1.Randomized, double-blind, parallel-controlled, multicenter, equivalence clinical trial of Jiuwei Xifeng Granules(Os Draconis replaced by Ostreae Concha) for treating tic disorder in children.
Qiu-Han CAI ; Cheng-Liang ZHONG ; Si-Yuan HU ; Xin-Min LI ; Zhi-Chun XU ; Hui CHEN ; Ying HUA ; Jun-Hong WANG ; Ji-Hong TANG ; Bing-Xiang MA ; Xiu-Xia WANG ; Ai-Zhen WANG ; Meng-Qing WANG ; Wei ZHANG ; Chun WANG ; Yi-Qun TENG ; Yi-Hui SHAN ; Sheng-Xuan GUO
China Journal of Chinese Materia Medica 2025;50(6):1699-1705
Jiuwei Xifeng Granules have become a Chinese patent medicine in the market. Because the formula contains Os Draconis, a top-level protected fossil of ancient organisms, the formula was to be improved by replacing Os Draconis with Ostreae Concha. To evaluate whether the improved formula has the same effectiveness and safety as the original formula, a randomized, double-blind, parallel-controlled, equivalence clinical trial was conducted. This study enrolled 288 tic disorder(TD) of children and assigned them into two groups in 1∶1. The treatment group and control group took the modified formula and original formula, respectively. The treatment lasted for 6 weeks, and follow-up visits were conducted at weeks 2, 4, and 6. The primary efficacy endpoint was the difference in Yale global tic severity scale(YGTSS)-total tic severity(TTS) score from baseline after 6 weeks of treatment. The results showed that after 6 weeks of treatment, the declines in YGTSS-TSS score showed no statistically significant difference between the two groups. The difference in YGTSS-TSS score(treatment group-control group) and the 95%CI of the full analysis set(FAS) were-0.17[-1.42, 1.08] and those of per-protocol set(PPS) were 0.29[-0.97, 1.56], which were within the equivalence boundary [-3, 3]. The equivalence test was therefore concluded. The two groups showed no significant differences in the secondary efficacy endpoints of effective rate for TD, total score and factor scores of YGTSS, clinical global impressions-severity(CGI-S) score, traditional Chinese medicine(TCM) response rate, or symptom disappearance rate, and thus a complete evidence chain with the primary outcome was formed. A total of 6 adverse reactions were reported, including 4(2.82%) cases in the treatment group and 2(1.41%) cases in the control group, which showed no statistically significant difference between the two groups. No serious suspected unexpected adverse reactions were reported, and no laboratory test results indicated serious clinically significant abnormalities. The results support the replacement of Os Draconis by Ostreae Concha in the original formula, and the efficacy and safety of the modified formula are consistent with those of the original formula.
Adolescent
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Child
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Child, Preschool
;
Female
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Humans
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Male
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Double-Blind Method
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Drugs, Chinese Herbal/therapeutic use*
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Tic Disorders/drug therapy*
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Treatment Outcome
2.One new sesquiterpene from Aquilariae Lignum Resinatum.
Jia-Min CAO ; Bin HU ; De-Shang MAI ; Cai-Xin CHEN ; Zhong-Xiang ZHAO ; Wei-Qun YANG
China Journal of Chinese Materia Medica 2025;50(8):2167-2172
The chemical constituents of sesquiterpenes from 95% ethanol extract of Aquilariae Lignum Resinatum were isolated and purified by various column chromatography techniques, including silica gel, Sephadex LH-20, octadecylsilyl(ODS), and semi-preparative high performance liquid chromatography(HPLC). Their planar structures and absolute configurations were elucidated by ultraviolet(UV) spectrometry, infrared(IR) spectroscopy, mass spectrometry(MS), nuclear magnetic resonance(NMR), electronic circular dichroism(ECD), and other techniques. Eight sesquiterpenoids were isolated and identified as(+)-(7R,10R)-selina-4,11-dien-12-dimethoxy-15-al(1),(+)-(7R,10R)-selina-4,11-diene-12,15-dial(2), agalleudesmanol B(3), aquisinenoid C(4), 12,15-dioxo-α-selinen(5), agarospiranic aldehyde B(6), neopetasane(7), and eremophila-7(11),9-dien-8-one(8). Compound 1 was a new compound, and it was the first time to find a dimethoxy substitution on the side chain of eudesmane-type sesquiterpene skeleton.
Sesquiterpenes/isolation & purification*
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Thymelaeaceae/chemistry*
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Molecular Structure
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Drugs, Chinese Herbal/isolation & purification*
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Magnetic Resonance Spectroscopy
3.Protective effect of sub-hypothermic mechanical perfusion combined with membrane lung oxygenation on a yorkshire model of brain injury after traumatic blood loss.
Xiang-Yu SONG ; Yang-Hui DONG ; Zhi-Bo JIA ; Lei-Jia CHEN ; Meng-Yi CUI ; Yan-Jun GUAN ; Bo-Yao YANG ; Si-Ce WANG ; Sheng-Feng CHEN ; Peng-Kai LI ; Heng CHEN ; Hao-Chen ZUO ; Zhan-Cheng YANG ; Wen-Jing XU ; Ya-Qun ZHAO ; Jiang PENG
Chinese Journal of Traumatology 2025;28(6):469-476
PURPOSE:
To investigate the protective effect of sub-hypothermic mechanical perfusion combined with membrane lung oxygenation on ischemic hypoxic injury of yorkshire brain tissue caused by traumatic blood loss.
METHODS:
This article performed a random controlled trial. Brain tissue of 7 yorkshire was selected and divided into the sub-low temperature anterograde machine perfusion group (n = 4) and the blank control group (n = 3) using the random number table method. A yorkshire model of brain tissue injury induced by traumatic blood loss was established. Firstly, the perfusion temperature and blood oxygen saturation were monitored in real-time during the perfusion process. The number of red blood cells, hemoglobin content, NA+, K+, and Ca2+ ions concentrations and pH of the perfusate were detected. Following perfusion, we specifically examined the parietal lobe to assess its water content. The prefrontal cortex and hippocampus were then dissected for histological evaluation, allowing us to investigate potential regional differences in tissue injury. The blank control group was sampled directly before perfusion. All statistical analyses and graphs were performed using GraphPad Prism 8.0 Student t-test. All tests were two-sided, and p value of less than 0.05 was considered to indicate statistical significance.
RESULTS:
The contents of red blood cells and hemoglobin during perfusion were maintained at normal levels but more red blood cells were destroyed 3 h after the perfusion. The blood oxygen saturation of the perfusion group was maintained at 95% - 98%. NA+ and K+ concentrations were normal most of the time during perfusion but increased significantly at about 4 h. The Ca2+ concentration remained within the normal range at each period. Glucose levels were slightly higher than the baseline level. The pH of the perfusion solution was slightly lower at the beginning of perfusion, and then gradually increased to the normal level. The water content of brain tissue in the sub-low and docile perfusion group was 78.95% ± 0.39%, which was significantly higher than that in the control group (75.27% ± 0.55%, t = 10.49, p < 0.001), and the difference was statistically significant. Compared with the blank control group, the structure and morphology of pyramidal neurons in the prefrontal cortex and CA1 region of the hippocampal gyrus were similar, and their integrity was better. The structural integrity of granulosa neurons was destroyed and cell edema increased in the perfusion group compared with the blank control group. Immunofluorescence staining for glail fibrillary acidic protein and Iba1, markers of glial cells, revealed well-preserved cell structures in the perfusion group. While there were indications of abnormal cellular activity, the analysis showed no significant difference in axon thickness or integrity compared to the 1-h blank control group.
CONCLUSIONS
Mild hypothermic machine perfusion can improve ischemia and hypoxia injury of yorkshire brain tissue caused by traumatic blood loss and delay the necrosis and apoptosis of yorkshire brain tissue by continuous oxygen supply, maintaining ion homeostasis and reducing tissue metabolism level.
Animals
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Perfusion/methods*
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Disease Models, Animal
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Brain Injuries/etiology*
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Swine
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Male
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Hypothermia, Induced/methods*
4.Mediating effect of sleep duration between depression symptoms and myopia in middle school students.
Wei DU ; Xu-Xiang YANG ; Ru-Shuang ZENG ; Chun-Yao ZHAO ; Zhi-Peng XIANG ; Yuan-Chun LI ; Jie-Song WANG ; Xiao-Hong SU ; Xiao LU ; Yu LI ; Jing WEN ; Dang HAN ; Qun DU ; Jia HE
Chinese Journal of Contemporary Pediatrics 2025;27(3):359-365
OBJECTIVES:
To explore the mediating role of sleep duration in the relationship between depression symptoms and myopia among middle school students.
METHODS:
This study was a cross-sectional research conducted using a stratified cluster random sampling method. A total of 1 728 middle school students were selected from two junior high schools and two senior high schools in certain urban areas and farms of the Xinjiang Production and Construction Corps. Questionnaire surveys and vision tests were conducted among the students. Spearman analysis was used to analyze the correlation between depression symptoms, sleep duration, and myopia. The Bootstrap method was employed to investigate the mediating effect of sleep duration between depression symptoms and myopia.
RESULTS:
The prevalence of myopia in the overall population was 74.02% (1 279/1 728), with an average sleep duration of (7.6±1.0) hours. The rate of insufficient sleep was 83.62% (1 445/1 728), and the proportion of students exhibiting depression symptoms was 25.29% (437/1 728). Correlation analysis showed significant negative correlations between visual acuity in both eyes and sleep duration with depressive emotions as measured by the Center for Epidemiologic Studies Depression Scale (with correlation coefficients of -0.064, -0.084, and -0.199 respectively; P<0.01), as well as with somatic symptoms and activities (with correlation coefficients of -0.104, -0.124, and -0.233 respectively; P<0.01) and interpersonal relationships (with correlation coefficients of -0.052, -0.059, and -0.071 respectively; P<0.05). The correlation coefficients for left and right eye visual acuity and sleep duration were 0.206 and 0.211 respectively (P<0.001). Sleep duration exhibited a mediating effect between depression symptoms and myopia (indirect effect=0.056, 95%CI: 0.029-0.088), with the mediating effect value for females (indirect effect=0.066, 95%CI: 0.024-0.119) being higher than that for males (indirect effect=0.042, 95%CI: 0.011-0.081).
CONCLUSIONS
Sleep duration serves as a partial mediator between depression symptoms and myopia in middle school students.
Humans
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Myopia/etiology*
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Male
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Female
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Depression/physiopathology*
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Cross-Sectional Studies
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Sleep
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Adolescent
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Students
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Child
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Time Factors
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Sleep Duration
5.Effect of Guilu Taohong Formula on semen quality and spermatogenic cell apoptosis in a varicocele model of rats.
Biao WANG ; Yang YANG ; Ze-Rui QIU ; En-Min FENG ; Xiang ZHAO ; Neng WANG ; Xin HUANG ; Qun-Fang LIN ; Qing ZHOU
National Journal of Andrology 2025;31(2):150-156
OBJECTIVE:
To observe the effect of Guilu Taohong Formula on semen quality in varicocele (VC) models of rats, and to explore its possible mechanism.
METHODS:
Forty-eight male SD rats were randomly divided into four groups (sham group, model group, Guilu Taohong Formula group and L-carnitine group). After the establishment of models, the rats were treated with intragastric administration for eight consecutive weeks. The general condition of the rats was observed. After the gavage, the testicular and epididymal indices were calculated. Semen quality was assessed using an automatic semen analyzer. Apoptosis of testicular cells was assessed by TUNEL staining. And the expression levels of B-cell lymphocytoma-2 (Bcl-2), Bcl-2-associated X protein (Bax) and cysteine aspartate protease-3 (caspase-3) in testicular tissue were detected by Western blot.
RESULTS:
Compared with the sham group, testicular index, epididymal index, sperm concentration, the percentage of progressive motility of sperm (PR%) and the expression level of Bcl-2 decreased in model group(P<0.01). An increased apoptosis rate of spermatogenic cells and the expression levels of Bax and caspase-3 proteins were observed in model group as well(P<0.01). Compared with the model group, the testicular index, epididymal index, sperm concentration, PR% and the expression level of Bcl-2 in Guilu Taohong Formula group increased significantly (P<0.05, P<0.01). A decreased apoptosis rate of spermatogenic cells and the expression levels of Bax and caspase-3 proteins were detected in Guilu Taohong Formula group as well(P<0.01). Similarly, the L-carnitine group showed increased testicular index, epididymal index, sperm concentration, PR% and the expression level of Bcl-2 protein (P<0.05, P<0.01), where showed decreased apoptosis rate of spermatogenic cells and the expression levels of Bax and caspase-3 proteins compared with model group (P<0.01, P<0.05).
CONCLUSION
Guilu Taohong Formula improves semen quality in VC model rats and reduces the apoptosis rate of spermatogenic cells in testicular tissue, which may be related to the promotion of Bcl-2 protein expression and the inhibition of Bax and caspase-3 protein expression levels.
Male
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Animals
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Varicocele/drug therapy*
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Rats
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Apoptosis/drug effects*
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Rats, Sprague-Dawley
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Drugs, Chinese Herbal/therapeutic use*
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Semen Analysis
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bcl-2-Associated X Protein/metabolism*
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Caspase 3/metabolism*
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Proto-Oncogene Proteins c-bcl-2/metabolism*
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Disease Models, Animal
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Spermatozoa/drug effects*
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Testis/drug effects*
7.Design of medical positive pressure protective suit for long-voyage aeromedical evacuation
Yu-Juan SU ; Li-Qun WANG ; Ya-Di ZHANG ; Xiang-Yi YANG ; Zhen-Yao SONG
Chinese Medical Equipment Journal 2024;45(11):113-116
Objective To develop a medical positive pressure protective suit for long-voyage aeromedical evacuation to realize protective isolation and drinking water and energy supply for medical personnel during long-voyage aeromedical evacuation of respiratory infectious disease patients.Methods The medical positive pressure protective suit had a one-piece structure,with its main part made of hydroentangled non-woven fabric,head and forebreast parts made of amorphous polyethylene terephthalate anti-fog material and wearing-and taking-off parts sealed with zipper and autohesion,which was equipped with a portable positive pressure air supply device,an airborne centralized positive pressure air supply device and a monitoring and warning device.The portable positive pressure air supply device was fixed in the back of the suit at the waist,the airborne device was made by modifying the commercially available positive pressure air supply fan,and the monitoring and warning device monitored the air supply volume of the fan,the battery power and the pressure inside the suit.Results The suit behaved well in protection,clean fresh air supply without time limitation and facilitating hydration and energy replenishment of medical personnel by forming three activity spaces.Conclusion The suit developed can continuously provide a clean and comfortable microenvironment,meeting the requirements of medical personnel for protection and hydration and energy replenishment during long-voyage aeromedical evacuation.[Chinese Medical Equipment Journal,2024,45(11):113-116]
8.In vitro expression and functional analyses of the mutants p.R243Q,p.R241C and p.Y356X of the human phenylalanine hydroxylase
Yong-Hong PANG ; Xiang-Yu GAO ; Zhen-Ya YUAN ; Hui HUANG ; Zeng-Qin WANG ; Lei PENG ; Yi-Qun LI ; Jie LIU ; Dong LIU ; Gui-Rong CHEN
Chinese Journal of Contemporary Pediatrics 2024;26(2):188-193
Objective To study the in vitro expression of three phenylalanine hydroxylase(PAH)mutants(p.R243Q,p.R241C,and p.Y356X)and determine their pathogenicity.Methods Bioinformatics techniques were used to predict the impact of PAH mutants on the structure and function of PAH protein.Corresponding mutant plasmids of PAH were constructed and expressed in HEK293T cells.Quantitative reverse transcription polymerase chain reaction was used to measure the mRNA expression levels of the three PAH mutants,and their protein levels were assessed using Western blot and enzyme-linked immunosorbent assay.Results Bioinformatics analysis predicted that all three mutants were pathogenic.The mRNA expression levels of the p.R243Q and p.R241C mutants in HEK293T cells were similar to the mRNA expression level of the wild-type control(P>0.05),while the mRNA expression level of the p.Y356X mutant significantly decreased(P<0.05).The PAH protein expression levels of all three mutants were significantly reduced compared to the wild-type control(P<0.05).The extracellular concentration of PAH protein was reduced in the p.R241C and p.Y356X mutants compared to the wild-type control(P<0.05),while there was no significant difference between the p.R243Q mutant and the wild type control(P>0.05).Conclusions p.R243Q,p.R241C and p.Y356X mutants lead to reduced expression levels of PAH protein in eukaryotic cells,with p.R241C and p.Y356X mutants also affecting the function of PAH protein.These three PAH mutants are to be pathogenic.[Chinese Journal of Contemporary Pediatrics,2024,26(2):188-193]
9.Assessment of malnutrition diagnosed with GLIM criteria in liver cirrhosis patients and its influencing factors
Shenhui LUO ; Lini WEI ; Qun XIANG ; Xiaofeng SHI ; Juan WANG ; Xuefeng LI
Chinese Journal of Clinical Nutrition 2024;32(4):232-238
Objective:To evaluate the incidence of malnutrition in hospitalized patients with liver cirrhosis using the Global Leadership Initiative on Malnutrition (GLIM) criteria, and to identify the risk factors of malnutrition.Methods:A total of 305 inpatients with liver cirrhosis were included from the Department of Gastroenterology of the People's Hospital of Xiangxi Tujia and Miao Autonomous Prefecture between January 1, 2023 to September 30, 2023. The patient characteristics, clinical indicators, complications, unplanned readmission within 90 days and death outcomes were collected. Malnutrition was diagnosed according to the GLIM criteria, the differences in various indicators were compared between the malnutrition group and the well-nourished group, and the influencing factors of malnutrition were analyzed. The relationship between malnutrition and short-term prognosis was also discussed.Results:Among the enrolled patients, 188 (61.6%) were diagnosed with malnutrition per GLIM criteria, of whom 18 were with Child-Turcotte-Pugh (CTP) Grade A liver function, 108 Grade B, and 62 Grade C. Compared with the well-nourished group, the malnutrition group showed prolonged length of hospital stay ( P<0.001), lower body mass index P=0.003), lower levels of red blood cell count, hemoglobin, serum albumin, serum albumin/globulin ratio, and serum calcium ( P<0.001), higher level of aspartate aminotransferase ( P=0.025), and increased levels of C-reactive protein, total bilirubin, international normalized ratio, plasma prothrombin time and model for end-stage liver disease score ( P<0.001). The proportion of patients with ascites, esophageal gastric varices, upper gastrointestinal bleeding, hepatic encephalopathy and unplanned readmission within 90 days were significantly increased ( P<0.001) in malnutrition group, and the mortality within 90 days was also higher ( P=0.042). Logistic regression analysis identified lower body mass index level ( OR=0.910, P=0.038), ascites ( OR=0.065, P<0.001) and upper gastrointestinal bleeding ( OR=0.184, P=0.001) as the influencing factors of malnutrition in liver cirrhosis patients. Conclusions:The prevalent malnutrition in patients with liver cirrhosis may affect the short-term prognosis. Lower body mass index, ascites and upper gastrointestinal bleeding are influencing factors for malnutrition in liver cirrhosis patients. Therefore, patients with liver cirrhosis should be screened for malnutrition to allow timely nutritional intervention measures.
10.The effect of probiotic therapy combined with the knowledge-attitude-practice model on the recovery and quality of life of patients with acute severe pancreatitis
Qun NIE ; Xiang LIN ; Qianwen ZHOU ; Yinong ZHOU
China Pharmacist 2024;27(4):640-647
Objective To investigate the effects of probiotic treatment combined with knowledge attitude and practice(KAP)model management on the recovery and quality of life of patients with severe acute pancreatitis.Methods Patients with severe acute pancreatitis from June 2020 to June 2023 in Quzhou People's Hospital were selected.The patients were divided into the control group,the probiotics group and the KAP combination group.All groups received symptomatic treatment.The control group was given routine nursing,the probiotic group was given daily oral administration of probiotic granules,and the KAP combination group was managed by KAP model on the basis of probiotic treatment,including targeted intervention in the dimensions of disease knowledge,behavior and belief.The APACHE Ⅱ scores,quality of life scale QOL-C30 scores,serum inflammatory factors C-reactive protein(CRP)and procalcitonin(PCT)levels were compared before and after treatment in three groups.Results A total of 108 patients were included,with 36 cases in each group.The CRP and PCT decreased significantly after treatment in three groups(P<0.05).The reduction ranges of the probiotics group and the KAP group were significantly higher than that of the control group(P<0.05).The self-management ability was significantly increased in all three groups after treatment compared to before treatment(P<0.05),and the increase was significantly greater in the KAP combination treatment group than in the probiotic and control groups(P<0.05).The APACHEⅡ scores decreased significantly and QOL-C30 scores increased significantly after treatment in the probiotics group and the KAP group(P<0.05).Conclusion Probiotic treatment could significantly improve the inflammatory status,clinical symptoms and quality of life of patients with severe acute pancreatitis.The KAP model management could further enhance the effect of probiotic treatment,effectively improve patients'organism recovery ability and quality of life.

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