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.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.
4.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.
5.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.
6.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.
7.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.
8.The study of relevance between platelet activity and HS1 phosphorylation in sepsis
Lei XU ; Dongfeng GUO ; Guorong LIU ; Qin SHI ; Changming ZHAO ; Min HANG
Chinese Journal of Emergency Medicine 2015;24(11):1253-1256
Objective To explore the change of function and expression of hematopoietic lineage cell specific protein-1 (HS1) and phosphorylated HS1 (p-HIS) and factors devoting to HS1 phosphorylation in platelet with sepsis.Methods Plasma with rich platelet was collected from 150 sepsis patients and 50 healthy subjects, and comparison of platelets adhesion and aggregation were detected by micro-pore method and platelet aggregation instrument.Meanwhile the ATP concentrations of washed platelet of two groups were detected by the kit to compare release reaction.And then total HS1 (t-HIS) and p-HS1 of platelet from two groups were compared by using western blot.Afterwards the specific inhibitors of Src and Syk were used to verify the HS1 activation regulated by Src and Syk in LPS-induced cell model.Results The significant differences were present between healthy subjects and sepsis patients in platelet counts, platelet distribution width (PDW) and mean platelet volume (MPV) (P < 0.01).The data showed the sepsis patients had greater ability than healthy subjects in adhesion, aggregation and release reaction.Meanwhile the platelets of sepsis patients had higher concentration of t-HS1 and p-HS1 than healthy subjects, and the specific inhibitors of Src and Syk , PP2 and piceatannol, inhibited the increase in p-HS1 in LPS-induced cell model.Conclusions Function of platelet is closely related to HS1 in sepsis and it will be a target for sepsis therapy.
9.Investigation on cognition and health information needs of hospitalized patients′ involvement in patient
Lei? SAFETYLUO ; Guorong WANG ; Haixin LIANG
Chinese Journal of Modern Nursing 2015;(19):2285-2287
Objective To investigate the level of cognition and health information needs of hospitalized patients′safety. Methods A total of 220 hospitalized patients were investigated in Sichuan Cancer Hospital using the self-designed questionnaire. Results The average score of hospitalized patients′ cognition to participating in patient safety was (4. 59 ± 0. 27). The score of supporting the participation of adverse event was (4. 74 ± 0. 49), which was the highest. The score of actual participation was (4. 17 ± 1. 16). The score of supporting the behavior encouragement was (3. 31 ± 0. 93), which was the lowest. There were statistically significant differences in actual participation, participation in patients′ safety, behavior encouragement ( P <0. 01). 95. 47% and 85. 53% patients needed the health information from the healthcare professionals and medical materials. Conclusions The level of patients′ perception of patient safety was high, but the encouragement of participation and practical participation behavior was inferior. They showed strong demands on the adverse event report. Medical staff should change the attitude and take measures to encourage health education for patients′safety.
10.Plasma brain natriuretic peptide and endothelin-1 levels in artial septal defect patients with pulmonary hypertension at altitude
Qiuhong CHEN ; Shenggui QI ; Yongping TANG ; Guorong QI ; Lin LU ; Ning TONG ; Lei YANG
Chinese Journal of Thoracic and Cardiovascular Surgery 2014;30(9):554-557
Objective To explore the change of Brain natriuretic peptide(BNP) and endothelin-1 (ET-1) levels in artial septal defect(ASD) patients and the relationship among BNP,ET-1 and pulmonary pressure.Methods 105 final diagnosed ASD patients were divide into non-pulmonary hypertension group (nPH group) and pulmonary hypertension group(PH group),and the PH group were divided into two subgroup:slight PH group,moderate and sever PH group.According to the altitude of habitation,105 ASD patients also were divided into 3 groups:< 2 500 m group,2 501-3 500 m group and > 3 500 m group.Plasma BNP were measured by radioimmunity method and ET-1 were measured by ELISA.The data analysis used single factor analysis and Fisher least singnificant difference t test.Results Both the plasma BNP levels (152.34 ± 40.61) pg/ml and ET-1 level (137.69 ± 37.17) pg/ml of the ASD-PH group were significantly higher than those [BNP (126.70 ± 32.27) pg/ml,ET-1 (92.92 ± 32.3) pg/ml] of ASD-nPH group.There were strong difference in plasma BNP levels and ET-1 levels among different degree PH groups(F =6.782,P < 0.05 ; F =8.475,P < 0.05).Statistical difference were also shown in BNP(F =6.846,P < 0.05) and ET-1 (F =9.327,P < 0.05) levels by compared difference altitude groups.The BNP levels are positively correlated with mean pulmonary artery pressure (r =0.326,P < 0.05),size of defect (r=0.301,P<0.05) and the altitude of habitation (r =0.252,P<0.05).Conclusion Plasma BNPand ET-1 levelsof ASD-PH group significantly higher than those of ASD-nPH group.By the increasing of the altitude and PH degree,the plasma BNP and ET-1 levels are increasing,which suggest that BNP and ET-1 play an important role on the proceeding and development of the PH and hypoxia promoted secretion of BNP and ET-1.

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