1.SWOT Analysis of Centralized Purchasing Management Model for Medicinal Material Under Separation of the Four Powers in Tertiary General Hospital
Dawei CAI ; Yong LIU ; Lijun ZHANG ; Guangyao GU ; Juan DU
China Pharmacy 2016;27(19):2663-2665
OBJECTIVE:To standardize hospital purchasing management for medicinal material. METHODS:The separation of the four powers,including plan,purchase,supply,and payment,was practiced on the basis of centralized purchasing medicinal material in our hospital. SWOT method was used to analyze the strengths,weaknesses,opportunities and threats of the model;im-provement measures were formulated;finally the effects of the model were evaluated. RESULTS:This model played an active role in the professional advantage of purchasing management,made up for the lack of management system and manpower shortage dis-advantage;adapted to policies to seize the opportunities for improvement,reduced the threat of standard deletion and purchasing cost,and promoted reasonable consumption of medicinal materials. And then the purchasing cost of our hospital was reduced after system procedure improvement,fine management of medicinal material and professional level improvement,medicine ratio fell from 42% in 2010 to 37% in 2014;logistics support became stable and standard,and the level of medicinal material supply was improved. CONCLUSIONS:The purchasing model for medicinal material under separation of the four powers provides the refer-ence for the correct course of the standardized,normalized and modernized hospital purchasing management.
2.Clinical Observation of Jiedu Xiaoyu Cream Combined with Glucosamine Potassium Sulfate Capsules in the Treatment of Knee Osteoarthritis
Dehui XU ; Dawei GU ; Guochao YIN ; Bo WANG
China Pharmacy 2016;27(8):1107-1109
OBJECTIVE:To observe clinical efficacy and safety of Jiedu xiaoyu cream combined with Glucosamine potassium sulfate capsules in the treatment of knee osteoarthritis. METHODS:196 patients with knee osteoarthritis were randomly divided in-to observation group and control group,with 98 cases. Both group were given Glucosamine potassium sulfate capsules 0.5 mg/time, bid;observation group additionally received Jiedu xiaoyu cream for local use,once a week;control group additionally received Di-clofenac diethylamine emulsifiable paste for local use,bid. A treatment course lasted for 2 weeks,and both groups received 3 cours-es of treatment. Clinical efficacy,VAS scores,WOMAC scores and ADR of 2 groups were observed. RESULTS:The total effec-tive rate of observation group was 94.7%,which was significantly higher than that of control group(88.3%),with statistical sig-nificance(P<0.05). Compared with before treatment,VAS and WOMAC scores of 2 groups decreased obviously,with statistical significance(P<0.05);the decrease of observation group was more significant than that of control group,with statistical signifi-cance(P<0.05). There was no statistical significance in the incidence of ADR between 2 groups(P>0.05). CONCLUSIONS:Jie-du xiaoyu cream combined with Glucosamine potassium sulfate capsules has good clinical efficacy in the treatment of knee osteoar-thritis,can relieve knee pain and improve the function of activity.
3.Preparation and Evaluation of Long-circulating Liposomes of Paraoxonase
Zhenkun HAN ; Jianbo SUN ; Dan LIU ; Haiyang HU ; Dawei CHEN ; Pengyi GU ; Min ZHAO
Journal of China Medical University 2010;(2):87-91
Objective To prepare the long-circulating liposomes of paraoxonase(PON).Methods The long-circulating liposomes of paraoxonase were prepared by film dispersion method.The encapsulation efficiency was determined by gel column.The effects of the factors on the encapsulation efficiency,such as the weight ratio of paraoxonase to phospholipid,cholesterol(Choi) to phospholipid,PEG-cholesterol (PEG-Chol) and the iron strength of water phase,were investigated respectively.Then the formulation was optimized by orthogonal design.Results The encapsulation efficiency of the paraoxonase liposomes was 87.66±3.46%,and the average diameter of the liposomes was about 126 nm.There was no significant change on encapsulation efficiency on 15 d at 4 ℃,and the activity of paraoxonase was maintained basically stable.Conclusion The preparation of PEG-modified paraoxonase liposomes was easy and practicable,and the property investigation in vitro showed that the paraoxonase liposomes were stable.
4.Use of light-stylet in the management of difficult airway with active oral bleeding
Maitao ZHOU ; Youzhi ZHENG ; Weiming HONG ; Dawei YU ; Chengyong GU ; Jun HUA ; Yushuang ZHONG
Chinese Journal of Emergency Medicine 2010;19(9):970-973
Objective To compare the rates of successful intubation between light-stylet and adjustable McCoy laryngoscope for the management of difficult airway with active oral bleeding. Method Thirty casualties traumatized with active oral bleeding were enrolled after failure of endotracheal intubation tried twice by an attending doctor with Macintosh laryngoscope. The patients were randomly( random number) divided into light-stylet (LS)group and McCoy laryngoscope(MC) group ( n = 15 in each group). The rate of successful intubation and the time consumed for intubation were recorded. Results The rate of successful intubation at the first attempt and the total rate of successful intubation in LS group were higher than those in MC group (14/15 vs. 6/15, P =0.005, 15/15 vs. 9/15, P =0.017, respectively). The time consumed for intubation was less in LS group than that in MC group (24 seconds in average,ranged from 23 ~ 34 seconds vs 48 seconds in average, ranged from 31 ~ 119 seconds, P =0.011). Conclusions The light-stylet is a novel tool for intubation in casualties with difficult airway and active oral bleeding with high success rate.
5.Study on Bioequiavailability in Human Body between Domestic and Imported Roxithromycin
Yubing ZHU ; Dawei XIAO ; Jianjun ZOU ; Wei QIAN ; Yunfang HU ; Cuixia YU ; Rong GU
China Pharmacy 2005;0(16):-
OBJECTIVE:To study the bioequiavailability of domestic roxithromycin tablets and imported ones.METH?ODS:20male healthy volunteers took single dose of150mg roxithromycin tablet orally in a random crossover design,blood concentrations were determined by LC-MS.RESULTS:The main pharmacokinetic parameters of domestic and imported tablets were determined respectively as follows,AUC 0~72 were(72.81?23.85)(mg?n)/L and(72.63?20.86)(mg?h)/L,AUC 0~∞ were(74.41?24.45)(mg?h)/L and(74.42?24.45)(mg?h)/L,C max were(6.46?1.51)mg/L and(6.58?1.55)mg/L,t max were(1.9?0.5)h and(1.8?0.5)h,t 1/2 were(13.56?1.35)h and(14.18?1.50)h,the relative bioavailability of the homemade tablet to imported one was(99.8?11.2)%.CONCLUSIONS:Domestic and imported roxithromycin are bioequivalent.
6.Determination of finasteride in human plasma and its pharmacokinetics and relative bioavailability by HPLC-electrospray mass spectrometry
Jianhua LI ; Xuelan GU ; Yiqun XU ; Jing WANG ; Liqing WU ; Jiahui CHEN ; Jianjun ZOU ; Yubing ZHU ; Hongwei FAN ; Dawei XIAO
Chinese Journal of New Drugs and Clinical Remedies 2006;25(7):537-541
AIM: A new HPLC-MS method was developed to determine finasteride in human plasma. METHODS: Two formulations of finasteride tablets were given to 20 healthy male volunteers according to a randomized 2-way cross-over design. The samples were extracted by ethyl acetate under basic conditions, then were separated by C18 column and determined by mass detector. RESULTS: The calibration curve of finasteride was linear and intra-day and inter-day RSD were less than 10 %. The pharmacokinetics parameters of the two formulations (4.5 ± 0.5) h for t1/2; (3.0 ± 0.7) and (2.8 ± 0.9) h for tmax, respectively. The results indicated that there was no significant difference on cmax, A UC0-24, t1/2 or tmax values between the two formulations. CONCLUTION: The relative bioavailability of tablets I with respect to tablets Ⅱ is (99.3 ± 9.2) % by the A UC0-24 measurement, and bioe quivalence is observed between the two tablets.
7.Pharmacokinetics and bioavailability of two kinds of gliclazide sustained release tablets following a single and multiple dose in healthy volunteers
Jianjun ZOU ; Dawei XIAO ; Yubing ZHU ; Ling MO ; Cuixia YU ; Rong GU ; Yunfang HU ; Wei QIAN ; Sheng LOU
Chinese Journal of New Drugs and Clinical Remedies 2005;24(5):337-341
AIM: To compare the pharmacokinetics and relative bioavailability of the domestic and imported sustained-release tablets of gliclazide in healthy volunteers. METHODS:The study was performed by an four-period crossover design with singledose and multiple-dose administration. The plasmadrug concentrations of twenty male healthy volunteers were determined by liquid chromatography with mass spectrum detector method (LC-MS). RESULTS:The pharmacokinetic parameters after a single oral dose of the domestic and imported gliclazide tablets were (7.2+s 1.5) h and (6.9 +1.4) h for tmax, (13.4 ±1.2) h and (13.7 +1.3) h for t1/2, (2.4 +0.8) mg ·L-1and (2.3 ±0.6) mg· L-1 forcmax, (48 ±14)mg · h · L-1 and (48 +14) mg· h · L-1 forAUC0-60,(51+15) mg· h· L-1 and (50±14) mg· h· L-1for AUC0-∞, (22.4 ± 1.9 ) h and (22.8 ± 1.9 ) h for MRT, respectively. The steady state pharmacokinetic parameters after multiple doses of the domestic and imported gliclazide tablets were (6. 1 ± 1.4) h and (6.5+1.4) h for tmax, (4.6±0.9) mg· L-1 and (4.7±1.1) mg· L-1 for cmax, (0.23 ±0.08) mg ·L-1and (0.26±0.08) mg· L-1 forcmin, (1.6±0.3) mg·L-1 and (1.6±0.3) mg · L-1 for mean value of steady plasma-drug concentration (cav),(94±19) mg· h · L-1 and (95 ±20) mg · h · L-1forAUCss, (282 ±33)% and (283 ±43)% for degree of fluctuation DF ), respectively. The relative bioavailability of the domestic gliclazide tablet to the imported gliclazide tablet following a single and multiple dose were ( 102 ± 9) % and (99 ± 10 ) %, respectively. Main pharmacokinetic parameters between the two formulations in both single and multiples dose studies showed no statistical difference ( P >0.05 ). CONCLUSION: The result of two one side t-test shows that the two formulations are bioequivalent.
8.Clinical efficacy of sorafenib in treatment of primary hepatic carcinoma and its effects on serum VEGFR -2 and PLGFlevels
Weirong LIAO ; Chao GU ; Dawei ZHANG
Journal of Clinical Hepatology 2018;34(6):1220-1224
To investigate the clinical efficacy of sorafenib in the treatment of primary hepatic carcinoma (PHC) and its effects on serum vascular endothelial growth factor receptor -2 (VEGFR -2) and placental growth factor (PLGF) levels.Methods A total of 110 patients with a confirmed diagnosis of PHC who received treatment in Jinshan Hospital Affiliated to Fudan University from July 2014 to March 2016 were randomly and equally divided into observation group and control group .The control group was given routine treatment, while the observation group received sorafenib in addition to the routine treatment .Serum levels of VEGFR -2 and PLGF were measured by ELISA.Liver function parameters, aspartate aminotransferase (AST), prothrombin time (PT), total bilirubin (TBil), albumin (Alb), and alanine aminotransferase (ALT), were also recorded.Comparison of continuous data between groups was made by independent samples t -test, and the changes in continuous data after intervention in each group were evaluated by paired samples t -test.Comparison of categorical data between groups was made by chi -square test.Results The observation group showed significant reductions in serum VEGFR -2 and PLGF levels after treatment (VEGFR -2: 7053.2 ±1836.1 ng/L vs 8721.4 ±2427.8 ng/L, t =4.089, P <0.001; PLGF: 468.4 ±136.5 pg/ ml vs 656.8 ±191.4 pg/ml, t =5.975, P <0.001).After treatment, the observation group had significantly lower serum VEGFR -2 and PLGF levels than the control group (VEGFR -2: 7053.2 ±1836.1 ng/L vs 8097.5 ±2325.4 ng/L, t =2.64, P <0.05; PLGF: 468.4 ± 136.5 pg/ml vs 643.3 ±195.8 pg/ml, t =2.48, P <0.05).The observation group showed significant changes in serum AST and ALT lev - els after treatment (t =4.302 and 3.097, both P <0.05).After treatment, the observation group had significantly lower serum AST and ALT levels than the control group (t =2.56 and 2.39, both P <0.05).Compared with the control group, the observation group had better follow -up results, with a significantly increased disease control rate (27.3% vs 47.3% , χ2 =4.705, P =0.030), and had a significantly higher survival rate at 40 months after treatment (43.6% vs 69.1%, χ2 =7.245, P =0.007).Conclusion Sorafenib is effective in the treatment of PHC patients, as it can significantly reduce the serum levels of VEGFR -2 and PLGF, prolong the survival time of patients, and improve the prognosis of patients.
9.Fabrication of the anti-tuberculosis controlled drug delivery system with Ti-PDA-PEG-PLGA-INH and investigation of the biological characteristics
Yunlong MA ; Litao LI ; Dan LI ; Mingli PENG ; Guanren ZHAO ; Dawei LI ; Zhanpeng LUO ; Suxi GU ; Fei YANG ; Yuanzheng MA
Chinese Journal of Orthopaedics 2016;36(11):725-734
Objective To fabricate an anti?tuberculosis controlled drug release coating with Ti?PDA?PEG?PLGA?INH and to investigate its surface characteristics, in vivo and in vitro drug release behavior, and tissue biocompatibility. Methods 4?arm?polyethylene glycol (PEG) was synthesized first. Then cover the surface of titanium (Ti) with a layer of poly dopamine (PDA) by Michael addition reaction. Use porous starch and 4?arm?PEG as a carrier, load with isoniazid (INH), then attach to the surface of titanium by casting or sol?gel dip coating methods, and then cover with a layer of poly lactic?co?glycolic acid (PLGA) by the same method, to fabricate the Ti?PDA?PEG?PLGA?INH composite coating finally. The functional group of 4?arm?PEG was charac?terized by proton nuclear resonance spectroscopy (HNMR). The surface characteristics of Ti?PDA?PEG?PLGA?INH were evaluated by scanning electron microscope (SEM), while drug release behaviors were detected by high performance liquid chromatography (HPLC) and the cumulative release rate was calculated, and carry out the antibacterial performance in vitro. The animal model of femoral condyle bone defect was established in 25 New Zealand white rabbits. Titanium rods covered with PDA?PEG?PLGA?INH coating were implanted into defect area. INH concentrations were detected by HPLC in venous blood, muscle and bone tissue at each time point postoperatively. Another 12 rabbits were randomly divided into experimental group and control group, the experi?mental group was implanted with titanium tablets and titanium rods coated with PDA?PEG?PLGA?INH in the paraspinous muscle and left femoral condyles respectively, while the control group was implanted with a blank sheet of titanium tablets and titanium rods in the same place. Hematoxylin and Eosin Staining were used to observe the biocompatibility of the composite system in vivo at 28 and 56 days postoperatively. Results Ti?PDA?PEG?PLGA?INH controlled drug release coating uniformly distributed on the surface of plates and rods, with translucent form and smooth surface. In vitro INH release kinetics exhibited a short?burst release during the first 8h, and the cumulative release of the INH was about 65%. On the 9th day, the cumulative release of the INH was about 90%, and then the release tended to be flat, and the drug release behavior in vitro continued more than 20d. In vivo release test showed that the concentration of INH in vein blood, muscle and bone tissue around the composite system was increased steadi?ly postoperatively. On about the 28th day, the concentration reached the max. However, the INH concentrations in muscle and bone tissue around the composite system were still higher than the minimum inhibitory concentration (MIC) on the 56th day. The antibacterial test in vitro showed that the titanium tablets coated with PDA?PEG?PLGA?INH formed obvious bacterial inhibition zones. The pathological results indicated that mild inflammatory reaction was seen in the 4th week postoperatively, and the reac?tive capsule formed with loose connective tissue. In the 8th week postoperatively, there's no obvious inflammation occurred, and the reactive capsule became more dense and thicker. Conclusion The study successfully fabricated the Ti?PDA?PEG?PLGA?INH anti?tuberculosis controlled drug release coating, with reasonable release behavior both in vivo and in vitro, effective antibac?terial effect of Mycobacterium tuberculosis in vitro and good tissue biocompatibility, which is a potentially effective drug delivery system for spinal tuberculosis.
10.Treatment of ankylosing spondylitis with a recombinant human tumor necrosis factor receptor-Fc fusion protein: a multicenter, randomized, double blind, controlled trial
Feng HUANG ; Xiaohu DENG ; Yamei ZHANG ; Jieruo GU ; Chunde BAO ; Jianglin ZHANG ; Dawei HU ; Zhiming LIN ; Chunhua YANG ; Dongfeng LIANG ; Junhua GUO ; Zetao LIAO
Chinese Journal of Rheumatology 2008;12(5):314-320
Objective To evaluate the efficacy and safety profile of a recombinant human tumor necrosis factor receptor: Fc fusion protein in ankylosing spondylitis (AS). Methods This was a multicenter,randomized, double-blind, placebo-controlled trial in the first 6 weeks and then followed by an open-labeled trial in the next 6 weeks. One hundred and forty-three patients of active AS were randomly assigned to receive 25 mg twice-weekly subcutaneous injections of rhTNFR:Fc or placebo for 6 weeks. The primary endpoint was proportion of ASAS20 responders at week 6. The secondary endpoints were the proportion of subjects achieving a BASDAI 20%, BASDAI 50% and BASDAI 70% improvement at week 6. Other secondary endpoints, related to reducing signs and symptoms of AS and improving range of motion and physical function, were evaluated.Results Treatment with rhTNFR:Fc resulted in significant improvement. At 6 weeks, 68% of the 71 patients in the rhTNFR: Fc group had a treatment response, as compared with 28% of those in the placebo group(P<0.01). Improvements over base-line values for other measures of disease activity were significantly greater in the rhTNFR:Fc group, rhTNFR:Fc was well tolerated, The most frequently treatment related adverse event was injection site reaction. Conclusion rhTNFR:Fc has demonstrated consistent evidence of efficacy and is well tolerated in the treatment of active AS.