1.Efficacy and safety of oliceridine for treatment of moderate to severe pain after surgery with general anesthesia: a prospective, randomized, double-blinded, multicenter, positive-controlled clinical trial
Gong CHEN ; Wen OUYANG ; Ruping DAI ; Xiaoling HU ; Huajing GUO ; Haitao JIANG ; Zhi-Ping WANG ; Xiaoqing CHAI ; Chunhui WANG ; Zhongyuan XIA ; Ailin LUO ; Qiang WANG ; Ruifeng ZENG ; Yanjuan HUANG ; Zhibin ZHAO ; Saiying WANG
Chinese Journal of Anesthesiology 2024;44(2):135-139
Objective:To evaluate the efficacy and safety of oliceridine for treatment of moderate to severe pain after surgery with general anesthesia in patients.Methods:The patients with moderate to severe pain (numeric pain rating scale ≥4) after abdominal surgery with general anesthesia from 14 hospitals between July 6, 2021 and November 9, 2021 were included in this study. The patients were assigned to either experiment group or control group using a random number table method. Experiment group received oliceridine, while control group received morphine, and both groups were treated with a loading dose plus patient-controlled analgesia and supplemental doses for 24 h. The primary efficacy endpoint was the drug response rate within 24 h after giving the loading dose. Secondary efficacy endpoints included early (within 1 h after giving the loading dose) drug response rates and use of rescue medication. Safety endpoints encompassed the development of respiratory depression and other adverse reactions during treatment.Results:After randomization, both the full analysis set and safety analysis set comprised 180 cases, with 92 in experiment group and 88 in control group. The per-protocol set included 170 cases, with 86 in experiment group and 84 in control group. There were no statistically significant differences between the two groups in 24-h drug response rates, rescue analgesia rates, respiratory depression, and incidence of other adverse reactions ( P>0.05). The analysis of full analysis set showed that the experiment group had a higher drug response rate at 5-30 min after giving the loading dose compared to control group ( P<0.05). The per-protocol set analysis indicated that experiment group had a higher drug response rate at 5-15 min after giving the loading dose than control group ( P<0.05). Conclusions:When used for treatment of moderate to severe pain after surgery with general anesthesia in patients, oliceridine provides comparable analgesic efficacy to morphine, with a faster onset.
2.Role of neoadjuvant rectal score in prognosis and adjuvant chemotherapy decision-making in locally advanced rectal cancer following neoadjuvant short-course radiotherapy and consolidation chemotherapy
Qiang ZENG ; Yuan TANG ; Haitao ZHOU ; Ning LI ; Wenyang LIU ; Silin CHEN ; Shuai LI ; Ningning LU ; Hui FANG ; Shulian WANG ; Yueping LIU ; Yongwen SONG ; Yexiong LI ; Jing JIN
Chinese Journal of Oncology 2024;46(4):335-343
Objectives:To assess the prognostic impact of the neoadjuvant rectal (NAR) score following neoadjuvant short-course radiotherapy and consolidation chemotherapy in locally advanced rectal cancer (LARC), as well as its value in guiding decisions for adjuvant chemotherapy.Methods:Between August 2015 and August 2018, patients were eligible from the STELLAR phase III trial (NCT02533271) who received short-course radiotherapy plus consolidation chemotherapy and for whom the NAR score could be calculated. Based on the NAR score, patients were categorized into low (<8), intermediate (8-16), and high (>16) groups. The Kaplan-Meier method, log rank tests, and multivariate Cox proportional hazard regression models were used to evaluate the impact of the NAR score on disease-free survival (DFS).Results:Out of the 232 patients, 24.1%, 48.7%, and 27.2% had low (56 cases), intermediate (113 cases), and high NAR scores (63 cases), respectively. The median follow-up period was 37 months, with 3-year DFS rates of 87.3%, 68.3%, and 53.4% ( P<0.001) for the low, intermediate, and high NAR score groups. Multivariate analysis demonstrated that the NAR score (intermediate NAR score: HR, 3.10, 95% CI, 1.30-7.37, P=0.011; high NAR scores: HR=5.44, 95% CI, 2.26-13.09, P<0.001), resection status ( HR, 3.00, 95% CI, 1.64-5.52, P<0.001), and adjuvant chemotherapy ( HR, 3.25, 95% CI, 2.01-5.27, P<0.001) were independent prognostic factors for DFS. In patients with R0 resection, the 3-year DFS rates were 97.8% and 78.0% for those with low and intermediate NAR scores who received adjuvant chemotherapy, significantly higher than the 43.2% and 50.6% for those who did not ( P<0.001, P=0.002). There was no significant difference in the 3-year DFS rate (54.2% vs 53.3%, P=0.214) among high NAR score patients, regardless of adjuvant chemotherapy. Conclusions:The NAR score is a robust prognostic indicator in LARC following neoadjuvant short-course radiotherapy and consolidation chemotherapy, with potential implications for subsequent decisions regarding adjuvant chemotherapy. These findings warrant further validation in studies with larger sample sizes.
3.Nerve decompression surgery for combined sacral plexus nerve injury through the lateral-rectus approach after sacral fracture fixation
Zilin LIANG ; Min ZENG ; Yong ZHU ; Ruibo ZHAO ; Haitao LONG ; Liang CHENG ; Zhangyuan LIN
Chinese Journal of Orthopaedic Trauma 2024;26(3):215-221
Objective:To investigate the efficacy and safety of nerve decompression surgery through the lateral-rectus approach for sacral plexus nerve injury after sacral fracture fixation.Methods:A retrospective study was conducted to analyze the 10 patients with combined sacral plexus nerve injury after sacral fracture fixation who had been admitted to Department of Orthopedics, Xiangya Hospital between May 2022 and May 2023. There were 2 males and 8 females with an age of 16.5 (15.0, 26.3) years. At the time of injury, the patients had been clearly diagnosed as sacral fracture combined with sacral plexus nerve injury. By the Denis classification of sacral fractures: 7 cases of type Ⅱ and 3 cases of type Ⅲ; sacral plexus nerve injury sites: 1 case of L 4, 8 cases of L 5, 7 cases of S 1, and 2 cases of S 2. All of them were treated with reduction and internal fixation via the posterior approach within 2 weeks after injury, but after surgery their manifestations of sacral plexus nerve injury still persisted which were confirmed by CT, magnetic resonance imaging and neuromuscular electromyography. Therefore, at (4.0±2.3) months after internal fixation, all patients were treated with nerve decompression surgery through the lateral-rectus approach. The operative time, intraoperative bleeding, length of hospitalization, Gibbons nerve damage score and neurological recovery at the last follow-up were recorded. Results:In the 10 patients, the operative time was (112.0±21.5) min, intraoperative bleeding (215.0±91.3) mL, and length of hospitalization 7.0 (6.0, 8.5) d. Intraoperatively, sacral plexus nerve compression was found in 9 cases (6 cases of nerve compression and pulling due to fracture displacement, 3 cases of nerve entrapment due to soft tissue scar adhesion), and 1 case of nerve root avulsion injury. No other intraoperative complications occurred. The 10 patients were followed up for (9.2±2.3) months after surgery. At the last follow-up, the Gibbons score for the 10 patients improved from preoperative 3.0 (3.0, 3.3) points to 1.0 (1.0, 2.0) point, and their British Medical Research Council (BMRC) nerve injury grading was improved from the preoperative grade 0.0 (0.0, 1.3) to grade 3.5 (2.8, 4.0) (1 case of M5, 4 cases of M4, 4 cases of M3, and 1 case of M2).Conclusion:The lateral-rectus approach is effective and safe for exploration and decompression of the sacral plexus nerve in patients combined with sacral plexus nerve injury despite sacral fracture fixation.
4.Role of neoadjuvant rectal score in prognosis and adjuvant chemotherapy decision-making in locally advanced rectal cancer following neoadjuvant short-course radiotherapy and consolidation chemotherapy
Qiang ZENG ; Yuan TANG ; Haitao ZHOU ; Ning LI ; Wenyang LIU ; Silin CHEN ; Shuai LI ; Ningning LU ; Hui FANG ; Shulian WANG ; Yueping LIU ; Yongwen SONG ; Yexiong LI ; Jing JIN
Chinese Journal of Oncology 2024;46(4):335-343
Objectives:To assess the prognostic impact of the neoadjuvant rectal (NAR) score following neoadjuvant short-course radiotherapy and consolidation chemotherapy in locally advanced rectal cancer (LARC), as well as its value in guiding decisions for adjuvant chemotherapy.Methods:Between August 2015 and August 2018, patients were eligible from the STELLAR phase III trial (NCT02533271) who received short-course radiotherapy plus consolidation chemotherapy and for whom the NAR score could be calculated. Based on the NAR score, patients were categorized into low (<8), intermediate (8-16), and high (>16) groups. The Kaplan-Meier method, log rank tests, and multivariate Cox proportional hazard regression models were used to evaluate the impact of the NAR score on disease-free survival (DFS).Results:Out of the 232 patients, 24.1%, 48.7%, and 27.2% had low (56 cases), intermediate (113 cases), and high NAR scores (63 cases), respectively. The median follow-up period was 37 months, with 3-year DFS rates of 87.3%, 68.3%, and 53.4% ( P<0.001) for the low, intermediate, and high NAR score groups. Multivariate analysis demonstrated that the NAR score (intermediate NAR score: HR, 3.10, 95% CI, 1.30-7.37, P=0.011; high NAR scores: HR=5.44, 95% CI, 2.26-13.09, P<0.001), resection status ( HR, 3.00, 95% CI, 1.64-5.52, P<0.001), and adjuvant chemotherapy ( HR, 3.25, 95% CI, 2.01-5.27, P<0.001) were independent prognostic factors for DFS. In patients with R0 resection, the 3-year DFS rates were 97.8% and 78.0% for those with low and intermediate NAR scores who received adjuvant chemotherapy, significantly higher than the 43.2% and 50.6% for those who did not ( P<0.001, P=0.002). There was no significant difference in the 3-year DFS rate (54.2% vs 53.3%, P=0.214) among high NAR score patients, regardless of adjuvant chemotherapy. Conclusions:The NAR score is a robust prognostic indicator in LARC following neoadjuvant short-course radiotherapy and consolidation chemotherapy, with potential implications for subsequent decisions regarding adjuvant chemotherapy. These findings warrant further validation in studies with larger sample sizes.
5.Failure mode and long-term survival after neoadjuvant therapy for locally advanced esophageal squamous cell carcinoma
Ruiqi WANG ; Lin WANG ; Xiao HU ; Honglian MA ; Guoqin QIU ; Zhun WANG ; Xiaojiang SUN ; Yongling JI ; Xiaojing LAI ; Wei FENG ; Liming SHENG ; Yuezhen WANG ; Xia ZHOU ; Youhua JIANG ; Changchun WANG ; Qiang ZHAO ; Xun YANG ; Jinshi LIU ; Jian ZENG ; Haitao JIANG ; Pu LI ; Xianghui DU ; Qixun CHEN ; Yujin XU
Chinese Journal of Radiation Oncology 2023;32(4):301-306
Objective:To analyze the fail mode of neoadjuvant therapy combined with surgery for locally advanced esophageal squamous cell carcinoma (ESCC) after long-term follow-up.Methods:Clinical data of consecutive 238 patients with locally advanced resectable ESCC who underwent neoadjuvant therapy combined with surgery in Zhejiang Cancer Hospital from September 2012 to October 2019 were retrospectively analyzed. The failure mode in the whole cohort was analyzed after long-term follow-up. The overall survival (OS) and disease free survival (DFS) rates were analyzed by Kaplan-Meier method. Survival differences were determined by log-rank test.Results:The pathological complete response (pCR) rate was 42.0% in 238 patients. After a median follow-up of 46.1 months, tumor progression occurred in 96 patients (40.3%), including 25 patients (10.5%) with local recurrence, 61 patients (25.6%) with distant metastases, and 10 patients (4.2%) with simultaneous local recurrence and distant metastases. The median OS and DFS were 64.7 months and 49.9 months. And the 3-, 5-, and 7-year OS and DFS rates were 70.0%, 52.8%, 36.4% and 63.5%, 42.5%, and 30.0%, respectively. The 3-, 5-, and 7-year locoregional recurrence-free survival rates and distant metastasis-free survival rates were 86.0%, 71.4%, 61.2% and 70.6%, 55.9%, 43.0%. Compared with non-pCR patients, the overall progression rate and distant metastasis rate of pCR patients were lower (26.0% vs. 50.7%, 16.0% vs. 32.6%, both P<0.05). And the 3-, 5-, and 7-year OS (83.0% vs. 60.2%, 69.7% vs. 41.7%, 50.4% vs. 27.7%, all P<0.001) and DFS rates (80.4% vs. 51.4%, 63.9% vs. 31.2%, 45.9% vs. 20.3%, all P<0.001) were significantly better in pCR patients. Conclusions:Distant metastasis is the main failure mode of patients with locally advanced ESCC after neoadjuvant therapy. Patients with postoperative pCR can achieve better long-term survival.
6.The clinical efficacy of robot-assisted internal fixation with sacroiliac screws for posterior pelvic ring fractures: a meta-analysis
Zhi LIU ; Guoqing YIN ; Shushan ZHAO ; Ruibo ZHAO ; Haitao LONG ; Liang CHENG ; Bangbao LU ; Buhua SUN ; Ming ZENG ; Can CHEN ; Yong ZHU ; Zhangyuan LIN
Chinese Journal of Orthopaedics 2023;43(19):1324-1333
Objective:To compare the clinical efficacy of robot-assisted versus fluoroscopy-assisted sacroiliac screw internal fixation for posterior pelvic ring fractures.Methods:China National Knowledge Infrastructure (CNKI), Wanfang Data, Chinese Medical Journal Full-text Database, PubMed, Web of Science and ScienceDirect were searched for literature on robot-assisted versus fluoroscopy-assisted sacroiliac screw internal fixation for posterior pelvic ring fractures. The search time was from the establishment of each database to March 2023. Meta-analysis was performed on the included literature. The random-effects model was used when the heterogeneity between groups was large, and the fixed-effects model was used when the heterogeneity between groups was small.Results:A total of 15 studies were included in the meta-analysis, including 465 patients in the robot-assisted group and 396 patients in the fluoroscopy-assisted group. Meta-analysis showed that the number of fluoroscopies [ SMD=-3.12, 95% CI (-4.34, -1.89), P<0.001], the number of guide pin adjustments [ SMD=-3.75, 95% CI (-6.77, -0.72), P=0.015], intraoperative blood loss [ SMD=-0.83, 95% CI (-1.18, -0.49), P<0.001], and operative time [ SMD=-2.59, 95% CI (-4.11, -1.08), P<0.001] were smaller than those in the fluoroscopy-assisted group. The rate of excellent screw implantation [ OR=10.13, 95% CI (3.67,27.98), P<0.001] of the robot-assisted was larger than the fluoroscopy-assisted group. There was no significant difference in Majeed functional score [ SMD=0.28, 95% CI (-0.0003, 0.55), P=0.050] and fracture healing time [ SMD=-0.14, 95% CI (-0.46, 0.17), P=0.367] between the two groups. Conclusion:Robot-assisted percutaneous sacroiliac screw fixation for posterior pelvic ring fractures has the advantages of less fluoroscopy, less guide pin adjustment, less intraoperative blood loss, shorter operation time, and higher rate of excellent screw position. However, there is no difference in Majeed score and fracture healing time between robot-assisted percutaneous sacroiliac screw fixation and fluoroscopy-assisted percutaneous sacroiliac screw fixation.
7.Research Progress in Antibodies Related to Autoimmune Encephalitis in Neuropsychiatric Systemic Lupus Erythematosus
Sixian CHEN ; Haitao REN ; Xiaofeng ZENG ; Hongzhi GUAN
JOURNAL OF RARE DISEASES 2022;1(2):217-222
Several anti-neural antibodies are associated with neuropsychiatric systemic lupus erythematosus (NPSLE) including anti-neuronal antibodies and anti-glial cell antibodies. The anti-neuronal antibodies has two types: anti-neuronal surface protein antibodies represented by anti-N-methyl-D-aspartate receptor (NMDAR) antibodies, and anti-neuronal intracellular protein antibodies. In this paper, we review and classify the anti-neural antibodies related to NPSLE.
8.Understanding the phase separation characteristics of nucleocapsid protein provides a new therapeutic opportunity against SARS-CoV-2.
Dan ZHAO ; Weifan XU ; Xiaofan ZHANG ; Xiaoting WANG ; Yiyue GE ; Enming YUAN ; Yuanpeng XIONG ; Shenyang WU ; Shuya LI ; Nian WU ; Tingzhong TIAN ; Xiaolong FENG ; Hantao SHU ; Peng LANG ; Jingxin LI ; Fengcai ZHU ; Xiaokun SHEN ; Haitao LI ; Pilong LI ; Jianyang ZENG
Protein & Cell 2021;12(9):734-740
9.Chinese expert consensus on the management of immune-related adverse events of hepato-cellular carcinoma treated with immune checkpoint inhibitors (2021 edition)
Guoming SHI ; Xiaoyong HUANG ; Zhenggang REN ; Yi CHEN ; Leilei CHENG ; Shisuo DU ; Yi FANG ; Ningling GE ; Aimin LI ; Su LI ; Xiaomu LI ; Qian LU ; Pinxiang LU ; Jianfang SUN ; Hanping WANG ; Lai WEI ; Li XU ; Guohuan YANG ; Zhaochong ZENG ; Lan ZHANG ; Li ZHANG ; Haitao ZHAO ; Ling ZHAO ; Ming ZHAO ; Aiping ZHOU ; Rongle LIU ; Xinhui LIU ; Jiaming WU ; Ying ZHANG ; Jia FAN ; Jian ZHOU
Chinese Journal of Digestive Surgery 2021;20(12):1241-1258
The clinical application of immune checkpoint inhibitors (ICIs) has significantly improved the prognosis of hepatocellular carcinoma (HCC) patients. With the widespread applica-tion of ICIs in HCC, the management of immune-related adverse events (irAE) gained more and more attention. However, the complicated disease characteristics and various combination therapies in HCC throw out challenges to irAE management. Therefore, the editorial board of the 'Chinese expert consensus on the management of immune-related adverse events of hepatocellular carcinoma treated with immune checkpoint inhibitors (2021 edition)' organizes multidisciplinary experts to discuss and formulate this consensus. The consensus focuses on issues related to HCC irAE manage-ment, and puts forward suggestions, in order to improve standardized and safety clinical medication, so as to maximize the benefits of immunotherapy for patients.
10.Expert consensus on microbiome sequencing and analysis.
Yunfeng DUAN ; Shengyue WANG ; Yubao CHEN ; Ruifu YANG ; Houkai LI ; Huaiqiu ZHU ; Yigang TONG ; Wenbin WU ; Yu FU ; Songnian HU ; Jun WANG ; Yuhua XIN ; Fangqing ZHAO ; Yiming BAO ; Wen ZHANG ; Juan LI ; Ming ZENG ; Haitao NIU ; Xin ZHOU ; Yan LI ; Shenghui CUI ; Jing YUAN ; Junhua LI ; Jiayi WANG ; Donglai LIU ; Ming NI ; Qing SUN ; Ye DENG ; Baoli ZHU
Chinese Journal of Biotechnology 2020;36(12):2516-2524
In the past ten years, the research and application of microbiome has continued to increase. The microbiome has gradually become the research focus in the fields of life science, environmental science, and medicine. Meanwhile, many countries and organizations around the world are launching their own microbiome projects and conducting a multi-faceted layout, striving to gain a strategic position in this promising field. In addition, whether it is scientific research or industrial applications, there has been a climax of research and a wave of investment and financing, accordingly, products and services related to the microbiome are constantly emerging. However, due to the rapid development of microbiome sequencing and analysis related technologies and methods, the research and application from various countries have not yet unified on the standards of technology, programs, and data. Domestic industry participants also have insufficient understanding of the microbiome. New methods, technologies, and theories have not yet been fully accepted and used. In addition, some of the existing standards and guidelines are too general with poor practicality. This not only causes obstacles in the integration of scientific research data and waste of resources, but also gives related companies unfair competition opportunity. More importantly, China still lacks national standards related to the microbiome, and the national microbiome project is still in the process of preparation. In this context, the experts and practitioners of the microbiome worked together and developed the consensus of experts. It can not only guide domestic scientific research and industrial institutions to regulate the production, learning and research of the microbiome, the application can also provide reference technical basis for the relevant national functional departments, protect the scale and standardized corporate company's interests, strengthen industry self-discipline, avoid unregulated enterprises from disrupting the market, and ultimately promote the benign development of microbiome-related industries.
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