Object to define defects of drug accurately and to initially discuss its law responsibility. Method With comparative study and system thinking,we acquired few scientific recognition of drug’s defects. Result & Conclusion Defects of drug are not equal to negative drug reaction. The former one should be an unreasonable and potential risk which induces no expectant therapeutic efficacy to provide. And its law responsibility could be no-fault liability accompanied by state compensation.

BACKGROUND: Prevention of implant from inflammation was an effective method to reduce expulsion rate of stainless steel micro-screw implant, and develop new type of antibiotic material.OBJECTIVE: To evaluate the cytotoxicity of a new type of antibiotic stainless steels.METHODS: Metal test samples (antibiotic stainless steel, medical stainless steel, and medial pure titanium) were made into rectangular solids with length of 15 mm × 10 mm × 3 mm. Samples were cleaned with high temperature and high pressure. Alloy leaching liquor was prepared with DMEM culture media according to the ratio betwean surface area and volume of culture solution (3 cm~2/mL). The leaching liquor was maintained in incubator at 37 ℃ for 96 hours, and then degerming was performed using microporous membrane. 6.4% phenol was added, which was considered as the positive control group, and DMEM culture media was considered as the blank control group. Growth of MG63 cells was observed under inverted phase contrast microscope;absorbanca of cells cultured for 24, 48, 72, 96, and 120 hours was detected using MTT test; cytotoxicity of antibiotic stainless steels was evaluated.RESULTS AND CONCLUSION: ① At 24 hours after culture, calls in the positive control group was abnormal; while, cells in other groups were well adherent-grew. ② After 48 hours of culture, with the culture time increased,cytotoxicity was detected out in the positive control group; cells in other groups and blank control groups were normal and grew well. Afew of cells in stainless steels group showed karyopyknosis. ③ The absorbance was the highest of medical pure titanium, and then of antibiotic stainless steel and of medical stainless steel, while there was no significant difference between the three materials. ④ The level of cytotoxicity was grade 0. The results suggested that the antibiotic stainless steel which had the same cytotoxicity grade as medical stainless steel and pure titanium was in line with the requirement of its clinical application.

BACKGROUND:316L-Cu antibacterial stainless steel is made by adding a certain amount of copper into the stainless steel fol owed by a special heat treatment to uniformly disperse copper-rich precipitates in stainless steel substrate, thereby harvesting the antibacterial properties. OBJECTIVE:To evaluate the antibacterial activity of the Cu ions released from 316L type Cu-bearing antibacterial stainless steels against Porphyromonas gingivalis, thereby providing biomedical evidence for its clinical application. METHODS:The medical 316L stainless steel samples at a surface area to volume ratio of 0.1 cm2/L were soaked in simulated body fluids at 37 ℃ for 1-10 days. A graphite furnace atomic absorption spectrophotometer was employed to detect the amount of Cu release in the simulated body fluids each day and then the rate of Cu release per day could be determined. The antibacterial activities of the steel samples were evaluated by a standard film-covered method under a scanning electron microscope. RESULTS AND CONCLUSION:The daily Cu releasing amount from the 316L-Cu stainless steel within 10 days was significantly higher than that of 316L stainless steel, and al the values remained nearly constant. With time, the sterilizing rate of 316L-Cu stainless steel was gradual y increased, and reached 100%until the 10th hour. Porphyromonas gingivalis showed some morphological changes at 3 hours after treated with 316L-Cu stainless steel, appeared with cleavage at 6 hours, and mostly disintegrated into pieces at 9 hours. The results indicated that the 316L-Cu antibacterial stainless steel showed excel ent antibacterial property against Porphyromonas gingivalis, slowly release Cu irons, and alter the surrounding microenvironment, which is a highly promising biomaterial and has good clinical value.

OBJECTIVETo observe the distribution of constitution types of Chinese medicine (CM) in patients with osteonecrosis of femoral head (ONFH).

METHODSTotally 130 ONFH patients were recruited. Constitution types of CM were identified in all patients. Distribution features of constitution types of CM in ONFH patients were observed. The differences of distribution in gender, age, single or bilateral hips, course of disease, staging, cause, and region were also analyzed.

RESULTSSeventy patients were of complicated constitutions, while 60 patients were of single constitution. Among the 60 single constitution cases, yang-deficiency constitution [18 (13.9%)], damp-heat constitution [10 (7.7%)], blood-stasis constitution [7 (5.4%)], and qi-deficiency constitution [7 (5.4%)] were mainly distributed. Of the complicated constitutions, yang-deficiency dominated constitution occupied the top ratio [30 (23.1%)], followed by blood-stasis dominated constitution [15 (11.5%)], damp-heat dominated constitution [9 (6.9%)]. By putting them together, yang-deficiency constitution occupied the top constitution of CM [48 (36.9%)], followed by blood-stasis constitution [ 22 (16.9%)] and damp-heat constitution [19 (14.6%)]. The aforesaid three constitutions accounted for 68.5% of the total. There were no statistical distribution differences in gender, age, single or bilateral hips, course of disease, staging, or cause.

CONCLUSIONYang-deficiency constitution, damp-heat constitution, and blood-stasis constitution were liable constitutions of CM in ONFH patients.

Femur ; pathology ; Humans ; Medicine, Chinese Traditional ; Osteonecrosis ; complications ; drug therapy ; Yang Deficiency

Objective To investigate dosimetric advantage of fixed field intensity-modulated radiotherapy (FF-IMRT),volumetric modulated arc therapy (VMAT) and helical tomotherapy (HT) for cervix uteri cancer.Methods CT datasets of ten patients with cervix uteri cancer were enrolled in the study.FF-IMRT,VMAT and HT plans were designed on Eclipse and HT treatment planning system.Plans were optimized with the aim to assess OAR while enforcing highly conformal target coverage.Institutional dose-volume constraints used in cervix uteri cancer were kept the same for three techniques.The different of three plan was play by single factor analysis of variance and compared to two groups by LSD method.Results All FF-IMRT,VMAT and HT resulted in equivalent target coverage but HT had an improved homogeneity index (P =0.000) and conformity index (P =0.000),or PTV of 105％ prescription dose (47.12％,45.83％ and 0.05％,P=0.000) and lowest Dmax dose (54.53 Gy,53.65 Gy,52.69 Gy,P=0.000).Compared with FF-IMRT and VMAT,the bladder V40 and Dmax of HT were lowest (50.01％,46.84％,42.98％,P=0.001 and 54.49 Gy,52.96 Gy,52.78 Gy,P=0.000),with the rectum V40 lowest (54.61％,48.34％,46.78％,P =0.006),the intestine Dmax lowest (54.53 Gy,53.65 Gy,52.66 Gy,P =0.000) and marrow Dmax lowest (54.51 Gy,54.44 Gy,52.13 Gy,P=0.000).But the delivery MU per fraction were highest (1429.20 MU,617.80 MU,7002.04 MU,P =0.000).Conclusions HT technology is feasible for clinical applications in cervical uteri cancer and can be used as a new method to promote.

Objective:To evaluate the efficacy and safety of stereotactic ablative radiotherapy (SABR) in patients with pulmonary oligometastases.Methods:Clinical data of patients with pulmonary metastases treated with SABR from 2011 to 2018 were retrospectively analyzed. The local control rate (LCR) and overall survival (OS) were calculated by Kaplan- Meier method. log-rank test was used for univariate analysis and Cox’s regression model for multivariate analysis. Results:A total of 214 lung metastases were detected in 159 patients, and the median follow-up time was 43 months. The 1-, 3-and 5-year LCR were 90.1%, 73.9% and 65.8%, respectively. The 1-, 3-and 5-year OS were 73.8%, 43.6% and 11.9%, respectively. Univariate analysis showed that biological effective dose (BED)≥100 Gy was significantly correlated with LCR ( P=0.033). Cox’s multivariate analysis showed that BED and primary tumor source were the independent prognostic factors of LCR ( P=0.023, P=0.043). No>grade 3 adverse events were observed in all patients during treatment. Conclusions:SABR is a safe and effective treatment of lung oligometastases. SABR should be actively aD ministered for pulmonary oligometastases, especially for those with lesions from lung cancer and the radiation dose should be selected as BED ≥100 Gy.

The objective of this experimental study was to assess the effects of a new kind of drug eluting coronary stent. Fourteen mini-pigs were used; seven normal stainless stents and seven new drug eluting stents were implanted in their normal coronary arteries, respectively. Angiography was performed and followed by pressure-fixation of the coronary arteries for light and electron microscopic examinations at the end of three months after implantation. Repeated angiography showed that all the stented coronary segments were open. With no additional antithrombotic treatment, there was no thrombus formed in the stented coronary segments. Scanning electron microscopy analysis showed the implanted stent surface was covered by endomembrane without thrombus formation. The endothelial cell in the membrane was clear and lined by the direction of blood flow. Histomorphological analysis revealed the neointima in normal stainless stent group was thicker than that in new drug eluting stent group, and the neointima was composed of smooth muscle cell and extracellular matrix. The result of this study shows that this kind of stent could reduce the rate of the re-stenosis and occlusion of PTCA. This stent can be used in clinical trials.
Angioplasty, Balloon, Coronary ; instrumentation ; Animals ; Coated Materials, Biocompatible ; chemistry ; Coronary Restenosis ; prevention & control ; Drug-Eluting Stents ; Random Allocation ; Swine ; Swine, Miniature ; Titanium ; chemistry

OBJECTIVETo evaluate whether garlicin can prevent reperfusion no-reflow in a catheter-based porcine model of acute myocardial infarction (AMI).

METHODSTwenty-two male Chinese mini swines were randomized into 3 groups: sham-operation group (n=6), control group (n=8), and garlicin group (n=8). The distal part of left anterior descending coronary artery (LAD) in swines of the latter two groups was completely occluded by dilated balloon for 2 h and a successful AMI model was confirmed by coronary angiography (CAG) and electrocardiograph (ECG), which was then reperfused for 3 h. In the sham-operation group, balloon was placed in LAD without dilatation. Garlicin at a dosage of 1.88 mg/kg was injected 10 min before LAD occlusion until reperfusion for 1 h in the garlicin group. To assess serial cardiac function, hemodynamic data were examined by catheter method before AMI, 2 h after occlusion and 1, 2, and 3 h after reperfusion. Myocardial contrast echocardiography (MCE) and double staining with Evans blue and thioflavin-S were performed to evaluate myocardial no-reflow area (NRA) and risk area (RA).

RESULTSLeft ventricular systolic pressure and left ventricular end-diastolic pressure significantly improved in the garlicin group after reperfusion compared with the control group P<0.05) and 2 h after AMI (P<0.05). MCE showed garlicin decreased reperfusion NRA after AMI compared with the control group (P <0.05). In double staining, NRA/RA in the garlicin group was 18.78%, significantly lower than that of the control group (49.84%, P<0.01).

CONCLUSIONSGarlicin has a preventive effect on the porcine model of myocardial infarction reperfusion no-reflow by improving hemodynamics and decreasing NRA.

Allyl Compounds ; pharmacology ; therapeutic use ; Animals ; Cardiotonic Agents ; pharmacology ; therapeutic use ; Contrast Media ; Disease Models, Animal ; Disulfides ; pharmacology ; therapeutic use ; Hemodynamics ; drug effects ; Male ; Myocardial Infarction ; complications ; diagnostic imaging ; drug therapy ; pathology ; Myocardial Reperfusion ; No-Reflow Phenomenon ; complications ; diagnostic imaging ; drug therapy ; pathology ; Swine ; Swine, Miniature ; Thiazoles ; metabolism ; Ultrasonography

Objective To investigate the expression and variation of MIP 1β,MIP-2,and IL-12p70 in mice with bloodstream infection caused by 4 kinds of bacteria.Methods CD-1 (ICR) mouse models of bloodstream infection with Staphylococcus aureus (S.aureus),Enterococcus f aecalis (E.f aecalis),Escherichia coli (E.coli),and K lebsiella pneumoniae (K.pneumoniae) were established.After mice in each trial group and PBS control group were infected by bacteria for 0.5h,1h,3h,6h,12h,24h,and 48h,concentrations of MIP-1β,MIP-2,and IL-12p70 were detected by Luminex liquid suspension chip system.Results Concentrations of MIP-1β increased significantly 1h after bacteria was in blood,S.aureus,E.faecalis,E.coli,K.pneumoniae,and control groups were (134.5 ± 18.3),(61.5 ± 15.4),(3 354.0 ±809.0),(6 888.4 ± 1 100.2),and (28.9 ± 4.6) pg/mL respectively;the peak values of IL-12p70 were (389.3 ± 118.1),(127.6 ± 10.0),(42.2 ± 3.5),(62.8 ± 8.4),and (4.8 ± 0.3) pg/mL respectively.Concentrations of MIP-1β and MIP-2 in E.coli and K.pneumoniae groups were significantly higher than other trial groups and control group (all P＜0.01),while concentrations of IL-12p70 in S.aureus and E.faecalis groups were both significantly higher than E.coli,K.pneumoniae,and control groups (all P＜0.01).Conclusion Concentrations of MIP-1β and MIP-2 in E.coli and K.pneumoniae groups were both significantly higher than those in S.aureus and E.faecalis groups,while concentrations of IL-12p70 in S.aureus and E.faecalis groups were both significantly higher than those in E.coli and K.pneumoniae groups.The combination detection of multiple cytokines or chemokines are valuable in predicting gram-positive or gram-negative bacterial infection,and can provide basis for treatment of early infection.

OBJECTIVE: To examine the serum levels of S100 calcium-binding protein A8/A9 complex (S100A8/ A9) in patients with acute coronary syndrome (ACS) and to explore the relation between the serum levels of S100A8/A9 and the degree of coronary lesion. METHODS: A total of 126 patients with coronary heart disease were enrolled from Xiangya Hospital of Central South University between September 2010 and January 2011, which included 51 patients with unstable angina pectoris (UAP group, n=51), 50 patients with acute myocardial infarction (AMI group, n=50), and 25 patients with stable angina pectoris (SAP group, n=25). Twenty-five healthy volunteers were served as a normal control group (NC group, n=25). According to the coronary artery lesion area, ACS patients were also divided into a single-branch group, a double-branch group and a triple-branch group. Serum levels of S100A8/A9 were measured by enzyme-linked immunosorbent assay on the day when the patients admitted to the hospital and on the day after one-week treatment (UAP group + AMI group). The serum levels were compared among the various branch groups. The short-term prognosis in patients with ACS was investigated by phone follow-up after 3 months. RESULTS: 1) The S100A8/A9 level in the SAP group was significantly higher than that in the normal control group (P<0.05). The serum levels of S100A8/A9 in the UAP group and the AMI group were significantly higher than that in the SAP group (all P<0.05); There was no significant difference in the S100A8/A9 level between the UAP group and the AMI group (P>0.05); 2) After one-week standard treatment, the serum levels of S100A8/A9 in patients with ACS were significantly reduced compared with that at the admission (P<0.01), but it was still elevated compared with that in the normal control group (P<0.01); 3) The serum level of S100A8/A9 in the triple-branch group was significantly higher than that in the single-branch group and the double-branch group (both P<0.05); 4) The short-term prognosis in patients with ACS was not correlated with the serum level of S100A8/A9 (r=0.012, P> 0.05). CONCLUSION The serum level of S100A8/A9 is significantly elevated in patients with ACS, which might be positively correlated with the number of the coronary lesion branches.
Acute Coronary Syndrome ; blood ; pathology ; Angina Pectoris ; Angina, Unstable ; Coronary Artery Disease ; Enzyme-Linked Immunosorbent Assay ; Humans ; Leukocyte L1 Antigen Complex ; blood ; Prognosis