OBJECTIVE:To clarify the responsibilities of drug clinical trial institution and ethics committee in China,and to provide reference for the improvement of drug clinical trial management. METHODS:The responsibility conflicts between drug clinical trial institution and ethics committee were summarized,and its reasons were analyzed to provide suggestions. RESULTS &CONCLUSIONS:The responsibility conflicts have been found between drug clinical trial institution and ethics committee,mainly manifesting as the essential person who submits protocol is not clear;the responsibilities in multicenter ethics investigation are con-troversial;the management of their track issues are not connected enough. 3 aspects of measures can be adopted,including reach-ing an agreement of responsibility assignment learning from foreign advanced ideas,improving laws and regulations;enhancing the management,promoting the implementation of policy and agreement. So,the responsibilities of drug clinical trial institution and ethics committee can be further clarified to improve the management of drug clinical trial.

OBJECTIVE:To systematically review the effect of stroke efficacy and bleeding risk of edoxaban versus warfarin in the prevention of patients with atrial fibrillation,and provide evidence-based reference for clinical treatment. METHODS:Re-trieved from Cochrane Library,Medline,EMBase,CJFD,Wangfang Database and VIP Database,randomized controlled trials (RCT)about the stroke efficacy and bleeding risk of edoxaban versus warfarin in patients with atrial fibrillation were collected. Me-ta-analysis was performed for the incidences of stoke and excessive hemorrhage by using Rev Man 5.3 software after data extract. RESULTS:Totally 13 RCTs were included,involving 24 950 patients. Results of Meta-analysis showed,compared with warfarin group,there were no significant differences in the incidences of stoke [RR=0.97,95%CI(0.88,1.08),P=0.60] and excessive hem-orrhage [RR=0.84,95%CI(0.59,1.19),P=0.33] in edoxaban group. But the subgroup analysis showed,when daily dose of edoxa-ban was more than 30 mg,the incidence of stroke in edoxaban group was significantly lower than warfarin group [RR=0.84,95%CI(0.72,0.97),P=0.02];when it was 30 mg,the incidence of excessive bleeding in edoxaban group was significantly lower than warfarin group [RR=0.46,95%CI(0.35,0.61),P<0.001],the difference was statistically significant. CONCLUSIONS:Compared with warfarin,higher doses(>30 mg/d)of edoxaban can more effectively prevent the occurrence of stroke and low doses(30 mg/d) can reduce the risk of excessive bleeding.

OBJECTIVE:A HPCE method for determination of paeoniflorin in Bazhen pills and Bazhen Yimu pills was developed METHODS:Measurements were carried out in a buffer solution containing 50mmol/L borax solution (pH 10 6),at detection wavelength 230nm with 20KV running voltage applied to a 50cm?50?m capillary RESULTS:The linear range of paeoniflorin was in the range of 0 0 625～1 0mg/ml(r=0 9 995),RSD within days was 1 61%,RSD between days was 3 15% The recovery of paeoniflorin was 98 19%～98 45% The results of detection for Bazhen pills and Bazhen Yimu pills were highly correlated to those obtained by HPLC CONCLUSION:The method is simple,rapid,economical and accurate

Objective To optimize the extracting process of alkaloid from Nelumbo nucifera leaves by multi-stage countercurrent extraction.Methods The spectrophotometry was used to determine the alkaloids.The extracting process of alkaloid was optimized by L16(44) to observe the effect of extraction time,extraction temperature,solid to liquid ratio,and ethanol concentration,respectively.Results The optimum extraction parameters were extraction time 25 min,extraction temperation 90 ℃,solid to liquid ratio 1∶50,and ethanol concentration 70%.Conclusion The multi-stage countercurrent extraction is used to the extracting process of alkaloid from N.nucifera leaves.

AIM:To evaluate the efficacy of amoxicillin/sulbactam in the treatment of bacterial infections METHODS:Fifty-six patients were divided into two groups:amoxicillin/sulbactam group(30 patients) and ampicillin/sulbactam group(26 patients) The test and control groups received amoxicillin/sulbactam and ampicillin/sulbactam 3g,iv,q8h for (8?2)d,respectively RESULTS:The overall effective rates of amoxicillin/sulbactam and ampicillin/sulbactam were 93% and 73%,the bacterial clearance rates were 92% and 83% and the ADRs were 6% and 11%,respectively CONCLUSION:Amoxicillin/sulbactam is a safe and potent antibacterial agent in the treatment of the bacterial infections

OBJECTIVE:A HPCE method for determination of Quercetin in acanthopanax and acanthopanax injection was developed.METHODS:Measurements were carried out in a buffer solution containing 50mmol/L boric acid solution and 50mmol/L SDS(pH 8.5),at 20kV running voltage applied to a 50cm?50?m capillary.The detection wavelength was 260nm.RESULTS:The linear range of quercetin was 0.0 125～1.0mg/ml.The recovery of acanthopanax was (98.99?0.63)%.The recovery of acanthopanax injection was (98.62?0.42)%.CONCLUSION:The method is simple,rapid,accurate and suitable for determination of quercetin in acanthopanax and acanthopanax injection.

OBJECTIVE:To prepare Zuojin gastric-mucoadhesive tablets and evaluate their drug release properties in vitro. METHODS:Zuojin gastric-mucoadhesive tablets were prepared with hydroxypropyl methyl cellulose K15M(HPMC-K15M),car-bomer 934P and HPMC-E50 as the bioadhesive and matrix materials,and basic magnesium carbonate(foaming material),95% al-cohol solution(adhesive)and aerosil(glidant and lubricant)as the adjuvants. With the accumulative release of total alkaloids from Coptis chinensis Franch. at 2,6 and 10 h(Q2 h,Q6 h and Q10 h)as the indexes,orthogonal design test was conducted to optimize the amounts of HPMC-K15M,carbomer 934P,HPMC-E50 and basic magnesium carbonate,and verification was carried out. Drug re-lease properties in vitro of the preparation and Zuojin conventional tablets were observed and in vitro adhesion thereof determined. RESULTS:The optimal formulation was as follows as that for 50 tablets,HPMC-K15M of 0.7 g,carbomer 934P of 0.2 g, HPMC-E50 of 3.5 g and basic magnesium carbonate of 0.4 g. The Q2 h,Q6 h and Q10 h of three batches of prepared samples were 24.32%,56.10% and 77.04% respectively. 1-12 h drug release in vitro of prepared samples was in conformity with Ritger-Peppas equation. The Q2 h of Zuojin conventional tablets and Zuojin gastric-mucoadhesive tablets were 80.46% and 24.04%,Q12 h thereof 92.15% and 95.83% and gastric adhesion thereof 24.2 and 74.0 g/cm2,respectively. CONCLUSIONS:Zuojin gastric-mucoadhesive tablets which have sustained-release effect and adhesive property have been prepared successfully.

0.05) among these pharmacokinetic parameters. The relative bioavailability of the test preparation was(107.8?30.0)%. CONCLUSION: The test and the reference preparation are bioequivalent.

Objective: To investigate the effects of microRNA-107 (miR-107) on the proliferation and in vitro vasculogenic mimicry of Ewing sarcoma cells, and to explore the possible mechanism. Methods: The expression level of miR-107 in several Ewing sarcoma cell lines was detected by real-time fluorescent quantitative PCR. The synthesized miR-107 mimic and the scramble mimic (as the control) were transfected into Ewing sarcoma RD-ES and SK-ES-1 cells, respectively. The recovery of miR-107 expression in RD-ES and SK-ES-1 cells after transfection was verified by real-time fluorescent quantitative PCR. The effects of miR-107 overexpression on the proliferation and vascular mimicry formation of RD-ES and SK-ES-1 cells were detected by CCK-8 assay and matrigel vasculogenic mimicry assay, respectively. The expressions of hypoxia inducible factor-1ß (HIF-1ß) mRNA and protein in RD-ES and SK-ES-1 cells after transfection with miR-107 mimic were detected by real-time fluorescent quantitative PCR and Western blotting. Results: Comparing with human mesenchymal stem cells, miR-107 was low expressed in Ewing sarcoma RD-ES and SK-ES-1 cells (both P < 0.01). After transfection with miR-107 mimic, the expression of miR-107 was significantly up-regulated in RD-ES and SK-ES-1 cells (both P < 0.01). The proliferation and vascular mimicry formation of RD-ES and SK-ES-1 cells were significantly inhibited after transfection with miR-107 mimic (all P < 0.05). Furthermore, miR-107 overexpression significantly suppressed the expressions of HIF-1ß mRNA and protein in RD-ES and SK-ES-1 cells (all P < 0.01). Conclusion: miR-107 was low-expressed in Ewing sarcoma RD-ES and SK-ES-1 cells. The overexpression of miR-107 can inhibit the proliferation and vascularization of Ewing sarcoma cells, which may be related to the targeting regulation of HIF-1ß expression.

Objective To evaluate the application of neutrophil CD 64 in diagnosis of sepsis in adult patients.Methods Literature retrieval from PubMed, EMBASE, ISI Web of Knowledge, Cochrane Library, CBM, CNKI, CQVIP, Wanfang Data from the establishment of database to the year 2015 was conducted to identify all studies on CD 64 in diagnosis of sepsis .The quality of the literature was evaluated with the quality assessment of diagnostic accuracy studies ( QUADAS).Meta-Disc 1.4 and STATA 12.0 were used for meta analysis . Fixed-effects or random-effects model was performed based on the heterogeneity.The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic odds ratio were calculated .Summary receiver operating characteristic curves ( SROC ) and area under the curve (AUC) were used to evaluate the diagnostic performance of CD 64 for sepsis.Results A total of 24 studies involving 3 198 patients were included for systemic review .The sensitivity, specificity, positive likelihood ratio, negative likelihood ratio and diagnostic odds ratio of CD 64 for diagnosis of sepsis were 0.79 (95 %CI:0.77-0.81), 0.86 (95 %CI:0.84-0.88), 7.40 (95 %CI:5.02-10.91), 0.15 (95 %CI:0.10-0.22) and 60.07 (95%CI: 29.19-123.60), respectively.The area under SROC of CD64 in diagnosis of sepsis was 0.95, and the Q* value was 0.88.Conclusion CD64 can be used to diagnose sepsis in adult patients , but it needs to be further confirmed by large multicenter studies .