1.Safety and efficacy of the early administration of levosimendan in patients with acute non-ST-segment elevation myocardial infarction and elevated NT-proBNP levels: An Early Management Strategy of Acute Heart Failure (EMS-AHF).
Feng XU ; Yuan BIAN ; Guo Qiang ZHANG ; Lu Yao GAO ; Yu Fa LIU ; Tong Xiang LIU ; Gang LI ; Rui Xue SONG ; Li Jun SU ; Yan Ju ZHOU ; Jia Yu CUI ; Xian Liang YAN ; Fang Ming GUO ; Huan Yi ZHANG ; Qing Hui LI ; Min ZHAO ; Li Kun MA ; Bei An YOU ; Ge WANG ; Li KONG ; Jian Liang MA ; Xin Fu ZHOU ; Ze Long CHANG ; Zhen Yu TANG ; Dan Yu YU ; Kai CHENG ; Li XUE ; Xiao LI ; Jiao Jiao PANG ; Jia Li WANG ; Hai Tao ZHANG ; Xue Zhong YU ; Yu Guo CHEN
Chinese Journal of Internal Medicine 2023;62(4):374-383
Objectives: To investigated the safety and efficacy of treating patients with acute non-ST-segment elevation myocardial infarction (NSTEMI) and elevated levels of N-terminal pro-hormone B-type natriuretic peptide (NT-proBNP) with levosimendan within 24 hours of first medical contact (FMC). Methods: This multicenter, open-label, block-randomized controlled trial (NCT03189901) investigated the safety and efficacy of levosimendan as an early management strategy of acute heart failure (EMS-AHF) for patients with NSTEMI and high NT-proBNP levels. This study included 255 patients with NSTEMI and elevated NT-proBNP levels, including 142 males and 113 females with a median age of 65 (58-70) years, and were admitted in the emergency or outpatient departments at 14 medical centers in China between October 2017 and October 2021. The patients were randomly divided into a levosimendan group (n=129) and a control group (n=126). The primary outcome measure was NT-proBNP levels on day 3 of treatment and changes in the NT-proBNP levels from baseline on day 5 after randomization. The secondary outcome measures included the proportion of patients with more than 30% reduction in NT-proBNP levels from baseline, major adverse cardiovascular events (MACE) during hospitalization and at 6 months after hospitalization, safety during the treatment, and health economics indices. The measurement data parameters between groups were compared using the t-test or the non-parametric test. The count data parameters were compared between groups using the χ² test. Results: On day 3, the NT-proBNP levels in the levosimendan group were lower than the control group but were statistically insignificant [866 (455, 1 960) vs. 1 118 (459, 2 417) ng/L, Z=-1.25,P=0.21]. However, on day 5, changes in the NT-proBNP levels from baseline in the levosimendan group were significantly higher than the control group [67.6% (33.8%,82.5%)vs.54.8% (7.3%,77.9%), Z=-2.14, P=0.03]. There were no significant differences in the proportion of patients with more than 30% reduction in the NT-proBNP levels on day 5 between the levosimendan and the control groups [77.5% (100/129) vs. 69.0% (87/126), χ²=2.34, P=0.13]. Furthermore, incidences of MACE did not show any significant differences between the two groups during hospitalization [4.7% (6/129) vs. 7.1% (9/126), χ²=0.72, P=0.40] and at 6 months [14.7% (19/129) vs. 12.7% (16/126), χ²=0.22, P=0.64]. Four cardiac deaths were reported in the control group during hospitalization [0 (0/129) vs. 3.2% (4/126), P=0.06]. However, 6-month survival rates were comparable between the two groups (log-rank test, P=0.18). Moreover, adverse events or serious adverse events such as shock, ventricular fibrillation, and ventricular tachycardia were not reported in both the groups during levosimendan treatment (days 0-1). The total cost of hospitalization [34 591.00(15 527.46,59 324.80) vs. 37 144.65(16 066.90,63 919.00)yuan, Z=-0.26, P=0.80] and the total length of hospitalization [9 (8, 12) vs. 10 (7, 13) days, Z=0.72, P=0.72] were lower for patients in the levosimendan group compared to those in the control group, but did not show statistically significant differences. Conclusions: Early administration of levosimendan reduced NT-proBNP levels in NSTEMI patients with elevated NT-proBNP and did not increase the total cost and length of hospitalization, but did not significantly improve MACE during hospitalization or at 6 months.
Male
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Female
;
Humans
;
Aged
;
Natriuretic Peptide, Brain
;
Simendan/therapeutic use*
;
Non-ST Elevated Myocardial Infarction
;
Heart Failure/drug therapy*
;
Peptide Fragments
;
Arrhythmias, Cardiac
;
Biomarkers
;
Prognosis
2.Multi-index components of Scutellariae Barbatae Herba according to UHPLC-QTRAP-MS coupled with chemometrics.
Jia-Lu JIANG ; An KANG ; Qin LI ; Meng-Meng SONG ; Hui-Fa HAN ; Yu-Qing CAI ; Zhui-Cheng XU ; Hai-Bo CHENG ; Dong-Dong SUN
China Journal of Chinese Materia Medica 2022;47(2):437-443
The present study developed an ultra-fast liquid chromatography coupled with triple quadrupole-linear ion trap composite mass spectrometry(UHPLC-QTRAP-MS) to simultaneously determine the content of potential active components in Scutellariae Barbatae Herba and also to provide a reference approach for screening out the differential quality control components among different batches of Scutellariae Barbatae Herba. Chromatographic separations were conducted on a Thermo Acclaim~(TM) RSLC 120 C_(18) column(3.0 mm×100 mm, 2.2 μm) in a gradient program. The mobile phase consisted of 0.1% aqueous formic acid and acetonitrile, and the column temperature was maintained at 40 ℃. The flow rate was 0.4 mL·min~(-1) and the injection volume was 2 μL. The targeted compounds were monitored in the multiple reaction monitoring(MRM) mode. The acquired data were processed by hierarchical cluster analysis(HCA) and partial least square discriminant analysis(PLS-DA). Sixteen compounds all showed good linear relationship within the corresponding linear ranges and the R~2 values were all higher than 0.993 2. The RSDs of precision, repeatability, and stability were less than or equal to 3.7%. Mean recovery rates were in the range of 95.67% and 104.8% with RSDs≤3.2%. According to HCA and PLS-DA, all samples were clustered into four categories. Scutellarin, acteoside, scutellarein, and scutebarbatine X(VIP>1) were considered as differential chemical markers in the four categories. In conclusion, the developed method can be used for the simulta-neous determination of the multiple components and quality control of Scutellariae Barbatae Herba.
Chemometrics
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Chromatography, High Pressure Liquid/methods*
;
Chromatography, Liquid
;
Scutellaria
;
Tandem Mass Spectrometry/methods*
3.An arthroscopic "inlay" Bristow procedure with suture button fixation: Surgical technique and radiology evaluation.
Zhen Xing SHAO ; Qing Fa SONG ; Yu Qing ZHAO ; Guo Qing CUI
Journal of Peking University(Health Sciences) 2021;53(5):896-901
OBJECTIVE:
To introduce an arthroscopic "inlay" Bristow procedure based on the Mortise-Tenon joint structure concept using suture button fixation, and to evaluate its clinical and radiology results postoperatively with a minimal 3-year follow-up.
METHODS:
A total of 56 patients who received arthroscopic "inlay" Bristow procedure with suture button fixation between June 2015 to June 2016 were eventually enrolled in this study. Radiological assessment on the 3D CT scan was performed preoperatively, immediately after operation, and postoperatively at the end of 3 months, 6 months and the final follow-up. Complications postoperatively were also recorded.
RESULTS:
A total of 56 patients were finally included in this study. The mean follow-up time was (36.1±3.7) months. Coracoid grafts (middle point) were positioned at about 4 o'clock (123.8°±12.3°) in the En-face view. In the axial view, 95% (53/56) of the grafts positioning were measured as flush, 5% (3/56) as medial. Bone union rate was 96.4% at the final follow-up. At the end of 3 months, 6 months, and the final follow-up, the length of the coracoid graft was 96.9%±4.9%, 91.9%±6.2%, and 91.6%±6.6% of the immediate postoperative length, respectively. Compared with the immediate postoperative length, the length measured at the end of 3 months shortened not significantly (t=2.12, P > 0.05). The coracoid graft shortened more pronouncedly 6 months postoperatively (t=4.98, P < 0.05) and then remained almost constant over time (t=-0.75, P > 0.05), with all grafted coracoid graft retaining more than 90% of their initial length by the 3-year follow-up. And new bone formation at the junction between the coracoid graft and glenoid neck in the axial view were obviously noted in 25 cases. The quantitative evaluation showed that the glenoid area in En-face view was significantly increased at the final follow-up than that immediately after surgery [(9.72±1.22) cm2 vs. (9.42±1.11) cm2]. No degenerative changes were noted on CT images in all the patients at the final follow-up.
CONCLUSION
This study reported a series of "inlay" Bristow procedure with suture button fixation for recurrent shoulder dislocation, providing satisfactory union rate and excellent graft positioning. And using suture button fixation instead of screw can reduce osteolysis and complications related to hardware implantation. Moreover, the bone remodeling between the coracoid process and glenoid could be beneficial to restoring the anterior stability of shoulder joint in a long term follow-up.
Arthroscopy
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Humans
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Joint Instability
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Radiology
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Shoulder Dislocation
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Shoulder Joint
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Sutures
4.Anatomical characteristics of patients with symptomatic severe aortic stenosis in China.
Tian-Yuan XIONG ; Yi-Ming LI ; Yi-Jun YAO ; Yu-Heng JIA ; Kai XU ; Zhen-Fei FANG ; Jun JIN ; Guo-Sheng FU ; Yi-Ning YANG ; Lei JIANG ; Wei-Dong LI ; Yan-Qing WU ; Yan-Song GUO ; Ran GUO ; Yun-Dai CHEN ; Yi LI ; Yi-Bing SHAO ; Yi ZHANG ; Bo-Sen YANG ; Yi-Ke ZHANG ; Jing-Jing HE ; Kai-Yu JIA ; Sheng-Hu HE ; Fa-Xin REN ; Jian-Cheng XIU ; Xing-Hua GU ; Liang-Long CHEN ; Ke HAN ; Yuan FENG ; Mao CHEN
Chinese Medical Journal 2021;134(22):2738-2740
6.Diagnostic Value of CT in Infantile Congenital Lung Malformation
Hai-lian ZHENG ; Ting SONG ; Wen-yan TANG ; Yong-lu CHEN ; Ting-wei CHEN ; Tian-fa DONG ; Mei-qing WEN
Journal of Sun Yat-sen University(Medical Sciences) 2020;41(6):959-966
【Objective】 To study the diagnostic value of computed tomography(CT) in the diagnosis of infantile congenital lung malformation(CLM) . 【Methods】 A total of 76 CLM patients diagnosed in the Third Affiliated Hospital of Guangzhou Medical University from May 2019 to May 2020 were selected. The diagnostic accuracy of preoperative CT and prenatal ultrasound(US) diagnosis of CLM was compared based on the gold standard of pathological results. The preoperative CT findings and differential diagnosis were analyzed. 【Results】 Among the 76 cases of CLM, there were 36 cases of congenital pulmonary airway malformation(CPAM), 26 cases of pulmonary sequestration(PS), 8 cases of congenital lobar emphysema(CLE), and 6 cases of mixed type. There was a moderate agreement between CT and US diagnosis of CLM(Kappa = 0.465, P < 0.05). The accuracy rate of CT diagnosis was 85.5%, which was higher than that of US(69.7%). McNemar test result is P = 0.001, the difference of diagnostic value between CT and US was statistically significant. In terms of CT manifestations, CPAM was mainly characterized by cystic lesions of different sizes. PS showed pulmonary mass with abnormal blood supply artery, mainly from the aortic branch. CLE was characterized by overexpansion of the pulmonary lobes and thinning of the pulmonary blood vessels. 【Conclusions】 In infantile CLM, preoperative CT is an important supplementary examination for prenatal US. Different types of CLM have different manifestations. CT can diagnose and distinguish different types of CLM, which provides an important basis for preoperative clinical evaluation.
7.Secukinumab demonstrates high efficacy and a favorable safety profile over 52 weeks in Chinese patients with moderate to severe plaque psoriasis.
Lin CAI ; Jian-Zhong ZHANG ; Xu YAO ; Jun GU ; Quan-Zhong LIU ; Min ZHENG ; Shi-Fa ZHANG ; Jin-Hua XU ; Cheng-Xin LI ; Hao CHENG ; Qing GUO ; Wei-Li PAN ; Shen-Qiu LI ; Ruo-Yu LI ; Zai-Pei GUO ; Zhi-Qi SONG ; Shan-Shan LI ; Xiu-Qin DONG ; Linda WANG ; Rong FU ; Pascaline REGNAULT ; Pascal CHAREF ; Rafal MAZUR ; Manmath PATEKAR
Chinese Medical Journal 2020;133(22):2665-2673
BACKGROUND:
Psoriasis is a chronic inflammatory skin disease, affecting about 0.6% of the Chinese population. Many patients are not well controlled by conventional treatments, thus there is need for new treatment regimens. In this study, we assessed the efficacy and safety of secukinumab in Chinese patients with moderate to severe plaque psoriasis.
METHODS:
This study was a 52-week, multicentre, randomized, double-blind, placebo-controlled, parallel-group, Phase 3 trial. A sub-population of study participants (≥18 years) of Chinese ethnicity were randomized to receive subcutaneous injections of 300 or 150 mg secukinumab, or placebo. The co-primary endpoints were psoriasis area severity index (PASI) 75 and Investigator's Global Assessment (IGA) 0/1 at Week 12.
RESULTS:
A total of 441 Chinese patients were enrolled in this study. Co-primary outcomes were achieved; 300 and 150 mg secukinumab were superior to placebo as shown in the proportion of patients that achieved PASI 75 (97.7% and 87.2% vs. 3.7%, respectively; P < 0.001), and IGA 0/1 (82.3% and 69.7% vs. 2.7%; P < 0.001) at Week 12. Treatment efficacy was maintained until Week 52. There was no increase in overall adverse events with secukinumab relative to placebo throughout the 52-week period.
CONCLUSION:
Secukinumab is highly effective and well tolerated in Chinese patients with moderate to severe plaque psoriasis.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03066609; https://clinicaltrials.gov/ct2/show/record/NCT03066609.
Antibodies, Monoclonal/therapeutic use*
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Antibodies, Monoclonal, Humanized
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China
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Double-Blind Method
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Humans
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Psoriasis/drug therapy*
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Severity of Illness Index
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Treatment Outcome
8. Chemical analysis and in vitro antimicrobial effects and mechanism of action of Trachyspermum copticum essential oil against Escherichia coli
Wei HUANG ; Jian-Qing WANG ; Hai-Yan SONG ; Qian ZHANG ; Guang-Fa LIU ; Wei HUANG
Asian Pacific Journal of Tropical Medicine 2017;10(7):663-669
Objective To find a natural plant essential oil (EO) with excellent antimicrobial effects on food-borne bacteria and to explore the mechanism of its antimicrobial function against Escherichia coli (E. coli). Methods The antimicrobial activity of seven EOs against Gram-negative E. coli ATCC 8739 and Gram-positive Staphylococcus aureus ATCC 6538 was investigated using agar disk diffusion method, and the minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) of each EO was determined using the broth dilution method. The chemical composition of the Trachyspermum copticum (T. copticum) EO was analyzed using gas chromatography–mass spectrometry (GC/MS). In order to explore the mechanism of the antimicrobial action, 1 MIC and 2 MIC of T. copticum EO was added to a suspension of E. coli, the growth curve and the scanning electron microscopy (SEM) analysis of E. coli, and the release of cell constituents and protein and potassium ions from the bacterial cell were measured. Results The T. copticum EO had the best antimicrobial activity against the test bacteria, and 10 compounds accounting for 94.57% of the total oil were identified, with the major components being thymol (46.22%), p-cymene (19.03%), and γ-terpinene (22.41%). The addition of 1 MIC that T. copticum EO significantly inhibited the growth of E. coli and increased the release of cell constituents and protein and potassium ions from the bacterial cells. Scanning electron micrographs showed that T. copticum EO caused most of the E. coli cell membranes to collapse and rupture, leading to cell death. Conclusions These results indicate that T. copticum EO is a good natural antimicrobial agent for food-borne pathogens.
9.Antipyretic and anti-asthmatic activities of traditional Chinese herb-pairs, Ephedra and Gypsum.
Fen MEI ; Xue-Feng XING ; Qing-Fa TANG ; Fei-Long CHEN ; Yang GUO ; Shuai SONG ; Xiao-Mei TAN ; Jia-Bo LUO
Chinese journal of integrative medicine 2016;22(6):445-450
OBJECTIVEMahuang-Shigao herb-pair is a famous formula composed of Ephedra and Gypsum. The herb-pair is frequently used for treating cold symptoms and bronchial asthma in the clinical practice of Chinese medicine (CM). In the present study, we evaluated evidence for the benefit of combined use of Ephedra and Gypsum by analyzing the antipyretic and anti-asthmatic activities of Ephedra-Gypsum.
METHODSThe antipyretic effects of Ephedra-Gypsum were evaluated in yeast-induced hyperthermia test. Thirty male Wistar rats were randomly divided into 5 groups, including control group, standard aspirin group, and 3 Ephedra- Gypsum groups of different doses (6, 12, 24 g/kg). Ephedra-Gypsum extract and asprin were administered orally 6 h after the injection of yeast solution and body temperature was measured every 1 h for 8 h. The antiasthmatic effects of Ephedra-Gypsum were evaluated using an ovalbumin (OVA)-induced asthmatic rat model. Thirty-six male SD rats were randomly divided into 6 groups. Rats were alternately sensitized and OVA+Al(OH) challenged by exposure to mists of ovalbumin. Ephedra-Gypsum extracts (6, 12, 24 g/kg) or dexamethasone were administered 45 min prior to the allergen challenge for 8 days. Latent period and the weight of wet to dry ratio of lung were determined. In addition, the eosinophils in blood and white blood cell (WBC) were counted by an YZ-Hemavet Analyzer.
RESULTSThe Ephedra-Gypsum extracts at test dose (6, 12, 24 g/kg) significantly and dose-dependently attenuated yeast-induced fever in rats. The Ephedra-Gypsum extracts also prolonged the latent period, reduced OVA-induced increases in eosinophils and WBC, and decreased the wet and dry weight ratio of the lungs in the anti-asthmatic test.
CONCLUSIONSThese findings indicate that the Ephedra-Gypsum extract has antipyretic and anti-asthmatic properties. Hence, the results support additional scientific evidence in prescriptions.
Alkaloids ; analysis ; Animals ; Anti-Asthmatic Agents ; therapeutic use ; Antipyretics ; therapeutic use ; Asthma ; drug therapy ; Calcium Sulfate ; therapeutic use ; Drugs, Chinese Herbal ; therapeutic use ; Ephedra ; chemistry ; Fever ; drug therapy ; Lung ; drug effects ; pathology ; Male ; Organ Size ; drug effects ; Ovalbumin ; Plant Extracts ; therapeutic use ; Rats, Sprague-Dawley ; Rats, Wistar
10.A novel thermosensitive in-situ gel of gabexate mesilate for treatment of traumatic pancreatitis: An experimental study.
Han-jing GAO ; Qing SONG ; Fa-qin LV ; Shan WANG ; Yi-ru WANG ; Yu-kun LUO ; Xing-guo MEI ; Jie TANG
Journal of Huazhong University of Science and Technology (Medical Sciences) 2015;35(5):707-711
Gabexate mesilate (GM) is a trypsin inhibitor, and mainly used for treatment of various acute pancreatitis, including traumatic pancreatitis (TP), edematous pancreatitis, and acute necrotizing pancreatitis. However, due to the characteristics of pharmacokinetics, the clinical application of GM still needs frequently intravenous administration to keep the blood drug concentration, which is difficult to manage. Specially, when the blood supply of pancreas is directly damaged, intravenous administration is difficult to exert the optimum therapy effect. To address it, a novel thermosensitive in-situ gel of gabexate mesilate (GMTI) was developed, and the optimum formulation of GMTI containing 20.6% (w/w) P-407 and 5.79% (w/w) P188 with different concentrations of GM was used as a gelling solvent. The effective drug concentration on trypsin inhibition was examined after treatment with different concentrations of GMTI in vitro, and GM served as a positive control. The security of GMTI was evaluated by hematoxylin-eosin (HE) staining, and its curative effect on grade II pancreas injury was also evaluated by testing amylase (AMS), C-reactive protein (CRP) and trypsinogen activation peptide (TAP), and pathological analysis of the pancreas. The trypsin activity was slightly inhibited at 1.0 and 5.0 mg/mL in GM group and GMTI group, respectively (P<0.05 vs. P-407), and completely inhibited at 10.0 and 20.0 mg/mL (P<0.01 vs. P-407). After local injection of 10 mg/mL GMTI to rat leg muscular tissue, muscle fiber texture was normal, and there were no obvious red blood cells and infiltration of inflammatory cells. Furthermore, the expression of AMS, CRP and TAP was significantly increased in TP group as compared with control group (P<0.01), and significantly decreased in GM group as compared with TP group (P<0.01), and also slightly inhibited after 1.0 and 5.0 mg/mL GMTI treatment as compared with TP group (P<0.05), and significantly inhibited after 10.0 and 20.0 mg/mL GMTI treatment as compared with TP group (P<0.01). HE staining results demonstrated that pancreas cells were uniformly distributed in control group, and they were loosely arranged, partially dissolved, with deeply stained nuclei in TP group. Expectedly, after gradient GMTI treatment, pancreas cells were gradually restored to tight distribution, with slightly stained nuclei. This preliminary study indicated that GMTI could effectively inhibit pancreatic enzymes, and alleviate the severity of trauma-induced pancreatitis, and had a potential drug developing and clinic application value.
Amylases
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metabolism
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Animals
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C-Reactive Protein
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metabolism
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Delayed-Action Preparations
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chemical synthesis
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pharmacokinetics
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pharmacology
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Gabexate
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chemistry
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pharmacokinetics
;
pharmacology
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Gels
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Male
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Muscle, Skeletal
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drug effects
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enzymology
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Oligopeptides
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metabolism
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Pancreas
;
drug effects
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enzymology
;
pathology
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Pancreatitis
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drug therapy
;
enzymology
;
etiology
;
pathology
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Poloxamer
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chemistry
;
Rats
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Rats, Sprague-Dawley
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Serine Proteinase Inhibitors
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chemistry
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pharmacokinetics
;
pharmacology
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Temperature
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Wounds, Penetrating
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complications
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drug therapy
;
enzymology
;
pathology

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