1.Discussion on the management model of subject screening and reasonable application of subject databases in phase Ⅰclinical trials in China
Ran XIE ; Xiao CHEN ; Xia ZHAO ; Yi-Min CUI
The Chinese Journal of Clinical Pharmacology 2016;32(8):749-752
It is particularly important to confirm that whether subjects were repeated to participate in the clinical trial, the time interval from the last dose in the recent clinical trial, whether the physical conditions of subjects accord with the clinical trial protocol in phase I clinical trials and so on.This paper will introduce two types of the subject database, one was established by our hospital, another one is subject networking database, and will introduce the operation mode, the present situation of subjects screening under the database management. To explore the existing problems, optimize the use of subject database and give long-term prospects of subject networking database.
2.Experimental study on relationship between pungent-hot herb property express and calmodulin.
Xin LIU ; Yan HU ; Yi-Ran CUI ; Xiao-Qing LIU ; Bing-Hua TANG ; Bing ZHANG
China Journal of Chinese Materia Medica 2014;39(5):873-878
OBJECTIVETo explain the essence of pungent-hot herb property express according to in vivo and in vitro studies on its effect on calmodulin on the base of the observation of the adjustment in hypothalamic-pituitary-gonad axis functions of Aconiti Lateralis Radix Praeparata, Curculiginis Rhizoma, Cinnamomi Cortex and bitter-cold herb Phellodendri Chinensis Cortex in rats under the state of yang deficiency.
METHODThe yang-deficient model was duplicated by intramuscularly injecting hydrocortisone sodium succinate powder injection. After the intervention with Aconiti Lateralis Radix Praeparata, Curculiginis Rhizoma, Cinnamomi Cortex and bitter-cold herb Phellodendri Chinensis Cortex for seven days, TSH, T3, T4, 17-OHCS, COR, T, E2 of hypothalamus-pituitary-target gland axis and other relevant indexes were detected. The calmodulin expression in livers and L02 cells cultured in vitro was detected by using Western blot.
RESULTPungent-hot herbs Aconiti Lateralis Radix Praeparata, Curculiginis Rhizoma, Cinnamomi Cortex can significantly correct indicators of hypothalamic-pituitary-gonad axis and calmodulin, whereas the bitter-cold herb Phellodendri Chinensis Cortex showed no obvious effect.
CONCLUSIONThe pungent-hot herb property expression may be closely related to calmodulin.
Animals ; Calmodulin ; metabolism ; Drugs, Chinese Herbal ; administration & dosage ; chemistry ; Gonads ; drug effects ; metabolism ; Hypothalamo-Hypophyseal System ; drug effects ; metabolism ; Liver ; drug effects ; metabolism ; Male ; Rats ; Rats, Sprague-Dawley ; Yang Deficiency ; drug therapy ; metabolism
3.Analysis on the status and trend of TB burden in China from the global views
Chinese Journal of Disease Control & Prevention 2020;24(3):258-263,283
Objective To analyze the status and trends for the prevalence,morbidity,mortality, and DALY of tuberculosis ( TB) in China from 1990 to 2017,so as to provide scientific basis for TB pre- vention and control. Methods From 1990 to 2017 in China,the United States,India,Japan,and the global,the TB ( standardized) prevalence,( standardized) morbidity,( standardized) mortality,and ( standardized) DALY rates were obtained from Institute for Health Metrics and Evaluation ( IHME) web- site,and comparative analysis of changes in these indicators with years were carried out. Results In 2017, the prevalence,morbidity,mortality,and DALY rate of TB in China were higher in the high-age group than in the low-age group. The prevalence,morbidity,mortality,and DALY rates were all higher for males than females. The prevalence was 29 641. 59/100 000 and 28 803. 26/100 000 for male and female,respectively. The male and female mortality rates were 72. 23/100 000 and 44. 85/100 000. The male and female mortali- ty rates were 3. 85/100 000 and 1. 67/100 000,and the DALY rate of male and female were 156. 95/100 000 and 84. 73/100 000. From 1990 to 2017,the prevalence of TB decreased from 32 178. 39/100 000 in 1990 to 29 231. 80/100 000 in 2017,the morbidity rate of TB decreased from 141. 83/100 000 in 1990 to 58. 83/100 000 in 2017,the mortality rate of TB decreased from 13. 82/100 000 in1990 to 2. 78/100 000 in 2017,and the DALY rate of TB decreased from 582. 87/100 000 in 1990 to 121. 60/100 000 in 2017. Conclusions The burden of TB in China declined markedly from 1990 to 2017. Although some progress has been made in the prevention and treatment of TB in China,but there is still a certain gap compared with de- veloped countries. It is still necessary to further reduce the morbidity rate and mortality rate of TB.
4.Trastuzumab-induced hepatotoxicity and analysis of adverse drug reaction: a case report
Ran XIE ; Nan ZHAO ; Yi-Min CUI
The Chinese Journal of Clinical Pharmacology 2017;33(10):936-938
Objective To analyze the the characteristics,risk factors and treatment of trastuzumab-induced hepatotoxicity in patients with breast cancer.Methods To analyze by a case report of trastuzumab-induced hepatotoxicity in a patient with breast cancer in practice combined with 4 related case reports in literatures.Results and conclution Trastuzumab-induced liver toxicity may have the following characteristics:early occurrence;previous use of medication with the side effect of liver damage may be one of the causes of hepatotoxicity;the grade of hepatotoxicity often reaches grade 3 and grade 4;long duration of liver function recovery;hepatotoxicity induced by trastuzumab may be dose-related.Focusing on past medical history and medication history and regular monitoring of liver function may be one of the effective measures to determine hepatotoxicity intensively and to avoid serious complications.
5.Case analysis of individualized tacrolimus treatment on patient with nephrotic syndrome
Xiao-Dan ZHANG ; Ran XIE ; Yi-Min CUI
The Chinese Journal of Clinical Pharmacology 2018;34(19):2345-2347
Objective To combine genotyping and therapeutic drug mo-nitoring ( TDM ) and to provide patients with reasonable treatment . Methods Clinical pharmacists were able to participate in the treatment of 1 patient with nephrotic syndrome ,analyze the causes of poor efficacy in the early stage of hospitalization , combine the genotyping result and remind the clinicians to adapt an appropriate drug dose ,or use a combi-nation of drugs to improve drug plasma concentration .It is recommended to monitor the plasma drug concentration of tacrolimus and develop ration-al use of immunosuppressant drugs .Results and conclusion The pa-tient's tacrolimus concentration quickly reached the standard and his condition improved.The patient was discharged.In clinical practice, pharmacists should combine the patient's diseases, medications, geno-types and other factors, with the use of drug interactions to increase plasma concentration of tacrolimus, save the patient's expenses, and fully use therapeutic drug monitoring and other means to improve the effectiveness of drug treatment and safety.
6.Endoscopic surgery using the low-temperature plasma radiofrequency for nasopharyngeal angiofibroma
Qing-Feng ZHANG ; Cui-Ping SHE ; Yi-Feng TONG ; Yan JIN ; Xin-Ran ZHANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2010;45(7):578-581
Objective To evaluate the feasibility of endoscopic surgery using the low-temperature plasma radiofrequency for nasopharyngeal angiofibroma (NA). Methods The clinical data of 4 patients treated between December 2005 and August 2009 were retrospectively analyzed. The tumor in one patient was at stage Ⅰ and three patients were at stage Ⅱ, all these patients were treated by endoscopic surgery using the low-temperature plasma radiofrequency under controlled hypotension anesthesia. Preoperative angiography and embolisation were underwent in all patients. Bipolar coagulation was used to help hemostasis during operation. Results The tumor in all 4 patients was completely removed. The operation time was 60,80, 110, 90 min respectively. The blood loss was 250, 250, 320, 280 ml respectively. Neither blood transfusion nor complications were encountered perioperatively. Follow-up ranged from 6 months to 4 years,none of the patients recurred. Conclusions Endoscopic surgery using low-temperature plasma radiofrequency for nasopharyngeal angiofibroma has many advantages such as less bleeding and total tumor removal. It is a minimally invasive surgical method for nasopharyngeal angiofibroma.
7.CiteSpace-based visualization and analysis of Chinese medicine diagnostic and treatment equipment
Dan-Dan CUI ; Yi-Xing LIU ; Dong-Ran HAN
Chinese Medical Equipment Journal 2024;45(3):76-80
Relevant literature on TCM diagnostic and treatment equipment from January 1994 to May 2023 was collected with three Chinese databases,namely,China National Knowledge Infrastructure,Wanfang and Wipu.CiteSpace software was used for the analyses of the trend of annual publication volume,co-occurrence of publication institutions,co-occurrence of keywords,cluster and burst and the generation of corresponding knowledge graphs.It's pointed out TCM diagnostic and treatment equipment had problems in low publication volume and collaboration between research institutions,hotspots of Chinese medicine diagnosis and treatment,diagnosis and treatment equipment,diagnosis device,Chinese medicine diagnosis,diagnosis and treatment technology and traditional Chinese medicine,and research frontiers of artificial intelligence,medical alliance,curriculum design and innovation and entrepreneurship.References were provided for relevant research in China.[Chinese Medical Equipment Journal,2024,45(3):76-80]
8.Detection of siderotic nodules in the liver with susceptibility weighted imaging: correlations to serum ferritin, Child-Pugh grade and hyaluronic acid levels.
Ran TAO ; Zhong-Lan YOU ; Jiu-Quan ZHANG ; Yong-Ming DAI ; Dai-Quan ZHOU ; Ping CAI ; Yi FAN ; Jin-Guo CUI ; Jian WANG
Chinese Medical Journal 2012;125(17):3110-3114
BACKGROUNDChronic liver disease causes aberrant formation of fibrous tissue that impedes normal liver function, ultimately resulting in liver cirrhosis. Iron uptake can occur within the hepatic parenchyma or within the various nodules that form in a cirrhotic liver, termed siderotic nodules (SN). We aimed to investigate the diagnostic performance of susceptibility weighted imaging (SWI) for detection of SN in patients with liver cirrhosis, and to evaluate the potential of SN numbers for assessing the degree of hepatic iron deposition, liver function, and liver fibrosis stage.
METHODSNinety-one patients with chronic liver cirrhosis, who underwent megnetic resonance imagine (MRI) scanning in our department between November 2010 and April 2011, were included in the study. A 3.0T MRI scanner was used to acquire T1WI, T2WI, T2WI, and SWI images. The number of nodules, signal intensity ratio (SIR), and contrast noise ratio (CNR) were recorded and analyzed by chi-square and ANOVA statistical tests. Correlation analysis was performed to evaluate the correlations between the number of SN and Child-Pugh classification, ferritin and hyaluronic acid levels.
RESULTSThe sensitivity of SWI, T1WI, T2WI, and T2 WI for detecting SN was 62.5%, 12.1%, 24.2% and 41.8%, respectively. SWI detected significantly more nodules than routine T1WI, T2WI, and T2 WI procedures (P < 0.05). The SIR was the lowest in SWI (0.361 ± 0.209), as compared to T1WI (0.852 ± 0.163), T2WI (0.584 ± 0.172), and T2 WI (0.497 ± 0.196). The CNR was the highest in SWI (13.932 ± 5.637), as compared to T1WI (9.147 ± 5.785), T2WI (9.771 ± 5.490), and T2 WI (11.491 ± 4.573). The correlation coefficients of the number of SN with ferritin, Child-Pugh classification, and hyaluronic acid levels were 0.672, -0.055, and 0.163, respectively.
CONCLUSIONSThe sensitivity and contrast of SWI for detecting SN in patients with liver cirrhosis are higher than conventional MRI. The number of SN can help to assess the degree of iron deposition in patients with liver cirrhosis.
Adult ; Diffusion Magnetic Resonance Imaging ; methods ; Female ; Ferritins ; blood ; Humans ; Hyaluronic Acid ; blood ; Liver ; pathology ; Liver Cirrhosis ; blood ; pathology ; Male ; Middle Aged ; Sensitivity and Specificity
9.Preparation and detection of pipettes for microinjection
xin Da CHENG ; ran Li XU ; qing Qing YU ; cui Shou GAO ; jing Xiao WANG ; Yi LIU ; qi En LIU ; hai Si ZHAO
Journal of Xi'an Jiaotong University(Medical Sciences) 2017;38(6):917-920
Objective To introduce an optimized practical method of making and detecting pipettes for microinjection.Methods Transfer pipette was made from hard glass capillary. We softened the hard glass capillary by rotating it in a spirit-lamp flame,then moved out from the flame and quickly pulled it into two transfer pipettes.After broken by a grinding wheel,the tip of the pipette was fire-polished by quickly touching the flame to make a fine opening.A hard glass capillary (1.0 mm,ouside diametre)was pulled into two holding pipettes by pipette Puller.The pipette shoulder was broken at desired position with a grinding wheel,then the fine pipette tip opening was heated by a microforge and shrinked into a diameter -15 μm.Injection pipette could be made directly from a capillary with filament by Puller.The solution loaded injection pipette and holding pipette were assembled into the micromanipulator and could be checked before use.We transfered both pipettes into the zygotes media drop,touched the holding pipette with the tip of the injection pipette to make a "suitable"opening.Then we switched injection pipette to the mineral oil and applied injection pressure through the injector to check whether the solution could come out of the tip smoothly and at a proper speed.It could be further verified by pronucleus microinjection of zygotes.Results The results showed that the method introduced in this paper could produce suitable pipettes for zygote microinjection.In particular,the method of detecting the opening of the injection pipette was helpful for achieving high efficiency of zygote microinjection.Conclusion The method introduced here to make and detect pipettes for microinjection is very helpful for establishing a standard microinjection manipulation procedure and improving the efficiency of zygote microinjection.
10.Comparative analysis of polysomnography and micro-sensitive mattress-sleep monitor used for obstructive sleep apnea hypopnea syndrome
Qing-Feng ZHANG ; Yi-Feng TONG ; Cui-Ping SHE ; Xin-Ran ZHANG ; Wei SONG ; Li-Mei WANG ; Chen-Jing CHENG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2010;45(12):1014-1019
Objective To assess the efficiency of mattress-type micro sensitive monitor(MMSM) in sleep monitoring. Methods Forty patients diagnosed as obstructive sleep apnea-hypopnea syndrome (OSAHS) by polysomnography (PSG) were randomly chosen, then received MMSM examination within 2 -5 days. The results of both methods were compared, using the respiratory disturbance index, sleep efficiency, and obstructive factors as indicators. Results All 40 patients were diagnosed as OSAHS, which were consistent with the results of PSG. There was no statistical difference when comparing the apnea hypopnea index (AHI, (-x)± s, 35.6 ± 21.3 and 37. 6 ± 18. 8, respectively) and the ratio of rapid eyes movement (REM) stage (15.0 ± 4. 5) % and (15.8 ± 6. 3) %, respectively (t were 1. 867 and 1. 014,P >0. 01). Some statistical sense was found when patients'deep sleep, shallow sleep and sleep efficiency were compared (P <0. 01). According to the severity diagnosed by PSG, patients with mild, moderate and severe OSAHS were 11, 7 and 22 cases, respectively, Comparing by MMSM, 2, 19 and 19 cases,respectively. Among seventeen volunteers diagnosed by PSG as normal subjects, 2 of them were diagnosed as mild OSAHS. The sensitivity of MMSM was 100. 0% and the specificity was 88. 2%. Conclusions With regard to the diagnosis of OSAHS, MMSM is well consistent with PSG. The MMSM can be applied clinically as a monitor technique.