1.Quality Research and Evaluation of Ketoconazole Lotion Based on National Drug Sampling and Testing
Yanbin XUN ; Kai DUO ; Changying XIN ; Xiaoxu HAN ; Xia ZHAO ; Siwen WANG ; Chunyu WANG ; Yu XIAO ; Longshan ZHAO ; Changyu WANG ; Xinying YU
Herald of Medicine 2025;44(10):1595-1600
Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.
2.Evaluation of direct economic burden of surgical site infection in orthope-dics based on propensity score matching
Zhijin HUA ; Jiao XIA ; Changyu GAN ; Qi FU ; Qingbi ZHANG
Chinese Journal of Infection Control 2025;24(3):410-416
Objective To analyze the direct economic burden caused by surgical site infection(SSI)in orthopedics and joint surgery,and provide evidence-based support for intervention measures.Methods 3 348 hospitalized pa-tients in the department of orthopedics and joint surgery of a hospital from July 2021 to July 2023 were selected.They were divided into an infection group and a control group based on whether they had SSI.The propensity score matching(PSM)method was adopted to match the two groups of patients in a 1∶1 ratio.The length of hospital stay and various hospitalization expenses between patients with different types of SSI and control group were compared.Results Among 3 348 hospitalized patients,259 had SSI,with an incidence of 7.74%.Superficial incisional wound infection had the highest number of patients(n=177,68.34%),followed by deep incisional wound infection(n=65,25.10%),organ/space infection had the lowest number of patients(n=17,6.56%).After PSM matching,257 pairs were successfully matched,with a matching rate of 99.23%.Infection group extended length of hospital stay by 18 days compared with the control group(P<0.001).The total hospitalization expenses and individual hos-pitalization expenses of infection group were all higher than those of the control group(all P<0.001).Among the various expenses,difference in drug expense was the largest,with an increase of 5 067.83 Yuan in Western medi-cine(P<0.001)and 957.30 Yuan in antimicrobial agents(P<0.001).Patients with different types of SSI all had longer hospital stay compared with the control group.Patients with deep incisional wound infection,superficial inci-sional wound infection,and organ/space infection had an extended hospital stay of 26,18,and 13 days,respectively(all P<0.05).The total hospitalization expenses,Western medicine expenses,and antimicrobial agent expenses of patients with different types of SSI were all higher than those of the control group(all P<0.05).Conclusion The occurrence of postoperative SSI in patients in the department of orthopedics and joint surgery can prolong the length of hospital stay,resulting in huge economic losses for the patient and the hospital.Effective control of healthcare-associated infection is of great significance for optimizing medical resources,improving medical quality,and ensuring patient safety.
3.Evaluation of direct economic burden of surgical site infection in orthope-dics based on propensity score matching
Zhijin HUA ; Jiao XIA ; Changyu GAN ; Qi FU ; Qingbi ZHANG
Chinese Journal of Infection Control 2025;24(3):410-416
Objective To analyze the direct economic burden caused by surgical site infection(SSI)in orthopedics and joint surgery,and provide evidence-based support for intervention measures.Methods 3 348 hospitalized pa-tients in the department of orthopedics and joint surgery of a hospital from July 2021 to July 2023 were selected.They were divided into an infection group and a control group based on whether they had SSI.The propensity score matching(PSM)method was adopted to match the two groups of patients in a 1∶1 ratio.The length of hospital stay and various hospitalization expenses between patients with different types of SSI and control group were compared.Results Among 3 348 hospitalized patients,259 had SSI,with an incidence of 7.74%.Superficial incisional wound infection had the highest number of patients(n=177,68.34%),followed by deep incisional wound infection(n=65,25.10%),organ/space infection had the lowest number of patients(n=17,6.56%).After PSM matching,257 pairs were successfully matched,with a matching rate of 99.23%.Infection group extended length of hospital stay by 18 days compared with the control group(P<0.001).The total hospitalization expenses and individual hos-pitalization expenses of infection group were all higher than those of the control group(all P<0.001).Among the various expenses,difference in drug expense was the largest,with an increase of 5 067.83 Yuan in Western medi-cine(P<0.001)and 957.30 Yuan in antimicrobial agents(P<0.001).Patients with different types of SSI all had longer hospital stay compared with the control group.Patients with deep incisional wound infection,superficial inci-sional wound infection,and organ/space infection had an extended hospital stay of 26,18,and 13 days,respectively(all P<0.05).The total hospitalization expenses,Western medicine expenses,and antimicrobial agent expenses of patients with different types of SSI were all higher than those of the control group(all P<0.05).Conclusion The occurrence of postoperative SSI in patients in the department of orthopedics and joint surgery can prolong the length of hospital stay,resulting in huge economic losses for the patient and the hospital.Effective control of healthcare-associated infection is of great significance for optimizing medical resources,improving medical quality,and ensuring patient safety.
4.Quality Research and Evaluation of Ketoconazole Lotion Based on National Drug Sampling and Testing
Yanbin XUN ; Kai DUO ; Changying XIN ; Xiaoxu HAN ; Xia ZHAO ; Siwen WANG ; Chunyu WANG ; Yu XIAO ; Longshan ZHAO ; Changyu WANG ; Xinying YU
Herald of Medicine 2025;44(10):1595-1600
Objective To evaluate the quality of ketoconazole lotion produced by different domestic companies.Methods Legal standards and exploratory research were used to conduct a comprehensive evaluation of 45 batches(40 batch numbers)of ketoconazole lotion for national drug sampling inspection in 2024,including related substances,antioxidant content,packaging oxygen permeability,in vitro permeation test,and viscosity,antibacterial efficacy,irritation,microstructure,etc.Results The legal standard inspection pass rate was 100.0%.Correlation analysis found that the main factors affecting the quality of this product are prescription technology and packaging.Conclusion It is recommended that manufacturers optimize the prescription process as soon as possible,and pay attention to choose suitable packaging materials,effectively improve the quality of ketoconazole lotion.
5.The role of NLRP3 signaling pathway in allergic rhinoconjunctivitis
Yubo GONG ; Xiaohua GUO ; Wen-Jun LU ; Yuanchao LI ; Changyu QIU ; Yuanyuan SHI ; Liping XIA ; Lin SHI ; Wei WU ; Ling LUO
The Journal of Practical Medicine 2024;40(14):1922-1927
Objective The objective of this study was to establish a mouse model of allergic rhinoconjunctivitis and investigate the role of the NLRP3 signaling pathway in allergic rhinoconjunctivitis.Methods Thirty-three female C57 mice(SPF)were randomLy divided into 3 groups:the control group,the experimental group,and the NLRP3-/-group.On days 0,4,7,14,and 21,the experimental group and NLRP3-/-group received a 0.2 mL intraperitoneal injection of medicine containing OVA(100 μg)and adjuvant Al(OH)3(4 mg),respectively.After an interval of 3 days,each eye and nose were dosed with 10 μL of 5%OVA for five consecutive days a week to induce allergic symptoms.During sensitization and excitation stages,the control group was replaced with an equiva-lent amount of PBS.Ocular and nasal symptoms were observed and scored.The levels of OVA-specific IgE,IL-4,IL-17,and IL-18 in serum were measured using ELISA,while changes in palpebral conjunctiva and nasal mucosa were assessed by hematoxylin-eosin staining.The expression of NLRP3 mRNA in conjunctival tissue and nasal mucosa was determined using real-time PCR analysis.Statistical analysis was performed using SPSS17.0 software with P<0.05 considered as statistically significant difference.Results The experimental group and NLRP3-/-group exhibited induced nasal and ocular allergic symptoms.In the experimental group,the duration of nasal allergy symptoms was(10.500±1.080)days,while the duration of eye allergy symptoms was(20.300±2.058)days.In the NLRP3-/-group,the duration of nasal allergy symptoms was(13.400±1.955)days,and for eye allergy symp-toms it was(20.900±2.132)days.The duration of nasal allergies in the NLRP3-/-group significantly exceeded that in the experimental group(P<0.05),whereas there were no significant differences observed in eye allergy durations between these two groups(P>0.05).Levels of OVA-specific IgE,IL-4,and IL-17 were significantly higher in both the experimental and NLRP3-/-groups compared to those in the control group(P<0.05).Additionally,serum IL-18 content increased significantly in the experimental group when compared with both control and NLRP3-/-groups(P<0.05).Conjunctival tissue lesions as well as nasal mucosa damage were evident in both experimental and NLRP3-/-groups.mRNA expression levels of NLRP3 within conjunctival tissue and nasal mucosa from the experimental group showed a significant increase when compared to those from both control and NLRP3-/-groups(P<0.05).Conclusion Allergic rhinoconjunctivitis pathogenesis is influenced by various factors;however,the involvement of NLPR3 signaling pathway promotes its development.
6. Study on purification effect of formaldehyde in cleanroom by new return air device
Kaili XU ; Hong YANG ; Jingxin XIE ; Jianfeng WANG ; Weimin SHEN ; Chen LING ; Xiangjin FU ; Yuyang XIA ; Changyu HAN ; Lishi ZHONG ; Yuying FAN
Chinese Journal of Industrial Hygiene and Occupational Diseases 2019;37(5):347-351
Objective:
To effectively reduce the concentration of poisons in cleanroom, protect the health of workers, realize the optimization and automatic control of the new return air device. And the influence of initial concentration, air volume, temperature and relative humidity of formaldehyde on the purification effect of the new return air device was explored.
Methods:
The purification effect of the new return air device installed with the activated carbon and the photocatalyst purification net or ordinary activated carbon purification network was tested in a 60 m3 simulated cleanroom. The concentration of formaldehyde was determined by solution absorption-phenol reagent spectrophotometry. Based on the single factor experiment to determine the combination of two purification nets. The effects of air volume, initial formaldehyde concentration, temperature and relative humidity on the purification effect of the new return air device were investigated by orthogonal test. Then, the performance parameters of the return air device to purify formaldehyde were determined.
Results:
The formaldehyde purification efficiency of the two types of purification nets in the new return air device was higher than that of the ordinary activated carbon purification network (
7.Clinical Study on Effect of Baohe Granules on Chronic Heart Failure Patients with TCM Syndrome and Gastrointestinal Hormone Secretion
Linping ZHU ; Xia LI ; Limin FENG ; Xuyan CAO ; Yan LIU ; Changyu LIU ; Wuxun DU ; Zongpei XU
World Science and Technology-Modernization of Traditional Chinese Medicine 2014;(1):87-92
This article was aimed to study the effect of Baohe granules for patients with chronic heart failure (CHF) of traditional Chinese medicine (TCM) syndrome and the effect of gastrointestinal hormone secretion. Patients with CHF were used as the object of study. A total of 80 selected patients were divided into 2 groups. The control group was treated with western medicine anti-heart failure therapy. The treatment group was treated with the combination of Baohe granules. All patients were compared in aspects of TCM efficacy, symptom score and serum gastrin, motilin secretion after two-week medication. The results showed that both treatments can significantly improve the TCM syn-drome and symptom total score of CHF patients. And the effect of the treatment group with Baohe granules was bet-ter. The TCM single symptom integral was also obviously improved in the treatment group combined with Baohe granules, which included heart palpitations, shortness of breath, abdominal distension, and loss of appetite. The GAS and MTL levels of CHF patients were significantly increased in the treatment group. It was concluded that the treat-ment combined with Baohe granules can improve CHF patients with TCM syndromes, symptoms and gastrointestinal hormone secretion. Thus, it contributed to the stability of the disease condition. It can slow the disease progression and improve prognosis. So it is worth using widely in the clinical practice.
8.Trueness Assessment for Serum Glucose Measurement Using Commercial Systems through the Preparation of Commutable Reference Materials.
Changyu XIA ; Ou LIU ; Lanzhen WANG ; Guobing XU
Annals of Laboratory Medicine 2012;32(4):243-249
BACKGROUND: Commutable reference materials (RMs) are suitable for end-users for evaluating the metrological traceability of values obtained using routine measurement systems. We assessed the performance of 6 routine measurement systems with validated secondary RMs. METHODS: We tested the homogeneity, stability, and commutability of 5 minimally processed human serum pools according to the standard guidelines. The serum pools were assigned values as per the reference procedure of the United States Centers for Disease Control and were used to evaluate the trueness of results from 6 commercial measurement systems based on enzymatic methods: 3 glucose oxidase (GOD) and 3 hexokinase (HK) methods. RESULTS: The prepared RMs were validated to be sufficiently homogenous, stable, and commutable with the patient samples. Method bias varied for different systems: GOD01, -0.17 to 2.88%; GOD02, 1.66 to 4.58%; GOD03, -0.17 to 3.14%; HK01, -3.48 to -0.85%; HK02, -3.83 to -0.11%, and HK03, -1.82 to -0.27%. CONCLUSIONS: We observed that the prepared serum glucose RMs were qualified for trueness assessment. Most of the measurement systems met the minimal quality specifications.
Blood Chemical Analysis/instrumentation/*standards
;
Blood Glucose/*analysis
;
Glucose Oxidase/metabolism
;
Hexokinase/metabolism
;
Humans
;
Reagent Kits, Diagnostic
;
Reference Standards
;
Regression Analysis
9.The clinical value of " Push-pull traction-relax homing-Repeatedly confirmed" in the prevention of bile duct injury in LC
Pingjun LI ; Zhenling JI ; Hongyuan SUN ; Junfeng YANG ; Wei HU ; Changyu LIU ; Defeng LU ; Xia LI ; Gaochao REN ; Huaiyan LI
Chinese Journal of Hepatobiliary Surgery 2011;17(2):102-103
Objective To study the value of the technique of "Push-pull traction-relax homingrepeatedly confirmed" in the prevention of bile duct injury in LC. Methods From March 2001-August 2009, we applied this technique in 4800 cases of LC. The technique of "Push-pull traction" showed the structures of in the Calot's triangle. The technique of "relax homing" was to restore the cystic duct,hepatic duct and common bile duct to their original anatomical positions. The technique of "repeatedly confirmed" repeatedly identified the positions of the cystic duct, the common hepatic duct and the common bile duct. Results There was no bile duct injury. Conversion to open surgery happened in 118patients due to difficulties in identifying the Calot's triangle structures, bile duct stones, gallbladder cancer, and gallbladder-duodenal fistula. Conclusions The "Push-pull traction-relax homing-repeatedly confirmed" technique could effectively prevent bile duct injury in LC. The method is simple, easy to master and worthy of promotion.
10.Accuracy investigation of commonly used creatinine assay systems
Xuejing WANG ; Guobin XU ; Changyu XIA ; Haixia LI ; Shukui LI ; Hongyun YANG
Chinese Journal of Laboratory Medicine 2011;34(11):1037-1043
Objective To evaluate the accuracy of Cr measurement value from commonly used homogenous detection systems,to investigate the variation among different systems and the corresponding bias of eGFR.Methods According to the CLSI EP14-A2 protocol,commutability of LN24 was validated among 10 enzymatic assays and 1 picrate assay.LN24 included 6 vials of solution with Cr values assigned by IDMS at NIST,and concentrations of Cr for each vial were 68.1,126.9,185.7,244.5,303.2 and 361.9μmol/L LN24 was used to evaluate the accuracy of the included systems and the variation among them,and the assigned values were taken as the target values.eGFR were calculated by MDRD equation using IDMStraced picrate Cr and CKD-EPI equation using enzymatic Cr.Results Commutability was exist among the 11 systems for LN24 detection.Four systems showed bias < 4.4 μmol/L at each level of LN24,two system showed bias >4.4 μmol/L at each level of LN24,one system showed a fixed negative bias( -4.2 ±0.7)μ mol/L,the other 4 systems showed diverse bias at different levels.Cr-bias-caused eGFR bias could reach 14.9 ml · min-1 · (1.73 m2) -1 at Cr level of 68.1 μmol/L SD among systems ascended with Cr level (2.6 -6.1 μmol/L) ;CV among systems descended with Cr level(4.0% - 1.7% ) ;After the 2 systems with obvious negative bias were removed,SD,CV among systems and eGFR bias decreased obviously.By measuring fresh serum,it was found that Cr bias among enzymatic systems was mostly < 10 μmol/L;that between enzymatic assays and picrate assay was much diffused(from - 15 to 20 μmol/L).When Cr < 100μmol/L,the eGFR difference between result of MDRD equation and that of CKD-EPI equation ranged from - 18 to 40 ml · min-1 (1.73 m2) -1.Conclusions Some enzymatic systems show good accuracy.Difference of Cr value is relatively fixed among enzymatic systems,and comparability can be reached through mathematic way.Un-acceptable difference between picrate assay and enzymatic assays still exists,thus comparability cannot be reached through mathematic way.At low Cr level,bias of Cr and using different equations may lead to significant bias of eGFR.We recommend that clinical laboratory should pay much attention to the accuracy and comparability at low level of Cr,and use uniform equation to calculate eGFR.

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