1.Evaluation of efficacy and tolerability of TCIC-001 for bowel preparation prior to colonoscopy: an exploratory randomized controlled clinical trial
Baohui SONG ; Xiaolong ZHUANG ; BAHETINUER JIASHAER ; Xiaoyue XU ; Jiaxin XU ; Danfeng ZHANG ; Yunshi ZHONG ; Pinghong ZHOU ; Mingyan CAI
Chinese Journal of Clinical Medicine 2025;32(5):743-747
Objective To compare the efficacy and tolerability of the novel bowel-cleansing agent TCIC-001 and the traditional polyethylene glycol (PEG) regimen for bowel preparation prior to colonoscopy. Methods Prospective inclusion of 62 patients who were scheduled to undergo colonoscopy at Zhongshan Hospital, Fudan University from July 2021 to July 2022. They were randomly divided into TCIC-001 group (n=31) and PEG group (n=31) using a random number table method. The TCIC-001 group took TCIC-001 orally, drinking water in stages, with a total liquid intake of 1 500 mL; the PEG group took PEG orally, taking it in 4 doses, with a total liquid intake of 3 000 mL. The primary endpoint indicator is the quality of intestinal hygiene evaluated by the Boston Bowel Preparation Scale (BBPS), the secondary endpoint indicators were medication adherence, medication duration, frequency of bowel movements, duration of bowel movements, and incidence of adverse events between two groups. Results No significant differences were observed in sex, age, or defecation frequency between the two groups. For efficacy, both groups achieved equivalent bowel cleanliness, with a “good preparation” rate of 93.55% and comparable BBPS score of each intestinal segment and total scores. For tolerability, the TCIC-001 group had a shorter medication duration compared to the PEG group ([48.8±25.9] min vs [82.8±28.4] min, P<0.001), a longer defecation duration ([288.6±74.0] min vs [236.5±74.3] min, P<0.001), and a lower incidence of first defecation before medication completion (9.68% vs 41.94%, P=0.004). Regarding safety, no significant differences were observed between the TCIC-001 group and the PEG group in incidences of chloride disturbances (0% vs 9.68%) and calcium disturbances (3.23% vs 6.45%), and no other adverse events. Conclusions TCIC-001 demonstrated comparable bowel-cleansing efficacy to PEG while significantly improving tolerability (reduced medication time and lower risk of premature defecation) and maintaining favorable safety.
2.Preclinical efficacy and safety evaluation of a novel gastrointestinal mucosal elevation gel in vivo porcine model
Yicheng TIAN ; BAHETINUER JIASHAER ; Yan ZHU ; Wei XIA ; Pinghong ZHOU ; Mingyan CAI
Chinese Journal of Clinical Medicine 2025;32(5):768-775
Objective To evaluate the efficacy and safety of a novel gastrointestinal mucosal elevation gel in vivo porcine model. Methods Eight healthy white pigs were selected, which were uesd to bump height evaluation (n=2) and safety evaluation (n=6). The sample (alimentary canal mucosa bump gel sample) and the control sample (disposable endoscopic submucosal filler of alimentary canal) were respectively injected into the submucosa of pig gastric antrum and gastric body. In the evaluation of elevation height, the morphology, persistence, and clinical safety of mucosal elevation were observed and recorded immediately and 30 minutes after injection. In safety evaluation, endoscopic mucosal resection was performed after injection, and the mucosal protrusion shape, product efficacy, and clinical safety were observed and recorded at immediate and 7-day time points. After observation, all animals were euthanized and tissue samples were collected and excised for histopathological evaluation. Results In elevation height evaluation, sample group showed a steep elevation immediately after surgery, exhibiting a more pronounced elevation morphology compared to control group (P=0.019). Only two (25%) sites of the elevation showed slight collapse in 30 minutes after surgery, and the durability notably increased compared to control group (8 all collapsed, P<0.001). In safety evaluation, the average trauma area of sample group was 1.77 mm2, which was significantly lower than control group (2.65 mm2, P<0.001). There was no statistical difference among average injection dose per unit area, surgical time per unit area, and en bloc resection rate. Sample group showed mild ulcers and only 1 (12.5%) site of mild bleeding at immediate time point after surgery. No bleeding, perforation, ulcer or edema was observed in sample group 7 days after surgery, and no statistical difference was identified compared to control group. Histopathological evaluation found that the gastric antrum and body tissues exhibited moderate injury and mild edema at immediate time point, accompanied by mild inflammatory cellular infiltration. At 7-day time point, gastric antrum tissues demonstrated moderate injury, mild edema and mild inflammatory cellular infiltration, with 1 (12.5%) site of tissues infected, while in gastric body tissues, no bleeding was observed, whereas moderate injury and mild edema were evident, accompanied by mild inflammatory cellular infiltration and 3 (37.5%) sites of tissues infected, all of which were not statistically different from control group. Conclusion The novel gastrointestinal mucosal elevation gel exhibited steep elevation morphology, long-lasting elevation height, and favorable efficacy and safety in preclinical animal trials, showing enormous clinical application potential.
3.Risk factors for surgical site infection in liver transplant recipients: A meta-analysis
Jianfen ZHOU ; Mingyan SHEN ; Tian HE ; Linqiu HAN
Chinese Journal of Clinical Infectious Diseases 2024;17(2):150-155
Objective:To analyze the risk factors for surgical site infections(SSI)in liver transplant recipients.Methods:Relevant studies on the risk factors for SSI in liver transplant recipients were searched in PubMed,Web of Science,EMbase,The Cochrane Library,CNKI,Wanfang,Vep,and the Chinese Biomedical Literature Database from inception to July 10,2023. The literature quality was assessed,and meta-analysis was performed using RevMan 5.4 and Stata 16 software.Results:A total of 10 studies involving 3 113 adult liver transplant recipients were included,and 723 cases of SSI were reported. Meta-analysis revealed that Roux-en-Y biliary reconstruction( OR=2.60,95% CI 1.45-4.65),bile leakage( OR=17.22,95% CI 8.48-34.96),repeat surgery( OR=7.22,95% CI 4.25-12.26),re-transplantation( OR=13.88,95% CI 7.71-24.97),prolonged surgical duration( MD=0.52,95% CI 0.19-0.84),dialysis( OR=3.44,95% CI 2.41-4.91),and extended hospital stay( MD=11.42,95% CI 5.73-17.12)were independent risk factors for SSI in liver transplant recipients. Conclusion:The identified risk factors for SSI in liver transplant recipients include Roux-en-Y biliary reconstruction,bile leakage,repeat surgery,re-transplantation,prolonged surgical duration,dialysis,and extended hospital stay. Clinicians should enhance the assessment of these factors and take effective intervention to improve clinical outcomes for liver transplant recipients.
4.Evaluation and management of gastrointestinal fistula after upper gastrointestinal tunnel endoscopic surgery
Liang ZHU ; Quanlin LI ; Zuqiang LIU ; Mingyan CAI ; Wenzheng QIN ; Weifeng CHEN ; Yiqun ZHANG ; Yunshi ZHONG ; Liqing YAO ; Pinghong ZHOU
Chinese Journal of Digestive Endoscopy 2023;40(12):1006-1010
To investigate the evaluation and management of gastrointestinal fistula after upper gastrointestinal tunnel endoscopic surgery, a retrospective analysis was performed on 15 patients with gastrointestinal fistula after upper gastrointestinal tunnel endoscopic surgery, who were treated at the Endoscopy Center of Zhongshan Hospital, Fudan University from January 2012 to October 2022. All patients were treated successfully after comprehensive treatment. Three patients received metal clipping and gastric tube drainage; 10 patients received gastric tube drainage combined with jejunal nutritional tube placement, and 7 of them had gastric tube directly put into the fistula cavity; 2 patients received covered esophageal stent placement combined with jejunal nutritional tube placement. Five patients received wound tissue glue spraying; 2 patients underwent purse-string suture with nylon loops and metal clips after reduced fistula burned by hot biopsy forcep or argon plasma coagulation. The gastrointestinal fistula after tunnel endoscopic surgery is a complex postoperative complication, which needs early detection, careful evaluation and comprehensive treatment.
5.Patient outcomes after neonatal tracheotomy: A retrospective case-control study.
Jie YU ; Fengzhen ZHANG ; Fei JIN ; Jingwen WENG ; Yaguang PENG ; Jingjing ZHOU ; Yan CHEN ; Jie ZHANG ; Mingyan HEI
Chinese Medical Journal 2023;136(10):1246-1248
6.Outcomes and post-discharge follow-up of neonatal tracheotomy in NICU
Fei JIN ; Jie YU ; Jingwen WENG ; Yaguang PENG ; Jingjing ZHOU ; Yan CHEN ; Jie ZHANG ; Mingyan HEI
Chinese Pediatric Emergency Medicine 2023;30(3):194-198
Objective:To study the outcomes and post-discharge follow-up of neonatal tracheotomy in neonatal intensive care unit(NICU).Methods:This study included patients who were admitted to NICU in Beijing Children′s Hospital from January, 2016 to August, 2021, and less than 28 days or 44 weeks(corrected age)on admission, and required tracheotomy.The patients were divided into tracheotomy group and the non-tracheotomy group (the parents signed to refuse the tracheotomy) according to whether perform tracheotomy.Demographic data, general hospitalization information, diagnosis, indications for tracheotomy, follow-up outcomes at 3/6/12 months of age after discharge of patients were collected and analyzed.Results:Totally 26 patients were included in this study, 14 cases in tracheotomy group and 12 cases in non-tracheotomy group.The average gestational age was(37.7±3.80)weeks and(38.99±1.83)weeks, and birth weight was(2 823.57±948.89)g and (3 320.83±378.76)g, respectively.There were no significant differences in sex, gestational age, birth weight, age on admission, weight on admission, age at diagnosis, ratio of endotracheal intubation for respiratory support on admission between two groups( P>0.05). The commonest indications of tracheotomy group were bilateral vocal cord paralysis(50.0%) and congenital anomaly/defect of throat/larynx(21.4%), and the commonest indications of non-tracheotomy group were bilateral vocal cord paralysis(50.0%) and vocal cord/subglottic mass(25.0%), and there was no significant difference between two groups( P>0.05). The rate of discharge-against-medical order of tracheotomy and non-tracheotomy group was 7.14% and 66.67%( P=0.003), respectively.The total follow-up rate of tracheotomy and non-tracheotomy group was 88.9% and 38.9%, while the follow-up rates at 3 months, 6 months, and 12 months were 100.0% vs. 50.0%, 83.3% vs. 41.7%, and 81.8% vs. 25.0%, respectively, whose differences were statistically significant(all P<0.05). In the 14 cases of tracheotomy group, 3 cases died, 4 cases successfully removed the tracheal cannula, 5 cases did not remove the tracheal cannula, and 2 cases were lost. Conclusion:Bilateral vocal cord paralysis is the commonest indication of neonatal tracheotomy.Parents′ compliance in the tracheotomy group is significantly higher than that in non-tracheotomy group.To give caring skill training for parents of neonates with tracheotomy before discharge is beneficial for improving the overall prognosis of children.
7.Expert consensus on recombinant B subunit/inactivated whole-cell cholera vaccine in preventing infectious diarrhea of enterotoxigenic Escherichia coli
Chai JI ; Yu HU ; Mingyan LI ; Yan LIU ; Yuyang XU ; Hua YU ; Jianyong SHEN ; Jingan LOU ; Wei ZHOU ; Jie HU ; Zhiying YIN ; Jingjiao WEI ; Junfen LIN ; Zhenyu SHEN ; Ziping MIAO ; Baodong LI ; Jiabing WU ; Xiaoyuan LI ; Hongmei XU ; Jianming OU ; Qi LI ; Jun XIANG ; Chen DONG ; Haihua YI ; Changjun BAO ; Shicheng GUO ; Shaohong YAN ; Lili LIU ; Zengqiang KOU ; Shaoying CHANG ; Shaobai ZHANG ; Xiang GUO ; Xiaoping ZHU ; Ying ZHANG ; Bangmao WANG ; Shuguang CAO ; Peisheng WANG ; Zhixian ZHAO ; Da WANG ; Enfu CHEN
Chinese Journal of Clinical Infectious Diseases 2023;16(6):420-426
Enterotoxigenic Escherichia coli(ETEC)infection can induce watery diarrhea,leading to dehydration,electrolyte disturbance,and even death in severe cases. Recombinant B subunit/inactivated whole-cell cholera(rBS/WC)vaccine is effective in preventing ETEC infectious diarrhea. On the basis of the latest evidence on etiology and epidemiology of ETEC,as well as the effectiveness,safety,and health economics of rBS/WC vaccine,National Clinical Research Center for Child Health(The Children’s Hospital,Zhejiang University School of Medicine)and Zhejiang Provincial Center for Disease Control and Prevention invited experts to develop expert consensus on rBS/WC vaccine in prevention of ETEC infectious diarrhea. It aims to provide the clinicians and vaccination professionals with guidelines on using rBS/WC vaccine to reduce the incidence of ETEC infectious diarrhea.
8.Overview of Chinese Neonatal Network: current and future
Siyuan JIANG ; Yun CAO ; Mingyan HEI ; Jianhua SUN ; Xiaoying LI ; Huayan ZHANG ; Xiaolu MA ; Hui WU ; Laishuan WANG ; Huiqing SUN ; Yuan SHI ; Wei ZHOU ; Chao CHEN ; Lizhong DU ; Wenhao ZHOU ; K. Shoo LEE
Chinese Pediatric Emergency Medicine 2023;30(11):809-815
The Chinese Neonatal Network(CHNN) was established in 2018 with the mission of establishing a national collaboration platform, conducting high-quality and collaborative research, and ultimately improving the quality of neonatal-perinatal care and health in China.At present, 112 hospitals across the country have joined CHNN.CHNN has established a national standardized cohort of very premature infants/very low birth weight infants with >10 000 enrollments each year, has been leading data-driven collaborative quality improvement initiatives, conducting multicenter clinical studies, and performing multi-level training programs.Guided by the principles of collaboration and sharing, data-driven, continuous improvement, and international integration, CHNN has become an important platform for clinical and research collaboration in neonatal medicine in China.
9.Role of occupational satisfaction and occupational proactive behavior in the relationship between nurse occupational insecurity and work engagement
Mingyan YANG ; Mei YANG ; Dejian ZENG ; Mingli GUO ; Xuehua WU ; Zhiling WANG ; Mingjian ZHOU
Chinese Journal of Modern Nursing 2023;29(24):3296-3301
Objective:To explore the effect of job insecurity on work engagement, and examine the mediating role of job satisfaction and the moderating role of occupational proactive behavior.Methods:Using the convenient sampling method, nurses from Southern University of Science and Technology Hospital and Jiangyou Second People's Hospital were selected as the research objects in July 2022. General information questionnaire, Occupational Insecurity Scale, Occupational Satisfaction Scale, Work Engagement Scale and Occupational Proactive Behavior were used for questionnaire investigation. A total of 598 valid questionnaires were collected. Model 4 and Model 7 in the SPSS 22.0 Process were used to test the mediating effect and the moderated mediating effect respectively.Results:Occupational insecurity was negatively correlated with occupational satisfaction and work engagement ( r=-0.202, -0.165, P<0.01) , while occupational satisfaction was positively correlated with work engagement ( r=0.549, P<0.01) . Work satisfaction played a completely mediating role in the effect of job insecurity on work engagement (mediating effect value: -0.090 9, 95% confidence interval: -0.14 - -0.04) , accounting for 65.30% of the total effect. Occupational active behavior positively moderated the relationship between job insecurity and job satisfaction (β=0.07, P<0.01) . Conclusions:Nurses' work engagement is at a high level, but occupational insecurity will reduce nurses' job satisfaction and thus reduce their work engagement. Nurses with high occupational proactive behavior can alleviate the weakening of job insecurity on job satisfaction.
10.Effect of Inoculation with Organophosphate Solubilizing Bacteria on Quality and Soil Fertility of Paris polyphylla var. yunnanensis
Zhuowei LI ; Jiaqi LANG ; Qi MENG ; Mingyan YE ; Jie WANG ; Rujie SHI ; Huihui DU ; Nong ZHOU
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(16):156-164
ObjectiveThe effect of inoculation with different organophosphate-resolving bacteria or compound bacteria on the quality of Paris polyphylla var. yunnanensis medicinal materials and rhizosphere soil fertility were studied to provide a reference for the development and application of biological bacterial fertilizer in artificial cultivation of P. polyphylla var. yunnanensis. MethodThe three dominant species of organophosphate-solubilizing bacteria were inoculated separately and in combination in sterilized soil by single-factor indoor pot planting, and no inoculation was used as the control group. The effect of inoculation of organophosphate-solubilizing bacteria on total saponins content in rhizomes of P. polyphylla var. yunnanensis, as well as microbial numbers, enzyme activities and nutrient contents in rhizosphere soil were analyzed. ResultIn the seven treatments inoculated with organophosphate-solubilizing bacteria, the total saponin content in the rhizomes of Paris polyphylla var. yunnanensis was increased by 16.42%, 3.83%, 16.86%, 33.69%, 2.11%, 13.44%, and 28.83%, respectively, compared with the control. Inoculation with organophosphate-solubilizing bacteria increased the number of soil microorganisms to varying degrees, and the effects of S6 and S7 treatments were the most significant. Inoculation with organophosphate-solubilizing bacteria improved the enzyme activity, and the effect of S7 treatment was the most significant. The activities of acid phosphatase, neutral phosphatase, alkaline phosphatase, protease, invertase and catalase were 49.96% and 104.67% , 110.17%, 99.61%, 26.26%, 11.29% higher than those of the control, respectively. Inoculation with organophosphate-solubilizing bacteria reduced the pH of the rhizosphere soil and increased the content of soil available nutrients. Under the S7 treatment, the contents of alkaline hydrolyzable nitrogen, available phosphorus and available potassium in the rhizosphere soil of P. polyphylla var. yunnanensis were 181.46%, 51.64% and 42.62% higher than those of the control, respectively. Correlation analysis showed that there was a significant positive correlation between total saponins and phosphatase activities, a significant positive correlation between soil microorganisms and soil enzyme activities, and a very significant positive correlation between soil nutrients. ConclusionInoculation of different organophosphate-resolving bacteria or compound bacteria can improve the quality and rhizosphere soil fertility of P. polyphylla var. yunnanensis. Among them, the mixed inoculation of three kinds of bacteria and the mixed inoculation of B. mycoides and B. wiedmannii have the best effect.

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