1.Construction of an evaluation scale for non-alcoholic fatty liver disease with internal retention of dampness and turbidity based on the method of combining disease and syndrome
Cheng ZHOU ; Jinqiu YANG ; Tong LIU ; Shanzheng LI ; Tong LIU ; Wenxia ZHAO
Journal of Clinical Hepatology 2025;41(4):650-660
ObjectiveTo develop a scale for evaluating the syndrome of internal retention of dampness and turbidity in nonalcoholic fatty liver disease (NAFLD) that combines disease and syndrome and has the characteristics of traditional Chinese medicine (TCM). MethodsAn item pool was established for evaluating the syndrome of internal retention of dampness and turbidity in nonalcoholic fatty liver disease (NAFLD) with reference to the guideline for developing international scales. A clinical survey was conducted among the outpatients and inpatients who were diagnosed with NAFLD and had the syndrome of internal retention of dampness and turbidity in Department of Hepatology and Spleen-Stomach, The First Affiliated Hospital of Henan University of Chinese Medicine, from June to August, 2023, and the items were screened based on the classical test theory and the item response theory. An expert questionnaire was developed, and expert discussions were conducted using the Delphi method to identify the items for evaluating the syndrome of internal retention of dampness and turbidity in NAFLD. Finally, the scale was given scientific scores. ResultsA preliminary item pool was established, with 16 primary items and 22 secondary items, and it was divided into the two dimensions of disease and syndrome type. Clinical pre-survey suggested to retain 9 primary items and 14 secondary items, while the Delphi expert questionnaire recommended to retain 11 primary items and 15 secondary items, and tongue manifestation and pulse manifestation were no longer used for assessing the severity of syndrome. After hierarchical analysis and scientific assignment of scores, the scale for evaluating the syndrome of internal retention of dampness and turbidity in NAFLD had a total score of 123 points and 9 important items, i.e., discomfort in the hypochondrium, abdominal fullness and distension, obesity, heaviness of the head and body, loose stool, anorexia, coughing up phlegm, nausea with a tendency to vomit, and lethargy. ConclusionA preliminary scale is established for evaluating the syndrome of internal retention of dampness and turbidity in NAFLD, which fills the gap in this research field and provides a basis for further clinical application.
2.Disease Burden of Malignant Tumors in Chinese and Global Non-Smoking Female Population from 1990 to 2021
Danqi HUANG ; Min YANG ; Huilin WANG ; Jingyi LIU ; Wanqing CHEN ; Jinqiu YUAN ; Jingbo ZHAI ; Jiang LI
China Cancer 2025;34(8):636-644
[Purpose]To analyze the disease burden of malignant tumors and its changing trends in Chinese and global non-smoking female population from 1990 to 2021.[Methods]Data of mortality and disability-adjusted life year(DALY)due to malignant tumors for Chinese and global non-smoking female malignant tumors from 1990 to 2021 were extracted from the Global Burden of Disease Study 2021(GBD 2021),and the average annual percentage change(AAPC)were calculated using Joinpoint regression model.[Results]From 1990 to 2021,the number of deaths for malignant tu-mors in Chinese non-smoking female population increased from 13.7 1×104 to 26.8 1×104,with a higher increased trend compared with the global(China:AAPC=2.19%,95%CI:2.06%~2.33%;Global:AAPC=1.92%,95%CI:1.80%~2.04%,P=0.003);the age-standardized mortality rate decreased from 32.42/105 to 24.58/105,with a higher decreased trend compared with the global(China:AAPC=-0.88%,95%CI:-1.00%~-0.76%;Global:AAPC=-0.59%,95%CI:-0.68%~-0.51%,P<0.001).From 1990 to 2021,the DALY for malignant tumors in Chinese non-smoking female population increased from 412.96×104 to 691.20×104 person-years,with a similar changing trend compared with the global(China:AAPC=1.68%,95%CI:1.56%~1.81%,Global:AAPC=1.63%,95%CI:1.52%~1.75%,P=0.536);the age-standardized DALY rate in Chinese non-smoking female population decreased from 889.58/105 to 642.65/105,with a higher decreased trend compared with the global(China:AAPC=-1.04%,95%CI:-1.15%~-0.92%;Global:AAPC=-0.69%,95%CI:-0.78%~-0.61%,P<0.001).The top five malignant tumors of high age-standardized mor-tality rate in Chinese non-smoking female population in 2021 were tracheal,bronchus and lung cancer,colon and rectum cancer,cervical cancer,breast cancer,and liver cancer.The top five malignant tumors of high age-standardized mortality rate globally in 2021 were cervical cancer,colon and rectum cancer,breast cancer,tracheal,bronchus and lung cancer,and pancreatic cancer.The age-standardized mortality rate and DALY rate of breast cancer,liver cancer,pan-creatic cancer and corpus cancer showed overall upward trends(all P<0.05).[Conclusion]From 1990 to 2021,the number of deaths and DALY of malignant tumors in Chinese and global non-smoking female population showed overall increased trends,and age-standardized mortality rate and DALY rate showed overall decreased trends.In future,more targeted cancer prevention measures are needed to reduce the disease burden of malignant tumors in non-smoking female population.
3.Analysis of risk factors for malnutrition in children under 5 years old after congenital heart disease surgery
Jinqiu HUANG ; Fawen LU ; Hongrui SHI ; Juxian YANG
Chongqing Medicine 2025;54(11):2481-2486,2491
Objective To analyze the incidence and influencing factors of postoperative malnutrition in children under 5 years old with congenital heart disease.Methods A retrospective analysis was conducted on the clinical data of 103 children under 5 years old with congenital heart disease who underwent open-heart rad-ical surgery at the hospital from August 2019 to December 2020.Age-specific height Z-scores(HAZ),age-spe-cific weight Z-scores(WAZ),and weight-for-height Z-scores(WHZ)were calculated.Malnutrition was de-fined as any Z-score<-2.Based on nutritional status,patients were divided into a malnutrition group and a normal nutrition group.Preoperative differences between the two groups in different age periods were com-pared,and nutritional status was followed up at 1,3,and 6 months postoperatively to analyze the influencing factors for postoperative malnutrition.Results Among 103 pediatric patients,42 had preoperative malnutri-tion,with a malnutrition incidence of 40.8%.The incidence of malnutrition decreased to 24.3%(25/103)six months after surgery.At one month postoperatively,HAZ,WAZ,and WHZ decreased compared with preoper-ative values across different age groups,while they increased at three and six months postoperatively;howev-er,only the WHZ in the toddler group showed a statistically significant difference compared to preoperative values(P<0.05).Multivariate logistic regression analysis indicated that preoperative malnutrition was a risk factor for malnutrition six months after surgery(P<0.05),whereas age stage had no effect on postoperative malnutrition at six months(P>0.05).Conclusion Children with congenital heart disease generally suffer from malnutrition before surgery,and early identification and intervention should be carried out to promote their growth and development.
4.Disease Burden of Malignant Tumors in Chinese and Global Non-Smoking Female Population from 1990 to 2021
Danqi HUANG ; Min YANG ; Huilin WANG ; Jingyi LIU ; Wanqing CHEN ; Jinqiu YUAN ; Jingbo ZHAI ; Jiang LI
China Cancer 2025;34(8):636-644
[Purpose]To analyze the disease burden of malignant tumors and its changing trends in Chinese and global non-smoking female population from 1990 to 2021.[Methods]Data of mortality and disability-adjusted life year(DALY)due to malignant tumors for Chinese and global non-smoking female malignant tumors from 1990 to 2021 were extracted from the Global Burden of Disease Study 2021(GBD 2021),and the average annual percentage change(AAPC)were calculated using Joinpoint regression model.[Results]From 1990 to 2021,the number of deaths for malignant tu-mors in Chinese non-smoking female population increased from 13.7 1×104 to 26.8 1×104,with a higher increased trend compared with the global(China:AAPC=2.19%,95%CI:2.06%~2.33%;Global:AAPC=1.92%,95%CI:1.80%~2.04%,P=0.003);the age-standardized mortality rate decreased from 32.42/105 to 24.58/105,with a higher decreased trend compared with the global(China:AAPC=-0.88%,95%CI:-1.00%~-0.76%;Global:AAPC=-0.59%,95%CI:-0.68%~-0.51%,P<0.001).From 1990 to 2021,the DALY for malignant tumors in Chinese non-smoking female population increased from 412.96×104 to 691.20×104 person-years,with a similar changing trend compared with the global(China:AAPC=1.68%,95%CI:1.56%~1.81%,Global:AAPC=1.63%,95%CI:1.52%~1.75%,P=0.536);the age-standardized DALY rate in Chinese non-smoking female population decreased from 889.58/105 to 642.65/105,with a higher decreased trend compared with the global(China:AAPC=-1.04%,95%CI:-1.15%~-0.92%;Global:AAPC=-0.69%,95%CI:-0.78%~-0.61%,P<0.001).The top five malignant tumors of high age-standardized mor-tality rate in Chinese non-smoking female population in 2021 were tracheal,bronchus and lung cancer,colon and rectum cancer,cervical cancer,breast cancer,and liver cancer.The top five malignant tumors of high age-standardized mortality rate globally in 2021 were cervical cancer,colon and rectum cancer,breast cancer,tracheal,bronchus and lung cancer,and pancreatic cancer.The age-standardized mortality rate and DALY rate of breast cancer,liver cancer,pan-creatic cancer and corpus cancer showed overall upward trends(all P<0.05).[Conclusion]From 1990 to 2021,the number of deaths and DALY of malignant tumors in Chinese and global non-smoking female population showed overall increased trends,and age-standardized mortality rate and DALY rate showed overall decreased trends.In future,more targeted cancer prevention measures are needed to reduce the disease burden of malignant tumors in non-smoking female population.
5.Clinical guideline for diagnosis and treatment of nonunion of osteoporotic vertebral fractures (version 2025)
Haipeng SI ; Le LI ; Junjie NIU ; Wencan ZHANG ; Fuxin WEI ; Jinqiu YUAN ; Qiang YANG ; Hongli WANG ; Guangchao WANG ; Shihong CHEN ; Yunzhen CHEN ; Xiaoguang CHENG ; Jianwen DONG ; Shiqing FENG ; Rui GU ; Yong HAI ; Tianyong HOU ; Bo HUANG ; Xiaobing JIANG ; Lei ZANG ; Chunhai LI ; Nianhu LI ; Hua LIN ; Hongjian LIU ; Peng LIU ; Xinyu LIU ; Sheng LU ; Shibao LU ; Chunshan LUO ; Lvy CHAOLIANG ; Lvy WEIJIA ; Xuexiao MA ; Wei MEI ; Chunyang MENG ; Cailiang SHEN ; Chunli SONG ; Ruoxian SONG ; Jiacan SU ; Honglin TENG ; Hui SHENG ; Beiyu WANG ; Bingwu WANG ; Liang WANG ; Xiangyang WANG ; Nan WU ; Guohua XU ; Yayi XIA ; Jin XU ; Youjia XU ; Jianzhong XU ; Cao YANG ; Maowei YANG ; Zibin YANG ; Xiaojian YE ; Hailong YU ; Xijie YU ; Hua YUE ; Zhili ZENG ; Xinli ZHAN ; Hui ZHANG ; Peixun ZHANG ; Wei ZHANG ; Zhenlin ZHANG ; Jianguo ZHANG ; Tengyue ZHU ; Qiang LIU ; Huilin YANG
Chinese Journal of Trauma 2025;41(10):932-945
Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.
6.Trabecular bone score and its association with muscle health in the postmenopausal population
Jinqiu SUN ; Jingjing TAN ; Junchao YANG ; Xiaosheng YANG ; Fengrong MA ; Junqiang QIU
Chinese Journal of Health Management 2025;19(5):349-354
Objective:To analyze the trabecular bone score (TBS) and its association with muscle health in the postmenopausal population.Methods:It was a cross-sectional study. A total of 214 postmenopausal individuals who underwent dual-energy X-ray absorptiometry testing at the Beijing Research Institute of Sports Science between January and December 2023 were consecutively included. The participants were divided into two groups based on the presence or absence of osteoporosis (OP): 62 cases in the OP group and 152 cases in the non-OP group. All subjects completed body composition assessments and scans of bilateral hip and lumbar spine bone mineral density (BMD)(All the BMD in this study were areal BMD). Demographic data, including age, age at menarche, age at menopause, and fracture history, were also collected. TBS was calculated using the TBS iNsight software. Muscle health indicators included upper limb, lower limb, trunk, and total muscle mass, lean body mass, appendicular skeletal muscle mass index (ASMI), and grip strength. The Pearson correlation analysis was used to determine the relationship between TBS and muscle health indicators, as well as between TBS and the BMD of lumbar spine (L 1-4). Further, multiple linear regression analysis was conducted to explore the independent association between TBS and muscle health indicators. Results:TBS, lean body mass, ASMI, grip strength, and muscle mass of the upper limb, lower limb, trunk, whole body in the OP group were all lower than those in the non-OP group [(1.27±0.07) vs (1.35±0.07) score, (36.64±3.45) vs (39.14±3.62) kg, (6.16±0.56) vs (6.44±0.63) kg/m2, (23.87±3.31) vs (25.34±4.33) kg, (3.54±0.47) vs (3.78±0.47) kg, (11.70±1.33) vs (12.68±1.49) kg, (16.57±1.68) vs (17.50±1.69) kg, and (34.91±3.33) vs (37.13±3.47) kg] (all P<0.05). Pearson analysis showed that TBS was positively correlated with lean body mass, ASMI, grip strength, and muscle mass of the upper limb, lower limb, whole body (all P<0.05). TBS was negatively correlated with age ( P<0.01). TBS was positively correlated with the BMD of lumbar spine (L 1-4) ( r=0.660, P<0.01). Multiple regression analysis demonstrated that ASMI was positively correlated with TBS ( β=0.284, P<0.01). Conclusion:In the postmenopausal population, individuals with OP have lower TBS. Furthermore, TBS is closely associated with muscle health.
7.Comparison of the efficacy of remimazolam and propofol in the induction and maintenance of general anesthesia in elderly patients undergoing thoracoscopic lobectomy
Chun LIU ; Juan HU ; Yu HUANG ; Jinqiu YANG ; Junjie LI ; Ping YANG ; Pengfei PAN
China Pharmacy 2025;36(16):2040-2045
OBJECTIVE To compare the clinical efficacy and safety of remimazolam and propofol in general anesthesia induction and maintenance for elderly patients undergoing thoracoscopic lobectomy. METHODS A total of 86 elderly lung cancer patients who underwent thoracoscopic lobectomy at Chongqing University Three Gorges Hospital from February to July 2024 were selected and divided into the propofol group and the remimazolam group according to the randomized numerical table method, with 43 cases in each group. During anesthesia induction, patients in the propofol group and the remimazolam group were intravenously administered 2 mg/kg of Propofol medium- and long-chain fat emulsion injection or 0.25 mg/kg of Remimazolam tosilate for injection, respectively; during anesthesia maintenance, the two groups received intravenous infusion of 6-10 mg/(kg·h) of Propofol medium- and long- chain fat emulsion injection or 1-3 mg/(kg·h) of Remimazolam tosilate for injection, respectively. The anesthesia effects, anesthesia-related indicators, intraoperative opioid and muscle relaxant dosages, Ramsay sedation score, numerical rating scale (NRS) score, and hemodynamic parameters were compared between the two groups, and the occurrence of adverse drug reactions was recorded. RESULTS A total of 41 patients in the propofol group and 43 patients in the remimazolam group completed the trial. The proportion of patients with grade Ⅰ anesthesia effect in the remimazolam group was significantly higher than that in the propofol group, while the proportion of patients with grade Ⅱ anesthesia effect was significantly lower than that in the propofol group (P<0.05). In this group, the disappearance time of eyelash reflex, the time taken for the bispectral index to drop to 60, and the Ramsay sedation scores (2 and 6 hours after operation) were all significantly prolonged or increased, while the recovery time, NRS scores (2 and 6 hours after operation), and the incidence of intraoperative hypotension were all significantly shortened or reduced; moreover, the improvements of the above sedation/NRS scores exhibited a time-dependent pattern within 2 to 24 hours after operation (P<0.05). Compared with before anesthesia induction (T0), the heart rate [except at 2 min after medication (T1), 60 min after anesthesia (T4), and at the end of surgery (T5) in the remimazolam group] and mean arterial pressure [except at T1 in the remimazolam group] of patients in both groups significantly decreased at T1, 5 min after medication (T2), at the start of surgery (T3), T4, and T5 (P<0.05). Meanwhile, regional cerebral oxygen saturation significantly increased in both groups. Furthermore, the heart rate and mean arterial pressure of patients in the remimazolam group were significantly higher than those in the propofol group at T1, T2 and T4 (P<0.05). No statistically significant differences were observed between the two groups in terms of postanesthesia care unit stay time, dosage of opioids and muscle relaxants, regional cerebral oxygen saturation, or peripheral oxygen saturation at various time points (P>0.05). CONCLUSIONS Compared to propofol, remimazolam demonstrates superior anesthesia effects when used for the induction and maintenance of general anesthesia in elderly patients undergoing thoracoscopic lobectomy. It not only provides more stable intraoperative hemodynamics and shortens the postoperative recovery time but also effectively reduces the incidence of intraoperative hypotension.
8.Clinical guideline for diagnosis and treatment of nonunion of osteoporotic vertebral fractures (version 2025)
Haipeng SI ; Le LI ; Junjie NIU ; Wencan ZHANG ; Fuxin WEI ; Jinqiu YUAN ; Qiang YANG ; Hongli WANG ; Guangchao WANG ; Shihong CHEN ; Yunzhen CHEN ; Xiaoguang CHENG ; Jianwen DONG ; Shiqing FENG ; Rui GU ; Yong HAI ; Tianyong HOU ; Bo HUANG ; Xiaobing JIANG ; Lei ZANG ; Chunhai LI ; Nianhu LI ; Hua LIN ; Hongjian LIU ; Peng LIU ; Xinyu LIU ; Sheng LU ; Shibao LU ; Chunshan LUO ; Lvy CHAOLIANG ; Lvy WEIJIA ; Xuexiao MA ; Wei MEI ; Chunyang MENG ; Cailiang SHEN ; Chunli SONG ; Ruoxian SONG ; Jiacan SU ; Honglin TENG ; Hui SHENG ; Beiyu WANG ; Bingwu WANG ; Liang WANG ; Xiangyang WANG ; Nan WU ; Guohua XU ; Yayi XIA ; Jin XU ; Youjia XU ; Jianzhong XU ; Cao YANG ; Maowei YANG ; Zibin YANG ; Xiaojian YE ; Hailong YU ; Xijie YU ; Hua YUE ; Zhili ZENG ; Xinli ZHAN ; Hui ZHANG ; Peixun ZHANG ; Wei ZHANG ; Zhenlin ZHANG ; Jianguo ZHANG ; Tengyue ZHU ; Qiang LIU ; Huilin YANG
Chinese Journal of Trauma 2025;41(10):932-945
Nonunion of osteoporotic vertebral fractures (OVF), predominantly affecting the elderly, can lead to intractable pain, vertebral collapse, progressive kyphotic deformity, and neurological impairment, significantly compromising patients′ quality of life. There exists considerable debate on diagnosis and management of OVF, encompassing key issues such as clinical diagnosis and staging criteria for nonunion, surgical indications and procedure selection, and postoperative rehabilitation planning. Currently, there lacks standardized clinical guideline and expert consensus on the diagnosis and management of OVF nonunion in China. To address this gap, Minimally Invasive Surgery Group of Chinese Orthopedic Association, Osteoporosis Committee of Chinese Association of Orthopedic Surgeons, Prevention and Rehabilitation Committee for Osteoporosis of Chinese Association of Rehabilitation Medicine and Minimally Invasive Orthopedic Surgery Branch of China Association for Geriatric Care jointly organized domestic experts in spinal surgery, endocrinology, and rehabilitation to formulate the Clinical guideline for the diagnosis and treatment for nonunion of osteoporotic vertebral fractures ( version 2025), based on existing literature and clinical experience and adhering to principles of scientific rigor and practicality. The guideline provided 13 evidence-based recommendations encompassing diagnosis and treatment of OVF nonunion, aiming to standardize its clinical management.
9.Trabecular bone score and its association with muscle health in the postmenopausal population
Jinqiu SUN ; Jingjing TAN ; Junchao YANG ; Xiaosheng YANG ; Fengrong MA ; Junqiang QIU
Chinese Journal of Health Management 2025;19(5):349-354
Objective:To analyze the trabecular bone score (TBS) and its association with muscle health in the postmenopausal population.Methods:It was a cross-sectional study. A total of 214 postmenopausal individuals who underwent dual-energy X-ray absorptiometry testing at the Beijing Research Institute of Sports Science between January and December 2023 were consecutively included. The participants were divided into two groups based on the presence or absence of osteoporosis (OP): 62 cases in the OP group and 152 cases in the non-OP group. All subjects completed body composition assessments and scans of bilateral hip and lumbar spine bone mineral density (BMD)(All the BMD in this study were areal BMD). Demographic data, including age, age at menarche, age at menopause, and fracture history, were also collected. TBS was calculated using the TBS iNsight software. Muscle health indicators included upper limb, lower limb, trunk, and total muscle mass, lean body mass, appendicular skeletal muscle mass index (ASMI), and grip strength. The Pearson correlation analysis was used to determine the relationship between TBS and muscle health indicators, as well as between TBS and the BMD of lumbar spine (L 1-4). Further, multiple linear regression analysis was conducted to explore the independent association between TBS and muscle health indicators. Results:TBS, lean body mass, ASMI, grip strength, and muscle mass of the upper limb, lower limb, trunk, whole body in the OP group were all lower than those in the non-OP group [(1.27±0.07) vs (1.35±0.07) score, (36.64±3.45) vs (39.14±3.62) kg, (6.16±0.56) vs (6.44±0.63) kg/m2, (23.87±3.31) vs (25.34±4.33) kg, (3.54±0.47) vs (3.78±0.47) kg, (11.70±1.33) vs (12.68±1.49) kg, (16.57±1.68) vs (17.50±1.69) kg, and (34.91±3.33) vs (37.13±3.47) kg] (all P<0.05). Pearson analysis showed that TBS was positively correlated with lean body mass, ASMI, grip strength, and muscle mass of the upper limb, lower limb, whole body (all P<0.05). TBS was negatively correlated with age ( P<0.01). TBS was positively correlated with the BMD of lumbar spine (L 1-4) ( r=0.660, P<0.01). Multiple regression analysis demonstrated that ASMI was positively correlated with TBS ( β=0.284, P<0.01). Conclusion:In the postmenopausal population, individuals with OP have lower TBS. Furthermore, TBS is closely associated with muscle health.
10.Safety of high-carbohydrate fluid diet 2 h versus overnight fasting before non-emergency endoscopic retrograde cholangiopancreatography: A single-blind, multicenter, randomized controlled trial
Wenbo MENG ; W. Joseph LEUNG ; Zhenyu WANG ; Qiyong LI ; Leida ZHANG ; Kai ZHANG ; Xuefeng WANG ; Meng WANG ; Qi WANG ; Yingmei SHAO ; Jijun ZHANG ; Ping YUE ; Lei ZHANG ; Kexiang ZHU ; Xiaoliang ZHU ; Hui ZHANG ; Senlin HOU ; Kailin CAI ; Hao SUN ; Ping XUE ; Wei LIU ; Haiping WANG ; Li ZHANG ; Songming DING ; Zhiqing YANG ; Ming ZHANG ; Hao WENG ; Qingyuan WU ; Bendong CHEN ; Tiemin JIANG ; Yingkai WANG ; Lichao ZHANG ; Ke WU ; Xue YANG ; Zilong WEN ; Chun LIU ; Long MIAO ; Zhengfeng WANG ; Jiajia LI ; Xiaowen YAN ; Fangzhao WANG ; Lingen ZHANG ; Mingzhen BAI ; Ningning MI ; Xianzhuo ZHANG ; Wence ZHOU ; Jinqiu YUAN ; Azumi SUZUKI ; Kiyohito TANAKA ; Jiankang LIU ; Ula NUR ; Elisabete WEIDERPASS ; Xun LI
Chinese Medical Journal 2024;137(12):1437-1446
Background::Although overnight fasting is recommended prior to endoscopic retrograde cholangiopancreatography (ERCP), the benefits and safety of high-carbohydrate fluid diet (CFD) intake 2 h before ERCP remain unclear. This study aimed to analyze whether high-CFD intake 2 h before ERCP can be safe and accelerate patients’ recovery.Methods::This prospective, multicenter, randomized controlled trial involved 15 tertiary ERCP centers. A total of 1330 patients were randomized into CFD group ( n = 665) and fasting group ( n = 665). The CFD group received 400 mL of maltodextrin orally 2 h before ERCP, while the control group abstained from food/water overnight (>6 h) before ERCP. All ERCP procedures were performed using deep sedation with intravenous propofol. The investigators were blinded but not the patients. The primary outcomes included postoperative fatigue and abdominal pain score, and the secondary outcomes included complications and changes in metabolic indicators. The outcomes were analyzed according to a modified intention-to-treat principle. Results::The post-ERCP fatigue scores were significantly lower at 4 h (4.1 ± 2.6 vs. 4.8 ± 2.8, t = 4.23, P <0.001) and 20 h (2.4 ± 2.1 vs. 3.4 ± 2.4, t= 7.94, P <0.001) in the CFD group, with least-squares mean differences of 0.48 (95% confidence interval [CI]: 0.26–0.71, P <0.001) and 0.76 (95% CI: 0.57–0.95, P <0.001), respectively. The 4-h pain scores (2.1 ± 1.7 vs. 2.2 ± 1.7, t = 2.60, P = 0.009, with a least-squares mean difference of 0.21 [95% CI: 0.05–0.37]) and positive urine ketone levels (7.7% [39/509] vs. 15.4% [82/533], χ2 = 15.13, P <0.001) were lower in the CFD group. The CFD group had significantly less cholangitis (2.1% [13/634] vs. 4.0% [26/658], χ2 = 3.99, P = 0.046) but not pancreatitis (5.5% [35/634] vs. 6.5% [43/658], χ2 = 0.59, P = 0.444). Subgroup analysis revealed that CFD reduced the incidence of complications in patients with native papilla (odds ratio [OR]: 0.61, 95% CI: 0.39–0.95, P = 0.028) in the multivariable models. Conclusion::Ingesting 400 mL of CFD 2 h before ERCP is safe, with a reduction in post-ERCP fatigue, abdominal pain, and cholangitis during recovery.Trail Registration::ClinicalTrials.gov, No. NCT03075280.

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