2.Chinese expert consensus on the Hazardous Drug List
Weihua DONG ; Zhanjun DONG ; Lulu SUN ; Yingbo ZHAO ; Zhuoyin XUE ; Min LIU ; Weiyi FENG
China Pharmacy 2026;37(12):1521-1527
OBJECTIVE To formulate the Hazardous Drug List in China, and provide a scientific basis for standardizing the management of hazardous drugs, preventing and controlling occupational exposure risks in medical institutions at all levels in China. METHODS Under the joint organization of the Intravenous Medication Admixture Management Professional Committee of the Chinese Pharmaceutical Association and the National Medical Quality Control Center for Pharmaceutical Management, based on literature research and international hazardous drug lists and their development procedures, the scope of hazardous drug selection, selection principles, and evidence confirmation criteria were determined through expert panel seminars and expert questionnaire survey method (Delphi method). Chemical drugs, biological agents, and Chinese patent medicines marketed in China that met the selecti on principles were screened to form the Chinese Expert Consensus on the Hazardous Drug List . RESULTS Five principles for selecting hazardous drugs were established (including protective labeling in package inserts, carcinogenicity, reproductive toxicity, genotoxicity, and organ toxicity at low doses), along with the corresponding evidence confirmation criteria. The Hazardous Drug List containing 210 drugs was formulated, covering anti-tumor drugs, endocrine system drugs, nervous system drugs, immunomodulators, anti-infective drugs, cardiovascular system drugs, hematological system drugs, urinary system drugs, obstetrics and gynecology drugs, dermatological drugs and other categories. Compared with international hazardous drug lists, 25 newly included hazardous drugs were added, including 15 anti-tumor drugs, 6 Chinese patent medicines and 4 biological agents. In addition, 88 Chinese patent medicines that may have potential occupational exposure risks are listed in the appendix for reference by medical institutions in management. CONCLUSIONS The development of this consensus closely aligns with the actual clinical drug use in China, with a scientific and rigorous methodology, and can serve as a reference for medical institutions at all levels to standardize the management of hazardous drugs and prevent and control occupational exposure risks.
3.Evaluation of the clinical effect of TESSYS technique in treating single-segment LSS based on CT imaging and traumatic stress indicators
Yingbo XIAO ; Tao CUI ; Keju LIU ; Haifang LI ; Qichao SU
China Medical Equipment 2025;22(1):41-46
Objective:To evaluate the clinical effect of transforaminal endoscopic spine system (TESSYS) technique in treating single-level lumbar spinal stenosis (LSS) based on computed tomography (CT) imaging and traumatic stress indicators. Methods:A total of 112 patients with single-level LSS admitted to The Third Hospital of Qinhuangdao from June 2019 to June 2021 were selected,and they were divided into observation group and control group by random number table method,with 56 cases in each group. The observation group was treated with TESSYS technique,and the control group was treated with "broad easy immediate surgery (BEIS)" technique of intervertebral foramen scope. The indicators of CT imaging of spinal canal area and protrusion ratio,as well as traumatic stress indicators included lactate dehydrogenase (LDH),myoglobin (MYO) and cortisol (COR),of two groups were compared before and 1 week after surgery. Oswestry Disability Index (ODI),Visual Analogue Scale (VAS) score and Japanese Orthopaedic Association (JOA) Scores were compared between the two groups. Excellent rates of treatment and postoperative complications of two groups were compared at the 6 th month after surgery. Results:The average hospital stay and operation time of observation group were respectively (4.29±1.08)d and (93.53±22.01)min,which were significantly shorter than (6.61±1.72)d and (112.29±26.68)min of control group,and the intraoperative blood loss of observation group was (30.15±8.26) ml,which was shorter than that (41.35±11.58) ml of control group,and the differences of them between two groups (t=8.548,4.059,5.892,P<0.05),respectively. At the 1st week after surgery,the ODI and VAS scores of observation group were lower than those of control group,and the JOA score was higher than that of control group,and the differences of them between two groups were significant (t=9.443,t=8.969,6.084,P<0.05),respectively. At the 3rd month after surgery,the ODI and VAS scores of observation group were respectively lower than those of control group,and JOA score of observation group was higher than that of control group,and the differences of them were significant (t=9.706,3.753,5.894,P<0.05),respectively. The rate of excellent and good treatment of observation group was 94.64%,which was higher than that (80.36%) of control group,and the differences of them between the two groups were statistically significant (t=5.225,P<0.05). At the 1st week after surgery,the vertebral canal area of observation group was larger than that of control group,and the ratio of protrusion invasion was less than that of control group,and the differences of them between the two groups were statistically significant (t=3.404,5.578,P<0.05),respectively. At the 1st d after surgery,the serum LDH,MYO and COR levels of observation group were lower than those of control group,and the differences of them between two groups were statistically significant (t=7.570,9.687,5.242,P<0.05),respectively. At the 3rd d after surgery,the serum LDH,MYO and COR levels of observation group were respectively than those of control group,and the differences of them between two groups were significant (t=6.856,9.729,2.744,P<0.05). There was no significant difference in complication rate between the two groups (P>0.05). Conclusion:Compared with BEIS technique,TESSYS technique has the advantages of less trauma,faster postoperative recovery and higher excellent and good rate in treating single-segment LSS,which can alleviate stress reaction of early postoperative trauma. Its comprehensively clinical efficacy is ideal.
4.Correlation between ScvO2,Lac,SaO2 and mechanical ventilation time in infants with congenital heart disease
Fuyan LIU ; Xiang ZHANG ; Fangfang LI ; Chengcheng LI ; Yingbo ZOU ; Bo HUANG
The Journal of Practical Medicine 2025;41(17):2715-2720
Objective To explore the correlation between central venous oxygen saturation(ScvO2),blood lactate(Lac),arterial oxygen saturation(SaO2)and mechanical ventilation time in infants with congenital heart disease(CHD).Methods Eighty-four CHD children treated in the First People's Hospital of Zunyi were enrolled between January 2020 and December 2024.According to postoperative mechanical ventilation time,they were divided into prolongation group(28 cases,mechanical ventilation time≥72 h)and non-prolongation group(56 cases,mechanical ventilation time<72 h).The clinical data,score of risk adjustment for congenital heart surgery(RACHS-1),levels of ScvO2,and Lac and SaO2 in the two groups were compared.The risk factors of postoperative mechanical ventilation time were analyzed by multivariate logistic regression analysis,and predictive value of ScvO2,Lac and SaO2 for prolonged mechanical ventilation time was analyzed by ROC curves.The clinical outcomes in the two groups were recorded.Results There were significant differences in age,preoperative pneumonia,RACHS-1 grading,and levels of ScvO2,Lac and SaO2 among children with different mechanical ventilation time(P<0.05).Multivariate logistic regression analysis showed that ScvO2,Lac and SaO2 were independent influencing factors of postoperative mechanical ventilation time(P<0.05).ROC curves analysis showed that area under the curve(AUC)values of ScvO2,Lac,SaO2 and combined detection for predicting prolonged postoperative mechanical ventilation were 0.846,0.863,0.839 and 0.917,and the best cut-off values were 67.64%,1.51mmol/L and 96.06%,respec-tively(P<0.05).The failure rate of weaning in the prolongation group was higher,and stay time in PICU and actual length of hospital stay were longer than those in non-prolongation group(P<0.05).Conclusion The levels of ScvO2,Lac and SaO2 are related to mechanical ventilation time in CHD infants.They are all independent risk factors affecting prolonged mechanical ventilation and can be applied as auxiliary detection indexes to predict the prolonga-tion of mechanical ventilation in clinical practice.
5.Correlation between ScvO2,Lac,SaO2 and mechanical ventilation time in infants with congenital heart disease
Fuyan LIU ; Xiang ZHANG ; Fangfang LI ; Chengcheng LI ; Yingbo ZOU ; Bo HUANG
The Journal of Practical Medicine 2025;41(17):2715-2720
Objective To explore the correlation between central venous oxygen saturation(ScvO2),blood lactate(Lac),arterial oxygen saturation(SaO2)and mechanical ventilation time in infants with congenital heart disease(CHD).Methods Eighty-four CHD children treated in the First People's Hospital of Zunyi were enrolled between January 2020 and December 2024.According to postoperative mechanical ventilation time,they were divided into prolongation group(28 cases,mechanical ventilation time≥72 h)and non-prolongation group(56 cases,mechanical ventilation time<72 h).The clinical data,score of risk adjustment for congenital heart surgery(RACHS-1),levels of ScvO2,and Lac and SaO2 in the two groups were compared.The risk factors of postoperative mechanical ventilation time were analyzed by multivariate logistic regression analysis,and predictive value of ScvO2,Lac and SaO2 for prolonged mechanical ventilation time was analyzed by ROC curves.The clinical outcomes in the two groups were recorded.Results There were significant differences in age,preoperative pneumonia,RACHS-1 grading,and levels of ScvO2,Lac and SaO2 among children with different mechanical ventilation time(P<0.05).Multivariate logistic regression analysis showed that ScvO2,Lac and SaO2 were independent influencing factors of postoperative mechanical ventilation time(P<0.05).ROC curves analysis showed that area under the curve(AUC)values of ScvO2,Lac,SaO2 and combined detection for predicting prolonged postoperative mechanical ventilation were 0.846,0.863,0.839 and 0.917,and the best cut-off values were 67.64%,1.51mmol/L and 96.06%,respec-tively(P<0.05).The failure rate of weaning in the prolongation group was higher,and stay time in PICU and actual length of hospital stay were longer than those in non-prolongation group(P<0.05).Conclusion The levels of ScvO2,Lac and SaO2 are related to mechanical ventilation time in CHD infants.They are all independent risk factors affecting prolonged mechanical ventilation and can be applied as auxiliary detection indexes to predict the prolonga-tion of mechanical ventilation in clinical practice.
6.Evaluation of the clinical effect of TESSYS technique in treating single-segment LSS based on CT imaging and traumatic stress indicators
Yingbo XIAO ; Tao CUI ; Keju LIU ; Haifang LI ; Qichao SU
China Medical Equipment 2025;22(1):41-46
Objective:To evaluate the clinical effect of transforaminal endoscopic spine system (TESSYS) technique in treating single-level lumbar spinal stenosis (LSS) based on computed tomography (CT) imaging and traumatic stress indicators. Methods:A total of 112 patients with single-level LSS admitted to The Third Hospital of Qinhuangdao from June 2019 to June 2021 were selected,and they were divided into observation group and control group by random number table method,with 56 cases in each group. The observation group was treated with TESSYS technique,and the control group was treated with "broad easy immediate surgery (BEIS)" technique of intervertebral foramen scope. The indicators of CT imaging of spinal canal area and protrusion ratio,as well as traumatic stress indicators included lactate dehydrogenase (LDH),myoglobin (MYO) and cortisol (COR),of two groups were compared before and 1 week after surgery. Oswestry Disability Index (ODI),Visual Analogue Scale (VAS) score and Japanese Orthopaedic Association (JOA) Scores were compared between the two groups. Excellent rates of treatment and postoperative complications of two groups were compared at the 6 th month after surgery. Results:The average hospital stay and operation time of observation group were respectively (4.29±1.08)d and (93.53±22.01)min,which were significantly shorter than (6.61±1.72)d and (112.29±26.68)min of control group,and the intraoperative blood loss of observation group was (30.15±8.26) ml,which was shorter than that (41.35±11.58) ml of control group,and the differences of them between two groups (t=8.548,4.059,5.892,P<0.05),respectively. At the 1st week after surgery,the ODI and VAS scores of observation group were lower than those of control group,and the JOA score was higher than that of control group,and the differences of them between two groups were significant (t=9.443,t=8.969,6.084,P<0.05),respectively. At the 3rd month after surgery,the ODI and VAS scores of observation group were respectively lower than those of control group,and JOA score of observation group was higher than that of control group,and the differences of them were significant (t=9.706,3.753,5.894,P<0.05),respectively. The rate of excellent and good treatment of observation group was 94.64%,which was higher than that (80.36%) of control group,and the differences of them between the two groups were statistically significant (t=5.225,P<0.05). At the 1st week after surgery,the vertebral canal area of observation group was larger than that of control group,and the ratio of protrusion invasion was less than that of control group,and the differences of them between the two groups were statistically significant (t=3.404,5.578,P<0.05),respectively. At the 1st d after surgery,the serum LDH,MYO and COR levels of observation group were lower than those of control group,and the differences of them between two groups were statistically significant (t=7.570,9.687,5.242,P<0.05),respectively. At the 3rd d after surgery,the serum LDH,MYO and COR levels of observation group were respectively than those of control group,and the differences of them between two groups were significant (t=6.856,9.729,2.744,P<0.05). There was no significant difference in complication rate between the two groups (P>0.05). Conclusion:Compared with BEIS technique,TESSYS technique has the advantages of less trauma,faster postoperative recovery and higher excellent and good rate in treating single-segment LSS,which can alleviate stress reaction of early postoperative trauma. Its comprehensively clinical efficacy is ideal.
7.Efficacy of transarterial chemoembolization combined with targeted therapy and immunotherapy in treating advanced hepatocellular carcinoma
Jun YANG ; Luyang LI ; Haoming LI ; Tian XIA ; Tao ZHANG ; Meng PU ; Yingbo MA ; Shuhan ZHANG ; Chengli LIU
Journal of Interventional Radiology 2025;34(4):398-402
Objective To discuss the efficacy of transcatheter arterial chemoembolization(TACE)in combination with targeted therapy and immune checkpoint inhibitors for advanced hepatocellular carcinoma(HCC),and to identify the influencing factors.Methods A total of 60 patients with advanced HCC,who were admitted to the Air Force Medical Center of China from January 2016 to December 2022,were enrolled in this study.Thirty patients received TACE combined with targeted therapy and immune checkpoint inhibitors(TACE-L-P group),and the other 30 patients received TACE combined with targeted therapy(TACE-L group).The progression-free survival(PFS),overall survival(OS),disease control rate(DCR),and objective response rate(ORR)were compared between the two groups.Results In the TACE-L group and TACE-L-P group,the median PFS(mPFS)was 7 months and 10 months respectively(P=0.011),the median OS(mOS)was 15.5 months and 29 months respectively(P=0.014).Child-Pugh class B(HR=3.89,95%CI:1.27-11.94,P=0.018)and Barcelona Clinic Liver Cancer(BCLC)stage C(HR=2.83,95%CI:1.32-6.03,P=0.007)were the independent risk factors for OS,while micro wave ablation(HR=0.21,95%CI:0.07-0.63,P=0.005)and TACE-L-P(HR=0.09,95%CI:0.03-0.3,P=0.001)were the independent protection factors for OS.Besides,elevated bilirubin level(HR=1.03,95%CI:1-1.06,P=0.032)and elevated gamma-glutamyl transferase(GGT)level(HR=1.01,95%CI:1-1.01,P=0.002)were the independent risk factors for disease progression,and TACE-L-P(HR=0.27,95%CI:0.09-0.79,P=0.017)was the independent protection factor for disease progression.The ORR and DCR in TACE-L-P group were remarkably higher than those in TACE-L group,which were 43.4%vs 13.3%and 63.4%vs 23.3%respectively,the differences between the two groups were statistically significant(both P<0.05).Conclusion In treating advanced HCC,TACE combined with targeted therapy and immune checkpoint inhibitors is superior to TACE combined with targeted therapy in therapeutic efficacy.
8.Study on the molecular mechanism of miR-886-5p targeting BAX to inhibit proliferation, migration and invasion of liver cancer cells
Shaopeng LIU ; Haichao LIU ; Hongxian YAN ; Minghui BAI ; Jixiang ZHANG ; Yingbo LI ; Chuang WANG ; Xiang ZOU
Chinese Journal of Hepatobiliary Surgery 2025;31(8):621-627
Objective:To investigate the molecular mechanism of miR-886-5p targeting BCL-2-associated X protein (BAX) to inhibit the proliferation, migration, and invasion of liver cancer cells.Methods:mRNA expression data of HCC patients were obtained from the Starbase database, including 370 liver cancer samples and 50 normal liver tissue samples adjacent to the cancer. Analyze the expression of miR-886-5p in the previously obtained data and investigate the relationship between miR-886-5p and BAX in liver cancer samples. After transfection of the corresponding plasmids into Huh7 and HepG2 cells, the following groups were established. Analyze the interaction between miR-886-5p and BAX in vitro, detect the protein expression by Western blotting, and verify the targeting relationship between the two by dual luciferase reporter gene assay.Results:Starbase database analysis found that the standardized expression level of miR-886-5p in 370 liver cancer samples was lower than that in normal liver tissue samples (0.12±0.07 vs. 0.73±0.27, t=-15.71, P<0.001), and the expression level of miR-886-5p was positively correlated with the expression level of BAX ( r=0.152, P=0.003). qRT-PCR analysis showed that the expression level of miR-886-5p in HL-7702 cells was higher than that in Huh7 (4.57±0.06 vs. 1.61±0.40, t=32.48) and HepG2 (4.57±0.06 vs. 1.03±0.13, t=143.9), and the expression level of BAX in HL-7702 cells was higher than that in Huh7 (4.01±0.12 vs. 1.28±0.09, t=82.20) and HepG2 (4.01±0.12 vs. 1.30±0.11, t=80.76), the differences were statistically significant (all P<0.001). The proliferation, migration, and invasion abilities of Huh7 and HepG2 cells decreased after transfection with miR-886-5p mimics, while the expression levels of BAX at the mRNA and protein levels increased. However, after inhibiting the expression of miR-886-5p, the above indicators of cells were the opposite, and the dif-ferences were statistically significant (all P<0.05). The viability, EdU positivity rate, cell migration rate, and number of transmembrane cells in the miR-886-5p+ BAX group were lower than those in the BAX group, and the relative expression levels of miR-886-5p, BAX mRNA, and BAX protein were higher than those in the BAX group. However, the above indicators in the Sponge+ BAX group showed opposite trends, and all differences were statistically significant (all P<0.05). There was a targeted binding site between miR-886-5p and BAX. Conclusion:Both miR-886-5p and BAX are downregulated in liver cancer, and miR-886-5p inhibits the proliferation, migration, and invasion of liver cancer cells by targeting BAX.
9.Clinical investigation of minimally invasive double anchoring combined with percutaneous vertebral augmentation in the treatment of Kümmell disease
Qing FENG ; Jun MIAO ; Shenglin CAO ; Zepei ZHANG ; Yingbo LIU ; Wang REN ; Hongwei FENG ; Bin DONG ; Chao LI ; Ning JI ; Bingyao ZHANG ; Lijun AN
Chinese Journal of Orthopaedics 2025;45(7):412-419
Objective:To investigate the clinical efficacy of minimally invasive double anchoring combined with percutaneous kyphoplasty (PKP) for Kümmell disease.Methods:The clinical data of 24 patients with Kümmell disease who were treated with minimally invasive double anchoring combined with PKP in Cangzhou People's Hospital from October 2022 to March 2024 were retrospectively analyzed. Among them, there were 2 T 10 vertebrae, 5 T 11 vertebrae, 7 T 12 vertebrae, 6 L 1 vertebrae, and 4 L 2 vertebrae. There were 6 males and 18 females. The average age was 72.05±4.52 years (range, 66-80 years). The bone mineral density T value was -3.41±0.77 (range, -2.5-4.5). The stages of Li's Kümmell disease included 13 cases of stage II and 11 cases of stage III. The operation time, intraoperative blood loss, and volume of bone cement injected were recorded. The vertebral index, vertebral angle and Cobb angle of diseased segment were measured before and after operation. The visual analogue scale (VAS) was used to assess the degree of pain, the Oswestry disability index (ODI) and the Japanese Orthopaedic Association (JOA) low back pain scale were used to assess spinal function. The Medical Outcome Study short form 36 item health survey (SF-36) was used to assess the general health status of the patients. The postoperative symptom recovery was evaluated by Odom criteria. Results:The mean operative time of the 24 patients was 35.32±6.86 min, the injected volume of bone cement was 4.39±1.72 ml, and the intraoperative blood loss was 16.56±5.21 ml. All patients were followed up for 10 to 14 months, with an average of 11.7 months. Postoperative CT examination showed that the screw positions were satisfactory, and no loosening or displacement of bone cement mass occurred. On the first day after surgery, the vertebral body index, vertebral body angle and Cobb angle of diseased segment were 77.71%±2.75%, 12.40°±1.53° and 25.77°±4.49°, respectively, which represented significant improvements from the preoperative values of 43.09%±5.66%, 22.12°±2.92° and 46.98°±5.68° before surgery ( P<0.05). At the last follow-up, the values were 76.18%±2.32%, 12.41°±2.53°, 26.14°±4.87°, respectively, which were significantly improved compared with those before surgery ( P<0.05), but there was no statistical significance compared with the first day after surgery ( P>0.05). The VAS, ODI and JOA scores on the first day after surgery were 2.11±0.87 points, 22.46±5.49 points and 27.68±2.45 points, respectively, which were significantly improved compared with those before surgery 7.50±0.98 points, 76.25±8.56 points and 14.96±4.91 points ( P<0.05). At the last follow-up, the values were 2.26±0.88, 23.87±3.25 and 26.58±2.77, respectively, which were significantly improved compared with those before surgery ( P<0.05), and there was no statistical significance compared with the first day after surgery ( P>0.05). All 24 patients completed SF-36 scale assessment, and the results showed that there were statistically significant differences in physiological function, physiological role, physical pain, general health status, social function scores and mental health between the patients before surgery and the last follow-up ( P<0.05), while there were no statistically significant differences in vitality and emotional function ( P>0.05). At the last follow-up, the Odom criteria showed excellent results in 18 cases, good in 4 cases, and fair in 2 cases. Conclusions:The application of minimally invasive double anchoring (single nail fixation) combined with PKP in the treatment of Kümmell disease can effectively prevent the loosening and displacement of bone cement masses, and the fixation effect is satisfactory, which can restore the height of the injured vertebrum, reduce kyphosis and improve spinal function. The clinical symptoms of the patients were significantly improved, and the quality of life was enhanced.
10.Analysis of OFD1 gene variant in a child with Oral-facial-digital syndrome.
Liya ZHANG ; Yu LIU ; Lulu YAN ; Xiamin JIN ; Lijiao ZHU ; Ting YANG ; Lili CHEN ; Yingbo CUI
Chinese Journal of Medical Genetics 2025;42(6):707-712
OBJECTIVE:
To explore the clinical characteristics and genetic etiology of a child with Oral-facial-digital syndrome type Ⅰ(OFDSⅠ).
METHODS:
A child with OFDSⅠ who received treatment at the Women and Children's Hospital Affiliated to Ningbo University in March 2023 was selected as the study subject. A retrospective research method was used to collect the clinical data of the child. Peripheral venous blood samples were collected from the child, her parents and sister. Genomic DNA was extracted, and whole exome sequencing (WES) was performed. Candidate variants were validated using Sanger sequencing for familial verification. According to the Standards and Guidelines for the Interpretation of Sequence Variants developed by the American College of Medical Genetics and Genomics (ACMG) (hereinafter referred to as the "ACMG Guidelines"), the pathogenicity of the candidate variant was rated. This study was approved by the Medical Ethics Committee of Ningbo University Affiliated Women and Children's Hospital (Ethic No.: EC 2024-063).
RESULTS:
The child was a prematurely born female with deformities of the oral cavity, fingers, and toes. She was admitted to the Neonatal Department of the Hospital where she was born due to shortness of breath 15 minutes after birth. The WES results indicated that the child has harbored a heterozygous c.710dup (p.Y238Vfs*2) frameshifting variant of the OFD1 gene. Sanger sequencing confirmed that neither of the child's parents nor her sister had carried the same variant. According to the ACMG guidelines, the variant was rated as pathogenic (PVS1+PS4_Moderate+PM2-Supporting+PM6_Supporting+PP4).
CONCLUSION
Children with OFDSⅠ have clinical features such as oral, finger, and toe deformities. The c.710dup (p.Y238Vfs*2) variant of the OFD1 gene probably underlay the OFDSⅠ in this child. Above result has enriched the mutational spectrum of the OFD1 gene.
Humans
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Female
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Orofaciodigital Syndromes/genetics*
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Exome Sequencing
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Retrospective Studies
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Mutation
;
Child
;
Proteins

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