Objective To sort out the management system of clinical trial drugs in our hospital,and analyze the construction and practical experience of the information system in the whole process management of clinical trial drugs,and to further improve the efficiency and quality of clinical trials.Methods Based on the original management of clinical trial drugs,an information system in line with the situation of our hospital was applied to manage the whole process of clinical trial drugs.Results Compared with the traditional management,the information system can automatically record the data of inbound and outbound storage,distribution,retrieval and return of trial drugs in real time,pre-review the prescriptions and randomized documents of clinical trial drugs,and realise paperless office.Conclusions The information system can ensure the safety,accuracy and traceability of the data of drugs used in clinical trial.The system can also save resources,improve the efficiency and quality of clinical trial management.

Objective To sort out the management system of clinical trial drugs in our hospital,and analyze the construction and practical experience of the information system in the whole process management of clinical trial drugs,and to further improve the efficiency and quality of clinical trials.Methods Based on the original management of clinical trial drugs,an information system in line with the situation of our hospital was applied to manage the whole process of clinical trial drugs.Results Compared with the traditional management,the information system can automatically record the data of inbound and outbound storage,distribution,retrieval and return of trial drugs in real time,pre-review the prescriptions and randomized documents of clinical trial drugs,and realise paperless office.Conclusions The information system can ensure the safety,accuracy and traceability of the data of drugs used in clinical trial.The system can also save resources,improve the efficiency and quality of clinical trial management.

Objective To explore the effect of 5M1E quality analysis tool-based hand hygiene(HH) comprehensive intervention measures on pediatric healthcare-associated infection(HAI).Methods HH status of 29 health care workers(HCWs) in the pediatric department of a hospital was monitored, April-June 2015 was baseline survey stage, 5M1E quality analysis tool was adopted to analyze various factors affecting the compliance rate of pediatric HH, intervention measures began to be taken in June 2015, and compared with HH in July 2015-March 2016.The occurrence of HAI between July 2014-March 2015 and July 2015-March 2016 was compared.Results HH compliance rate of HCWs increased from 30.86% in April-June 2015 to 81.94% in January-March 2016;HH correct rate increased from 68.14% to 93.75%;HH compliance rate and correct rate of HCWs gradually increased(X2=2 608.626, 630.798,respectively, both P<0.001).Qualified rate of detection of HCWs' HH sampling increased from 20.69% in April-June 2015 to 89.66% in January-March 2016(X2=31.957,P<0.001).Incidence of HAI decreased from 7.74% in July 2014-March 2015 to 3.62% in July 2015-March 2016(X2=46.717,P<0.001).Conclusion Application of 5M1E quality analysis tool in the investigation, analysis, and comprehensive intervention in HCWs' HH in pediatric department has greatly enhanced HCWs' HH compliance rate, and reduced the incidence of HAI in pediatric patients.

BACKGROUND:There are many methods that can repair Pilon fracture, but the effects are not ideal. With the development of science and technology, fundamental change of fracture fixation principle and innovation of technology and idea has brought new opportunities for Pilon fracture repair. Biological immobilization technology can further reduce the further damage to blood supply of bone outer membrane on the fracture end, do not disturb biomechanical environment of fracture healing, and is the new trend of present research and development. OBJECTIVE:To investigate the effect of locking compression plate fixation for repair of Pilon fracture using biological fixation technique. METHODS:Clinical data of 76 patients with Pilon fracture treated using locking compression plate fixation in the Nanhai District Economic Development Zone Guanyao Branch of the People’s Hospital from June 2008 to December 2013 were retrospectively analyzed. There were 49 males and 27 females, at the age of 39.5 years on average (range from 19 to 60 years). According to Ruedi-Algower classification, there were 54 cases of type II and 22 cases of type III. In accordance with biological fixation technique, locking compression plate fixation was applied to treat Pilon fracture. Folowing treatment, they were regularly folowed up. Reduction quality was assessed by Burwel-Charnley radiological criteria. X-ray films were reviewed to observe fracture healing. During final folow-up, ankle function was evaluated according to Baird-Jackson score. RESULTS AND CONCLUSION:A total of 76 patients were folowed up for 6 to 24 months. Reduction quality assessed by Burwel-Charnley radiological criteria was as folows: anatomic reduction of 68 cases, reduction of 8 cases, 71 cases of one-stage wound healing, and 5 cases of wound healing after dressing change, with the rate of one-stage healing of 93%. Fractures of al patients were healed. The healing time was 4 to 8.5 months, averagely 6.25 months. During final folow-up, ankle function assessed by Baird-Jackson score was as folows: there were 69 excelent cases, 5 good cases and 2 average cases. These results indicate that locking compression plate fixation for Pilon fracture obtained good stability, could effectively avoid the damage of fracture end blood supply, shorten the healing time; it was simple to operate, had smal injury to soft tissue, and was an effective fixation method to repair Pilon fracture.

Objective To observe functional changes of renal tubular epithelial cells stimulated by high mobility group protein box 1 (HMGB1) and associated mechanism.Methods Renal tubular epithelial cells (NRK52E) were divided into control group,HMGB1 group and HMGB1+ lipopolysaccharide from Rhodobactersphaeroides (LPS RS) group.Toll-like receptor 4 (TLR4) expression was detected by immunofluorescence and Western blotting.Apoptosis rate and cell cycle arrest were identified with flow cytometry.The activation of MAPK signaling pathway and NF-κB were detected by Western blotting.The IL-1,IL-6 and tissue inhibitor of metalloproteinases 2 (TIMP2) mRNA levels were measured by real-time PCR.The secretion levels of IL-1,IL-6 and TIMP2 were measured by protein chips assay.Results TLR4 was expressed by NRK52E cells.Compared with the control group,there were increased cell cycle G1 arrest,MAPK signaling pathway and NF-κB activation in HMGB1 group.Furthermore,IL-1,IL-6 and TIMP2 mRNA levels were increased and IL-1,IL-6 and TIMP2 were secreted by NRK52E when stimulated with HMGB1 (all P ＜0.05).However,effects mediated by HMGB1 stimulation could be inhibited by LPS RS (all P＜0.05).Conclusions Inflammatory activation of NRK52E cells can be mediated by the interaction of HMGB1 and TLR4.

OBJECTIVETo establish a HPLC method for the analysis of Danshensu (DSS), protocatechuic acid (PA) and protocatechuic aldehyde (PAL) of Xiangdan injection in rat's plasma, and to study pharmacokinetic characteristics of Xiangdan injection components in rats with m-hydroxybenzoic acid as internal standard.

METHODprotein was precipitated by 10% trichloroacetic acid and extracted by ethyl acetate. The plasma concentration was detected by HPLC, The pharmacokinetics parameters of DSS, PA and PAL were calculated by DAS2.0 software after iv injection.

RESULTDSS, PA and PAL have a good linear relationship in 0.68-44.0 mg x L(-1), 0.43-14.0 mg x L(-1) and 0.38-12.0 mg x L(-1), respectively. The average recoveries were more than 92% and the RSD of precision and stability of the test were between 0.4%-4.8%. DSS, PA and PAL showed a two-compartment open model, the half-life of absorption (t(1/2alpha)) were (6.26 +/- 4.6), (5.93 +/- 4.9), (18.44 +/- 2.4) min, the half-life of elimination (t(1/2beta)) were (64.11 +/- 8.8), (63.28 +/- 0.13), (69.315 +/- 0) min, the area under curve(AUC(0-infinity)) were (852.98 +/- 175.6), (83.84 +/- 58.8), (147.79 +/- 12.3) mg x min(-1) x L(-1).

CONCLUSIONA method with high recovery rate and good stability was established to determine the blood concentration of DSS, PA, PAL in Xiangdan injection and applied in its pharmacokinetics successfully.

Animals ; Drugs, Chinese Herbal ; administration & dosage ; chemistry ; Female ; Hydroxybenzoates ; blood ; pharmacokinetics ; Injections ; Limit of Detection ; Linear Models ; Male ; Rats ; Rats, Sprague-Dawley

OBJECTIVETo study the influence of processing on metabolism of the main component of bitter almond-amygdalin in rat.

METHODThe blood was collected at different times after amygdalin given by injection and oral, bitter almond and its processed production given by oral respectively, and then detected by both HPLC and HPLC-MS(n) methods after extraction pretreatment.

RESULTAfter injection, amygdalin was absorbed in prototype to blood rapidly, while the other three kinds of medicine given by oral were all not detected the prototype of amygdalin, but two metabolites were detected which were isomers of prunasin confirmed by mass spectrometry. The metabolic pathway of prunasin in processed bitter almond group was markedly different from the bitter almond group.

CONCLUSIONProcessing has a significant effect on bitter almond metabolic processes in rats.

Amygdalin ; analysis ; metabolism ; Animals ; Female ; Male ; Prunus ; chemistry ; Rats ; Rats, Sprague-Dawley

OBJECTIVETo investigate the influence of Shi herb (Santalum album, SA) to the tissue distribution of danshensu (DSS) which is the main hydrosoluble component of Jun herb (Salvia miltiorrhiza, SM) in rabbits by HPLC.

METHODRabbits were oral administrated decoction of SM and SM-SA, respectively. Perchloric acid (10%) was used to precipitate the tissue samples of rabbits heart, brain, liver, kidney, acetic ether was used to extracte supernatant, and the internal standard was p-hydroxybenzoic acid. The content of DSS of SM in tissues was detected.

RESULTThe content of DSS reached the highest point close to 50 min in the mentioned tissues. Before and after co-administration, the sequences of average concentration of DSS in tissues were C(kidney) > C(heart) > C(brain) > C(liver) and C(kidney) > C(liver) > C(brain) > C(heart) respectively. Compared with SM administrated singly, the content of DSS in every tissues of co-administration was higher.

CONCLUSIONIn Danshenyin Formulae, SA can increase concentration of DSS in target tissues significantly, and therefore therapeutic effect of SM for cardiovascular disease is raised.

Animals ; Brain ; drug effects ; Chromatography, High Pressure Liquid ; Drugs, Chinese Herbal ; administration & dosage ; analysis ; pharmacokinetics ; Heart ; drug effects ; Kidney ; drug effects ; Lactates ; administration & dosage ; analysis ; pharmacokinetics ; Liver ; drug effects ; Rabbits ; Santalum ; chemistry

OBJECTIVETo study the effect of borneol on the pharmacokinetics of protocatechuic acid (PA) in rabbits.

METHODA method for determinating PA in rabbit plasma by high performance liquid chromatography (HPLC) was established. The 12 healthy New Zealand rabbits were randomly divided into 2 groups. PA concentration in plasma samples of rabbits was determined by HPLC after oral administration of PA (30 mg x kg(-1)) and PA combined with borneol (protocatechuic acid 30 mg x kg(-1) + borneol 15 mg x kg(-1)). The data were processed by DAS 2.0 software to calculate the pharmacokinetic parametes.

RESULTChromatographic peaks were separated well by the HPLC method. Regression analysis of the data of PA concentration against its peak area showed a good straight line in the range of 0.04-2.0 mg x L(-1) (r = 0.9983). In comparison with PA alone, the pharmacokinetics parameters of PA (t1/2Ka, T(max), V1/F, CL/F) in the PA + borneol combination group were decreased, while the AUC(0-infinity) was increased.

CONCLUSIONBorneol could significantly promote absorption, increase the dose absorption and slow elimination of PA in rabbits. Borneol could improve the bioavailability of PA.

Animals ; Bornanes ; pharmacology ; Chromatography, High Pressure Liquid ; Female ; Hydroxybenzoates ; blood ; pharmacokinetics ; Linear Models ; Male ; Rabbits ; Regression Analysis ; Reproducibility of Results

Aim: To establish the metabolic fingerprint and profile of bioactive components in human plasma after sublingual administration of compound Danshen dripping pills. Methods: Human plasma samples were collected at different time intervals. Powerlab tension system was used to measure their ability of expanding blood vessel and column switching system was employed to purify and enrich the components of interest. Results: The plasma sample of 1.5h had the strongest ability for expanding blood vessel, and had five new peaks in the chromatogram. Conclusion: After being identified, the intensity ratio of these 5 peaks was calculated. The diagram called metabolic profile was established to link bioactive compounds with pharmacodynamic action.