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.Application value of renal artery resistance index in the diagnosis of intra-abdominal hypertension in critically ill patients
Baoquan CHEN ; Ming CHEN ; Jinyang XU ; Guorong LYU ; Yanfen YANG ; Shuping YANG
Chinese Journal of Emergency Medicine 2024;33(3):360-364
Objective:To explore the application value of renal artery resistance index in the diagnosist of intra-abdominal hypertension (IAH) in critically ill patients.Methods:89 patients with risk factors of IAH in the intensive care unit of Zhangzhou Hospital Affiliated to Fujian Medical University from February 2022 to June 2022 were retrospective analyzed. The intra-abdominal pressure (IAP) were measured by bladder, and patients divided into IAH group (IAP≥12 mmHg) and non-IAH group (IAP <12 mmHg). The resistance index (RI) of the right renal aorta, segment artery and interlobar artery were measured by color Doppler ultrasound. The difference between the measurement indicators of patients in the IAH and non-IAH groups and the correlation with IAP were analyzed. As for different indicators to predict the diagnostic efficacy of IAH, ROC curve analysis was used to evaluate the effect. And further multivariate logistic regression analysis was to find independent risk predictor.Results:A total of 89 patients were included in the study, including 44 patients with normal IAP and 45 patients diagnosed IAH. There were significant differences in the right renal aorta, segmental artery and interlobar artery RI (all P<0.01). The interlobar artery RI≥0.698 was the highest diagnostic cut-off,area under the curve was 0.914, sensitivity was 82.2%, specificity was 97.7%, and Jordon index was 0.799. The Spearman correlation analysis of IAP and the ultrasonographic measurements revealed a strong correlation between right renal interlobar artery RI and IAP ( r=0.741, P<0.01). The multivariate logistic regression analysis showed that the right renal interlobar artery RI ( OR= 24.472, 95% CI:5.122~116.919, P<0.01) was an independent risk predictor of IAH ( P<0.01). Conclusion:Right renal interlobar artery RI had better diagnostic efficacy of IAH,renal ultrasound could be used as an alternative, non-invasive technique for the diagnosis and follow-up of IAH.
4.Prognostic value of the Second Revision of the International Staging System in patients with newly diagnosed transplant-eligible multiple myeloma
Huixing ZHOU ; Yuan JIAN ; Juan DU ; Junru LIU ; Zhiyao ZHANG ; Chuanying GENG ; Guangzhong YANG ; Guorong WANG ; Weijun FU ; Juan LI ; Wenming CHEN ; Wen GAO
Chinese Journal of Internal Medicine 2024;63(1):81-88
Objective:To verify the predictive value of the Second Revision of the International Staging System (R2-ISS) in newly diagnosed patients with multiple myeloma (MM) who underwent first-line autologous hematopoietic stem cell transplantation (ASCT) in a new drug era in China.Methods:This multicenter retrospective cohort study enrolled patients with newly diagnosed MM from three centers in China (Beijing Chao-Yang Hospital, Capital Medical University; the First Affiliated Hospital, Sun Yat-Sen University, and the Second Affiliated Hospital of Naval Medical University) from June 2008 to June 2018. A total of 401 newly diagnosed patients with MM who were candidates for ASCT were enrolled in this cohort, all received proteasome inhibitor and/or immunomodulator-based induction chemotherapy followed by ASCT. Baseline and follow-up data were collected. The patients were regrouped using R2-ISS. Progression-free survival (PFS) and overall survival (OS) were analyzed. The Kaplan-Meier method was used to analyze the survival curve and two survival curves were compared using the log-rank test. Cox regression analysis were performed to analyze the relationship between risk factors and survival.Results:The median age of the patients was 53 years (range 25-69 years) and 59.5% (240 cases) were men. Newly diagnosed patients with renal impairment accounted for 11.5% (46 cases). According to Revised-International Staging System (R-ISS), 74 patients (18.5 %) were diagnosed with stage Ⅰ, 259 patients (64.6%) with stage Ⅱ, and 68 patients (17.0%) with stage Ⅲ. According to the R2-ISS, the distribution of patients in each group was as follows: 50 patients (12.5%) in stage Ⅰ, 95 patients (23.7%) in stage Ⅱ, 206 patients (51.4%) in stage Ⅲ, and 50 patients (12.5%) in stage Ⅳ. The median follow-up time was 35.9 months (range, 6-119 months). According to the R2-ISS stage, the median PFS in each group was: 75.3 months for stage Ⅰ; 62.0 months for stage Ⅱ, 39.2 months for stage Ⅲ, and 30.3 months for stage Ⅳ; and the median OS was not reached, 86.6 months, 71.6 months, and 38.5 months, respectively. There were statistically significant differences in PFS and OS between different groups (both P<0.001). Multivariate Cox regression analysis showed that stages Ⅲ and Ⅳ of the R2-ISS were independent prognostic factors for PFS ( HR=2.37, 95% CI 1.30-4.30; HR=4.50, 95% CI 2.35-9.01) and OS ( HR=4.20, 95% CI 1.50-11.80; HR=9.53, 95% CI 3.21-28.29). Conclusions:The R2-ISS has significant predictive value for PFS and OS for transplant-eligible patients with MM in the new drug era. However, the universality of the R2-ISS still needs to be further verified in different populations.
5.Comparison of etoposide combined with G-CSF and cyclophosphamide combined with G-CSF in the mobilization of autologous peripheral blood stem cells in patients with multiple myeloma
Guorong WANG ; Guangzhong YANG ; Chuanying GENG ; Yun LENG ; Yin WU ; Aijun LIU ; Wenming CHEN
Chinese Journal of Hematology 2024;45(4):351-356
Objective:The effect and safety of etoposide combined with G-CSF were compared with those of cyclophosphamide combined with G-CSF in autologous peripheral blood mobilization in patients with multiple myeloma (MM) .Methods:Patients with MM who received autologous peripheral blood stem cell mobilization and collection in the Department of Hematology, Beijing Chaoyang Hospital Affiliated to Capital Medical University from January 1, 2020 to July 31, 2023 were included. A total of 134 patients were screened by propensity score matching technology according to a 1∶1 ratio. A total of 67 cases were each treated with ETO combined with G-CSF mobilization scheme (ETO group) and CTX combined with G-CSF mobilization scheme (CTX group). Their clinical data were retrospectively analyzed.Results:①Collection results: the ETO and CTX groups [2 (1-3) d vs 2 (1-5) d; P<0.001] and CD34 + cells [7.62×10 6 (2.26×10 6-37.20×10 6) /kg vs 2.73×10 6 (0.53×10 6-9.85×10 6) /kg; P<0.001] were collected. The success rate of collection was 100.0% (67/67) versus 76.1% (51/67) ( P<0.001). Excellent rate of collection was 82.1% (55/67) versus 20.9% (14/67; P<0.001). Two patients in the ETO group switched protocols after 1 day of collection, and 11 patients in the CTX group switched protocols after 1-2 days of collection. ②Adverse reactions: granular deficiency with fever (21.5%[14/65] vs. 10.7%[6/56]; P=0.110), requiring platelet transfusion [10.7% (7/65) vs 1.8% (1/56) ; P=0.047]. ③Until the end of follow-up, 63 cases in the ETO group and 54 cases in the CTX group have undergone autologous transplantation. The median number of CD34 + cells infused in the two groups was 4.62×10 6 (2.14×10 6-19.89×10 6) /kg versus 2.62×10 6 (1.12×10 6-5.31×10 6) /kg ( P<0.001), neutrophil implantation time was 11 (9-14) d versus 11 (10-14) d ( P=0.049), and platelet implantation time was 11 (0-19) d vs. 12 (0-34) d ( P=0.035). One case in the CTX group experienced delayed platelet implantation. Conclusion:The mobilization scheme of etoposide combined with G-CSF requires relatively platelet transfusion, but the collection days are shortened. The collection success rate, excellent rate, and the number of CD34 + cells obtained are high, and the neutrophil and platelet engraftment is accelerated after transplantation.
6.Effect of Ditan Decoction combined with aripiprazole and olanzapine in treatment of schizophrenia and its influence on serum inflammatory factors changes
Yumei HE ; Guorong XIE ; Qing YANG ; Dinglun DUAN ; Yue QIN ; Xinlong WANG ; Minggui LUO ; Fangyan DONG
Chongqing Medicine 2024;53(19):2970-2974,2980
Objective To study the effect of Ditan Decoction combined with aripiprazole and olanzapine in the treatment of schizophrenia and its influence on serum inflammatory factors chnage.Methods Seventy-seven patients with schizophrenia meeting the requirements visiting the outpatient department and hospitalized in Dazu District Hospital of Traditional Chinese Medicine and Dazu District Mental Health Center from July 2021 to March 2023 were selected as the study subjects and divided into the observation group(n=38)and control group(n=39).The control group was treated with aripiprazole and olanzapine,and the observation group was combined with Ditan Decoction on the basis of the control group.After 8 weeks of treatment,the TCM syndrome scores,Positive and Negative Syndrome Scale(PANSS)score,serum inflammatory factors(IL-6,IL-1β,IL-17)levels were compared between the two groups.Results The total effective rate was 97.37%in the observation group and 84.65%in the control group,and the difference was statistically signifi-cant(P<0.05).The TCM syndrome score of each item and total scores after treatment in the observation group were lower than those in the control group(P<0.05),the PANSS positive symptoms,negative symp-toms,general psychopathology and total scores in the observation group were lower than those in the control group(P<0.05).The IL-17,IL-6 and IL-1β levels after treatment in observation group were lower than those in the control group(P<0.05).Conclusion Ditan Decoction combined with aripiprazole and olanzapine has significant clinical efficacy in the treatment of schizophrenia,which could further reduce the symptom score of the patients and improve the serum inflammatory factors levels.The treatment is highly safe and worthy of clinical recommendation.
7.Application value of observed tumor enhancement characteristics by dynamic enhancement MRI in assessing blood supply of small hepatocellular cancer
Yang SUN ; Tingting ZHANG ; Xiaowen HU ; Mengli WANG ; Xiaolong PAN ; Guorong LI
China Medical Equipment 2024;21(11):51-56
Objective:To explore application value of observed tumor enhancement characteristics by dynamic enhancement magnetic resonance imaging(MRI)in assessing blood supply of small hepatocellular cancer.Methods:The cases data of 80 patients with suspected small hepatocellular cancer who admitted to Yichang Central People's Hospital from January 2019 to January 2023 were retrospectively analyzed.The enhancement characteristics of tumors of all patients were real-timely observed by MRI scanner,which included the relative enhancement degree(RSI),enhancement mode,time-signal intensity curve,etc.The enhanced characteristics of the tumors were recorded,which were combined with a series of variables included disease history,tumor type,tumor size,the number of tumor,liver function status of patients to conduct analysis.The receiver operating characteristics(ROC)curve was adopted to analyze the application value of the observed tumor enhancement characteristics by dynamic enhancement MRI in assessing the status of blood supply of small hepatocellular cancer.Results:There were statistically significant differences in the RSI(F=40.151,P<0.05),enhancement degree(x2=27.374,P<0.05),and time-signal intensity curve(x2=20.950,P<0.05)of dynamic enhanced MRI among different stages of small hepatocellular cancer.The differences in medical history(F=17.844,P<0.05),tumor type(x2=11.219,P<0.05),tumor size(x2=14.081,P<0.05),and the number of tumor(x2=74.310,P<0.05)among different enhancement degrees of arterial phase were also statistically significant.With the enhancement degree increased,the asymptomatic period increased,and the number of malignant tumors increased,and tumor size increased.The differences in liver function status among different time-signal intensity curves were statistically significant(F=330.182,325.872,216.689,P<0.05).The area under curve(AUC)value of the ROC of the RSI of observed tumor enhancement characteristics by dynamic enhancement MRI was 0.582(95%CI:0.493-0.670)in assessing blood supply of small hepatocellular cancer.Conclusion:Dynamic enhancement MRI can observe the vascular generation and hemodynamic changes of small hepatocellular cancer,which has a certain application value in assessing blood supply of small hepatocellular cancer,and it can help doctors to choose appropriate treatment plan and assess treatment effect.
8.Pig-tail catheter-assisted 6.5 F guiding catheter versus 6 F guiding catheter in transradial interventional treatment of coronary artery lesions:a comparative study
Xue LIU ; Hua YANG ; Xiaohong WANG ; Gaigai WEN ; Guorong HAO
Journal of Interventional Radiology 2023;32(12):1174-1177
Objective To compare the efficacy and safety of pig-tail catheter-assisted 6.5 F guiding catheter and 6 F guiding catheter in transradial interventional treatment of coronary artery lesions.Methods A total of 390 patients with coronary artery lesions,who received percutaneous coronary intervention(PCI)at the Xijing Hospital of Air Force Medical University of China between January 2021 and June 2022,were enrolled in this study.By using the random number table method the patients were divided into pig-tail catheter-assistance group(n=130),6.5 F sheath group(n=130)and 6 F sheath group(n=130).The success rate of the guiding catheter being inserted in place,radial artery spasm,forearm pain or discomfort,forearm hematoma,radial artery wound compression time,hemostasis success rate,postoperative radial artery diameter,resolution time of distal swelling,pseudoaneurysm,and incidence of radial artery occlusion were compared between each other among the three groups.Results The differences in the time of guiding catheter being inserted in place,radial artery wound compression time,forearm hematoma,hemostasis success rate,postoperative radial artery diameter and incidence of radial artery occlusion between each other among the three groups were not statistically significant(all P>0.05).The differences in the intraoperative radial artery spasm and forearm pain or discomfort between 6.5 F sheath group and 6 F sheath group were not statistically significant(both P>0.05).The degrees of radial artery spasm and forearm pain or discomfort in the pig-tail catheter-assistance group were remarkably lower than those in the 6.5 F sheath group and 6 F sheath group(both P<0.05).Conclusion In transradial PCI,the use of 6.5 F guiding catheter carries the same safety and effectiveness as the use of 6 F guiding catheter,while the use of pig-tail catheter-assisted 6.5 F guiding catheter can improve radial artery spasm and reduce forearm pain.(J Intervent Radiol,2023,32:1174-1177)
9.A summary of the best evidence for manual rehabilitation therapy in patients with breast cancer related lymphedema
Naifang XING ; Guorong WANG ; Jing YANG ; Yeh CHAOHSING ; Tian ZHANG ; Changying TIAN ; Si CHEN
Chinese Journal of Nursing 2023;58(21):2589-2597
Objective To extract and summarize the best evidence of manual rehabilitation therapy in patients with breast cancer related lymphedema.It aims to provide evidence-based basis for clinical nursing staff interven-tion.Methods According to the"6S evidence resource pyramid model",we systematically retrieved from UpTo-Date,BMJ best clinical practice,JBI evidence-based medicine center database of Joanna Briggs Institute in Australi-a,Embase,Cochrane Library,Pubmed,GIN,New Zealand Guidelines collaboration group,SIGN,American Cancer So-ciety,American Association for Physical Therapy,American Society for Lymphatic,American Lymphedema Website,Ontario Association of Registered Nurses of Canada,Yimaitong,CNKI,VIP,CBM,WanFang,CHINAL,Web of Science and OVID databases from establishment of database to January 2023.It mainly includes guidelines,consensuses,evi-dence summaries,clinical decision-making,systematic evaluation and primitive research.There were 2 researchers who independently evaluated the quality of the literature and extracted evidence.Results A total of 19 pieces of the literature were involved,including 4 guidelines,4 consensuses,3 system reviews,1 recommended practice,2 clinical decision-making,1 summary of evidence,4 primitive research.Finally,26 pieces of best evidence are summarized from the 5 aspects of indications,contraindications,treatment points,treatment effects and precautions of manual re-habilitation.Conclusion This study summarized the evidence of manual rehabilitation therapy in breast cancer re-lated lymphedema.It can provide practical basis for clinical nursing staff.In clinical practice,it is important to strictly evaluate whether patients have contraindications to treatment,to follow the recommended treatment plan and monitor complications during treatment.

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