OBJECTIVE: To evaluate the efficacy and safety of Shexiang Tongxin Dropping Pill (STDP) in treating stable angina patients with phlegm-heat and blood-stasis syndrome by exercise duration and metabolic equivalents. METHODS: This multicenter, randomized, double-blind, placebo-controlled clinical trial enrolled stable angina patients with phlegm-heat and blood-stasis syndrome from 22 hospitals. They were randomized 1:1 to STDP (35 mg/pill, 6 pills per day) or placebo for 56 days. The primary outcome was the exercise duration and metabolic equivalents (METs) assessed by the standard Bruce exercise treadmill test after 56 days of treatment. The secondary outcomes included the total angina symptom score, Chinese medicine (CM) symptom scores, Seattle Angina Questionnaire (SAQ) scores, changes in ST-T on electrocardiogram and adverse events (AEs). RESULTS: This trial enrolled 309 patients, including 155 and 154 in the STDP and placebo groups, respectively. STDP significantly prolonged exercise duration with an increase of 51.0 s, compared to a decrease of 12.0 s with placebo (change rate: -11.1% vs. 3.2%, P<0.01). The increase in METs was significantly greater in the STDP group than in the placebo group (change: -0.4 vs. 0.0, change rate: -5.0% vs. 0.0%, P<0.01). The improvement of total angina symptom scores (25.0% vs. 0.0%), CM symptom scores (38.7% vs. 11.8%), reduction of nitroglycerin consumption (100.0% vs. 11.3%), and all domains of SAQ, were significantly greater with STDP than placebo (all P<0.01). The changes in Q-T intervals at 28 and 56 days from baseline were similar between the two groups (both P>0.05). Twenty-five participants (16.3%) with STDP and 16 (10.5%) with placebo experienced AEs (P=0.131), with no serious AEs observed. CONCLUSION STDP could improve exercise tolerance in patients with stable angina and phlegm-heat and blood stasis syndrome, with a favorable safety profile. (Registration No. ChiCTR-IPR-15006020).
Humans ; Double-Blind Method ; Drugs, Chinese Herbal/adverse effects* ; Male ; Female ; Middle Aged ; Angina, Stable/physiopathology* ; Aged ; Syndrome ; Treatment Outcome ; Placebos ; Tablets

Objective:To evaluate the 1-year postoperative efficacy of four bariatric procedures, namely sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S), and biliopancreatic diversion with duodenal switch (BPD/DS) for treating super obesity.Methods:In this retrospective observational study, we analyzed the clinical data of 40 patients with super obesity (body mass index [BMI]≥50 kg/m 2) who had undergone bariatric surgery in the China-Japan Union Hospital of Jilin University from November 2015 to December 2020. The study cohort consisted of 21 men and 19 women of average age 31.7±9.0 years. The preoperative weight and BMI were (159.2±16.9) kg and (53.4±3.0) kg/m 2, respectively. Prior to the surgery, 30 individuals had hypertension, 27 hyperuricemia, 15 type 2 diabetes, 10 abnormally high total cholesterol, 20 abnormally high triglycerides, and 24 abnormally high low-density lipoprotein. We divided the participants into four groups according to the type of operation: SG group ( n=16), RYGB group ( n=9), SADI-S group ( n=9) and BPD/DS group ( n=6). We examined the following factors: weight, BMI, excess weight loss (%), total weight loss (%), and remission of preoperative metabolic diseases (including hypertension, hyperuricemia, type 2 diabetes, and hyperlipidemia) 3, 6, and 12 months after surgery. The variables assessed for hypertension were systolic and diastolic blood pressure; for type 2 diabetes, glycated hemoglobin; and for hyperlipidemia, total cholesterol, triglycerides, and low-density lipoprotein 1-year after the surgery. The safety of surgery was also assessed. Results:All patients successfully completed laparoscopic procedures, none of them requiring conversion to laparotomy. The amount of blood loss during surgery was less than 50 mL. Postoperative hospital stay was 6–16 days. There were no deaths during the perioperative period. However, two postoperative complications occurred in the RYGB group, namely bleeding and anastomotic leakage. No complications were detected in the other groups. At 3, 6, and 12 months after surgery, percentage of excess weight loss was 36.6±11.0, 62.4±15.7, and 68.2±16.0 ( F=21.830, P<0.001) in the SG group; 30.6±6.9, 42.5±5.8, and 50.6±11.1 ( F=13.222, P<0.001) in the RYGB group; 39.7±7.8, 54.6±12.7, and 81.9±12.0 ( F=33.821, P<0.001) in the SADI-S group; and 40.2±4.8, 57.7±11.8, and 82.8±14.9 ( F=21.552, P<0.001), respectively, in the BPD/DS group. The percentage of excess weight loss increased significantly over the 12-month observation period in all groups . Compared with before surgery, hypertension and hyperuricemia in the SG, SADI-S, and BPD-DS groups showed significant improvement after one year (all P<0.05). However, only the SADI-S group exhibited a significant decrease in glycosylated hemoglobin concentrations ( P=0.038). Only the BPD-DS group showed significant decreases in various indicators of hyperlipidemia (all P<0.05). The improvements in obesity-related complication indexes did not reach statistical significance in the RYGB group (all P>0.05). Conclusion:SG, RYGB, SADI-S and BPD/DS are all safe and effective treatments for super obesity. All of these procedures can improve the associated metabolic diseases to a certain extent.

Humans ; Stroke, Lacunar ; Mendelian Randomization Analysis ; Leukocytes ; Telomere/genetics* ; Genome-Wide Association Study ; Polymorphism, Single Nucleotide

OBJECTIVES: To study the protective effect of melatonin (Mel) against oxygen-induced retinopathy (OIR) in neonatal mice and the role of the HMGB1/NF-κB/NLRP3 axis. METHODS: Neonatal C57BL/6J mice, aged 7 days, were randomly divided into a control group, a model group (OIR group), and a Mel treatment group (OIR+Mel group), with 9 mice in each group. The hyperoxia induction method was used to establish a model of OIR. Hematoxylin and eosin staining and retinal flat-mount preparation were used to observe retinal structure and neovascularization. Immunofluorescent staining was used to measure the expression of proteins and inflammatory factors associated with the HMGB1/NF-κB/NLRP3 axis and lymphocyte antigen 6G. Colorimetry was used to measure the activity of myeloperoxidase. RESULTS: The OIR group had destruction of retinal structure with a large perfusion-free area and neovascularization, while the OIR+Mel group had improvement in destruction of retinal structure with reductions in neovascularization and perfusion-free area. Compared with the control group, the OIR group had significant increases in the expression of proteins and inflammatory factors associated with the HMGB1/NF-κB/NLRP3 axis, the expression of lymphocyte antigen 6G, and the activity of myeloperoxidase (P<0.05). Compared with the OIR group, the OIR+Mel group had significant reductions in the above indices (P<0.05). Compared with the control group, the OIR group had significant reductions in the expression of melatonin receptors in the retina (P<0.05). Compared with the OIR group, the OIR+Mel group had significant increases in the expression of melatonin receptors (P<0.05). CONCLUSIONS Mel can alleviate OIR-induced retinal damage in neonatal mice by inhibiting the HMGB1/NF-κB/NLRP3 axis and may exert an effect through the melatonin receptor pathway.
Animals ; Mice ; HMGB1 Protein ; Melatonin/therapeutic use* ; Mice, Inbred C57BL ; NF-kappa B ; NLR Family, Pyrin Domain-Containing 3 Protein ; Oxygen/adverse effects* ; Peroxidase ; Receptors, Melatonin ; Retinal Diseases/drug therapy*

Objective:To evaluate the 1-year postoperative efficacy of four bariatric procedures, namely sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), single anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S), and biliopancreatic diversion with duodenal switch (BPD/DS) for treating super obesity.Methods:In this retrospective observational study, we analyzed the clinical data of 40 patients with super obesity (body mass index [BMI]≥50 kg/m 2) who had undergone bariatric surgery in the China-Japan Union Hospital of Jilin University from November 2015 to December 2020. The study cohort consisted of 21 men and 19 women of average age 31.7±9.0 years. The preoperative weight and BMI were (159.2±16.9) kg and (53.4±3.0) kg/m 2, respectively. Prior to the surgery, 30 individuals had hypertension, 27 hyperuricemia, 15 type 2 diabetes, 10 abnormally high total cholesterol, 20 abnormally high triglycerides, and 24 abnormally high low-density lipoprotein. We divided the participants into four groups according to the type of operation: SG group ( n=16), RYGB group ( n=9), SADI-S group ( n=9) and BPD/DS group ( n=6). We examined the following factors: weight, BMI, excess weight loss (%), total weight loss (%), and remission of preoperative metabolic diseases (including hypertension, hyperuricemia, type 2 diabetes, and hyperlipidemia) 3, 6, and 12 months after surgery. The variables assessed for hypertension were systolic and diastolic blood pressure; for type 2 diabetes, glycated hemoglobin; and for hyperlipidemia, total cholesterol, triglycerides, and low-density lipoprotein 1-year after the surgery. The safety of surgery was also assessed. Results:All patients successfully completed laparoscopic procedures, none of them requiring conversion to laparotomy. The amount of blood loss during surgery was less than 50 mL. Postoperative hospital stay was 6–16 days. There were no deaths during the perioperative period. However, two postoperative complications occurred in the RYGB group, namely bleeding and anastomotic leakage. No complications were detected in the other groups. At 3, 6, and 12 months after surgery, percentage of excess weight loss was 36.6±11.0, 62.4±15.7, and 68.2±16.0 ( F=21.830, P<0.001) in the SG group; 30.6±6.9, 42.5±5.8, and 50.6±11.1 ( F=13.222, P<0.001) in the RYGB group; 39.7±7.8, 54.6±12.7, and 81.9±12.0 ( F=33.821, P<0.001) in the SADI-S group; and 40.2±4.8, 57.7±11.8, and 82.8±14.9 ( F=21.552, P<0.001), respectively, in the BPD/DS group. The percentage of excess weight loss increased significantly over the 12-month observation period in all groups . Compared with before surgery, hypertension and hyperuricemia in the SG, SADI-S, and BPD-DS groups showed significant improvement after one year (all P<0.05). However, only the SADI-S group exhibited a significant decrease in glycosylated hemoglobin concentrations ( P=0.038). Only the BPD-DS group showed significant decreases in various indicators of hyperlipidemia (all P<0.05). The improvements in obesity-related complication indexes did not reach statistical significance in the RYGB group (all P>0.05). Conclusion:SG, RYGB, SADI-S and BPD/DS are all safe and effective treatments for super obesity. All of these procedures can improve the associated metabolic diseases to a certain extent.

【Objective】 To study the annual financial expenditure in blood stations with different scales, and to establish the regression equation between blood collection units and total expenditure. 【Methods】 The annual total expenditure, the per capita cost of serving population, as well as the collection units of whole blood and apheresis platelet of 24 blood stations were collected. The financial expenditure required for collecting 10 000U blood was calculated.The statistical analysis was carried out with SPSS statistical software. 【Results】 From 2017 to 2020, the total annual financial expenditure of 24 blood stations showed an upward trend. The total expenditure among blood stations was different. The per capita cost of servicing population in the areas where the 24 blood stations were located had been increasing year by year. The 24 blood stations were divided into two grades according to the blood collection volume as 50 000 U, and the relationship equation between the blood collection volume and the annual total expenditure had been established. After testing, each equation was effective(P<0.05); There was no difference in the financial expenditure required for collecting 10 000U blood among blood stations with different scales. 【Conclusion】 From 2017 to 2020, the blood stations with an annual collection volume more than 50 000 U demonstrated a higher financial expenditure and the per capita cost of serving population than those <50 000 U. The blood collection volume of blood stations is significantly correlated with the annual total expenditure and the per capita cost of serving population.

OBJECTIVE: To establish and validate predictive nomogram for liver fibrosis in patients with Wilson disease (WD) showing abnormal lipid metabolism. METHODS: We retrospectively collected the clinical data of 500 patients with WD showing abnormalities in lipid metabolism, who were treated in the Department of Encephalopathy of the First Affiliated Hospital of Anhui University of Chinese Medicine from December, 2018 to December, 2021 and divided into modeling group and validation group. The independent risk factors of liver fibrosis in these patients were screened using LASSO regression and multivariate logistic regression analysis for establishment of the predictive nomogram. The area under the curve (AUC), calibration curve and decision curve of the receiver-operating characteristic curve (ROC) were used for internal and external verification of the nomogram in the modeling and validation group and evaluating the differentiation, calibration and clinical practicability of the model. RESULTS: Triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and apolipoprotein B (Apo-B) were independent risk factors for the development of liver fibrosis in patients with WD and abnormal lipid metabolism (P < 0.05). The predictive nomogram showed good discrimination, calibration and clinical utility in both the modeling and validation groups. CONCLUSION The established predictive nomogram in this study has a high accuracy for early identification and risk prediction of liver fibrosis in patients with WD having abnormal lipid metabolism.
Humans ; Hepatolenticular Degeneration ; Lipid Metabolism ; Retrospective Studies ; Liver Cirrhosis ; Cholesterol, LDL

Objective: To investigate the safety and learning curve of Da Vinci robotic single-anastomosis duodenal-ileal bypass with sleeve gastrectomy (SADI-S) in the treatment of obesity patients. Methods: A descriptive case series study was performed. Clinical data of obesity patients who were treated with Da Vinci robotic SADI-S in China-Japan Union Hospital of Jilin University from March 2020 to May 2021 were analyzed retrospectively. Case inclusion criteria: (1) uncomplicated obese patients with body mass index (BMI)≥37.5 kg/m(2); (2) patients with BMI of 28 to <37.5 kg/m(2) complicated with type 2 diabetes or two metabolic syndrome components, or obesity comorbidities; (3) patients undergoing SADI-S by Da Vinci robotic surgery system. Those who received other bariatric procedures other than SADI-S or underwent Da Vince robotic SADI-S as revisional operation were excluded. A total of 77 patients were enrolled in the study, including 31 males and 46 females, with median age of 33 (18-59) years, preoperative body weight of (123.0±26.2) kg, BMI of (42.2±7.1) kg/m(2) and waistline of (127.6±16.3) cm. According to the order of operation date, the patients were numbered as 1-77. The textbook outcome (TO) and Clavien-Dindo grading standard were used to analyze the clinical outcome of each patient and to classify surgical complications, respectively. The standard of textbook outcome was as follows: the operative time less than or equal to the 75th percentile of the patient's operation time (210 min); the postoperative hospital stay less than or equal to the 75th percentile of the patient's postoperative hospital stay (7 d); complication grade lower than Clavien grade II; no readmission; no conversion to laparotomy or death. The patient undergoing robotic SADI-S was considered to meet the TO standard when meeting the above 5 criteria. The TO rate was calculated by cumulative sum analysis (CUSUM) method. The curve was drawn by case number as X-axis and CUSUM (TO rate) as Y-axis so as to understand the learning curve of robotic SADI-S. Results: The operative time of 77 robotic SADI-S was (182.9±37.5) minutes, and the length of postoperative hospital stay was 6 (4-55) days. There was no conversion to laparotomy or death. Seven patients suffered from complications (7/77, 9.1%). Four patients had grade II complications (5.2%), including one with duodeno-ileal anastomotic leakage, one with abdominal bleeding, one with peritoneal effusion and one with delayed gastric emptying; two patients were grade IIIb complications (2.6%) and both of them were diagnosed with gastric leakage; one patient was grade IV complication diagnosed with postoperative respiratory failure (1.3%), and all of them were cured successfully. A total of 51 patients met the textbook outcome standard, and the TO rate was positive and was steadily increasing after the number of surgical cases accumulated to the 46th case. Taking the 46th case as the boundary, all the patients were divided into learning stage group (n=46) and mastery stage group (n=31). There were no significant differences between the two groups in terms of gender, age, weight, body mass index, waist circumference, ASA classification, standard liver volume, operative time and morbidity of postoperative complication (all P>0.05). The percent of abdominal drainage tube in learning stage group was higher than that in mastery stage group (54.3% versus 16.1%, P<0.05). The length of postoperative hospital stay in learning stage group was longer than that in mastery stage group [6 (4-22) d versus 6 (5-55) d, P<0.05)]. Conclusion: The Da Vinci robotic SADI-S is safe and feasible with a learning curve of 46 cases.
Adult ; Anastomosis, Surgical ; Diabetes Mellitus, Type 2/surgery* ; Female ; Gastrectomy/methods* ; Gastric Bypass/adverse effects* ; Humans ; Learning Curve ; Male ; Middle Aged ; Obesity/surgery* ; Obesity, Morbid/surgery* ; Retrospective Studies ; Robotic Surgical Procedures

Objective:To investigate the clinical outcome and influencing factor of one-anastomosis duodenal switch (OADS) for obesity.Methods:The retrospective cohort study was conducted. The clinical data of 104 obesity patients who underwent OADS in the China-Japan Union Hospital of Jilin University from October 2018 to June 2021 were collected. There were 42 males and 62 females, aged 33(range, 18?66)years. The clinical outcome of each patient was evaluated using Textbook Outcome (TO). Observation indicators: (1) treatment situations for patients; (2) TO situa-tions; (3) analysis of factors affecting postoperative TO. Follow-up was conducted using outpatient examination or telephone interview to detect postoperative complication of patients up to November 2021. Measurement data with normal distribution were represented as Mean± SD, and comparison between groups was conducted using the t test. Measurement data with skewed distribution were represented as M (range), and comparison between groups was conducted using the Wilcoxon rank sum test. Count data were described as absolute numbers or percentages, and comparison between groups was conducted using chi-square test. Multivariate analysis was conducted using the binary Logistic regression model. Results:(1) Treatment situations for patients. All 104 patients under-went OADS without conversion to laparotomy or death of patient. The operation time and duration of postoperative hospital stay of the 104 patients were (187±39)minutes and 6(range, 4?55)days, respectively. Two of the 104 patients were readmitted. The experiences of surgeons on OADS was (53±30)cases. There were 82 patients underwent OADS using the Da Vinci robotic surgical system, while there were 22 patients underwent OADS using laparoscopic surgery system. The complication rate of 104 patients was 7.69%(8/104). Cases with stage Ⅱ, stage Ⅲb and stage Ⅳ complications of the Clavien Dindo classification were 5, 2 and 1, respectively. (2) TO situation. Of the 104 patients, 62 cases achieved TO, while 42 cases did not achieve TO. The operation time, retention time of abdominal drainage tube, duration of postoperative hospital stay, experiences of surgeons on OADS, number of OADS for surgeons using Da Vinci robotic surgical system were (166±26)minutes, 0(range, 0?7)days, 6(range, 4?7)days, 62±28, 54 in patients achieved TO, versus (218±34)minutes, 3 (range, 0?11)days, 8(range, 5?55)days, 38±27, 28 in patients not achieved TO, showing significant differences in the above indicators between them ( t=?8.81, Z=?3.63, ?5.33, t=4.27, χ2=6.27, P<0.05). Cases with complications were 0 in patients achieved TO, versus 8 in patients not achieved TO, showing a significant difference between them ( P<0.05). (3) Analysis of factors affecting postoperative TO. Results of multivariate analysis showed that the experiences of surgeons on OADS was an independent influencing factor for postoperative TO in patients undergoing OADS ( odds ratio=1.04, 95% confidence interval as 1.01?1.06, P<0.05). Conclusions:OADS is safe and feasible for obesity patients with low postoperative complication incidence and satisfactory clinical outcome. The experiences of surgeons on OADS is an independent influencing factor for postoperative TO in patients undergoing OADS.

Objective:To investigate the application value of 'N' shaped Trocar placement in Da Vinci robotic bariatric and metabolic surgery.Methods:The retrospective and descriptive study was conducted. The clinical data of 69 patients who underwent Da Vinci robotic bariatric and metabolic surgery in the China-Japan Union Hospital of Jilin University from March to October 2020 were collected. There were 18 males and 51 females, aged from 12 to 67 years, with a median age of 34 years. The surgery was performed with the 'N' shaped Trocar placement by the same team of surgeons. The Da Vinci robotic sleeve gastrectomy, Da Vinci robotic single-anastomosis duodenal-ileal bypass with sleeve gastrectomy or Da Vinci robotic biliopancreatic diversion with duodenal switch was selected according to the patient's condition. Observation indicators: (1) surgical and post-operative conditions; (2) follow-up. Follow-up using the outpatient examination, telephone interview and WeChat to detect the body weight, body mass index, fasting blood glucose, glycosylated hemoglobin, total cholesterol, Trocar-related complications of patients at postoperative 3 months. The follow-up was up to November 2020. Measurement data with normal distribution were represented as Mean± SD, and comparison of general data before and after surgery was analyzed using the paired t test. Measurement data with skewed distribution were represented as M (range). Count data were described as absolute numbers. Results:(1) Surgical and postoperative conditions: of the 69 patients, 34 cases received Da Vinci robotic sleeve gastrectomy, 34 cases received Da Vinci robotic single-anastomosis duodenal-ileal bypass with sleeve gastrectomy, and 1 case received Da Vinci robotic biliopancreatic diversion with duodenal switch. There was no conversion to open surgery or laparoscopic surgery. The operation time of 69 patients was (161±52)minutes, and the volume of intraoperative blood loss was 30 mL(range, 10-100 mL). Two of 69 patients had post-operative complications. One of them with postoperative abdominal hemorrhage was cured after symptomatic treatment and discharged on the 10th day after surgery. The other one patient with postoperative peritoneal effusion was cured and discharged from hospital after puncture drainage and symptomatic treatment. No Trocar-related complication such as Trocar foramen bleeding and Trocar foramen hernia occurred in the 69 patients. The duration of postoperative hospital stay of 69 patients was (6±3)days. (2) Follow-up: 47 of 69 patients were followed up for 3 months. The body mass, body mass index, fasting blood glucose, glycosylated hemoglobin, and total cholesterol were (86±19)kg, (30±5)kg/m 2, (5.2±0.7)mmol/L, 5.3%±0.6%, (4.3±1.3)mmol/L at postoperative 3 months, which had significant differences compared with the preoperative indicators ( t=6.101, 8.261, 2.973, 2.567, 2.098, P<0.05). All the 47 patients had no Trocar-related complications during the follow-up. Conclusion:The 'N' shaped Trocar placement method is safe and feasible in the Da Vinci robotic bariatric and metabolic surgery, with good efficacy.