1.Optimization of gas chromatographic method for the determination of residual benzene content in carbomers
Qinying CHEN ; Yerong XIONG ; Zuoxun FENG ; Dongsheng HE ; Chunmeng SUN ; Jiasheng TU
Drug Standards of China 2024;25(4):398-404
Objective:To develop and validate gas chromatographic methods for the determination of residual benzene in carbomer copolymer,carbomer homopolymer and carbomer interpolymer,to address the issues of the current method in the Chinese Pharmacopoeia in the actual detection process,such as low sensitivity and poor repeatability of benzene detection in the mixed reference solution,and to optimize and improve the current stand-ards for series of carbomer pharmaceutical excipients.Methods:Samples were separated on a column DB-624(30 m ×0.530 mm,3.00 μm)with temperature programming,the inlet temperature of 140 ℃,the detector tem-perature of 250 ℃,and the split ratio of 5∶1.The external standard method was adopted for the quantitative deter-mination of residual benzene.Results:The linearity was great across the range of 0.04-1.00 μg·mL-1(r=0.996 8),the injection precision of benzene was 6.8%(n=6),and the average recovery rate was 96.89%(RSD=8.1%,n=9).Conclusion:The gas chromatographic method established in this research is more specif-ic,with higher accuracy and precision compared to the current method in the Chinese Pharmacopoeia.This optimized method is more suitable for the determination of residual benzene content in carbomer copolymer,car-bomer homopolymer and carbomer interpolymer,providing reference and guidance for the quality management and the control of carbomer.
2.Cost-effectiveness analysis of simple hysterectomy compared to radical hysterectomy for early cervical cancer: analysis from the GCIG/CCTG CX.5/SHAPE trial
Janice S. KWON ; Helen MCTAGGART-COWAN ; Sarah E. FERGUSON ; Vanessa SAMOUËLIAN ; Eric LAMBAUDIE ; Frédéric GUYON ; John TIDY ; Karin WILLIAMSON ; Noreen GLEESON ; Cor de KROON ; Willemien van DRIEL ; Sven MAHNER ; Lars HANKER ; Frédéric GOFFIN ; Regina BERGER ; Brynhildur EYJÓLFSDÓTTIR ; Jae-Weon KIM ; Lori A. BROTTO ; Reka PATAKY ; Shirley S.T. YEUNG ; Kelvin K.W. CHAN ; Matthew C. CHEUNG ; Juliana UBI ; Dongsheng TU ; Lois E. SHEPHERD ; Marie PLANTE
Journal of Gynecologic Oncology 2024;35(6):e117-
Objective:
SHAPE (Simple Hysterectomy And PElvic node assessment) was an international phase III trial demonstrating that simple hysterectomy was non-inferior to radical hysterectomy for pelvic recurrence risk, but superior for quality of life and sexual health.The objective was to conduct a cost-effectiveness analysis comparing simple vs. radical hysterectomy for low-risk early-stage cervical cancer.
Methods:
Markov model compared the costs and benefits of simple vs. radical hysterectomy for early cervical cancer over a 5-year time horizon. Quality-adjusted life years (QALYs) were estimated from health utilities derived from EQ-5D-3L surveys. Sensitivity analyses accounted for uncertainty around key parameters. Monte Carlo simulation estimated complication numbers according to surgical procedure.
Results:
Simple hysterectomy was more effective and less costly than radical hysterectomy. Average overall costs were $11,022 and $12,533, and average gains were 3.56 and 3.54 QALYs for simple and radical hysterectomy, respectively. Baseline health utility scores were 0.81 and 0.83 for simple and radical hysterectomy, respectively. By year 3, these scores improved for simple hysterectomy (0.82) but not for radical hysterectomy (0.82). Assuming 800 early cervical cancer patients annually in Canada, the model estimated 3 vs. 82 patients with urinary retention, and 49 vs. 86 patients with urinary incontinence persisting 4 weeks after simple vs.radical hysterectomy, respectively. Results were most sensitive to variability in health utilities after surgery, but stable through wide ranges of costs and recurrence estimates.
Conclusion
Simple hysterectomy is less costly and more effective in terms of quality-adjusted life expectancy compared to radical hysterectomy for early cervical cancer.
3.Cost-effectiveness analysis of simple hysterectomy compared to radical hysterectomy for early cervical cancer: analysis from the GCIG/CCTG CX.5/SHAPE trial
Janice S. KWON ; Helen MCTAGGART-COWAN ; Sarah E. FERGUSON ; Vanessa SAMOUËLIAN ; Eric LAMBAUDIE ; Frédéric GUYON ; John TIDY ; Karin WILLIAMSON ; Noreen GLEESON ; Cor de KROON ; Willemien van DRIEL ; Sven MAHNER ; Lars HANKER ; Frédéric GOFFIN ; Regina BERGER ; Brynhildur EYJÓLFSDÓTTIR ; Jae-Weon KIM ; Lori A. BROTTO ; Reka PATAKY ; Shirley S.T. YEUNG ; Kelvin K.W. CHAN ; Matthew C. CHEUNG ; Juliana UBI ; Dongsheng TU ; Lois E. SHEPHERD ; Marie PLANTE
Journal of Gynecologic Oncology 2024;35(6):e117-
Objective:
SHAPE (Simple Hysterectomy And PElvic node assessment) was an international phase III trial demonstrating that simple hysterectomy was non-inferior to radical hysterectomy for pelvic recurrence risk, but superior for quality of life and sexual health.The objective was to conduct a cost-effectiveness analysis comparing simple vs. radical hysterectomy for low-risk early-stage cervical cancer.
Methods:
Markov model compared the costs and benefits of simple vs. radical hysterectomy for early cervical cancer over a 5-year time horizon. Quality-adjusted life years (QALYs) were estimated from health utilities derived from EQ-5D-3L surveys. Sensitivity analyses accounted for uncertainty around key parameters. Monte Carlo simulation estimated complication numbers according to surgical procedure.
Results:
Simple hysterectomy was more effective and less costly than radical hysterectomy. Average overall costs were $11,022 and $12,533, and average gains were 3.56 and 3.54 QALYs for simple and radical hysterectomy, respectively. Baseline health utility scores were 0.81 and 0.83 for simple and radical hysterectomy, respectively. By year 3, these scores improved for simple hysterectomy (0.82) but not for radical hysterectomy (0.82). Assuming 800 early cervical cancer patients annually in Canada, the model estimated 3 vs. 82 patients with urinary retention, and 49 vs. 86 patients with urinary incontinence persisting 4 weeks after simple vs.radical hysterectomy, respectively. Results were most sensitive to variability in health utilities after surgery, but stable through wide ranges of costs and recurrence estimates.
Conclusion
Simple hysterectomy is less costly and more effective in terms of quality-adjusted life expectancy compared to radical hysterectomy for early cervical cancer.
4.Cost-effectiveness analysis of simple hysterectomy compared to radical hysterectomy for early cervical cancer: analysis from the GCIG/CCTG CX.5/SHAPE trial
Janice S. KWON ; Helen MCTAGGART-COWAN ; Sarah E. FERGUSON ; Vanessa SAMOUËLIAN ; Eric LAMBAUDIE ; Frédéric GUYON ; John TIDY ; Karin WILLIAMSON ; Noreen GLEESON ; Cor de KROON ; Willemien van DRIEL ; Sven MAHNER ; Lars HANKER ; Frédéric GOFFIN ; Regina BERGER ; Brynhildur EYJÓLFSDÓTTIR ; Jae-Weon KIM ; Lori A. BROTTO ; Reka PATAKY ; Shirley S.T. YEUNG ; Kelvin K.W. CHAN ; Matthew C. CHEUNG ; Juliana UBI ; Dongsheng TU ; Lois E. SHEPHERD ; Marie PLANTE
Journal of Gynecologic Oncology 2024;35(6):e117-
Objective:
SHAPE (Simple Hysterectomy And PElvic node assessment) was an international phase III trial demonstrating that simple hysterectomy was non-inferior to radical hysterectomy for pelvic recurrence risk, but superior for quality of life and sexual health.The objective was to conduct a cost-effectiveness analysis comparing simple vs. radical hysterectomy for low-risk early-stage cervical cancer.
Methods:
Markov model compared the costs and benefits of simple vs. radical hysterectomy for early cervical cancer over a 5-year time horizon. Quality-adjusted life years (QALYs) were estimated from health utilities derived from EQ-5D-3L surveys. Sensitivity analyses accounted for uncertainty around key parameters. Monte Carlo simulation estimated complication numbers according to surgical procedure.
Results:
Simple hysterectomy was more effective and less costly than radical hysterectomy. Average overall costs were $11,022 and $12,533, and average gains were 3.56 and 3.54 QALYs for simple and radical hysterectomy, respectively. Baseline health utility scores were 0.81 and 0.83 for simple and radical hysterectomy, respectively. By year 3, these scores improved for simple hysterectomy (0.82) but not for radical hysterectomy (0.82). Assuming 800 early cervical cancer patients annually in Canada, the model estimated 3 vs. 82 patients with urinary retention, and 49 vs. 86 patients with urinary incontinence persisting 4 weeks after simple vs.radical hysterectomy, respectively. Results were most sensitive to variability in health utilities after surgery, but stable through wide ranges of costs and recurrence estimates.
Conclusion
Simple hysterectomy is less costly and more effective in terms of quality-adjusted life expectancy compared to radical hysterectomy for early cervical cancer.
5.Determination of residual impurities in pharmaceutical excipient cetomacrogol 1000 by gas chromatography
Haoyu LI ; Baoqiang TANG ; Dongsheng HE ; Jiasheng TU
Journal of China Pharmaceutical University 2022;53(3):293-299
For the quality control of cetomacrogol 1000, a gas chromatographic method for the determination of residual impurities in cetomacrogol 1000, such as ethylene oxide, 1, 4-dioxane, ethylene glycol, diethylene glycol and triethylene glycol, was established and validated.The DB-1 column with headspace injection was used to detect ethylene oxide and 1, 4-dioxane with the inlet temperature of 150 °C, the FID temperature of 250 °C, the headspace equilibration temperature of 70 °C and the equilibration time of 45 min.The VF-17MS column with liquid injection was used to detect ethylene glycol, diethylene glycol and triethylene glycol with the inlet temperature of 270 °C, and the FID temperature of 290 °C.The results showed that ethylene oxide and 1,4-dioxane have a good linearity within their specified addition amount ranges (r > 0.999), with the RSD of precision of below 8.0% and the average recovery rates of 90.6% and 101.2%; and that ethylene glycol, diethylene glycol and triethylene glycol also have a good linearity between 3 ? 60 μg/mL (r > 0.999), with the RSD of precision of below 3.0%, and the recovery rates of 96% ~ 103%.The method established in this study has good specificity, linearity, precision and recovery rate, which can effectively detect the multi-component and trace impurities.
6. Primary vesicoureteric reflux in 72 children
Ling WAN ; Chaoying CHEN ; Dongsheng BAI ; Juan TU ; Yuan LIN
Chinese Journal of Applied Clinical Pediatrics 2019;34(17):1317-1320
Objective:
To summarize the treatment and prognosis of children with primary vesicoureteric reflux (PVUR) and the correlation between PVUR and urinary tract infections(UTI).
Methods:
The children with PVUR (72 cases) who were hospitalized at the Department of Nephrology and Urology of Children′s Hospital Affiliated to Capital Institute of Pediatrics from June 2007 to April 2018 were selected, and the clinical manifestations were summarized.
Results:
A total of 72 patients (52 boys, 20 girls) were involved, and the median age at diagnosis was 8 months, in which 44 cases (61.1%) were less than 1 year old.There were 55 cases with UTI onset (76.4%), 94.5%(52/55 cases) with recurrent UTI(twice or more than twice) and 2 cases (2.8%) ended with renal failure.Refluxes were unilateral in 34 patients and bilateral in 38 patients.There were 110 ureters, in which 74 reflux ureters (67.3%) were identified as low-grade (Ⅰ-Ⅲ) PVUR, and 36 reflux ureters(32.7%) were high-grade (Ⅳ-Ⅴ) PVUR.Forty patients received conservative treatment, and significant differences of the remission rate were observed between group Ⅰ-Ⅱ grade PVUR(72.2%, 13/18 cases) and group Ⅲ-Ⅴ grade PVUR(32.5%, 13/40 cases)(
7.Determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188 by gas chromatography
Yajuan LEI ; Yerong XIONG ; Yanyue ZHU ; Mengru DUAN ; Chunmeng SUN ; Dongsheng HE ; Jiasheng TU
Journal of China Pharmaceutical University 2019;50(6):694-698
The gas chromatography method was developed for the determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188 to provide scientific basis for the quality control. The samples was separated on column VF-17ms(30 m×0. 53 mm, 1. 0 μm)with temperature programming, inlet temperature was 270 °C, detector temperature was 290 °C and the split ratio was 10 ∶1. The method showed great linearity over the range of 6-15 μg/mL(r≥0. 999). The injection precision(n=8)of the three residual impurities were 3. 3%, 3. 0%, 2. 3% and the average recoveries were 99. 05%(RSD=2. 9%, n=9), 102. 20%(RSD=4. 0%, n=9), 101. 91%(RSD=3. 1%, n=9), respectively. The analytical method is specific, accurate and sensitive, which is suitable for the determination of ethylene glycol, diethylene glycol and triethylene glycol in poloxamer 188, providing reference and guidance for the production and quality control of poloxamer 188.
8.Practice and strategy considerations for hospital talents introduction
Jianfeng TU ; Yaping ZHANG ; Yue YANG ; Zhiming HU ; Dongsheng HUANG
Chinese Journal of Hospital Administration 2018;34(1):44-47
The paper probed into key challenges in talents introduction of hospitals ,especially introduction strategy and practical considerations.In its"MVPPS"(Money ,Value ,Platform ,Promise , Service)theory framework ,V(value)is the core ,and P(platform)is the key ,while P(promise)and M (money ,remuneration)are the cornerstone.The hospital can attract excellent talents by means of common value ,reasonable material conditions ,ideal development platform and service ,and promises fulfilled ,thus achieving fast disciplines development .
9.Study on multi-area universal newborn hearing screening in countryside of China
Lihui HUANG ; Zhenghua CAI ; Hua ZHANG ; Shichun PENG ; Dongsheng WU ; Lei WANG ; Weiping FAN ; Rulan YANG ; Yan HUANG ; Xia LUO ; Lin TU ; Hui EN ; Beier QI ; Yong ZHEN ; Demin HAN
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2009;(16):737-742
Objective:To investigate the feasibility of universal newborn hearing screening in countryside in order to provide reliable evidence in launching this program all over the countryside of China. Method:Subjects were 12 638 infants who were born in 9 counties from Jan 2004 to Dec 2005. TEOAE was used for the fast hearing screening. Infants were screened on the 2-7 days after the birth. The re-screening was conducted in 4-6 weeks if failed in the initial screening,and follow-up were provided continually if they also failed in the re-screening. Result; Ten thouand eight hundred and forty-five of 12 638(85. 8%) were screened including 9 963(91. 9%) normal newborns and 882(8. 1%) newborns with high-risk. Seven thouand four hundred and fifty (68. 7%) newborns passed the initial screening, and 3 395 (31. 3%) people failed. One thouand seven hundred and ninty-three (14. 2%) infants were refused to be screened.Only 2 536 (74. 7%) were re-screened on time, and 859(25. 3%) did not receive re-screening. One hundred and twenty were failed in the re-screening or first screening, and 79 (65. 8%)of them received diagnostic assessment. Among the infants received diagnostic assessment, 6(7.6%)ca-ses were found to have profound hearing loss in both ears, 9(11. 4%)cases were found to be severe hearing loss(7 in both ears and 2 in single ear) , 11(13. 9%)cases were found to be moderate hearing loss (5 in both ear and 6 in single ear), 26 (32. 9%) were found to have slight hearing loss (11 in both ear and 15 in single ears), and 27 (34.2%) were normal. Fifty-two infants were diagnosed as hearing loss with a prevalence of congenital hearing loss(in binaural and monaural) of 0. 5%(52/10845)and a prevalence of bilateral hearing loss of 0. 3%(29/10845). A prevalence of congenital hearing loss was 0. 2% (22/9 963) in well infants and 3. 4% (30/882) in high risk infants. Among the 13 cases of children with severe and profound hearing loss in both ears children, 8(61. 5%)cases were fitted with hearing aids and 1 (7. 7%) case was implanted with cochlear implants. Conclusion:It is necessary and feasible to conduct hearing screening program in the rural area. However, the suitable model to perform the program in the countryside needs to be set up as soon as possible in order to get more poor infants to participate into the hearing screening program for free and increase the screening rate.
10.Study on multi-area universal newborn hearing screening in countryside of China.
Lihui HUANG ; Zhenghua CAI ; Hua ZHANG ; Shichun PENG ; Dongsheng WU ; Lei WANG ; Weiping FAN ; Rulan YANG ; Yan HUANG ; Xia LUO ; Lin TU ; Hui EN ; Beier QI ; Yong ZHEN ; Demin HAN
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2009;23(16):737-742
OBJECTIVE:
To investigate the feasibility of universal newborn hearing screening in countryside in order to provide reliable evidence in launching this program all over the countryside of China.
METHOD:
Subjects were 12,638 infants who were born in 9 counties from Jan 2004 to Dec 2005. TEOAE was used for the fast hearing screening. Infants were screened on the 2-7 days after the birth. The re-screening was conducted in 4-6 weeks if failed in the initial screening, and follow-up were provided continually if they also failed in the re-screening.
RESULT:
Ten thousand eight hundred and forty-five of 12,638 (85.8%) were screened including 9,963 (91.9%) normal newborns and 882 (8.1%) newborns with high-risk. Seven thousand four hundred and fifty (68.7%) newborns passed the initial screening, and 3,395 (31.3%) people failed. One thousand seven hundred and ninety-three (14.2%) infants were refused to be screened. Only 2,536 (74.7%) were re-screened on time, and 859 (25.3%) did not receive re-screening. One hundred and twenty were failed in the re-screening or first screening, and 79 (65.8%) of them received diagnostic assessment. Among the infants received diagnostic assessment, 6 (7.6%) cases were found to have profound hearing loss in both ears, 9 (11.4%) cases were found to be severe hearing loss (7 in both ears and 2 in single ear), 11 (13.9%) cases were found to be moderate hearing loss (5 in both ear and 6 in single ear), 26 (32.9%) were found to have slight hearing loss (11 in both ear and 15 in single ears), and 27 (34.2%) were normal. Fifty-two infants were diagnosed as hearing loss with a prevalence of congenital hearing loss (in binaural and monaural) of 0.5% (52/10845) and a prevalence of bilateral hearing loss of 0.3% (29/10845). A prevalence of congenital hearing loss was 0.2% (22/9,963) in well infants and 3.4% (30/882) in high risk infants. Among the 13 cases of children with severe and profound hearing loss in both ears children, 8 (61.5%) cases were fitted with hearing aids and 1 (7.7%) case was implanted with cochlear implants.
CONCLUSION
It is necessary and feasible to conduct hearing screening program in the rural area. However, the suitable model to perform the program in the countryside needs to be set up as soon as possible in order to get more poor infants to participate into the hearing screening program for free and increase the screening rate.
China
;
epidemiology
;
Feasibility Studies
;
Hearing Loss
;
diagnosis
;
epidemiology
;
Hearing Tests
;
Humans
;
Infant, Newborn
;
Neonatal Screening
;
Otoacoustic Emissions, Spontaneous
;
Prevalence
;
Rural Population

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