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OBJECTIVE:To discuss the countermeasure on the quality improvement of the drug clinical trials in our hospital based on the discovery of key links of the quality of clinical trials. METHODS:Quality results of 14 drug clinical trials in 10 ma-jors from the drug clinical trial institute in our hospital in 2014 were investigated. Referring to the grading and classifying methods of the inspection problems in European Medicines Agency,the key links of occurring problems were analyzed,and the effects of interventions for key links were evaluated. RESULTS:In 2014,totally 125 important and general problems were found,in which, the numbers of problems occurred in case report form filling,informed consent of subjects,enrolling and screening of subjects,in-vestigational products management accounted for 79.20%. The above 4 links were the key links affecting quality of drug clinical tri-als. According to strengthening the training about relevant knowledge of the researchers,improving system and standard operation procedures management,enhancing link quality control,introducing project clinical research coordinator,developing centralized drug management and other interventions,the total numbers of found important and general problems in 2015 and 2016 were 68 and 59,respectively. Compared with 2014,the differences were statistically significant(P0.05). There were no severe problems during 2014-2016. After interventions,numbers of occurring prob-lems in majors with less complex drug clinical trial had obviously declined in 2016. Compared with 2014,the differences were sta-tistically significant (P0.05). CONCLUSIONS:Controlling the key links in drug clinical trial process can obviously reduce the occurrence of general problems while has little effect on the occurrence of im-portant problems. It is different for different majors in undertaking drug clinical trial projects,so as the links and degree of occur-ring problems. It should be distinguished in quality control checking.
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[Objective]To explore the effect of HSYA on pro/anti-inflammatory cytokine′s levels and mRNA expression in peripheral blood of mice.with sepsis.[Methods]Dividing NIH mice into four groups,as normal group,sham group,CLP group and HSYA group,24 mice in each group. The CLP sepsis mouse model was established. HSYA(120 mg/kg)were injected intravenously at 12 h before the operation ,and 0 h and 12 h following CLP ,and other groups were given normal saline. observed the animals behavior changes,measured the levels WBC,PLT,ALT,AST,BUN in serum,detected the levels and mRNA expression of IL-6, IL-10 ,TNF-α in peripheral blood. cultured of peripheral blood bacteria loads.[Results]24 h after surgery ,mice in CLP group appeared furring,feces residues on anus etc. compared to normal group,sham group and HSYA group,WBC,PLT,ALT,AST, BUN,levels and mRNA expression of IL-6,IL-10,TNF-αshowed significant increases,it was also found that bacterial load was significant increased in model group.[Conclusions]HSYA has a therapeutic effect in mice with sepsis ,can reduce bacteria into the blood,and inhibit inflammatory mediators which caused tissue damage.
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Objective To explore the operative technique and clinical outcomes of tiled flaps from foot with bone graft for reconstruction of thumb defects.Methods From January, 2008 to December, 2013, 8 cases of thumb defects with varying degrees were treated with tiled flaps from foot and iliac bone graft.Among them, 4 cases caused by emergency trauma, the other 4 cases was old defect after trauma, including 1 case of double thumb defect that caused by electrical burn.The thumb defects was caterorized as type Ⅰ A in 1 case, type Ⅰ B in 2 cases, type Ⅱ A in 1 case, type ⅡB in 2 cases and type ⅢA in 2 cases.Five cases in which were treated with free wrap-around flap from the ipsilateral big toe and tibial lateral-flap from the opposite second toe, 3 cases using free wrap-around flap with series connection of dorsal artery.Results All 8 reconstructed thumbs were survived.The wound healed primarily.In 1 case, the unhealed wound was healing after dressing where skin grafts in the donor sites of the foot were partial necrosis.Postoperative follow-up ranged from 6 to 72 months, the appearance of the thumb was satisfying when was compared with normal thumb.Thumb nail grew well, the blood supply was good, and sensory recovery from S2 to S4.According to the criteria issued by the Hand Surgery Society of Chinese Medical Association for functional assessment of reconstucted thumb and fingers, 5 were excellent and 3 were good.The donor site skin graft had no scar contracture and no ulceration.There was no apparent impairment on the foot function.Conclusion Combined tiled flaps from foot and iliac bone graft for reconstruction of thumb is a good method, which can recover the appearance of thumb without sacrificing toes of the donor foot.
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Objective To explore the surgical methods and clinical application effects of repairing hand soft tissue defect with free vascularized flaps based on the distal perforator of ulnar artery.Methods From March, 2001 to December, 2012 in our hospital, 90 patients with hand soft tissue defects were repaired by free vascularized flaps based on the distal perforator of ulnar artery, including 74 patients cases were repaired by Phase Ⅰ emergency surgery, 16 patients cases with scar contracture were repaired by Phase Ⅱ surgery.There were 34 cases were rebuild the sensory by repaired the continuity between the dorsal branch of the ulnar nerve and dorsal digital nerve or palmar digital nerve.The free vascularized flaps that used the emerging point of perforator of the ulnar artery as center of the flap was designed, which based on the distal perforator to repairing the hand soft tissue defect.Results All 89 patients postoperative flaps were survived.Necrosis was seen in 1 flap which was repaired by skin grafting.Follow-up ranged from 3 to 36 months with an average of 12 months.The appearance of flap was not clumsy, the quality was good.The sensation was S3-S3+ in 34 cases after nerve reconstruction surgery.The active and passive activity of 16 cases with scar contracture were improved significantly.The incision in 72 cases for direct suture were healed without scar contracture, 18 cases of skin grafts were all survived without contracture.Conclusion The free vascularized flaps based on the distal perforator of ulnar artery has constant perforating point, which can carry sensory nerves and leads to little donor site damage without major vascular injury.The flap serves as a simple approach to repair hand defects, and get satisfied skin flap appearance and texture, the fingers feel and function recovered well.
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Objective To study the tumor necrosis factor-α(TNF-α) and interleukin-6 (IL-6) expressed in invasive pituitary adenomas (IPA). Methods The expression of TNF-α and IL-6 were observed with immunohistochemstry (SP approach) in tissue from 40 cases of non-invasive pituitary adenomas (NIPA) and 40 cases of IPA. Results The expression of both TNF-αand IL-6 was significantly increased in the IPA tissues compared with those of NIPA (P<0.05). Conclusion TNF-αand IL-6 may play a role in the occurrence and development of IPA.
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@#Objective To study the tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) expressed in invasive pituitary adenomas (IPA). Methods The expression of TNF-α and IL-6 were observed with immunohistochemstry (SP approach) in tissue from 40 cases of non-invasive pituitary adenomas (NIPA) and 40 cases of IPA. Results The expression of both TNF-α and IL-6 was significantly increased in the IPA tissues compared with those of NIPA (P<0.05). Conclusion TNF-α and IL-6 may play a role in the occurrence and development of IPA.
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OBJECTIVE:To explore the regulating effect of pravastatin on hyperlipidemia and hypertension in patients with coronary heart disease.METHODS:80 patients with coronary heart disease were randomly divided into 2 groups,pravastatin treatment group(pravastatin,20 mg,qd,n=42)and placebo control group(placebo,qd,n=38).The course of treatment was 4 weeks in both groups,serum total cholesterol(TC),triglycerides(TG),high density lipoprotein cholesterol(HDL-C)were assayed,and systolic blood pressure(SBP)as well as diastolic blood pressure(DBP)were measured before and after 4 weeks of treatment.RESULTS:There was a significant decrease of serum TC and TG levels,as well as DBP in treatment group after treatment,as compared with control group,while HDL-C level increased significantly(P
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OBJECTIVE: To study the relationship among the dosage, serum concentration and clinical effect of phenytoin(PHT) in treating epileptic patients .METHODS: 130 steady -- state serum concentrations of PHT were determined by fluores-cence polarization immunoassay(FPIA) in 70 patients with or without other drugs used in combination .RESULTS: The indi-vidual difference among the patients who received routine dosage of PHT was very significant. Intoxication occurred ex-tremely often in patients whose PHT serum concentrations were over 30?g/ml .CONCLUSION: It is necessary to perform TDM(Therapeutic Drug Monitoring) and individualize the use of PHT,so that the safe and effective use of drug can be ensured.
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OBJECTIVE:To find the quick detection method for serum benzodiazepines concentrations.METHODS:Using flurosence polarization immunoassay method to detect the serum concentration of benzodiazepines(BZDs)in149patients who were suspicious of receiving drug overdose in emergency unit.RESULTS:We got positive results in104samples from149pa?tients,but the levels of BZDs concentration were not coincident with the state of drug overdose.CONCLUSION:The method used in our report is a quick and useful assay for patients with unconfirmed drug overdose in emergency unit,but caution should be taken in the result interpretation to doctors.
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OBJECTIVE:To examine the effects of sanazole and of sanazole combining with ?-ray irradiation on the colony formation ratio of granuloid/macrophage committed progenitor cell(CFU-GM)from mouse bone marrow in vivo.METHODS:(1)After a series of doses of sanazole solution(50,100,200mg/kg)was given to mice intravenously,CFU-GMs were separated from mouse bone marrow for evaluating their colony formation ratio.(2)To evaluate the radiosensitization of sanazole,a series of doses of sanazole solution(50,100,200mg/kg)was given to mice intravenously 30min before the mice were exposed to ?-ray irradiation in different doses(5,10,20Gy)respectively.After each treatment,CFU-GMs were separated from mice marrow for counting the ratio of colony formation.RESULTS:(1)Sanazole especially in large doses didn’t showed considerable cytotoxicity to CFU-GM colony formation in mice in vivo.(2)The inhibiting effect of a series of doses of sanazole solution combined with a series of doses of radiation (5,10,20Gy)on colony formation of CFU-GM from mice bone marrow was the same as that of radiation alone.CONCLUSION:Large doses of sanazole showed no obvious effect on the colony formation of CFU-GM of mouse bone marrow in vivo.No radiosensitization to the colony formation of CFU-GM was found in vivo when a series of doses of sanazole in combination with radiation were used.