OBJECTIVE:To provide reference for revising Drug Administration Law.METHODS:By reviewing the pertinent literature,the defects of the Drug Administration Law and the suggestions on its improvement were analyzed comprehensively.RESULTS & CONCLUSIONS:The Drug Administration Law was imperfect in that the concept of"drug"was not scientific,the division for counterfeit and substandard drugs was not reasonable,graded penalty based on the factors such as the primary-secondary responsibility,subjective factor,the severity of consequence etc was not imposed,and the legislation for some of the links was absent etc.It can take the Food,Drug and Cosmetics Law in US as reference to revise the Drug Administration Law by revising the concept of"drug",classifying the unqualified drugs,rectifying the legislative absence of the original links,making a balance between legal liability and the legal obligation so as to achieve gradual perfection.

Histiocytic sarcoma is a rare kind of histiocytic lymphoma with an undetectable onset, no specific clinical and imaging mani-festations, and rapid progression. At diagnosis, the histiocytic sarcoma has already spread significantly in most patients. The diagnosis of histiocytic sarcoma depends on the basis of its mitotic figures and at least expression of one of the following:CD68, CD163, and lyso-zyme. Operation excision, radiotherapy, and chemotherapy are currently the more common treatment methods for histiocytic sarco-ma. However, no unified curative and treatment standard exists, and prognosis is poor. This review summarizes the diagnosis and treat-ment of histiocytic sarcoma.

Scatchard, pseudoscatchard and competitive analyses showed that there were two glucocorticoid (GC) binding sites in rat hepatic cytosol: high-affinity glucocorticoid binding sites (HAGS) and low-affinity glucocorticoid binding sites (LAGS). Pseudoscatchard analysis showed the dissociation constant (Kd) of LAGS was 4.1+1.4umol/L (n=4). The inactivation of LAGS in vitro was slower" than that of HAGS. LAGS and HAGS could not be separated by DEAE-cellulose chfomatography. HAGS were saturable and had steroid specificity for glucocorticoid just as the classic glucocorticoid receptor. Triamcinolone acetonide, RU486 and RU26988 competed equally well to LAGS while aldosterone, progesterone, estradiol and testosterone did not compete with LAGS. These results suggest that LAGS have steroid specificity for glucocorticoids. The biological actions of LAGS await fur ther study.

Objective To investigate the clinical outcomes of three kinds oi internal fixations via posterior approach for treating adjacent two-segment thoracic and lumbar vertebral fractures.Methods A retrospective analysis was done on data of 34 patients with adjacent two-segment thoracic and lumbar vertebral fractures treated between 2003 and 2010.The treatments included three different pedicle screw fixations via posterior approach,ie,fixation with four verlebrae and four screws (Group Ⅰ,n ＝ 14),fixation with four vertebrae and six screws ( Group Ⅱ,n ＝ 11 ),fixation with four vertebrae and eight screws ( Group Ⅲ,n ＝ 9).The changes of spinal Cobb' s angle before and after operation and at the last final follow-up were statistically analyzed.Oswestry disability index (ODI) score,Denis pain scale and Denis work scale at the final follow-up were evaluated.Also,the recovery of neurological function was observed.Results The duration of follow-up was average 24 months (range,10-48 months).The neurological function of all the patients recovered to some degree.Two patients had pedicle screw breakage and one had spontaneous fusion of the collaprsed vertebra in Group Ⅰ.The Cobb' s angles of the three groups were decreased immediately after operation,but all obtained some degree of enhancement at the final follow-up.In Group Ⅰ,the mean Cobb's angle was (7.5 ±3.0)° postoperatively and then improved to ( 13.7 ±5.1 )°at the final follow-up,with correction loss of (6.2 ±2.1)°.In Group Ⅱ,the average Cobb's angle was( 1.4 ± 1.5) ° postoperatively and later increased to (4.5 ± 2.4)° at the final follow-up,with correction loss of (3.1 ± 1.1 )°.In Group Ⅲ,the mean Cobb' s angle was ( 0.0 ± 1.1 )° postoperatively but was increased to ( 1.3 ± 1.2 )° at the last follow -up,with correction loss of ( 1.3 ± 0.0 1 )°.The three groups showed statistical difference regarding the correction loss of Cobb' s angle ( P ＜ 0.05 ).Group Ⅱ and Group Ⅲ showed no significant differences in aspects of ODI score and Denis work and pain scale at the final follow-up,but the differences were significant when Group Ⅰ was compared with Group Ⅱ and Group Ⅲ (P ＜ 0.05 ).Conclusions The posterior transvertebral pedicle screw fixation with 4 vertebrae and 8 screws for adjacent two-segment thoracic and lumbar vertebral fractures is beneficial to gaining well reduction and fixation,maintaining deformity correction,preserving motion segment and releasing pain.The operation,a simple and convenient technique,has the prospect of clinical application.

Because the huge number of images of the digestive tract by Wireless Capsule Endoscopy (WCE) are left to the medical personnels detected by their eyes, huge burden leaves to doctors. This article provides a classification of method based on SVM (Support Vector Machine) for the capsule endoscopy bleeding intelligent recognition. We created a new kind of feature parameter, and the experiment result can reach 83% specificity and 94% sensitivity.
Capsule Endoscopy ; Gastrointestinal Tract ; pathology ; Hemorrhage ; diagnosis ; Humans ; Sensitivity and Specificity ; Support Vector Machine

Objective:To study the influence of thrombus aspiration combined tirofiban on patients with acute ST seg-ment elevation myocardial infarction (STEMI)after primary percutaneous coronary intervention (PCI).Methods:A total of 98 patients,who received primary PCI because of STEMI in our hospital from Jan 2012 to Mar 2013,were selected.They were divided into thrombus aspiration group (n=48,received pure thrombus aspiration)and com-bined treatment group (n = 50,received thrombus aspiration combined intracoronary tirofiban injection during PCI).Coronary angiography (CAG)instantly after PCI and follow-up condition during hospitalization and six months after discharge were compared between two groups.Results:(1)Compared with thrombus aspiration group after PCI,there were significant rise in TIMI blood flow grade [(2.3±0.6)grades vs.(2.7±0.3)grades],per-centage of TIMI flow grade 3 (72.9% vs.90.0%)and ST segment regression >50% rate within 90min after PCI (52.1% vs.74.0%),P < 0.05 or < 0.01,and significant reduction in percentage of postoperative no-reflow (18.8% vs.4.0%,P =0.038)in combined treatment group in hospital;(2)After six-month follow-up,left ven-tricular ejection fraction (LVEF)of combined treatment group was significantly higher than that of thrombus aspi-ration group [(58±6.3)% vs.(51±5.6)%,P <0.05].Conclusion:Thrombus aspiration combined tirofiban can effectively reduce coronary thrombus burden and improve cardiac function in STEMI patients during primary PCI.

Objective To investigate the impact of hepatectomy combined with splenectomy on hepatitis B virus (HBV) reactivation in patients with hepatocellular carcinoma (HCC) ≤5 cm and with hypersplenism.Methods This is a retrospective case-control study on 167 patients with HCC ≤5 cm and with hypersplenism who underwent hepatectomy combined with splenectomy at the Shengli Oilfield Central Hospital between May 2008 and June 2015.64 patients underwent hepatectomy combined with splenectomy,and 103 patients hepatectomy alone.The patients were assigned to the hepatectomy combined with splenectomy group (the combined group,n =61) or the hepatectomy alone group (the control group,n =61) using propensity score matching (PSM).Logistic regression was used to evaluate the relative clinical factors associated with HBV reactivation.The stratified Chi-squared test was utilized to determine the impact of the surgical procedure and preoperative anti-viral therapy on postoperative hepatitis B virus reactivation of these patients.Results The serum PLT level,Child-Pugh grading,tumor diameter and surgical procedures were shown to be independent risk factors associated with postoperative HBV reactivation (P ＜ 0.05).To study the impact of preoperative anti-viral therapy on postoperative HBV reactivation:-the incidence of HBV reactivation was higher in the control group than in the combined group (19.7％ vs.6.6％,P ＜ 0.05).In the combined group,there was no significant difference between patients who received anti-viral therapy and those who were treatment-naive (5.3％ vs.7.1％,P ＞0.05).In the control group,a higher incidence of HBV reactivation was found in patients with treatment-na(i)ve than in patients who received anti-viral therapy (26.1 ％ vs.0,P ＜ 0.05).For the patients who received anti-viral therapy,there was no significant difference between the combined group and the control group (5.3％ vs.0,P ＞ 0.05).In patients with treatment-na(i)ve,a higher incidence of HBV reactivation was observed in the control group than the combined group (26.1％ vs.7.1％,P ＜ 0.05).Conclusions In patients who were not treated with antiviral therapy,hepatectomy combined with splenectomy decreased the incidence of postoperative HBV reactivation in patient with HCC ≤5 cm and with hypersplenism.For the patients who received preoperative anti-viral therapy,the incidence of postoperative HBV reactivation was not decreased with hepatectomy combined with splenectomy.

Objective To analyze the causes for the failures after posterior pedicle screw instrumentation for thoracolumbar fractures.Methods From June 2003 to December 2014,182 patients with thoracolumbar fracture were treated by fixation through the posterior approach using pedicle screws and fully followed up in our institute.We analyzed the cases of postoperative infection,recovery of neural symptoms,breakage and loosening of pedicle screws and connecting rod,non-union of the fractured vertebra,and correction loss of kyphosis in associations with the AO classification and Loading Sharing Classification of Spine Fracture (LSCSF) system,osteoporosis,intervertebral disc injury and methods of internal fixation.Results In this series,altogether 27 cases failed(14.8％).The rate of postoperative infection was 1.1％ (2/182).The rate of breakage of pedicle screw or connecting rod was 7.7％ (14/182).The implant breakage rates for fractures of AO types A1,A2 and A3.1 were significantly lower than for other types (P ＜ 0.05).The implant breakage rate for the patients with ≤6 LSCSF points was significantly lower than for those with ≥7 LSCSF points (P ＜ 0.05).The implant breakage occurred in 3 cases of those who underwent fixation of one normal vertebra respectively below and above the two contiguous segments but not in those who underwent additional fixation of the injured vertebrae.The rate of screw loosening was 2.2％ (4/182).The non-union rate of the injured vertebra was 2.7％ (5/182).The rate of kyphosis recurrence was 1.1％ (2/182).Conclusions To prevent the failure of posterior pedicle screw fixation,surgeons should pay more attention to the following key points before operation:the type and evaluation of spinal fractures,a proper approach and method of internal fixation,and the weight bearing capability of the anterior column.

Objective To evaluate effects of autologous cytokine-induced killer cell (CIK) transfusion on the survival and hepatitics B virus (HBV) reactivation after radiofrequency ablation (RFA) combined with transcatheter arterial chemoembolization (TACE).Methods A retrospective analysis was conducted on 185 patients with hepatocellular carcinoma treated from Mar 2007 to Oct 2013.Patients were divided into study group (RFA,TACE,CIK) of 98 cases and control group (RFA,TACE) of 87 cases.According to tumor size,numbers and vascular invasion,patients were stratified into 4 subgroups:the high and the low risk group respectively with tumor ≤ 5 cm and ＞ 5 cm.Results The 1-,3-,5-year survival rate between study and control group were not significantly different:75.5％ (74/98),57.1％ (56/98),20.4％ (20/98) vs.71.2％ (62/87),54.0％ (47/87),21.8％ (19/87) (P ＞ 0.05).Only the study group's 1-,3-,5-year survival rate of high risk patients with tumor ≤ 5 cm were higher than the control group:75.0％ (21/28),53.6％ (15/28),35.7 ％ (10/28) vs.61.9％ (13/21),42.9％ (9/21),23.5％ (5/21) (P ＜ 0.05).The incidence of HBV reactivation was lower in dunantiviral patients who received CIK therapy than those who had 6.0％ (3/50) vs.23.5％ (12/61) (P ＜ 0.05).Conclusion Postoperative adjuvant CIK therapy with tumor≤5cm after RFA combined with TACE was beneficial to the survival of high risk patients and decreased the risk of HBV reactivation.

Objective To evaluate the peri-operative and survival outcomes of hepatectomy combined with splenectomy in patients with hepatocellular carcinoma with Barcelona Clinic Liver Cancer Stage A and portal hypertension.Methods We retrospectively analyzed the data on patients with hepatocellular carcinoma with Barcelona Clinic Liver Cancer Stage A and portal hypertension who underwent surgery at the Shengli Oilfield Central Hospital between July 2008 and June 2015.According to the operative method,the patients were classified as the experimental group (hepatectomy combined with splenectomy) and the control group (hepatectomy).We compared and analyzed the clinical data between these two groups,which included the operation time,blood loss,duration of hepatic portal occlusion,width of surgical resection margin,liver function,PLT,HBV reactivation,time to remove drainage tube,complications,upper gastrointestinal hemorrhage rate and survival outcomes.Results (1) The operation time,blood loss,PLT at 1 week and 1 month after surgery in the experimental group were all significantly higher than the control group [(161.4 ± 38.3) min vs.(119.2±36.4) min,(268.7±72.1) vs.(201.3±61.3) ml,(189.2±51.3) ×109/L vs.(81.9±32.2) ×109/L,(327.4±69.1) ×109/L vs.(84.5±28.5) × 109/L (all P＜0.05),respectively].The time to remove drainage tube,duration of hepatic portal occlusion,width of resection surgical margin,TBil,complications and upper gastrointestinal hemorrhage rates of the two groups were not significantly different (all P ＞ 0.05).The HBV reactivation rate,ALT and AST in the experimental group were significantly lower than the control group [3.9％ (2/51) vs.18.2％ (12/66),(45.7 ± 11.4) U/L vs.(58.3±14.7) U/L,(48.1±12.4) U/Lvs.(61.3±15.1) U/L (allP＜0.05),respectively].(2) The 1,3 and 5-year recurrence free survival rates were not significantly different between the experimental and control groups [84.3 ％,34.1％,27.3 ％ vs.78.8 ％,42.1％,9.7 ％ (all P ＞ 0.05),respectively].The 1,3 and 5-year overall survival rates in the experimental Group were significantly higher than the control group [94.1％,66.3 ％,33.5 ％ vs.90.9％,46.7％,16.1％ (all P ＜ 0.05),respectively].Conclusion Combined liver and spleen resection was a safe and efficacious modality to treat patients with BCLC A hepatocellular carcinoma,which reduced the incidence of HBV reactivation and improved the overall survival.