1.Construction of drug utilization evaluation criteria for Dezocine injection based on evidence-based methodology and Delphi method
Yuanyuan GUO ; Chao WANG ; Yinpeng QIN ; Yi ZHANG ; Yishan BU
China Pharmacy 2025;36(15):1841-1845
OBJECTIVE To construct the drug utilization evaluation criteria for Dezocine injection, so as to provide reference for the rational drug use in medical institutions. METHODS On the basis of evidence methodology, relevant guidelines/expert consensus, systematic reviews/meta-analysis were consulted; the evaluation criteria framework for Dezocine injection was established after screening evidence. Delphi method was employed, whereby 28 clinicians and clinical pharmacists from secondary and above-level medical institutions across eight provinces, including Tianjin, Beijing and Shandong, were selected to participate in two rounds of questionnaire surveys. The final indicators were determined based on the experts’ enthusiasm coefficient, authority coefficient, and degree of coordination. RESULTS The effective recovery rate of questionnaire was 100% in the first round and 92.86% in the second round; expert authority coefficient was 0.82 in the first round and 0.81 in the second round; the coordination degree of experts in the first round was 0.29, and in the second round was 0.31 (P<0.001). Drug utilization evaluation standard system for Dezocine injection was formed finally, including three dimensions of medication indications, medication process and medication results, with a total of 11 first-level indicators (such as indications, usage and dosage) and 33 second-level indicators (such as labor analgesia and the management of severe pain following major or moderate surgeries combined with other analgesic drugs). The average importance scores for each indicator ranged from 4.08 to 5.00 points, with an overall average score of 4.61 points and coefficient of variation ranging from 0 to 0.19. CONCLUSIONS The drug utilization evaluation criteria for Dezocine injection established based on evidence-based methodology and Delphi method is authoritative and scientific, which provides a reference for subsequent evaluation of the rationality of clinical medication.
2.Clinical trial of propofol and remazolam in patients of painless fiberoptic bronchoscopic biopsy
Zhi-Hua HUANG ; Yan-Fang WANG ; Chao-Sheng QIN ; Yi-Hong JIANG
The Chinese Journal of Clinical Pharmacology 2024;40(12):1699-1703
Objective To observe clinical outcomes of propofol and remazolam in patients undergoing elective painless fiberoptic bronchoscopic biopsy.Methods Patients who underwent painless fibreoptic bronchoscopic biopsy in our hospital from March 2022 to April 2023 were selected for the study and divided into 2 groups using simple randomisation method.In the control group,anaesthesia was induced with 1 mg·kg-1 propofol,3 μg·kg-1 fentanyl,0.1 mg·kg-1 cis-atracurium,and anaesthesia was maintained with 4-6 mg·kg-1·h-1 propofol.In the treatment group,anaesthesia was induced with 0.2 mg·kg-1 remazolam,3 μg·kg-1 fentanyl,0.1 mg·kg-1 cis-atracurium,and anaesthesia was maintained with 0.2-0.4 mg·kg-1·h-1 remazolam.We compared the awakening time,laryngeal mask removal time,microscopy time,and the proportion of additional anaesthetics in the 2 groups,and detected the levels of S100β,neuron-specific enolase(NSE),interleukin-6(IL-6),tumour necrosis factor-alpha(TNF-α)in the 2 groups preoperatively and at 24 h postoperatively,and statistically counted the occurrences of adverse reactions in the 2 groups.Results The time for pulling out the laryngeal mask in the treatment group was significantly lower than that in the control group,while the time for microscopy,time for awakening,and proportion of additional anaesthesia drugs were not statistically significant when compared with that in the control group(all P>0.05).The overall anaesthesia effect grading of the test group was not statistically significant when compared with the control group(P>0.05).S100β were(0.66±0.17)and(0.78±0.21)μg·L-1;NSE were(8.47±1.78)and(11.47±2.06)μg·L-1;IL-6 were(8.64±1.21)and(12.89±1.47)pg·mL-1;TNF-α were(6.27±1.07)and(9.13±1.41)pg·mL-1,respectively,which were higher than that of preoperative period,and the treatment group was lower than that of the control group at 24 h postoperatively,and the difference was statistically significant(all P<0.05).The incidence of adverse drug reactions in the treatment group and the control group were 13.75%and 22.50%,respectively,and the difference was not statistically significant(P>0.05).Conclusion The use of remazolam in painless fiberoptic bronchoscopic biopsy is less neurologically damaging,stabilizes hemodynamics.
3.Clinical and molecular biological characterization of patients with accelerated chronic lymphocytic leukemia.
Zi Yuan ZHOU ; Luo Meng Jia DAI ; Ye Qin SHA ; Tong Lu QIU ; Shu Chao QIN ; Yi MIAO ; Yi XIA ; Wei WU ; Han Ning TANG ; Wei XU ; Jian Yong LI ; Hua Yuan ZHU
Chinese Journal of Hematology 2023;44(11):917-923
Objective: To investigate the clinical and molecular biological characteristics of patients with accelerated chronic lymphocytic leukemia (aCLL) . Methods: From January 2020 to October 2022, the data of 13 patients diagnosed with aCLL at The First Affiliated Hospital of Nanjing Medical University were retrospectively analyzed to explore the clinical and molecular biological characteristics of aCLL. Results: The median age of the patients was 54 (35-72) years. Prior to aCLL, five patients received no treatment for CLL/small lymphocytic lymphoma (SLL), while the other patients received treatment, predominantly with BTK inhibitors. The patients were diagnosed with aCLL through pathological confirmation upon disease progression. Six patients exhibited bulky disease (lesions with a maximum diameter ≥5 cm). Positron emission tomography (PET) -computed tomography (CT) images revealed metabolic heterogeneity, both between and within lesions, and the median maximum standardized uptake value (SUVmax) of the lesion with the most elevated metabolic activity was 6.96 (2.51-11.90). Patients with unmutated IGHV CLL accounted for 76.9% (10/13), and the most frequent genetic and molecular aberrations included +12 [3/7 (42.9% ) ], ATM mutation [6/12 (50% ) ], and NOTCH1 mutation [6/12 (50% ) ]. Twelve patients received subsequent treatment. The overall response rate was 91.7%, and the complete response rate was 58.3%. Five patients experienced disease progression, among which two patients developed Richter transformation. Patients with aCLL with KRAS mutation had worse progression-free survival (7.0 month vs 26.3 months, P=0.015) . Conclusion: Patients with aCLL exhibited a clinically aggressive course, often accompanied by unfavorable prognostic factors, including unmutated IGHV, +12, ATM mutation, and NOTCH1 mutation. Patients with CLL/SLL with clinical suspicion of disease progression, especially those with bulky disease and PET-CT SUVmax ≥5, should undergo biopsy at the site of highest metabolic uptake to establish a definitive pathological diagnosis.
Humans
;
Middle Aged
;
Aged
;
Leukemia, Lymphocytic, Chronic, B-Cell/genetics*
;
Positron Emission Tomography Computed Tomography
;
Retrospective Studies
;
Biopsy
;
Disease Progression
4.A new cinnamic acid ester derivative from Liquidambaris Resina.
Shao-Ying XU ; Qin-Wen XIAO ; Su-Min ZHAO ; Yi-Jian GUAN ; Liao-Heng YUAN ; Yao ZHU ; Chao-Jie WANG ; Peng-Cheng YAN ; Jian-Yong DONG
China Journal of Chinese Materia Medica 2023;48(15):4130-4136
Twelve compounds were isolated from Liquidambaris Resina by silica gel column chromatography and thin layer chromatography. Their structures were identified on the basis of spectral data, electron capture detector data, and physicochemical properties as(2'R, 3'R)-2',3'-dihydroxy-hydrocinnamyl-(E)-cinnamate(1),(E)-cinnamyl-(E)-cinnamate(2), cinnamic acid(3), 28-norlup-20(29)-en-3-one-17β-hydroperoxide(4), erythrodiol(5), 13β,28-epoxy-30-hydroxyolean-1-en-3-one(6),(3β)-olean-12-ene-3,23-diol(7), 2α,3α-dihydroxy-olean-12-en-28-oic acid(8), 28-hydroxyolean-12-en-3-one(9), 3-epi-oleanolic acid(10), 3-oxo-oleanolic acid(11), and hederagenin(12). Compound 1 was a new cinnamic acid ester derivative and compounds 2-4,6-8, and 12 were isolated from Liquidambaris Resina for the first time. Compounds 4, 5, 10, and 12 exerted inhibitory effects on the proliferation of human umbilical vein endothelial cells(HUVEC) with the IC_(50) values of(17.43±2.17),(35.32±0.61),(27.50±0.80), and(46.30±0.30) μmol·L~(-1), respectively.
Humans
;
Oleanolic Acid
;
Endothelial Cells
;
Esters
;
Cinnamates
;
Triterpenes/chemistry*
;
Molecular Structure
5.Clinical Efficacy of Niaoxue No.1 Prescription in Treatment of Henoch-Schönlein Purpura Nephritis with Blood Heat and Stasis Syndrome in Children
Shan ZHENG ; Zhongyu WEN ; Yun QIN ; Yi LIU ; Chao YUAN ; Jiaxi LI ; Lei LUO ; Yuying ZHANG ; Ke CHANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(18):87-94
ObjectiveTo investigate the clinical efficacy of Niaoxue No.1 Prescription in treating Henoch-Schönlein purpura (HSP) nephritis with blood heat and stasis syndrome and its effect on urine erythrocyte, urine protein, blood neutrophils, and blood routine-derived indicators. MethodA multicenter, randomized controlled trial (RCT) was conducted involving 108 HSP nephritis patients from three hospitals. The patients were randomly divided into a control group (54 cases) and a treatment group (54 cases). The treatment group received Niaoxue No.1 prescription once daily, while the control group was treated with captopril and ferulic acid tablets. Both groups underwent a 4-week course of treatment. The urine erythrocyte, urine microalbumin (mAlb), urine sediment red blood cell count, traditional Chinese medicine (TCM) syndrome score, 24-hour urine protein, blood neutrophil count, neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), lymphocyte to monocyte ratio (LMR), D-dimer, and immunoglobulin A were detected. The recurrence rate of HSP nephritis was followed up for 6 months. ResultThe total effective rates were 88.9% (48/54) in the treatment group and 70.4% (38/54) in the control group, and the treatment group was superior to the control group (χ2=5.708, P<0.05). Compared with the results before treatment, after 14 days of treatment, the TCM syndrome total score, urine erythrocyte, urine mAlb, and 24-hour urine protein in both groups significantly decreased (P<0.05,P<0.01), and the improvement was more significant in the treatment group than the control group (P<0.05). After 28 days of treatment, compared with the results before treatment, the TCM syndrome total score, urine erythrocyte, urine mAlb, urine sediment red blood cell count, D-dimer, and 24-hour urine protein in both groups significantly decreased (P<0.05,P<0.01), with the treatment group showing a more significant reduction in urine mAlb than the control group (P<0.05). On the 14th and 28th days of treatment, the neutrophil percentage and NLR were lower in the treatment group than in the control group (P<0.05), while there was no statistically significant difference in PLR and LMR. The recurrence rate of nephritis in both groups showed no statistically significant difference after a 6-month follow-up. ConclusionNiaoxue No.1 Prescription in the treatment of HSP nephritis with blood heat and stasis syndrome can significantly improve clinical symptoms, shorten the course of the disease, and reduce urine erythrocyte, urine mAlb, 24-hour urine protein, blood neutrophils, and NLR, thereby effectively alleviating the inflammatory state and reducing kidney damage in children with HSP nephritis.
6.Efficacy and safety of BTK inhibitor combined with bendamustine and rituximab in the first-line treatment of chronic lymphocytic leukemia/small lymphocytic lymphoma.
Shu Chao QIN ; Rui JIANG ; Ye Qin SHA ; Jing Yan QIU ; Hong Ling MI ; Yi MIAO ; Wei WU ; Li WANG ; Lei FAN ; Wei XU ; Jian Yong LI ; Hua Yuan ZHU
Chinese Journal of Hematology 2023;44(2):158-161
7.Relationship between the gross motor function classification system and hip and lumbar spine development in children with spastic cerebral palsy.
Gang LIU ; Li LIU ; Lin XU ; Chao MA ; Bo-Wen DENG ; Sheng-Yuan JIANG ; Rui-Qin YU ; Yi ZHAO ; Xiao-Hong MU
China Journal of Orthopaedics and Traumatology 2023;36(1):79-85
OBJECTIVE:
To investigate the relationship among the gross motor function classification system (GMFCS)and the development of hip joint and lumbar spine in children with spastic cerebral palsy.
METHODS:
The clinical data of 125 children with spastic cerebral palsy admitted from January 2018 to July 2021 were retrospectively analyzed. There were 85 males and 40 females, aged from 4 to 12 years old with an average of (8.4±2.9) years. According to GMFCS, the patients were divided into gradeⅠ, Ⅱ, Ⅲ and Ⅳ groups. There were 27 cases in gradeⅠgroup, 40 cases in gradeⅡgroup, 35 cases in grade Ⅲ group and 23 cases in grade Ⅳ group. The migration percentage(MP), central edge angle(CE), neck-shaft angle(NSA), acetabular index(AI) were measured by the radiograph of pelvis, abnormal parameters were selected to evaluate the relationship between different GMFCS grades and hip joint development. Lumbar sagittal Cobb angle, lumbar sacral angle, lumbar lordosis index and apical distance were measured by lateral lumbar radiographs to evaluate the relationship between different GMFCS grades and lumbar spine development.
RESULTS:
①Among the 125 spastic cerebral palsy children, there were 119 cases of pelvic radiographs that met the measurement standards. In the four groups with gradeⅠ, Ⅱ, Ⅲ, Ⅳ, MP was (22.72±3.88), (26.53±4.36), (33.84±4.99), and (49.54±7.87)%, CE was(30.10±6.99) °, ( 22.92±4.19) °, ( 17.91±5.50) °, and (-0.70±17.33)°, AI was (16.41±2.77) °, (20.46±4.63) °, (23.76±5.10) °, and ( 29.15±7.35)°, respectively, there were significant differences between the two comparisons (P<0.05). And the higher GMFCS grade, the greater MP and AI, and the smaller CE.The NSA was(142.74±10.03) °, (148.66±9.09) °, (151.66±10.52) °, and (153.70±8.05)° in four groups with gradeⅠ, Ⅱ, Ⅲ, Ⅳ, respectively. The differences between the two comparisons of the GMFCS gradeⅠgroup and the other three groups were statistically significant (P<0.05). NSA of GMFCSⅠgroup was significantly lower than that of the others, there was no significant difference among other groups(P>0.05). ② Among the 125 spastic cerebral palsy children, there were 88 cases of lumbar spine radiographs that met the measurement standards. ③The lumbar sagittal Cobb angle was(32.62±11.10) °, (29.86±9.90) °, (31.70±11.84) °, and (39.69±6.80)° in the four groups with gradeⅠ, Ⅱ, Ⅲ, Ⅳ, respectively;GMFSS of grade Ⅳ group was significantly higher than that of other three groups, there was significant difference between the two comparisons (P<0.05);there were no significant differences between other groups (P>0.05). In the four groups with gradeⅠ, Ⅱ, Ⅲ, Ⅳ, the lumbosacral angle was (31.02±9.91) °, ( 26.57±9.41) °, (28.08±8.56) °, and ( 27.31±11.50)°, the lumbar lordosis index was (4.14±12.89), (8.83±13.53), (13.00±11.78), and (10.76±9.97) mm, the arch apex distance was (9.50±6.80), (6.68±3.20), (7.16±4.94), and (6.62±4.13) mm, respectively, there were no significant differences between the two comparisons(P>0.05).
CONCLUSION
①In children with GMFCS gradeⅠ-Ⅳ, the higher the GMFCS grade, the worse the hip develops. ② Children with GMFCS grade Ⅲ-Ⅳ may be at greater risk for lumbar kyphosis.
Male
;
Female
;
Humans
;
Child
;
Child, Preschool
;
Lordosis
;
Retrospective Studies
;
Cerebral Palsy
;
Hip Dislocation
;
Lumbar Vertebrae/diagnostic imaging*
;
Muscle Spasticity
8.The deubiquitinating enzyme 13 retards non-alcoholic steatohepatitis via blocking inactive rhomboid protein 2-dependent pathway.
Minxuan XU ; Jun TAN ; Liancai ZHU ; Chenxu GE ; Wei DONG ; Xianling DAI ; Qin KUANG ; Shaoyu ZHONG ; Lili LAI ; Chao YI ; Qiang LI ; Deshuai LOU ; Linfeng HU ; Xi LIU ; Gang KUANG ; Jing LUO ; Jing FENG ; Bochu WANG
Acta Pharmaceutica Sinica B 2023;13(3):1071-1092
Nowadays potential preclinical drugs for the treatment of nonalcoholic steatohepatitis (NASH) have failed to achieve expected therapeutic efficacy because the pathogenic mechanisms are underestimated. Inactive rhomboid protein 2 (IRHOM2), a promising target for treatment of inflammation-related diseases, contributes to deregulated hepatocyte metabolism-associated nonalcoholic steatohepatitis (NASH) progression. However, the molecular mechanism underlying Irhom2 regulation is still not completely understood. In this work, we identify the ubiquitin-specific protease 13 (USP13) as a critical and novel endogenous blocker of IRHOM2, and we also indicate that USP13 is an IRHOM2-interacting protein that catalyzes deubiquitination of Irhom2 in hepatocytes. Hepatocyte-specific loss of the Usp13 disrupts liver metabolic homeostasis, followed by glycometabolic disorder, lipid deposition, increased inflammation, and markedly promotes NASH development. Conversely, transgenic mice with Usp13 overexpression, lentivirus (LV)- or adeno-associated virus (AAV)-driven Usp13 gene therapeutics mitigates NASH in 3 models of rodent. Mechanistically, in response to metabolic stresses, USP13 directly interacts with IRHOM2 and removes its K63-linked ubiquitination induced by ubiquitin-conjugating enzyme E2N (UBC13), a ubiquitin E2 conjugating enzyme, and thus prevents its activation of downstream cascade pathway. USP13 is a potential treatment target for NASH therapy by targeting the Irhom2 signaling pathway.
9.Metabolic Disease Management Guideline for National Metabolic Management Center(2nd edition)
Weiqing WANG ; Yufan WANG ; Guixia WANG ; Guang NING ; Dalong ZHU ; Ping LIU ; Libin LIU ; Jianmin LIU ; Zhaoli YAN ; Xulei TANG ; Bangqun JI ; Sunjie YAN ; Heng SU ; Jianling DU ; Sheli LI ; Li LI ; Shengli WU ; Jinsong KUANG ; Yubo SHA ; Ping ZHANG ; Yifei ZHANG ; Lei CHEN ; Zunhai ZHOU ; Chao ZHENG ; Qidong ZHENG ; Zhongyan SHAN ; Dong ZHAO ; Zhigang ZHAO ; Ling HU ; Tingyu KE ; Yu SHI ; Yingfen QIN ; Mingjun GU ; Xuejiang GU ; Fengmei XU ; Zuhua GAO ; Qijuan DONG ; Yi SHU ; Yuancheng DAI
Chinese Journal of Endocrinology and Metabolism 2023;39(6):538-554
The latest epidemiological data suggests that the situation of adult diabetes in China is severe, and metabolic diseases have become significant chronic illnesses that have a serious impact on public health and social development. After more than six years of practice, the National Metabolic Management Center(MMC) has developed distinctive approaches to manage metabolic patients and has achieved a series of positive outcomes, continuously advancing the standardized diagnosis and treatment model. In order to further improve the efficiency, based on the first edition, the second edition guideline was composed by incorporating experience of the past six years in conjunction with the latest international and domestic guidelines.
10.Risk factors for neonatal asphyxia and establishment of a nomogram model for predicting neonatal asphyxia in Hubei Enshi Tujia and Miao Autonomous Prefecture: a multicenter study.
Fang JIN ; Yu CHEN ; Yi-Xun LIU ; Su-Ying WU ; Chao-Ce FANG ; Yong-Fang ZHANG ; Lu ZHENG ; Li-Fang ZHANG ; Xiao-Dong SONG ; Hong XIA ; Er-Ming CHEN ; Xiao-Qin RAO ; Guang-Quan CHEN ; Qiong YI ; Yan HU ; Lang JIANG ; Jing LI ; Qing-Wei PANG ; Chong YOU ; Bi-Xia CHENG ; Zhang-Hua TAN ; Ya-Juan TAN ; Ding ZHANG ; Tie-Sheng YU ; Jian RAO ; Yi-Dan LIANG ; Shi-Wen XIA
Chinese Journal of Contemporary Pediatrics 2023;25(7):697-704
OBJECTIVES:
To investigate the risk factors for neonatal asphyxia in Hubei Enshi Tujia and Miao Autonomous Prefecture and establish a nomogram model for predicting the risk of neonatal asphyxia.
METHODS:
A retrospective study was conducted with 613 cases of neonatal asphyxia treated in 20 cooperative hospitals in Enshi Tujia and Miao Autonomous Prefecture from January to December 2019 as the asphyxia group, and 988 randomly selected non-asphyxia neonates born and admitted to the neonatology department of these hospitals during the same period as the control group. Univariate and multivariate analyses were used to identify risk factors for neonatal asphyxia. R software (4.2.2) was used to establish a nomogram model. Receiver operator characteristic curve, calibration curve, and decision curve analysis were used to assess the discrimination, calibration, and clinical usefulness of the model for predicting the risk of neonatal asphyxia, respectively.
RESULTS:
Multivariate logistic regression analysis showed that minority (Tujia), male sex, premature birth, congenital malformations, abnormal fetal position, intrauterine distress, maternal occupation as a farmer, education level below high school, fewer than 9 prenatal check-ups, threatened abortion, abnormal umbilical cord, abnormal amniotic fluid, placenta previa, abruptio placentae, emergency caesarean section, and assisted delivery were independent risk factors for neonatal asphyxia (P<0.05). The area under the curve of the model for predicting the risk of neonatal asphyxia based on these risk factors was 0.748 (95%CI: 0.723-0.772). The calibration curve indicated high accuracy of the model for predicting the risk of neonatal asphyxia. The decision curve analysis showed that the model could provide a higher net benefit for neonates at risk of asphyxia.
CONCLUSIONS
The risk factors for neonatal asphyxia in Hubei Enshi Tujia and Miao Autonomous Prefecture are multifactorial, and the nomogram model based on these factors has good value in predicting the risk of neonatal asphyxia, which can help clinicians identify neonates at high risk of asphyxia early, and reduce the incidence of neonatal asphyxia.
Infant, Newborn
;
Humans
;
Male
;
Pregnancy
;
Female
;
Nomograms
;
Retrospective Studies
;
Cesarean Section
;
Risk Factors
;
Asphyxia Neonatorum/etiology*

Result Analysis
Print
Save
E-mail