1.Current Situation and Methodological Reflections on Blinding Assessment in Randomised Controlled Trials of Acupuncture
Hang ZHOU ; Liqiong WANG ; Jianfeng TU ; Guangxia SHI ; Jingwen YANG ; Shiyan YAN ; Cunzhi LIU
Journal of Traditional Chinese Medicine 2024;65(19):1978-1982
Blinding is an important means to control and reduce measurement bias in clinical research, and blinding assessment is the main method to measure the success of the blinding method. By summarizing the current situation of blinding assessment in randomized controlled trials (RCT) of acupuncture, it was found that the report rate of blinding assessment by acupuncture RCT was relatively low, and the studies reporting blinding assessment had several problems, such as incomplete assessment individuals, unreasonable assessment questionnaires, and unscientific analysis methods, and the setting of the assessment time point is controversial. Given the above problems, this paper discussed the key elements of blinding assessment individuals, assessment questionnaires, assessment time points, and analysis methods. It is suggested that blinding assessment should be carried out on all blinded participants and personnel in the study; the assessment questionnaire should be designed by direct inquiry, with responses designed using three or more categorical options that include an "unclear" option; the early stage of the trial should be taken as the mandatory time point for assessment, integrating the evaluation index of the James blinding index and the Bang blinding index, in order to standardize the application of blinding assessment in acupuncture RCT and improve the quality of acupuncture clinical research.
2.Risk factors of frailty in older adult patients with chronic obstructive pulmonary disease and its correlation with oxidative stress
Jiao LI ; Jingru XIE ; Guangxia WANG
Chinese Journal of Primary Medicine and Pharmacy 2024;31(5):681-685
Objective:To analyze the risk factors for frailty in older adult patients with chronic obstructive pulmonary disease (COPD) and its correlation with oxidative stress.Methods:A total of 168 patients with COPD aged 60 years and above, who were treated at Pingxiang People's Hospital from August 2022 to August 2023, were selected as the study subjects using the convenient sampling method. The FRAIL scale was utilized to assess frailty status. Patients were divided into two groups based on their FRAIL scale scores: the frail group (≥ 3 points, n = 109), the non-frail/pre-frail group (< 3 points, n = 59). Patients in the non-frail/pre-frail group were sub-divided into the pre-frail group (1-2 points, n = 23), and the non-frail group (0 points, n = 36). Serum levels of 8-hydroxydeoxyguanosine and malondialdehyde, and total antioxidant capacity were measured. One-way analysis of variance was performed to compare differences between groups, and correlation analysis was conducted. Logistic regression was used to identify the risk factors for frailty. Results:The incidence of frailty among 168 older adult patients with COPD was 64.9% (109/168). Multivariable logistic regression analysis revealed that age ( OR = 1.59, 95% CI 1.02-2.25), body mass index ( OR = 4.11, 95% CI 2.02-8.42), comorbidities ( OR = 2.57, 95% CI 1.31-5.02), activities of daily living ( OR = 3.07, 95% CI 1.54-6.06), malnutrition ( OR = 2.97, 95% CI 1.56-5.41), and cognitive impairment ( OR = 2.87, 95% CI 1.42-5.88) were risk factors for frailty in older patients with COPD ( P < 0.05). The frailty scores of older adult patients with COPD were significantly positively correlated with serum levels of 8-hydroxydeoxyguanosine and malondialdehyde ( γ= 0.67, 0.65, P = 0.008, 0.006), and negatively correlated with total antioxidant capacity ( γ= -0.54, P = 0.012). Conclusion:Age, body mass index, comorbidities, activities of daily living, malnutrition, and cognitive impairment are risk factors for frailty in older adult patients with COPD, and the severity of frailty is markedly associated with levels of oxidative stress products.
3.Application of probiotics in neonates with late-onset sepsis
Jinling ZHANG ; Guangxia LEI ; Jian WANG
Chinese Pediatric Emergency Medicine 2023;30(9):675-679
The intestinal is the main and most important part of human flora settlement.The factors affecting the composition and diversity of intestinal flora in early life mainly include gestational age, delivery mode, feeding mode, antibiotic exposure, etc.The occurrence of neonatal late-onset sepsis(LOS)is associated with intestinal flora imbalance.The use of probiotics to regulate intestinal flora can reduce the incidence and mortality of LOS, which is helpful for treatment and prevention of LOS.
4.Correlation between exhaled nitric oxide and obstructive sleep apnea-hypopnea syndrome
Jiao LI ; Zhou YANG ; Guangxia WANG
Chinese Journal of Primary Medicine and Pharmacy 2023;30(4):561-564
Objective:To investigate the correlation between exhaled nitric oxide and obstructive sleep apnea-hypopnea syndrome (OSAHS).Methods:Eighty patients with OSAHS (OSAHS group) who received treatment in Pingxiang People's Hospital from September 2019 to September 2021 were included in this study. An additional 60 patients with snoring (snoring group) who concurrently received treatment in the same hospital were included in the control group. The value of exhaled nitric oxide was measured using an exhaled nitric oxide detector. The relationship between exhaled nitric oxide and apnea-hypopnea index, and the lowest oxygen saturation level during sleep (LSaO 2) was analyzed using Pearson correlation analysis. The optimal cut-off value of exhaled nitric oxide for predicting OSAHS was analyzed using the receiver operating characteristic curve. Results:Exhaled nitric oxide and apnea-hypopnea index in the OSAHS group were (18.61 ± 6.23) μg/L and (44.50 ± 16.15) times/hour, respectively, which were significantly greater than (11.17 ± 4.31) μg/L and (2.91 ± 0.79) times/hour in the snoring group ( t = 7.94, 14.08, both P < 0.05). LSaO 2 in the OSAHS group was significantly lower than that in the snoring group [(66.53 ± 10.17)% vs. (92.15 ± 1.62)%, t = -13.61, P < 0.05]. Correlation analysis showed that exhaled nitric oxide levels in patients with OSAHS were positively correlated with apnea-hyponea index ( r = 0.56, P = 0.001), and negatively correlated with the lowest oxygen saturation level ( r = -0.54, P = 0.002). The receiver operating characteristic curve analysis revealed that when the optimal cut-off value of exhaled nitric oxide was 11.5 μg/L, the area under the curve was 0.846, with sensitivity of 91.3%, and specificity of 63.3%. Conclusion:Patients with OSAHS have airway inflammatory reactions. The level of nitric oxide in exhaled air is positively correlated with the severity of OSAHS, which has a certain clinical value.
5.Study on effect of astragaloside Ⅳ on apoptosis of thyroid cells in rats with Hashimoto's thyroiditis and RhoA/ROCK2 pathway
Guangxia LIU ; Fang CHEN ; Wei GAO ; Xiaoya WANG ; Yamin LU ; Zhan HOU ; Lianchun ZHAO
Chinese Journal of Immunology 2023;39(12):2517-2522
Objective:To investigate the effect of astragaloside Ⅳ on the apoptosis of thyroid cells in Hashimoto's thyroiditis(HT)rats and Ras homolog gene family member A(RhoA)/Rho-associated coiled-coil containing kinase 2(ROCK2)pathway.Methods:The HT rat model was induced by subcutaneous injection of thyroglobulin combined with high iodine drinking water and randomly divided into model group,astragaloside(80 mg/kg)group,Rhosin(RhoA inhibitor,40 mg/kg)group,astragaloside Ⅳ(80 mg/kg)+ Rhosin(40 mg/kg)group(12 rats in each group),another 12 SD rats were selected and drank water normally and injected the same dose of saline subcutaneously as control group.After the drugs were grouped and processed,the serum anti-thyroglobulin antibody(TGAb),anti-thyroid peroxidase antibody(TPOAb)levels and the inflammatory factors IL-6,IL-17,IL-1β contents were measured by ELISA kits;the pathological changes of thyroid tissue in each group were detected by hematoxylin-eosin(HE)staining;the apopto-sis rate of rat thyroid cells in each group were detected by TUNEL staining;the expressions of RhoA/ROCK2 pathway proteins in thy-roid tissues of rats in each group were detected by Western blot.Results:Compared with the control group,the thyroid follicles in the model group had abnormal structure,some atrophy or disappearance,disordered arrangement,surrounding inflammatory cell infiltra-tion,and obvious pathological damage to the thyroid tissue,the serum TGAb,TPOAb,IL-6,IL-17 and IL-1β levels,thyroid cell apoptosis rate,and thyroid tissue RhoA and ROCK2 protein expression levels were significantly increased(P<0.05);compared with model group,the pathological damage of the thyroid tissue of rats in the drug intervention group were reduced,the serum TGAb,TPOAb,IL-6,IL-17 and IL-1β levels,thyroid cell apoptosis rate,and thyroid tissue RhoA and ROCK2 protein expression levels were decreased(P<0.05);compared with astragaloside Ⅳ group and the Rhosin group respectively,the pathological damage of the thyroid tissue of rats in the astragaloside Ⅳ+Rhosin group were further reduced,the serum TGAb,TPOAb,IL-6,IL-17 and IL-1β levels,thyroid cell apoptosis rate,thyroid tissue RhoA and ROCK2 protein expression levels were decreased(P<0.05).Conclusion:Astragaloside Ⅳ may down-regulate the expression of RhoA/ROCK2 pathway to reduce the inflammatory injury of thyroid tissue,inhib-it thyroid cell apoptosis,and improve the symptoms of HT in rats.
6.Treatment of cough variant asthma based on the pathogenic characteristics of "wind phlegm and blood stasis"
Zheng GUO ; Yiming HOU ; Yuan LIANG ; Xiuying SI ; Guangxia PAN ; Qihui HU ; Youpeng WANG
International Journal of Traditional Chinese Medicine 2022;44(7):721-724
The wind, phlegm, and blood stasis are important pathogenic factors of cough variant asthma in children, and they are also the pathological products in the occurrence and development of this disease. They have typical pathogenic characteristics. The main pathogenesis characteristics of cough caused by wind, phlegm and blood stasis are as follows that external wind attacks the lungs and induces internal wind, phlegm and dampness accumulates in the lungs, and the lungs fail to declare and descend, and blood stasis obstructs the collaterals and stagnation of Qi. The wind, phlegm, and blood stasis have their own pathogenic characteristics, and their cough-causing also have their own pathogenic characteristics and clinical characteristics. Based on the characteristics of wind, phlegm, and blood stasis, the application of medicine based on the differentiation of symptoms and signs can effectively prevent and treat this disease, and provide theoretical basis and treatment ideas for the treatment of cough variant asthma in children with Chinese medicine.
7.Risk factors of periventricular-intraventricular hemorrhage in premature infants
Xinxin DU ; Guangxia LEI ; Jinling ZHANG ; Chunyan LIAO ; Xiaoxia CHEN ; Jian WANG
Chinese Pediatric Emergency Medicine 2022;29(9):665-670
Objective:To analyze the potential risk factors of periventricular-intraventricular hemorrhage(PIVH)in premature infants.Methods:A retrospective study was conducted on clinical data of 279 premature infants admitted to the Affiliated Hospital of Guizhou Medical University From January 1, 2019 to December 31, 2019, who completed cranial ultrasound during hospitalization.According to the cranial ultrasound with or without PIVH, the cases were divided into PIVH group and non-PIVH group.The premature infants with PIVH were divided into severe PIVH(grade Ⅲ and Ⅳ)group and mild PIVH(grade Ⅰand Ⅱ)group according to the PIVH grades.A total of 25 factors, which may influnce PIVH, were analyzed by univariate analysis, and then multivariate Logistic stepwise regression analysis(stepwise backwards method)was performed to determine the major risk factors.Results:(1)A total of 279 premature infants were included in the study, 133 of them in PIVH group, and 146 of them in non-PIVH group.Univariate analysis showed that there were statistically significant differences in 14 factors between two groups, including full treatment of antenatal steroid, gestation age, birth weight, neonatal asphyxia, hypothermia, early onset sepsis, metabolic acidosis, hypernatremia, anemia, respiratory distress syndrome, noninvasive ventilation, invasive ventilation, invasive ventilation within 72 hours after birth, and lumbar puncture within 72 hours after birth( P<0.05). Multivariate analysis showed that gestational age( OR=0.709, 95% CI 0.602-0.835), and full treatment of antenatal steroid( OR=0.354, 95% CI 0.189-0.664) were protective factors for PIVH in premature infants, while neonatal asphyxia( OR=2.425, 95% CI 1.171-5.023), hypothermia( OR=2.097, 95% CI 1.088~4.041), early onset sepsis( OR=12.898, 95% CI 1.433-115.264), metabolic acidosis( OR=2.493, 95% CI 1.398-4.442), invasive ventilation within 72 hours after birth( OR=5.408, 95% CI 1.156-25.297), lumbar puncture within 72 hours after birth ( OR=5.035, 95% CI 1.269-19.993) were independent risk factors for PIVH in premature infants( P<0.05). (2) Among 133 cases of premature PIVH, 20 cases were severe PIVH and 13 cases were mild PIVH.Univariate analysis showed that there were statistically significant differences in 5 factors between two groups, including antenatal magnesium sulfate, gestation age, early onset sepsis, abnormal coagulation, and lumbar puncture within 72 hours after birth.Multivariate analysis showed that early onset sepsis( OR=4.392, 95% CI 1.343-14.367) and abnormal coagulation( OR=3.502, 95% CI 1.234-9.867) were independent risk factors for severe PIVH in premature infants( P<0.05). Conclusion:Gestational age is negatively correlated with the occurrence of PIVH in premature infants, and completion of more than a course of treatment for antenatal dexamethasone is an independent protective factor of PIVH in premature infants.Neonatal asphyxia, metabolic acidosis, hypothermia(<35 ℃), early onset sepsis, invasive ventilation within 72 hours after birth, and lumbar puncture within 72 hours after birth are independent risk factors for PIVH in premature infants.Abnormal coagulation and early onset sepsis are independent risk factors for severe PIVH in premature infants.
8.Clinical effect of anti-PD-1/PD-L1 immunotherapy combined with concurrent radiotherapy and chemotherapy in the treatment of locally advanced cervical cancer
Shasha SHAO ; Liyan CAO ; Guangxia WANG ; Baohong FU ; Zhanzhao FU
Journal of Chinese Physician 2022;24(6):916-921
Objective:To investigate the clinical effect of programmed death receptor-1 (PD-1)/programmed death receptor ligand-1 (PD-L1) immunotherapy combined with concurrent radiotherapy and chemotherapy in the treatment of locally advanced cervical cancer (LACC).Methods:From November 2018 to October 2019, 51 LACC patients in Qinhuangdao First Hospital who received anti-PD-1/PD-L1 immunotherapy (pembrolizumab) combined with concurrent radiotherapy and chemotherapy [intensity modulated radiotherapy (IMRT)+ TP (taxol+ carboplatin) chemotherapy] were selected as the observation group. 51 LACC patients who received concurrent chemotherapy and radiotherapy were selected as the control group. The objective remission rate, disease control rate, tumor markers [squamous cell carcinoma antigen (SCCAg), soluble cytokeratin 19 fragment (CYFRA21-1), and carcinoembryonic antigen (CEA), carbohydrate antigen 125 (CA125)], proliferation and apoptosis indicators [survivin (Survivin), B-cell lymphoma-2 (Bcl-2), Caspase-3 (Caspase-3), apoptosis-promoting substance (Bax)], PD-1/PD-L1 [soluble PD-L1 (sPD-L1), CD4 + T cell surface PD-1 expression (PD-1 CD4 + T cells), CD8 + T cell surface PD-1 expression (PD-1 CD8 + T cell) and CD14 + monocyte surface PD-L1 expression (PD-L1 CD14 + monocyte)], safety and survival rate within 1 year were compared between the two groups. Results:(1) Disease control and safety: the objective response rate and disease control rate of the observation group were 80.39%(41/51) and 92.16%(47/51), respectively, which were higher than those of the control group by 39.22%(20/51) and 70.59%(36/51) (all P<0.05), but there was no significant difference in the incidence of side effects between the groups (all P>0.05). (2) Tumor markers and proliferation and apoptosis indexes: compared with those before treatment, the levels of serum SCCAg, CYFRA21-1, CEA, CA125, survivin and Bcl-2 in the two groups after treatment were significantly lower, and the levels of Caspase-3 and Bax were significantly higher; the above indexes in the observation group were better than those in the control group after treatment (all P<0.05). (3) PD-1/PD-L1: after treatment, sPD-L1, PD-1 CD4 + T cells, PD-1 CD8 + T cells and PD-L1 CD14 + monocytes in the observation group were significantly lower than those before treatment (all P<0.05). After treatment, the sPD-L1, PD-1 CD4 + T cells, PD-1 CD8 + T cells, PD-L1 CD14 + monocytes in the observation group were lower than those in the control group (all P<0.05). (4) Survival: the survival rate of the observation group was higher than that of the control group within 1 year ( P<0.05). Conclusions:The clinical effect of anti-PD-1/PD-L1 immunotherapy combined with concurrent radiotherapy and chemotherapy in the treatment of LACC is significant. It can effectively inhibit the progression of the disease by regulating tumor markers, proliferation and apoptosis indicators and PD-1/PD-L1 expression without increasing the risk of treatment, and has a positive effect on improving the survival rate of patients.
9.Relationship between CD8 +FoxP3 +CD25 + T cell subsets and the therapeutic effect of pembrolizumab in patients with uterine cervical cancer
Shasha SHAO ; Liyan CAO ; Guangxia WANG ; Baohong FU ; Zhanzhao FU
Cancer Research and Clinic 2022;34(6):408-412
Objective:To investigate the relationship between CD8 +FoxP3 +CD25 + T cell subsets and the therapeutic effect of programmed death receptor 1 (PD-1) inhibitor pembrolizumab in treatment of uterine cervical cancer. Methods:The data of 105 patients with uterine cervical cancer who received pemblizumab therapy based on chemotherapy in the First Hospital of Qinhuangdao from January 2018 to January 2020 were retrospectively analyzed. Flow cytometry was used to detect the ratio of CD8 +FoxP3 +CD25 + T cell in peripheral blood of patients. The efficacy and safety were analyzed. According to the efficacy, all patients were divided into remission group (complete remission + partial remission) and non-remission group (stable disease + progressive disease). The clinical characteristics and CD8 +FoxP3 +CD25 + T cell ratio of the two groups were compared. Multivariate logistic regression model was used to analyze the influencing factors for the efficacy. The efficacy of CD8 +FoxP3 +CD25 + T cell ratio predicting the therapeutic effect of patients was analyzed by using receiver operating characteristic (ROC) curve. Results:The objective remission rate of all patients was 17.14% (18/105), and the incidence of adverse reaction was 39.05% (41/105). The proportion of patients with a family history of cervical cancer in the remission group was lower than that than in the non-remission group [5.56% (1/18) vs. 34.48% (30/87)], and the difference was statistically significant ( χ2=6.00, P=0.014). The proportion of CD8 +FoxP3 +CD25 + T cell of 105 patients before and after treatment was (0.83±0.21)% and (0.77±0.10)%, respectively; the proportion of CD8 +FoxP3 +CD25 + T cell before and after treatment in the remission group was (0.55±0.26)%, (0.31±0.12)%, respectively; the proportion of CD8 +FoxP3 +CD25 + T cell before and after treatment in the non-remission group was (0.89±0.30)%, (0.87±0.28)%, respectively. The proportion of CD8 +FoxP3 +CD25 + T cell after treatment in the remission group was lower than that before treatment ( P < 0.05); there was no statistically significant difference in the proportion of CD8 +FoxP3 +CD25 + T cell before and after treatment in the non-remission group ( P>0.05). The proportion of CD8 +FoxP3 +CD25 + T cell before and after treatment in the non-remission group was higher than that in the remission group (all P<0.001). The proportion of CD8 +FoxP3 +CD25 + T cell higher than the mean value of both groups before treatment and the proportion of CD8 +FoxP3 +CD25 + T cell higher than the mean value of both groups after treatment were independent risk factor of disease remission ( OR=2.542, 95% CI 1.649-3.918, P<0.001; OR=2.936, 95% CI 2.154-4.002, P<0.001). ROC curve analysis showed that the area under the curve of CD8 +FoxP3 +CD25 + T cell ratio predicting the disease remission before treatment was 0.720, and its best cut-off value was 0.77%, the senfitivity was 77.78%, the specificity was 70.11%. Conclusions:Early detection of CD8 +FoxP3 +CD25 + T cell ratio helps to predict the effect of PD-1 inhibitor pembrolizumab therapy for uterine cervical cancer.
10.Effect of miRNA-5193 on the sensitivity of cervical cancer Caski cells to cisplatin
Guangxia WANG ; Shasha SHAO ; Lixin DONG
Cancer Research and Clinic 2021;33(3):161-167
Objective:To investigate the effect and mechanism of miRNA-5193 (miR-5193) on the sensitivity of cervical cancer Caski cells to cisplatin.Methods:The expression of miR-5193 in cervical cancer cell lines C33A, SiHa, Caski and normal cervical cell line Ect1/E6E7 were determined by real-time fluorescent quantitative polymerase chain reaction (qRT-PCR). Caski cells were divided into control group (no transfection, normally cultured), miR-5193-negative control (miR-NC) group (transfected with miR-NC mimic), miR-5193 group (transfected with miR-5193 mimic), miR-NC+cisplatin group (transfected with miR-NC mimic and treated with 10 μg/ml cisplatin), miR-5193+cisplatin group (transfected with miR-5193 mimic and treated with 10 μg/ml cisplatin), miR-5193+cisplatin+NC group (cotransfected with Foxp3-negative control vector and miR-5193 mimic, and treated with 10 μg/ml cisplatin), and miR-5193+cisplatin+Foxp3 group (cotransfected with Foxp3 overexpression vector and miR-5193 mimic, and treated with 10 μg/ml cisplatin). Proliferation was detected by methyl thiazolyl tetrazolium (MTT), cell cycle was detected by PI single staining method, cell apoptosis was detected by Annexin V-FITC/PI double staining method, and expressions of CDK2, p27 and C-caspase-3 proteins in cells were detected by Western blot. Bioinformatics software was used to predict miR-5193 target genes, and the luciferase reporting system was used to identify the targeting relationship.Results:The relative expression of miR-5193 in cervical cancer C33A, SiHa and Caski cells was lower than that in normal cervical Ect1/E6E7 cells (0.56±0.06, 0.41±0.03, 0.23±0.02 vs. 1.00±0.10, all P < 0.05). Compared with the control group and miR-NC group, the cell proliferation activity (absorbance value) in miR-5193, miR-NC+cisplatin and miR-5193+cisplatin groups decreased (0.58±0.06, 0.59±0.07 vs. 0.38±0.04, 0.40±0.05, 0.23±0.02, all P < 0.05), the cell apoptosis rate increased [(2.5±0.2)%, (2.7±0.3)% vs. (12.6±1.2)%, (11.9±1.5)% , (18.9±1.7)%, all P < 0.05], and the proportion of cells in G 0/G 1 phase increased [(50.4±4.2)%, (51.3±6.3)% vs. (62.3±3.2)%, (61.9±5.8)%, (71.4±5.4)%, all P < 0.05]. The expression levels of p27 and C-caspase-3 proteins increased, and the expression level of CDK2 protein decreased. The software predicted that the target gene of miR-5193 was Foxp3, which was confirmed by the luciferase reporting system. Compared with the miR-5193+cisplatin+NC group, the cell proliferation activity (absorbance value) in miR-5193+ cisplatin+Foxp3 group increased (0.24±0.03 vs. 0.65±0.05, t = 21.094, P < 0.01), the proportion of cells in G 0/G 1 phase decreased [(71.0±6.4)% vs. (60.3±4.1)%, t = 4.196, P < 0.01], the apoptosis rate of cells decreased [(19.6±1.6)% vs. (11.5±1.2)%, t = 11.880, P < 0.01], the expression levels of p27 and C-caspase-3 proteins in cells decreased, and the expression levels of CDK2 and Foxp3 proteins increased. Conclusion:The miR-5193 may increase the sensitivity of cervical cancer Caski cells to cisplatin in vitro by targeted inhibition of the Foxp3 gene.

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