1.Emphasis on the cause-effect deduction in clinical studies——Discussion of association factors,predicting factors and risk factors
Chinese Journal of Endocrinology and Metabolism 2000;0(06):-
Cause-effect deduction is the basis of both natural and social sciences. Both wealthy knowledge and logical design are essential in obtaining the true causality among medical studies. Though association analysis provides important information for cause-effect deduction, it does not mean causality itself. Before the existence of the causality between two variables being identified, rigorous criteria must be followed. A number of indexes, such as the significance and the degree of the association, the dose-response relationship, the biology-based possibility, as well as the consistency and specificity, all should be examined very carefully. Clear verifiable hypotheses, rational selection of subjects, reliable experimental methods, appropriate statistical analysis and correct logical deductions, all are the integral parts that finally constitute a faithful deduction.
2.Efficacy and safety of orlistat in Chinese obese patients
Yifan SHI ; Guangwei LI ; Xixing ZHU
Chinese Journal of Endocrinology and Metabolism 2000;0(06):-
Objective To evaluate the clinical efficacy and safety of orlistat in Chinese overweight and obese patients. Methods In six research centers, 444 overweight and obese patients (body mass index 25~40 kg/m 2) were divided into orlistat group (296 patients) and placebo group (148 patients) with a low-energy diet for 24 weeks by a randomized, double-blinded, placebo-controlled study. Results For intent-to-treat analysis, 286 orlistat-treated and 142 placebo-treated subjects were evaluated. After 24 weeks, orlistat-treated patients lost more weight 〔(6.1?3.6)kg,( x ?s)〕 than placebo-treated patients did (3.0?3.5)kg (P
3.Needs of Rehabilitation for People with Physical Disability in Beijing
Jiliang SHI ; Dechun SANG ; Hong PENG ; Jia LI ; Guangwei ZHANG
Chinese Journal of Rehabilitation Theory and Practice 2008;14(9):886-888
Objective To investigate the needs of rehabilitation in people with physical disability in Beijing.Methods 2390 Beijing physical disabled persons surveyed in the Second China National Sample Survey on Disability were involved,their rehabilitation condition and requisition were evaluated.Results 54.85% of them needed rehabilitation in institute,38.20% need rehabilitation in community and family,6.95% need extend service.41.06% need medicine service,30.70% need rehabilitation training,28.24% need assistance articles and utensils.Conclusion There are huge rehabilitation requisitions of physical disability in Beijing,which must be met with various approaches.
4.Effect of heparin slow-release stent implantation combined with myocardium drilling on myocardial regeneration of pigs with acute myocardial infarction
Guangwei ZHANG ; Xiaocheng LIU ; Rongfang SHI ; Xiaobin ZHAO ; Tianjun LIU ; Feng LU
Chinese Journal of Tissue Engineering Research 2010;14(3):438-442
BACKGROUND: A new method, i.e., heparin slow-release stent implantation combined with myocardium drilling, is discovered for myocardial revasculadzation, which remarkably improves myocardial perfusion. OBJECTIVE: To investigate the effect of heparin slow-release stent implantation combined with myocardium drilling on myocardial regeneration of pigs with acute myocardial infarction.METHODS: Anterior descending coronary of pig was ligated to induce myocardial infarction model, which was randomly divided into control and implantation groups, with 6 pigs for each group. Self-made borer was used in the implantation group to drill two transmural channels (3.5 mm diameter) on epicardium. A heparin slow-release stent was fixed in the transmural channel. Following intravenous injection, BrdU was used to label DNA duplication so as to observe stromal cell-derived factor-1 (SDF-1) mRNA expression, myocardial perfusion, newborn yocardium, and heart function prior to and following implantation. RESULTS AND CONCLUSION: As compared with control group, SDF-1 expression was enhanced in the implantation group at 6 weeks after stent implantation (P < 0.001), perfusion mass defect percentage was significantly decreased (P < 0.001), ejection fraction of left ventricle was increased (P < 0.05), newborn myocardium was increased (P< 0.001), and survival myocardium in the ischemic region was increased (P < 0.001). The results demonstrated that heparin slow-release stent implantation combined with myocardium drilling could repair damaged myocardial cells and improve heart function through increasing SDF-1 expression and myocardial perfusion.
5.Efficacy and safety of sibutramine in Chinese obese patients
Yifan SHI ; Changyu PAN ; Guangwei LI ; Xin GAO ; Bangyao LUO ; Jianping WENG ; Jieying DENG ; Chengxun ZHANG
Chinese Journal of Endocrinology and Metabolism 1985;0(01):-
Objective To evaluate the clinical efficacy and safety of sibutramine (Reductile )in Chinese obese patients. Methods Obese adults (BMI 27~45 kg/m 2) in six research centers received sibutamine 10 mg or placebo one tablet each day with a controlled-energy diet for 24 weeks by randomized, double-blinded, placebo-controlled study. Results For intent-to-treat analysis, 125 sibutramine-treated subjects and 126 placebo-treated subjects were evaluated. After 24 weeks, sibutramine-treated patients lost more weight (6.52?3.95)kg than placebo-treated patients (3.18?3.59)kg(P
6.Bioequivalence of Domestic Meloxicam Tablets in Healthy Volunteers
Jie HAN ; Aixin SHI ; Guangwei HE ; Lei LIU ; Qi YIN ; Chunhua SUN ; Youhua SONG
China Pharmacy 2001;0(12):-
OBJECTIVE:The bioequivalence and pharmacokinetics of two kinds of domestic meloxicam tablets were studied in 20 healthy male volunteers METHODS:A dose of 15mg of domestic or imported meloxicam(test and reference preparation)was given according to arandomized 2-way cross-over design,blood samples were withdrawn up to 96 hours post administration,and plasma concentration of meloxicam was determined by high performance liquid chromatography(HPLC)method RESULTS:The peak plasma levels(Cmax)of meloxicam test drug and reference drug were (2 736 2?312 0)and(2 665 6?333 8)?g/L,respectively,the peak time(Tmax)were(4 25?1 16)h and(4 00?1 30)h,respectively,T1/2ke were(21 67?3 81)h and(21 05?3 30)h,respectively,and AUC0~t were(96 454 6?25 526 6)and(95 692 5?24 532 6)?g/(h?L),respectively There were no significant differences in AUC0~t,Tmax,Cmax and T1/2ke between two kinds of tablet CONCLUSION:The relative bioavailability data obtained in the study furnished definite proof of bioequivalence of both domestic meloxicam tablets and imported meloxicam tablets The relative bioavailablility of the test drug was(101 3?11 9)%
7.Significant association between SNPs in IRF6 and non-syndromic cleft lip with or without cleft palate in West China
Yongqing HUANG ; Min MA ; Jian MA ; Yadi LI ; Yingchun LI ; Long WANG ; Jun GAO ; Lei ZHANG ; Guangwei QIAO ; Bing SHI
Journal of Practical Stomatology 2010;26(2):227-231
Objective:To study the association between the rs2013162 and rs2235375 polymorphisms in IRF6 and risk of NSCL/P in west Chinese population. Methods: The study group consisted of 332 NSCL/P patients, their parents (289 mothers, 243 fathers and 206 complete families), and 174 controls. PCR-RFLP method was used to identify genotypes and both case-parent and case-control designs were carried out on samples from west China. Results: There were significant differences in the frequency distributions of both genotypes and alleles when cases were compared with control infants at the rs2235375(P<0.01, P<0.01 respectively). We found strong evidence of over-transmission of the G allele at rs2235375 in cleft case-parent trios(P<0.01). Five specific haplotypes showed significant over-and under-transmission. Conclusion: These results suggest IRF6 variants play a role in NSCL/P in west Chinese populations.
8.Effect of self-made Yiqi Yangyin Decoction on immune function, tumor markers and toxic and side effects of chemotherapy in patients with advanced gastric cancer chemotherapy
Guangwei SHI ; Wendong JING ; Xingyu JIN ; Xiaoting ZHENG ; Shengbao WU
International Journal of Traditional Chinese Medicine 2022;44(2):154-158
Objective:To explore the effect of self-made Yiqi Yangyin Decoction on immune function, serum tumor markers and toxic and side effects of chemotherapy in patients with advanced gastric cancer chemotherapy.Methods:A total of 88 patients with advanced gastric cancer who met the inclusion criteria in the hospital between December 2018 and December 2020 were divided into two groups according to the random number table method, with 44 in each group. The control group was treated with chemotherapy, and the observation group was given self-made Yiqi Yangyin Decoction on the basis of the control group. The two groups were treated for 4 consecutive cycles with 3 weeks as 1 cycle. The Traditional Chinese Medicine (TCM) symptoms were scored before and after treatment, and the levels of IgG, IgA and IgM were detected by immunoturbidimetry. The levels of carcinoembryonic antigen (CEA) and cancer antigen 125 (CA125) were detected by ELISA. The gastrointestinal reactions, thrombocytopenia, anemia, leukopenia and neurotoxicity were recorded and evaluated during treatment, and the clinical efficacy was assessed.Results:The total effective rate was 81.8% (36/44) in observation group and 61.4% (27/44) in control group (χ 2=4.53, P<0.05). After treatment, the scores of stomachache and gastric distension, poor appetite, shortness of breath, and drooping spirit in observation group were significantly lower than those in the control group ( t=17.28, 11.91, 5.02, 5.65, all Ps<0.001) while the levels of serum IgG [(9.39±0.46)g/L vs. (8.54±0.23) g/L, t=10.96], IgA [(1.35±0.42) g/L vs. (1.07±0.15) g/L, t=6.90] and IgM [(0.92±0.09) g/L vs. (0.78±0.10) g/L, t=4.17] were significantly higher than those in the control group ( P<0.01). The levels of serum CEA [(9.07±1.01) μg/L vs. (14.89±2.13) μg/L, t=16.38] and CA125 [(24.87± 4.68) kU/L vs. (30.75±5.33) kU/L, t=5.50] were significantly lower than those in the control group ( P<0.01). During treatment, the toxic and side effects of gastrointestinal reactions, thrombocytopenia, anemia, leukopenia and neurotoxicity were significantly lower in the observation group than those in the control group ( Z=18.52, 2.54, 3.12, 3.84, 2.34, P<0.05). Conclusion:Self-made Yiqi Yangyin Decoction can improve the TCM symptoms, enhance the immunity, reduce the levels of serum tumor markers, and relieve the toxic and side effects of chemotherapy of patients undergoing chemotherapy for advanced gastric cancer.
9.Meta-analysis of dosimetric comparison between volumetric-modulated arc therapy and intensity-modulated radiotherapy for breast cancer after modified radical mastectomy
Yan GAO ; Heli ZHONG ; Zhuangling LI ; Guangwei ZHANG ; Longxing LI ; Yabin SHI ; Xianming LI
Chinese Journal of Radiation Oncology 2021;30(11):1159-1166
Objective:To compare the dosimetric differences between volumetric-modulated arc therapy (VMAT) and intensity-modulated radiation therapy (IMRT) on planning target volume (PTV) and organ-at-risk (OAR) for breast cancer after modified radical mastectomy, aiming to provide evidence-based reference for clinical practice.Methods:According to strict inclusion and exclusion criteria, literature search was performed in PubMed, Cochrane Library, FMRS, CNKI, Wanfang Data and VIP full text databases from the inception of databases up to March 2020. The controlled clinical trials of dosimetric comparison between VMAT and IMRT for breast cancer following modified radical mastectomy were selected. The meta-analysis was performed using Stata14 software.Results:The meta-analysis included 281 patients from 13 observational studies. Compared with IMRT, VMAT significantly increased the PTV dose coverage D 95%( P<0.001) and significantly improved the PTV homogeneity index (HI, P<0.001) and conformity index (CI, P=0.004). Compared with IMRT, VMAT more effectively decreased the ipsilateral lung V 20Gy (WMD=1.332, P=0.027) and contralateral lung V 10Gy ( P=0.003). There were no significant differences in theD mean, V 5Gy, V 10Gy and V 30Gy of the ipsilateral lung, D mean and V 5Gy of the contralateral lung, D mean, V 10Gy and V 30Gy of the heart between VMAT and IMRT (all P>0.05). Compared with VMAT, IMRT reduced the cardiac V 5Gy ( P=0.001). However, sensitivity analysis of included literature on cardiac V 5Gy showed that the P value was reversed, indicating that the stability of the results was poor. VMAT significantly shortened the delivery time ( P<0.001) and the number of monitor units ( P<0.001) compared to IMRT. Conclusion:Compared with IMRT, VMAT can achieves superior target dose coverage, HI and CI, better protection for the ipsilateral and contralateral lung, fewer monitor units and shorter delivery time.