OBJECTIVE: To introduce the methodology validation and quality control in bioanalytical procedures and its expected trend of development.METHODS: According to the bioanalytical validation reflected in FDA guidelines and other publications,based on the guidance of SFDA and the standard operating procedure of our phase I clinical trial lab,we summarized the procedure and questions of bioanalytical methodology validation.RESULTS: The methodology validation and quality control in bioanalytical procedures and the possible risks involved in the methodology validation were summarized.CONCLUSIONS: The established methodology validation in bioanalytical procedure and quality control contents were basically consummate,but the standards for the methodology validation should be formulated based on reality.

Ductus Arteriosus ; surgery ; Ductus Arteriosus, Patent ; drug therapy ; therapy ; Humans ; Ibuprofen ; administration & dosage ; therapeutic use ; Indomethacin ; administration & dosage ; therapeutic use ; Infant, Low Birth Weight ; Infant, Newborn ; Infant, Premature ; Infant, Premature, Diseases ; drug therapy ; surgery ; therapy ; Ligation ; methods ; Treatment Outcome

Objective To study the diagnostic value of achilles tendon injury(ATJ) and the diagnostic standards for different severities of the injury by MRI.Methods Twenty-six cases of traumatic ATJ proved both clinically and surgically and had complete MRI materials were selected.The characteristic MRI appearances were summed up and retrospectively compared with that of 10 normal achilles tendons.Results The results were as follows :(1) MRI appearances of 10 normal achilles tendons : regular course,smooth margin,homogenous hypointensity on T_1WI and T_2WI;(2) MRI appearances of 17 partial ATJs:tendon thickening,decreased ratio of wide/vertical diameter,localized hyperintensity in tendon on T_1WI and T_2WI,crude and irregular fibrous bundles but at least keeping one continuous layer on sagital view;(3) MRI appearances of 9 total ATJs: tendon thickened and irregular appearance,totally discontinuous fibrous bundles,"brush" or "pestle" change and mixed hyperintensity on T_1WI and T_2WI;(4) 7 cases with bone contrusion and soft tissue injury,2 cases with ligament injury,2 cases with bone and cartilage injury and 11 cases with fluid collected around tendon.Conclusion MRI can accurately judge thenature,range,degree and complications of ATJ and is of great value for preoperative plan of the treatment program and the postoperativeanalysis of the therapeutic effect.

Objective To investigate the clinical applied value of the early slope value of MR contrast-enhancement in differentitating benign from malignant musculoskeletal neoplasms.Methods 48 patients with benign or malignant musculoskeletal masses(26 benign,22 malignant) confirmed by pathology underwent dynamic contrast-enhanced scanning.The largest slope of dynamic enhancement in early stage and SI-Time curve type were gained and the difference of them in benign and malignant musculoskeletal tumours were analysed.Spearman rank correlation analysis was used to determine the relation between slope and microvessel density of tumor tissues.Results There were 3 SI-Time curve types in all cases with typeⅠ(precipitous rise) in 22 cases,type Ⅱ(slow rise) in 21 cases and type Ⅲ(slight rise) in 5 cases.The average early slope value of enhancement was(4.23?2.68)% per second(range 0.96%~10.53%)in malignant tumors,and(1.44?0.99)% per second(range 0.36%~3.76%)in benign tumors.There was an apparent statistical significance between benign and malignant tumors(P

OBJECTIVE: To faciliate the implementation of the new Prescription Administrative Policy in ward area pharmacy. METHODS: Based on our practical working experience, the Prescription Administrative Policy was studied from perspective of quality of personnel, sense of responsibility and drug standards etc. And the difficulty encountered in the implementation of the prescription administrative policy was explained. RESULTS & CONCLUSIONS: Solving such problems as including medical orders in prescription management, clarifying the responsibility of irrational medication without sticking to instrcutions of drug package inserts, the demanding requirements on pharmacists’s quality and the enforcement of precription evaluation contributes to the implementation of the new Prescription Administrative Policy in ward area pharmacy.

Adult ; Echinococcosis ; Heart Diseases ; parasitology ; Humans ; Male

Objective To investigate the effect of dexmedetomidine on liver function,plasma cytokine levels,and oxidative stress due to ischemia/reperfusion injury in patients undergoing hepatolobectomy.Methods A total of 106 patients who underwent hepatolobectomy in General Hospital of Jizhong Energy Fengfeng Group Co.,Ltd.from January 2014 to January 2016 were enrolled and randomly divided into control group and observation group,with 53 patients in each group.The patients in the observation group were given 1 μg/kg/h dexmedetomidine within 10 minutes,followed by continuous intravenous infusion of 0.5 μg/kg/h dexmedetomidine,and those in the control group were given an equal volume of 0.9％ sodium chloride.The two groups were compared in terms of liver function parameters,plasma cytokine levels,and oxidative stress due to ischemia/reperfusion injury after anesthesia (T1),before abdominal closure (T2),and at 1,4,and 8 hours after surgery (T3,T4,and T5,respectively).The chi-square test was used for comparison of categorical data between groups;the t-test was used for comparison of indices between groups,the sphericity test was used for comparison of indices at different time points,and an analysis of variance was performed for repeated measurement data with P ＜ 0.05.Results The two groups had significantly higher alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels at T2,T3,T4,and T5 than at T1 (ALT:F =43.72 and 44.16,both P ＜ 0.001;AST:F =53.87 and 65.44,both P ＜ 0.001),and the observation group had significantly lower levels than the control group atT2,T3,T4,andT5 (ALT:t =20.54,22.01,36.68,and 38.15,all P＜0.001;AST:t =32.27,41.08,52.82,and71.89,all P ＜ 0.001).The two groups had significantly higher levels of tumor necrosis factor α (TNFα) and interleukin-8 (IL-8) at T3,T4,and T5 than at T1 (TNFα:F =54.37 and 24.75,both P ＜ 0.001;IL-8:F =47.24 and 27.39,both P ＜ 0.001),and the observationgroup had significantly lower levels than the control group at T3,T4,and T5 (TNFα:t =59.39,86.32,and 83.16,all P ＜ 0.001;IL-8:t =74.47,72.29,and 76.67,all P ＜ 0.001).The two groups had a significantly higher level of malondialdehyde at T3,T4,and T5 than at T1 (F =37.65 and 17.44,both P ＜0.001),and the observation group had a significantly lower level than the control group at T3,T4,and T5 (t =17.35,19.11,and 24.12,all P ＜ 0.001).The two groups had a significantly lower level of superoxide dismutase at T3,T4,and T5 than at T1 (F =36.54 and 33.65,both P ＜0.001),and the observation group had a significantly higher level than the control group at T3,T4,and T5 (t =68.64,66.35,and 59.48,all P ＜0.001).Conclusion Dexmedetomidine can effectively inhibit liver injury,reduce the levels of cytokines,and alleviate ischemia/reperfusion injury in patients undergoing hepatectomy.

Objective To study the exact function of HBeBP4A so as to investigate the gene expression of HBeBP4A in yeast cell.Methods Reverse transcription polymerase chain reaction(RT-PCR)was employed to amplify the gene of HBeBP4A from recombinant plasmids pcDNA 3.1/myc-HisA-HBeBP4A,and the gene was cloned into pGEM-T vector.The gene of HBeBP4A was cut from pGEM-T-HBeBP4A vector and cloned into yeast expressive plasmid pGBKT7,and pGBKT7-HBeBP4A was then transformed into yeast AH109.The yeast protein was isolated and analyzed with sodium dodecyl sulfate-polyacrylamide gel electrophoresis(SDS-PAGE)and Western blotting hybridization.Results HBeBP4A gene was successfully amplified and identified by DNA sequencing.The digested fragment was cloned into pGBKT7 vector and transformed into yeast cell AH109.The SDS-PAGE and Western blotting assay showed that the relative molecular weight of the expressed product was about 61.37kD,and HBeBP4A protein existed in yeast cells.Conclusion The findings suggested that HBeBP4A was successfully expressed into yeast system.

Objective To study the relation between hyperglycaemia and the prognosis in patients with type 2 diabetes mellitus undergoing coronary revascularization. Methods Study retrospectively 334 type 2 diabetes mellitus patients underwent coronary revascularization, we compare the incidence of hyperglycaemia between patients with good prognosis and patients with bad prognosis undergoing coronary artery bypass graft and percutaneous transluminal coronary angioplasty. We identify by logistic regression analysis the extent of hyperglycaemia as risk factor in the prognosis individually. Results In patients undergoing coronary artery bypass graft and percutaneous transluminal coronary angioplasty, the incidence of hyperglycaemia is higher in patients with bad prognosis than in patients with good prognosis. It is identified by logistic regression analysis that hyperglycaemia deteriorates the prognosis of patients undergoing coronary artery bypass graft (OR=2.033, P=0.008) and patients undergoing percutaneous transluminal coronary angioplasty (OR=2.476, P=0.006). Conclusion To control hyperglycaemia efficiently following coronary revascularization in patients with type 2 diabetes mellitus is mandatory.

AIM: To evaluate the efficacy and safety on the radio-heating-chemotherapy in treatment of patients with malignant pleural effusion (MPE). METHODS: 60 patients of MPE were randomly devided into two groups, radio-chemotherapy group (treatment group) and chemotherapy group (control group). The drugs, according to the types of tumor cells, were select to take intravenous injection and pleural cavity administration. The patient’s pleural cavity was drained continuously by pleurocentesis. These treatments were made once two week lasting for 4-6 weeks with NS 30 ml+cisplatin 60 mg by perfusion of pleural cavity. After the perfusin of pleural cavity, radio-heating was performed 60-90 min, twice one week for 8-10 times in the treatment group. RESULTS: The response rate was 90% (CR+PR) in the treatment group, and 67% (CR+PR) in the control group. The rates were higher than those in the control group (P