1.Effect of Jiuxin Pill (救心丸)on Exercise Tolerance and Quality of Life in Patients of Stable Angina Pectoris:A Randomized,Double-Blind,Placebo-Controlled,Multi-Center Clinical Trial
Xianliang WANG ; Mingjun ZHU ; Daimei NI ; Jianguang WU ; Yitao XUE ; Chenglong WANG ; Xiaohua DAI ; Qian LIN ; Jun LI ; Zhiqiang ZHAO ; Shuai WANG ; Yingfei BI ; Tongzuo LIU ; Zhou ZHOU ; Jingyuan MAO
Journal of Traditional Chinese Medicine 2024;65(24):2549-2557
ObjectiveTo evaluate the effect and safety of Jiuxin Pill (救心丸) on exercise tolerance and quality of life in patients with stable angina pectoris (SAP). MethodsA randomised, double-blind, placebo-controlled, multicentre study design was used to enroll 170 patients of SAP from nine centres, which were divided into 85 patients each in the trial group and control group with 1∶1 ratio. Both groups maintained the original western medicine treatment plan, and added Jiuxin Pill or placebo respectively, 2 pills (0.05 g) each time twicely for 28 days. The main outcomes were total exercise time (TED) in the exercise treadmill test and Seattle Angina Questionnaire (SAQ) scores including physical limitation (PL), angina stability (AS), angina frequency (AF), treatment satisfaction (TS), and disease perception (DP). The secondary outcomes were exercise treadmill test indicators including heart rate recovery in 1 min (HRR1), metabolic equivalents (METs), maximum magnitude of ST-segment depression, and the Borg rating of perceived exertion scale, the average number of angina attacks per week, withdrawal and reduction rate of nitroglycerin, traditional Chinese medicine syndrome scores, incidence of major adverse cardiovascular events. Safety indicators were evaluated and the occurrence of adverse events during the trial was recorded. Data was collected before treatment, day 28±2 in treatment period, and follow-up at day 56 which is 28±2 days after treatment period finished. ResultsEighty-four and eighty-five patients respectively from trial group and control group were included to the full analysis set (FAS) and safety analysis set (SS). Compared with the group before treatment and with the control group after treatment, the trial group had higher TED, HRR1, and METs, and lower maximum magnitude of ST-segment depression and Borg rating of perceived exertion scores after treatment (P<0.01). Compared with the group before treatment and with the control group after treatment and at follow-up, the total SAQ score and scores of AS, AF, TS and DP of the trial group after treatment and at follow-up elevated, while the average number of angina attacks per week and traditional Chinese medicine syndrome scores reduced (P<0.01). There was no statistically significant difference in the withdrawal and reduction rate of nitroglycerin between groups (P>0.05). Major adverse cardiovascular events occurred in 1 case (1/84, 1.19%) in the trial group and 1 case (1/85, 1.18%) in the control group, and the difference between groups was not statistically significant (P>0.05). A total of 3 cases of adverse events occurred in the trial group (3/84, 3.57%), and a total of 6 cases of adverse events occurred in the control group (6/85, 7.06%), and there was no statistically significant difference in the incidence of adverse events between groups (P>0.05). ConclusionIn the treatment of SAP, Jiuxin Pill combined with conventional western medicine can further enhance exercise tolerance, improve quality of life, and demonstrate great safety.
2.A nationwide multicenter prospective study on the perioperative impact of closure of mesen-teric fissure in laparoscopic right hemicolectomy
Gang LIU ; Weimin XU ; Da LI ; Lei QIAO ; Jieqing YUAN ; Dewei ZHANG ; Yan LIU ; Shuai GUO ; Xu ZHANG ; Wenzhi LIU ; Yingfei WANG ; Hang LU ; Xiaowei ZHANG ; Xin CHEN ; Zhaohui XU ; Xingyang LUO ; Ge LIU ; Cheng ZHANG ; Jianping ZHOU
Chinese Journal of Digestive Surgery 2024;23(6):812-818
Objective:To investigate the perioperative impact of closure of mesenteric fissure in laparoscopic right hemicolectomy.Methods:The prospective randomized controlled trial was conducted. The clinical data of 320 patients who underwent laparoscopic right hemicolectomy in 11 medical centers, including The First Affiliated Hospital of China Medical University et al, from November 2022 to August 2023 were selected. Based on block randomization, patients were alloca-ted into the mesenteric fissure non-closure group and the mesenteric fissure closure group. Observa-tion indicators: (1) grouping of the enrolled patients; (2) intraoperative conditions; (3) postopera-tive conditions. Measurement data with skewed distribution were represented as M( Q1, Q3) and com-parison between groups was conducted using the Mann-Whitney U test. Count data were represen-ted as absolute numbers or percentages, and comparison between groups was conducted using the chi-square test or Fisher's exact probability. Comparison of ordinal data was conducted using the rank sum test. Comparison of visual analog scores was analyzed using generalized estimating equations. Results:(1) Grouping of the enrolled patients. A total of 320 patients with colon cancer were screened for eligibility, including 156 males and 164 females, aged 68(59,73)years. All the 320 patients were allocated into the mesenteric fissure non-closure group with 164 cases and the mesenteric fissure closure group with 156 cases. There was no significant difference in the age, body mass index, American Society of Anesthesiologist score, maximum tumor diameter, anastomosis location, anastomosis method, surgical approach, range of lymph node dissection, tumor staging between the two groups ( P>0.05) and there was a significant difference in the sex between them ( P<0.05). (2) Intraoperative conditions. There was no significant difference between the mesenteric fissure closure group and the mesenteric fissure non-closure group in the volume of intraoperative blood loss, operation time, conversion to laparotomy, intraoperative complication ( P>0.05). Three patients in the mesenteric fissure non-closure group were converted to laparotomy. One patient in the mesenteric fissure closure group was converted to laparotomy, and 2 cases with intraoperative complication were mesenteric hematoma. (3) Postoperative conditions. There was no significant difference between the mesenteric fissure non-closure group and the mesenteric fissure closure group in the overall postoperative complications ( χ2=0.28, P>0.05). There was no significant difference in the occurrence of postoperative intestinal obstruction, abdominal distension, ascites, pleural effusion, gastric paralysis, anastomotic bleeding, anastomotic leakage, or surgical wound infection between the two groups ( P>0.05). There was no significant difference between the two groups in the reoperation, postoperative gastric tube replacement. There was no significant differ-ence in time to postoperative first flatus, time to postoperative initial liquid food intake, time to post-operative resumption of bowel movements, duration of postoperative hospital stay, total hospital expenses between the two groups ( Z=-0.01, 0.43, 1.04, -0.54, -0.36, P>0.05). One patient in the mesenteric fissure non-closure group received reoperation. No perioperative internal hernia or death occurred in either group. The visual analog score decreased with time in both groups. There was no significant difference in the visual analog score between the mesenteric fissure closure group and the mesenteric fissure non-closure group [ β=-0.20(-0.53,0.13), P>0.05]. Conclusion:Compared with closure of mesenteric fissure, non-closure of mesenteric fissure during laparoscopic right hemi-colectomy dose not increase perioperative complications or postoperative management risk.
3.Effect of acupoint pre-embedding thread on autonomic nervous system and gastrointestinal function in patients undergoing gynecological laparoscopic surgery under general anesthesia
Haiyan XIA ; Jianyou ZHANG ; Yingfei OU ; Naichao WANG ; Feifei LI ; Zhong ZHENG
The Journal of Clinical Anesthesiology 2024;40(7):699-703
Objective To explore the effects of multiple groups of acupoint pre-embedding thread on the autonomic nervous system and gastrointestinal function in patients undergoing gynecological laparo-scopic surgery under general anesthesia.Methods Sixty patients,aged 25-64 years,BMI 18.5-30.0 kg/m2,ASA physical status Ⅰ or Ⅱ,were selected for laparoscopic gynecological surgery under general anesthesia.Patients were divided into two groups using a random number table method:control group(group C)and acupoint thread embedding group(group M),30 patients in each group.Patients in group M received thread embedding at 10 acupoints in 5 groups,including Neiguan,Sanyinjiao,Geshu,Jueyin,and Weishu on the day before surgery.Patients in group C did not undergo thread embedding at acupoints before surgery.The HR,MAP,normalized unit of low frequency(LF),normalized unit of high frequency(HF)and LF/HF were recorded at 5 minutes before anesthesia induction,immediately after tracheal intu-bation,immediately after establishing pneumoperitoneum,10,20,and 30 minutes after pneumoperitoneum,and when tracheal intubation was removed.Motilin and gastrin concentrations in serum were measured on the day before surgery and 24 hours after surgery.The time of first postoperative exhaust and defecation,as well as the occurrence of nausea and vomiting within 48 hours after surgery were recorded.Results Compared with group C,the HR was significantly lower,and the MAP,the LF and LF/HF in group M were significant-ly reduced at 10,20,and 30 minutes after pneumoperitoneum,while HF was significantly increased(P<0.05).The first postoperative time of exhaust and defecation in group M was significantly shortened(P<0.05),and the incidence of nausea and vomiting within 24 hours after surgery was significantly reduced(P<0.05).The concentrations of motilin and gastrin in serum of group M were significantly increased 24 hours after surgery(P<0.05).Conclusion The combination of acupoints and pre-embedding thread can regu-late the autonomic nervous function of patients undergoing gynecological laparoscopic surgery under general anesthesia,which is beneficial for the recovery of postoperative gastrointestinal function and improves the quality of rehabilitation.
4.The relationship between hypertriglyceridemic-waist phenotype and muscle mass loss in the 18-65 year-old adults
Xiaohui ZHANG ; Fang LIU ; Yingfei DIAO ; Yueying LI ; Yanling LI
Chinese Journal of Endocrinology and Metabolism 2023;39(12):1045-1049
Objective:To detect the incidence of muscle mass loss in the adults and explore its relevant influencing factors.Methods:A total of 1 503 participants aged between 18 and 65 years old were collected from the Department of Preventive Treatment of Disease and Health Management Center of First Teaching Hospital of Tianjin University of Traditional Chinese Medicine from March 2019 to October 2021. All subjects completed physical and laboratory examination and bioelectrical impedance analysis. According to the cutpoint of plasma triglycerides concentration≥1.7 mmol/L, waist circumference≥85 cm in men or≥80 cm in women, 1 503 subjects were divided into four groups: normal triglycerides and waist circumference group, normal waist circumference and hypertriglyceridemia group, abdominal obesity and normal triglycerides group, and hypertriglyceridemic-waist phenotype(HTWC) group. Subjects were also divided into 4 groups according to age. Skeletal muscle mass index(ASMI) was calculated according to the skeletal muscle mass of the limbs. Differences of the ASMI and other relevant indicators among the above four groups were analyzed, and body composition was compared among four age groups. Then explore whether HTWC phenotype was an independent risk factor for the occurrence of sarcopenia in different age groups of different gender.Results:The level of triglycerides, fasting blood glucose, systolic blood pressure, and diastolic blood pressure in HTWC group were higher than those in the normal group(all P<0.001). But the incidence of the muscle mass loss in the HTWC group was much lower than that in the other three groups( P<0.001). The incidence of muscle mass loss in overall subjects was 9.2%, in which man was 2.05 times higher than women(12.9% vs 6.3%). There is no statistically significant difference in the incidence of muscle mass loss between the 18-35 age group and the 56-65 age group. Multivariate logistic regression analysis revealed that body mass index, body fat percentage, bone mineral content were independent factors affecting muscle loss in 18-45 year-old adults. After adjustment for other risk factors, HTWC phenotype was still not an independent influencing factor of sarcopenia( OR=1.679, 95% CI 0.523-5.386, P=0.384). Conclusion:HTWC phenotype was not an independent influencing factor of sarcopenia. To prevent the occurrence of sarcopenia in middle-aged and young adults, in addition to assessing the muscle mass, attention should also be given to the measurement of body mass index, bone mineral content, and body fat percentage.
5.18F-FDG PET/CT images quality and its impact factors in diabetic and non-diabetic patients with coronary artery disease
Ziwei ZHU ; Zhi CHANG ; Xiaopeng SHI ; Xiaofen XIE ; Quan LI ; Jingjing MENG ; Yingfei PI ; Xue CAO ; Jian JIAO ; Xia LU ; Yingsheng ZHOU ; Xiaoli ZHANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2020;40(5):281-287
Objective:To evaluate the image quality (IQ) of 18F-fluorodeoxyglucose (FDG) PET/CT imaging and identify its influenfial factors in diabetes mellitus (DM) and non-DM patients with coronary artery disease (CAD). Methods:A total of 196 consecutive CAD patients (174 males, 22 females, 68 DM; age: (57±10) years) in Beijing Anzhen Hospital between June 2016 and February 2018 were retrospectively analyzed. All patients underwent 18F-FDG myocardial PET/CT imaging. The standardized fasting+ oral glucose loading (OGL) and intravenously injection of insulin protocol was performed. According to the FDG uptake by myocardium, background activity in blood and other visceral organ nearby the heart, the IQ was visually evaluated and scored by 0-4. Zero-two was considered as good IQ, 3-4 was regarded as poor IQ. Patients were divided into three groups: group 1 (non-DM+ good IQ), group 2 (DM+ good IQ), group 3 (DM+ poor IQ). Factors which may affect IQ were analyzed, which including OGL, the injection dose of insulin, fasting blood glucose (FBG), peak blood glucose (PBG), blood glucose (BG) level at 18F-FDG injection (BG injnection), BG increasing rate ((PBG-FBG)/FBG, %), and BG decreasing rate ((PBG-BG injection)/PBG, %). One-way analysis of variance, Spearman correlation analysis and logistic regression analysis were used for data analysis. Results:There were significant differences ( F values: 13.074-38.371, all P<0.05) of FBG, PBG, OGL, BG decreasing rate and the injection dose of insulin among group 1 ( n=132, 67.3%), group 2 ( n=53, 27.1%), group 3 ( n=11, 5.6%). All those parameters, except for OGL, were positively correlated with FDG PET/CT IQ ( r s values: 0.142-0.262, all P<0.05). OGL was negatively correlated with IQ ( r s=-0.324, P<0.05). Logistic regression analysis showed that FBG (odds ratio ( OR)=0.687, 95% CI: 0.633-0.746), PBG( OR=0.786, 95% CI: 0.746~0.829), BG injection( OR=0.631, 95% CI: 0.595-0.716), OGL( OR=0.897, 95% CI: 0.873-0.922), the injection dose of insulin( OR=0.680, 95% CI: 0.618-0.748) were predictive factors (all P<0.01) for good IQ in all patients. For DM patients, OGL was the only predictive factor for good IQ( OR =0.940, 95% CI: 0.904-0.960; P<0.01). Conclusions:FBG, PBG, BG injection, OGL, the injection dose of insulin can predict IQ for all patients with CAD. For DM patients with CAD, OGL is the only predictive factor for good IQ. A good IQ of 18F-FDG PET/CT could be obtained in majority of CAD patients, with the standardized fasting + OGL and intravenously injection of insulin protocol and adjust according to the personal status, and prevent the hypoglycemia from happening.
6. Regulation and its mechanism of MeCP2 on biological behavior and epithelial-mesenchymal transition of LECs
Chao NIU ; Zhong WU ; Yalin HUANG ; Ying ZHANG ; Yingfei WANG ; Xiaohua LI ; Wenlong LU
Chinese Journal of Experimental Ophthalmology 2020;38(1):32-37
Objective:
To investigate the role of methyl-CpG-binding protein 2 (MeCP2) in the regulation and epithelial-mesenchymal transition (EMT) of human lens epithelial cells (LECs) and its possible mechanism.
Methods:
Human LEC lines (SRA01/04) were divided into MeCP2-mimic group, MeCP2-NC group and small interferening RNA-MeCP2 (si-MeCP2) group, and MeCP2 analog plasmid, blank plasmid and MeCP2 si-RNA plasmid was used respectively to transfect the cells.The expression of MeCP2 mRNA in the cells was detected by using real-time PCR 24 hours after transfection.At 48 hours after transfection, the migration rate of the cells was evaluated by scratching test, and the expression of Wnt3a protein in the cells was detected by immunofluorescence stainning.The relative expressions of β-catenin, E-cadherin, Vimentin, matrix metallo proteinase (MMP)-9, MMP-7 and secreted frizzled-related protein 5 (SFRP5) proteins in the cells were detected by Western blot.
Results:
After 24 hours of transfection, the relative expression of MeCP2 mRNA in the cells was significantly different among the MeCP2-mimic group, MeCP2-NC group and si-MeCP2 group (
7.Clinical observastion of Bushen-Qiangjin capsule and calcium D on aromatase inhibitors-induced osteopenia in breast cancer patients
Suwen ZOU ; Zhitao GUO ; Ying ZHONG ; Xuezhen LI ; Yingfei HUANG
International Journal of Traditional Chinese Medicine 2018;40(6):507-509
Objective To observe the clinical effect of the Bushen-Qiangjin capsule and calcium D in the treatment of aromatase inhibitors-associated bone loss (AIBL) in breast cancer patients. Methods A total of 65 patients were randomized into a treatment group and a control group, 32 in the control group taking calcium D, and 33 in the treatment group taking calcium D and Bushen-Qiangjin capsule. After a 3-month treatment, the bone mineral density T (BMD), bone-specific alkaline phosphatase (BALP), bone gla protein (BGP) and tartrate resistant acid phosphatase (TrACP) of two groups were evaluated. Results The BMD increased significantly after treatment in both groups (P<0.05), and the therapeutic efficacy of the treatment group was better than of the control group (P<0.05). After treatment, the level of BALP (308.76 ± 10.99 U/L vs. 280.00 ± 7.44 U/L, t=8.170) and the BGP (42.21 ± 3.04 ng/ml vs. 34.38 ± 2.06 ng/ml, t=6.818) of the treatment group were significantly higher than those of the control group (P<0.01). The level of TrACP decreased significantly after treatment in both groups (P<0.05), and the TrACP (60.12 ± 4.58 U/L vs. 67.25±4.06 U/L, t=1.653) of treatment group was significantly lower than that of the control group (P<0.05). Conclusions The Bushen-Qiangjin capsule can produce a content efficacy in treating AIBL in breast cancer patients, improving the BMD and bone metabolism.
8.Variation of CYP2D6 genotype between Caucasian and Asian population and inconsistency of serum endox-ifen concentration and phenotype of CYP2D6 in Chinese breast cancer patients
Wei YANG ; Su LI ; Yingfei DENG ; Caiyun HE ; Hai LIAO ; Wenwen WEI ; Yanxia SHI
The Journal of Practical Medicine 2018;34(12):1995-1999,2003
Objective To conduct a prospective phase Ⅱ clinical study to explore the distribution of CYP2D6 gene polymorphism in Chinese population and its relationship with the metabolism of tamoxifen in early-stage hormonal receptor-positive breast cancer. Methods CYP2D6 genotype was tested by Sanger sequencing using the ABI 3500 Genetic Analyzer. Plasma concentrations of tamoxifen and endoxifen were measured using the HPLC-MS/MS(API 2000)assay. We downloaded the data of CYP2D6 allele from the CPIP database. Results In Chi-nese patients,the most common alleles were CYP2D6*1,*2,and *10;the predominant diplotypes were *1/*10 (38.3%)and*10/*10(18.8%). The distribution of metabolic phenotype,plasma concentration of endoxifen,and endoxifen:tamoxifen plasma concentration ratio were inconsistent between the normal metabolic phenotype(EM) and the intermediate phenotype(IM)under different CYP2D6 activity prediction criteria.The differences in the ratios and endoxifen plasma concentrations were statistically significant between the three groups by cluster analysis. Conclusions The CYP2D6 genotype distribution in Chinese population is different from that in the Western popu-lation. There is considerable variation of serum endoxifen concentration in Chinese breast cancer patients possess-ing the phenotype previously known as the intermediate active metabolizers of CYP2D6. Therefore,in the current era of precision medicine,the standard CYP2D6 genotype-phenotype classification system cannot properly stratify the Chinese population with different levels of endoxifen plasma concentration.
9.Expression of lncRNA LINC01001 in breast cancer and its effect on proliferation of MCF-7 cells
MEI Hong ; LI Changen ; YANG Liang ; GAO Yingfei
Chinese Journal of Cancer Biotherapy 2018;25(2):158-162
[Abstract] Objective: To investigate the expression of long non-coding RNA LINC01001 in breast cancer tissues and its effect on the proliferation of breast cancer MCF-7 cells. Methods: The expression levels of lncRNA LINC01001 were analyzed in 12 cases of cancer and para-cancer tissues from breast cancer patients, who underwent surgical resection in Affiliated People’s Hospital of Hubei University of Medicine from March 2016 to June 2017. The plasmid over-expressing LINC01001 was transfected into human breast cancer MCF-7 cells. The cell cycle distribution and proliferation ability of MCF-7 cells were detected by flow cytometry and MTT assay, respectively. The mRNA expressions of miR-485-5p and CDKN1A mRNA were detected by qRT-PCR, and the protein expressions of CDKN1A, CDK4, CDK6 and Cyclin D1 were detected by Western blotting. Results: The expression level of lncRNA LINC01001 in breast cancer tissues was lower than that in para-cancer tissues (P<0.01). LINC01001 recombinant plasmid transfection significantly inhibited cell cycle progression (P<0.05) and cell proliferation (P<0.05) of MCF-7 cells. qRT-PCR showed that the expression level of miR-485-5p was decreased (P<0.01) and the expression level of CDKN1A mRNA was increased (P<0.01) after over-expressing LINC01001. Western blot results confirmed that over-expression of LINC01001 could promote the expression of CDKN1A protein, but decrease the expressions of CDK4, CDK6 and Cyclin D1 proteins. Conclusion: The expression of LINC01001 in breast cancer tissues was decreased. LINC01001 may down-regulate the expression of miR-485-5p to up-regulate the expression of CDKN1A, and further to inhibit the proliferation of breast cancer MCF-7 cells, providing experimental basis for the clinical application of lncRNA.
10.Association of anterior chamber angle open parameters with postoperative intraocular pressure following laser peripheral iridotomy
Qian LIU ; Yangzeng DONG ; Haijun LI ; Yingfei WANG ; Yalin HUANG ; Liang DONG ; Changgeng LIU
Chinese Journal of Experimental Ophthalmology 2018;36(4):289-293
Objective To evaluate the relationship between anterior chamber angle and intraocular pressure (IOP) after laser peripheral iridotomy (LPI) treatment.Methods A retrospective cases control study was adopted.Fifty-eight patients (58 eyes) who were diagnosed as primary angle closure (PAC) were included in this study.Ultrasound biomicroscopy (UBM) parameters in angle opening distance (AOD),trabecular iris area (TISA) and angle recess area (ARA) examination were performed before LPI.The changes of intraocular pressure (IOP) were compared between different time-points (before and 1 hour,2 hours,8 hours,24 hours,2 weeks,6 months and 12 months after LPI).The patients were divided into IOP≤21 mmHg group (41 eyes) and IOP>21 mmHg group (17 eyes) after LPI.Relationship between anterior chamber angle and IOP after LPI treatment was explored.This study was approved by Ethic Committee of the Henan Eye Institute and informed consent was obtained from each patient.Results The IOPs were increased in 1 hour,2 hours after LPI and lowered in 2 weeks,6 months,12 months after LPI compared with IOP before LPI,with significant differences between them (all at P<0.01).Twelve patients suffered transient elevated IOP and recovered by self-healing or treatment.IOP of 4 patients were elevated after 6 months to 1 year follow-up.The IOPs in 2 weeks,6 months and 12 months after LPI were lowered compared with IOP before LPI,with significant differences between them (all at P<0.01).The UBM parameters were significantly increased in 2 weeks,6 months,12 months after LPI in comparison with IOP before IPL (all at P<0.01).IOP and UBM parameters values were significantly different between IOP>21 mmHg group and ≤21 mmHg group after LPI.Regression analysis indicated that ARA750 (OR =0.75,P<0.05) was correlated to the IOP after LPI rather than IOP before operation,AOD and TISA (P>0.05).Conclusions ARA750 value is correlated with the IOP variations after LPI.UBM structured observation can improve the surgical successful rates and safty and prevent complications.

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