1.Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
Yue YANG ; Jingwei ZHOU ; Jialiang ZOU ; Guorong MEI ; Yifan SHI ; Lei ZHONG ; Jiaojiao WANG ; Xuelian GAN ; Dewen ZENG ; Xin CHEN ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):187-196
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design(QbD) and to assess its health risk. MethodsTaking whole iron content, Fe2+ dissolution content and looseness as critical quality attributes(CQAs), and calcination temperature, calcination time, spreading thickness and particle size as critical process parameters(CPPs) determined by the failure mode and effect analysis(FMEA), the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation(AHP-CRITIC) hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry, and the health risk assessment was carried out by daily exposure(EXP), target hazard quotient(THQ) and lifetime cancer risk(LCR), and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃, calcination time of 1 h, particle size of 0.2-0.5 cm, spreading thickness of 1 cm, and vinegar quenching for 1 time[Haematitum-vinegar(10:3)]. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1, while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4, and the LCR of the rest was<1×10-6, and the LCRs of calcined Haematitum were all<1×10-6, indicating that the carcinogenic risk of calcined Haematitum was low, but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg were formulated as 1 014, 25, 17, 27, 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible, and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
2.Process Optimization and Health Risk Assessment of Calcined Haematitum Based on QbD Concept
Yue YANG ; Jingwei ZHOU ; Jialiang ZOU ; Guorong MEI ; Yifan SHI ; Lei ZHONG ; Jiaojiao WANG ; Xuelian GAN ; Dewen ZENG ; Xin CHEN ; Lin CHEN ; Hongping CHEN ; Shilin CHEN ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):187-196
ObjectiveTo investigate the processing technology of calcined Haematitum based on the concept of quality by design(QbD) and to assess its health risk. MethodsTaking whole iron content, Fe2+ dissolution content and looseness as critical quality attributes(CQAs), and calcination temperature, calcination time, spreading thickness and particle size as critical process parameters(CPPs) determined by the failure mode and effect analysis(FMEA), the processing technology of calcined Haematitum was optimized by orthogonal test combined with analytic hierarchy process-criteria importance through intercriteria correlation(AHP-CRITIC) hybrid weighting method. The contents of heavy metals and harmful elements were determined by inductively coupled plasma mass spectrometry, and the health risk assessment was carried out by daily exposure(EXP), target hazard quotient(THQ) and lifetime cancer risk(LCR), and the theoretical value of the maximum limit was deduced. ResultsThe optimal processing technology for calcined Haematitum was calcination at 650 ℃, calcination time of 1 h, particle size of 0.2-0.5 cm, spreading thickness of 1 cm, and vinegar quenching for 1 time[Haematitum-vinegar(10:3)]. The contents of 5 heavy metals and harmful elements in 13 batches of calcined Haematitum were all decreased with reductions of up to 5-fold. The cumulative THQ of 2 batches of samples was>1, while the cumulative THQ of all batches of Haematitum was>1. The LCR of As in 1 batches of Haematitum was 1×10-6-1×10-4, and the LCR of the rest was<1×10-6, and the LCRs of calcined Haematitum were all<1×10-6, indicating that the carcinogenic risk of calcined Haematitum was low, but special attention should still be paid to Haematitum medicinal materials. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg were formulated as 1 014, 25, 17, 27, 7 mg·kg-1. ConclusionThe optimized processing technology of calcined Haematitum is stable and feasible, and the contents of heavy metals and harmful elements are reduced after processing. Preliminary theoretical values of the maximum limits of Cu, As, Cd, Pb and Hg are formulated to provide a scientific basis for the formulation of standards for the limits of harmful elements in Haematitum.
3.Develop a rehabilitation nursing model of external treatment of traditional Chinese medicine for knee osteoarthritis
Lingyun SHI ; Jingjing ZHANG ; Jiaojiao SHU ; Jiaxue LI ; Yuan ZHANG ; Jiaju ZHAO ; Guoliang HOU ; Maimaiti PALIDA
Modern Clinical Nursing 2025;24(5):33-40
Objective To develop a rehabilitation nursing model for knee osteoarthritis(KOA)of external treatment in traditional Chinese medicine(TCM).Methods Between February and June 2023,a preliminary KOA rehabilitation nursing model was developed through literature search and semi-structured interview method.Two rounds of Delphi consultations were conducted with the selected experts,to establish a rehabilitation nursing model for KOA of TCM external treatment.Results A total of 24 experts from different regions participated in the consultation.The final rehabilitation nursing model of TCM external treatment for KOA included 3 primary indicators,16 secondary indicators and 91 tertiary indicators.The response rates from the two rounds of expert consultation were 96.00%and 100.00%,respectively,and the rates of expert opinion proposal were 58.33%and 8.33%,respectively.The expert authority coefficient were 0.906 and 0.923.The two rounds of expert consultation were 0.137 and 0.236 in Kendall's coefficient of concordance(W),with statistically significant differences(both P<0.001).The importance scores of each item in the second inquiry ranged from 3.75 to 4.88,and the coefficient of variation ranged from 0.07 to 0.30,and the full score ratio ranged from 20.83%to 87.50%.Conclusion The rehabilitation nursing model for KOA of TCM external treatment developed in this study is significant,scientific and feasible.It provides a guidance for medical professionals.
4.Effect of walking-cognition dual-task training combined with active self-disclosure on elderly patients with acute ischemic stroke
Qinqin HU ; Xueying SHI ; Anna WANG ; Pengchao WU ; Qin ZHOU ; Jiaojiao LI ; Xing YUAN ; Jian LI
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2025;27(2):197-201
Objective To observe the effect of specialist team-led walking-cognition dual-task train-ing combined with active self-disclosure on control and balance abilities in elderly patients with acute ischemic stroke(AIS).Methods A total of 90 elderly AIS patients treated in our hospital from January 2022 to January 2024 were enrolled and randomly assigned into the control group and the observation group,with 45 cases in each group.The control group received routine walk-ing training,while the observation group received specialist team-led walking-cognition dual-task training combined with active self-disclosure intervention.Control ability,balance ability,walking ability,cognitive function and psychological status were compared between the two groups.Results After intervention,the scores of Sheikh Trunk Control Scale and Fugl-Meyer Assessment(FMA),and the static balance score,dynamic balance score and total score of Berg Balance Scale(BBS)were significantly increased in both the observation and the control groups(P<0.05),and all above scores were obviously higher in the former group than the latter one(P<0.01).The two groups also obtained notably shorter single-and dual-task walking time after intervention,but there were no statistical difference in the single-task walking time in both groups before and after intervention(P>0.05).After intervention,the observation group had significantly shorter dual-task walking time(22.87±7.36 s vs 27.52±8.71 s,P=0.008)and lower walking time cost of dual task[(11.16±4.07)%vs(25.61±7.82)%,P=0.000]when compared with the control group.After intervention,the scores of Mini-Mental Status Examination were increased,and the scores of Hamilton Depression Rating Scale and Hamilton Anxiety Rating Scale were decreased in the two groups(P<0.05).Conclusion Specialist team-led walking-cognition dual-task training com-bined with active self-disclosure intervention can effectively improve trunk control ability,balance ability,walking ability,cognitive function and psychological state in elderly AIS patients,has cer-tian clinical application value.
5.Analysis of Differences in Secondary Metabolites Between Dendrobium nobile Bionic Wild Cultivated on Epiphytic Stones and Trees Based on Widely Targeted Metabolomics
Yifan SHI ; Changqing ZHOU ; Jiaojiao WANG ; Lin CHEN ; Hongping CHEN ; Fu WANG ; Yuan HU ; Youping LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(10):218-224
ObjectiveTo explore the differences in the accumulation of secondary metabolites of Dendrobium nobile cultivated on epiphytic stones and trees, so as to elucidate the scientific connotation of "only those that grow on stones has superior quality", and provide a direction for the cultivation and quality evaluation of D. nobile. MethodsUltra-performance liquid chromatography-triple quadrupole/linear ion trap mass spectrometry(UPLC-QTRAP-MS/MS)-based widely targeted metabolomics was used to detect the metabolites of D. nobile cultivated on epiphytic stones and trees. And the combination of principal component analysis(PCA), hierarchical cluster analysis(HCA), and orthogonal partial least squares-discriminant analysis(OPLS-DA) was performed for multivariate statistical analysis of metabolites. Differential metabolites were screened by variable importance in the projection(VIP) value≥1 and log2fold change(FC)≥1 or ≤-1, and Kyoto Encyclopedia of Genes and Genomes(KEGG) enrichment analysis was conducted. ResultsA total of 1 267 metabolites were identified in the stems of D. nobile from the two cultivation modes, dominated by flavonoids(292), phenolic acids(284), and alkaloids(189). Through OPLS-DA screening, 473 differential metabolites were obtained. Compared to epiphytic tree-cultivated D. nobile, epiphytic stone-cultivated D. nobile exhibited upregulation of flavonoids, phenolic acids, alkaloids, lignans and coumarins, while quinones and terpenoids were down-regulated. The differential metabolites mainly included flavonoid glycosides and alkaloids, and these differential metabolites significantly contributed to characterizing the two cultivation patterns. KEGG enrichment analysis revealed significant enrichment in pathways of flavone and flavonol biosynthesis, flavonoid biosynthesis, tyrosine metabolism, and phenylalanine metabolism in epiphytic stone-cultivated D. nobile. ConclusionEpiphytic stone cultivation is beneficial for the accumulation of phenolic acids, flavonoids, and alkaloids in D. nobile, indicating that the "only those that grow on stones has superior quality" documented in the materia medica has certain scientific basis, and the findings also provide a reference for quality evaluation and discrimination research between epiphytic stone and tree cultivated D. nobile.
6.Correlation between the expression of serum miR-1298-5p,miR-625-5p and miR-155 and the degree of Helicobacter pylori infection in elderly gastric cancer patients
Chunli TANG ; Shujuan FAN ; Sheng TAO ; Jianning LIU ; Feng SU ; Caiyun YUAN ; Meiling ZHU ; Ruimei ZHONG ; JiaoJiao CAO ; Yun WANG
International Journal of Laboratory Medicine 2025;46(2):151-156
Objective To explore the correlation between the expression of serum microRNA(miR)-1298-5p,miR-625-5p,and miR-155 with the degree of Helicobacter pylori(Hp)infection in elderly gastric cancer patients.Methods From January 2021 to November 2023,120 elderly patients with gastric cancer admitted to the hospital from January 2021 to November 2023 were selected as the gastric cancer group,and 130 non-gas-tric cancer patients who underwent gastroscopy were selected as the control group.The expression levels of miR-1298-5p,miR-625-5p and miR-155 in serum were detected by fluorescence quantitative PCR(qPCR).Car-bon 13 urea breath test was used to detect the positive rate of Hp infection in two groups,and the degree of Hp infection in elderly patients with gastric cancer were evaluated.Receiver operating characteristic(ROC)curve was applied to analyze the diagnostic value of serum miR-1298-5p,miR-625-5p,and miR-155 expression levels for Hp infection in elderly gastric cancer patients.Pearson method was applied to analyze the correlation between serum miR-1298-5p,miR-625-5p,miR-155 expression and positive rate of Hp infection in elderly gas-tric cancer patients.Results Compared with the control group,the expression levels of miR-1298-5p and miR-625-5p in serum of gastric cancer group decreased(P<0.05),while the positive rate of Hp infection and the expression level of serum miR-155 increased(P<0.05).The expression levels of serum miR-1298-5p and miR-625-5p in elderly gastric cancer patients with Hp grade Ⅰ,Ⅱ,and Ⅲ infection were lower than those without Hp infection,while the expression level of miR-155 was higher(P<0.05).Patients with poor differ-entiation,lymph node metastasis,and TNM stage Ⅲ-Ⅳ had lower expressions of serum miR-1298-5p and miR-625-5p(P<0.05),and higher expression of miR-155(P<0.05)than those with moderate-high differen-tiation,no lymph node metastasis,and TNM stage Ⅰ-Ⅱ.The expression levels of serum miR-1298-5p and miR-625-5p were negatively correlated with the positive rate of Hp infection in elderly patients with gastric cancer(r=-0.443,-0.386,both P<0.001),and the expression levels of serum miR-155 were positively correlated with the positive rate of Hp infection(r=0.525,P<0.001).The area under the curve(AUC)of serum miR-1298-5p,miR-625-5p and miR-155 combined diagnosis of Hp infection in elderly gastric cancer pa-tients was higher than that of single diagnosis(P<0.05).Conclusion The expression levels of miR-1298-5p and miR-625-5p in serum of elderly gastric cancer patients with Hp infection decrease,while the expression level of miR-155 increases.These three factors are related to the degree of Hp infection and have good diag-nostic value for the occurrence of Hp infection.
7.Efficacy and safety of tegoprazan in the treatment of gastroesophageal reflux disease:a systematic review and Meta-analysis
Ronghua LU ; Jiaojiao LIU ; Tengfei PANG ; Rui CAI ; Jian YUAN
Chinese Journal of Pharmacoepidemiology 2025;34(11):1294-1301
Objective To systematically review the efficacy and safety of tegoprazan in the treatment of gastroesophageal reflux disease(GERD).Methods PubMed,Embase,Web of Science,Cochrane Library,SinoMed,CNKI,VIP,and WanFang Data databases were electronically searched to collect randomized controlled trials(RCTs)on tegoprazan for GERD treatment from inception to January 1,2025.Two researchers independently screened the literature,extracted data and assessed the risk of bias of the included studies.Meta-analysis was performed using RevMan 5.4 software and Stata 16 software.Results A total of 7 RCTs were included,involving 1,329 patients.The results of Meta-analysis showed that there was no statistically significant difference in the overall effective rate between the tegoprazan group and the control group(placebo or proton pump inhibitors)[RR=1.08,95%CI(0.99,1.17),P=0.07].There was also no statistically significant difference in the cure rate between the tegoprazan group and the control group(proton pump inhibitors)[RR=0.99,95%CI(0.96,1.02),P=0.53].Comparing the incidence of treatment-emergent adverse events(TEAE)and serious adverse events(SAE)during treatment between the tegoprazan group and the control group,no statistically significant differences were found[TEAE:RR=0.90,95%CI(0.62,1.32),P=0.60;SAE:RR=0.61,95%CI(0.26,1.48),P=0.28].In terms of specific adverse event,the incidence of abnormal liver function was significantly higher in the tegoprazan group compared to the control group[RR=7.60,95%CI(1.40,42.27),P=0.02],while the incidence of other adverse reactions showed no significant differences(P>0.05).Conclusion Tegoprazan has relatively good overall efficacy and safety in the treatment of GERD,and its efficacy is similar to that of proton pump inhibitors,which can be used as an alternative treatment for proton pump inhibitors.Due to the limited quality and quantity of the included studies,more high-quality RCTs are needed to verify the above conclusion.
8.Study on the applied value of combined clinical and ultrasound multiparameter constructed nomogram for predicting HER-2-positive breast cancer
Xinran ZHANG ; Yan SHEN ; Jiaojiao HU ; Qingqing CHEN ; Yangjie XIAO ; Feng LU ; Shasha YUAN ; Xiaohong FU
The Journal of Practical Medicine 2025;41(18):2812-2819
Objective To evaluate the predictive value of a nomogram model developed by integrating clinical and ultrasound multiparameters for HER-2-positive breast cancer.Methods This study retrospectively enrolled 343 patients with pathologically confirmed breast cancer from three medical centers and randomly divided them into training and validation cohorts.Univariate analysis,LASSO regression,and multivariate logistic regres-sion were conducted on the training set to identify independent prognostic factors and construct a nomogram model.Bootstrap resampling with 1000 iterations was performed to evaluate the model's robustness.Model calibration was assessed using calibration curves and the Hosmer-Lemeshow goodness-of-fit test.Receiver operating characteristic(ROC)curves were generated to evaluate model discrimination,and the area under the curve(AUC)along with other performance metrics were calculated.Decision curve analysis was employed to assess the clinical utility of the model,and the validation cohort was used for external validation.Results Univariate,LASSO,and multivariate regression analyses demonstrated that age,TTP(time to peak),and the presence of a filling defect sign were independent predictors of HER-2-positive breast cancer(all P<0.05).Based on these independent predictors,a nomogram model was constructed.Bootstrap validation with 1,000 resamples indicated that the model's predictive performance was stable.The Hosmer-Lemeshow test confirmed satisfactory model calibration,while the calibration curve illustrated accurate prediction probabilities.The area under the curve(AUC)for the training set was 0.863(95%CI:0.806~0.920),and for the validation set,it was 0.846(95%CI:0.764~0.929),indicating strong discriminative and generalization capabilities.Additionally,the clinical decision curve analysis demonstrated favor-able clinical utility.Conclusion A nomogram model integrating clinical and multimodal ultrasound parameters demonstrates potential utility in predicting HER-2-positive breast cancer.
9.Behavioral causes of lack of compliance with life care in the transplant warehouse in hematopoietic stem cell transplantation patients: a qualitative study
Yuan TIAN ; Xiaofei LIN ; Yuanyuan LIN ; Jiaojiao WENG ; Xin'en LYU ; Shujuan ZHOU
Chinese Journal of Modern Nursing 2025;31(10):1364-1370
Objective:To explore the causes of lack of compliance with life care in hematopoietic stem cell transplantation recipients while living alone in the transplant warehouse, and to provide a basis for developing targeted promotion measures.Methods:Using purposive sampling method, from June to December 2023, on-site observations were conducted on the voluntary completion of life care by hematopoietic stem cell transplant patients (with a 30 day observation period) admitted to the Blood Transplantation Center of the First Affiliated Hospital of Wenzhou Medical University. The compliance was calculated after the observation period. Patients with a compliance of less than 80% were selected, and semi-structured interviews were conducted with 17 of them after informed consent. The Colaizzi 7-step analysis method was applied to organize and analyze the interview data.Results:Three core themes on lack of compliance were distilled, namely physical factors impeding compliance (somatic specific symptoms leading to distraction, somatic non-specific symptoms leading to activity intolerance), psychological factors impeding compliance (negative emotions, comfort zone dilemmas, regression phenomena, constraints of personality psychological traits), and cognitive factors impeding compliance (subjective cognitive unperceived benefit, poor modeling resulting in cognitive biases, limited perceived attention) .Conclusions:The behavioral causes of lack of compliance with life care of hematopoietic stem cell transplant patients while living alone in the transplant warehouse are due to multiple factors of the body and mind, among which psychologically mediated mechanisms are key to compliance. Healthcare professionals should pay attention to both the physiological and psychological needs of patients, actively alleviate physical symptoms, appropriately provide psychological care to remove psychological barriers, help them actively seek family and social support, and promote cognitive improvement, thereby improving compliance.
10.Efficacy and safety of tegoprazan in the treatment of gastroesophageal reflux disease:a systematic review and Meta-analysis
Ronghua LU ; Jiaojiao LIU ; Tengfei PANG ; Rui CAI ; Jian YUAN
Chinese Journal of Pharmacoepidemiology 2025;34(11):1294-1301
Objective To systematically review the efficacy and safety of tegoprazan in the treatment of gastroesophageal reflux disease(GERD).Methods PubMed,Embase,Web of Science,Cochrane Library,SinoMed,CNKI,VIP,and WanFang Data databases were electronically searched to collect randomized controlled trials(RCTs)on tegoprazan for GERD treatment from inception to January 1,2025.Two researchers independently screened the literature,extracted data and assessed the risk of bias of the included studies.Meta-analysis was performed using RevMan 5.4 software and Stata 16 software.Results A total of 7 RCTs were included,involving 1,329 patients.The results of Meta-analysis showed that there was no statistically significant difference in the overall effective rate between the tegoprazan group and the control group(placebo or proton pump inhibitors)[RR=1.08,95%CI(0.99,1.17),P=0.07].There was also no statistically significant difference in the cure rate between the tegoprazan group and the control group(proton pump inhibitors)[RR=0.99,95%CI(0.96,1.02),P=0.53].Comparing the incidence of treatment-emergent adverse events(TEAE)and serious adverse events(SAE)during treatment between the tegoprazan group and the control group,no statistically significant differences were found[TEAE:RR=0.90,95%CI(0.62,1.32),P=0.60;SAE:RR=0.61,95%CI(0.26,1.48),P=0.28].In terms of specific adverse event,the incidence of abnormal liver function was significantly higher in the tegoprazan group compared to the control group[RR=7.60,95%CI(1.40,42.27),P=0.02],while the incidence of other adverse reactions showed no significant differences(P>0.05).Conclusion Tegoprazan has relatively good overall efficacy and safety in the treatment of GERD,and its efficacy is similar to that of proton pump inhibitors,which can be used as an alternative treatment for proton pump inhibitors.Due to the limited quality and quantity of the included studies,more high-quality RCTs are needed to verify the above conclusion.

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