into the non-HTG group (TG≤1.7 mmol/L, n=60) and new-onset HTG group (TG>1.7 mmol/L, n=89). Baseline data of all recipients were compared between two groups. The risk factors of HTG in kidney transplant recipients were analyzed by generalized estimating equation (GEE), and validated by multiple regression equations. Results No significant differences were observed in baseline data between two groups (all P>0.05). Multivariate analysis showed that the incidence of HTG in the middle and high tacrolimus (Tac) concentration groups was higher than that in the low Tac concentration group [odds ratio (OR) 3.11, 95% confidence interval (CI) 1.22-7.93, P=0.018 in the middle Tac concentration group; OR 5.11, 95%CI 1.31-19.98, P=0.019 in the high Tac concentration group]. Compared with type-A blood recipients, the risk of new-onset HTG was significantly increased in type-O blood counterparts (OR 2.77, 95%CI 1.14-6.71, P=0.024). The risk of new-onset HTG was decreased along with the increase of preoperative globulin level (OR 0.93, 95%CI 0.87-0.99, P=0.043). At postoperative 3 months, Tac blood concentration in the new-onset HTG group was significantly higher compared with that in the non-HTG group, and significant difference was observed (P<0.05). Multiple regression equations confirmed that the risk of new-onset HTG in type-O blood kidney transplant recipients was higher than that in type-A blood counterparts, and the risk of new-onset HTG in the middle and high Tac concentration groups was higher than that in the low Tac concentration group (all P<0.05). Conclusions Type-O blood kidney transplant recipients are more prone to HTG. It is necessary to strengthen postoperative monitoring and control of blood lipids. The blood concentration of Tac probably affects the new-onset HTG in kidney transplant recipients. Maintaining an appropriate blood concentration of Tac may be beneficial to lowering the risk of HTG.
5.Effects of Medication Therapy Management for Female Depressed Patients of Different Ages: A Stratified Randomized Controlled Trial
Kejing WANG ; Chenggang JIANG ; Yangmei LEI ; Lin CHEN
Chinese Journal of Modern Applied Pharmacy 2023;40(23):3288-3296
OBJECTIVE To assess the effect of medication therapy management(MTM) on symptom improvement and medication adherence in depressed female patients, and to explore the depression severity and adherence characteristics of female patients of different ages. METHODS A total of 180 female depressed patients from February 2022 to July 2022 were recruited and randomly divided into two groups according to age and depression severity: the control group and the management group,with 90 cases in each group. Patients in the control group were given conventional therapy, while those in the management group were given MTM on top of conventional therapy. The self-rating depression scale(SDS)was applied at enrollment and 3 months after treatment to assess symptom improvement in both groups, and the Morisky Medication Adherence Scale- 8(MMAS-8) was applied at the end of 4, 8 and 12 weeks of treatment to compare adherence differences between the two groups, and subgroup analysis was performed based on stratification factors. RESULTS A total of 147 patients completed all assessments and follow-up, and there was no statistically significant difference in drop-out rate between the control group and the management group(χ2=3.006, P=0.083). Patients who dropped-out with different depression severity were compared with those who did not, with a statistically significant difference(χ2=13.927, P=0.001). For the comparison of SDS scores by age group, the highest SDS scores before and after treatment were found in adolescence, followed by menopause, and the lowest in childbearing age, with statistically significant differences(P<0.05). The SDS scores of each subgroup of different age groups and each subgroup of different depression severity in the management group were lower than those of the corresponding groups in the control group, with statistically significant differences except for the menopausal subgroup and the mild subgroup(P<0.05). The overall compliance score of 176 patients was (5.69±1.37) points. In the full assessment the adherence scores were the highest in childbearing, followed by adolescence, and the lowest and the lowest in menopause, with statistically significant difference(χ2=6.61, P=0.037). The adherence scores of the different age groups were higher in the management group than those in the control group,with statistically significant differences in adolescence(χ2=25.573, P<0.001), childbearing age(χ2=7.772, P=0.005)and menopause(χ2=19.776, P<0.001) for the full assessment. Except for the 1st and 2nd follow-up in childbearing age, there were statistically significant differences between management group and control group at three age groups in the three follow-up visits(P<0.05). CONCLUSION The depression severity in female depressed patients varies by age, with the heaviest in adolescence and the least severe in childbearing age. The overall level of medication adherence is low in female patients. The adherence is highest in childbearing age and lowest in menopause. MTM boasts to be effective in promoting symptom improvement and adherence in female depressed patients of different ages.
6.Treatment of geriatric osteoporotic femoral intertrochanteric fractures with proximal femoral nail antiro-tation and bone cement enhancement
Zhiyong TIAN ; Hongqiang CHEN ; Kejing DAI ; Limin HE ; Tingting FAN
Chinese Journal of Orthopaedic Trauma 2021;23(6):539-542
Objective:To investigate the efficacy of proximal femoral nail anti-rotation (PFNA) plus bone cement enhancement in the treatment of geriatric osteoporotic femoral intertrochanteric fractures.Methods:A retrospective analysis was conducted of the 52 elderly patients with osteoporotic femoral intertrochanteric fracture who had been treated at Department of Bone and Joint Surgery, The Fourth People's Hospital of Guiyang from September 2012 to October 2018 by PFNA internal fixation plus bone cement enhancement. They were 8 males and 44 females, aged from 65 to 91 years (average, 78 years). The time from injury to operation averaged 4.4 d. By the AO/OTA classification, there were one case of type 31-A1.2, 2 cases of type 31-A2.1, 8 cases of type 31-A2.2, 34 cases of type 31-A2.3, one case of type 31-A3.1, and 6 cases of type 31-A3.3. The patients' operation time, intraoperative bleeding, hospital stay, fracture reduction, postoperative weight-bearing time, fracture union time, function of the affected hip and complications were recorded.Results:The operation time for this cohort averaged 79.4 min, intraoperative bleeding 123.6 mL, and hospital stay 11.9 d. By the Francisco evaluation, the reduction of intertrochanteric fracture was assessed as good in 43 cases and as fair in 9 cases. Of this cohort, 45 were followed up for 5 to 12 months (average, 6 months) and 7 lost to follow-up. By the Harris hip scores at the last follow-up, 14 cases were rated as excellent, 25 as good and 6 as fair, giving an excellent to good rate of 88.9% (39/45). No complications like loosening, cut-out or breakage of implants or femoral head necrosis occurred during follow-up.Conclusion:In the treatment of geriatric osteoporotic femoral intertrochanteric fractures, PFNA plus bone cement enhancement can achieve satisfactory clinical efficacy.
7.Preparation of a novel tri-specific T cell engager targeting CD19 antigen and its anti-leukemia effect exploration
Manling CHEN ; Nan PENG ; Xiaoyu LIU ; Ting ZHANG ; Yingxi XU ; Zheng TIAN ; Haiyan XING ; Kejing TANG ; Qing RAO ; Jianxiang WANG ; Min WANG
Chinese Journal of Hematology 2021;42(3):217-223
Objective:To prepare a novel tri-specific T cell engager (19TriTE) targeting CD19 antigen, and to investigate its immunotherapeutic effect on CD19-positive hematological malignancies.Methods:19TriTE was constructed by molecular cloning technology and successfully expressed through the eukaryotic expressing system. The effects of 19TriTE on the proliferation and activation of T cells, as well as the specific cytotoxicity against CD19 positive tumor cell lines were verified.Results:①19TriTE expressing plasmid was constructed and successfully expressed through the eukaryotic expressing system. ②19TriTE can specifically bind to T cells and Nalm6 cells, with equilibrium dissociation constants of 19.21 nmol/L and 11.67 nmol/L, respectively. ③The expression rates of CD69 positive T cells and CD25 positive T cells were 35.4% and 49.8% respectively, when 2 nmol/L 19TriTE were added in the co-culture system, which were significantly higher than those in the control group. ④19TriTE can significantly promote the proliferation of T cells. The absolute count of T cells expanded from the initial one million to 74 million with an 74 fold increase at the concentration of 1 nmol/L on day 12. ⑤19TriTE can significantly mediate T cells killing of CD19 positive target cells in a dose-dependent manner. At the concentration of 10 nmol/L, the target cells lysis reached 50%. ⑥Degranulation experiment verified that 19TriTE can activate T cells in the presence of CD19 positive target cells, and the activation of T cells positively correlated with the dose of 19TriTE. ⑦When 19TriTE fusion protein co-cultured with T cells and target cells overexpression RFP and luciferase genes respectively, 19TriTE can notably mediate T cells killing of CD19 positive target cells through fluorescent microscope or bioluminescence imaging technology.Conclusion:In this study, we successfully constructed and expressed 19TriTE fusion protein and verified that it can effectively activate T cells and promote their proliferation in vitro. At the same time, it can bind to CD19 positive target cells and T cells, as well as enhance T cells anti-leukemia effect in vitro, providing the foundation for further clinical research.
8.The research of brain glioma therapy for nude mouse using transgenic human umbilical cord mesenchymal stem cells overexpressing TRAIL
Wencui SUN ; Danying YI ; Kejing WU ; Yonggang ZHANG ; Mowen LAI ; Qiongxiu ZHOU ; Feng MA ; Yongjun CHEN ; Shaoxian LIU ; Bo CHEN
Chinese Journal of Blood Transfusion 2021;34(6):567-573
【Objective】 To explore the establishment methods of transgenic human umbilical cord mesenchymal stem cells (hUC-MSCs) overexpressing tumor necrosis factor(TNF)-related apoptosis-inducing ligand (TRAIL) based on the transposons, and attempt to apply it on the nude mice mode with glioma. 【Methods】 PiggyBac transposon system specially designed by us was used to prepare non-targeting and Her2-targeting hUC-MSCs that can stably express TRAIL through puromycin screening. The glioma cells expressing firefly luciferase (U87MG-LUC) were injected into the skull of the immunodeficient mice (BALB/c-nu/nu) with 1×106 cells per mouse. After 7 days of injection, the mice transplanted with U87MG were detected with a small animal living imager to determine the size and location of the tumors in skull. Then we injected the glioma-transplantation nude mouse with two kinds of transgenic hUC-MSCs expressing TRAIL (named as untarget-TRAIL and target-TRAIL, respectively), or the non-transgenic hUC-MSCs (all 1×106 cells per mouse) or PBS (named as WT-MSCs and PBS for negative control) respectively, and then monitored the changes of tumor signals by a small animal living imager every week for 3~4 weeks. 【Results】 After six passages to expand the cells, the both transgenic cell lines can stably express TRAIL gene. Their ratio of green fluorescent protein (GFP) positive cells can reach 93%-97%, and the positive ratio of their MSC-specific surface markers still maintained normal (CD34+, CD45+, and HLA-DR+ all <0.1%, CD90>99%, CD73>88%, and CD105 >60%). The median survival time (d) of U87MG-transplanted nude mice in the groups of untarget-TRAIL, target-TRAIL, WT-MSCs, and PBS was 41 vs 39 vs 24 vs 23(P<0.05). 【Conclusion】 The transgenic hUC-MSCs overexpressing TRAIL gene can significantly prolong the survival time of nude mice with brain glioma.
9.Data Analysis of the Risks of Abnormal Female Reproductive System Haemorrhages Induced by Novel Oral An- ticoagulants Based on FAERS
Xiaojiang TIAN ; Yuntao JIA ; Kejing WANG ; Lin CHEN
China Pharmacy 2020;31(14):1751-1755
OBJECTIVE:To eva luate the risk of abno rmal female reproductive system haemorrhage induced by novel oral anticoagulants (NOACs). METHODS :The abnormal female reproductive system haemorrhage reports induced by 4 kinds of NOACs as “dabigatran etexilate ”,“rivaroxaban”,“apixaban”and“edoxaban”were used as the first suspected dugs to collected from FDA adverse event reporting system (FAERS)database during Jan. 1st,2004-May 31st,2019. The report odd ratio (ROR) method was used to detect the signal of abnormal female reproductive system haemorrhage induced by NOACs. RESULTS :A total of 2 658 adverse events related to abnormal female reproductive system haemorrhage were collected from FAERS database , involving 330 reports of dabigatran etexilate ,2 049 reports of rivaroxaban ,267 reports of apixaban ,and 12 reports of edoxaban. The abnormal female reproductive system haemorrhage caused by dabigatran etexilate ,apixaban and edoxaban mainly occurred in patients aged 75 and older ,accounting for 37.27%,36.70% and 58.33% respectively;that of rivaroxaban mainly occurred in patients with 45-64 years old ,accounting for 33.04%. The incidence of severe adverse events (SAE)induced by dabigatran etexilate,rivaroxaban,apixaban and edoxaban were 96.36%,84.53%,47.19% and 58.33%,respectively. All of patients in the included reports were mainly hospitalized and hospitalization stay wa s prolonged ,accounting for 64.78%,90.01%,86.51% and 71.43% ,respectively. A total of 12 suspected signals were detected,involving cervix uteri ,fallopian tube ,ovary,pelvis cavity,uterus,vagina,urinary tract ,etc. Among them ,there were 11 positive signals of rivaroxaban ,and the bleeding events were concentrated in vaginal hematoma [ROR =12.07, 药。95%CI(8.51,17.12)],postmenopausal hemorrhage [ROR = 9.89,95%CI(8.31,11.77)],pelvic hematoma [ROR =7.68,95%CI(5.66,10.43)]. There were 4,4 and 2 suspicious signals for dabigatran etexilate ,apixaban and edoxaban. The main bleeding events of both apixaban [ ROR=5.18,95%CI(1.81,5.85)] and edoxaban [ROR =48.19,95%CI(6.76,343.77)] were vaginal hematoma ;dabigatran etexilate-induced pelvic hematoma [ROR = 12.56,95%CI(8.92,17.70)] had the strongest signal ,followed by urinary tract bleeding [ROR =5.41,95%CI(3.34,8.76)] and pelvic hemorrhage [ ROR=2.53,95%CI(1.88,3.40)]. CONCLUSIONS :Totally 4 kinds of NOACs can cause abnormal female reproductive system haemorrhage ,and the incidence of SAE is high ,of requiring hospitalization or prolonging hospitalization time. The risk of haemorrhage in rivaroxaban is the highest ,usually manifesting as vaginal hematoma ,postmenopausal hemorrhage and pelvic hematoma. Dabigatran etexilate mainly induce pelvic hematoma ,while apixaban and edoxaban are mainly cause vaginal hematoma.
10.Application of diversified training based on dynamic case in standardized training of new nurses in Neurological Intensive Care Unit
Kaili YE ; Kejing HUANG ; Xiaoqing CHEN ; Pin YE
Chinese Journal of Modern Nursing 2019;25(24):3066-3070
ObjectiveTo explore the application effect of diversified training based on dynamic case in standardized training of new nurses in Neurological Intensive Care Unit. MethodsTotally 62 new nurses were selected from the First Affiliated Hospital of Wenzhou Medical University in 2017 and 2018. A total of 30 nurses in 2017 were assigned into the control group and 32 new nurses in 2018 were in the observation group. The control group was trained in stages by traditional training methods, while the observation group added one dynamic case to each training stage, and implemented diversified training and assessment methods such as scenario simulation training, video teaching, tutorial system teaching, etc. The theoretical assessment, skill assessment,adverse event and comprehensive nursing ability were compared between the two groups. ResultsAfter diversified training, the scores of theoretical assessment (92.58±2.55) and skill assessment (94.72±2.67) in the observation group were higher than those in the control group with statistical differences (t=-8.018, - 10.151; P<0.01). There were 2 nurses with adverse events in the observation group and 6 nurses in the control group, but there was no significantly statistical difference (χ2=1.525, P>0.05). The nurses in the observation group were all qualified in terms of the comprehensive nursing ability while 2 nurses the control group were not qualified, there was significant difference between the two groups (Z=-3.473, P< 0.05). ConclusionsThe diversified training based on dynamic case can effectively improve the theoretical and operational performance of rotating nurses, the qualified rate of teaching, the comprehensive ability of nursing and the confidence of practitioners. It is worthy of further application in the standardized training of newly admitted nurses in Neurological Intensive Care Unit.


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