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1.
Chinese Medical Journal ; (24): 341-350, 2023.
Artículo en Inglés | WPRIM | ID: wpr-970069

RESUMEN

BACKGROUND@#Liver biopsy for the diagnosis of non-alcoholic steatohepatitis (NASH) is limited by its inherent invasiveness and possible sampling errors. Some studies have shown that cytokeratin-18 (CK-18) concentrations may be useful in diagnosing NASH, but results across studies have been inconsistent. We aimed to identify the utility of CK-18 M30 concentrations as an alternative to liver biopsy for non-invasive identification of NASH.@*METHODS@#Individual data were collected from 14 registry centers on patients with biopsy-proven non-alcoholic fatty liver disease (NAFLD), and in all patients, circulating CK-18 M30 levels were measured. Individuals with a NAFLD activity score (NAS) ≥5 with a score of ≥1 for each of steatosis, ballooning, and lobular inflammation were diagnosed as having definite NASH; individuals with a NAS ≤2 and no fibrosis were diagnosed as having non-alcoholic fatty liver (NAFL).@*RESULTS@#A total of 2571 participants were screened, and 1008 (153 with NAFL and 855 with NASH) were finally enrolled. Median CK-18 M30 levels were higher in patients with NASH than in those with NAFL (mean difference 177 U/L; standardized mean difference [SMD]: 0.87 [0.69-1.04]). There was an interaction between CK-18 M30 levels and serum alanine aminotransferase, body mass index (BMI), and hypertension ( P  < 0.001, P  = 0.026 and P  = 0.049, respectively). CK-18 M30 levels were positively associated with histological NAS in most centers. The area under the receiver operating characteristics (AUROC) for NASH was 0.750 (95% confidence intervals: 0.714-0.787), and CK-18 M30 at Youden's index maximum was 275.7 U/L. Both sensitivity (55% [52%-59%]) and positive predictive value (59%) were not ideal.@*CONCLUSION@#This large multicenter registry study shows that CK-18 M30 measurement in isolation is of limited value for non-invasively diagnosing NASH.


Asunto(s)
Humanos , Enfermedad del Hígado Graso no Alcohólico/diagnóstico , Queratina-18 , Biomarcadores , Biopsia , Hepatocitos/patología , Apoptosis , Hígado/patología
2.
Journal of Clinical Hepatology ; (12): 2682-2688, 2023.
Artículo en Chino | WPRIM | ID: wpr-998827

RESUMEN

‍Nonalcoholic fatty liver disease (NAFLD) is a group of highly heterogeneous diseases closely associated with metabolic dysfunction. Sarcopenia is a syndrome caused by a continuous decline in muscle mass, strength, and function, and it is often accompanied by NAFLD. Insulin resistance is the main pathological mechanism for sarcopenia and NAFLD, and in addition, factors such as changes in proteins and branched‍-‍chain amino acid, hyperammonemia, intestinal flora, and endocrine dysfunction can also lead to sarcopenia and NAFLD. With the deepening of clinical research, many published prospective studies have confirmed the existence of a bidirectional and complex pathophysiological relationship between sarcopenia and NAFLD. This article reviews the bidirectional relationship between sarcopenia and NAFLD, discusses the common pathogenesis of sarcopenia and NAFLD, summarizes the challenges faced in this field, and proposes new directions for the research on the bidirectional relationship between NAFLD and sarcopenia.

3.
Journal of Clinical Hepatology ; (12): 2464-2469, 2023.
Artículo en Chino | WPRIM | ID: wpr-998316

RESUMEN

‍Traditionally, the progression from compensated liver cirrhosis to decompensated liver cirrhosis has been considered an irreversible point in the natural history of the disease; however, with the suppression of underlying etiology, cure, and disease regression, this view is challenged by an increasing number of new evidence, and the idea of “recompensation of liver cirrhosis” is gradually being accepted. In recent years, scholars in China and globally have been exploring the specific definition of recompensation of liver cirrhosis and the clinical features of patients. By summarizing the recent studies on recompensation of liver cirrhosis in China and globally, integrating existing views, and analyzing related research evidence, this article points out the main challenges in the field of recompensation at this stage, including the lack of in-depth clinical and basic research, the need to define recompensation in the context of NAFLD, and related ethical issues, in order to provide new directions for future research in this field.

4.
Chinese journal of integrative medicine ; (12): 369-374, 2021.
Artículo en Inglés | WPRIM | ID: wpr-880544

RESUMEN

OBJECTIVE@#To observe the effects and safety of Tongyan Spray () on the range and time of hyoid motion in patients with ischemic post-stroke dysphagia.@*METHODS@#Seventy-two patients with ischemic post-stroke dysphagia were selected and randomly assigned to a treatment group (36 cases) and a control group (36 cases) by a random number table from January 2013 to October 2014. All patients swallowed 4 kinds of barium meals with different traits respectively, and each patient underwent video fluoroscopy (VF) examination twice. In the treatment group, Tongyan Spray was sprayed to the pharynx on both sides and the middle part once respectively. The spray was applied 30 min before the second examination. Purified water at room temperature was used as placebo in the control group. The changes in the range and time of hyoid motion in both groups were observed before and after treatment.@*RESULTS@#Six patients dropped out in each group, and 60 patients completed the study and were included in the final analysis. Significant improvement was observed in the range of superior hyoid excursion distance and the time of hyoid motion in the treatment group compared with the control group (P<0.05). There were no obvious adverse reactions observed in oral mucosa in both groups during the whole study.@*CONCLUSION@#Tongyan Spray was an effective and safe medicine for improving swallowing function in patients with ischemic post-stroke dysphagia.

5.
Chinese Journal of Digestion ; (12): 393-399, 2020.
Artículo en Chino | WPRIM | ID: wpr-871475

RESUMEN

Objective:To explore the optimization strategy of the Asia-Pacific colorectal screening (APCS) scoring system in the screening of colorectal neoplasms.Methods:From February to Decomber in 2016 and March to December in 2018, at Xijing Hospital of Air Force Military Medical University and the First Affiliated Hospital of Xi′an Medical University, patients who received opportunistic screening colonoscopy were enrolled. Before colonoscopy, the APCS score (low-risk zero to one points, medium-risk two to three points and high-risk four to seven points), body mass index (BMI), fecal occult blood test (FOBT) and plasma methylated Septin9 gene ( mSEPT9) of all patients were detected and recorded. The results of colonoscopy and biopsy pathology were taken as the gold standard, the efficacies of the above methods in screening colorectal neoplasms were compared to determine and optimize the screening efficiency of APCS scoring system. Chi-square test was used for statistical analysis. Results:A total of 494 patients were screened, of whom 133 cases were diagnosed with colorectal polyps, including 86 cases of colorectal adenomatous polyps (82 cases of non-progressive adenoma, and four cases of advanced-adenoma), and 47 cases of non-adenomatous polyps. According to the APCS score, the detection rate of colorectal adenomatous polyps of the high-risk group (33.3%, 33/99) was 2.02 and 3.76 times higher than those of the medium-risk group (16.5%, 39/237) and low-risk group (8.9%, 14/158), respectively (both Bonferroni correction test, both P<0.016). The detection rate of colorectal adenomatous polyps of patients with BMI>23.9 kg/m 2 was significantly higher than that of patients with BMI≤23.9 kg/m 2 (22.2%, 59/266 vs. 11.8%, 27/228), and the difference was statistically significant ( χ2=9.126, P=0.003). There was no statistically significant difference in the detection rate of colorectal adenomatous polyps between patients with positive- mSEPT9 expression and patients with negative- mSEPT9 expression (22.4%, 15/67 vs. 17.3%, 47/271) ( χ2=0.913, P=0.378). Among 158 low and medium risk patients (APCS score≤three points) who underwent simultaneous BMI measurement, FOBT and plasma mSEPT9 test, the detection rate of colorectal adenomatous polyps in patients with BMI>23.9 kg/m 2 was higher than that in patients with BMI≤23.9 kg/m 2 (17.8%, 16/90 vs. 5.9%, 4/68), and the difference was statistically significant ( χ2=4.957, P=0.030). The redetection efficacy of colorectal adenomatous polyps in patients with BMI>23.9 kg/m 2 and FOBT-positive was higher than that in patients with BMI≤23.9 kg/m 2 and FOBT-negative (28.1%, 9/32 vs. 8.0%, 4/50) and the difference was statistically significant ( χ2=5.942, P=0.027). In addition, the redetection rate of colorectal adenomatous polyps of patients with positive expression of FOBT and plasma mSEPT9 was also higher than that of patients with negative expression (5/14 vs. 12.9%, 12/93), and the difference was statistically significant ( χ2=4.738, P=0.045). Conclusions:When the APCS scoring system is used for sequential screening of colorectal tumors, the optinal choice of BMI replacement or combined with FOBT can improve the patients′ compliance and screening efficiency, which has significant clinical significance and promotion value in the early diagnosis and treatment of colorectal neoplasms.

6.
Journal of Clinical Hepatology ; (12): 1402-1406, 2020.
Artículo en Chino | WPRIM | ID: wpr-822201

RESUMEN

The outbreak of viral pneumonia caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in Wuhan, China poses a major threat to public health. SARS-CoV-2 is highly homologous to severe acute respiratory syndrome-associated coronavirus and Middle East respiratory syndrome-associated coronavirus, all of which may cause severe respiratory symptoms. In addition to respiratory symptoms, a considerable proportion of patients with SARS and SARS-CoV-2 infection have varying degrees of liver injury, but their epidemiological features and pathogenesis remains unclear. This article summarizes the epidemiology of SARS-CoV-2 and elaborates on the current status of the research on SARS-CoV-2, possible mechanism of liver injury caused by SARS-CoV-2, and effective treatment regimens, so as to provide a reference and new research ideas for the prevention and treatment of liver injury in patients with SARS-CoV-2 infection.

7.
Journal of Clinical Hepatology ; (12): 433-436, 2020.
Artículo en Chino | WPRIM | ID: wpr-820983

RESUMEN

The prevalence rate of nonalcoholic fatty liver disease (NAFLD) is increasing year by year, and at present, it has become one of the most common chronic liver diseases in adults in China. NAFLD can progress from nonalcoholic fatty degeneration of the liver to nonalcoholic steatohepatitis, liver cirrhosis, hepatocellular carcinoma, NAFLD-associated cardiovascular events, and death. This article reviews the risk factors for the development of NAFLD and the progression of NAFLD to major diseases such as liver fibrosis, liver cirrhosis, liver cancer, related cardiovascular events, and death, in order to further explore the mechanism of the development and progression of NAFLD, reduce the prevalence rate of NAFLD, slow down the progression of NAFLD, reduce the mortality rate of related diseases, and achieve better prevention and treatment.

8.
Journal of Clinical Hepatology ; (12): 2597-2600, 2020.
Artículo en Chino | WPRIM | ID: wpr-829649

RESUMEN

Nonalcoholic fatty liver disease (NAFLD) has become the most important chronic liver disease in the world, but there is still no approved drug for clinical practice. Due to the heterogeneity of NAFLD itself, although drug therapy is being developed, the response rate seems to remain low. In order to meet the needs of clinical trial design and provide accurate information for drug developers, relevant scholars have proposed to change the name of NAFLD to metabolic associated fatty liver disease This article summarizes the origin of NAFLD heterogeneity and the background of NAFLD renaming, so as to provide new ideas for accelerating the development of new therapies.

9.
Journal of Clinical Hepatology ; (12): 1623-1626, 2020.
Artículo en Chino | WPRIM | ID: wpr-822905

RESUMEN

Childhood nonalcoholic fatty liver disease (NAFLD) is one of the most common cause of chronic liver diseases in children and adolescents; its unique histopathological and clinical features may lead to its progression to liver fibrosis, liver cirrhosis, and liver cancer, and compared with adult NAFLD, it is more likely to cause other diseases and increase mortality rate. Therefore, early identification of risk factors for childhood NAFLD, effective screening of high-risk population, active prevention, and early diagnosis and treatment are key to effective clinical management of this disease. This article elaborates on the risk factors, screening methods, and preventive healthcare measures for childhood NAFLD, in order to standardize the comprehensive management of NAFLD, reduce the prevalence rate of NAFLD, delay its progression, and alleviate the economic and public health burden brought by the disease.

10.
Chinese Journal of Digestion ; (12): 741-745, 2019.
Artículo en Chino | WPRIM | ID: wpr-801180

RESUMEN

Objective@#To explore the expression and clinical significance of plasma methylated Septin9 gene (mSEPT9) in patients with gastric cancer.@*Methods@#From March to October in 2018, 380 patients visited Xijing Hospital of Digestive Diseases were selected. The patients were divided into gastric cancer (GC) group, atrophic gastritis (AG) group and non-atrophic gastritis (NAG) group. The positive expression rate of plasma circulating mSEPT9 of the three groups were detected by polymerase chain reaction (PCR) fluorescence probe method, its correlation with clinicopathological characteristics of gastric cancer were analyzed and also compared with the positive rate of carcinoembryonic antigen (CEA), carbohydrate antigen 19-9 (CA19-9). Chi-square test and continuity correction chi-square test were performed for statistical analysis.@*Results@#The actual number of valid samples was 357 including 147 of GC group, 83 of AG group and 127 of NAG group. The positive rate of plasma mSEPT9 of GC group was higher than those of AG group and NAG group (46.9%, 69/147 vs. 4.8%, 4/83 and 3.9%, 5/127), and the differences were statistically significant (χ2=43.438 and 63.912, both P<0.016). The sensitivity and specificity of plasma mSEPT9 in patients with gastric cancers were 46.9%(69/147) and 95.7%(201/210), respectively. The positive rate of mSEPT9 was higher in gastric cancer patients with tumor maximum diameter over 5.0 cm, intestinal-type gastric cancer in Lauren classification, lymphatic metastasis, vascular and neurological invasion, middle-late stage (stage Ⅲ and Ⅳ) in clinical classification, which were 57.6% (38/66) vs. 35.6% (26/73), 52.6%(51/97) vs. 31.0% (13/42), 53.0% (61/115) vs. 25.0% (8/32), 55.6% (65/117) vs. 13.3% (4/30), 50.8% (65/128) vs. 4/19 and 53.5% (61/114) vs. 24.2% (8/33), respectively; and the differences were statistically significant (χ2=6.728, 5.517, 7.905, 17.091, 5.871 and 8.998, all P<0.05). The positive rate of plasma mSEPT9 in gastric cancer patients was higher than those of CEA and CA19-9 (46.9%, 69/147 vs. 32.0%, 47/147 and 17.7%, 26/147, respectively), and the differences were statistically significant (χ2=6.892 and 17.437, both P<0.016).@*Conclusions@#The positive expression of plasma mSEPT9 in gastric cancer patients has not only high sensitivity but good specificity as well, and it is also related to the clinical stage. The detection of this gene may have important clinical significance in non-invasive diagnosis and prognosis evaluation in patients with advanced gastric cancer.

11.
Journal of Clinical Hepatology ; (12): 835-839, 2019.
Artículo en Chino | WPRIM | ID: wpr-778795

RESUMEN

ObjectiveTo investigate whether glucocorticoids, anti-tumor necrosis factor (anti-TNF) drugs, and a past history of surgical treatment of inflammatory bowel disease (IBD) are the risk factors for the coexistence of IBD and nonalcoholic fatty liver disease (NAFLD). MethodsPubMed, Embase, Cochrane Library, Wanfang Data, CNKI, and VIP were searched for clinical trials of the coexistence of IBD and NAFLD published up to October 2018. The articles included were summarized and quality assessment was performed according to inclusion and exclusion criteria. RevMan 5.2 was used for data processing; the random effects model was used for data with heterogeneity, and the fixed effect model was used for data with homogeneity. ResultsA total of 7 articles were included, with 1645 patients. The meta-analysis showed that glucocorticoids might not be a risk factor for the coexistence of IBD and NAFLD (odds ratio (OR)=1.19, 95% confidence interval (CI): 0.90-1.57, P=0.23); anti-TNF drugs were not a risk factor for the coexistence of IBD and NAFLD (OR = 0.86, 95%CI: 0.65-1.13, P=0.27); a past history of surgical treatment of IBD was a risk factor for the coexistence of IBD and NAFLD (OR=1.50, 95%CI: 1.09-2.05, P=0.01). ConclusionGlucocorticoids and anti-TNF drugs for the treatment of IBD may not increase the incidence rate of the coexistence of IBD and NAFLD, while surgical treatment for IBD may increase this incidence rate.

12.
Chinese Journal of Digestion ; (12): 741-745, 2019.
Artículo en Chino | WPRIM | ID: wpr-824840

RESUMEN

Objective To explore the expression and clinical significance of plasma methylated Septin 9 gene ( mSEPT9) in patients with gastric cancer .Methods From March to October in 2018, 380 patients visited Xijing Hospital of Digestive Diseases were selected .The patients were divided into gastric cancer (GC) group, atrophic gastritis (AG) group and non-atrophic gastritis (NAG) group.The positive expression rate of plasma circulating mSEPT9 of the three groups were detected by polymerase chain reaction (PCR) fluorescence probe method, its correlation with clinicopathological characteristics of gastric cancer were analyzed and also compared with the positive rate of carcinoembryonic antigen ( CEA), carbohydrate antigen 19-9 ( CA19-9). Chi-square test and continuity correction chi-square test were performed for statistical analysis .Results The actual number of valid samples was 357 including 147 of GC group, 83 of AG group and 127 of NAG group.The positive rate of plasma mSEPT9 of GC group was higher than those of AG group and NAG group (46.9%, 69/ 147 vs.4.8%, 4/83 and 3.9%, 5/127), and the differences were statistically significant ( χ2 =43.438 and 63.912, both P?0.016).The sensitivity and specificity of plasma m SEPT9 in patients with gastric cancers were 46.9%(69/147) and 95.7%(201/210), respectively.The positive rate of mSEPT9 was higher in gastric cancer patients with tumor maximum diameter over 5.0 cm, intestinal-type gastric cancer in Lauren classification, lymphatic metastasis, vascular and neurological invasion , middle-late stage (stageⅢandⅣ) in clinical classification, which were 57.6%(38/66) vs.35.6%(26/73), 52.6%(51/97) vs.31.0%(13/42), 53.0%(61/115) vs.25.0%(8/32), 55.6%(65/117) vs.13.3%(4/30), 50.8%(65/128) vs. 4/19 and 53.5%(61/114) vs.24.2%(8/33), respectively; and the differences were statistically significant (χ2 =6.728, 5.517, 7.905, 17.091, 5.871 and 8.998, all P?0.05).The positive rate of plasma mSEPT9 in gastric cancer patients was higher than those of CEA and CA 19-9 (46.9%, 69/147 vs.32.0%, 47/147 and 17.7%, 26/147, respectively), and the differences were statistically significant (χ2 =6.892 and 17.437, both P?0.016).Conclusions The positive expression of plasma m SEPT9 in gastric cancer patients has not only high sensitivity but good specificity as well , and it is also related to the clinical stage .The detection of this gene may have important clinical significance in non-invasive diagnosis and prognosis evaluation in patients with advanced gastric cancer .

13.
Journal of Clinical Hepatology ; (12): 2702-2706, 2018.
Artículo en Chino | WPRIM | ID: wpr-778946

RESUMEN

Nonalcoholic fatty liver disease (NAFLD) is a disease affecting about a quarter of the general population and has become the most important chronic liver disease in China and Western countries, causing huge medical and economic burdens. The prevalence rate of NAFLD is estimated to be as high as 40% in patients with inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn’s disease. This article mainly introduces the current status, economic burden, and risk factors for NAFLD in IBD patients and summarizes the current status and prospects of such diseases, in order to lay a foundation for further research in this field.

14.
Chinese Journal of Hepatology ; (12): 476-480, 2018.
Artículo en Chino | WPRIM | ID: wpr-806721

RESUMEN

The global prevalence rate of nonalcoholic fatty liver disease (NAFLD) has increased year by year, and it has become the number one cause for chronic liver disease in China. In addition, the trend of NAFLD has become more pronounced and evident in female gender and younger age group. The long-term persistence of fatty liver disease may cause serious consequences. There are no accepted diagnostic criteria for diagnosing noninvasive diagnosis of NAFLD. Alpha-ketoglutarate is a newly discovered serological marker of high diagnostic value and considered the most valuable potential biomarker along with cytokeratine-18 (CK-18).

15.
Chinese Journal of Traumatology ; (6): 224-228, 2018.
Artículo en Inglés | WPRIM | ID: wpr-691007

RESUMEN

<p><b>PURPOSE</b>To investigate the effects of estrogen G protein-coupled receptor 30 (GPR30) agonist G1 on hippocampal neuronal apoptosis and microglial polarization in rat traumatic brain injury (TBI).</p><p><b>METHODS</b>Male SD rats were randomly divided into sham group, TBI + vehicle group, TBI + G1 group. Experimental moderate TBI was induced using Feeney's weigh-drop method. G1 (100μg/kg) or vehicle was intravenously injected from femoral vein at 30 min post-injury. Rats were sacrificed at 24 h after injury for detection of neuronal apoptosis and microglia polarization. Neuronal apoptosis was assayed by immunofluorescent staining of active caspase-3. M1 type microglia markers (iNOS and IL-1β) and M2 type markers (Arg1 and IL-4) were examined by immunoblotting or ELISA. Total protein level of Akt and phosphorylated Akt were assayed by immunoblotting.</p><p><b>RESULTS</b>G1 significantly reduced active caspase-3 positive neurons in hippocampus. Meanwhile G1 increased the ratio of Arg1/iNOS. IL-1β production was decreased but IL-4 was increased after G1 treatment. G1 treatment also increased the active form of Akt.</p><p><b>CONCLUSIONS</b>GPR30 agonist G1 inhibited neuronal apoptosis and favored microglia polarization to M2 type.</p>


Asunto(s)
Animales , Masculino , Ratas , Apoptosis , Lesiones Traumáticas del Encéfalo , Quimioterapia , Patología , Polaridad Celular , Hipocampo , Interleucina-1beta , Microglía , Neuronas , Proteínas Proto-Oncogénicas c-akt , Metabolismo , Ratas Sprague-Dawley , Receptores Acoplados a Proteínas G
16.
Genet. mol. biol ; 40(4): 743-750, Oct.-Dec. 2017. tab, graf
Artículo en Inglés | LILACS | ID: biblio-892440

RESUMEN

Abstract Heparanase activity is involved in cancer growth and development in humans and single nucleotide polymorphisms (SNPs) in the heparanase gene (HPSE) have been shown to be associated with tumors. In this study, we investigated whether SNPs in HPSE were a risk factor for hepatocellular carcinoma (HCC) by undertaking a comprehensive haplotype-tagging, case-control study. For this, six haplotype-tagging SNPs (htSNPs) in HPSE were genotyped in 400 HCC patients and 480 controls by polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) analysis. A log-additive model revealed significant correlations between the HPSE polymorphisms rs12331678 and rs12503843 and the risk of HCC in the overall samples (p = 0.0046 and p = 0.0055). When the analysis was stratified based on hepatitis B virus (HBV) carrier status, significant interactions between rs12331678 and rs12503843 and HBV were observed. Conditional logistic regression analysis for the independent effect of one significant SNP suggested that rs12331678 or rs12503843 contributed an independent effect to the significant association with the risk of HCC, respectively. Our findings suggest that the SNPs rs12331678 and rs12503843 are HCC risk factors, although the potential functional roles of these two SNPs remain to be fully elucidated.

17.
Journal of Huazhong University of Science and Technology (Medical Sciences) ; (6): 849-854, 2017.
Artículo en Chino | WPRIM | ID: wpr-333415

RESUMEN

The mediastinal lymph node tuberculous abscesses (MLNTAs) are secondary to mediastinal tuberculous lymphadenitis.Surgical excision is often required when cold abscesses form.This study was aimed to examine video-assisted thoracoscopic surgery (VATS) for the treatment of MLNTA.Clinical data of 16 MLNTA patients who were treated in our hospital between December 1,2013 and December 1,2015 were retrospectively analyzed.All of the patients underwent the radical debridement and drainage of abscesses,and intrathoracic lesions were removed by VATS.They were also administered the intensified anti-tuberculosis treatment (ATT),and engaged in normal physical activity and follow-up for 3 to 6 months.The results showed that VATS was successfully attempted in all of the 16 MLNTA patients and they all had good recovery.Two patients developed complications after surgery,with one patient developing recurrent laryngeal nerve injury,and the other reporting poor wound healing.It was concluded that VATS is easy to perform,and safe,and has high rates of success and relatively few side-effects when used to treat MLNTA.

18.
China Pharmacy ; (12): 1732-1735, 2017.
Artículo en Chino | WPRIM | ID: wpr-512443

RESUMEN

OBJECTIVE:To provide reference for improving the data integrity management system of pharmaceutical produc-tion enterprises. METHODS:According to related reports in US Food and Drug Administration(FDA)and China Food and Drug Administration(CFDA),the source of data integrity problems was analyzed,its reasons were summarized and solutions were put forward. RESULTS&CONCLUSIONS:The reasons why there were data integrity problems in enterprises can be attributed to 3 as-pects(staff,hardware/software system and quality management),and the 3 aspects showed large gap with current standards. It is suggested that enterprises evaluate the existing system by adopting the gap analysis,establish a data integrity management project team,strengthen personnel training,upgrade hardware/software system to ensure its safety,stability and effectiveness;and opti-mize the quality management system by developing good ducument specification,special regulation system of data integrity. In addi-tion,the enterprise should establish quality culture,pay attention to industry and regulatory trends in real time to guarantee the data integrity effectively.

19.
Journal of Clinical Hepatology ; (12): 2433-2438, 2017.
Artículo en Chino | WPRIM | ID: wpr-663415

RESUMEN

Nonalcoholic fatty liver disease (NAFLD)has become a major liver disease in the world and its prevalence rate continues to in-crease. As a component of metabolic syndrome,it has become a risk factor for many serious cerebrovascular and cardiovascular diseases. Due to the complex pathogenesis of NAFLD or the combined/ mutual effect of pathogenic factors,there are still no widely accepted effective therapies. In recent years,more and more studies have revealed new pathogeneses of NAFLD and the prospects of corresponding treatment. This article introduces the recent advances in the treatment of NAFLD,including lifestyle intervention,drug therapy,integrated traditional Chinese and Western medicine therapy,and bariatric surgery. In the aspect of drug therapy,this article introduces the drugs commonly used in clinical practice and new drugs in phase Ⅱ and Ⅲ clinical trials and their therapeutic effects.

20.
Chinese Journal of Integrated Traditional and Western Medicine ; (12): 476-479, 2013.
Artículo en Chino | WPRIM | ID: wpr-287530

RESUMEN

<p><b>OBJECTIVE</b>To observe the therapeutic efficacy of guiling pa'an granule (GPG) in treating non-motor symptoms of Parkinson's disease (PD) patients of Gan-Shen deficiency syndrome (GSDS).</p><p><b>METHODS</b>A multi-center,third party-central online, network randomized, double-blinded, double-dummy, and placebo controlled clinical trial was conducted. Totally 121 patients with confirmed diagnosis of PD by Western medicine and of GSDS by syndrome typing were assigned to the control group and the treatment group. Under the premise of the same treatment baseline, the placebo and GPG at the same dose was respectively administered to patients in the control group and the treatment group. The therapeutic course was 6 months for all. The changes of 8 non-motor symptoms (including witless expression, seborrhea, sialorrhea, cognitive impairment, constipation, hyperhidrosis, insomnia and dreaminess, and psychosis) were observed in the two groups, when compared with the baseline.</p><p><b>RESULTS</b>Satisfactory effectiveness in the 8 non-motor symptoms of PD patients were obtained in the treatment group (P<0.01). Besides, less adverse reactions occurred.</p><p><b>CONCLUSION</b>GPG could improve the non-motor symptoms of PD patients.</p>


Asunto(s)
Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Método Doble Ciego , Medicamentos Herbarios Chinos , Usos Terapéuticos , Medicina Tradicional China , Enfermedad de Parkinson , Diagnóstico , Quimioterapia , Fitoterapia , Resultado del Tratamiento
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