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.Endoscopic submucosal dissection of gastrointestinal polyps with a novel plasma radio frequency generator and a disposable mucosal incision knife: A prospective, multicenter, non-inferiority, randomized, controlled clinical trial
Baohui SONG ; Guijun SHI ; Xiaoyue XU ; Jiaxin XU ; Li FENG ; Jianguang XU ; Pinghong ZHOU ; Mingyan CAI
Chinese Journal of Gastrointestinal Surgery 2025;28(4):384-391
Objective:To evaluate the efficacy and safety of a new plasma radiofrequency generator and a disposable mucosal incision knife for endoscopic submucosal dissection (ESD) of gastrointestinal lesions.Methods:This study is a prospective, randomized, non-inferiority multicenter study (Chinese Clinical Trial Registry No.: ChiCTR2000041394). The inclusion criteria for cases are as follows: (1) being able to understand and voluntarily participate in this clinical trial, and voluntarily signing the informed consent form; (2) being 18-70 years old, regardless of gender; (3) having a gastrointestinal lesion and meeting the endoscopic treatment conditions for the indications of endoscopic submucosal dissection (ESD). The exclusion criteria are: (1) meeting the contraindications for ESD; (2) having a surgical contraindication due to coagulation dysfunction or still taking anticoagulants 1 week before surgery; (3) having coagulation dysfunction, that is, the prothrombin time is prolonged by more than 3 seconds (more than 5 seconds in patients with liver disease), or the activated partial thromboplastin time is prolonged by more than 10 seconds, and the platelet count is < 70×10?/L; (4) having severe cardiopulmonary insufficiency and being unable to tolerate the surgery; (5) being a reproductive-aged woman with a positive blood or urine pregnancy test or a lactating woman; (6) the investigator deems that there are other factors that are not suitable for inclusion or affect the subject's participation. Patients who underwent ESD treatment for gastrointestinal lesions from March 2019 to April 2023 at the Endoscopy Center of Zhongshan Hospital Affiliated to Fudan University, the Department of Gastroenterology of Minhang District Central Hospital in Shanghai, and the Department of Gastroenterology of Quzhou People's Hospital were prospectively included. The experimental group used a new plasma radiofrequency therapy instrument and a disposable mucosal incision knife, while the control group used a high-frequency electrosurgical system and a disposable mucosal incision knife. The primary efficacy indicator was the en bloc resection success rate, the secondary efficacy indicators included the coagulation success rate, and the operation stability of the plasma radiofrequency therapy instrument and the disposable mucosal incision knife; the safety indicators included the incidence of intraoperative bleeding, intraoperative perforation, and postoperative complications. Results:The study cohort comprised 194 patients, 95 in the experimental group and 99 in the control group. Analysis of the full set showed rates of en bloc resection of 97.89% (93/95) and 96.97% (96/99) in the experimental and control groups, respectively; the difference being 0.53% (-5.58%, 6.64%). Analysis of the compliance set showed rates of en bloc resection of 97.83% (90/92) and 96.88% (93/96) in the experimental and control groups, respectively; the difference being 0.58% (-5.79%, 6.94%). These data indicate that the rate of en bloc resection in the experimental group using plasma radiofrequency therapy and disposable mucosal incision was not inferior to that of the control group. The rates of achieving intraoperative coagulation in the experimental and control groups were 7.14% (5/70) and 5.97% (4/67), respectively; this difference is not statistically significant ( P=1.000). The control group had a significantly better rate of using the same instruments throughout the procedure than did the experimental group ( P<0.001). In the safety analysis set, the incidences of intraoperative and postoperative adverse events did not differ significantly between the two groups (both P>0.05). Conclusion:Plasma radiofrequency therapy equipment and a disposable mucosal incision knife are safe and effective instruments for performing ESD of gastrointestinal lesions.
3.Preliminary exploration of endoscopic submucosal dissection for hypopharyngeal hemangioma (with video)
Xucheng HUO ; Baohui SONG ; Rongkui LUO ; Na SHEN ; Yunshi ZHONG ; Pinghong ZHOU ; Xu ZHOU ; Mingyan CAI
Chinese Journal of Digestive Endoscopy 2025;42(4):319-322
Objective:To evaluate the efficacy and safety of endoscopic submucosal dissection (ESD) for hypopharyngeal hemangioma.Methods:A retrospective analysis was performed on data of patients with hypopharyngeal hemangioma who were treated with ESD at the endoscopy center of Zhongshan Hospital, Fudan University from October 2023 to February 2024. The en bloc resection rate, complete resection rate, procedure time, length of hospital stay, and incidence of adverse events were recorded.Results:A total of five patients were included, aged 28-78, four females and one male, with a median tumor long diameter of 1.5 cm (1.0-4.0 cm). All ESD procedures were successfully performed for hypopharyngeal hemangioma, and the rate of en bloc resection was 80.0% (4/5). Complete resection rate was 100.0% (5/5). The median procedure time was 35 minutes (18-60 minutes). None of them underwent prophylactic tracheotomy, and all of them were confirmed as hemangiomas by postoperative pathology. Open diet 1 day postoperatively, and the median length of hospital stay was 6 days (3-8 days). There were no serious adverse events related to ESD during or after the procedure.Conclusion:ESD can be a potential new method for the treatment of hypopharyngeal hemangioma, demonstrating satisfactory effectiveness and safety.
4.Preliminary exploration of endoscopic submucosal dissection for hypopharyngeal hemangioma (with video)
Xucheng HUO ; Baohui SONG ; Rongkui LUO ; Na SHEN ; Yunshi ZHONG ; Pinghong ZHOU ; Xu ZHOU ; Mingyan CAI
Chinese Journal of Digestive Endoscopy 2025;42(4):319-322
Objective:To evaluate the efficacy and safety of endoscopic submucosal dissection (ESD) for hypopharyngeal hemangioma.Methods:A retrospective analysis was performed on data of patients with hypopharyngeal hemangioma who were treated with ESD at the endoscopy center of Zhongshan Hospital, Fudan University from October 2023 to February 2024. The en bloc resection rate, complete resection rate, procedure time, length of hospital stay, and incidence of adverse events were recorded.Results:A total of five patients were included, aged 28-78, four females and one male, with a median tumor long diameter of 1.5 cm (1.0-4.0 cm). All ESD procedures were successfully performed for hypopharyngeal hemangioma, and the rate of en bloc resection was 80.0% (4/5). Complete resection rate was 100.0% (5/5). The median procedure time was 35 minutes (18-60 minutes). None of them underwent prophylactic tracheotomy, and all of them were confirmed as hemangiomas by postoperative pathology. Open diet 1 day postoperatively, and the median length of hospital stay was 6 days (3-8 days). There were no serious adverse events related to ESD during or after the procedure.Conclusion:ESD can be a potential new method for the treatment of hypopharyngeal hemangioma, demonstrating satisfactory effectiveness and safety.
5.Endoscopic submucosal dissection of gastrointestinal polyps with a novel plasma radio frequency generator and a disposable mucosal incision knife: A prospective, multicenter, non-inferiority, randomized, controlled clinical trial
Baohui SONG ; Guijun SHI ; Xiaoyue XU ; Jiaxin XU ; Li FENG ; Jianguang XU ; Pinghong ZHOU ; Mingyan CAI
Chinese Journal of Gastrointestinal Surgery 2025;28(4):384-391
Objective:To evaluate the efficacy and safety of a new plasma radiofrequency generator and a disposable mucosal incision knife for endoscopic submucosal dissection (ESD) of gastrointestinal lesions.Methods:This study is a prospective, randomized, non-inferiority multicenter study (Chinese Clinical Trial Registry No.: ChiCTR2000041394). The inclusion criteria for cases are as follows: (1) being able to understand and voluntarily participate in this clinical trial, and voluntarily signing the informed consent form; (2) being 18-70 years old, regardless of gender; (3) having a gastrointestinal lesion and meeting the endoscopic treatment conditions for the indications of endoscopic submucosal dissection (ESD). The exclusion criteria are: (1) meeting the contraindications for ESD; (2) having a surgical contraindication due to coagulation dysfunction or still taking anticoagulants 1 week before surgery; (3) having coagulation dysfunction, that is, the prothrombin time is prolonged by more than 3 seconds (more than 5 seconds in patients with liver disease), or the activated partial thromboplastin time is prolonged by more than 10 seconds, and the platelet count is < 70×10?/L; (4) having severe cardiopulmonary insufficiency and being unable to tolerate the surgery; (5) being a reproductive-aged woman with a positive blood or urine pregnancy test or a lactating woman; (6) the investigator deems that there are other factors that are not suitable for inclusion or affect the subject's participation. Patients who underwent ESD treatment for gastrointestinal lesions from March 2019 to April 2023 at the Endoscopy Center of Zhongshan Hospital Affiliated to Fudan University, the Department of Gastroenterology of Minhang District Central Hospital in Shanghai, and the Department of Gastroenterology of Quzhou People's Hospital were prospectively included. The experimental group used a new plasma radiofrequency therapy instrument and a disposable mucosal incision knife, while the control group used a high-frequency electrosurgical system and a disposable mucosal incision knife. The primary efficacy indicator was the en bloc resection success rate, the secondary efficacy indicators included the coagulation success rate, and the operation stability of the plasma radiofrequency therapy instrument and the disposable mucosal incision knife; the safety indicators included the incidence of intraoperative bleeding, intraoperative perforation, and postoperative complications. Results:The study cohort comprised 194 patients, 95 in the experimental group and 99 in the control group. Analysis of the full set showed rates of en bloc resection of 97.89% (93/95) and 96.97% (96/99) in the experimental and control groups, respectively; the difference being 0.53% (-5.58%, 6.64%). Analysis of the compliance set showed rates of en bloc resection of 97.83% (90/92) and 96.88% (93/96) in the experimental and control groups, respectively; the difference being 0.58% (-5.79%, 6.94%). These data indicate that the rate of en bloc resection in the experimental group using plasma radiofrequency therapy and disposable mucosal incision was not inferior to that of the control group. The rates of achieving intraoperative coagulation in the experimental and control groups were 7.14% (5/70) and 5.97% (4/67), respectively; this difference is not statistically significant ( P=1.000). The control group had a significantly better rate of using the same instruments throughout the procedure than did the experimental group ( P<0.001). In the safety analysis set, the incidences of intraoperative and postoperative adverse events did not differ significantly between the two groups (both P>0.05). Conclusion:Plasma radiofrequency therapy equipment and a disposable mucosal incision knife are safe and effective instruments for performing ESD of gastrointestinal lesions.
6.Neuroprotective effect of histone deacetylase 3 specific inhibitor RGFP966 on traumatic brain injury by inhibiting pyroptosis
Lanjuan XU ; Baohui JIA ; Tingting AN ; Qiong WU ; Xiangyang LI ; Yifan MA ; Huihui DING ; Tao SONG ; Liqing LI ; Chengjian LI
Chinese Journal of Neuromedicine 2023;22(9):875-883
Objective:To investigate the neuroprotective effect of histone deacetylase 3 (HDAC3) specific inhibitor RGFP966 on traumatic brain injury (TBI) and its mechanism in rats.Methods:Forty-eight SD rats were randomly divided into sham-operated group, TBI group, TBI+vehicle group and TBI+RGFP966 group ( n=12). Rats in the later 3 groups accepted hydraulic impact brain injury to establish TBI models; and then, RGFP966 (dissolved in 1% DMSO at a dose of 10 mg/kg) was injected intraperitoneally 30 min after modeling, twice a day for 3 d, in TBI+RGFP966 group; same amount of DMSO was injected into TBI+vehicle group at the same time. Three d after modeling, neurological function was tested by modified neurological severity score (mNSS), water content of brain tissues was detected by dry-wet weight method, proportion of injured neurons at the frontal cortical tissues on the affected side was detected by Nissl staining, expressions of HDAC3 and pyroptosis related proteins were detected by immunohistochemical staining and Western blotting, and serum content of inflammatory factors was detected by ELISA. Results:Three d after modeling, compared with the TBI+vehicle group, the TBI+RGFP966 group had significantly decreased mNSS scores (9.83±0.75 vs. 6.67±0.82), water content of the injured cerebral cortex (82.73%±0.36% vs. 80.92%±0.66%), proportion of damaged neurons (75.60%±7.44% vs. 55.87%±4.10%), and HDAC3 protein expression (0.67±0.09 vs. 0.51±0.07), and significantly increased acetylated H3 (Ace-H3) and acetylated H4 (Ace-H4) protein expressions (0.81±0.02 vs. 1.22±0.02; 0.74±0.01 vs. 1.07±0.02), and statistically decreased protein expressions of nuclear factor-κB (NF-κB, 1.20±0.05 vs. 0.94±0.04), NOD-like receptor thermal protein domain associated protein 3 (NLRP3, 0.72±0.02 vs. 0.40±0.03), Caspase-1 containing cysteine (Caspase-1), dermatin D N-terminal fragment (GSDMD-N, 0.71±0.03 vs. 0.52±0.01), significantly decreased NF-κB and NLRP3 immunohistochemical staining scores, and significantly decreased serum contents of tumor necrosis factor-α, interleukin(IL)-1β and IL-18 ( P<0.05). Conclusion:Early intervention with RGFP966 after TBI can reduce the pyroptosis and inflammatory reaction of nerve cells and play neuroprotective role, whose mechanism may be related to inhibited activation of NF-κB/NLRP3/GSDMD pathway.
7.Chinese Experts Consensus on Immune Checkpoint Inhibitors for Non-small Cell Lung Cancer (2020 Version).
Caicun ZHOU ; Jie WANG ; Baocheng WANG ; Ying CHENG ; Zhehai WANG ; Baohui HAN ; You LU ; Gang WU ; Li ZHANG ; Yong SONG ; Bo ZHU ; Yi HU ; Ziping WANG ; Qibin SONG ; Shengxiang REN ; Yayi HE ; Xiaohua HU ; Jian ZHANG ; Yu YAO ; Hongyun ZHAO ; Zhijie WANG ; Qian CHU ; Jianchun DUAN ; Jingjing LIU ; Shukui QIN
Chinese Journal of Lung Cancer 2021;24(4):217-235
Non-small cell lung cancer (NSCLC) is the most common pathological type of lung cancer. The systemic antitumor therapy of advanced NSCLC has undergone renovations of chemotherapy, targeted therapy and immunotherapy, which results in greatly improved survival for patients with advanced NSCLC. Immune checkpoint inhibitors (ICIs), especially targeting programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1), has changed the treatment paradigm of NSCLC. ICIs have become the standard treatment for advanced NSCLC without epidermal growth factor receptor(EGFR) mutation or anaplastic lymphomakinase(ALK) translocation in the first- or second-line setting, and for locally advanced NSCLC following concurrent radiotherapy and chemotherapy. ICIs are also promising in adjuvant/neoadjuvant therapy. More and more ICIs have been approved domestically for the treatment of NSCLC. Led by the NSCLC expert committee of Chinese Society of Clinical Oncology (CSCO), this consensus was developed and updated based on thoroughly reviewing domestic and foreign literatures, clinical trial data, systematic reviews, experts' discussion and the consensus(2019 version). This consensus will aid domestic clinicians in the treatment of NSCLC with ICIs.
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8.Chinese Experts Consensus on Immune Checkpoint Inhibitors for Non-small Cell Lung Cancer (2019 version).
Caicun ZHOU ; Jie WANG ; Hong BU ; Baocheng WANG ; Baohui HAN ; You LU ; Zhehai WANG ; Bo ZHU ; Ziping WANG ; Qibin SONG ; Shengxiang REN ; Dongmei LIN ; Yayi HE ; Xiaohua HU ; Hongyun ZHAO ; Shukui QIN
Chinese Journal of Lung Cancer 2020;23(2):65-76
Non-small cell lung cancer (NSCLC) is the most common pathological type of lung cancer, most NSCLC patients are at advanced stage at the time of diagnosis. For patients without sensitive driven-oncogene mutations, chemotherapy is still the main treatment at present, the overall prognosis is poor. Improving outcomes and obtaining long-term survival are the most urgent needs of patients with advanced NSCLC. In recent years, immunotherapy has developed rapidly. Immune checkpoint inhibitors (ICIs), especially targeting programmed death-1 (PD-1)/programmed death-ligand 1 (PD-L1), have made a breakthrough in the treatment of NSCLC, beneficial to patients' survival and changed the treatment pattern for NSCLC. It shows more and more important role in the treatment of NSCLC. Led by NSCLC expert committee of Chinese society of clinical oncology (CSCO), relevant experts in this field were organized. On the basis of referring to domestic and foreign literature, systematically evaluating the results of Chinese and foreign clinical trials, and combining the experiences of the experts, the experts group reached an agreement to develop this consensus. It will guide domestic counterparts for better application of ICIs to treat NSCLC.
9. Clinical research of Lishi-Jianpi-Quyu decoction combined with conventional western medicine for the patients with oral lichen planus
Baohui GUO ; Jingwen WANG ; Hui SONG
International Journal of Traditional Chinese Medicine 2019;41(11):1193-1196
Objective:
To evaluate the therapeutic effect of
10.Problem-based Learning Based on Web for Rehabilitation Therapy Teaching
Hong NIAN ; Baohui SONG ; Qiuling XU ; Yanzhong GUAN ; Guilian LIU
Chinese Journal of Rehabilitation Theory and Practice 2011;17(9):897-899
Objective To apply the problem-based learning (PBL) based on the web in the rehabilitation therapy teaching. Methods The 64 students of rehabilitation therapy in grade 2009 and 2010 were taught with selected 3 chapters of physiology, using traditional teaching and PBL based on the web respectively. They were investigated through questionnaire after learning. Results Compared with he traditional teaching, PBL based on the web could improve the interesting of learning, self-study ability, and scope of knowledge. Conclusion PBL based on the web could improve the quality of physiology teaching for students of rehabilitation therapy.


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