1.The Solomon Four-Group Design:Key Considerations in Design and Statistical Analysis and Their Significance in Clinical Trials of Traditional Chinese Medicine
Wenqian ZHANG ; Yufei LI ; Tong LIN ; Xintong WEI ; Yingjie WANG ; Jianping LIU ; Ying ZHANG
Journal of Traditional Chinese Medicine 2025;66(16):1649-1655
The Solomon four-group design, a critical method for improving internal validity in clinical research, can reduce bias and control the interference of Hawthorne effects and pretest sensitization on research results, which offers unique advantages in evaluating complex intervention outcomes. This paper systematically outlined the core framework and key points of statistical analysis of the Solomon four-group design, summarized its applications in clinical research at home and abroad, explored its advantages and limitations, and discussed the potential value in traditional Chinese medicine (TCM) clinical trials. It is believed that the Solomon four-group design can help distinguish between testing effects and intervention effects in TCM clinical studies, and reduce the bias in the evaluation of subjective indicators. Meanwhile, given the complexity of the Solomon four-group design and the particularity of TCM clinical research, it is proposed that future TCM clinical studies should focus on using psychological scales, know-ledge, attitude, and behavior measurements, and other similat evaluations as endpoints. It also advocates strengthening interdisciplinary collaboration to provide new methodological paths for TCM clinical research.
2.Analysis of Alleviating Effect of Calcium Cyanamide on Replanting Problems of Rehmannia glutinosa
Lianghua LIN ; Hengrui ZHANG ; Haoxiang YU ; Fan YANG ; Yufei WANG ; Caixia XIE ; Tao GUO ; Zhongyi ZHANG ; Liuji ZHANG ; Bao ZHANG ; Suiqing CHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(22):212-222
ObjectiveTo investigate the alleviating effect of calcium cyanamide (CaCN2) soil fumigation on replanting problems of Rehmannia glutinosa. MethodsNewly soil (NP) was used as the control group, while three treatment groups were established: replanted soil (RP), newly soil treated with CaCN2 (120 g·m², tillage depth 25 cm) (NPCC), and replanted soil treated with CaCN2 (RPCC). R. glutinosa was cultivated in all groups. At harvest, the tuber agronomic traits (number of enlarged roots, maximum root diameter, fresh weight, dry weight) were measured. The content of catalpol and rehmannioside D was quantified by ultra-high-performance liquid chromatography (UPLC) to evaluate medicinal quality. Rhizosphere soil available nutrients and enzyme activities were analyzed by assay kits. The community structure and composition of fungi and bacteria in rhizosphere soil were assessed via internal transcribed spacer 2 (ITS2) sequencing and 16S rDNA sequencing, respectively. ResultsCompared with NP, the RP group showed obviously reduced in tuber agronomic traits and quality indicators (P0.05). However, the RPCC group showed significant improvement in agronomic traits and a notable increase in rehmannioside D content compared to RP (P0.05). The contents of available phosphorus and potassium in RPCC and NP groups were obviously lower than those in RP (P0.05). The polyphenol oxidase soil (S-PPO) activity in RP was obviously lower than in NP (P0.05), while sucrose soil (S-SC), acid phosphatase soil (S-ACP), and S-PPO activities in RPCC were obviously higher than in RP (P0.05). Microbial richness and diversity in RP were obviously higher than in NP (P0.05), whereas no significant differences were observed between the RPCC and NP. The relative abundances of fungal genera Nectria, Myrothecium, Tomentella, and bacterial genus Skermanella were obviousl lower in RPCC and NP than in RP (P0.05). Correlation analysis that S-ACP activity was positively correlated with the content of rehmannioside D (P0.05). Fungal genera Engyodontium and Alternaria, and bacterial genera Pir4 lineage, Pirellula, Methyloversatilis, Brevundimonas, Ralstonia, and Acidibacter were obviously positively correlated with tuber dry weight (P0.05). Conversely, fungal genera Pseudaleuria, Nectria, Haematonectria, Ceratobasidium, and bacterial genera Streptomyces, Skermanella, RB41, Gemmatimonas, and Bacillus were obviously negatively correlated with dry weight (P0.05). The fungal genus Alternaria and bacterial genera Brevundimonas, Ralstonia, Acidibacter, and Dongia showed positive correlations with medicinal quality of R.glutinosa tuber, while fungal genera Pseudaleuria, Nectria, Stachybotrys, Fusarium, Gibberella, Ceratobasidium, and bacterial genera Sphingomonas, Skermanella, RB41, Gemmatimonas, and Bacillus were obviously negatively correlated (P0.05). ConclusionCaCN2 soil fumigation can significantly improve enzyme activities in replanted Rehmannia rhizosphere soil, enhance the utilization of available nutrients, reshape microbial community structure of replanted R.glutinosa at the family and genus level, and notably improve tuber agronomic traits and medicinal quality. This study provides a novel approach to alleviating replanting problems and offers insights for the integrated development of standardized cultivation techniques, including soil disinfection, nutrient-targeted regulation, and microbial inoculant application.
3.Efficacy and safety of white-browed snake venom hemocoagulase for injection in surgical tresis vulnus:a Meta-analysis
Qianhang SHAO ; Xuemei LIU ; Lin HUANG ; Yufei FENG
China Pharmacist 2024;27(5):864-874
Objective To evaluate the efficacy and safety of white-browed venom hemocoagulase for injection in surgical tresis vulnus.Methods Wanfang,VIP,and CNKI were computerized searched to collect randomized controlled trials(RCTs)of white-browed snake venom thrombin for hemostasis in surgical incisions from the construction of databases to December 1,2023.Meta-analysis was performed using RevMan 5.4 software.Results A total of 13 RCTs with 1 027 patients were included.Meta-analysis showed that the mean hemostasis time,bleeding per unit area,intraoperative bleeding,and thrombin time(TT)on the first postoperative day in the white-browed snake venom hemocoagulase group were smaller than those in the control group(P<0.05);the activated partial thromboplastin time(APTT),prothrombin time(PT),and fibrinogen(FIB)content between the two groups were not statistically significant(P>0.05).Subgroup analysis showed that among different types of surgical incisions,the hemostasis time,bleeding per unit area and intraoperative bleeding were reduced in the white-browed snake venom hemocoagulase group(P<0.05).PT in the white-brow snake venom hemocoagulase group was greater than that in the control group on the first postoperative day of neurosurgical incisions(P<0.05),and the differences in TT,APTT,and FIB between the two groups were not statistically significant(P>0.05);in the first postoperative day of nasal endoscopic surgery and general surgical incisions,there were no statistically significant differences between the two groups in terms of TT,APTT,PT,and FIB(P>0.05);and in the first postoperative day of gynecological incisions,the TT and PT of the white-browed snake venom hemocoagulase group were lower than those of the control group(P<0.05),and the differences in APTT and FIB between the two groups were not statistically significant(P>0.05).A total of six studies reported adverse reactions after the use of white-browed snake venom hemocoagulase,of which four studies did not observe any adverse reactions.Conclusion Compared with the control group,white-browed snake venom hemocoagulase has better hemostatic efficacy for surgical incisions,and has less effect on the coagulation function of patients,without increasing the occurrence of adverse events,and has a better safety profile.
4.Summary of best evidence for non-pharmacological management of postoperative delirium in adult liver transplant recipients
Ao FENG ; Dan ZHOU ; Bingliang ZHANG ; Yinghao ZHOU ; Hui LIN ; Yufei GONG ; Lin ZHAO
Chinese Journal of Modern Nursing 2024;30(3):365-371
Objective:To summarize the best evidence for non-pharmacological management of postoperative delirium in adult liver transplant recipients, providing reference for postoperative delirium management in liver transplant recipients.Methods:Evidence on non-pharmacological management of postoperative delirium in adult liver transplant recipients was retrieved through computer in databases such as UpToDate, British Medical Journal (BMJ) Best Practice, Embase, PubMed, Cochrane Library, Joanna Briggs Institute Evidence-Based Health Care Center Database, Guidelines International Network, China Biology Medicine disc, China National Knowledge Infrastructure, WanFang Data, and VIP. The search period was from database establishment to January 31, 2023. The types of literature included guidelines, clinical decision-making, best practices, systematic review, summary of evidence, and expert consensus. Two researchers conducted quality evaluation and evidence extraction on the included literature.Results:A total of 10 articles were included, involving 1 clinical decision-making, 4 guidelines, 3 systematic reviews, and 2 expert consensuses. A total of 25 best pieces of evidence for non-pharmacological management of postoperative delirium in adult liver transplant recipients were summarized from four aspects, including screening, evaluation, non-pharmacological prevention, and non-pharmacological treatment.Conclusions:The best evidence on non-pharmacological management of postoperative delirium in adult liver transplant recipients summarized provides a reference for postoperative delirium management in liver transplant recipients.
5.Mediating effect of individual resilience between work stress and work engagement among nurses in Emergency Department
Yinghao ZHOU ; Dan ZHOU ; Ao FENG ; Yufei GONG ; Lin ZHAO
Chinese Journal of Modern Nursing 2024;30(12):1632-1637
Objective:To explore the relationship between individual resilience, work stress, and work engagement among nurses in Emergency Department.Methods:A questionnaire survey was conducted on 350 nurses from six Class Ⅲ Grade A hospitals in Shandong Province from April to September 2022, using the General Information Questionnaire, the Chinese version of the Stressor Scale for Emergency Nurse, the Chinese version of the Utrecht Work Engagement Scale, and the Medical Staff Composition Resilience Scale. Pearson correlation was used to analyze the correlation between nurse work stress, work engagement, and individual resilience. The structural equation model was constructed using a mediating effect testing program to analyze the relationships between variables.Results:A total of 350 questionnaires were distributed, and 330 valid questionnaires were collected, with an effective response rate of 94.28%. The scores of nurse work engagement, work stress, and individual resilience were (54.26±10.08), (77.36±25.48), and (67.76±12.33), respectively. Work stress was negatively correlated with work engagement and individual resilience (all P<0.01), while individual resilience was positively correlated with work engagement ( P<0.01). Individual resilience was a mediating variable between work stress and work engagement among nurses in Emergency Department, with a mediating effect accounting for 31.38% of the total effect. Conclusions:Most nurses of Emergency Department have moderate levels of work stress, work engagement, and individual resilience. Individual resilience partially mediates the relationship between work stress and work engagement among nurses in Emergency Department. Nursing managers should attach importance to the organizational culture atmosphere and develop corresponding measures to enhance the individual resilience of nurses and encourage them to be energetic and enthusiastic in their work.
6.Effect of statins combined with PCSK9 inhibitors on coronary atheromatous plaque assessed by intravascular imaging: a Meta-analysis
Linze LIU ; Yufei ZHAO ; Jiong XIAO ; Jingyan HAO ; Wenhua LIN
Chinese Journal of Primary Medicine and Pharmacy 2024;31(3):405-411
Objective:To evaluate the effect of statins combined with PCSK9 inhibitors on coronary artery atherosclerotic plaque, as well as to verify the lipid-lowering effect of the combined therapy.Methods:A computerized search of PubMed, Embase, Web of Science, Cochrane Library, Wanfang, and CNKI databases was conducted to retrieve published literature from inception to December 20, 2022. The English search terms utilized included "PCSK9 inhibitors," "Alirocumab," "Evolocumab," "plaque," "IVUS," and "OCT." The corresponding Chinese search terms were "PCSK9 inhibitors," "plateau," "intravascular ultrasound," and "optical coherence tomography." The literature that examined the effect of statins alone or in combination with PCSK9 inhibitors on coronary atherosclerotic plaques using intravascular ultrasound or optical coherence tomography was identified. The collected data were subsequently processed using Review Manager (Revman) version 5.4.Results:In the final analysis, nine studies involving 1912 patients were included. The analysis results revealed that compared with statins alone, statins combined with PCSK9 inhibitors significantly reduced the percentage of atherosclerotic volume ( MD: -2.08 mm 3, 95% CI: -2.94 to -1.23 mm 3, P < 0.001), accelerated the regression of atherosclerotic volume ( MD: -1.13 mm 3, 95% CI: -1.49 to -0.77 mm 3, P < 0.001), slightly, but not significantly, reduced the overall atherosclerotic volume ( MD: -6.42 mm 3, 95% CI: -14.34-1.51 mm 3, P = 0.110). Nevertheless, the combined therapy contributed to a significant reduction in atherosclerotic volume ( MD: -5.16 mm 3, 95% CI: -7.09 to -3.23 mm 3, P < 0.001) and significantly increased the fiber cap thickness of thin cap plaques ( MD: 8.46 μm, 95% CI: 5.13-11.79 μm, P < 0.001). Additionally, this combined therapy significantly lowered blood lipid levels. Conclusion:The combination of statins and PCSK9 inhibitors can significantly improve the characteristics and phenotype of atherosclerotic plaques and significantly reduce blood lipid levels. For patients with high cardiovascular risk, it is recommended to initiate treatment with statins combined with PCSK9 inhibitors as soon as possible and maintain it for a long time to ensure more benefits.
7.Efficacy and safety of 4 kinds of hemocoagulases combined with proton pump inhibitor for nonvariceal upper gastrointestinal bleeding:a network meta-analysis
Qianhang SHAO ; Xuemei LIU ; Lin HUANG ; Yufei FENG
China Pharmacy 2023;34(5):600-606
OBJECTIVE To systematically evaluate the difference of efficacy and safety of four kinds of commonly used haemocoagulases combined with proton pump inhibitor (PPI) for nonvariceal upper gastrointestinal bleeding (NVUGIB), and to provide evidence-based basis for clinical decision-making. METHODS Retrieved from PubMed, Web of Science, Wanfang data, VIP and CNKI databases, randomized controlled trials (RCTs) or cohort studies about Hemocoagulase agkistrodon blomhoffii, Haemocoagulase agkistrodon, hemocoagulase and Hemocoagulase bothrops atrox combined with PPI were collected during the inception to Dec. 2021. Two researchers independently screened the literature, extracted data and evaluated the quality of included studies. ADDIS 1.16.8 software was used to conduct a Bayesian network meta-analysis. RESULTS A total of 33 studies were included, involving 3 602 patients. Results of network meta-analysis showed that: in terms of hemostatic efficacy, compared with PPI monotherapy, four kinds of haemocoagulases combined with PPI could significantly improve the hemostatic efficacy of patients (P<0.05); there was no statistical significance in the pairwise comparison of different hemocoagulases (P>0.05). The optimal probabilistic ranking of network meta-analysis was as follows: Hemocoagulase agkistrodon blomhoffii combined with PPI> Hemocoagulase bothrops atrox combined with PPI>Haemocoagulase agkistrodon combined with PPI>hemocoagulase combined with PPI>PPI alone. In terms of the incidence of adverse drug reactions (ADR), compared with PPI monotherapy, there was no statistical difference in the incidence of ADR among four kinds of haemocoagulases combined with PPI (P>0.05). There was no statistical significance in the pairwise 88325750。E-mail:fengyufei@126.com comparison of different hemocoagulases (P>0.05). The optimal probabilistic ranking of network meta-analysis was as follows: hemocoagulase combined with PPI>Hemocoagulase bothrops atrox combined with PPI>Hemocoagulase agkistrodon blomhoffii combined with PPI>Haemocoagulase agkistrodon combined with PPI>PPI alone. CONCLUSIONS Compared with PPI monotherapy, four different sources of hemocoagulases combined with PPI have better efficacy and similar safety in the treatment of NVUGIB. There is no significant difference in efficacy and safety among different hemocoagulases.
8.Pathogenic risk of Vibrio parahaemolyticus infection in raw aquatic products of animal origin by using sQMRA
Hailin LI ; Weiyu ZHANG ; Yufei LIU ; Yan LI ; Xiaohua LIN ; Qin ZHOU ; Kuncai CHEN
Journal of Public Health and Preventive Medicine 2023;34(6):53-56
Objective To evaluate the risk of disease of Vibrio parahaemolyticus in aquatic products of raw food animals for population in guangzhou,and determine risk management points. Methods VP quantitative detection was carried out in aquatic products of raw food animals sold in Guangzhou from 2009 to 2022.sQMRA was applied to assess Vibrio parahaemolyticus risk of aquatic products of raw food animals. According to stratified analysis based on the pollution of Vibrio parahaemolyticus and evaluation results,carry out risk management and analysis. Results Among the 98 samples were detected positive of VP from 1 343 samples from 2009 to 2022 , with an overall positive rate of 7.30%.The number of Vibrio parahaemolyticus infection cases caused by eating aquatic products of raw food animals in Guangzhou was 3012. If the proportion of raw food is reduced , the number of Vibrio parahaemolyticus infection cases will be significantly reduced. The number of cases caused by eating raw fash will be reduced from 2128 to 217.The detection rate of Vibrio parahaemolyticus in raw fresh water products was much higher than that in marine products. The probability of infection in the population was higher. The number of cases caused by eating raw fash was the highest.The detection rate of Vibrio parahaemolyticus was higher in raw crustaceans and molluscs. The incidence of Vibrio parahaemolyticus infection cases caused by eating raw fash in the four quarters varied from high to low as such sequence ,4.93×10-5 in the three quarters , 2.53×10-5 in the second quarter , 2.40×10-5 in the first quarter ,1.77×10-5 in the fourth quarter . Conclusion The risk of disease of Vibrio parahaemolyticus in aquatic products of raw food animals was higher. The public health education should be done well. Aquatic products should be cooked thoroughly before eating . Reduce the intake of raw aquatic products and avoid cross contamination. Focus on the risks of summer and autumn seasons and seafood such as crustaceans and molluscs. Concentrate on scientific research on Vibrio parahaemolyticus pollution of fresh water products.
9.The full process operating procedure for the using of multi -center retrospective electronic medical record data
Xue ZHONG ; Dongfang QIAN ; Zixuan ZHANG ; Siyuan TAN ; Jianfeng LIU ; Xueyan CUI ; Ruifang NIE ; Ting LI ; Qian WANG ; Qi GUO ; Qiushuang LIU ; Yan LIANG ; Lin HUANG ; Lizong LI ; Yufei FENG
China Pharmacy 2022;33(19):2314-2320
With the gradual improvement of medical informatization and the vigorous development of medical and health big data,the exploration and practice of real -world research are becoming more and more mature ,and real -world data have become an important source of evidence for post marketing re -evaluation of drugs . As an important high -quality real -world medical data , electronic medical record data is an indispensable data source for post marketing re -evaluation of drugs . Most of the existing guidelines and norms of real -world research are designed from the perspective of prospective research ,and do not propose specific measures and methods in the implementation of retrospective research ,especially for the operation suggestions on the technical level of using conventionally collected electronic medical record data . In combination with the operational process framework formulated by the existing guidelines and norms ,this paper creatively adds the operating procedures for dataE- validation,data integration ,data verification ,and throughout quality control ,data management and storage of retrospectiveelectronic medical record data ,and describes the data analysis methods and key points involved in carrying out multi -center retrospective real -world research using electronic medical record data ,taking the post marketing safety research of drugs as an example. Finally,the full process operation procedure applicable to the use of multi -center retrospective electronic medical record data is established .
10.Quantitative Evaluation of the Prophylactic Use Rationality of Antibiotics in Orthopedic Type Ⅰ Incision Surgery of Our Hospital Based on AHP-TOPSIS
Yi LIU ; Xinyu LIANG ; Jiawei SONG ; Yue LIU ; Lei HU ; Kelu HOU ; Xia SI ; Mei ZHAO ; Wenpei WANG ; Silu LIU ; Lin HUANG ; Ying LIU ; Yufei FENG
China Pharmacy 2021;32(5):623-629
OBJECTIVE:To establish quantitative e valuation system of the prophylactic use of antibiotics in orthopedic type Ⅰ incision surgery ,and to provide reference for evaluating the rational prevention use of antibiotics in this type surgery scientifically. METHODS:Based on the Guidelines of Clinical Use of Antimicrobial Agents (2015 edition),drug instructions ,related guidelines and references ,experts from relevant departments jointly discussed and formulated the evaluation criteria for the rationality of the use of antibiotics in type Ⅰ incision in orthopedic surgery. AHP method was used to assign the weights for various indexes of evaluation criteria ;TOPSIS method was used to retrospectively analyze and evaluate the rationality of 120 cases of type Ⅰ incision surgery from 3 orthopedic departments in Peking University People ’s Hospital during Sept. 1st-30th,2019. RESULTS :Established evaluation system included 4 primary indicators (medication indication ,usage and dosage ,medication timing ,other factors )and 12 secondary indicators. Among the secondary indicators ,indications,drug selection and timing of preoperative administration were the most important (weights were 0.209,0.140,0.117). Among 120 cases,30.83% of drug use were reasonable ,47.50% were basically reasonable and 21.67% were unreasonable. Evaluation results obtained by AHP-TOPSIS were consistent with the actual situation. CONCLUSIONS :The rationality evaluation method of prophylactic use of antibiotics in type Ⅰ incision surgery based on AHP-TOPSIS method can quantitatively evaluate the rationality of drug use by combining multiple indicators. The method is feasible ,operable,and the evaluation results can be quantified ,which has a wide range of application.


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