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.Clinical effect analysis of endoscopic radical thyroidectomy via three-port gasless intermuscular approach
Chenlei SHI ; Guorong LEI ; Yingming LIU ; Xiaocong ZHANG ; Yang LIU ; Tiefeng SHI ; Huadong QIN ; Jing YAO ; Bing WANG ; Wen TIAN
Chinese Journal of Surgery 2025;63(4):354-360
Objective:To explore the clinical effect of endoscopic radical thyroidectomy via three-port gasless intermuscular approach.Methods:This is a retrospective cohort study. The data of 148 patients who underwent radical thyroidectomy at the Fourth General Surgery Department of the Second Affiliated Hospital of Harbin Medical University from January to June 2024 were retrospectively analyzed. There were 31 males and 117 females,aging (43.5±9.6) years (range: 21 to 64 years). The surgical method was selected according to the needs and wishes of patients. Among them, 77 cases underwent endoscopic radical thyroidectomy via unilateral three-port gasless intermuscular approach (three-port gasless group),and 71 cases underwent unilateral conventional open radical thyroidectomy(open group). The surgical technique exploration curve of the three-port gasless group was drawn based on the operation time and the number of lymph node dissections,and the technical exploration period and the technical maturity period were divided. The clinical data of the cases in the three-port gasless group and the open group were compared during the technical maturity period. The independent sample t test was used to compare the quantitative data between the two groups, and the χ2 test or Fisher exact probability method was used to compare the categorical data, respectively. Results:According to the technical exploration curve,there were 11 cases in the technical exploration period of the three-port gasless group,and 66 cases in the technical maturity period. In the technical mature period,the injury rate of temporary recurrent laryngeal nerve in the three-port gasless group was 1.5% (1/65),and the number of lymph node dissections was 5.9±3.5(range:0 to 14),which was not statistically significant compared with 4.4% (3/68) and 5.8±3.7(range:0 to 16) in the open group (all P>0.05). In the technical mature period,the operation time of the three-port gasless group was (39.2±6.2)minutes(range:30 to 55 minutes) and the postoperative drainage volume was (57.6±11.8) ml(range:30 to 90 ml),which were lower than those of the open group((67.8±13.9) minutes (range: 30 to 105 minutes) and (82.9±22.4)ml(range:50 to 175 ml)),and the differences were statistically significant ( t=15.303, 8.177, both P>0.05). During the technical maturity period,the postoperative hospital stay in the three-port gasless group was (3.2±0.4)days(range:3 to 4 days), which was not statistically different from that of the open group((3.2±0.4)days(range:3 to 5 days))( P>0.05). The incision satisfaction of patients in the three-port gasless group one month after the operation was higher than that of the control group (100% vs. 62.0%) ( P<0.01). Conclusion:Compared with open surgery,endoscopic radical thyroidectomy via three-port gasless intermuscular approach has certain advantages in terms of operation time, postoperative drainage volume and patient cosmetic satisfaction.
4.Developing a polygenic risk score for pelvic organ prolapse: a combined risk assessment approach in Chinese women.
Xi CHENG ; Lei LI ; Xijuan LIN ; Na CHEN ; Xudong LIU ; Yaqian LI ; Zhaoai LI ; Jian GONG ; Qing LIU ; Yuling WANG ; Juntao WANG ; Zhijun XIA ; Yongxian LU ; Hangmei JIN ; Xiaowei ZHANG ; Luwen WANG ; Juan CHEN ; Guorong FAN ; Shan DENG ; Sen ZHAO ; Lan ZHU
Frontiers of Medicine 2025;19(4):665-674
Pelvic organ prolapse (POP), whose etiology is influenced by genetic and clinical risk factors, considerably impacts women's quality of life. However, the genetic underpinnings in non-European populations and comprehensive risk models integrating genetic and clinical factors remain underexplored. This study constructed the first polygenic risk score (PRS) for POP in the Chinese population by utilizing 20 disease-associated variants from the largest existing genome-wide association study. We analyzed a discovery cohort of 576 cases and 623 controls and a validation cohort of 264 cases and 200 controls. Results showed that the case group exhibited a significantly higher PRS than the control group. Moreover, the odds ratio of the top 10% risk group was 2.6 times higher than that of the bottom 10%. A high PRS was significantly correlated with POP occurrence in women older than 50 years old and in those with one or no childbirths. As far as we know, the integrated prediction model, which combined PRS and clinical risk factors, demonstrated better predictive accuracy than other existing PRS models. This combined risk assessment model serves as a robust tool for POP risk prediction and stratification, thereby offering insights into individualized preventive measures and treatment strategies in future clinical practice.
Humans
;
Female
;
Pelvic Organ Prolapse/epidemiology*
;
Middle Aged
;
Risk Assessment/methods*
;
China/epidemiology*
;
Multifactorial Inheritance
;
Aged
;
Risk Factors
;
Genome-Wide Association Study
;
Genetic Predisposition to Disease
;
Case-Control Studies
;
Adult
;
Polymorphism, Single Nucleotide
;
Genetic Risk Score
;
East Asian People
5.Clinical effect analysis of endoscopic radical thyroidectomy via three-port gasless intermuscular approach
Chenlei SHI ; Guorong LEI ; Yingming LIU ; Xiaocong ZHANG ; Yang LIU ; Tiefeng SHI ; Huadong QIN ; Jing YAO ; Bing WANG ; Wen TIAN
Chinese Journal of Surgery 2025;63(4):354-360
Objective:To explore the clinical effect of endoscopic radical thyroidectomy via three-port gasless intermuscular approach.Methods:This is a retrospective cohort study. The data of 148 patients who underwent radical thyroidectomy at the Fourth General Surgery Department of the Second Affiliated Hospital of Harbin Medical University from January to June 2024 were retrospectively analyzed. There were 31 males and 117 females,aging (43.5±9.6) years (range: 21 to 64 years). The surgical method was selected according to the needs and wishes of patients. Among them, 77 cases underwent endoscopic radical thyroidectomy via unilateral three-port gasless intermuscular approach (three-port gasless group),and 71 cases underwent unilateral conventional open radical thyroidectomy(open group). The surgical technique exploration curve of the three-port gasless group was drawn based on the operation time and the number of lymph node dissections,and the technical exploration period and the technical maturity period were divided. The clinical data of the cases in the three-port gasless group and the open group were compared during the technical maturity period. The independent sample t test was used to compare the quantitative data between the two groups, and the χ2 test or Fisher exact probability method was used to compare the categorical data, respectively. Results:According to the technical exploration curve,there were 11 cases in the technical exploration period of the three-port gasless group,and 66 cases in the technical maturity period. In the technical mature period,the injury rate of temporary recurrent laryngeal nerve in the three-port gasless group was 1.5% (1/65),and the number of lymph node dissections was 5.9±3.5(range:0 to 14),which was not statistically significant compared with 4.4% (3/68) and 5.8±3.7(range:0 to 16) in the open group (all P>0.05). In the technical mature period,the operation time of the three-port gasless group was (39.2±6.2)minutes(range:30 to 55 minutes) and the postoperative drainage volume was (57.6±11.8) ml(range:30 to 90 ml),which were lower than those of the open group((67.8±13.9) minutes (range: 30 to 105 minutes) and (82.9±22.4)ml(range:50 to 175 ml)),and the differences were statistically significant ( t=15.303, 8.177, both P>0.05). During the technical maturity period,the postoperative hospital stay in the three-port gasless group was (3.2±0.4)days(range:3 to 4 days), which was not statistically different from that of the open group((3.2±0.4)days(range:3 to 5 days))( P>0.05). The incision satisfaction of patients in the three-port gasless group one month after the operation was higher than that of the control group (100% vs. 62.0%) ( P<0.01). Conclusion:Compared with open surgery,endoscopic radical thyroidectomy via three-port gasless intermuscular approach has certain advantages in terms of operation time, postoperative drainage volume and patient cosmetic satisfaction.
6.Management of cancer day-chemotherapy ward in Class Ⅱor Ⅲ hospitals of Sichuan Province
Lei LUO ; Guorong WANG ; Xiaohui TAN ; Chang SU
Chinese Journal of Modern Nursing 2020;26(3):287-292
Objective To explore the development and management of cancer day-chemotherapy ward in Sichuan Province so as to provide a basis for standardized development. Methods From January to November 2018, this study selected totals of 64 Class Ⅱ or Ⅲ hospitals from 21 cities and autonomous prefectures in Sichuan Province by convenience sampling as subjects. All of subjects were investigated with the self-designed Cancer Day-Chemotherapy Ward Management Questionnaire. Frequency and percentage were used to descriptive statistics. Results In Sichuan, there were 15 Class Ⅱ or Ⅲ hospitals with cancer day-chemotherapy service distributed in developed culture and economic areas of Central Sichuan. Patients with clear consciousness, light condition and self-care met inclusive criteria were selected in day-chemotherapy ward by all hospitals, and 40.00%(6/15) hospitals not accepted patients with the initial chemotherapy. Management modes were mainly day-care ward in words-oriented; staffing were mainly professional nurses and rotation doctors. There were 60.00%(9/15) of hospitals installed with the humanistic equipment and emergency area; 40.00%(6/15) of hospitals centralized allocation of chemotherapeutic drugs;80.00%(12/15) of hospitals formulated quality control standards. Conclusions Cancer day-chemotherapy wards are uneven distributed in Sichuan Province. There are differences in the development models, consulting models, management models, staffing, environments,occupational protections and quality control among hospitals. Management needs to be standardized further. Unified basic standards and management rules should be built to promote the development of cancer day-chemotherapy ward.
7.Exploration of Pharmaceutical Practice for Drug-induced Liver Injury
Lei KANG ; Xiaowei LIN ; Guodong WANG ; Yufei XI ; Jing TANG ; Gaolin LIU ; Guorong FAN
China Pharmacist 2017;20(11):2025-2029
Objective:To explore a new way of pharmaceutical service mode for disease treatment. Methods:Clinical pharmacists actively participated in the pharmaceutical care for a patient with mixed liver injury, and provided clinical pharmaceutical services through the adverse reaction analysis,etiological mechanisms exploration,therapeutic drugs selection and risk factors prevention. Re-sults:Clinical pharmacists cooperating closely with physicians helped to identify problems in time,and then the medication analysis in the fields of drug selection, dose determination, efficacy evaluation and indicators detection was performed, so that the strategies on medicine treatment could be adjusted timely as the disease progressed. With the gradual recovery of liver function, the patient dis-charged after the conditions were improved. Conclusion:By participating in pharmaceutical practice,clinical pharmacists can provide clinical pharmaceutical service,which is helpful to safety improvement and efficiency of drug administration. It is also an effective way to enhance the learning ability of pharmacists,and cultivate their clinical thinking and practice capacity.
8.Differential expression of D2 and D3 alternative splicing sites of hepatocellular carcinoma-associated antigen kinectin in human hepatocellular carcinoma tissues and normal liver tissues in Guangxi Province
Lei YAN ; Hong WU ; Kaijun LI ; Xudong ZHANG ; Yuezhen LI ; Shuang LI ; Jing HU ; Huashu JIN ; Guorong LUO
Chinese Journal of Endemiology 2017;36(8):562-565
Objective To analyze the differential expression of D2 and D3 alternative splicing sites of human kinectin in human hepatocellular carcinoma (HCC) tissues, adjacent non-cancerous tissues and normal liver tissues, and to investigate a possible relationship between alternative splicing sites of kinectin and hepatocarcinogenesis. Methods The cDNA was obtained by RT-PCR in 45 coupled HCC cancerous and adjacent tissues, and 10 normal liver tissues. The difference in the expression of D2 and D3 alternative splicing sites in cDNA was examined by semi-quantitative PCR, and statistical analysis was performed. Results The ratio of D2L (long segment contains of the D2 region)/D2S (short segment that does not contain a D2 zone) in hepatocellular cancerous tissues was 2.709 ± 1.025, the ratio of D2L/D2S in adjacent non-cancerous tissues was 1.564 ± 0.357, and the ratio of D2L/D2S in normal liver tissues was 1.507 ± 0.499. The differences were statistically significant (F=29.698, P<0.05);the ratio of D2L/D2S in hepatocellular cancerous tissues was higher than that of adjacent non-cancerous tissues and normal liver tissues (P<0.05). The ratio of D3L (long segment contains of the D3 region)/D3S (short segment that does not contain a D3 zone) in hepatocellular cancerous tissues was 1.232 ± 0.041, the ratio of D3L/D3S in adjacent non-cancerous tissues was 1.156 ± 0.309, and the ratio of D3L/D3S in normal liver tissues was 1.282 ± 0.343. The ratio of D3L/D3S was not significantly different among hepatocellular cancerous tissues, adjacent non-cancerous tissues and normal liver tissues (F = 0.989, P > 0.05). Conclusion Variant containing D2 is over expressed in cancerous tissues and this alteration may be tumor associated.
9.A prospective study on the incidence and occurence time of PICC-related upper extremity venous thrombosis in cancer patients
Lei LUO ; Guorong WANG ; Ying QIN
Chinese Journal of Practical Nursing 2016;32(8):576-580
Objective To investigate the incidence and occurrence time of PICC-related upper extremity asymptomatic and symptomatic venous thrombosis in cancer patients;to explore the risk of asymptomatic venous thrombosis' developing into symptomatic venous thrombosis.Methods A total of 246 cancer patients who were scheduled to receive PICC between April and October 2014 were prospectively studied and divided into 2 groups by random digits table method.The time-phased follow-up observation on PICC cathertering cancer patients was conducted by Doppler ultrasound.The follow-up visiting inspection on the cathering upper limb vein by Doppler ultrasound at the 2nd,7th,14th,21st,28th,35th,42nd day were arranged after insertion of the catheter in experimental group (127 cases) to understand the incidence and occurrence time of asymptomatic venous thrombosis,while the control group (119 cases) were investigated for inspecting whether there were venous thrombosis through clinical symptoms or not.Once the clinical symptoms occurred,the incidence and time of occurrence of symptomatic venous thrombosis would be diagnosed by Doppler ultrasound and recorded.Results The incidence rate of asymptomatic thrombosis in the experimental group was 48.82%(62/127),the median time was 3 days,and there was no symptomatic thrombosis.Among them,85.48%(53/62) of the asymptomatic thrombosis occurred within 1 week,11.29% (7/62) occurred in 2-3 weeks,and 3.23% (2/62) occurred in 4-6 weeks after catheter insertion.Meanwhile,the incidence and median time of symptomatic thrombosis was 23.53%(28/119) and 12 days respectively in the control group.And 32.14% (9/28) of these cases occurred within 1 week,50.00% (14/28) occurred in 2-3 weeks,and 17.86% (5/28) occurred in 4-6 weeks after catheter insertion.Conclusions The incidence of PICC-related upper extremity venous thrombosis in cancer patients is relatively high,and most cases have no symptoms and occur in an early time.Cancer patients are high-risk patients of venous thrombus.We should take early preventive intervention and treatment to reduce the incidence of venous thrombosis after catheter insertion.
10.Efficacy and safety of pregabalin in neuropathic cancer pain: a randomized control multicentre trial
Lei SIMA ; Bifa FAN ; Zhonghuang XU ; Tingjie ZHANG ; Donglin JIA ; Guorong ZHANG
Chinese Journal of Neuromedicine 2016;15(10):1032-1035
Objective To examine the efficacy and safety of pregabalin in patients with neuropathic cancer pain (NCP).Methods A prospective randomized control multicenter trial was conducted in five hospitals;from January 2015 to January 2016,one hundred and twenty two eligible inpatients and outpatients were divided into pregablin treatment group (n=60) and control group (n=62).Patients in the pregablin group added pregablin to opiod background analgesia,while those in the control group raised opioid dose instead.The Numerical Pain Rating Scale (NRS) scores,paraesthesia scale scores,Hamilton's Depression (HAMD) scale scores,analgesia dose,patiends satisfaction,and adverse events were recorded 14 d after each treatment.Results After each treatment,the NRS scores were decreased by (2.3 ±1.1) and (1.3±1.5),the paraesthesia scale scores were decreased by (1.6±0.6) and (0.4±0.3),and the HAMD scale scores were decreased by (4.4±1.2) and (2.4±1.0) in the pregablin treatment group and control group,respectively,with significant differences (P<0.05).Morphine dose for breakthrough pain in pregabalin group was statistically less than that in control group ([30.6±3.5] mg/d vs.[70.9±12.3] mg/d,P<0.05).Patients satisfaction in the pregablin treatment group was significantly higher than that in the control group (P<0.05).Pregabalin treatment group had less severe adverse effects (3/56,5%) as compared with control group (10/59,16.1%,P<0.05).Conclusion Pregabalin has positive roles in patients with NCP already receiving opioid;pregabalin has better pain-control and mood improvement.

Result Analysis
Print
Save
E-mail