1.ICP-MS determination of elemental impurities in pharmaceutical excipient sucrose
Mingzhen WU ; Yue LI ; Jianping ZHU ; Zhuangwei LIU ; Rui YANG ; Xia ZHAO
Drug Standards of China 2024;25(4):423-429
Objective:An ICP-MS method was established for the determination of arsenic(As),cadmium(Cd),mercury(Hg),lead(Pb),cobalt(Co),nickel(Ni),vanadium(V),lithium(Li),antimony(Sb),copper(Cu)and other 10 elements in pharmaceutical excipients sucrose to assess their risks.Methods:The pharmaceuti-cal excipient sucrose was dissolved in 0.1%HN03 solution directly,and the contents of 75 As,111Cd,202Hg,208Pb,59 Co,60 Ni,51V,7 Li,121 Sb,and 63 Cu in sucrose were determined by the ICP-MS method with the optimized instru-mental parameters in the STD mode.Results:The results showed that the linearity of the method was great in the range of 0-100 ng·mL-1 for As,Cd,Pd,Co,Ni,V,Li,Sb and Cu(the correlation coefficient r was not less than 0.99),and the linearity of the method was good in the range of 0-2 ng·mL-1 for Hg(r=0.999 1).The average recoveries for the 10 elements were in the range of 99.8%-100.0%,and the RSDs were less than 5%(n=6).Conclusion:The method is easy to operate and has high accuracy.It can be used for the determination of 10 elemental impurities in pharmaceutical excipient sucrose.It can be seen that the content of the above ten elements in sucrose is much lower than the specified value in ICH Q3D,and the risk is small.The heavy metal item can no longer be considered separately when revising the standard.
2.Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial
Wenbo MENG ; W. Joseph LEUNG ; Zhenyu WANG ; Qiyong LI ; Leida ZHANG ; Kai ZHANG ; Xuefeng WANG ; Meng WANG ; Qi WANG ; Yingmei SHAO ; Jijun ZHANG ; Ping YUE ; Lei ZHANG ; Kexiang ZHU ; Xiaoliang ZHU ; Hui ZHANG ; Senlin HOU ; Kailin CAI ; Hao SUN ; Ping XUE ; Wei LIU ; Haiping WANG ; Li ZHANG ; Songming DING ; Zhiqing YANG ; Ming ZHANG ; Hao WENG ; Qingyuan WU ; Bendong CHEN ; Tiemin JIANG ; Yingkai WANG ; Lichao ZHANG ; Ke WU ; Xue YANG ; Zilong WEN ; Chun LIU ; Long MIAO ; Zhengfeng WANG ; Jiajia LI ; Xiaowen YAN ; Fangzhao WANG ; Lingen ZHANG ; Mingzhen BAI ; Ningning MI ; Xianzhuo ZHANG ; Wence ZHOU ; Jinqiu YUAN ; Azumi SUZUKI ; Kiyohito TANAKA ; Jiankang LIU ; Ula NUR ; Elisabete WEIDERPASS ; Xun LI
Chinese Medical Journal 2024;137(12):1437-1446
Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.
3.Clinical analysis of plastic bronchitis caused by adenoviral pneumonia in 9 children
Jingjing HUANG ; Lin YUAN ; Zhiqiang ZHUO ; Qiguo ZHU ; Mingzhen LI
Chinese Journal of Applied Clinical Pediatrics 2020;35(16):1260-1263
Objective:To analyze the clinical characteristics of plastic bronchitis(PB) caused by adenoviral pneumonia.Methods:The clinical data of 9 children diagnosed with PB caused by adenoviral pneumonia in the Xiamen Children′s Hospital from March to June 2019 were retrospectively analyzed.Results:Among the 9 children(3 boys and 6 girls), 6 patients were under 2 years old.All patients had fever, cough and dyspnea, with the duration of 6-15 days.Laboratory tests showed that procalcitonin(PCT) and increased in 7 children, D-dimer, fibrinogen degraded product (FDP) were increased in 6 children, and lactate dehydrogenase(LDH) was increased in 8 children.Chest imaging examination showed atelectasis with pulmonary consolidation in 9 children, including 4 cases of left lower lobe consolidation, 2 cases of right lower lobe consolidation, 1 case of right upper lung consolidation, and 2 cases of consolidation of multiple lungs in the lower lobe.Seven cases had pleural effusion.By fiberoptic bronchoscopy, the bronchial plastics was removed from the left lower lobe in 5 patients, from the right lower lobe in 3 patients, and from the right upper lobe in 1 patient on the 6th to 20 th day of the disease.Eight patients were discharged after clinical cure.One patient deve-loped multiple organ failure, and discharged from the hospital after the family members gave up rescue.The death was reported by the telephone follow-up death. Conclusions:PB is considered when patients with adenovirus pneumonia have persistent high fever, shortness of breath, dyspnea, pulmonary consolidation/lung atelectasis, increased PCT and LDH, hypercoagulability of the blood, and pleural effusion.Fiberoptic bronchoscopy plays an important role in confirming the diagnosis and improving the prognosis.
4.Expression and Clinical Significance of IGF-1R and VEGFR2 Protein in Colorectal Cancer Tissue
Jingyu ZHANG ; Mingzhen ZHU ; Zhichao SUN ; Yan WU ; Haiyan XU
China Pharmacy 2017;28(35):4901-4906
OBJECTIVE:To observe the expression of IGF-1R and VEGFR2 in colorectal cancer tissue,and to explore its clinical significance. METHODS:Totally 98 colorectal cancer patients underwent surgery were selected from our hospital during Jan. 2011-Dec. 2012. The tumor tissue and paracancerous tissue were collected. The expression of IGF-1R and VEGFR2 protein were detect-ed by immunohistochemical SP method. The mRNA expression of both were detected by RT-PCR. The correlation of the expression of IGF-1R and VEGFR2 protein with clinical pathological characteristics of colorectal cancer patients were investigated,and its effects on 4-year disease-free survival rate of postoperative assisted chemotherapy patients were also investigated. RESULTS:The positive rates of IGF-1R and VEGFR2 protein expression in colorectal cancer tissue were 66.3%and 60.2%respectively,but their expression was not found in paracancerous tissue,with statistical significance(P<0.05). Relative expression of IGF-1R mRNA and VEGFR2 mRNA in tumor tissue were significantly higher than paracancerous tissue,with statistical significance(P<0.05). There was positive correla-tion between their mRNA expression in tumor tissue(r=0.729,P<0.05). The expression of IGR-1R protein was independent from pa-tient's gender and age,tumor location and formation of vascular tumor thrombus(P>0.05);but it was associated with the histological grading,depth of invasion and lymph node metastasis(P<0.05). The expression of VEGFR2 protein had nothing to do with patient's gender and age(P>0.05),but it was associated with tumor location,histological grading,depth of invasion,lymph node metastasis, and formation of vascular tumor thrombus(P<0.05). Among 98 colorectal cancer patients,14 patients didn't underwent chemothera-py after surgery;and 4-year disease-free survival rate of other 84 patients was 76.2%(64/84). Four-year disease-free survival rates of TGF-1R protein negative expression and VEGFR2 protein negative expression patients(82.8%,78.8%)were significantly higher than those of positive expression patients(72.7%,74.5%),with statistical significance(P<0.05). The multiple factor Logistic regression analysis was used to correct gender,age,histological grading,tumor location,depth of invasion,lymph node metastasis,and forma-tion of vascular tumor thrombus;the expression of IGR-1R and VEGFR2 protein were still associated with 4-year disease-free survival rate [adjusted OR were 2.31,2.15;95%CI were(0.57,4.15),(0.45,4.03);P<0.05]. CONCLUSIONS:The expression of IGF-1R, VEGFR2 protein and mRNAs increase significantly in colorectal cancer tissue;the protein expression is associated with histological grading,depth of invasion,lymph node metastasis and the prognosis of postoperative assisted chemotherapy patients. Their examina-tion can provide reference for target therapy for colorectal cancer patients.
5.Oncomelania hupensis status monitoring in Changzhou City,Jiangsu Prov-ince from 2013 to 2016
Mingzhen HE ; Yiqing XIE ; Hong CHEN ; Yonggen ZOU ; Shiying ZHU ; Yanli GUO
Chinese Journal of Schistosomiasis Control 2017;29(4):520-522
Objective To analyze the Oncomelania hupensis snail distribution and the changes of snail situation in Chang-zhou City from 2013 to 2016,so as to provide the evidence for formulating the schistosomiasis prevention and control interven-tions. Methods The data of snail monitoring in Changzhou City from 2013 to 2016 were collected and statistically analyzed. Re-sults The total area with snails was 40.17 hm2 and the newly discovered area was 30.63 hm2 in Changzhou City from 2013 to 2016. In the four years,3454 snails were dissected,and no schistosome infected snails were found. There were totally 51 spots with snails,and the areas with snails of different types of marshland,inland and mountain were 12.13(30.19%),25.54 hm2 (63.57%)and 2.51 hm2(6.24%),respectively. In the newly discovered snail environment,the areas of types of marshland and inland were 8.00 hm2(26.12%)and 22.63 hm2(73.88%),respectively. The main causes for snail existence were external input and adjacent diffusion. In the past four years,the total snail control area with molluscicides was 71.74 hm2,the consolidated snail control area with molluscicides was 155.15 hm2,and the total environmental modification areas in the current snail spots and historic snail spots were 15.90 hm2 and 11.30 hm2 respectively. Conclusion The diffusion of snails in inland rivers is the key of the newly discovered snail areas in Changzhou City in recent years,and the snail monitoring and control measures should be strengthened in the future.
6.Investigation on knowledge,attitude,and practice of schistosomiasis pre-vention and control and infection status in Armed Police Forces stationed along Yangtze River
Mingzhen HE ; Yiqing XIE ; Yanli GUO ; Hong CHEN ; Yonggen ZOU ; Shiying ZHU ; You ZHANG
Chinese Journal of Schistosomiasis Control 2017;29(3):346-348,384
Objective To understand the status of knowledge,attitude,and practice of schistosomiasis prevention and con-trol and infection status in Armed Police Forces stationed along the Yangtze River,so as to provide the reference for formulating the schistosomiasis prevention and control measures in Armed Police Forces. Methods A questionnaire survey was conducted in the Armed Police Forces along the Yangtze River in Jiangsu Province,and the investigation content included social demo-graphic data,schistosomiasis prevention knowledge,attitude and behavior. All the subjects were examined for Schistosoma ja-ponicum infection. Results Totally 376 soldiers were investigated in 2 sites. The total passing rate of schistosomiasis knowl-edge was 72.87%. The passing rate among different age groups had no significant difference( χ2 =0.26,P > 0.05). The passing rate of soldiers from endemic areas was significantly higher than that of the soldiers from non-endemic areas( χ2 =4.71,P <0.05). The passing rate of officers was significantly higher than that of the soldiers(χ2 = 4.21,P <0.05). The passing rate of sol-diers with the education levels of junior school,high school,college,undergraduate and above increased gradually,with a sig-nificant difference( χ2 =8.16,P < 0.05). The soldiers with positive attitude accounted for 93.88%. Among the water contact be-haviors,training accounted for 17.55% and participating in the task(such as flood fighting and water work)accounted for 86.44%. When launching,the rate of taking protective measures was 52.93%. The rate of taking protective measures in the knowledge passing group was much higher than that in the knowledge failed group( χ2 =10.55,P < 0.05). The stool was harm-lessly treated in the two camps. Among 376 soldiers,the positive rate of blood examinations was 0.53%,but the stool examina-tions were all negative. Conclusions The overall level of knowledge and correct behavior of schistosomiasis prevention in the Armed Police Forces along the Yangtze River still should be improved. The better health education and behavior intervention are crucial to schistosomiasis prevention in the army.
7.Assessment and authentication of malaria elimination in Changzhou City
Shiying ZHU ; Yiqing XIE ; Mingzhen HE ; Weiming WANG
Chinese Journal of Schistosomiasis Control 2016;28(5):589-593
Objective To analyze the results of assessment and authentication of malaria elimination of 7 county?level cities and districts in Changzhou City,Jiangsu Province,and explore the suitable monitoring methods for malaria after the elimination in this region,so as to provide the evidence for formulating and adjusting the malaria elimination strategies and measures. Meth?ods The data from the network reports of malaria epidemic situation,blood examinations of febrile patients,epidemiological questionnaires of malaria cases,investigation of epidemic focuses and disposal tables were collected and analyzed in Changzhou City from 2009 to 2014. The clinicians were assessed with the closed?book written examinations for their ability of the diagnosis and treatment of malaria. The inspection personnel were assessed by the microscopical examinations of Plasmodium. Totally 30 negative blood slides were reviewed. In the natural village where the last local case of malaria was located ,200 blood filter pa?pers were collected for gene detection of Plasmodium. Results From 2009 to 2014,145 malaria cases were reported in Chang?zhou City. Totally 170 638 febrile patients received blood detections for malaria,of which 137 cases were positive and the posi?tive rate was 0.08%. The majority of malaria cases were imported except 8 local malaria infection cases in 2009 and 2 local ma?laria infection cases in 2010. Four of seven county?level cities(districts)gained an average score of 20 points on the microscopi?cal examinations of Plasmodium. Liyang City got a minimum average score of 18.8 points. In capacity assessment of malaria diag?nosis and treatment,Liyang City gained the highest average score of 19.8 points,and Qishuyan District got the lowest average score of 18.0 points. The malaria elimination assessment scores of the 7 county?level cities(districts)were all above 93 points. Four county?level cities(districts)(Xinbei District,Wujin District,Liyang City,and Jintan City)carried out the active case detections. A total of 731 cases were detected and the results were all negative. Liyang City in 2012,Zhonglou District and Jin?tan City in 2013,Tianning District,Qishuyan District,Xinbei District and Wujin District in 2014,passed the malaria elimina?tion assessment at county(district)level,respectively. Conclusions All the 7 county?level cities(districts)of Changzhou City have passed the malaria elimination assessment at a high score. After the malaria elimination ,the monitoring should contin?ue to consolidate the achievements.
8.Quality analysis of malaria blood smears of fever patients in Changzhou City in 2014
Yiqing XIE ; Mingzhen HE ; Yonggen ZOU ; Shiying ZHU
Chinese Journal of Schistosomiasis Control 2016;28(4):467-469
Objective To understand the quality of blood smears for Plasmodium detection in Changzhou City,so as to pro?vide the technical support for malaria surveillance in the post?elimination period. Methods The blood smears of fever patients from each cities(districts)in Changzhou City in 2014,including more than 3%of the negatives and all the positives,were se?lected. The quality of the blood smear making,dyeing,cleanliness and results were reviewed by the experts from the municipal malaria microscopy station,and the data were analyzed statistically. Results Totally 996 negative blood smears were reviewed in 2014,with a review rate of 4.52%. The qualified rates of blood smear making,dyeing and cleanliness were 92.87%,93.27%and 94.48%,respectively. A total of 34 positive blood smears were reviewed,and there were no false detections and leak detec?tions. The qualified rates of blood smear making and dyeing were more than 90%in all the seven cities(districts). As for quali?fied rate of cleanliness,except the rate in Qishuyan District(81.36%),those in the other six cities(districts)were all above 90%. The qualified rates of blood smear making,dyeing and cleanliness were all more than 90%in first?class,second?class and third?class hospitals. The major quality defects of the blood smears were sediment,abnormal making and thick membrane shed?ding,and the proportions were 25.91%,21.76%and 19.17%,respectively. Conclusions The quality of blood smears for Plas?modium detection in Changzhou City is satisfying. In the future,the training and supervision still should be strengthened to guar?antee the capacity of microscopic examinations for Plasmodium detection in the surveillance of post?elimination period.
9.Correlation among HIF-1α,ERCC1 genetic polymorphisms and outcome of NSCLC patients receiving platinum-based chemotherapy
Mingzhen ZHU ; Haiyan XU ; Hua JIANG
The Journal of Practical Medicine 2016;32(3):385-388
Objective To analyze the relationship among HIF-1α, ERCC1 gene polymorphisms and the effects of platinum-based chemotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) Methods HIF-1α C1772T and ERCC1 C118T loci were genotyped with PCR-RFLP method. The relationship between genotypes and the outcome of treatment as well as TTP was investigated. Results HIF-1α and ERCC1 of 102 patients were under the Hardy-Weinberg equilibrium. Patients with HIF-1α CT+TT genotype showed a significantly higher chemotherapeutic efficiency compared with patients with CC genotype; Patients with ERCC1 CC genotype showed a significantly higher chemotherapeutic efficiency compared with patients with CT+TT genotype. The median TTP was 7.0 months for the 98 patients followed-up; 7.0 months for HIF-1α CT+TT genotype, and 6.0 months for CC genotype, and the difference showed no significance; The median TTP was 7.0 months for ERCC1 CC genotype, and 6.0 months for CT+TT genotype, and the difference was statistically significant. Conclusions Patients with HIF-1α CT+TT genotype or ERCC1 CC genotype have showed higher chemotherapeutic efficiency, and patients with ERCC1 CC genotype show longer median TTP.
10.Effect of comprehensive schistosomiasis control in Changzhou City from 2004 to 2014
Mingzhen HE ; Hong CHEN ; Yiqing XIE ; Yonggen ZOU ; Shiying ZHU
Chinese Journal of Schistosomiasis Control 2016;28(3):310-312
Objective To evaluate the effect of comprehensive schistosomiasis control in Changzhou City in recent 10 years, so as to provide the evidences for formulating the future prevention and control strategy. Methods The work reports and the da?ta of the schistosomiasis comprehensive control projects in Changzhou City from 2004 to 2014 were collected,the infection sta?tus of residents and livestock as well the Oncomelania hupensis snail situation were analyzed,and the implementation effect of the comprehensive control projects was evaluated. Results From 2004 to 2014,totally 215 368 person?times were examined, and the positive rate of the blood examinations of the population was 0.24%(478/198 356),and there were no positive cases de?tected out by using the miracidium hatching method. Totally 11 935 domestic animals were detected and no positives were found. From 2004 to 2014,the total area with snails was 92.27 hm2,and marshland,inland and mountain environments accounted for 34.75%,34.82%and 30.43%,respectively. The newly discovered area with snails was 34.40 hm2,and marshland,inland and mountain environments accounted for 2.62%,71.22% and 26.16%,respectively. Totally 8 511 snails were dissected and no schistosome infected snails were found. From 2004 to 2014,a total of 242 600 harmless toilets were built,2 704 700 domestic animals were reared in pens,5.82 km?long rivers were dredged,2 250.11 hm2 of protective forests were constructed,a total area of 625.79 hm2 were controlled with molluscicides,and an area of 149.58 hm2 were environmentally transformed. Totally 5.4 mil?lion people received health education. The awareness rate of knowledge on schistosomiasis control of residents was 96.00% in 2014. Conclusions There exists the risks of snails import and diffusion and schistosomiasis resurrection in Changzhou City, but under the condition of continuous implementation of comprehensive control measures,the endemic situation of schistosomia?sis is stable and the control achievement is consolidated in this city.

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