1.Shexiang Tongxin Dropping Pill Improves Stable Angina Patients with Phlegm-Heat and Blood-Stasis Syndrome: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.
Ying-Qiang ZHAO ; Yong-Fa XING ; Ke-Yong ZOU ; Wei-Dong JIANG ; Ting-Hai DU ; Bo CHEN ; Bao-Ping YANG ; Bai-Ming QU ; Li-Yue WANG ; Gui-Hong GONG ; Yan-Ling SUN ; Li-Qi WANG ; Gao-Feng ZHOU ; Yu-Gang DONG ; Min CHEN ; Xue-Juan ZHANG ; Tian-Lun YANG ; Min-Zhou ZHANG ; Ming-Jun ZHAO ; Yue DENG ; Chang-Jiang XIAO ; Lin WANG ; Bao-He WANG
Chinese journal of integrative medicine 2025;31(8):685-693
OBJECTIVE:
To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents.
METHODS:
This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs).
RESULTS:
This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed.
CONCLUSION
STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans
;
Double-Blind Method
;
Drugs, Chinese Herbal/adverse effects*
;
Male
;
Female
;
Middle Aged
;
Angina, Stable/physiopathology*
;
Aged
;
Syndrome
;
Treatment Outcome
;
Placebos
;
Tablets
2.Comparison of the effect of sodium bicarbonate Ringer's solution and compound Ringer's solution in controlled low central venous pressure hepatectomy
Yan MI ; Yu BAI ; Gang XU ; Sufen LI ; Xihua LU
Journal of Xinxiang Medical College 2024;41(5):438-442
Objective To investigate the influence of sodium bicarbonate Ringer's solution and compound Ringer's solution on patients'acid-base balance and liver and kidney function during controlled low central venous pressure(CLCVP)hepatectomy.Methods A total of 60 patients with primary liver cancer who underwent CLCVP hepatectomy in the Affiliated Cancer Hospital of Zhengzhou University from June 2020 to June 2022 were selected and randomly divided into the sodium bicarbonate Ringer's solution group and compound Ringer's solution group,with 30 patients in each group.Patients in the sodium bicarbonate Ringer's solution group were infused with sodium bicarbonate Ringer's solution,while patients in the compound Ringer's solution group were infused with compound Ringer's solution after anesthesia induction and before liver parenchymal disconnection.The pH value,base excess(BE)and blood lactic acid(Lac)levels were detected using the blood gas analyzer in the two groups before anesthesia induction(T,),at the beginning of surgery(T2),2 h during surgery(T3),4 h during surgery(T4),and at the end of surgery(T5),respectively.The levels of serum alanine aminotransferase(ALT),aspartate aminotransferase(AST),blood urea nitrogen(BUN),and serum creatinine(Scr)were detected using the automatic biochemical analyzer 24 h before and 24 h after surgery,respectively.The body mass,surgical time,intraoperative infusion volume,urine volume,changes in body acid-base balance during surgery,and changes in liver and kidney function before and after surgery between the two groups were compared.Results There was no statistically significant difference in body mass,surgical time,intraoperative infusion volume,and urine volume between the two groups of patients(P>0.05).At T,,there was no statistically significant difference in pH value,BE and Lac levels between the two groups of patients(P>0.05).Compared to T,,the pH value in the compound Ringer's solution group increased at T2 and decreased at T3,T4 and T5,while BE and Lac levels from T2 to T5 showed an increasing trend(P<0.05);compared to T,,the pH value in the sodium bicarbonate Ringer's solution group increased at T2 and decreased at T3,BE and Lac levels increased at T2 and T3(P<0.05),and there was no statistically significant difference in pH value,BE and Lac levels at T4 and T5 compared to T1(P>0.05).At T5,the pH value in the sodium bicarbonate Ringer's solution group was significantly higher than that in the compound Ringer's solution group,while the BE and Lac levels were significantly lower than those in the compound Ringer's solution group(P<0.05).There was no statisti-cally significant difference in the levels of ALT,AST,BUN and Scr 24 hours before surgery between the two groups of patients(P>0.05);compared to 24 hours before surgery,there was no significant change in the levels of ALT,AST,BUN and Scr 24 hours after surgery(P>0.05);there was no statistically significant difference in the levels of ALT,AST,BUN and Scr 24 hours after surgery between the two groups(P>0.05).Conclusion Compared to compound Ringer's solution,sodium bicarbonate Ringer's solution has a smaller impact on the internal environment of the body during the CLCVP hepatectomy and can effectively maintain the stability of the body's acid-base balance.Both the two solutions have no significant impact on the patient's liver and kidney function.
3.Urinary protein and renal pathological features in children with immunoglobulin A vasculitis with nephritis and hypercoagulability
Meng-Ke BAI ; Xiao-Qing YANG ; Xiao-Feng MEI ; Jin-Gang LI ; Yue-Li YANG ; Yan-Jie HUANG
Chinese Journal of Contemporary Pediatrics 2024;26(2):164-168
Objective To study the association of hypercoagulability with urinary protein and renal pathological damage in children with immunoglobulin A vasculitis with nephritis(IgAVN).Methods Based on the results of coagulation function,349 children with IgAVN were divided into a hypercoagulability group consisting of 52 children and a non-hypercoagulability group consisting of 297 children.Urinary protein and renal pathological features were compared between the two groups,and the factors influencing the formation of hypercoagulability in children with IgAVN were analyzed.Results Compared with the non-hypercoagulability group,the hypercoagulability group had significantly higher levels of urinary erythrocyte count,24-hour urinary protein,urinary protein/creatinine,urinary immunoglobulin G/creatinine,and urinary N-acetyl-β-D-glucosaminidase(P<0.05).The hypercoagulability group also had a significantly higher proportion of children with a renal pathological grade of Ⅲ-Ⅳ,diffuse mesangial proliferation,capillary endothelial cell proliferation,or>25% crescent formation(P<0.05).The multivariate logistic regression analysis showed that capillary endothelial cell proliferation and glomerular crescent formation>25% were associated with the formation of hypercoagulability in children with IgAVN(P<0.05).Conclusions The renal injury in IgAVN children with hypercoagulability is more severe,with greater than 25% crescent formation and increased proliferation of glomerular endothelial cells being important contributing factors that exacerbate the hypercoagulable state in IgAVN.[Chinese Journal of Contemporary Pediatrics,2024,26(2):164-168]
4.Rapid enzyme-free colorimetric analysis of alpha-fetoprotein by combining triple-helix molecular probe and catalytic hairpin assembly reaction
Qin WENG ; Yan DONG ; Gang BAI ; Xiaodong LEI ; Hua YU
Chongqing Medicine 2024;53(19):2892-2897,2906
Objective To construct a novel enzyme-free colorimetric biosensor(T-CHA)based on tri-ple-helix molecular probe(THMP)and catalytic hairpin assembly(CHA)reaction for visual detection and precise quantitative analysis of low-abundance alpha-fetoprotein(AFP).Methods The absorbance produced by AFP induced T-CHA system was recorded by gel electrophoresis and ultraviolet-visible spectrophotometer to evaluate the feasibility of T-CHA strategy.The molar concentration ratio of THMP and CHA,reaction time of CHA,temperature and pH value of buffer solution were optimized respectively.The color reaction of T-CHA was induced by different concentrations of AFP to explore the detection efficiency of T-CHA.Results Under the op-timal experimental conditions,the logarithmic values of AFP at different concentrations showed a linear rela-tionship from 5 μg/mL to 10 ng/mL,and the detection limit was 2.29 μg/mL.The T-CHA system could com-plete accurate quantitative analysis of low abundance AFP and visual free-labeled detection within 105 min,moreover the sensitivity of T-CHA was superior to that of ELISA.Conclusion Utilizing the low background leakage of THMP and the high catalytic efficiency of CHA,the T-CHA system could realize the early accurate diagnosis of hepatocellular carcinoma,moreover which has a certain application prospect in the real time detec-tion.
5.The value of high-throughput sequencing data reanalysis in identifying ERBB2 amplification in colorectal cancer patients
Min-Na SHEN ; Li ZHANG ; Xin-Ning CHEN ; Fei HUANG ; Chao-Gang BAI ; Li-Meng CHEN ; Hai-Xiang PENG ; Yan ZHOU ; Bei-Li WANG ; Bai-Shen PAN ; Wei GUO
Fudan University Journal of Medical Sciences 2024;51(2):166-171
Objective To evaluate the value of high-throughput sequencing(HTS)data reanalysis that does not include ERBB2 copy number variation(CNV)analysis,in identifying ERBB2 amplification in patients with colorectal cancer.Methods The HTS data of 252 cases of colorectal cancer diagnosed by pathological biopsy who received peripheral blood cfDNA HTS detection samples were retrospectively analyzed.According to the HTS data of ERBB2 non-amplified samples judged by immunohistochemistry(IHC)and/or fluorescence in situ hybridization(FISH),the number of chromosome 17(Chr17)reads in the total number of reads was calculated the range of the ratio was initially determined as the threshold for prompting ERBB2 amplification.Suspected positive samples were screened according to thresholds and verified by digital PCR,IHC and FISH.Results The proportion of the number of Chr17 reads accounts for the number of total reads in the 89 cases of ERBB2 non-amplified samples determined by IHC and/or FISH ranged from 0.188 to 0.299(0.239±0.192).Using 0.298(1.25 times the mean)as the threshold indicating ERBB2 amplification,the data of 163 samples were analyzed,of which 7 cases were suspected to be positive,and the ratio ranged from 0.302 to 0.853.Among them,5 cases were determined to be positive by IHC and/or FISH,and 6 cases were confirmed to be positive by digital PCR.The ratio of the number of Chr17 reads to the number of total reads was positively correlated with the ratio of ERBB2/EIF2C1,and the correlation was good(r2=0.909).Conclusion The high-throughput sequencing data that does not cover the ERBB2 CNV analysis has a certain hint value for ERBB2 amplification in patients with colorectal cancer.
6.EWSR1-SMAD3 positive fibroblastic tumor: a clinicopathological analysis.
Hai Yan SU ; Lu ZHAO ; Gang JI ; Qian Lan YAO ; Qian Ming BAI ; Xiao Yan ZHOU ; Jian WANG
Chinese Journal of Pathology 2023;52(1):19-24
Objective: To investigate the clinicopathological features, immunophenotypes and molecular genetics of EWSR1-SMAD3 positive fibroblastic tumor (ESFT) with an emphasis on differential diagnosis. Methods: The clinicopathological data, immunohistochemical profiles and molecular profiles of 3 ESFT cases diagnosed at the Department of Pathology, Fudan University Shanghai Cancer Center from 2018 to 2021were analyzed. The related literature was also reviewed. Results: There were two males and one female. The patients were 24, 12 and 36 years old, respectively. All three tumors occurred in the subcutis of the foot with the disease duration of 6 months to 2 years. The tumors were presented with a slowly growing mass or nodule, accompanied with pain in 1 patient. The tumors ranged in size from 0.1 to 1.6 cm (mean, 1.0 cm). Microscopically, the tumors were located in the subcutaneous tissue with a nodular or plexiform growth pattern. They were composed of cellular fascicles of bland spindle cells with elongated nuclei and fine chromatin. One of the tumors infiltrated into adjacent adipose tissue. There was no nuclear atypia or mitotic activities. All three tumors showed prominent stromal hyalinization with zonal pattern present in one case. Focal punctate calcification was noted in two cases. The immunohistochemical studies showed that tumor cells were diffusely positive for ERG and negative for CD31 and CD34, with Ki-67 index less than 2%. Fluorescence in situ hybridization on the two tested cases identified EWSR1 gene rearrangement. The next generation sequencing analysis demonstrated EWSR1-SMAD3 fusion in all three cases. During the follow up, one patient developed local recurrence 24 months after the surgery. Conclusions: ESFT is a benign fibroblastic neoplasm and has a predilection for the foot, characterized by ERG immunoreactivity and EWSR1-SMAD3 fusion. Local recurrence might occur when incompletely excised. Familiarity with its clinicopathological features is helpful in distinguishing it from other spindle cell neoplasms that tend to occur at acral sites.
Adult
;
Child
;
Female
;
Humans
;
Male
;
Biomarkers, Tumor/analysis*
;
China
;
In Situ Hybridization, Fluorescence
;
Neoplasms, Fibrous Tissue/pathology*
;
RNA-Binding Protein EWS/genetics*
;
Smad3 Protein/genetics*
;
Soft Tissue Neoplasms/surgery*
7.Value of personalized osteotomy in primary total knee arthroplasty for severe varus knee osteoarthritis.
Ying-Jie YAN ; Gang JIA ; Ding-Wen BAI
China Journal of Orthopaedics and Traumatology 2023;36(4):386-392
OBJECTIVE:
To explore application value and efficacy of personalized osteotomy in primary total knee arthroplasty (TKA) for severe varus knee osteoarthritis.
METHODS:
From June 2018 to January 2020, 36 patients (49 knees) with severe varus knee osteoarthritis were treated, including 15 males (21 knees) and 21 females (28 knees), aged from 59 to 82 years old with an average of (67.6 ± 6.5) years old;the course of disease ranged from 9.5 to 20.5 years with an average of (15.0 ± 5.0) years;11 patients (15 knees) with Kellgren-Lawrence grade Ⅲ and 25 patients (34 knees) with grade Ⅳ according to Kellgren-Lawrence grading. According to AORI clsssification of tibial bone defects, 8 patients (15 knees) were typeⅠTa and 16 patients (18 knees) were typeⅡ T2a. All patients' femor-tibial angle (FTA) was above 15°, and received primary TKA with personalized osteotomy. Thirty-three patients (45 knees) were treated with posterior-stabilized (PS) prostheses, 13 patients (15 knees) with PS prostheses combined with a metal pad and extension rod on the tibial side, and 3 patients (4 knees) with legacy constrained condylar knee (LCCK) prostheses. FTA, posterior condylar angle (PCA), medial proximal tibial angle (MPTA) and lateral distal femoral angle (LDFA) before and after operation at 1 month were measured and compared by using picture archiving and communication systems (PACS). Recovery of lower limbs before and after operation at 12 months was evaluated by American Knee Society Score(KSS), and complications were observed and recorded.
RESULTS:
All 36 patients (49 knees) were followed up from 15 to 40 months with an average of (23.46±7.65) months. FTA, MPTA were corrected from preoperative (18.65±4.28)° and (83.75±3.65)° to postoperative (2.35±1.46)° and (88.85±2.25)° at 1 month, respectively (P<0.001). PCA was decreased from (2.42±2.16)° before operation to (1.65±1.35)° at 1 month after operation, LDFA improved from (89.56 ± 3.55)° before operation to (91.63±3.38)° at 1 month after operation (P<0.05). KSS increased from (67.58±24.16) before opertion to(171.31±15.24) at 12 months after operation, 14 patients (19 knees) got excellent result, 19 (26 knees) good, and 3 (4 knees) fair.
CONCLUSION
Personalized osteotomy is helpful for recovery of axial alignment of lower limbs and correct placement of prosthesis, could effectively relieve pain of knee joint, recover knee joint function.
Male
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Female
;
Humans
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Child
;
Adolescent
;
Young Adult
;
Adult
;
Arthroplasty, Replacement, Knee
;
Osteoarthritis, Knee/surgery*
;
Retrospective Studies
;
Knee Joint/surgery*
;
Osteotomy
;
Tibia/surgery*
8.Analysis of KIF1A gene variant in a Chinese pedigree affected with Spastic paraplegia type 30.
Gang XU ; Jianwei LI ; Zhanjin DENG ; Yuan XIA ; Tao WANG ; Yan BAI ; Yan QI ; Yong An ZHOU
Chinese Journal of Medical Genetics 2023;40(4):419-422
OBJECTIVE:
To explore the genetic basis for a Chinese pedigree affected with hereditary spastic paraplegia type 30 (HSP30).
METHODS:
A proband presented at the Second Hospital of Shanxi Medical University in August 2021 was selected as the study subject. The proband was subjected to whole exome sequencing, and candidate variant was verified by Sanger sequencing and bioinformatic analysis.
RESULTS:
The proband was found to have harbored a heterozygous c.110T>C variant in exon 3 of the KIF1A gene, which can cause substitution of isoleucine by threonine at position 37 (p.I37T) and alter the function of its protein product. The same variant was not found in his parents, elder brother and elder sister, suggesting that it has a de novo origin. Based on the guidelines of the American College of Medical Genetics and Genomics (ACMG), the variant was rated as likely pathogenic (PM2_Supporting+PP3+PS2).
CONCLUSION
The c.110T>C variant of the KIF1A gene probably underlay the HSP30 in the proband. Above finding has enable genetic counseling for this family.
Humans
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Male
;
East Asian People
;
Kinesins/genetics*
;
Mutation
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Pedigree
;
Spastic Paraplegia, Hereditary/genetics*
;
Female
9.Analysis of Chinese Medical Syndrome Features of Ischemic Stroke Based on Similarity of Symptoms Subgroup.
Xiao-Qing LIU ; Run-Shun ZHANG ; Xue-Zhong ZHOU ; Hong ZHOU ; Yu-Yao HE ; Shu HAN ; Jing ZHANG ; Zi-Xin SHU ; Xue-Bin ZHANG ; Jing-Hui JI ; Quan ZHONG ; Li-Li ZHANG ; Zi-Jun MOU ; Li-Yun HE ; Lun-Zhong ZHANG ; Jie YANG ; Yan-Jie HU ; Zheng-Guang CHEN ; Xiao-Zhen LI ; Yan TAN ; Zhan-Feng YAN ; Ke-Gang CAO ; Wei MENG ; He ZHAO ; Wei ZHANG ; Li-Qun ZHONG
Chinese journal of integrative medicine 2023;29(5):441-447
OBJECTIVE:
To derive the Chinese medicine (CM) syndrome classification and subgroup syndrome characteristics of ischemic stroke patients.
METHODS:
By extracting the CM clinical electronic medical records (EMRs) of 7,170 hospitalized patients with ischemic stroke from 2016 to 2018 at Weifang Hospital of Traditional Chinese Medicine, Shandong Province, China, a patient similarity network (PSN) was constructed based on the symptomatic phenotype of the patients. Thereafter the efficient community detection method BGLL was used to identify subgroups of patients. Finally, subgroups with a large number of cases were selected to analyze the specific manifestations of clinical symptoms and CM syndromes in each subgroup.
RESULTS:
Seven main subgroups of patients with specific symptom characteristics were identified, including M3, M2, M1, M5, M0, M29 and M4. M3 and M0 subgroups had prominent posterior circulatory symptoms, while M3 was associated with autonomic disorders, and M4 manifested as anxiety; M2 and M4 had motor and motor coordination disorders; M1 had sensory disorders; M5 had more obvious lung infections; M29 had a disorder of consciousness. The specificity of CM syndromes of each subgroup was as follows. M3, M2, M1, M0, M29 and M4 all had the same syndrome as wind phlegm pattern; M3 and M0 both showed hyperactivity of Gan (Liver) yang pattern; M2 and M29 had similar syndromes, which corresponded to intertwined phlegm and blood stasis pattern and phlegm-stasis obstructing meridians pattern, respectively. The manifestations of CM syndromes often appeared in a combination of 2 or more syndrome elements. The most common combination of these 7 subgroups was wind-phlegm. The 7 subgroups of CM syndrome elements were specifically manifested as pathogenic wind, pathogenic phlegm, and deficiency pathogens.
CONCLUSIONS
There were 7 main symptom similarity-based subgroups in ischemic stroke patients, and their specific characteristics were obvious. The main syndromes were wind phlegm pattern and hyperactivity of Gan yang pattern.
Humans
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Syndrome
;
Ischemic Stroke
;
Medicine, Chinese Traditional
;
Liver
;
Phenotype
10.Yinlai Decoction Protects Microstructure of Colon and Regulates Serum Level of D-Lactic Acid in Pneumonia Mice Fed with High-Calorie and High-Protein Diet.
Yun-Hui WANG ; He YU ; Tie-Gang LIU ; Teck Chuan KONG ; Zi-An ZHENG ; Yu-Xiang WAN ; Chen BAI ; Yu HAO ; Ying-Qiu MAO ; Jun WU ; Jing-Nan XU ; Li-Jun CUI ; Yu-Han WANG ; Yan-Ran SHAN ; Ying-Jun SHAO ; Xiao-Hong GU
Chinese journal of integrative medicine 2023;29(8):714-720
OBJECTIVE:
To investigate the effect of Yinlai Decoction (YD) on the microstructure of colon, and activity of D-lactic acid (DLA) and diamine oxidase (DAO) in serum of pneumonia mice model fed with high-calorie and high-protein diet (HCD).
METHODS:
Sixty male Kunming mice were randomly divided into 6 groups by the random number table method: normal control, pneumonia, HCD, HCD with pneumonia (HCD-P), YD (229.2 mg/mL), and dexamethasone (15.63 mg/mL) groups, with 10 in each group. HCD mice were fed with 52% milk solution by gavage. Pneumonia mice was modeled with lipopolysaccharide inhalation and was fed by gavage with either the corresponding therapeutic drugs or saline water, twice daily, for 3 days. After hematoxylin-eosin staining, the changes in the colon structure were observed under light microscopy and transmission electron microscope, respectively. Enzyme-linked immunosorbent assay was used to detect the protein levels of DLA and DAO in the serum of mice.
RESULTS:
The colonic mucosal structure and ultrastructure of mice in the normal control group were clear and intact. The colonic mucosal goblet cells in the pneumonia group tended to increase, and the size of the microvilli varied. In the HCD-P group, the mucosal goblet cells showed a marked increase in size with increased secretory activity. Loose mucosal epithelial connections were also observed, as shown by widened intercellular gaps with short sparse microvilli. These pathological changes of intestinal mucosa were significantly reduced in mouse models with YD treatment, while there was no significant improvement after dexamethasone treatment. The serum DLA level was significantly higher in the pneumonia, HCD, and HCD-P groups as compared with the normal control group (P<0.05). Serum DLA was significantly lower in the YD group than HCD-P group (P<0.05). Moreover, serum DLA level significantly increased in the dexamethasone group as compared with the YD group (P<0.01). There was no statistical significance in the serum level of DAO among groups (P>0.05).
CONCLUSIONS
YD can protect function of intestinal mucosa by improving the tissue morphology of intestinal mucosa and maintaining integrity of cell connections and microvilli structure, thereby reducing permeability of intestinal mucosa to regulate the serum levels of DLA in mice.
Mice
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Male
;
Animals
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Lactic Acid/pharmacology*
;
Intestinal Mucosa
;
Colon/pathology*
;
Dexamethasone/pharmacology*
;
Diet, High-Protein
;
Pneumonia/pathology*

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