1.Comparison of clinically relevant factors in bipolar disorder patients with different age of onset
Yan MA ; Xiaoyi TIAN ; Yueqin HUANG ; Zhaorui LIU ; Yongyan DENG ; Liang ZHOU ; Yan LIU ; Bo LIU ; Jie ZHANG ; Yuandong GONG ; Xiang FU ; Qiongxian ZHAO ; Jin LU ; Wannian SHA ; Hao HE ; Zonglin SHEN ; Tingting ZHANG ; Wenming CHEN
Chinese Mental Health Journal 2024;38(1):42-49
Objective:To compare clinical characteristics,treatment patterns and physiological indicators in bipolar disorder(BD)patients with different age of onset.Methods:Totally 380 patients with DSM-5 BD were se-lected in this study.Psychiatrists diagnosed the patients using the Mini International Neuropsychiatric Interview.The clinical information questionnaire and the Global Assessment of Functioning scale were utilized to collected clinical characteristics,treatment status,and physiological indicators.The onset age of BD was divided into 21 and 35 years as cut-off points.Multivariate logistic regression and linear regression were used to analyze related factors.Results:Among the 380 patients with BD,199 cases were early-onset group(52.4%),121 cases were middle-onset group(31.8%),and 60 cases were late-onset group(15.8%).There were 26.6%of patients in the early-onset group in-itially diagnosed as depression,23.1%in the middle-onset group,and 11.7%in the late-onset group.Multivariate analysis revealed that compared to the early-onset group of BD,the middle-onset(OR=2.22)and late-onset(OR=4.99)groups had more risk to experience depressive episodes,and the late-onset group(OR=6.74)had 6.74 times of risk to suffer from bipolar Ⅱ disorder.Additionally,patients in the middle-onset(β=-1.52)and late-on-set(β=-4.29)groups had shorter durations of delayed treatment,and those in the middle-onset(β=-1.62)and late-onset(β=-3.14)groups had fewer hospitalizations.Uric acid levels were lower in both the middle-onset(β=-28.39)and late-onset(β=-31.47)groups,and total cholesterol level was lower in the middle-onset group(β=-0.23).Conclusion:Patients with BD in different age of onset show significant differences in clinical charac-teristics,treatment conditions and physiological indicators.
2.Clinical trial of naratinib combined with capecitabine in the treatment of advanced breast cancer patients with HER2 positive
Tuan-Jie ZHANG ; Fu-Yu GONG ; Yu-Ning LU ; Liang DING ; Xiang LI
The Chinese Journal of Clinical Pharmacology 2024;40(17):2474-2478
Objective To observe the clinical efficacy and safety of naratinib maleate tablets combined with capecitabine tablets in the treatment of advanced breast cancer patients with human epidermal growth factor receptor 2(HER2)positive.Methods The advanced breast cancer patients with HER2 positive were randomly divided into control group and treatment group.The control group was given 1 250 mg·m-2 capecitabine tablets,bid,orally administered,and stopped for 1 week after 2 weeks of treatment.On the basis of treatment in the control group,the treatment group was treated with a combination of naratinib maleate tablets 240 mg,qd,orally.Both groups of patients continued to take medication until the disease progressed or the patient could not tolerate it,with one course of treatment every three weeks.The clinical efficacy,tumor marker levels,survival status,and the safety was evaluated.Results Treatment group were enrolled 55 cases,1 case dropped out,and 54 cases were finally included in the statistical analysis.Control group were enrolled 55 cases,2 cases dropped out,and 53 cases were finally included in the statistical analysis.After treatment,the disease control rates of treatment and control groups were 64.81%(35 cases/54 cases)and 35.85%(19 cases/53 cases);the objective response rates were 37.04%(20 cases/54 cases)and 18.87%(10 cases/53 cases);the differences were statistically significant(all P<0.05).After treatment,the levels of carcinoembryonic antigen in the treatment and control groups were(14.88±1.96)and(17.25±2.01)ng·mL-1;the levels of carbohydrate antigen 15-3 were(28.42±4.27)and(32.56±4.85)U·mL-1;the levels of tissue peptide specific antigen were(101.76±10.64)and(106.23±11.16)U·L-1;the overall one-year survival rates were 31.48%and 15.09%;the progression free survival time was 7.00 and 6.00 months;the total survival time was 9.00 and 8.00 months,respectively.The differences of above indexes were statistically significant(all P<0.05).The adverse drug reactions of two groups were mainly diarrhea,leukopenia,hand foot syndrome,nausea and abdominal pain.The incidences of diarrhea in the treatment and control groups were 79.63%and 60.38%with significant difference(P<0.05);and there were no significant differences in the incidence of other adverse drug reactions between two groups(all P>0.05).Conclusion The clinical efficacy of naratinib maleate tablets combined with capecitabine tablets in the treatment of the advanced breast cancer is better than that of capecitabine alone;the former can better reduce the levels of tumor markers,prolong the survival time,and improve the short-term survival rate.
3.Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients (version 2024)
Yao LU ; Yang LI ; Leiying ZHANG ; Hao TANG ; Huidan JING ; Yaoli WANG ; Xiangzhi JIA ; Li BA ; Maohong BIAN ; Dan CAI ; Hui CAI ; Xiaohong CAI ; Zhanshan ZHA ; Bingyu CHEN ; Daqing CHEN ; Feng CHEN ; Guoan CHEN ; Haiming CHEN ; Jing CHEN ; Min CHEN ; Qing CHEN ; Shu CHEN ; Xi CHEN ; Jinfeng CHENG ; Xiaoling CHU ; Hongwang CUI ; Xin CUI ; Zhen DA ; Ying DAI ; Surong DENG ; Weiqun DONG ; Weimin FAN ; Ke FENG ; Danhui FU ; Yongshui FU ; Qi FU ; Xuemei FU ; Jia GAN ; Xinyu GAN ; Wei GAO ; Huaizheng GONG ; Rong GUI ; Geng GUO ; Ning HAN ; Yiwen HAO ; Wubing HE ; Qiang HONG ; Ruiqin HOU ; Wei HOU ; Jie HU ; Peiyang HU ; Xi HU ; Xiaoyu HU ; Guangbin HUANG ; Jie HUANG ; Xiangyan HUANG ; Yuanshuai HUANG ; Shouyong HUN ; Xuebing JIANG ; Ping JIN ; Dong LAI ; Aiping LE ; Hongmei LI ; Bijuan LI ; Cuiying LI ; Daihong LI ; Haihong LI ; He LI ; Hui LI ; Jianping LI ; Ning LI ; Xiying LI ; Xiangmin LI ; Xiaofei LI ; Xiaojuan LI ; Zhiqiang LI ; Zhongjun LI ; Zunyan LI ; Huaqin LIANG ; Xiaohua LIANG ; Dongfa LIAO ; Qun LIAO ; Yan LIAO ; Jiajin LIN ; Chunxia LIU ; Fenghua LIU ; Peixian LIU ; Tiemei LIU ; Xiaoxin LIU ; Zhiwei LIU ; Zhongdi LIU ; Hua LU ; Jianfeng LUAN ; Jianjun LUO ; Qun LUO ; Dingfeng LYU ; Qi LYU ; Xianping LYU ; Aijun MA ; Liqiang MA ; Shuxuan MA ; Xainjun MA ; Xiaogang MA ; Xiaoli MA ; Guoqing MAO ; Shijie MU ; Shaolin NIE ; Shujuan OUYANG ; Xilin OUYANG ; Chunqiu PAN ; Jian PAN ; Xiaohua PAN ; Lei PENG ; Tao PENG ; Baohua QIAN ; Shu QIAO ; Li QIN ; Ying REN ; Zhaoqi REN ; Ruiming RONG ; Changshan SU ; Mingwei SUN ; Wenwu SUN ; Zhenwei SUN ; Haiping TANG ; Xiaofeng TANG ; Changjiu TANG ; Cuihua TAO ; Zhibin TIAN ; Juan WANG ; Baoyan WANG ; Chunyan WANG ; Gefei WANG ; Haiyan WANG ; Hongjie WANG ; Peng WANG ; Pengli WANG ; Qiushi WANG ; Xiaoning WANG ; Xinhua WANG ; Xuefeng WANG ; Yong WANG ; Yongjun WANG ; Yuanjie WANG ; Zhihua WANG ; Shaojun WEI ; Yaming WEI ; Jianbo WEN ; Jun WEN ; Jiang WU ; Jufeng WU ; Aijun XIA ; Fei XIA ; Rong XIA ; Jue XIE ; Yanchao XING ; Yan XIONG ; Feng XU ; Yongzhu XU ; Yongan XU ; Yonghe YAN ; Beizhan YAN ; Jiang YANG ; Jiangcun YANG ; Jun YANG ; Xinwen YANG ; Yongyi YANG ; Chunyan YAO ; Mingliang YE ; Changlin YIN ; Ming YIN ; Wen YIN ; Lianling YU ; Shuhong YU ; Zebo YU ; Yigang YU ; Anyong YU ; Hong YUAN ; Yi YUAN ; Chan ZHANG ; Jinjun ZHANG ; Jun ZHANG ; Kai ZHANG ; Leibing ZHANG ; Quan ZHANG ; Rongjiang ZHANG ; Sanming ZHANG ; Shengji ZHANG ; Shuo ZHANG ; Wei ZHANG ; Weidong ZHANG ; Xi ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Xiaojun ZHANG ; Guoqing ZHAO ; Jianpeng ZHAO ; Shuming ZHAO ; Beibei ZHENG ; Shangen ZHENG ; Huayou ZHOU ; Jicheng ZHOU ; Lihong ZHOU ; Mou ZHOU ; Xiaoyu ZHOU ; Xuelian ZHOU ; Yuan ZHOU ; Zheng ZHOU ; Zuhuang ZHOU ; Haiyan ZHU ; Peiyuan ZHU ; Changju ZHU ; Lili ZHU ; Zhengguo WANG ; Jianxin JIANG ; Deqing WANG ; Jiongcai LAN ; Quanli WANG ; Yang YU ; Lianyang ZHANG ; Aiqing WEN
Chinese Journal of Trauma 2024;40(10):865-881
Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.
4.Analysis of the current status of cancer incidence and mortality in Shanghai,2017 and trends of 2002-2017
Kai GU ; Yi PANG ; Chunxiao WU ; Chunfang WANG ; Liang SHI ; Yongmei XIANG ; Yangming GONG ; Peng PENG ; Jianming DOU ; Mengyin WU ; Xiaocong ZHANG ; Ganling DING ; Jianying YAN ; Yan SHI ; Chen FU
Tumor 2023;43(4):241-256
Background and purpose:The Shanghai Municipal Center for Disease Control and Prevention provides annual updates on cancer occurrence and trends in Shanghai.This study aimed to investigate the cancer incidence and mortality in 201 7 and their trends from 2002 to 2017 in Shanghai. Methods:Data of new cancer diagnoses and deaths from 2002 to 2017 were obtained from the Shanghai Municipal Center for Disease Control and Prevention population-based cancer registry and Vital Statistics System.Cancer incidence and mortality stratified by year of diagnosis or death,gender and age group were analyzed.Number,proportion,crude rate,age-specific rate,age-standardized rate and others were calculated.The number,proportion and rates of common cancers in different groups were also calculated.Trends in age-standardized rate of incidence and death rates for all cancers combined and for the common cancer types by gender were estimated by joinpoint analysis and characterized by the annual percent change(APC)and average annual percent change(AAPC).Segi's 1960 world standard population was used for calculating age-standardized incidence and mortality. Results:The new cancer cases and deaths were 79 378 and 37 186 in Shanghai in 2017.The crude rate of incidence was 546.55/105,and the age-standardized rate was 246.31/105.The age-standardized rate of incidence was higher among females than among males.The crude rate of mortality was 256.04/1 05,and the age-standardized rate was 88.41/105.The age-standardized rate of mortality was higher among males than among females.The age-specific numbers and rates of incidence and mortality increased with age.The age-specific number and rate of incidence reached the peak at the age groups of 60-64 years and older than 85 years,and those of mortality among males reached the peak at the age groups of 60-64 years and older than 85 years,and those of mortality among females reached the peak at the age groups of older than 85 years,respectively.The sites of top 10 common cancer types sorted by the number of incidence cases among males were lung,colorectum,stomach,prostate,liver,thyroid,pancreas,bladder,kidney and oesophagus,and among females were lung,breast,thyroid,colorectum,stomach,pancreas,liver,brain,central nervous system(CNS),cervix uteri and gallbladder,the sites of those sorted by the number of deaths among males were lung,stomach,colorectum,liver,pancreas,prostate,oesophagus,bladder,lymphoma and gallbladder,among females were lung,colorectum,breast,stomach,pancreas,liver,gallbladder,brain,CNS,ovary and lymphoma.The top 10 common cancer types stratified by gender and the top 5 common cancer types stratified by common age groups merged of incidence and mortality had wide variations.Overall,the age-standardized rates of incidence were stable from 2002 to 2009,and increased 2.88%on average per year from 2009 to 201 7.The age-standardized rates of mortality were stable from 2002 to 2011,and decreased 2.66%on average per year from 2011 to 201 7.The trends differed by gender and cancer type. Conclusion:Lung cancer,colorectal cancer,pancreatic cancer,thyroid cancer,female breast cancer,cervical cancer and male prostate cancer are the most common cancers in Shanghai,the appropriate screening technical scheme should be formulated according to the current situation of malignant tumors in Shanghai,promote cancer opportunistic screening,promote appropriate technologies for intervention and management of cancer patients in the community,reduce the disease burden of malignant tumors.
5.Survival analysis of cancer cases diagnosed during 2002-2013 in Shanghai:a population-based study
Chunxiao WU ; Kai GU ; Yi PANG ; Chunfang WANG ; Liang SHI ; Yongmei XIANG ; Yangming GONG ; Peng PENG ; Jianming DOU ; Mengyin WU ; Xiaocong ZHANG ; Ganling DING ; Jiaying YAN ; Yan SHI ; Chen FU
Tumor 2023;43(4):257-265
Objective:To investigate the survival of cancer cases diagnosed during 2002-2013 in Shanghai. Methods:Data on new cancer cases with dead and follow-up information were obtained from the population-based cancer registry and vital statistics system of Shanghai Municipal Center for Disease Control and Prevention.Survival indicators stratified by year of diagnosis,gender,site and age were analyzed.Number of cases and proportion were calculated.The observed survival rates were calculated based on the life table.The probabilities of surviving from 0 to 99 years old were estimated according to the Elandt-Johnson model,and then the cumulative expected survival rates were calculated according to the Ederer Ⅱ method.Finally,the relative survival rates and average annual percent changes of their trends were calculated.The age-standardized relative survival rates adjusted by International Cancer Survival Standard weights were calculated. Results:Total 644 520 new cancer cases were diagnosed during 2002-2013 in Shanghai,accounting for 643 545(99.85%)cases included in the observed cohort for survival analysis.The 5-year observed survival rate increased from 37.61%to 46.47%.The 5-year relative survival rate increased from 42.1 8%to 51.11%.The 5-year age-standardized relative survival rate increased from 40.57%to 49.80%.Among the 5-year relative survival rates of cases diagnosed during 2011 to 2013,99.43%of thyroid cancer was the highest,followed by female breast cancer(88.35%)and corpus uteri cancer(85.56%);5.87%of pancreas cancer was the lowest,followed by gallbladder cancer(13.64%)and oesophagus cancer(17.72%).the rate of lung cancer with the largest number of cases was 23.59%,followed by colorectal cancer(59.82%)and stomach cancer(38.65%).The 5-year relative survival rate of total cases of all sites increased from 40.55%in 2002 to 52.77%in 2013,with an average annual percent change of 2.40%.13 cancer types showed increasing trends,such as liver cancer and lung cancer,while the trends of other cancer types were not statistically significant,such as pancreatic cancer and gallbladder cancer. Conclusion:The diagnostic levels and survival rates of cancer cases have been improved continuously in Shanghai.The trends of different cancer types were varied.
6.The incidence and mortality of lung cancer in 2016 and their trends from 2002 to 2016 in Shanghai
Jianming DOU ; Chunxiao WU ; Yi PANG ; Pingping BAO ; Chunfang WANG ; Yangming GONG ; Liang SHI ; Yongmei XIANG ; Mengyin WU ; Xiaocong ZHANG ; Yan SHI ; Chen FU ; Kai GU
Tumor 2023;43(4):266-276
Objective:To investigate the lung cancer incidence and mortality in 2016 and their trends from 2002 to 2016 in shanghai. Methods:The data of incidence and death on lung cancer in shanghai from 2002 to 2016 were obtained from the Shanghai Municipal Center for Disease Control and Prevention population-based cancer registry and Vital Statistics System.Lung Cancer incidence and mortality stratified by age of diagnosis or death,gender and age-group were analyzed.The number of cases and deaths,proportion,crude rates,age-specific rates,age-standardized rates,corresponding truncated age-standardized rates(35-64 years)and cumulative rates were calculated.Segi's 1960 world standard population was used for calculating age-standardized rates of incidence and mortality as well as truncated age-standardized rates.Trends in age-standardized rates of incidence and death for lung cancer in Shanghai from 2002-2016 were estimated by Joinpoint analysis and characterized by the annual percent change(APC). Results:The new lung cancer cases and deaths were 14 395 and 9 170 in Shanghai in 2016.The crude rate of incidence was 99.41/105,and the age-standardized rate of incidence was 39.76/105.New cases of lung cancer accounted for 19.34%of all malignant tumors in shanghai,ranking the first in the incidence spectrum of malignant tumors.The crude rate of mortality was 63.33/105,and the age-standardized rate was 21.57/105.Deaths of lung cancer accounted for 24.78%of all malignant tumor deaths in shanghai,ranking the first in the mortality spectrum of malignant tumors.The age-standardized rates of incidence and mortality for males were higher than those for females.The age-specific numbers and rates of incidence and mortality increased with age.The age-specific number and rate of incidence reached the peak at the age group of 60-64 years and 80-84 years respectively,and those of mortality peaked at the age group of 80-84 years and older than 85 years respectively.The incidence of lung cancer increased from 33.70/105 in 2002 to 39.76/1 05 in 2016 in Shanghai.Joinpoint analyses showed that the age-standardized rate of lung cancer incidence remained stable from 2002 to 2010(APC=-0.79,t=-1.46,P=0.175)but showed a significant upward trend with an average annual increase rate of 5.12%from 2010 to 2016(APC=5.12,t=6.97,P<0.001).The standardized mortality showed a downward trend with an average annual decrease rate of 0.87%from 2002 to 2016(APC=-0.87,t=-2.87,P=0.013). Conclusion:The incidence of lung cancer in Shanghai during 2002-2016 presented an upward trend while the mortality of lung cancer showed a gradual downward trend.There are differences in the incidence and mortality of lung cancer among different gender and age groups.
7.Analysis on the current status of liver cancer incidence and mortality in Shanghai,2016 and trends during 2002-2016
Liang SHI ; Kai GU ; Chunxiao WU ; Yi PANG ; Yangming GONG ; Yongmei XIANG ; Jianming DOU ; Xiaocong ZHANG ; Mengyin WU ; Chunfang WANG ; Yan SHI ; Chen FU
Tumor 2023;43(4):277-286
Objective:To investigate the liver cancer incidence and mortality in 2016 and their trends during 2002 through 2016 in Shanghai. Methods:Data on new liver cancer diagnoses and deaths during 2002 through 2016 were obtained from the Shanghai Municipal Center for Disease Control and Prevention population-based cancer registry and Vital Statistics System,the numbers,crude rates and age-standardized rates of incidence and mortality of liver cancer were calculated.Segi's 1960 world standard population was used to calculate age-standardized rates.Joinpoint analysis was used to analyze the trend changes and to estimate the annual percent change of incidence and mortality rates. Results:There were 3 842 new liver cancer cases in Shanghai in 201 6,69.44%of which were males,and 3 275 deaths of liver cancer,69.44%of which were males.Mortality to incidence ratio was 0.85.The crude rate of incidence was 26.53/105,and the age-standardized rate was 10.60/105.The crude rate of mortality was 22.62/105,and the age-standardized rate was 8.65/105.The Sex ratios for age-standardized incidence and mortality were 2.91∶1 and 2.97∶1,respectively.The age-specific numbers and rates of incidence and mortality increased with age.Overall,the age-standardized rate of incidence of liver cancer was decreased 3.69%on average per year during 2002 through 2016,and the age-standardized rate of mortality of liver cancer was decreased 3.82%on average per year. Conclusion:The incidence and mortality of liver cancer in Shanghai have been remarkably decreased to a low level countrywide,while liver cancer is still one of the leading malignancies and it brings serious threat to public health,comprehensive prevention and control efforts should be strengthened according to its epidemic characteristics and risk factors.
9.Analysis of the clinical effect of percutaneous pedicle screw fixation combined with transpedicular bone grafting in the treatment of thoracolumbar fracture.
Xiang-Qian LI ; Ming-Hu WU ; Dong-Liang GONG ; Jun ZHANG ; Wen-Qin FU ; Ru-Feng GAO ; Nong CHEN
China Journal of Orthopaedics and Traumatology 2023;36(10):936-942
OBJECTIVE:
To investigate the clinical efficacy of percutaneous screw fixation combined with minimally invasive transpedicular bone grafting and non-bone grafting in the treatment of thoracolumbar fractures.
METHODS:
From Janury 2021 to June 2022, 40 patients with thoracolumbar fracture were divided into the experimental group and the control group. There were 26 patients in the experimental group, including 21 males and 5 females with an aberage age of (47.3±12.3) years old, who underwent percutaneous pedicle screw fixation combined with transpedicular autogenous bone grafting. In the control group, 14 patients received percutaneous pedicle screw fixation only. including 7 makes and 7 females with an average age of (50.2±11.2) years old. The operative time, intraoperative blood loss, anterior height ratio of injured vertebrae, Cobb angle, visual analogue score (VAS), MacNab scores, loosening or broken of the implants. were compared and analyzed.
RESULTS:
There was no significant difference in operation time, intraoperative blood loss, VAS and anterior height ratio of injured vertebrae between the two groups. Compared with the preoperative results, VAS and anterior height ratio of injured vertebrae were improved statistically(P<0.05). For Cobb angle of injured vertebra, there was no significant difference between the two groups before surgery (P=0.766). While at 1 week, 3 months and 12 months after surgery, there were statistically differences between the two groups (P values were 0.042, 0.007 and 0.039, respectively). The Cobb angle of injured vertebrae one year after operation was statistically decreased in both groups compared with that before surgery (P<0.001). One year after surgery, the excellent and good rate of Macnab scores was 96.15% in the experimental group and 92.86% in the control group, and there was no statistical differences between the two groups (P=0.648). There was one patient in the control group suffering superficial wound infection on the third day, which was cured by dressing change and anti-infection treatment. There were no postoperative screw loosening and broken in both groups.
CONCLUSION
The two surgical methods have the advantages of less trauma, less pain and quicker recovery, which can restore the height of the injured vertebra, reconstruct the spinal sequence and reduce the fracture of the vertebral body. Transpedicular autogenous bone grafting can increase the stability of the fractured vertebra and maintain the height of the vertebra better after surgery, thus reducing the possibility of complications such as kyphosis, screw loosening and broken.
Male
;
Female
;
Humans
;
Adult
;
Middle Aged
;
Pedicle Screws
;
Bone Transplantation
;
Blood Loss, Surgical
;
Lumbar Vertebrae/injuries*
;
Thoracic Vertebrae/injuries*
;
Fracture Fixation, Internal/methods*
;
Spinal Fractures/surgery*
;
Treatment Outcome
;
Retrospective Studies
10.Quality Evaluation and Suggestions on Pharmacopoeia Standard of Eucommiae Folium
Ping WANG ; Shaojia LIANG ; Wenwen ZHANG ; Weihong FENG ; Hong YI ; Chun LI ; Fengqian GUO ; Qin SI ; Dejing FU ; Man GONG ; Zhengtao WANG ; Hongchu ZHENG ; Xiaoqian LIU ; Zhimin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(2):10-17
ObjectiveTo establish a quantitative analysis multi-components by single marker method (QAMS) for five main components (aucubin, geniposidic acid, chlorogenic acid, asperuloside and rutin) in Eucommiae Folium, to verify its feasibility and applicability in the determination of Eucommiae Folium, so as to provide a scientific basis for the development of quality standard of this herb. MethodHigh performance liquid chromatography was performed on a Welch Boltmatetm™ C18 column (4.6 mm×100 mm, 2.7 μm) with methanol (A)-0.2% phosphoric acid aqueous solution (B) as the mobile phase for gradient elution (0-8 min, 3%A; 8-10 min, 3%-11%A; 10-26 min, 11%A; 26-27 min, 11%-25%A; 27-60 min, 25%-32%A), the column temperature was set at 30 ℃, the flow rate was 0.6 mL·min-1, the detection wavelengths were at 210 nm and 254 nm. Chlorogenic acid was used as an internal reference to establish the relative correction factors (f) between it and the other four components, and the contents of the five components in 14 batches of Eucommiae Folium were determined by QAMS and external standard method (ESM), respectively. ResultThe f values of chlorogenic acid to aucubin, geniposidic acid, asperuloside and rutin were 3.13, 1.45, 2.64 and 0.56, respectively. Repeatability was good under different experimental conditions, relative standard deviation (RSD) was <5.0%. The contents of aucubin, geniposidic acid, chlorogenic acid, asperuloside and rutin in 14 batches of Eucommiae Folium were 1.340-28.975, 0.252-36.086, 10.016-27.443, 1.396-8.646, 0.533-1.766 mg·g-1, respectively. There were no significant difference between content results of QAMS and that of ESM (RSD<5.0%). ConclusionQAMS established with chlorogenic acid as the internal reference can be used to determine the contents of five components in Eucommiae Folium, and this method is simple and accurate. After comprehensive evaluation, the quality standard of Eucommiae Folium in subsequent editions of Chinese Pharmacopoeia is suggested that three main active components, chlorogenic acid, aucubin and geniposidic acid, are selected as quality markers, and their content limits are recommended not less than 1.5%, 1.0% and 1.0%, respectively. This quality standard draft can avoid the potential quality risk due to poor specificity and low content limit of the index component (chlorogenic acid) in the previous editions of Chinese Pharmacopoeia.

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