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.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.
4.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).
5.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
6.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
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.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.
9.Relationship between myocardial glucose metabolism in right heart and cardiac function in patients with idiopathic dilated cardiomyopathy
Xinghong MA ; Lei WANG ; Liwei XIANG ; Yong YANG ; Shuliang HU ; Shihua ZHAO ; Wei FANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2015;35(2):81-84
Objective To explore the relationship between myocardial glucose metabolism in the right heart and cardiac function in patients with idiopathic dilated cardiomyopathy (IDCM).Methods From October 2010 to May 2013,64 consecutive patients (45 males,19 females; mean age:(53 ± 12) years) with IDCM were enrolled in this study.All patients underwent 18F-FDG myocardial PET imaging,late-gadolinium enhancement cardiac MRI (cMRI-LGE) and UCG.TrueD software was used to determine the SUVmax in right (SUV-R) and left (SUV-L) ventricular free wall,and the ratio of SUV-R to SUV-L (SUV-R/L) was calculated.The cMRI-LGE was used to evaluate LVEF,RVEF and LGE in left heart.Pulmonary artery systolic pressure (PASP) was measured by UCG.Two-sample t test and Pearson correlation analysis were used to analyze the data.Results Both SUV-R and SUV-R/L had negative correlation with LVEF (r=-0.48,-0.33; both P<0.01) and also with RVEF (r=-0.45,-0.44; both P<0.01).SUV-R/L positively correlated with PASP (r =0.58,P<0.01).SUV-R/L of patients with and without LGE were statistically different (0.45±0.18 vs 0.36±0.12; t=2.50,P<0.05).SUV-R and SUV-L of patients with LGE were 2.0±0.9 and 4.7±1.6,and those of patients without LGE were 1.7±0.9 and 5.0±2.8.Both differences of SUV-R and SUV-L between the two groups were not statistically significant (t=0.54 and 0.63,both P>0.05).Conclusions Myocardial glucose metabolism in right heart is closely correlated with left and right ventricular function.The assessment of 18F-FDG uptake in right heart by PET imaging is potentially useful for evaluation of the severity and prognosis in IDCM patients.
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.