1.Analysis on the Defects of 31 Pharmaceutical Enterprises Tracking Inspection in Guangxi Zhuang Autono-mous Region after Implementing the New GMP
Shihua LU ; Yingying WEI ; Guanghui WEI
China Pharmacy 2017;28(19):2601-2604
OBJECTIVE:To further enhance the implementation level of new Good Manufacturing Practices (GMP) in phar-maceutical enterprises. METHODS:Based on the new GMP criteria and Guidelines for Risk Assessment of Pharmaceutical Produc-tion Site Inspection,a tracking inspection was conducted for the 31 pharmaceutical enterprises in 11 prefecture-level cities of Guangxi area. Defects of implementing new GMP and their causes were analyzed,and the suggestions were put forward. RESULTS& CONCLUSIONS:In the 31 pharmaceutical enterprises,there were 30 enterprises(96.8%)passed the new GMP tracking inspec-tion. Totally 331 defect items were found,focusing on equipment(76 items,23.0%),factory and facilities(47 items,14.2%),quality control and quality assurance(43 items,13.0%). Causes for defects were mainly institutions and staff training,factory and facilities,equipments management,maintenance and periodic check were far from satisfactory;material and product did not speci-fy a validity period or a retest period;relevant confirmation was incomplete with verification;the quality control,assurance,man-agement,document and production management were not standard and completed;and self-test program was too simple,etc. It is suggested that drug regulatory authorities should establish and improve the legal system,explore new patterns of drug GMP track-ing inspection (such as sudden unannounced inspection,detailed inspection),strengthen inspector team training and unify inspec-tion scale. And the pharmaceutical enterprises should produce drugs in line with the requirements of new GMP,focus on the update of key knowledge,strengthen relevance of training to ensure the drugs quality effectively by multilateral force.
2.Heavy ion beam radiotherapy for malignant tumor of bone and soft tissue
Sha LI ; Shihua WEI ; Hong ZHANG
Journal of International Oncology 2011;38(6):462-464
The malignant tumor of bone and soft tissue is conventional rays(X,γrays)resistant. The heavy ion rays 12C+ have following characteristics: high linear energy transfer, Bragg peak, small scattering, high biological effect, lethal damage to tumor cell, and double-strand break to the DNA. Therefore, heavy ion rays Call allow tumor target area obtain high radiation doses while surrounding normal tissues get best protection Recent progress of basic and clinical research on heavy ion treating malignant tumor of bone and soft tissue is discussed.
3.Construction of the Reporter Vector Controlled by Two Tandem Copies of Estrogen Response Elements in Yeast
Shihua HE ; Zenghui LIANG ; Wei ZHAN
Journal of Environment and Health 1993;0(01):-
Objective To establish the recombinant yeast estrogen system(RYES),a reporter vector controlled by estro-gen response elements(ERE)in yeast was constructed.Methods pLacZi-1RER was obtained first by inserting an ERE which was synthesized artificially into the yeast reporter vector pLacZi which had already been lined by SalI and the terminal dephos-phorized by CIAP.Then,pLacZi-zERE.was obtained by inserting another ERE into the XhoI site nearby the ERE in pLacZi-1ERE.Results Sequence analysis indicated that the yeast reporter vector controlled by two tandem copies of ERE was con-structed successfully.Conclusion The yeast reporter vector controlled by ERE,pLacZi-2ERE,was constructed successfully,which was the very important groundwork for further establishment of the recombinant yeast estrogen system(RYES).
4.Medical Ethics Education for Clinical Interns in Minorities Area
Shihua XU ; Leban NONG ; Jie WEI
Chinese Medical Ethics 1995;0(04):-
Clinical practice is an important process for the formation of the clinical skills and decent medical ethics of medical students.This paper clarifies various issues arising in the current medical ethics education,and proposes relevant countermeasures from the perspectives of medical colleges,training hospitals,guidance teachers,and so on.
5.Comparison of 99Tcm-MIBI SPECT/18F-FDG PET imaging and cardiac MRI in assessment of myocardial injury cases with idiopathic dilated cardiomyopathy
Lei WANG ; Wei FANG ; Chaowu YAN ; Minfu YANG ; Shihua ZHAO
Chinese Journal of Nuclear Medicine and Molecular Imaging 2013;(2):141-145
Objective To evaluate the relationship of myocardial MR contrast delay-enhancement and nuclear perfusion-metabolism pattern in patients with idiopathic dilated cardiomyopathy (IDCM).Methods Forty-two consecutive patients (29 men and 13 women,age:(53 ±12) years) diagnosed clinically with IDCM were enrolled.All patients underwent 99Tcm-MIBI SPECT,18F-FDG PET imaging and MR contrast delay-enhancement imaging within 3-7 d.The myocardial perfusion-metabolism segment analysis was performed using a 17-segment model.Segmental 99Tcm-MIBI and 18F-FDG uptakes were scored visually using a 4-grade scoring system (0 =normal uptake,1 =mildly reduced uptake,2 =moderately reduced uptake,3 =severely reduced uptake).Patterns of perfusiorn/metabolism were classified as normal,mismatch,mild-to-moderate match and severe match.Myocardial MR contrast delay-enhancement was classified into 3 categories (non,mid-wall and transmural delay-enhancement).x2 test was used to analyze the differences of perfusion/metabolism patterns among non,mid-wall and transmural delay-enhancement groups and the myocardial MR contrast delay-enhancement incidence among four perfusion/metabolism groups.Resuits Among the 42 patients,myocardial delay-enhancement was present in 18 patients,of which 94.4% (17/18) showed abnormal myocardial perfusion/metabolism patterns and only 33.3 % (8/24) patients without abnormal myocardial delay-enhancement had abnormal myocardial perfusion/metabolism patterns (x2 =15.944,P < 0.001).Perfusion/metabolism patterns varied in three different categories of non,mid-wall and transmural delay-enhancement (x2 =14.276,P < 0.001).The normal peffusion/metabolism pattern proportions in the non,mid-wall and transmural delay-enhancement groups were 86.2% (526/610),71.0% (44/62) and 28.6% (12/42),respectively.The incidence of transmural delay-enhancement (44.4% (12/27)) was significantly higher in segments with severe match than that in the other 3 groups (normal:2.1% (12/582) ; mismatch:18.1% (15/83) ; mild-to-moderate match:13.6% (3/22) ; x2 =112.530,P < 0.001).Conclusions MR contrast delay-enhancement is much more sensitive in detecting moderate fibrosis,while nuclear perfusion-metabolism imaging can detect more impaired but viable myocardium.Combining the two imaging modalities is useful for providing comprehensive evaluations of myocardial injury in patients with IDCM.
6.Combined chemo-radiotherapy for Stage II-III non-small cell lung cancer
Yangjun YUE ; Yunsheng LI ; Sha LI ; Shihua WEI ; Zhongze TIAN
Chinese Journal of Radiation Oncology 1993;0(03):-
Objective To evaluate the effects of induction chemotherapy plus radiotherapy (ICRT) and concurrent chemotherapy plus radiotherapy (CCRT) for Stage Ⅱ -Ⅲ non-small cell lung carcinoma (NSCLC) . Methods From July 19% to July 1999, 64 patients with Stage Ⅱ -Ⅲ NSCLC were randomized into two groups: ICRT group (32 patients) induction chemotherapy with DDP( 100mg/m2,dl) and VP-16 (100mg/m2,dl-d3) per week, one cycle per 4 weeks was given. Radiation was given after 2-3 cycles. CCRT group (32 patients) received radiotherapy plus concurrent chemotherapy with DDP(20 mg/m2,dl-d5) and VP-16 (50 mg/m2,dl-d5) per week for 8 weeks. In either group, radiation was given with a total dose of 60-70 Gy/6-7 weeks. Results One patient was excluded from ICRT group for development of distant metastasis, and 3 from CCRT group for their acute complications or other diseases. The overall response rates ( CR + PR) of ICRT and CCRT groups were 81.3% and 84.4%, respectively . NR + PD rates of both groups were 18.7% and 15.6% . The median survival periods were 13.4 months in ICRT group and 21.6 months in CCRT group (t = 2.58, P
7.On the Ethical and Moral Construction in Minorities Area Medical Colleges in the New Era
Shihua XV ; Leban NONG ; Jie WEI ; Huiheng TAN ; Bing GUAN
Chinese Medical Ethics 1995;0(04):-
To strengthen the ethical and moral construction in minorities area medical colleges and universities is essential for the carrying out of the scientific development concept and the promotion of public health in minorities area,whose core is the establishment of an educational system of ethics and morality consummating "educates the human takes the labor of duty,the moral education for first",including content and means construction of ethical and moral education.
8.Effect of L-Arg on plasma content of endothelin and expression of c-fos mRNA in the left ventricle of rats with renovascular hypertensive hypertrophy
Shihua YIN ; Lixin XIAO ; Changlin HUA ; Jinb WEI
Chinese Journal of Pathophysiology 1989;0(06):-
AIM: To study the effect of L-Arg on plasma content of endothelin (ET) and the expression of proto-oncogene c-fos mRNA in the left ventricle of rats with renovascular hypertensive hypertrophy. METHODS: The level of c-fos mRNA were measured by in situ hybridization. The ET in plasma were measured by radioimmunoassay. RESULTS: After eight weeks of treatment with L-Arg, the expression of c-fos decreased markedly ( P
9.Influencing factors of serum uric acid and the critical concentration of serum uric acid to prevent and treat metabolic syndrome in female inhabitants from coastal area of Shandong province
Yangang WANG ; Shihua ZHAO ; Xinyan CHEN ; Feng XU ; Wei SONG ; Changgui LI ; Shengli YAN
Chinese Journal of Tissue Engineering Research 2006;10(40):147-151
BACKGROUND: What are the influencing factors of serum uric acid of inhabitants from coastal area? What is the critical concentration of serum uric acid to prevent and treat metabolic syndrome?OBJECTIVE: To probe into the relationship between serum uric acid and metabolic syndrome in female inhabitants aged more than 20 years from coastal area of Shandong province.DESIGN: A clusting stratified random sampling survey.SETTING: Department of Endocrinology, Affiliated Hospital of Medical College of Qingdao University.PARTICIPANTS: The survey was carried out in the female inhabitants of five cities from coastal area of Shandong province (Qingdao, Rizhao, Yantai, Weihai and Dongying) between May and October 2004. The inhabitants, aged 20 to 80 years, lived there for 5 or more than 5 years, and they were natural crowd taking family as unit.METHODS: Investigations in the manner of entering every family and being on the spot were combined. Questionnaires were filled in on the first day, and fasting blood was taken to perform serum uric acid examination on the morning of the second day. For those with serum uric acid higher than normal, they were given rechecking on the third day, and education about prevention and treatment of gout and hyperuricemia was conducted at the same time.MAIN OUTCOME MEASURES: ① Investigation on general condition:Including health status, diet, physical activity, labour intensity and economics. ② Investigation on nutrition: Consists of food intake frequency and dietary. ③ Body height, body mass, waistline, hip circum, blood pressure and body mass index. ④ Levels of fasting blood glucose(FBG), serum uric acid, total cholesterol (TC), triacylglycerol (TG), high-density lipoprotein cholesterol(HDL-C), urea nitrogen (UN) and creatinine(Cr).RESULTS: ① With the increase of concentration of serum uric acid, levels of systolic pressure (SP), diastolic pressure (DP), pulse pressure (PP),body mass index(BMI) , waistline, waist-to-hip ratio(WHR), UN, Cr, TG,TC were all gradually increased. Each index was significantly higher in the serum uric acid 280-319 μmol/L group, serum uric acid 320-349 μmol/L group and serum uric acid > 350 μmol/L group (hyperuricemia group)than that in serum uric acid < 280 μmol/L (P < 0.05-0.01 ), While the concentration of HDL-C was decreased with the increase of concentration of serum uric acid (all P < 0.01). ② The incidence of hypertension, lipid metabolic disorder, overweight and obesity, glycometabolism disorder as well as metabolic syndrome was increased with the increase of uric acid;Compared with serum uric acid < 280 μmol/L group, OR value of metabolic syndrome was 2.29(95%CI: 1.81-2.89),4.15(95%CI:3.10-5.55),4.96 (95%CI:3.85-6.39) in the serum uric acid 280-319 μmol/L group,320-349 μmol/L group and hyperuricemia group , respectively. ③Noncondition Logistic multiple stepwise regression analysis showed that age,hypertension, shellfish intake volume, UN, Cr, TG and WHR and light physical activity were the independent risk factors for female patients with hyperuricemia and HDL-C was protective factor.CONCLUSION: The incidence of metabolic syndrome is increased with the increase of concentration of serum uric acid in female inhabitants from coastal area of Shandong province. 280 μmol/L should be as the critical concentration of serum uric acid to prevent and treat metabolic syndrome.Controlling metabolic syndrome and reducing intake of shellfish and other marine products which contain high level of purine is one of means to prevent hyperuricemia. Clinical physicians should paid more attention to the pathopoiesis of hyperuricemia.
10.The significance of genetic expression of IGF-Ⅰ , ERK, and GLUT4 in adipose tissue of patients with metabolic syndrome and colorectal cancer and its significance
Yan FENG ; Cui LIN ; Shihua ZHAO ; Wei WANG ; Yangang WANG ; Fenglian WANG
Chinese Journal of Endocrinology and Metabolism 2013;29(10):876-878
[Summary] To explore the mRNA expression of insulin-like growth factor-Ⅰ (IGF-Ⅰ),extracellular signal regulated kinase (ERK),and glucose transporter 4 (GLUT4) in greater omental adipose tissue of patients with metabolic syndrome and colorectal cancer.The mRNA expression of IGF-Ⅰ,ERK,and GLUT4 in greater omental adipose tissue of the subjects was measured by RT-PCR.(1) The mRNA expression level of IGF-Ⅰ and ERK in the metabolic syndrome group was significantly higher than that in the control group (P<0.01),while in colorectal cancer subgroup the expression was significantly higher than that in the non-colorectal cancer subgroup (P< 0.01).The expression of GLUT4 was obviously lowered (P<0.01).(2) The expression of ERK was positively correlated with that of IGF-Ⅰ (r =0.608,P<0.01).The fasting insulin was positively correlated with the expression of ERK and IGF-Ⅰ(r =0.538,0.439,P < 0.01),and negatively with that of GLUT4 (r =-0.457,P < 0.01).There may be relationship between ERK plus IGF-Ⅰ and metabolic syndrome complicated with colorectal cancer.The lowered GLUT4 expression may be related to insulin resistance in metabolic syndrome.