1.Evaluation of colistin sulfate administration regimen based on PK/PD theory and Monte Carlo simulation
Yingchao MA ; Xia WU ; Yongjing WANG ; Jianjun GU ; Xiuling YANG
China Pharmacy 2025;36(4):459-463
OBJECTIVE To evaluate the therapeutic efficacy of 5 regimens of colistin sulfate for common Gram-negative bacilli infection based on pharmacokinetics (PK)/pharmacodynamics (PD) theory and Monte Carlo simulation. METHODS Minimal inhibitory concentration (MIC) data of colistin sulfate against Acinetobacter baumannii, Pseudomonas aeruginosa, Klebsiella pneumoniae, Escherichia coli and Enterobacter cloacae in 2023 were collected from the China Antimicrobial Resistance Surveillance System. Monte Carlo simulation was conducted with the ratio of the area under the concentration-time curve from 0 to 24 hours in the unbound state to the MIC (fAUC0-24 h/MIC) ≥15 as the target value, the probabilities of target attainment (PTA) of 5 regimens of colistin sulfate to achieve the target ratio were obtained at different MIC; and the expected population PTA, specifically the cumulative fraction of response (CFR), for each regimen within a specific bacterial population was further calculated, to evaluate the therapeutic efficacy of the five colistin sulfate regimens. RESULTS When bacterial MIC≤0.5 µg/mL, PTA of all colistin sulfate regimens (500 000 IU, q12 h; 500 000 IU, q8 h; 750 000 IU, q12 h; 750 000 IU, q8 h; 1 000 000 IU, q12 h) were all more than 90%. When bacterial MIC=1 µg/mL, PTA for regimen (750 000 IU, q8 h) against A. baumannii, K. pneumoniae, P. aeruginosa, E. coli and E. cloacae, and for regimen (1 000 000 IU, q12 h) against the other four bacterial species (excluding P. aeruginosa) remained above 90%. When bacterial MIC≥2 µg/mL, PTA of 5 colistin sulfate regimens were all lower than 90%. For E. coli, the CFR of only colistin sulfate regimen (500 000 IU, q12 h) was less than 90%; for K. pneumoniae, the CFR of only colistin sulfate regimen (750 000 IU, q8 h and 1 000 000 IU, q12 h) was greater than 90%; for the other three bacteria, CFR of 5 regimens were all less than 90%. CONCLUSIONS When the MIC of Gram-negative bacteria is less than 0.5 µg/mL, colistin sulfate regimen with a routine dose can be selected for treatment. When MIC was 1 µg/mL, an increase in the dosing amount or frequency is required. The empirical treatment of the other four bacterial infections excluding E. coli requires the use of off-label doses.
2.Impact factor selection for non-fatal occupational injuries among manufacturing workers by LASSO regression
Yingheng XIAO ; Chunhua LU ; Juan QIAN ; Ying CHEN ; Yishuo GU ; Zeyun YANG ; Daozheng DING ; Liping LI ; Xiaojun ZHU
Journal of Environmental and Occupational Medicine 2025;42(2):133-139
Background As a pillar industry in China, the manufacturing sector has a high incidence of non-fatal occupational injuries. The factors influencing non-fatal occupational injuries in this industry are closely related at various levels, including individual, equipment, environment, and management, making the analysis of these influencing factors complex. Objective To identify influencing factors of non-fatal occupational injuries among manufacturing workers, providing a basis for targeted interventions and surveillance. Methods A total of
3.Distribution characteristics of self-reported diseases and occupational injuries among workers in manufacturing enterprises
Lin ZHANG ; Zhi’an LI ; Yishuo GU ; Juan QIAN ; Chunhua LU ; Jianjian QIAO ; Yong QIAN ; Zeyun YANG ; Xiaojun ZHU
Journal of Environmental and Occupational Medicine 2025;42(2):165-170
Background Diseases severely affect the efficiency of workers. Comorbidity refers to the coexistence of two or more chronic diseases or health problems in the same individual. Previous studies have primarily focused on occupational injuries caused by environmental exposures, while the analysis of the epidemiological characteristics of self-reported diseases and occupational injuries among manufacturing workers has been insufficient. Objective To analyze the distribution of self-reported diseases and occupational injuries among manufacturing workers, the strength of correlation between different diseases, and common disease combinations, and to preliminarily explore the relationship between self-reported diseases and occupational injuries. Methods A cross-sectional survey was conducted to investigate the occupational injuries of
4.Analysis of the dilemmas of the simplified ethical review procedure in practice
Benze HU ; Yuhong HUANG ; Xufang GU ; Weihua GUO ; Siyuan HU ; Yaqing YANG
Chinese Medical Ethics 2025;38(1):46-51
In September 2023, the Measures for Scientific and Technological Ethics Review (Trial Implementation) was issued, revising the provisions related to the simplified procedure for ethical review in Chapter 3, Section 3. This revision of these provisions provides systematic guarantees for further optimizing ethical review work, ensuring that ethical review procedure is well-regulated, and improving scientific research efficiency. The “simplified procedure” does not mean reducing the quality and requirements of the review. Instead, based on always following internationally recognized ethical standards and emphasizing not violating national laws and regulations, improving the efficiency of ethical review and subsequent research work, and promoting the development of life sciences and medical research involving humans. In practical work, it introduces numerous new opportunities and challenges for the improvement of ethics review ability, such as new tests on the judgment and decision-making power of ethics committees, how to ensure the reliability and controllability of the conditions related to the simplified review procedure, and how to determine the basic conditions for adopting the simplified review procedure for review. Therefore, to actively respond to the challenges and possible risks brought by the simplified procedure review, efforts should be made to achieve three “unifications”, including the unification of researchers’ moral autonomy and the heteronomy of supervision implemented by relevant departments; the unification of the standard formulation of the simplified procedure review and the review work in practice; and the unification of ethical responsibility and legal responsibility.
5.Comparison of the accuracy of an ultrasonic-based jaw tracking device with conventional electronic tracking device
Xinyi GU ; Tingzi HU ; Zidan ZHANG ; Fuming HE ; Jiejun SHI ; Haiping YANG
The Journal of Advanced Prosthodontics 2025;17(1):47-58
PURPOSE:
This study aimed to evaluate the accuracy of the ultrasonic jaw tracking system by comparing with the conventional electronic system in recording condylar movements.
MATERIALS AND METHODS:
Twenty-six subjects with normal occlusion participated in the study. The CADIAX® 4 and Jaw Motion Analyzer (JMA) systems were used to record condylar movement trajectories during mandibular border movements (protrusive/retrusive, lateral, and wide mouth opening), with each movement repeated three times. Both systems used facebows and sensors to locate the condylar axis points and capture movement trajectory data. Paired t-tests were used for normally distributed data, while the Wilcoxon rank-sum test was applied to non-normally distributed data. The level of significance was set at α = .05.
RESULTS:
The maximum condylar displacement in the sagittal plane during mandibular border movements and the sagittal condylar inclination (SCI) values on both the left and right sides showed no significant difference between the two systems (P > .05). The Bennett angle (BA) values on both the left and right sides measured by the JMA system were significantly higher than those measured by the CADIAX® 4 system (P < .05). The comfort levels of the JMA system were significantly higher than the CADIAX® 4 system (P < .05).
CONCLUSION
Through this study, it was found that the accuracy of the ultrasonic jaw tracking system was comparable with the conventional electronic system, except for the Bennett angle measurement. In terms of comfort and ease of use, the ultrasonic jaw tracking system is more favored.
6.Clinical observation on Jiu-Wei-Yong-An granule combined with cetirizine in the treatment of eczema with damp-heat accumulation of skin syndrome
Yuanyuan MENG ; Yunyang WU ; Tingru CHEN ; Qinwufeng GU ; Yanlong YANG
Journal of Pharmaceutical Practice and Service 2025;43(6):298-302
Objective To observe the clinical effect of Jiu-Wei-Yong-An granule combined with cetirizine in the treatment of damp-heat accumulation syndrome of eczema. Methods 108 eczema patients with syndrome of damp-heat accumulated in the skin, treated in the Department of Traditional Chinese Surgery in the First Affiliated Hospital of Naval Medical University from December 2021 to March 2023, were selected. They were randomly divided into an observation group and a control group, 54 cases in each. Both groups took cetirizine tablets orally for basic treatment. The observation group was given Jiu-Wei-Yong-An granules, and the control group was given placebos of the same. The clinical efficacy before and after treatment in the two groups was observed and compared, including TCM syndrome scores, eczema area and severity index (EASI), visual analogue scale (VAS), and adverse reactions. Results After treatment, the total effective rate of the observation group (88.9%) was higher than that of the control group (77.8%), and the difference was statistically significant (P<0.05). After treatment, the TCM syndrome score, EASI and VAS in the observation group were significantly lower than those in the control group (P<0.05), and the difference was statistically significant. There was no significant difference in the total rate of adverse reactions between the two groups (P>0.05). Conclusion The combination of Jiu-Wei-Yong-An granules and cetirizine tablets in the treatment of damp-heat eczema showed significantly better clinical outcomes in the observation group compared to the control. It effectively improved patient conditions, reduced skin lesion areas, and alleviated itching, with both safety and efficacy that merit clinical promotion.
7.Associations of volatile organic compounds/semi-volatile organic compounds exposure on asthma: A review of epidemiological studies and diagnostic applications
Tiantian GU ; Jin ZHANG ; Teng YANG ; Jiawei WANG ; Qinsheng KONG ; Guoxing LI ; Jing HUANG
Journal of Environmental and Occupational Medicine 2025;42(6):756-761
Volatile organic compounds (VOCs) and semi-volatile organic compounds (SVOCs) are common organic compounds in indoor and outdoor air, and enter the human body primarily through the respiratory tract and directly damage the respiratory system. Previous studies have suggested that exposure to VOCs/SVOCs may associate with the prevalence, incidence, and progression of asthma, but the extent of the associations is still vague. Furthermore, biomarkers for efficient and simple asthma diagnosis, typing, and attack prediction remain unclear at this stage. From the perspective of the collection and detection methods of VOCs/SVOCs, this paper summarized the epidemiological associations and underlying biological mechanisms between VOCs/SVOCs exposure and the prevalence, incidence, and progression of asthma in children/adults. It also demonstrated the application of VOCs/SVOCs in recent years in assisting asthma diagnosis, such as distinguishing asthma patients from the healthy population, differentiating different asthma phenotypes, and predicting asthma acute exacerbations, aiming to provide a scientific basis for improving current asthma management.
8.Study on the correlation of peak blood concentrations of compound sulfamethoxazole and its metabolites with clinical efficacy and adverse reactions in critically ill patients
Xiangxiang FU ; Lili ZHONG ; Jiangfan GU ; Mengyu MEI ; Xinxin LI ; Yang DENG ; Min WANG
China Pharmacy 2025;36(14):1775-1780
OBJECTIVE To analyze the correlation of the peak blood concentration (cmax) of compound sulfamethoxazole (TMP/SMZ) and its metabolite N-acetyl sulfamethoxazole (NSMZ) with clinical efficacy and adverse reactions in critically ill patients. METHODS The data of critically ill patients treated with TMP/SMZ in various ICU of Hainan General Hospital from December 2023 to January 2025 were retrospectively collected. The patients were divided into success group and failure group based on the treatment outcome. Simple linear regression and Spearman correlation analysis were used to analyze the correlation of TMP cmax, SMZ cmax, and NSMZ cmax with clinical efficacy and adverse reactions. The receiver operating characteristic curve (ROC) was used to determine the cutoff values of cmax for predicting the occurrence of adverse reactions. RESULTS Among critically ill patients with an acute physiology and chronic health evaluation Ⅱ (APACHE-Ⅱ) ≥15 points 24 h of check-in at ICU, SMZ cmax of success group was significantly higher than failure group (P<0.05). The daily total dose of TMP/SMZ was positively correlated with TMP cmax and SMZ cmax( P<0.05). TMP cmax was significantly correlated with hepatotoxicity and nephrotoxicity, SMZ cmax with hepatotoxicity, and NSMZ cmax with nephrotoxicity (P<0.05). The cutoff values of TMP cmax for predicting nephrotoxicity and hepatotoxicity were 7.25 μg/mL and 6.63 μg/mL, respectively. The cutoff value of SMZ cmax for predicting hepatotoxicity was 138.00 μg/mL, and that of NSMZ cmax for predicting nephrotoxicity was 60.76 μg/mL. CONCLUSIONS Among critically ill patients with an APACHE-Ⅱ ≥15 points 24 h of check-in at ICU, SMZ cmax is associated with treatment success. Hepatotoxicity risk significantly increases when TMP cmax ≥6.63 μg/mL or SMZ cmax ≥138.00 μg/mL; nephrotoxicity risk significantly increases when TMP cmax ≥7.25 μg/mL or NSMZ cmax ≥60.76 μg/mL.
9.Effect Mechanism and Law of Sterilization by 60Co-γ Ray Irradiation on Chemical Composition of Chinese Materia Medica: A Review
Tingting ZHU ; Jian RANG ; Rangyanpo LUO ; Rui GU ; Yue YANG ; Si LU ; Shihong ZHONG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(18):306-314
60Co-γ ray irradiation has the unique advantages of high efficiency, strong penetration, operation at room temperature and no residue, which has been widely used in the sterilization of Chinese medicinal materials, decoction pieces, Chinese patent medicine. However, the irradiation effect may cause changes in the content of chemical components in Chinese materia medica or the emergence of new radiolysis products, leading to reduced efficacy and uncontrollable safety risks. This paper reviewed the relevant literature at home and abroad, summarized the effect of irradiation sterilization on various types of chemical compositions of Chinese medicinal materials and their preparations, and analyzed and explored the rule of change. The results showed that the content changes of various chemical components in Chinese materia medica after 60Co-γ ray irradiation sterilization varied. The contents of most flavonoids, terpenoids, phenylpropanoids and quinones decreased after irradiation, and the degree of decrease increased with the elevated irradiation dose. The contents of lignans, alkaloids, isoflavones and some terpenoids did not change significantly before and after irradiation, while the content changes of triterpenoid saponins, dihydroflavonols, chalcones, sugars and glycosides after irradiation were not yet uniform. Therefore, it is recommended to pay attention to the compositional changes of irradiated Chinese medicines, strengthen the research on the standards of irradiated Chinese medicines, and standardize the irradiation and sterilization of Chinese medicines in order to promote the healthy and rational application of irradiated Chinese medicines.
10.Meta-analysis of external treatment by Traditional Chinese Medicine for skin pruritus induced by eczema
Tingru CHEN ; Qinwufeng GU ; Yunyang WU ; Yuanyuan MENG ; Yanlong YANG ; Ruimin LI
Journal of Pharmaceutical Practice and Service 2025;43(8):383-389
Objective To evaluate the clinical efficacy of Traditional Chinese Medicine (TCM)external treatment methods in alleviating skin pruritus caused by eczema through a Meta-analysis. Methods Randomized clinical trials investigating the use of TCM external treatment methods for skin pruritus caused by eczema were searched in databases including China National Knowledge Infrastructure (CNKI), VIP, Wanfang, Sinomed, PubMed, Embase, LILACS, and Cochrane, up to December 2024. Two reviewers independently screened and entered the statistical data, conducted bias risk assessment by the Cochrane Handbook for Systematic Reviews of Interventions, version 5.1.0, and performed Meta-analysis using RevMan 5.4.1. Results Ultimately, 14 studies involving 1 788 patients were included. Compared to the control group, TCM external treatment methods (treatment group)showed better improvement in pruritus scores (Z=11.88, P<0.000 01), better improvement in Eczema Area and Severity Index (EASI) scores (Z=23.15, P<0.000 01), higher overall clinical efficacy rate (Z=6.21, P<0.000 01), better improvement in TCM symptoms (Z=5.49, P<0.000 01), and lower clinical recurrence rate (Z=2.88, P=0.004). Three of the included studies mentioned adverse reactions, with the treatment group showing lower adverse reactions than the control group. Conclusion The external treatment of TCM was more effective in treating skin pruritus caused by eczema compared to the control group. Given the biases and heterogeneity in the included literature, this conclusion needs to be further substantiated by more large-scale, multi-center, randomized, controlled, and double-blind studies.

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