1.Development and application of hospital drug traceability code management model based on full-cycle perspective
Mei ZHANG ; Chunhua GONG ; Guanghui CHEN ; Jiawei LIN ; Haiwei ZHANG ; Kaifeng QIU
China Pharmacy 2026;37(7):854-858
OBJECTIVE To explore and establish a full-cycle management model for drug traceability codes that aligns with national policy requirements and the practical needs of healthcare institutions, thereby enhancing the refinement of drug management and the level of medication safety. METHODS A tripartite strategy integrating “hardware deployment, system transformation, and process re-engineering” was adopted. This involved the introduction of intelligent identification devices (personal digital assistant, high-definition industrial reader), the modification of the hospital information system interface, and the re-engineering of workflows (drug warehousing, dispensing and distribution, drug withdrawal, uploading to the insurance platform) to achieve comprehensive, informatized collection and association of drug traceability codes throughout all stages. RESULTS A full-cycle management model for drug traceability codes was successfully established, realizing the goals of making drugs “traceable to their source, trackable in their distribution, and accountable in their responsibility”. The patient waiting time for medication dispensing before and after the implementation was [3.08(1.67,5.58)] min and [3.28(1.77,5.98)] min, respectively. Among them, the patient waiting time under the pre-preparation mode was [3.60(2.13,6.35)] min and [3.50(2.03,6.30)] min, respectively; the patient waiting time under the real-time mode was [2.05(0.83,4.03)] min and [2.78(1.18,5.38)] min, respectively; the number of dispensing errors was 3, 0, respectively; the staffing of relevant positions had not been increased. CONCLUSIONS The drug traceability code management model constructed from a full-cycle perspective effectively meets national policy requirements. It provides data support for refined hospital management and offers solid technical and procedural safeguards for ensuring patient medication safety and strengthening medical insurance fund supervision, demonstrating practical value.
2.Influencing factors of liver injury in breast cancer patients after chemotherapy:a Meta-analysis
Haiwei ZHANG ; Kai ZHOU ; Dongliang YANG ; Haixia ZHAO
Chinese Journal of Pharmacoepidemiology 2025;34(1):47-56
Objective To systematically review the risk factors for liver injury in breast cancer patients after chemotherapy.Methods PubMed,Cochrane Library,Embase,Web of Science,CNKI,SinoMed,WanFang Data and VIP databases were electronically searched to collect studies on the influential factors of liver injury in breast cancer patients from inception to March 31,2024.Two reviewers independently screened the literature,extracted data and evaluated the risk of bias of the included studies.Meta-analysis was performed by using RevMan 5.3 software.Results A total of 15 studies involving 6,486 patients were included.The results of Meta-analysis showed that hepatitis B virus infection[OR=2.41,95%CI(1.52,3.82),P<0.001],lymph node metastasis[OR=1.27,95%CI(1.05,1.55),P=0.02],hyperlipidemia[OR=1.58,95%CI(1.13,2.20)P=0.007],liver metastasis[OR=3.19,95%CI(2.11,4.84),P<0.001],tumor node metastasis(TNM)stage Ⅲ to Ⅳ[OR=1.49,95%CI(1.17,1.90),P<0.001],were risk factors for liver injury after breast cancer chemotherapy.Compared with other chemotherapy agents/regimens,the use of fluorouracil[OR=0.58,95%CI(0.42,0.80),P<0.001],cyclophosphamide[OR=0.65,95%CI(0.47,0.89),P=0.008],AC regimen[OR=0.38,95%CI(0.22,0.66),P<0.00 1]and neoadjuvant chemotherapy[OR=0.61,95%CI(0.43,0.88),P=0.007]were associated with a lower risk of liver injury,the use of paclitaxel drugs[OR=2.85,95%CI(2.31,3.52),P<0.001],intensive regimen[OR=3.48,95%CI(2.15,5.62),P<0.001],TAC regimen[OR=2.42,95%CI(1.38,4.24),P=0.002]increased the risk of liver injury.Tumor TNM stage I[OR=0.63,95%CI(0.51,0.78),P=0.001]were protective factors for liver injury after chemotherapy in breast cancer patients.Conclusion The current evidence shows that multiple factors influence the incidence of liver injury after breast cancer chemotherapy.Medical staff can formulate targeted chemotherapy programs according to the influencing factors and clinical characteristics to reduce the risk of liver injury after chemotherapy.
3.Development and application of core competency evaluation index system for ethics committee members of drug clinical trial institution
Xiaohua TANG ; Qingqing JIANG ; Haiwei ZHANG ; Weiran MAO ; Yuanyuan YIN ; Jiangdong SUI ; Jun LI ; Xia CHEN
China Pharmacy 2025;36(20):2489-2494
OBJECTIVE To construct an evaluation index system for the core competencies of ethics committee members of drug clinical trial institution,providing a basis for optimizing the training system for committee members,improving the quality of ethical review,and fully safeguarding the safety and rights of subjects.METHODS Using methods such as literature research and expert consultation,a preliminary core competency evaluation index system was constructed.The Delphi method was employed to revise and validate it,ultimately forming an evaluation index system for the core competencies of ethics committee members.Based on this system,a questionnaire survey was conducted among 90 ethics committee members from 29 drug clinical trial institutions nationwide,comparing their importance rating and self-assessment scores of the core competency indexes.RESULTS The evaluation system constructed included 4 primary indicators(ethics and professional knowledge,ethics review ability,communication and expression ability,moral integrity and work style)and 39 secondary indicators(familiarity with the content of clinical trial-related laws and regulations,ability to complete project ethics review and identify ethical defects in research protocols within a short period of time,ability to judge the scientific value of clinical research,etc.).The results of questionnaire survey showed that the interviewed ethics committee members had significant capability gaps in dimensions such as regulatory knowledge,ethical norms,review efficiency,risk judgment,and problem analysis.The differences between the importance rating scores of corresponding secondary indicators and the self-assessment scores were all no less than 0.38.CONCLUSIONS This study has developed a quantifiable and stratified core competency assessment tool for ethics committee members.It can provide a scientific framework for committee member training,qualification certification,and standardized management of ethics committees.
4.Liquiritin inhibits osteoclast differentiation and alleviates bone loss
Wensheng ZHANG ; Haiwei GUO ; Rui WENG ; Ling MO ; Zhenjie SONG ; Han TIAN ; Yelin ZHONG ; Yuancheng WANG ; Hanwu TANG ; Caijun LIU ; Chao YUAN ; Ying LI
Chinese Journal of Tissue Engineering Research 2025;29(12):2429-2437
BACKGROUND:Relatively or absolutely active bone resorption function of osteoclasts is one of the causative factors of osteoporosis. Therefore,how to inhibit the formation of osteoclasts and reduce the bone resorption activity is a key element in the prevention and treatment of osteoporosis. Liquiritin,which is derived from licorice,plays a role in the clinical treatment of bone diseases,but there are fewer studies addressing the application of liquiritin in osteoporosis and the mechanism is unknown.OBJECTIVE:To confirm,through both in vivo and in vitro experiments,that liquiritin inhibits osteoclast differentiation and alleviates bone loss.METHODS:Cell counting kit-8 was used to detect whether Liquiritin exerts toxic or proliferative effects on mouse bone marrow-derived macrophages,and tartrate-resistant acid phosphatase staining was performed to observe the effect of liquiritin in inhibiting osteoclast differentiation. The affinity of liquiritin binding to proteins related to osteoclast differentiation was verified by network pharmacology. RT-PCR and western blot assays were performed to detect the inhibitory effects of liquiritin on osteoclast-specific protein and gene expression as well as relevant signaling pathways. Finally,the mitigating effect of liquiritin on bone loss was verified in the C57BL/6J mouse osteoporosis model.RESULTS AND CONCLUSION:Liquiritin,at concentrations of 20 μmol/L and below,could inhibit the formation and differentiation of osteoclasts. Concurrently,it exhibited a high affinity with osteoclast-specific proteins such as nuclear factor of activated T-cells 1,Cathepsin K,c-Fos,and matrix metalloproteinase 9,and reduced the relative expression levels of these genes and proteins. Liquiritin could also effectively lower the phosphorylation expression level of JNK in the MAPK signaling pathway at the 15th,30th,45th,and 60th minutes,and it could salvage the degradation of nuclear factor-κB inhibitor α in the nuclear factor-κB signaling pathway at the 60th minute. In vivo experiments demonstrated that liquiritin could mitigate bone loss caused by osteoclasts and improve parameters related to trabecular bone. To conclude,liquiritin possesses the capacity to inhibit osteoclast differentiation and alleviate bone loss,thereby exerting a protective role against osteoporosis.
5.Analysis of synovial fluid Asporin levels in patients with temporomandibular joint disorders
Lei ZHANG ; Haiwei BU ; Tianyu XU ; Mingxu ZHANG ; Ping NIU ; Feng HUO ; Rui LIU
STOMATOLOGY 2025;45(7):525-528
Objective To investigate the changes and clinical significance of synovial fluid Asporin level in patients with tem-poromandibular joint disorders(TMD).Methods A total of 48 TMD patients who were treated in our hospital from January 2021 to December 2023 due to irritant pain and mouth opening limitation were randomly selected as the observation group,and 48 healthy vol-unteers were selected as the control group.The synovial fluid Asporin levels of the two groups were detected by enzyme-linked immu-nosorbent assay(ELISA).The difference of synovial fluid Asporin levels between the two groups was compared.The correlation be-tween the synovial fluid Asporin levels and the clinical symptoms of TMD was analyzed.Results The synovial fluid Asporin level in the experimental group was significantly higher than that in the control group(P<0.05).The synovial fluid Asporin level was positively correlated with the pain degree of TMD patients(Rs=0.825,P<0.001),negatively correlated with the degree of mouth opening(Rs=-0.945,P<0.001).Conclusion The level of Asporin in synovial fluid of TMD patients was significantly increased.The level of As-porin in synovial fluid of TMD patients is correlated with the clinical symptoms of TMD,which provides a basis for the diagnosis and evaluation of TMD.
6.Influencing factors of liver injury in breast cancer patients after chemotherapy:a Meta-analysis
Haiwei ZHANG ; Kai ZHOU ; Dongliang YANG ; Haixia ZHAO
Chinese Journal of Pharmacoepidemiology 2025;34(1):47-56
Objective To systematically review the risk factors for liver injury in breast cancer patients after chemotherapy.Methods PubMed,Cochrane Library,Embase,Web of Science,CNKI,SinoMed,WanFang Data and VIP databases were electronically searched to collect studies on the influential factors of liver injury in breast cancer patients from inception to March 31,2024.Two reviewers independently screened the literature,extracted data and evaluated the risk of bias of the included studies.Meta-analysis was performed by using RevMan 5.3 software.Results A total of 15 studies involving 6,486 patients were included.The results of Meta-analysis showed that hepatitis B virus infection[OR=2.41,95%CI(1.52,3.82),P<0.001],lymph node metastasis[OR=1.27,95%CI(1.05,1.55),P=0.02],hyperlipidemia[OR=1.58,95%CI(1.13,2.20)P=0.007],liver metastasis[OR=3.19,95%CI(2.11,4.84),P<0.001],tumor node metastasis(TNM)stage Ⅲ to Ⅳ[OR=1.49,95%CI(1.17,1.90),P<0.001],were risk factors for liver injury after breast cancer chemotherapy.Compared with other chemotherapy agents/regimens,the use of fluorouracil[OR=0.58,95%CI(0.42,0.80),P<0.001],cyclophosphamide[OR=0.65,95%CI(0.47,0.89),P=0.008],AC regimen[OR=0.38,95%CI(0.22,0.66),P<0.00 1]and neoadjuvant chemotherapy[OR=0.61,95%CI(0.43,0.88),P=0.007]were associated with a lower risk of liver injury,the use of paclitaxel drugs[OR=2.85,95%CI(2.31,3.52),P<0.001],intensive regimen[OR=3.48,95%CI(2.15,5.62),P<0.001],TAC regimen[OR=2.42,95%CI(1.38,4.24),P=0.002]increased the risk of liver injury.Tumor TNM stage I[OR=0.63,95%CI(0.51,0.78),P=0.001]were protective factors for liver injury after chemotherapy in breast cancer patients.Conclusion The current evidence shows that multiple factors influence the incidence of liver injury after breast cancer chemotherapy.Medical staff can formulate targeted chemotherapy programs according to the influencing factors and clinical characteristics to reduce the risk of liver injury after chemotherapy.
7.Causes and management strategies of anesthetic complications during percutaneous spinal endoscopic surgery under local anesthesia
Baoshan XU ; Shuaishuai WEI ; Wenyi LI ; Qiang YANG ; Binggang GUAN ; Chao CHEN ; Haiwei XU ; Ning LI ; Lilong DU ; Tongxing ZHANG ; Jiawen GUAN ; Zhaomin ZHENG ; Yue ZHOU
Chinese Journal of Orthopaedics 2025;45(1):51-58
Objective:To investigate the causes and management strategies of anesthetic complications during percutaneous spinal endoscopic surgery under local anesthesia.Methods:A total of 16 800 patients (8 625 males and 8 175 females) who underwent percutaneous spinal endoscopic surgery under local anesthesia (including intravenous basic anesthesia) in Tianjin Hospital, Shandong Public Health Clinical Center and Hebei General Hospital from February 2012 to February 2023 were retrospectively analyzed. The average age was 45.3±21.6 years (range, 12-84 years). There were 220 cases of posterior cervical keyhole endoscopic surgery, 50 cases of thoracic transforaminal endoscopic surgery, 70 cases of thoracic posterior interlaminar endoscopic surgery, 11 670 cases of lumbar transforaminal endoscopic surgery, and 4 790 cases of lumbar posterior interlaminar endoscopic surgery. The occurrence time, clinical manifestations, management of intraoperative anesthesia complications were recorded, as well as surgical segments, puncture sites, complication symptoms, signs, outcome and prognosis.Results:All patients received percutaneous water-mediated uniaxial spinal endoscopic surgery under local anesthesia. There were 9 patients experienced anesthesia complications, including 6 cases of epidural diffusion of anesthetics and 3 cases of anesthetics mistakenly entering the subarachnoid space. There were 4 males and 5 females, aged 48.4±18.2 years (range, 28-84 years). There were 1 case of T 12L 1 disc herniation, 1 case of C 5-6 disc herniation, 3 cases of L 4-5 disc herniation and 4 cases of L 5S 1 disc herniation. Surgical segments and procedures: 1 case of C 5-6 posterior Keyhole endoscopic surgery, 1 case of T 12L 1 transforaminal endoscopic surgery, 2 cases of L 4-5 transforaminal endoscopic surgery, 1 case of L 4-5 interlaminar endoscopic surgery, and 4 cases of L 5S 1 interlaminar endoscopic surgery. Anesthesia complications all appeared 5-10 min after injection of local anesthetics, with symptoms of decreased oxygen saturation, decreased blood pressure, altered consciousness, and sensory and motor dysfunction of limbs. 6 patients with epidural diffusion of anesthetics recovered completely after symptomatic treatment in 5 cases, and 1 case was left with foot drop. Three patients with anesthetics mistakenly entering the subarachnoid space were immediately converted to the supine position, of which one recovered by mask oxygenation; 1 patient improved after emergency tracheal intubation, rehydration, and application of vasoconstrictive medications; and 1 patient developed multiple complications such as multiorgan failure, rhabdomyolysis, and sepsis after tracheal intubation, and recovered at 3 months after surgery with symptomatic treatment. Conclusions:Epidural diffusion and entering into subarachnoid space of anesthetics are serious complications of local anesthesia in percutaneous spinal endoscopic surgery. In addition to sensory and motor dysfunction of the limbs, the functions of the respiratory and circulatory systems can also be affected. It is necessary to be alert to the occurrence of anesthesia-related complications during operation and early identification and treatment.
8.Analysis of synovial fluid Asporin levels in patients with temporomandibular joint disorders
Lei ZHANG ; Haiwei BU ; Tianyu XU ; Mingxu ZHANG ; Ping NIU ; Feng HUO ; Rui LIU
STOMATOLOGY 2025;45(7):525-528
Objective To investigate the changes and clinical significance of synovial fluid Asporin level in patients with tem-poromandibular joint disorders(TMD).Methods A total of 48 TMD patients who were treated in our hospital from January 2021 to December 2023 due to irritant pain and mouth opening limitation were randomly selected as the observation group,and 48 healthy vol-unteers were selected as the control group.The synovial fluid Asporin levels of the two groups were detected by enzyme-linked immu-nosorbent assay(ELISA).The difference of synovial fluid Asporin levels between the two groups was compared.The correlation be-tween the synovial fluid Asporin levels and the clinical symptoms of TMD was analyzed.Results The synovial fluid Asporin level in the experimental group was significantly higher than that in the control group(P<0.05).The synovial fluid Asporin level was positively correlated with the pain degree of TMD patients(Rs=0.825,P<0.001),negatively correlated with the degree of mouth opening(Rs=-0.945,P<0.001).Conclusion The level of Asporin in synovial fluid of TMD patients was significantly increased.The level of As-porin in synovial fluid of TMD patients is correlated with the clinical symptoms of TMD,which provides a basis for the diagnosis and evaluation of TMD.
9.Comparison of SEC-RI-MALLS and SEC-RID methods for determining molecular weight and molecular weight distribution of PLGA
WANG Baocheng ; ZHANG Xiaoyan ; ZHOU Xiaohua ; ZHAO Xun ; MA Congyu ; GAO Zhengsong ; SHI Haiwei ; YUAN Yaozuo ; HANG Taijun
Drug Standards of China 2025;26(1):110-116
Objective: To establish a method for determining the molecular weight and molecular weight distribution of Poly(Lactide-co-Glycolide Acid) (PLGA) using Size Exclusion Chromatography-Refractive Index-Multiangle Laser Light Scattering (SEC-RI-MALLS) and Size Exclusion Chromatography-Refractive Index (SEC-RID), and to compare the results obtained from these two methods.
Methods: For SEC-RI-MALLS, tetrahydrofuran was used as the mobile phase, Shodex GPC KF-803L was employed as the chromatographic column with a flow rate of 1 mL·min-1, column temperature at 30 ℃, and an injection volume of 100 μL. For SEC-RID, tetrahydrofuran was also used as the mobile phase, Agilent PLgel 5 μm MIXD-D was used as the chromatographic column with a flow rate of 1 mL·min-1, column temperature at 30 ℃, differential detector temperature at 35 ℃, and an injection volume of 20 μL. The molecular weight and molecular weight distribution were calculated using Agilent’s GPC software. The newly established methods were validated methodologically, and the molecular weight and molecular weight distribution of 13 batches of samples were determined.
Results: The precision, accuracy, stability, and repeatability tests for SEC-RI-MALLS showed RSD values of 1.35%, 1.58%, 1.53%, and 1.26%, respectively. The SEC-RID method exhibited good linearity (r=0.999 9), with RSD values for precision, accuracy, stability, and repeatability tests (n=6) of 2.05%, 1.62%, 1.30%, and 2.97%, respectively. The results obtained from SEC-RI-MALLS were lower than those from SEC-RID, and the molecular weight distribution coefficient was smaller, but the results from the paired T-test performed with the value measured by SEC-RID method and the value measured by SEC-RI-MALLS method multiplied a conversion coefficient of 1.5 showed no significant difference between the two methods.
Conclusion: Both methods are stable and reliable, and can be used for the determination of PLGA molecular weight and molecular weight distribution based on the specific situations.
10.Liquiritin inhibits osteoclast differentiation and alleviates bone loss
Wensheng ZHANG ; Haiwei GUO ; Rui WENG ; Ling MO ; Zhenjie SONG ; Han TIAN ; Yelin ZHONG ; Yuancheng WANG ; Hanwu TANG ; Caijun LIU ; Chao YUAN ; Ying LI
Chinese Journal of Tissue Engineering Research 2025;29(12):2429-2437
BACKGROUND:Relatively or absolutely active bone resorption function of osteoclasts is one of the causative factors of osteoporosis. Therefore,how to inhibit the formation of osteoclasts and reduce the bone resorption activity is a key element in the prevention and treatment of osteoporosis. Liquiritin,which is derived from licorice,plays a role in the clinical treatment of bone diseases,but there are fewer studies addressing the application of liquiritin in osteoporosis and the mechanism is unknown.OBJECTIVE:To confirm,through both in vivo and in vitro experiments,that liquiritin inhibits osteoclast differentiation and alleviates bone loss.METHODS:Cell counting kit-8 was used to detect whether Liquiritin exerts toxic or proliferative effects on mouse bone marrow-derived macrophages,and tartrate-resistant acid phosphatase staining was performed to observe the effect of liquiritin in inhibiting osteoclast differentiation. The affinity of liquiritin binding to proteins related to osteoclast differentiation was verified by network pharmacology. RT-PCR and western blot assays were performed to detect the inhibitory effects of liquiritin on osteoclast-specific protein and gene expression as well as relevant signaling pathways. Finally,the mitigating effect of liquiritin on bone loss was verified in the C57BL/6J mouse osteoporosis model.RESULTS AND CONCLUSION:Liquiritin,at concentrations of 20 μmol/L and below,could inhibit the formation and differentiation of osteoclasts. Concurrently,it exhibited a high affinity with osteoclast-specific proteins such as nuclear factor of activated T-cells 1,Cathepsin K,c-Fos,and matrix metalloproteinase 9,and reduced the relative expression levels of these genes and proteins. Liquiritin could also effectively lower the phosphorylation expression level of JNK in the MAPK signaling pathway at the 15th,30th,45th,and 60th minutes,and it could salvage the degradation of nuclear factor-κB inhibitor α in the nuclear factor-κB signaling pathway at the 60th minute. In vivo experiments demonstrated that liquiritin could mitigate bone loss caused by osteoclasts and improve parameters related to trabecular bone. To conclude,liquiritin possesses the capacity to inhibit osteoclast differentiation and alleviate bone loss,thereby exerting a protective role against osteoporosis.

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