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1.
Beijing Da Xue Xue Bao Yi Xue Ban ; 56(4): 729-734, 2024 Aug 18.
Artigo em Chinês | MEDLINE | ID: mdl-39041572

RESUMO

OBJECTIVE: To investigate the expression level and application value of anti-carbamylated protein (CarP) antibody in rheumatoid arthritis (RA). METHODS: Demographic data and laboratory test results of RA patients, non-RA patients and healthy controls in the physical examination center were reviewed from December 2018 to June 2019 in the Rheumatology and Immunology Department of the People' s Hospital of Xinjiang Uygur Autonomous Region. The serum concentrations of anti-CarP antibodies in all the subjects were measured by ELISA and statistically analyzed. RESULTS: A total of 259 subjects were included in this study, including 158 in the RA group (45 serum-negative RA patients), 59 in the non-RA group and 42 in the healthy control group. The concentration of anti-CarP antibody in RA group [8.31 (5.22, 15.26) U/mL] was higher than that in non-RA group [4.50 (3.35, 5.89) U/mL] and healthy control group [3.46 (2.76, 4.92) U/mL]. The concentration of anti-CarP antibody in non-RA group was not significantly different from that in healthy control group (P=0.10). Receiver operating characteristic (ROC) curve analysis showed that the sensitivity of anti-CarP antibody in the diagnosis of RA was 58.2%, and the specificity was 93.1%. The sensitivity of the combined detection of anti-CarP antibody, anti-cyclic peptide containing citrulline (CCP) antibody and rheumatoid factor (RF) was 82.3%, and the specificity was 96.5%. The positive rate of anti-CarP antibody in serum-negative RA patients was 44.4% (20/45). Univariate Logisitic regression analysis showed that age, C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), RF, glucose-6-phosphate isomerase (GPI), anti-CCP antibody and anti-CarP antibody were risk factors for RA. Multivariate Logisitic regression analysis showed that anti-CCP antibody and anti-CarP antibody were independent risk factors for RA. Spearman correlation analysis showed that there was no significant correlation between anti-CarP antibody and swollen joint count (SJC), tenderness joints count (TJC), ESR, disease activity score for 28 joints (DAS28), clinical disease activity index (CDAI), simplified disease activity index (SDAI). The concentration of anti-CarP antibody in RA with bone erosion (n=88) was higher than that in RA without bone erosion (n=70), and there was significant difference between the two groups (P < 0.05). CONCLUSIONS: Anti-CarP antibody is an effective serological marker for the diagnosis of RA. The combined detection of RF, anti-CCP antibody and anti-CarP antibody can improve its diagnostic value, and anti-CarP antibody may be an effective assistant diagnostic tool for serum negative RA. The high serum concentration of anti-CarP antibody in patients with RA may indicate an increased risk of bone erosion and should be treated early, but further cohort studies are needed for follow-up observation.


Assuntos
Artrite Reumatoide , Autoanticorpos , Carbamilação de Proteínas , Humanos , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/imunologia , Artrite Reumatoide/sangue , Feminino , Autoanticorpos/sangue , Masculino , Carbamilação de Proteínas/imunologia , Ensaio de Imunoadsorção Enzimática , Pessoa de Meia-Idade , Estudos de Casos e Controles
2.
Photodiagnosis Photodyn Ther ; 45: 103885, 2024 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-37931694

RESUMO

OBJECTIVE: Rheumatoid arthritis and Ankylosing spondylitis are two common autoimmune inflammatory rheumatic diseases that negatively affect activities of daily living and can lead to structural and functional disability, reduced quality of life. Here, this study utilized Fourier transform infrared (FTIR) spectroscopy on dried serum samples and achieved early diagnosis of rheumatoid arthritis and ankylosing spondylitis based on deep learning models. METHOD: A total of 243 dried serum samples were collected in this study, including 81 samples each from ankylosing spondylitis, rheumatoid arthritis, and healthy controls. Three multi-scale convolutional modules with different specifications were designed based on the multi-scale convolutional neural network (MSCNN) to effectively fuse the local features to enhance the generalization ability of the model. The FTIR was then combined with the MSCNN model to achieve a non-invasive, fast, and accurate diagnosis of ankylosing spondylitis, rheumatoid arthritis, and healthy controls. RESULTS: Spectral analysis shows that the curves and waveforms of the three spectral graphs are similar. The main differences are distributed in the spectral regions of 3300-3250 cm-1, 3000-2800 cm-1, 1750-1500 cm-1, and 1500-1300 cm-1, which represent: Amides, fatty acids, cholesterol, proteins with a carboxyl group, amide II, free amino acids, and polysaccharides. Four classification models, namely artificial neural network (ANN), convolutional neural network (CNN), improved AlexNet model, and multi-scale convolutional neural network (MSCNN) were established. Through comparison, it was found that the diagnostic AUC value of the MSCNN model was 0.99, and the accuracy rate was as high as 0.93, which was much higher than the other three models. CONCLUSION: The study demonstrated the superiority of MSCNN in distinguishing ankylosing spondylitis from rheumatoid arthritis and healthy controls. FTIR may become a rapid, sensitive, and non-invasive means of diagnosing rheumatism.


Assuntos
Artrite Reumatoide , Aprendizado Profundo , Fotoquimioterapia , Espondilite Anquilosante , Humanos , Espondilite Anquilosante/diagnóstico , Espectroscopia de Infravermelho com Transformada de Fourier , Atividades Cotidianas , Qualidade de Vida , Fotoquimioterapia/métodos , Fármacos Fotossensibilizantes , Artrite Reumatoide/diagnóstico , Amidas
3.
Sci Rep ; 13(1): 15719, 2023 09 21.
Artigo em Inglês | MEDLINE | ID: mdl-37735599

RESUMO

Surface-enhanced Raman spectroscopy (SERS), as a rapid, non-invasive and reliable spectroscopic detection technique, has promising applications in disease screening and diagnosis. In this paper, an annealed silver nanoparticles/porous silicon Bragg reflector (AgNPs/PSB) composite SERS substrate with high sensitivity and strong stability was prepared by immersion plating and heat treatment using porous silicon Bragg reflector (PSB) as the substrate. The substrate combines the five deep learning algorithms of the improved AlexNet, ResNet, SqueezeNet, temporal convolutional network (TCN) and multiscale fusion convolutional neural network (MCNN). We constructed rapid screening models for patients with primary Sjögren's syndrome (pSS) and healthy controls (HC), diabetic nephropathy patients (DN) and healthy controls (HC), respectively. The results showed that the annealed AgNPs/PSB composite SERS substrates performed well in diagnosing. Among them, the MCNN model had the best classification effect in the two groups of experiments, with an accuracy rate of 94.7% and 92.0%, respectively. Previous studies have indicated that the AgNPs/PSB composite SERS substrate, combined with machine learning algorithms, has achieved promising classification results in disease diagnosis. This study shows that SERS technology based on annealed AgNPs/PSB composite substrate combined with deep learning algorithm has a greater developmental prospect and research value in the early identification and screening of immune diseases and chronic kidney disease, providing reference ideas for non-invasive and rapid clinical medical diagnosis of patients.


Assuntos
Aprendizado Profundo , Doenças do Sistema Imunitário , Nanopartículas Metálicas , Insuficiência Renal Crônica , Humanos , Silício , Prata , Algoritmos , Análise Espectral Raman , Insuficiência Renal Crônica/diagnóstico
4.
Technol Health Care ; 31(6): 2135-2143, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-37393448

RESUMO

BACKGROUND: Early postoperative activity, an important part of enhanced recovery after surgery (ERAS) in clinical practice, is considered to be a significant component of postoperative quality care. OBJECTIVE: To evaluate the effect of a standardized early activity program on ERAS in patients after surgery for pulmonary nodules. METHODS: A total of 100 patients with pulmonary nodules who underwent a single-port thoracoscopic segmental resection or a wedge resection of the lung were selected for the present study. These patients were divided into a control group (n= 50) and an intervention group (n= 50) by a digital random method. The patients in the control group received routine perioperative nursing intervention for thoracic surgery due to lung cancer, and those in the intervention group received an intervention using a standardized early activity program along with routine nursing care. The evaluation indexes in both groups included postoperative indwelling time of the closed chest drainage tube, the time to the first off-bed activity after surgery, the incidence of postoperative pulmonary complications, the length of postoperative hospital stay, and patient satisfaction. RESULTS: The postoperative indwelling time of the closed chest drainage tube and the time to the first off-bed activity in the intervention group were less than in the control group. The length of the postoperative hospital stay in the intervention group was shorter than in the control group, and the patient satisfaction in the intervention group was higher than in the control group. The difference for these evaluation indexes were statistically significant (P< 0.05). The number of cases of postoperative complications was four and eight in the intervention group and the control group, respectively, and the difference was not statistically significant (P> 0.05). CONCLUSION: A standardized early activity program is a safe and effective nursing measure for ERAS for patients after surgery for pulmonary nodules, which can promote earlier off-bed activity, shorten the postoperative indwelling time of the closed chest drainage tube, shorten the postoperative hospital stay, improve patient satisfaction, and promote rapid recovery.


Assuntos
Recuperação Pós-Cirúrgica Melhorada , Neoplasias Pulmonares , Humanos , Neoplasias Pulmonares/cirurgia , Cuidados Pós-Operatórios , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/prevenção & controle , Drenagem , Tempo de Internação , Estudos Retrospectivos
5.
Sci Rep ; 13(1): 5137, 2023 03 29.
Artigo em Inglês | MEDLINE | ID: mdl-36991016

RESUMO

The aim of this study was to explore the feasibility of Raman spectroscopy combined with computer algorithms in the diagnosis of primary Sjögren syndrome (pSS). In this study, Raman spectra of 60 serum samples were acquired from 30 patients with pSS and 30 healthy controls (HCs). The means and standard deviations of the raw spectra of patients with pSS and HCs were calculated. Spectral features were assigned based on the literature. Principal component analysis (PCA) was used to extract the spectral features. Then, a particle swarm optimization (PSO)-support vector machine (SVM) was selected as the method of parameter optimization to rapidly classify patients with pSS and HCs. In this study, the SVM algorithm was used as the classification model, and the radial basis kernel function was selected as the kernel function. In addition, the PSO algorithm was used to establish a model for the parameter optimization method. The training set and test set were randomly divided at a ratio of 7:3. After PCA dimension reduction, the specificity, sensitivity and accuracy of the PSO-SVM model were obtained, and the results were 88.89%, 100% and 94.44%, respectively. This study showed that the combination of Raman spectroscopy and a support vector machine algorithm could be used as an effective pSS diagnosis method with broad application value.


Assuntos
Síndrome de Sjogren , Máquina de Vetores de Suporte , Humanos , Síndrome de Sjogren/diagnóstico , Análise Espectral Raman/métodos , Algoritmos , Análise de Componente Principal
6.
Front Immunol ; 14: 1328228, 2023.
Artigo em Inglês | MEDLINE | ID: mdl-38162641

RESUMO

Introduce: Ankylosing spondylitis (AS), rheumatoid arthritis (RA), and osteoarthritis (OA) are three rheumatic immune diseases with many common characteristics. If left untreated, they can lead to joint destruction and functional limitation, and in severe cases, they can cause lifelong disability and even death. Studies have shown that early diagnosis and treatment are key to improving patient outcomes. Therefore, a rapid and accurate method for rapid diagnosis of diseases has been established, which is of great clinical significance for realizing early diagnosis of diseases and improving patient prognosis. Methods: This study was based on Fourier transform infrared spectroscopy (FTIR) combined with a deep learning model to achieve non-invasive, rapid, and accurate differentiation of AS, RA, OA, and healthy control group. In the experiment, 320 serum samples were collected, 80 in each group. AlexNet, ResNet, MSCNN, and MSResNet diagnostic models were established by using a machine learning algorithm. Result: The range of spectral wave number measured by four sets of Fourier transform infrared spectroscopy is 700-4000 cm-1. Serum spectral characteristic peaks were mainly at 1641 cm-1(amide I), 1542 cm-1(amide II), 3280 cm-1(amide A), 1420 cm-1(proline and tryptophan), 1245 cm-1(amide III), 1078 cm-1(carbohydrate region). And 2940 cm-1 (mainly fatty acids and cholesterol). At the same time, AlexNet, ResNet, MSCNN, and MSResNet diagnostic models are established by using machine learning algorithms. The multi-scale MSResNet classification model combined with residual blocks can use convolution modules of different scales to extract different scale features and use resblocks to solve the problem of network degradation, reduce the interference of spectral measurement noise, and enhance the generalization ability of the network model. By comparing the experimental results of the other three models AlexNet, ResNet, and MSCNN, it is found that the MSResNet model has the best diagnostic performance and the accuracy rate is 0.87. Conclusion: The results prove the feasibility of serum Fourier transform infrared spectroscopy combined with a deep learning algorithm to distinguish AS, RA, OA, and healthy control group, which can be used as an effective auxiliary diagnostic method for these rheumatic immune diseases.


Assuntos
Artrite Reumatoide , Aprendizado Profundo , Osteoartrite , Doenças Reumáticas , Espondilite Anquilosante , Humanos , Espectroscopia de Infravermelho com Transformada de Fourier/métodos , Algoritmos , Artrite Reumatoide/diagnóstico , Amidas
7.
Front Surg ; 9: 872221, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35784915

RESUMO

Objective: To explore the early oral food intake on the quality of life of postoperative patients with esophageal cancer. Methods: A total of 100 patients with esophageal cancer were randomized into an observation group and a control group, with 50 patients in each group. The patients in the control group were routinely indwelt with a gastric tube and fasted for seven days. If no abnormality was found in examinations, the patients were instructed to attempt drinking water and gradually try eating liquid, semi-liquid, and common foods. The patients in the observation group were subjected to the early oral food intake strategy. The recovery and gastrointestinal symptoms of the patients were evaluated using the six-minute walk test and gastrointestinal symptom rating scale (GSRS) at discharge. The quality of life of patients was evaluated using the QLQ-C30 scale and QLQ-OES18 scale during the return visit to the hospital one month after discharge. Results: The GSRS score of the observation group was markedly lower than that of the control group. The six-minute walk distance in the observation group was significantly higher than that in the control group; the difference was statistically significant (P < 0.01). In comparing the QLQ-C30 scores of the two groups, the scores in physical function, emotional function, and general health condition in the observation group were higher than those in the control group. In comparing the QLQ-OES18 scores of the two groups, the scores in dysphagia, eating, reflux, pain domains, and choking symptoms in the observation group were lower than those in the control group; the differences were statistically significant (P < 0.01), and there were no statistically significant differences in other symptoms and related functions between the two groups (P > 0.05). Conclusion: The early oral food intake strategy can reduce gastrointestinal symptoms, promote recovery of postoperative patients with esophageal cancer, and improve quality of life.

8.
Int J Gen Med ; 14: 6839-6845, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34703288

RESUMO

OBJECTIVE: To investigate the application effect of hospice care in patients with advanced esophageal cancer (EC), provide a practical basis for improving sleep quality, dignity, and subjective well-being, and relieving depression and anxiety in patients with advanced EC. METHODS: A randomized cluster sampling method was used to select 60 patients with advanced EC who received routine intervention (control group) and 64 patients with advanced EC who received hospice care (study group). The intervention time was three months, and the self-rated anxiety scale (SAS) before and after the interventions was compared between the two groups. The Hamilton Depression Scale (HAMD), the Pittsburgh Sleep Quality Index (PSQI), the General Well-being Scale (GWB), the Patient Dignity Scale (PDI), and patients' physical pain state were recorded. RESULTS: No significant differences were found in the HAMD, SAS, PSQI, GWB, or PDI scores between the two groups before the interventions (P > 0.05); after the interventions, the HAMD, SAS, PSQI, and PDI scores of the two groups were significantly decreased, and the HAMD, SAS, PSQI, and PDI scores of the study group were lower compared with the control group. The GWB scores of the two groups were significantly increased, and those of the study group were significantly higher compared with the control group; the difference was statistically significant (P < 0.05). After the interventions, pain grades of III and above decreased in both groups to grade II, and pain sensation in the study group was lower compared with the control group; the difference was statistically significant (P < 0.05). CONCLUSION: Hospice care can reduce the level of pain related to depression and anxiety in patients with advanced EC and improve their sleep quality, as well as their sense of dignity and subjective well-being.

9.
Diabetes Care ; 44(6): 1324-1333, 2021 06.
Artigo em Inglês | MEDLINE | ID: mdl-33832957

RESUMO

OBJECTIVE: This study aimed to evaluate the efficacy and safety of mulberry twig alkaloids (Sangzhi alkaloids [SZ-A]) in the treatment of type 2 diabetes (T2D). RESEARCH DESIGN AND METHODS: This was a multicenter, randomized, double-blind, double-dummy, and parallel controlled noninferiority clinical trial that was conducted for 24 weeks. A total of 600 patients were randomly allocated to the SZ-A group (n = 360) or acarbose group (n = 240). The primary efficacy end point was the change of glycosylated hemoglobin (HbA1c) compared with baseline. In addition, adverse events (AEs), severe AEs (SAEs), treatment-related AEs (TAEs), and gastrointestinal disorders (GDs) were monitored. RESULTS: After treatment for 24 weeks, the change in HbA1c was -0.93% (95% CI -1.03 to -0.83) (-10.2 mmol/mol [-11.3 to -9.1]) and -0.87% (-0.99 to -0.76) (-9.5 mmol/mol [-10.8 to -8.3]) in the SZ-A and acarbose groups, respectively, and the least squares mean difference was -0.05% (95% CI -0.18 to 0.07) (-0.5 mmol/mol [-2.0 to 0.8]) between the two groups, with no significant difference on the basis of covariance analysis (P > 0.05). The incidence of TAEs and GDs was significantly lower in the SZ-A group than the acarbose group (P < 0.01), but no differences for AEs or SAEs between the two groups were observed (P > 0.05). CONCLUSIONS: SZ-A exhibited equivalent hypoglycemic effects to acarbose in patients with T2D. Nevertheless, the incidence of TAEs and GDs was lower following SZ-A treatment than acarbose treatment, suggesting good safety.


Assuntos
Alcaloides , Diabetes Mellitus Tipo 2 , Morus , Alcaloides/uso terapêutico , Glicemia , Diabetes Mellitus Tipo 2/tratamento farmacológico , Método Duplo-Cego , Quimioterapia Combinada , Hemoglobinas Glicadas/análise , Humanos , Hipoglicemiantes , Morus/química , Comprimidos , Resultado do Tratamento
10.
Sichuan Da Xue Xue Bao Yi Xue Ban ; 50(6): 925-929, 2019 Dec.
Artigo em Chinês | MEDLINE | ID: mdl-31880126

RESUMO

OBJECTIVE: To compare the difference of health-related quality of life after oncologic esophagectomy between the patients using Jiang's gastroesophageal anastomosis and traditional end-to-end gastroesophageal anastomosis. METHODS: A total of 419 patients (223 in Jiang's anastomosis group, and 196 in end-to-end anastomosis group) underwent minimal invasive esophagectomy with cervical anastomosis from October 2012 to August 2016. All patients received radical esophageal cancer resection and cervical anastomosis. EORTC-QLQ-C30 and QLQ-OES18 were used to assess the health-related quality of life at the 1st, 3rd, 6th, 12th, 24th month after esophagectomy. RESULTS: There were 25 dimensions and items in EORTC-QLQ-C30 and QLQ-OES18. The postoperative quality of life decreased obviously at the 1st month and then recovered obviously at the 6th month after the surgery, and it ranged small at the 12th and 24th month. Compared with end-to-end anastomosis group, Jiang's anastomosis group had less reflux and less cough at the 1st month (P=0.023, P=0.010) and the 3rd month (P=0.004, P=0.013), then had better emotional function, less reflux and less cough at the 6th month (P=0.013, P=0.014, P=0.043), better emotional function, less nausea, and less reflux at the 12th month(P=0.004, P=0.023, P=0.021), as well as less reflux at the 24th month (P=0.020). There was no significant difference in other dimensions and items between the two groups during the follow-up period. CONCLUSION: Jiang's anastomosis is safe and feasible, and could improve the postoperative quality of life of the patients with esophagectomy. It is worth to further application in clinical practice.


Assuntos
Neoplasias Esofágicas , Refluxo Gastroesofágico , Anastomose Cirúrgica , Esofagectomia , Humanos , Qualidade de Vida
11.
Pestic Biochem Physiol ; 154: 32-38, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30765054

RESUMO

Cotton bollworm, Helicoverpa armigera (Hübner) (Lepidoptera: Noctuidae), is a polyphagous lepidopteran pest distributed worldwide with a broad spectrum of host plants. However, the mechanism of H. armigera adaptation to various insecticides and defensive allelochemicals in its host plants is not fully understood. Therefore, this study examined the influence of consumption of plant allelochemicals on larval tolerance to methomyl and chlorpyrifos insecticides in H. armigera and its possible mechanism. Twelve plant allelochemicals were screened to evaluate their effects on larval sensitivity to methomyl. Of which flavone, coumarin, DIMBOA (2,4-Dihydroxy-7-methoxy-1,4-benzoxazin-3-one) and visnagin significantly reduced larval sensitivity to methomyl. Application of cytochrome P450 inhibitor piperonyl butoxide (PBO) significantly increased the mortality of methomyl-treated larvae. In contrast, PBO addition significantly decreased the mortality of chlorpyrifos-treated larvae. Moreover, allelochemical consumption enhanced the activities of glutathione S-transferase, carboxylesterase, cytochrome P450 and acetylcholinesterase in the midgut and fat body. The qRT-PCR analysis confirms that P450 genes, CYP6B2, CYP6B6 and CYP6B7 were induced by the four allelochemicals in the midguts and the fat bodies. In conclusion, the generalist H. armigera can take benefit of plant allelochemicals from its host plants to elaborate its defense against insecticides.


Assuntos
Resistência a Inseticidas/efeitos dos fármacos , Inseticidas/toxicidade , Larva/efeitos dos fármacos , Mariposas/efeitos dos fármacos , Feromônios/farmacologia , Compostos Fitoquímicos/farmacologia , Animais , Carboxilesterase/genética , Clorpirifos/toxicidade , Sistema Enzimático do Citocromo P-450/genética , Feminino , Regulação Enzimológica da Expressão Gênica/efeitos dos fármacos , Glutationa Transferase/genética , Proteínas de Insetos/genética , Resistência a Inseticidas/genética , Larva/genética , Masculino , Metomil/toxicidade , Mariposas/genética
12.
Guang Pu Xue Yu Guang Pu Fen Xi ; 36(7): 2266-70, 2016 Jul.
Artigo em Chinês | MEDLINE | ID: mdl-30036005

RESUMO

The sliding zone soil of Motuo and GelinLandslides were tested with X-ray diffraction, X-ray fluorescence, and infrared absorption spectra. Its compositins of main minerals and clay minerals, even the chemical compositions were comprehensively analyzed. The results show that the composition of the main minerals was controlled by alluvial fan composition, and the contents of clay minerals accounted for 9% and 10% respectively, with a large number of illitecontained in the sliding zone soilofMotuoLandslide, which reflects that the landslide had a high slip rate. There were no exotic corbonates minerals or secondary clay minerals contained corrosive substance with poor mechanical properties filled into theslidingplane because of the closed system, based on the infrared absorption spectrum with no peaks arising from CO2-3, HCO1-3 or C­H, as a positive affect result of the stability of these lamdsiles.The samples of sliding zone soil contain a certain amount of halloysite, reflecting that the landslides in the area of Motuo developed in a very humid and warm environment. With Na2O and CaO preserved in the closed system, a large number of illite/montmorillonite mixed layer formed in the sliding zone soilofGelinlandslide due to the strong water-rock interaction in thesliding plane with the decomposition of illite. The frictional strength of sliding zone was largely reduced due to the clay mineral assemblages, leading to the activity risk of landslide increasing.

13.
Zhonghua Nei Ke Za Zhi ; 54(11): 949-53, 2015 Nov.
Artigo em Chinês | MEDLINE | ID: mdl-26759214

RESUMO

OBJECTIVE: To evaluate the efficacy and safety of alogliptin in Chinese patients with type 2 diabetes (T2DM). METHODS: This was a multicenter, randomized, double-blind, placebo-controlled phase III trial. A total of 491 subjects with T2DM were randomized in a 1:1 ratio to receive alogliptin (25 mg once daily) or placebo for 16 weeks. Among them, 181 were in the monotherapy group (group A), 186 were in the add-on to metformin group (group B), and 124 were in the add-on to pioglitazone group (group C). RESULTS: After 16 weeks of therapy, glycosylated hemoglobin A1c (HbA1c) levels decreased in both alogliptin and placebo groups. The mean changes in HbA1c for alogliptin and placebo were 1.00% and 0.43% (P<0.001), 0.91% and 0.23% (P<0.001), and 0.76% and 0.25% (P<0.001) in group A, B and C, respectively. Compared with placebo, alogliptin treatment led to a greater decrease in fasting plasma glucose (FPG) and a higher percentage of subjects who achieved HbA1c targets of ≤ 6.5% and ≤ 7.0%. The percentage of subjects who experienced all adverse events including hypoglycemia with alogliptin were comparable to those with placebo. CONCLUSIONS: Alogliptin 25 mg once daily reduced HbA1c and FPG, and increased a greater proportion of subjects achieving HbA1c goals of ≤6.5% and ≤7.0% compared with placebo when used as a monotherapy, add-on to metformin, or add-on to pioglitazone. The hypoglycemia rates and safety profiles with alogliptin were similar to those with placebo.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Piperidinas/uso terapêutico , Uracila/análogos & derivados , Povo Asiático , Glicemia , China , Método Duplo-Cego , Quimioterapia Combinada , Hemoglobinas Glicadas/química , Humanos , Hipoglicemia , Metformina/uso terapêutico , Pioglitazona , Segurança , Tiazolidinedionas/uso terapêutico , Uracila/uso terapêutico
14.
Zhonghua Nei Ke Za Zhi ; 52(11): 932-5, 2013 Nov.
Artigo em Chinês | MEDLINE | ID: mdl-24439186

RESUMO

OBJECTIVE: To assess the design and the Mainland China subgroup baseline characteristics of the study to evaluate the efficacy and safety of alogliptin versus placebo in subjects with type 2 diabetes (T2DM) as monotherapy, add-on to metformin or add-on to pioglitazone. METHODS: This was a multi-center, randomized, double-blind, placebo-controlled, 16-week study comparing alogliptin (ALO, 25 mg, 1/d) versus placebo (PLA) as monotherapy (A), add-on to metformin (B) or add-on to pioglitazone ± metformin (C). The T2DM subjects with glycosylated hemoglobin A1c(HbA1c) between 7% and 10% and aged between 18 years and 75 years were enrolled and randomized to the alogliptin group and the placebo group in 1: 1 ratio with 16 weeks treatment. All patients were followed up every 4 weeks. The safety endpoints consisted of the incidence of hypoglycemia and other adverse events. RESULTS: A total of 491 patients were enrolled in the Mainland China subgroup of the study (181 in group A, 186 in group B and 124 in group C). In each treatment group, the baseline characteristics including age, gender, body mass index, diabetes duration, HbA1c, fasting plasma glucose, body weight, daily dosage of metformin and daily dosage of pioglitazone were all well balanced. CONCLUSION: The demographic data, medical history, glycemic profile and treatment regimen at baseline in Mainland China subgroup are well balanced. The result of this study will provide the clinical evidence for the use of alogliptin in Chinese T2DM patients.


Assuntos
Diabetes Mellitus Tipo 2/tratamento farmacológico , Piperidinas/efeitos adversos , Piperidinas/uso terapêutico , Uracila/análogos & derivados , Adulto , China , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Projetos de Pesquisa , Resultado do Tratamento , Uracila/efeitos adversos , Uracila/uso terapêutico
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