1.PD-1 Inhibitor Combined with Azacitidine and HAG Regimen for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia: A Prospective, Single-Arm, Phase II Clinical Study.
Cheng-Sen CAI ; Ru-Ju WANG ; Xiao-Yan XU ; Cheng-Yuan GU ; Hui-Zhu KANG ; Yue-Jun LIU ; Yue HAN
Journal of Experimental Hematology 2025;33(4):972-979
OBJECTIVE:
To evaluate the efficacy and safety of PD-1 inhibitor combined with azacitidine and HAG regimen in the treatment of relapsed/refractory acute myeloid leukemia (R/R AML).
METHODS:
This study is a prospective, single-arm, phase II clinical trial that included R/R AML patients who met the inclusion criteria and were treated at The First Affiliated Hospital of Soochow University from December 2020 to August 2023. Patients could undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT) after salvage therapy. The efficacy and safety were evaluated.
RESULTS:
Twenty patients were enrolled, including 14 males and 6 females, with an average age of (50.7±15.3) years. The overall response rate (ORR) after one cycle of the treatment was 75.0% (15/20), and 35.0% (7/20) of the patients achieved complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) after two cycles of the treatment. Eight patients received allo-HSCT. The main adverse events were hematologic toxicities, and no grade 5 adverse events occurred.
CONCLUSION
The combination of PD-1 inhibitor, azacitidine, and the HAG regimen is a feasible and relatively safe treatment option for R/R AML, thus, to be worth further study.
Humans
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Leukemia, Myeloid, Acute/drug therapy*
;
Azacitidine/administration & dosage*
;
Male
;
Female
;
Middle Aged
;
Prospective Studies
;
Adult
;
Hematopoietic Stem Cell Transplantation
;
Antineoplastic Combined Chemotherapy Protocols/therapeutic use*
;
Programmed Cell Death 1 Receptor/antagonists & inhibitors*
;
Aged
2.Current situation of clinical trial registration in acupuncture anesthesia: A scoping review.
Yue LI ; You-Ning LIU ; Zhen GUO ; Mu-En GU ; Wen-Jia WANG ; Yi ZHU ; Xiao-Jun ZHUANG ; Li-Ming CHEN ; Jia ZHOU ; Jing LI
Journal of Integrative Medicine 2025;23(3):256-263
BACKGROUND:
Modern acupuncture anesthesia is a combination of Chinese and Western medicine that integrates the theories of acupuncture with anesthesia. However, some clinical studies of acupuncture anesthesia lack specific descriptions of randomization, allocation concealment, and blinding processes, with subsequent systematic reviews indicating a risk of bias.
OBJECTIVE:
Clinical trial registration is essential for the enhancement of the quality of clinical trials. This study aims to summarize the status of clinical trial registrations for acupuncture anesthesia listed on the World Health Organization International Clinical Trials Registry Platform (ICTRP).
SEARCH STRATEGY:
We searched the ICTRP for clinical trials related to acupuncture anesthesia registered between January 1, 2001 and May 31, 2023. Additionally, related publications were retrieved from PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure, China Science and Technology Journal Database, and Wanfang Data. Registrations and publications were analyzed for consistency in trial design characteristics.
INCLUSION CRITERIA:
Clinical trials that utilized one of several acupuncture-related therapies in combination with pharmacological anesthesia during the perioperative period were eligible for this review.
DATA EXTRACTION AND ANALYSIS:
Data extracted from articles included type of surgical procedure, perioperative symptoms, study methodology, type of intervention, trial recruitment information, and publication information related to clinical enrollment.
RESULTS:
A total of 166 trials related to acupuncture anesthesia from 21 countries were included in the analysis. The commonly reported symptoms in the included studies were postoperative nausea and vomiting (19.9%) and postoperative pain (13.3%). The concordance between the publications and the trial protocols in the clinical registry records was poor, with only 31.7% of the studies being fully compatible. Inconsistency rates were high for sample size (39.0%, 16/41), blinding (36.6%, 15/41), and secondary outcome indicators (24.4%, 10/41).
CONCLUSION
The volume of acupuncture anesthesia clinical trials registered in international trial registries over the last 20 years is low, with insufficient disclosure of results. Postoperative nausea and vomiting as well as postoperative pain, are the most investigated for acupuncture intervention. Please cite this article as: Li Y, Liu YN, Guo Z, Gu ME, Wang WJ, Zhu Y, Zhuang XJ, Chen LM, Zhou J, Li J. Current situation of clinical trial registration in acupuncture anesthesia: A scoping review. J Integr Med. 2025; 23(3): 256-263.
Humans
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Acupuncture Analgesia
;
Acupuncture Therapy
;
Anesthesia
;
Clinical Trials as Topic
;
Registries
3.Superior vena cava syndrome and pulmonary artery stenosis in a patient with lung metastases of bladder cancer
Jian-Ke LI ; Ya-Nan GU ; Jun-Hao LI ; Liang-Wen WANG ; Ning-Zi TIAN ; Wei CHEN ; Xiao-Lin WANG ; Yi CHEN
Fudan University Journal of Medical Sciences 2024;51(2):277-279,284
Superior vena cava syndrome(SVCS)is a group of clinical syndromes caused by obstruction of the superior vena cava and its major branches from various causes.Pulmonary artery stenosis(PS)is a complication of lung cancer or mediastinal tumours.SVCS combined with PS due to pulmonary metastases from bladder cancer is extremely rare and has not been reported in the literature.Here we reported an old male patient with pulmonary metastases from bladder cancer presenting with swelling of the head,neck and both upper limbs.SVCS combined with PS was clarified by pulmonary artery computed tomography angiography(CTA)and digital subtraction angiography(DSA).Endovascular stenting was used to treat SVCS.Angiography also showed that PS had not caused pulmonary hypertension and did not need to be treated.The swelling of the patient's head,neck and upper limbs was gradually reduced after the procedure.
4.Optimization of Preparation Technology of Xinqingduyin Granules Based on Characteristic Chromato-grams and Index Components
Xiaomeng LU ; Yuzheng GU ; Ruimei LIU ; Yinhui LIN ; Shanyu ZHOU ; Xinxin HE ; Fei XIAO ; Jun ZHANG ; Xin'an HUANG
Traditional Chinese Drug Research & Clinical Pharmacology 2024;35(2):263-273
Objective To establish high performance liquid chromatography(HPLC)characteristic chromatograms of Xinqingduyin Granules(composed of Taraxaci Herba,Lonicerae Japonicae Flos,Chrysanthemi Indici Flos,etc.)and content determination of chicory acid and glycyrrhizic acid,and to optimize the preparation process of Xinqingduyin Granules.Methods Using the characteristic chromatograms of Xinqingduyin and the retention rate of chicory acid and glycyrrhizic acid as indexes,we carried out orthogonal experiment to optimize the extraction process of Xinqingduyin,and studied the concentration process.The molding process of Xinqingduyin Granules was conducted by screening the types and dosage of auxiliary materials,then three batches of pilot experiments were carried out.Results HPLC characteristic chromatograms of Xinqingshuyin Granules and the determination methods of chicory acid and glycyrrhizic acid were established.The optimal preparation technology was as follows:8 times amount of water was added,the drug was decocted for 3 times,with 1 hour per time.After the extract was concentrated under reduced pressure at 80℃,the appropriate amount of steviol glycoside and lactose was added into the extract and mixed.One-step granulation and packaging were adopted.The retention rates of chicoric acid and glycyrrhizic acid in the 3 batches of Xinqingduyin Granules,which were prepared on the pilot scale,were(54.56±1.63)%and(54.96±1.08)%,and the rate of finished product was(87.47±0.49)%,respectively.The quality is uniform,and the characteristic map of Xinqingduyin Granules showed high similarity with that of decoction prepared from the same batch of slices.Conclusion The optimized preparation technology is reasonable,feasible and reproducible.This preparation can be used to obtain the granule with similar materials of Xinqingduyin decoction.
5.Research progress on the antitumor efficacy improvement for nanomedicine by combinatorial modification with multiligand
Xiao-yu ZHANG ; Song-gu WU ; Hui XU ; Jun-bo GONG ; Jin-feng XING ; Zhen-ping WEI
Acta Pharmaceutica Sinica 2024;59(7):1942-1951
After entering the body from the drug delivery site, antitumor nanomedicines need to cross a series of physiopathological barriers to reach the target site of action to effectively exert antitumor therapeutic effects. The ligand modification strategy is a classic method to enhance the efficiency of nanomedicine delivery
6.Study on inhibitory effect of alisol B on non-small cell lung cancer based on network pharmacology and its mechanism
Liu-Yan XIANG ; Wen-Xuan WANG ; Si-Meng GU ; Xiao-Qian ZHANG ; Lu-Yao LI ; Yu-Qian LI ; Yuan-Ru WANG ; Qi-Qi LEI ; Xue YANG ; Ya-Jun CAO ; Xue-Jun LI
Chinese Pharmacological Bulletin 2024;40(12):2375-2384
Aim To explore the potential genes and mechanism of alisol B in the treatment of non-small cell lung cancer(NSCLC).Methods The proliferation and migration of NSCLC cells were detected by CCK-8 and Transwell.Genes of NSCLC and alisol B were col-lected through TCGA and compound gene prediction database,and their intersection genes were obtained.The network of protein-protein interaction(PPI)was constructed by using String database,and the top 20 key nodes were screened out,and the prognosis-related proteins related to the prognosis of NSCLC were screened out by using R language,and the intersection of them was obtained.The potential mechanism of ali-sol B on NSCLC was explored by KEGG and GO en-richment analysis and the relationship between related genes and immune cells,which was verified by cell-lev-el experiments.Results Alisol B inhibited the cell activity and migration ability of NSCLC cells.Five im-portant genes were identified by network pharmacologi-cal analysis:CCNE1,CDK1,COL1A1,COL1A2 and COL3A1.The results of cell experiment showed that al-isol B down-regulated the expression of Cyclin E1,CDK1 and COL1A2 in NSCLC cells.In addition,alisol B could inhibit the expression of COL1A2 and M2 macrophage marker CD206 in macrophages.Conclu-sions Alisol B may inhibit the proliferation of tumor cells by down-regulating CDK1 and Cyclin E1,and may affect the function of macrophages by inhibiting COL1A2,thus regulating the tumor immune microenvi-ronment and inhibiting NSCLC.
7.Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome (version 2024)
Junyu WANG ; Hai JIN ; Danfeng ZHANG ; Rutong YU ; Mingkun YU ; Yijie MA ; Yue MA ; Ning WANG ; Chunhong WANG ; Chunhui WANG ; Qing WANG ; Xinyu WANG ; Xinjun WANG ; Hengli TIAN ; Xinhua TIAN ; Yijun BAO ; Hua FENG ; Wa DA ; Liquan LYU ; Haijun REN ; Jinfang LIU ; Guodong LIU ; Chunhui LIU ; Junwen GUAN ; Rongcai JIANG ; Yiming LI ; Lihong LI ; Zhenxing LI ; Jinglian LI ; Jun YANG ; Chaohua YANG ; Xiao BU ; Xuehai WU ; Li BIE ; Binghui QIU ; Yongming ZHANG ; Qingjiu ZHANG ; Bo ZHANG ; Xiangtong ZHANG ; Rongbin CHEN ; Chao LIN ; Hu JIN ; Weiming ZHENG ; Mingliang ZHAO ; Liang ZHAO ; Rong HU ; Jixin DUAN ; Jiemin YAO ; Hechun XIA ; Ye GU ; Tao QIAN ; Suokai QIAN ; Tao XU ; Guoyi GAO ; Xiaoping TANG ; Qibing HUANG ; Rong FU ; Jun KANG ; Guobiao LIANG ; Kaiwei HAN ; Zhenmin HAN ; Shuo HAN ; Jun PU ; Lijun HENG ; Junji WEI ; Lijun HOU
Chinese Journal of Trauma 2024;40(5):385-396
Traumatic supraorbital fissure syndrome (TSOFS) is a symptom complex caused by nerve entrapment in the supraorbital fissure after skull base trauma. If the compressed cranial nerve in the supraorbital fissure is not decompressed surgically, ptosis, diplopia and eye movement disorder may exist for a long time and seriously affect the patients′ quality of life. Since its overall incidence is not high, it is not familiarized with the majority of neurosurgeons and some TSOFS may be complicated with skull base vascular injury. If the supraorbital fissure surgery is performed without treatment of vascular injury, it may cause massive hemorrhage, and disability and even life-threatening in severe cases. At present, there is no consensus or guideline on the diagnosis and treatment of TSOFS that can be referred to both domestically and internationally. To improve the understanding of TSOFS among clinical physicians and establish standardized diagnosis and treatment plans, the Skull Base Trauma Group of the Neurorepair Professional Committee of the Chinese Medical Doctor Association, Neurotrauma Group of the Neurosurgery Branch of the Chinese Medical Association, Neurotrauma Group of the Traumatology Branch of the Chinese Medical Association, and Editorial Committee of Chinese Journal of Trauma organized relevant experts to formulate Chinese expert consensus on the diagnosis and treatment of traumatic supraorbital fissure syndrome ( version 2024) based on evidence of evidence-based medicine and clinical experience of diagnosis and treatment. This consensus puts forward 12 recommendations on the diagnosis, classification, treatment, efficacy evaluation and follow-up of TSOFS, aiming to provide references for neurosurgeons from hospitals of all levels to standardize the diagnosis and treatment of TSOFS.
8.A trinity strategy for the treatment of multiple orthopedic trauma and assessment of its clinical application
Xiao CHEN ; Guangchao WANG ; Hao ZHANG ; Kaiyang LYV ; Qirong ZHOU ; Yunfei NIU ; Yan HU ; Yuanwei ZHANG ; Zuhao LI ; Hao SHEN ; Jin CUI ; Sicheng WANG ; Zhengrong GU ; Zhen GENG ; Dongliang WANG ; Zhehao FAN ; Shihao SHENG ; Chongru HE ; Jun FEI ; Yunfeng CHEN ; Haodong LIN ; Guohui LIU ; Zhiyong HOU ; Jiacan SU
Chinese Journal of Trauma 2024;40(10):888-896
Objective:To explore the clinical value of a trinity strategy for the treatment of multiple orthopedic trauma.Methods:A retrospective case series study was conducted to analyze the clinical data of 1 267 patients with multiple orthopedic trauma admitted to Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and the First Affiliated Hospital of Navy Medical University from June 2013 to May 2023, including 862 males and 405 females, aged 18-93 years [(55.2±19.8)years]. Associated injuries included hemorrhagic shock in 632 patients, traumatic wet lung in 274, cranial injuries in 135, abdominal and pelvic bleeding in 116, pneumothorax in 89, urinary injury in 13, and vesical rupture in 8. All the patients were treated with the trinity strategy and the treatment process was divided into the phases of first aid, remodeling, and rehabilitation. The first aid phase focused on stabilizing symptoms and saving lives; the remodeling phase centered on restoring the anatomical structure and alignment; the rehabilitation phase aimed for functional recovery through the integration of both Western and traditional Chinese medicine. The all-cause mortality within 30 days after surgery and fracture healing time were calculated; the excellent and good rates of Constant-Murley shoulder score, Mayo elbow score, Gartland-Werley wrist score, Harris hip score, Hospital for Special Surgery (HSS) knee score and the American Orthopedic Foot & Ankle Society (AOFAS) ankle-hindfoot score at the last follow-up and the overall excellent and good rate of all joint function scores were measured. The short form health survey (SF-36) scores were collected preoperatively and at 6 months postoperatively, including 8 aspects such as physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health. The incidence of postoperative complications was recorded.Results:All the patients were followed up for 6-18 months [(10.2±4.2)months]. The mortality rate during the acute phase (within 30 days after surgery) was 2.37% with 12 deaths due to hemorrhagic shock, 10 due to traumatic brain injury, 6 due to multiple organ dysfunction syndrome (MODS), and 2 due to pulmonary infection. The average fracture healing time averaged 3.8-18 months [(11.5±4.2)months], with 89.49% of the patients having bone union within 12 months after surgery, 8.93% having bone union within 18 months after surgery, and 1.58% undergoing reoperation. For the patients with internal fixation failure and nonunion, the average healing time was extended to (10.2±2.2)months and (13.7±3.3)months respectively. At the last follow-up, the excellent and good rates of Constant-Murley shoulder score, Mayo elbow score, Gartland-Werley wrist score, Harris hip score, HSS knee score, and AOFAS ankle-hindfoot score were 83.93%, 90.24%, 94.12%, 85.57%, 88.46%, and 92.31% respectively, with an overall excellent and good rate of 89.11%. At 6 months after surgery, the SF-36 scores of all the patients in the eight dimensions,including the physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health were (74.4±8.6)points, (44.7±14.4)points, (77.4±10.9)points, (68.4±18.2)points, (72.5±16.0)points, (76.8±8.7)points, (49.9±17.6)points, and (72.8±17.9)points, significantly improved compared with those before operation [(63.4±12.7)points, (30.9±17.4)points, (56.4±18.0)points, (55.4±24.7)points, (53.5±21.0)points, (55.8±24.3)points, (36.9±24.0)points, (58.8±21.6)points] ( P<0.01). Complications of different degrees occurred in 214 patients (16.89%), including lung infections in 118 patients (9.31%), lower extremity deep vein thrombosis in 50(3.95%), pressure injuries in 26(2.05%), internal fixation failure in 12(0.95%), and nonunion in 8(0.63%). Conclusions:The trinity strategy provides whole-process management, personalized treatment, and overall rehabilitation for multiple orthopedic trauma. It can decrease mortality, shorten fracture healing time, improve joint function and quality of life, and reduce the incidence of complications.
9.On-line Measurement of Styrene Secondary Organic Aerosol Using Synchrotron Radiation Vacuum Ultraviolet Photoionization Aerosol Mass Spectrometer
Ming-Qiang HUANG ; Xiao-Bin SHAN ; Liu-Si SHENG ; Zhen-Ya WANG ; Chang-Jin HU ; Xue-Jun GU ; Wei-Jun ZHANG
Chinese Journal of Analytical Chemistry 2024;52(8):1200-1210
Secondary organic aerosol(SOA)produced by photooxidation of styrene and other aromatic compounds is a major part of fine particles in urban atmosphere.In this study,the measurement of component and content of SOA formed from photooxidation of styrene in smog chamber using synchronous radiation vacuum-ultraviolet photoionization aerosol mass spectrometer(VUV-PIAMS)was conducted.Photoionization mass spectra of styrene SOA was detected by synchrotron radiation photon with 10.5 eV,and the proportion of main components was quantified based on the peak area of each ion peak.The photoionization efficiency curve of ion peak was obtained under synchrotron radiation photons in the range from 7.5 to 11.5 eV,and then the ionization potential was acquired for qualitative analysis of the component structure.The results showed that the photoionization mass spectra of styrene SOA mainly contained ion peaks at m/z 106,108,120 and 122,and the ionization potentials of each peak were(9.41±0.03)eV,(8.93±0.03)eV,(9.24±0.03)eV and(9.25±0.03)eV,respectively.Combined with quantum chemistry calculation and off-line measurement verification of infrared absorption spectra and electrospray ionization mass spectra,it was determined that benzaldehyde,benzyl alcohol,4-vinylphenol and benzoic acid were main components of styrene SOA,accounting for 32.5%,17.5%,25%and 15%of the measured components,respectively,and the generated quantity ratio was 13∶7∶10∶6.VUV-PIAMS could overcome the disadvantages of off-line method,and could on-line detect component and content of SOA,proving a useful tool to measure the chemical components and reveal the formation process of SOA particles.
10.Clinical efficacy and safety of endoscopic submucosal dissection for early rectal or anal canal lesions involving the dentate line (with video)
Qiang ZHANG ; Limei GU ; Qide ZHANG ; Jun XIAO ; Yuhong ZHOU ; Tingsheng LING
Chinese Journal of Digestive Endoscopy 2024;41(11):901-905
A retrospective analysis was conducted on data of 13 patients with rectal or anal canal lesions involving the dentate line who underwent endoscopic submucosal dissection (ESD) at the Digestive Endoscopy Center of Jiangsu Province Hospital of Chinese Medicine from January 2022 to July 2023. The efficacy and safety of ESD were evaluated. ESD was performed on 14 lesions in 13 patients. The lesions had a length of 1.4 to 12.5 cm and 5.4 cm in average, which were removed entirely in a single session, with an R0 resection rate of 92.31% (12/13). The ESD procedure duration ranged from 35 to 225 minutes, with an average of 88.3 minutes. Anal canal stenosis occurred in 1 case after ESD, which was improved after treatment with anal dilatation. No delayed bleeding, perforation, or other complications occurred. Pathological examination after ESD revealed 6 tubulovillous adenoma, 2 tubular adenoma, 3 tubular adenocarcinoma, and 2 squamous epithelial intraepithelial neoplasia (both 2 lesions were combined with human papillomavirus infection). In one case of tubular adenocarcinoma, the local resection margin showed focal tubulovillous adenoma, while the other cases were negative on lateral margins around and basal margins. The median follow-up period was 7.0 months (range 2 to 13 months), with no local residue, recurrence or metastasis observed. ESD is safe and effective for early rectal or anal canal lesions involving the dentate line, and is worthy of clinical promotion and application.

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