1.Effect of new labor process on early postpartum pelvic floor muscle strength
Yu WANG ; Xinnan HOU ; Lei ZHANG ; Songwen NIAN ; Ruilin GUO ; Bingbing XIAO ; Xiaoqing WANG ; Xiaoxiao WANG ; Ye LU
Chinese Journal of Perinatal Medicine 2024;27(6):499-503
Objective:To explore the changes in early postpartum pelvic floor muscle strength following the implementation of the new labor process.Methods:This retrospective cohort study selected 1 834 primiparous women with singleton, full-term pregnancies who delivered at Peking University First Hospital from February 2011 to March 2016 and had a pelvic floor re-examination 6-8 weeks postpartum. Out of these, 738 cases who followed the old labor process before 2014 were categorized as the old process group, and 1 096 cases who followed the new labor process after 2014 were categorized as the new process group. Basic data, childbirth information, and postpartum pelvic floor muscle strength of the two groups were compared. Data were statistically analyzed using t-test, Chi-square test, Mann-Whitney U test, Wilcoxon rank-sum test, and ordered multicategory logistic regression to assess the impact of the new and old labor process and other factors on pelvic floor muscle strength. Results:The total duration of labor, as well as the duration of the first, second, and third stages of labor, were longer in the new process group than in the old process group [549.0 min (360.0-768.0 min) vs. 482.5 min (328.0-635.0 min), 465.0 min (297.5-672.5 min) vs. 420.0 min (285.0-555.0 min), 42.0 min (24.0-74.0 min) vs. 27.0 min (18.0-45.0 min), with Z-value of-5.72,-3.95, and-9.28, all P<0.05). The rates of vaginal delivery and labor analgesia were higher in the new process group [72.1% (790/1 096) vs. 67.2% (496/738), χ2=7.41; 67.4% (739/1 096) vs. 53.4% (394/738), χ2=36.82; both P<0.05]. There were no statistically significant differences in the comparison of Class Ⅰ and Class Ⅱ muscle strength grades between the two groups (all P>0.05). Conclusion:There was no significant decline in early postpartum pelvic floor muscle strength following the implementation of the new labor process standards.
2.Efficacy evaluation of extending or switching to tenofovir amibufenamide in patients with chronic hepatitis B: a phase Ⅲ randomized controlled study
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Chaonan JIN ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):883-892
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the efficacy of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects who were previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extended or switched TMF treatment for 48 weeks. Efficacy was evaluated based on virological, serological, biological parameters, and fibrosis staging. Statistical analysis was performed using the McNemar test, t-test, or Log-Rank test according to the data. Results:593 subjects from the initial TMF group and 287 subjects from the TDF group were included at week 144, with the proportions of HBV DNA<20 IU/ml at week 144 being 86.2% and 83.3%, respectively, and 78.1% and 73.8% in patients with baseline HBV DNA levels ≥8 log10 IU/ml. Resistance to tenofovir was not detected in both groups. For HBeAg loss and seroconversion rates, both groups showed a further increase from week 96 to 144 and the 3-year cumulative rates of HBeAg loss were about 35% in each group. However, HBsAg levels were less affected during 96 to 144 weeks. For patients switched from TDF to TMF, a substantial further increase in the alanine aminotransferase (ALT) normalization rate was observed (11.4%), along with improved FIB-4 scores.Conclusion:After 144 weeks of TMF treatment, CHB patients achieved high rates of virological, serological, and biochemical responses, as well as improved liver fibrosis outcomes. Also, switching to TMF resulted in significant benefits in ALT normalization rates (NCT03903796).
3.Safety profile of tenofovir amibufenamide therapy extension or switching in patients with chronic hepatitis B: a phase Ⅲ multicenter, randomized controlled trial
Zhihong LIU ; Qinglong JIN ; Yuexin ZHANG ; Guozhong GONG ; Guicheng WU ; Lvfeng YAO ; Xiaofeng WEN ; Zhiliang GAO ; Yan HUANG ; Daokun YANG ; Enqiang CHEN ; Qing MAO ; Shide LIN ; Jia SHANG ; Huanyu GONG ; Lihua ZHONG ; Huafa YIN ; Fengmei WANG ; Peng HU ; Xiaoqing ZHANG ; Qunjie GAO ; Peng XIA ; Chuan LI ; Junqi NIU ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(10):893-903
Objective:In chronic hepatitis B (CHB) patients with previous 96-week treatment with tenofovir amibufenamide (TMF) or tenofovir disoproxil fumarate (TDF), we investigated the safety profile of sequential TMF treatment from 96 to 144 weeks.Methods:Enrolled subjects that previously assigned (2:1) to receive either 25 mg TMF or 300 mg TDF with matching placebo for 96 weeks received extending or switching TMF treatment for 48 weeks. Safety profiles of kidney, bone, metabolism, body weight, and others were evaluated.Results:666 subjects from the initial TMF group and 336 subjects from TDF group with at least one dose of assigned treatment were included at week 144. The overall safety profile was favorable in each group and generally similar between extended or switched TMF treatments from week 96 to 144. In subjects switching from TDF to TMF, the non-indexed estimated glomerular filtration rate (by non-indexed CKD-EPI formula) and creatinine clearance (by Cockcroft-Gault formula) were both increased, which were (2.31±8.33) ml/min and (4.24±13.94) ml/min, respectively. These changes were also higher than those in subjects with extending TMF treatment [(0.91±8.06) ml/min and (1.30±13.94) ml/min]. Meanwhile, switching to TMF also led to an increase of the bone mineral density (BMD) by 0.75% in hip and 1.41% in spine. On the other side, a slight change in TC/HDL ratio by 0.16 (IQR: 0.00, 0.43) and an increase in body mass index (BMI) by (0.54±0.98) kg/m 2 were oberved with patients switched to TMF, which were significantly higher than that in TMF group. Conclusion:CHB patients receiving 144 weeks of TMF treatment showed favorable safety profile. After switching to TMF, the bone and renal safety was significantly improved in TDF group, though experienceing change in metabolic parameters and weight gain (NCT03903796).
4.Application Progress of Drug Crystal form in Clinical and Crystallization Process
Chunyan LYU ; Xiaoqing HOU ; Wenyu CUI ; Wenjun ZHANG ; Wenqian WANG ; Rui HAN
Herald of Medicine 2024;43(8):1296-1302
The difference in the crystal form of the drug leads to different solubility and stability,affecting drug's the clinical efficacy and bioavailability.Therefore,in recent years,drug crystal forms have received more and more attention from researchers.By reviewing and sorting out relevant literature,this paper summarizes the research progress of drug crystallization theory in recent years from the aspects of influencing factors of drug crystal form,identification and control of drug crystal form,drug crystal form evaluation methods,and applications,aiming to provide a reference for drug crystal form control and process screening.
5.Research Progress in Environment-responsive Nano-drug Delivery System Based on Traditional Chinese Medicine Monomer in Tumor Therapy
Chunyan LYU ; Rui HAN ; Wenyu CUI ; Wenqian WANG ; Xiaoqing HOU ; Wenjing XIN ; Wenjun ZHANG
Herald of Medicine 2024;43(11):1799-1804
Traditional Chinese medicine monomer has certain curative effects in tumor treatment,but its low targeting and difficulty in gathering at the tumor site limit its application.As a new type of drug delivery method,environmentally responsive nano drug delivery system has the advantages of targeted drug delivery,reducing drug side effects,and environmentally responsive release,and has been widely used in tumor treatment.In this paper,by consulting and sorting out the relevant literature,the general situation of traditional Chinese medicine monomers in the treatment of tumors,the classification of environment-responsive traditional Chinese medicine monomer nano drug delivery system,and its application in tumor treatment are summarized in three aspects,to provide ideas for solving the limitations of traditional Chinese medicine monomer in the treatment of tumor.
6.Principles for the rational use of national key monitoring drugs (the second batch)
Yuan BIAN ; Min CHEN ; Shan DU ; Wenyuan LI ; Lizhu HAN ; Qinan YIN ; Xiaojiao CUI ; Xuefei HUANG ; Zhujun CHEN ; Yang LEI ; Yingying HOU ; Xiaoqing YI ; Yueyuan WANG ; Xi ZHENG ; Xinxia LIU ; Ziyan LYU ; Yue WU ; Lian LI ; Xingyue ZHENG ; Liuyun WU ; Junfeng YAN ; Rongsheng TONG
China Pharmacy 2023;34(20):2433-2453
In order to strengthen the supervision of the use of drugs in hospitals,the Sichuan Academy of Medical Sciences· Sichuan Provincial People’s Hospital took the lead in compiling the Principles for the Rational Use of National Key Monitoring Drugs (the Second Batch) with a number of experts from multiple medical units in accordance with the Second Batch of National Key Monitoring Rational Drug Use List (hereinafter referred to as “the List”) issued by the National Health Commission. According to the method of the WHO Guidelines Development Manual, the writing team used the Delphi method to unify expert opinions by reading and summarizing the domestic and foreign literature evidence of related drugs, and applied the evaluation, formulation and evaluation method of recommendation grading (GRADE) to evaluate the quality of evidence formed, focusing on more than 30 drugs in the List about the evaluation of off-label indications of drugs, key points of rational drug use and key points of pharmaceutical monitoring. It aims to promote the scientific standardization and effective management of clinical medication, further improve the quality of medical services, reduce the risk of adverse drug reactions and drug abuse, promote rational drug use, and improve public health.
7.Effects of breast milk intake ratio during hospitalization on antibiotic therapy duration in preterm infants less than 34 gestational weeks: a multicenter retrospective cohort study
Chengpeng GU ; Wenjuan CHEN ; Shuping HAN ; Yan GAO ; Rongping ZHU ; Jihua ZHANG ; Rongrong CHEN ; Yan XU ; Shanyu JIANG ; Yuhan ZHANG ; Xingxing LU ; Mei XUE ; Mingfu WU ; Zhaojun PAN ; Dongmei CHEN ; Xiaobo HAO ; Xinping WU ; Jun WAN ; Huaiyan WANG ; Songlin LIU ; Danni YE ; Xiaoqing CHEN ; Weiwei HOU ; Li YANG
Chinese Journal of Perinatal Medicine 2023;26(7):546-553
Objective:To investigate the effects of breast milk to total milk intake ratio during hospitalization on the duration of antibiotic therapy in preterm infants less than 34 weeks of gestation.Methods:Clinical data of preterm infants ( n=1 792) less than 34 gestational weeks were retrospectively collected in 16 hospitals of Jiangsu Province Neonatal-Perinatal Cooperation Network from January 1, 2019, to December 31, 2021. The days of therapy (DOT) were used to evaluate the duration of antibiotic administration. The median DOT was 15.0 d (7.0-27.0 d). The patients were divided into four groups based on the quartiles of DOT: Q 1 (DOT≤7.0 d), Q 2 (7.0 d
8.Comparison of early cholecystectomy versus delayed cholecystectomy after percutaneous transhepatic gallbladder drainage for over 80-year-old patients with acute cholecystitis
Qiang NIU ; Kezhu HOU ; Xiaoqing JIANG
Chinese Journal of Hepatobiliary Surgery 2023;29(11):847-850
Objective:Comparison of early cholecystectomy (EC) and delayed cholecystectomy (DC) after percutaneous transhepatic gallbladder drainage (PTGD) for over 80-year-old patients with acute cholecystitis.Methods:Clinical data of 297 over-80-year-old patients of with acute cholecystitis undergoing surgery in Shidong Hospital Affiliated to the University of Shanghai for Science and Technology from January 2016 to January 2023 were retrospectively analyzed, including 123 males and 174 females, aged (86.1±5.2) years. There were 176 cases in EC group and 121 in PTGD-DC group. Demographic data and perioperative outcomes were compared between the groups, including gender, age, ASA score, lab test, grades of acute cholecystitis, symptom, time before EC or PTGD, intraoperative blood loss, conversion, respiratory disfunction, gangrenous cholecystitis, abdominal drainage time, postoperative complication, hospital stay, intensive care time.Results:The baseline characteristics were similar between EC and PTGD-DC groups, including demographics, ASA score, grades of acute cholecystitis, white blood cell counting, platelet counting, level of serum procalcitonin, time before EC or PTGD, and percentage of comorbidity. Compared to PTGD-DC group, Patients in DC group experienced more intraoperative blood loss (118±62 vs 32±31ml], longer operative time (135±43 vs 61±31) min], higher incidence of gangrenouscholecystitis [23.2%(41/176) vs 9.9%(12/121)], more respiratory support [16.5%(29/176) vs 11.6%(14/121)], more conversion to open surgery [22.7%(40/176) vs 9.1%(11/121)], longer postoperative abdominal drainage time (9.1±2.6 vs 3.8±2.3d], longer hospitalization (8.2±3.1 vs 6.1±2.2 d], longer intensive care (9.0±0.3 vs 4.6±0.2 h] (all P<0.05). More complications were observed in EC group, such as bile leakage, postoperative bleeding, unscheduled reoperation, bile duct injury (all P<0.05). Conclusion:PTGD and DC could lower the perioperative risk of elderly patients with acute cholecystitis.
9.Analysis of the predictive effect of early postoperative blood lipid metabolism and ratio of C-reactive protein to albumin on postoperative anastomotic fistula of esophageal cancer
Shuai ZHANG ; Xiaoqing GE ; Jin ZHANG ; Lu HOU ; Kunpeng YANG
Clinical Medicine of China 2022;38(3):199-204
Objective:To investigate the predictive effect of postoperative blood lipid metabolism and C-reactive protein/albumin ratio (CAR) on anastomotic fistula after radical resection of esophageal cancer.Methods:A retrospective case-control study was conducted on 256 patients with esophageal squamous cell carcinoma (all aged >50 years) who underwent radical esophagectomy in the thoracic surgery of the Second Affiliated Hospital of Zhengzhou University from January 2017 to December 2020. Total cholesterol, triglyceride, high density lipoprotein cholesterol (HDL-C) and low density lipoprotein cholesterol (LDL-C), ratio of C-reactive protein to albumin (CAR) and hemoglobin test index were collected. According to whether there was anastomotic fistula after operation, the patients were divided into anastomotic fistula group and non-anastomotic fistula group. The measurement data of normal distribution were compared by t-test, the measurement data of non-normal distribution were expressed by M( Q 1, Q 3), the comparison between groups was expressed by Mann-Whitney U test, and the counting data were expressed by (case(%)).The comparison between groups was performed by χ 2 test. Logistic regression model was used for multivariate analysis. ROC curve and Kappa value were used to evaluate the predictive value of total cholesterol and CAR in postoperative anastomotic fistula. Results:The preoperative body mass index (BMI) ((18.71±1.90) kg/m 2) in anastomotic fistula group was higher than that in non-anastomotic fistula group ((20.59±2.88) kg/m 2), and the difference was statistically significant ( t=3.48, P=0.001). The postoperative total cholesterol ((5.44±1.09) mmol/L), LDL-C ((3.82±1.15) mmol/L) and CAR(0.64(0.41, 0.95)) in anastomotic fistula group were higher than those in non-anastomotic fistula group ((4.54±0.94) mmol/L, (2.92±0.76) mmol/L, 0.27(0.13,0.45)). There were significant differences between the two groups (the statistical values were t=4.84, t=5.69, Z=5.16, all P<0.001)). The hemoglobin concentration of 103.20 (84.94,110.48) g/L was lower than that of non anastomotic fistula group (107.68 (99.20,125.20) g/L), the difference was statistically significant ( Z=2.82, P=0.005). Lower BMI( OR=0.652,95% CI 0.482-0.882), higher total cholesterol( OR=3.240,95% CI 1.430-7.340), lower hemoglobin ( OR=0.837,95% CI 0.777-0.902) and higher CAR( OR=2.161,95% CI 1.597-2.925) were the risk factors of anastomotic fistula in esophageal squamous cell carcinoma( P values were 0.006, 0.005, <0.001 and <0.001,respectively). ROC curve analysis showed that the areas under the curve of total cholesterol and CAR were 0.742 (95% CI:0.643-0.841, P<0.001) and 0.790 (95% CI:0.690-0.890, P<0.001) respectively. The cutoff values were 4.915 mmol/L and 0.605, the sensitivity were 80.0% and 80.0%, the specificity were 82.3% and 92.5%, respectively, and the Kappa values were 0.418 and 0.625 respectively (all P<0.001). Conclusion:Total cholesterol and CAR after radical resection of esophageal cancer have a certain predictive value for postoperative anastomotic fistula in patients with esophageal squamous cell carcinoma. The predictive result of CAR is better than that of total cholesterol.
10.Decreased vitamin D-binding protein level portends poor outcome in acute-on-chronic liver failure caused by hepatitis B virus
Daxian WU ; Qunfang RAO ; Zhongyang XIE ; Xiaoqing ZHU ; Yuanmei CHE ; Jian WU ; Hainv GAO ; Jingyu ZHANG ; Zhouhua HOU ; Xiaoyu CHENG ; Zeyu SUN
Clinical and Molecular Hepatology 2022;28(4):912-925
Background/Aims:
Acute-on-chronic liver failure (ACLF) is a catastrophic illness. Few studies investigated the prognostic value of vitamin D-binding protein (VDBP) for hepatitis B virus (HBV)-related ACLF (HBV-ACLF) resulted in conflicting results.
Methods:
Two prospective HBV-ACLF cohorts (n=287 and n=119) were enrolled to assess and validate the prognostic performance of VDBP.
Results:
VDBP levels in the non-survivors were significantly lower than in the survivors (P<0.001). Multivariate Cox regression demonstrated that VDBP was an independent prognostic factor for HBV-ACLF. The VDBP level at admission gradually decreased as the number of failed organs increased (P<0.001), and it was closely related to coagulation failure. The areas under the receiver operating characteristic curve (AUCs) of the Child-Pugh-VDBP and chronic liver failuresequential organ failure assessment (CLIF–SOFA)-VDBP scores were significantly higher than those of Child-Pugh (P<0.001) and CLIF-SOFA (P=0.0013). The AUCs of model for end-stage liver disease (MELD)-VDBP were significantly higher than those of MELD (P= 0.0384) only in the case of cirrhotic HBV-ACLF patients. Similar results were validated using an external multicenter HBV-ACLF cohort. By longitudinal observation, the VDBP levels gradually increased in survivors (P=0.026) and gradually decreased in non-survivors (P<0.001). Additionally, the VDBP levels were found to be significantly decreased in the deterioration group (P=0.012) and tended to be decreased in the fluctuation group (P=0.055). In contrast, they showed a significant increase in the improvement group (P=0.036).
Conclusions
The VDBP was a promising prognostic biomarker for HBV-ACLF. Sequential measurement of circulating VDBP shows value for the monitoring of ACLF progression.

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