1.Clinical trial of brexpiprazole in the treatment of adults with acute schizophrenia
Shu-Zhe ZHOU ; Liang LI ; Dong YANG ; Jin-Guo ZHAI ; Tao JIANG ; Yu-Zhong SHI ; Bin WU ; Xiang-Ping WU ; Ke-Qing LI ; Tie-Bang LIU ; Jie LI ; Shi-You TANG ; Li-Li WANG ; Xue-Yi WANG ; Yun-Long TAN ; Qi LIU ; Uki MOTOMICHI ; Ming-Ji XIAN ; Hong-Yan ZHANG
The Chinese Journal of Clinical Pharmacology 2024;40(5):654-658
Objective To evaluate the efficacy and safety of brexpiprazole in treating acute schizophrenia.Methods Patients with schizophrenia were randomly divided into treatment group and control group.The treatment group was given brexpiprozole 2-4 mg·d-1 orally and the control group was given aripiprazole 10-20 mg·d-1orally,both were treated for 6 weeks.Clinical efficacy of the two groups,the response rate at endpoint,the changes from baseline to endpoint of Positive and Negative Syndrome Scale(PANSS),Clinical Global Impression-Improvement(CGI-S),Personal and Social Performance scale(PSP),PANSS Positive syndrome subscale,PANSS negative syndrome subscale were compared.The incidence of treatment-related adverse events in two groups were compared.Results There were 184 patients in treatment group and 186 patients in control group.After treatment,the response rates of treatment group and control group were 79.50%(140 cases/184 cases)and 82.40%(150 cases/186 cases),the scores of CGI-I of treatment group and control group were(2.00±1.20)and(1.90±1.01),with no significant difference(all P>0.05).From baseline to Week 6,the mean change of PANSS total score wese(-30.70±16.96)points in treatment group and(-32.20±17.00)points in control group,with no significant difference(P>0.05).The changes of CGI-S scores in treatment group and control group were(-2.00±1.27)and(-1.90±1.22)points,PSP scores were(18.80±14.77)and(19.20±14.55)points,PANSS positive syndrome scores were(-10.30±5.93)and(-10.80±5.81)points,PANSS negative syndrome scores were(-6.80±5.98)and(-7.30±5.15)points,with no significant difference(P>0.05).There was no significant difference in the incidence of treatment-related adverse events between the two group(69.00%vs.64.50%,P>0.05).Conclusion The non-inferiority of Brexpiprazole to aripiprazole was established,with comparable efficacy and acceptability.
2.An overview of research based on intestinal microecology to explore musculoskeletal attenuation diseases
Yan-Dong LIU ; Qiang DENG ; Ran-Dong PENG ; Yu-Rong WANG ; Tie-Feng GUO ; Qian-Qian XIANG ; Jian-Qiang DU ; Ping-Yi MA
Parenteral & Enteral Nutrition 2023;30(5):309-314
Sarcopenia,osteoporosis and osteosarcoporosis,which belong to the same category of musculoskeletal unit disease,seriously impair the homeostasis of the musculoskeletal system in the aging process of the human body.In recent years,researchers have applied various emerging technologies to conduct multi-disciplinary,multi-level and multi-dimensional research on musculoskeletal decay disease,and have come to realized that the disease involves complex biochemical and mechanical crosstalk,and the intestinal microecology has also aroused great interest in this crosstalk because of its profound impact on musculoskeletal health.In view of this,this paper takes the close relationship between intestinal microecology and musculoskeletal decay disease as the starting point,and under the guidance of the overall concept,we deeply analyzes the mechanism and regulatory information behind this relationship,and on this basis,we excavates the potential therapeutic targets for musculoskeletal decay disease,so that we can provide new ideas and strategies for the management of the disease in the context of the musculoskeletal subunit.
3.Course of disease and related epidemiological parameters of COVID-19: a prospective study based on contact tracing cohort.
Yan ZHOU ; Wen Jia LIANG ; Zi Hui CHEN ; Tao LIU ; Tie SONG ; Shao Wei CHEN ; Ping WANG ; Jia Ling LI ; Yun Hua LAN ; Ming Ji CHENG ; Jin Xu HUANG ; Ji Wei NIU ; Jian Peng XIAO ; Jian Xiong HU ; Li Feng LIN ; Qiong HUANG ; Ai Ping DENG ; Xiao Hua TAN ; Min KANG ; Gui Min CHEN ; Mo Ran DONG ; Hao Jie ZHONG ; Wen Jun MA
Chinese Journal of Preventive Medicine 2022;56(4):474-478
Objective: To analyze the course of disease and epidemiological parameters of COVID-19 and provide evidence for making prevention and control strategies. Methods: To display the distribution of course of disease of the infectors who had close contacts with COVID-19 cases from January 1 to March 15, 2020 in Guangdong Provincial, the models of Lognormal, Weibull and gamma distribution were applied. A descriptive analysis was conducted on the basic characteristics and epidemiological parameters of course of disease. Results: In total, 515 of 11 580 close contacts were infected, with an attack rate about 4.4%, including 449 confirmed cases and 66 asymptomatic cases. Lognormal distribution was fitting best for latent period, incubation period, pre-symptomatic infection period of confirmed cases and infection period of asymptomatic cases; Gamma distribution was fitting best for infectious period and clinical symptom period of confirmed cases; Weibull distribution was fitting best for latent period of asymptomatic cases. The latent period, incubation period, pre-symptomatic infection period, infectious period and clinical symptoms period of confirmed cases were 4.50 (95%CI:3.86-5.13) days, 5.12 (95%CI:4.63-5.62) days, 0.87 (95%CI:0.67-1.07) days, 11.89 (95%CI:9.81-13.98) days and 22.00 (95%CI:21.24-22.77) days, respectively. The latent period and infectious period of asymptomatic cases were 8.88 (95%CI:6.89-10.86) days and 6.18 (95%CI:1.89-10.47) days, respectively. Conclusion: The estimated course of COVID-19 and related epidemiological parameters are similar to the existing data.
COVID-19
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Cohort Studies
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Contact Tracing
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Humans
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Incidence
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Prospective Studies
4.Practice of Palliative Care Consultation Proposed by the Emergency Department in Peking Union Medical College Hospital.
Xiao-Hong NING ; Jia-Yi LI ; Xiao-Yan DAI ; Qian LIU ; Di SHI ; Xiao-Xuan ZHAO ; Jie LI ; Lei WANG ; Nan GE ; Xuan QU ; Tie-Kuan DU ; Hua-Dong ZHU
Acta Academiae Medicinae Sinicae 2022;44(5):763-767
Objective To summarize the palliative care consultations proposed by the Emergency Department of Peking Union Medical College Hospital. Methods A retrospective study was conducted on 22 palliative care consultations in the Emergency Department of Peking Union Medical College Hospital from January 2017 to June 2020. Results A total of 18 patients (6 males and 12 females) received palliative care consultations in the Emergency Department,with the average age of (65±8) years (36-88 years).Specifically,10 and 6 patients received once and twice consultations,respectively,and 2 patients did not complete the consultation.Of the patients receiving palliative care consultations,15 had malignant tumors and 3 had non-neoplastic diseases.The reasons for palliative care consultations included communication (61.1%,11/18) and pain relief (61.1%,11/18).In terms of the place of death,8 patients died in the hospital and 6 patients in other medical institutions. Conclusion There is a clear demand for palliative care consultation in the Emergency Department of Peking Union Medical College Hospital,and the consultation can bring help to both emergency doctors and patients.
Male
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Female
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Humans
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Middle Aged
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Aged
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Palliative Care/methods*
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Retrospective Studies
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Referral and Consultation
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Hospitals
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Emergency Service, Hospital
5.Clinical characteristics and diagnosis and treatment strategies of patients with severe traumatic aortic injury.
Ying Zhen BU ; Xuan Ze LIU ; Tie Nan ZHOU ; Xu Dong LIU ; Hong Xu JIN ; Xiao Jiang LIU ; Xiao Zeng WANG
Chinese Journal of Cardiology 2022;50(8):767-773
Objective: To investigate the clinical characteristics and diagnosis and treatment strategies of patients with severe traumatic aortic injury (TAI). Methods: A total of 25 patients with TAI, who hospitalized in our hospital between August 2005 to March 2021 and underwent thoracic aortic endovascular repair (TEVAR), were included in this retrospective study. According to the time from admission to TEVAR, the patients were divided into emergency TEVAR group (14 cases, TEVAR within 24 h of admission) and elective TEVAR group (11 cases, patients underwent surgery or fracture reduction and fixation first for serious injuries and then underwent TEVAR more than 24 h after admission). The general clinical data of patients, injury severity score (ISS), time from admission to intervention, total hospital stay, the proportion of closed chest drainage and the proportion of abdominal organ repair were obtained and compared. Clinical follow-up and 1-year postoperative aortic computed tomography angiography (CTA) were performed on the patients. Death, the occurrence of aortic adverse events and injury recovery were followed up and recorded. Results: The mean age of these 25 TAI patients was (41.4±14.4) years, 20 patients were males (80.0%). 21 patients (84.0%) had persistent chest and back pain, 17 (68.0%) had pleural effusion and 5 (20.0%) had mediastinal hematoma. The injury severity score (ISS) was significantly higher in the elective TEVAR group than in the emergency TEVAR group (24.9±14.4 vs. 35.5±9.3, P=0.044). The time from admission to intervention ((1.0±0.0) d vs. (3.4±0.9) d, P<0.001], the time from admission to TEVAR ((1.0±0.0) d vs. (11.5±13.8) d, P=0.030) and total hospital stay ((6.1±2.3) d vs. (26.8±7.7) d, P<0.001) were significantly longer in elective TEVAR group than in emergency TEVAR group. The proportion of thoracic closed drainage was significantly lower in the elective TEVAR group than in the emergency TEVAR group (9 (64.3%) vs. 2 (18.2%), P=0.042). The proportion of abdominal organ repair was significantly higher than in the emergency TEVAR group (0 vs. 4 (36.4%), P=0.026). All of 25 patients were discharged alive and followed up for (84.0±30.5) months. All patients survived and completed 1-year postoperation CTA. There were no aortic adverse events occurred, and no complications after surgery, and the fractures and organ injuries healed well. Conclusions: The clinical characteristics of severe TAI are acute multi-injuries combined with persistent chest and/or back pain, pleural effusion, and mediastinal hematoma. Timely diagnosis and treatment are important factors for the outcome. The treatment strategy for multi-injuries should give priority to dealing with life-threatening injuries. TEVAR is the primary treatment strategy for severe TAI and is related to satisfactory outcomes.
Adult
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Aorta, Thoracic/surgery*
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Aortic Diseases
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Blood Vessel Prosthesis Implantation/adverse effects*
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Endovascular Procedures/methods*
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Female
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Hematoma/surgery*
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Humans
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Male
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Middle Aged
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Pleural Effusion/surgery*
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Retrospective Studies
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Risk Factors
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Treatment Outcome
6. Comprehensive Evaluation and Application of Experimental Sources of Variation in Gut Microbiome Sequencing Studies
Ke-Lin XU ; Yue ZHUANG ; Si-Bo ZHU ; Jiang-Li XUE ; Yan-Feng JIANG ; Zi-Yu YUAN ; Chen SUO ; Tie-Jun ZHANG ; Ming LV ; Xing-Dong CHEN ; Si-Bo ZHU ; Yan-Feng JIANG ; Jiu-Cun WANG ; Xing-Dong CHEN ; Si-Bo ZHU ; Yan-Feng JIANG ; Xing-Dong CHEN ; Chen SUO ; Tie-Jun ZHANG ; Ming LV
Chinese Journal of Biochemistry and Molecular Biology 2022;38(7):959-970
Gut microbiome sequencing studies have great potential to translate microbial analysis outcomes into human health research. Sequencing strategies of 16S amplicon and whole-metagenome shotgun (WMS) are two main methods in microbiome research with respective advantages. However, how sample heterogeneity, sequencers and library preparation protocols affect the sequencing reproducibility of gut microbiome needs further investigation. This study aims to provide a reference for the selection of sequencing technologies by comparing differences in microbial composition from different sampling sites. The results of three widely adopted sequencers showed that the technical repetition correlation (r= 0. 94) was high in WMS method, while the biological repetition correlation (r = 0. 69) was low. Bray-Curtis distance identified that dissimilarity from biological replicates was larger than that of technical replicates (P<0. 001). In addition, dissimilarity and specific taxonomic profiles were observed between 16S and WMS datasets. Our results imply that homogenization is a necessary step before sample DNA extraction. The sequencers contributed less to taxonomic variation than the library preparation protocols. We developed an empirical Bayes approach that " borrowed information" in calculations and analyzed batch effect parameters using standardized data and prior distributions of (non-) parameters, which may improve population comparability between 16S and WMS and provide a basis for further application to fusion analysis of published 16S and microbial datasets.
7.An improved maximal information coefficient algorithm applied in the analysis of functional corticomuscular coupling for stroke patients.
Tie LIANG ; Qingyu ZHANG ; Lei HONG ; Xiaoguang LIU ; Bin DONG ; Hongrui WANG ; Xiuling LIU
Journal of Biomedical Engineering 2021;38(6):1154-1162
The functional coupling between motor cortex and effector muscles during autonomic movement can be quantified by calculating the coupling between electroencephalogram (EEG) signal and surface electromyography (sEMG) signal. The maximal information coefficient (MIC) algorithm has been proved to be effective in quantifying the coupling relationship between neural signals, but it also has the problem of time-consuming calculations in actual use. To solve this problem, an improved MIC algorithm was proposed based on the efficient clustering characteristics of K-means ++ algorithm to accurately detect the coupling strength between nonlinear time series. Simulation results showed that the improved MIC algorithm proposed in this paper can capture the coupling relationship between nonlinear time series quickly and accurately under different noise levels. The results of right dorsiflexion experiments in stroke patients showed that the improved method could accurately capture the coupling strength of EEG signal and sEMG signal in the specific frequency band. Compared with the healthy controls, the functional corticomuscular coupling (FCMC) in beta (14~30 Hz) and gamma band (31~45 Hz) were significantly weaker in stroke patients, and the beta-band MIC values were positively correlated with the Fugl-Meyers assessment (FMA) scale scores. The method proposed in this study is hopeful to be a new method for quantitative assessment of motor function for stroke patients.
Algorithms
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Electroencephalography
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Electromyography
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Humans
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Motor Cortex
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Muscle, Skeletal
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Stroke
8.Baihutang Syndrome and Treatment: A New Interpretation Based on Six Dimensional Syndrome Differentiation Theory
Xun-xin LI ; He YU ; Yu-han WANG ; Bo-chuan WANG ; Zhen-dong WANG ; Li-jun CUI ; Tie-gang LIU ; Xiao-hong GU
Chinese Journal of Experimental Traditional Medical Formulae 2021;27(15):181-187
Six dimensional syndrome differentiation theory, put forward by professor GU Xiao-hong at Beijing University of Chinese Medicine based on her theoretical teaching and clinical experience, emphasizes that the syndrome differentiation should be carried out from six dimensions including etiology, disease location, disease stage, disease condition, pathology, and disease nature, which is conducive to clinical thinking training and formation of traditional Chinese medicine (TCM). The differentiation and treatment of Baihutang syndrome frequently seen in cold damage and warm disease still need to be explored. Guided by the six dimensional syndrome differentiation theory coupled with diverse viewpoints of cold damage and warm disease schools, this paper summarized and reinterpreted the understandings and thoughts of GU Xiao-hong and YU He, warm disease specialists of two generations. Considering the lung-stomach dysfunction caused by the internal invasion of exogenous pathogens, Baihutang syndrome was staged into Qi aspect. In this stage, exuberant pathogens and sufficient healthy Qi allowed the prevailing of internal heat and the consumption of body fluid, manifested as high fever, profuse sweating, thirst, and the pulse corresponding to interior excess and heat syndrome. This paper also pointed out that the Baihutang syndrome involved both lung and stomach, and the adoption of Baihutang contributed to preventing tu from restricting shui in the case of extreme excess of Yang brightness and protecting the kidney Yin. As revealed by the dynamic analysis of prognosis of Baihutang syndrome based on the six dimensional syndrome differentiation theory, even though the Baihutang syndrome could be present in both cold damage and warm disease, the specific disease stage, transmission and change, condition, prognosis, pathology, and medication differed. On this basis, a series of prescriptions have been modified from Baihutang, which has expanded the application scope of Baihutang and enriched its research value, thus better promoting its clinical application.
9.Adefovir Dipivoxil plus Chinese Medicine in HBeAg-Positive Chronic Hepatitis B Patients: A Randomized Controlled 48-Week Trial.
Xiao-Ke LI ; Ming-Xiang ZHANG ; Feng-Zhen SHAO ; Da-Qiao ZHOU ; Jing-Dong XUE ; Tie-Jun LIU ; Xiao-Ling CHI ; Bing-Jiu LU ; Xian-Bo WANG ; Qin LI ; Jun LI ; De-Wen MAO ; Hua-Sheng YANG ; Hong-Zhi YANG ; Wen-Xia ZHAO ; Yong LI ; Guo-Liang ZHANG ; Yi-Ming ZHAO ; Jian-Dong ZOU ; Meng-Yang LIU ; Ke-Ke ZHANG ; Xian-Zhao YANG ; Da-Nan GAN ; Ying LI ; Peng ZHANG ; Zhi-Guo LI ; Shuo LI ; Yong-An YE
Chinese journal of integrative medicine 2020;26(5):330-338
OBJECTIVE:
To evaluate the effects of a 48-week course of adefovir dipivoxil (ADV) plus Chinese medicine (CM) therapy, namely Tiaogan Jianpi Hexue () and Tiaogan Jiedu Huashi () fomulae, in hepatitis B e antigen (HBeAg)-positive Chinese patients.
METHODS:
A total of 605 HBeAg-positive Chinese CHB patients were screened and 590 eligible participants were randomly assigned to 2 groups in 1:1 ratio including experimental group (EG, received ADV plus CM) and control group (CG, received ADV plus CM-placebo) for 48 weeks. The major study outcomes were the rates of HBeAg and HBV-DNA loss on week 12, 24, 36, 48, respectively. Secondary endpoints including liver functions (enzymes and bilirubin readings) were evaluated every 4 weeks at the beginning of week 24, 36, and 48. Routine blood, urine, and stool analyses in addition to electrocardiogram and abdominal B scan were monitored as safety evaluations. Adverse events (AEs) were documented.
RESULTS:
The combination therapy demonstrated superior HBeAg loss at 48 weeks, without additional AEs. The full analysis population was 560 and 280 in each group. In the EG, population achieved HBeAg loss on week 12, 24, 36, and 48 were 25 (8.90%), 34 (12.14%), 52 (18.57%), and 83 (29.64%), respectively; the equivalent numbers in the CG were 20 (7.14%), 41 (14.64%), 54 (19.29%), and 50 (17.86%), respectively. There was a statistically significant difference between these group values on week 48 (P<0.01). No additional AEs were found in EG. Subgroup analysis suggested different outcomes among treatment patterns.
CONCLUSION
Combination of CM and ADV therapy demonstrated superior HBeAg clearance compared with ADV monotherapy. The finding indicates that this combination therapy may provide an improved therapeutic effect and safety profile (ChiCTR-TRC-11001263).
Adenine
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analogs & derivatives
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therapeutic use
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Adult
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Antiviral Agents
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therapeutic use
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Double-Blind Method
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Drug Therapy, Combination
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Drugs, Chinese Herbal
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therapeutic use
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Female
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Hepatitis B e Antigens
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immunology
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Hepatitis B, Chronic
;
drug therapy
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immunology
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Humans
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Male
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Medicine, Chinese Traditional
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Organophosphonates
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therapeutic use
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Young Adult
10.A drug-eluting Balloon for the trEatment of coronarY bifurcatiON lesions in the side branch: a prospective multicenter ranDomized (BEYOND) clinical trial in China.
Quan-Min JING ; Xin ZHAO ; Ya-Ling HAN ; Ling-Ling GAO ; Yang ZHENG ; Zhan-Quan LI ; Ping YANG ; Hong-Liang CONG ; Chuan-Yu GAO ; Tie-Min JIANG ; Hui LI ; Jun-Xia LI ; Dong-Mei WANG ; Geng WANG ; Zhan-Chun CONG ; Zhong ZHANG
Chinese Medical Journal 2020;133(8):899-908
BACKGROUND:
Treatment of coronary bifurcation lesions remains challenging; a simple strategy has been preferred as of late, but the disadvantage is ostium stenosis or even occlusion of the side branch (SB). Only a few single-center studies investigating the combination of a drug-eluting stent in the main branch followed by a drug-eluting balloon in the SB have been reported. This prospective, multicenter, randomized study aimed to investigate the safety and efficacy of a paclitaxel-eluting balloon (PEB) compared with regular balloon angioplasty (BA) in the treatment of non-left main coronary artery bifurcation lesions.
METHODS:
Between December 2014 and November 2015, a total of 222 consecutive patients with bifurcation lesions were enrolled in this study at ten Chinese centers. Patients were randomly allocated at a 1:1 ratio to a PEB group (n = 113) and a BA group (n = 109). The primary efficacy endpoint was angiographic target lesion stenosis at 9 months. Secondary efficacy and safety endpoints included target lesion revascularization, target vessel revascularization, target lesion failure, major adverse cardiac and cerebral events (MACCEs), all-cause death, cardiac death, non-fatal myocardial infarction, and thrombosis in target lesions. The main analyses performed in this clinical trial included case shedding analysis, base-value equilibrium analysis, effectiveness analysis, and safety analysis. SAS version 9.4 was used for the statistical analyses.
RESULTS:
At the 9-month angiographic follow-up, the difference in the primary efficacy endpoint of target lesion stenosis between the PEB (28.7% ± 18.7%) and BA groups (40.0% ± 19.0%) was -11.3% (95% confidence interval: -16.3% to -6.3%, Psuperiority <0.0001) in the intention-to-treat analysis, and similar results were recorded in the per-protocol analysis, demonstrating the superiority of PEB to BA. Late lumen loss was significantly lower in the PEB group than in the BA group (-0.06 ± 0.32 vs. 0.18 ± 0.34 mm, P < 0.0001). For intention-to-treat, there were no significant differences between PEB and BA in the 9-month percentages of MACCEs (0.9% vs. 3.7%, P = 0.16) or non-fatal myocardial infarctions (0 vs. 0.9%, P = 0.49). There were no clinical events of target lesion revascularization, target vessel revascularization, target lesion failure, all-cause death, cardiac death or target lesion thrombosis in either group.
CONCLUSIONS:
In de novo non-left main coronary artery bifurcations treated with provisional T stenting, SB dilation with the PEB group demonstrated better angiographic results than treatment with regular BA at the 9-month follow-up in terms of reduced target lesion stenosis.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT02325817; https://clinicaltrials.gov.

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