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Safety and efficacy of T-614 in the treatment of patients with active rheumatoid arthritis： a double blind, randomized, placebo-controlled and multicenter trial

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Chinese Medical Journal 2008年第7期121卷 615-619页

作者： Lu Liang-jing TENGJia-lin BAO Chun-de HAN Xing-hai SUN Ling-yun XU Jiang-hua LI Xing-fu WU Hua-xiang Department of Rheumatology Renji Hospital Shanghai Jiao TongUniversity Shanghai 200001 China Department of Rheumatology Changhai Hospital Second MilitaryUniversity Shanghai 200001 China Department of Rheumatology Gulou Hospital Nanjing UniversityNanjing Jiangsu 210000 China Department of Rlaeumatology Frist Alliliated Hospital AnlluiMedical University Hefei Anhui 230000 China Department of Rheumatology Qilu Hospital of ShandongUniversity Jinan Shandong 250012 China Department of Rheumatology Second Affiliated HospitalZhejiang University Hangzhou Zhejiang 510000 China

Background A novel anti-rheumatic drug, T-614, has been shown to have an anti-inflammatory effect and to improve abnormal immunological findings in rheumatoid arthritis （RA）. To assess the safety and efficacy of T-614 versus placebo in patients with active RA we conducted a 24-week clinical study in 280 Chinese patients. Methods In a multicenter, randomized, double blind, placebo controlled study, 280 patients were randomly assigned to receive placebo （n=95） or T-614 at 50 mg （n=93） or 25 mg （n=92） daily. Active disease was defined by 4 of the following 5 criteria：〉5 tender joints, 〉3 swollen joints, morning stiffness lasting for 〉60 minutes, and Westergren erythrocyte sedimentation rate （ESR）〉28 mm/h, the assessment of pain at the rest by patient as moderate or severe. Clinical and laboratory parameters were analyzed at baseline, 2, 4, 6, 12, 18 and 24 weeks. The primary efficacy variable at week 24 was the American College of Rheumatology （ACR） response rate using the intent-to-treat population. Results The ACR response rate was significantly higher in the T-614 treatment group compared with the placebo group within 8 weeks after the initiation of treatment. After 24 weeks, the 25 mg/d and 50 mg/d dosage groups and the placebo group showed 39.13%, 61.29% and 24.21% in ACR20 and 23.91%, 31.18% and 7.37% in ACR50, respectively. A time-response in ACR response was observed, with clear superiority for the 25 mg/d and 50 mg/d dosage groups compared to placebo （P〈0.0001）, and the 50 mg/d dose compared to the 25 mg/d dose （P〈0.05） when using the ACR response analyses after 24 weeks. ESR and c-reactive protein （CRP） were significantly different in the treatment groups after 24 weeks. The incidence of adverse events （AEs） was not significantly higher with T-614 than with placebo, but upper abdominal discomfort, leucopenia, elevated serum alanine aminotransferase （sALT）, skin rash and/or pruritus were more common in the 50 mg and 25 mg dosage groups. Conclusion T-614, a n

关键词： arthritis, rheumatoid T-614 randomized controlled trial

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Safety and immunogenicity of inactivated SARS-CoV-2 vaccine in high-risk occupational population:a randomized,parallel,controlled clinical trial

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Infectious Diseases of Poverty 2021年第6期10卷 27-37页

作者： Yongliang Feng Jing Chen Tian Yao Yue Chang Xiaoqing Li Rongqin Xing Hong Li Ruixue Xie Xiaohong Zhang Zhiyun Wei Shengcai Mu Ling Liu Lizhong Feng Suping Wang Department of Epidemiology School of Public HealthShanxi Medical University56 Xinjian South RoadTaiyuan 030001Shanxi ProvinceChina Center of Clinical Epidemiology and Evidence Based Medicine Shanxi Medical UniversityTaiyuanChina Shanxi Provincial Center for Disease Control and Prevention 8 Xiaonanguan StreetTaiyuan 030012Shanxi ProvinceChina Shanxi Provincial Key Laboratory for Major Infectious Disease Response TaiyuanChina Outpatient Department of Shanxi Aviation Industry Group Co.LTD TaiyuanChina

Background: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) have a substantial burden on health-care systems around the world. This is a randomized parallel controlled trial for assessment of the immunogenicity and safety of an inactivated SARS-CoV-2 vaccine, aiming to determine an appropriate vaccination interval of the vaccine for high-risk occupational ***: In an ongoing randomized, parallel, controlled phase IV trial between January and May 2021 in Taiyuan City, Shanxi Province, China, we randomly assigned the airport ground staff and public security officers aged 18 to 59 years to receive two doses of inactivated SARS-CoV-2 vaccine at 14 days, 21 days, or 28 days. The serum neutralizing antibody to live SARS-CoV-2 was performed at baseline and 28 days after immunization. Long-term data are being collected. The primary immunogenicity endpoints were neutralization antibody seroconversion and geometric mean titer (GMT) at 28 days after the second dose. Analysis of variance (ANOVA), chi-square, and logistic regression analysis were used for data ***: A total of 809 participants underwent randomization and received two doses of injections: 270, 270, 269 in the 0-14, 0-21, and 0-28 vaccination group, respectively. By day 28 after the second injection, SARS-CoV-2 neutralizing antibody of GMT was 98.4 (95%CI: 88.4-108.4) in the 0-14 group, which was significantly lower compared with 134.4 (95%CI: 123.1-145.7) in the 0-21 group (P < 0.001 vs 0-14 group) and 145.5 (95%CI: 131.3-159.6) in the 0-28 group (P < 0.001 vs 0-14 group), resulting in the seroconversion rates to neutralizing antibodies (GMT ≥ 16) of 100.0% for all three groups, respectively. The intention-to-treat (ITT) analysis yielded similar results. All reported adverse reactions were ***: Both a two-dose of inactivated SARS-CoV-2 vaccine at 0-21 days and 0-28 days regimens significantly improv

关键词： COVID-19 Inactivated SARS-CoV-2 vaccine Immunogenicity Safety High-risk occupational population randomized controlled trial

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Reduction of serum level of interleukin-2 and pruritus severity after acupuncture at Quchi(LI11)in hemodialysis patients:a placebo-controlled randomized clinical trial

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Journal of Acupuncture and Tuina Science 2022年第2期20卷 126-133页

作者： Dedi ARDINATA Rozaimah ZAIN-HAMID Irma D MAHADI Hasan MIHARDJA Department of Physiology Faculty of MedicineUniversitas Sumatera UtaraMedan20155Indonesia Department of Pharmacology and Therapeutic Faculty of MedicineUniversitas Sumatera UtaraMedan20155Indonesia Department of Dermatology and Venereology Faculty of MedicineUniversitas Sumatera UtaraMedan20155Indonesia Department of Medical Acupuncture Faculty of MedicineUniversitas IndonesiaJakarta10430Indonesia

Objective To observe the effect of acupuncture at Quchi(LI11)on the serum interleukin-2(IL-2)level and the severity of uremic pruritus(UP)in hemodialysis *** Sixty hemodialysis patients with UP were randomized into an acupuncture group and a control group,with 30 cases in each *** the acupuncture group,patients were treated with acupuncture at Quchi(LI11)twice a week for six *** the control group,each patient received a placebo treatment(sham acupuncture).Before and after the intervention,the pruritis severity was examined using a 5-D scale,and the serum IL-2 level was measured using an enzyme-linked immunosorbent assay *** There were no statistically significant differences in the demographic or clinical factors between the control group and the acupuncture group at *** reduction in pruritus severity in patients was more significant in the acupuncture group(P=0.027).Acupuncture therapy also significantly decreased the serum IL-2 level in the patients(P=0.011).Throughout the acupuncture procedures,the incidence of pain and mild bleeding was 3.6%and 2.5%,*** Six-week acupuncture treatment at Quchi(LI11)can effectively decrease the severity of UP and the serum IL-2 ***-scale,long-duration,and multi-center studies are needed to fully understand the role of IL-2 in inflammation and neuroimmune stimulation during acupuncture.

关键词： Acupuncture Therapy Point Quchi (LI11) Interleukin-2 Pain Pruritus Hemodialysis randomized controlled trial

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Alveolar Ridge Preservation Utilizing Composite (Bioceramics/Collagen) Graft: A Cone-Beam Computed Tomography Assessment in a randomized Split-Mouth controlled trial

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Journal of Biomedical Science and Engineering 2021年第2期14卷 64-73页

作者： Khalil Yosouf Omar Heshmeh Khaldoun Darwich Department of Oral and Maxillofacial Surgery Faculty of Dentistry Damascus University Damascus Syria

Background: The vast percentage of the alveolar bone resorption process happens within the first 12 to 24 weeks post extraction;however, this phenomenon is chronic, and the alveolar ridge continues to resorb. In order to prevent this reduction or at least recompense the loss of bone dimensions, the alveolar ridge preservation (ARP) technique was developed. Objectives: This research studied the vertical and horizontal bone dimensional changes as a result of non-molar teeth extraction alone against extraction with alveolar ridge preservation utilizing composite (bioceramics/collagen) graft by cone-beam computed tomography radiographies analyses. Material and Methods: This research was a randomized split-mouth controlled trial. 12 patients need extraction of the maxillary non-molar teeth were enrolled and allocated into 2 groups. 12 sockets after atraumatic extraction were filled with a composite graft in the role of the test group, 12 sockets left to unassisted healing after atraumatic extraction without any graft materials in the role of the control group. Two CBCT radiographs were taken at baseline and at 4 months after extraction for comparison. Both vertical and horizontal resorptions of the alveolar ridge were analyzed between test and control group by CBCT radiographs. Results: 4 months after extraction, there was a mean of vertical alveolar bone resorption compared with the baseline (0.56 ± 0.15 mm) in the test group and (1.47 ± 0.30 mm) in the control group. Whereas it was a mean of horizontal alveolar bone resorption compared with the baseline (0.90 ± 0.16 mm) in the test group and (2.26 ± 0.30 mm) in the control group. Therefore, there was a significant difference between the two groups. Conclusions: Within the limitations of this research, we demonstrated that the osteogen-plug technique significantly decreased the reduction of the bone dimensional in comparison to the tooth extraction alone, and showed that the dimensional change of the alveolar ridge afte

关键词： randomized controlled trial Composite Graft Alveolar Ridge Preservation Atraumatic Extraction Cone-Beam Computed Tomography

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A multicenter randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of rhubarb in treating acute exacerbation of chronic obstructive pulmonary disease of the syndrome type phlegm-heat obstructing the lungs

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Journal of Traditional Chinese Medical Sciences 2016年第2期3卷 71-80页

作者： Fengjie Zheng Yan Sun Xianggen Zhong Yueqi Wang Ruohan Wu Miao Liu Yuchao Liu Kuo Gao Yuhang Li School of Preclinical Medicine Beijing University of Chinese MedicineBeijing 100029China

Objective:To observe the clinical efficacy and safety of oral administration of the traditional Chinese herb rhubarb to treat acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Method:This was a multicenter randomized double-blinded placebo controlled study that took place in 7 provinces of China that enrolled 244 patients(aged 18e80 years)who had acute exacerbation of COPD with the traditional Chinese syndrome pattern of phlegm-heat obstructing *** were divided into experimental and control *** experimental group received 4.5 g of rhubarb granules twice daily and the control group received placebo *** groups also received conventional Western therapy consisting of oxygen therapy,an antibiotic,expectorant,and a *** lasted 10 *** scores for cough,sputum volume and color,wheezing and chest tightness before treatment and on days 3,5,7,and 10 during the treatment were *** function,arterial blood gas and levels of serum inflammatory factors,interleukin-4(IL-4),interleukin-8(IL-8),and interleukin-10(IL-10)and tumor necrosis factor-alpha(TNF-a),before and after treatment were ***:The sample size of the full analysis set(FAS)was 244 participants,and the sample size of per protocol set(PPS)was *** 10 days’treatment,symptom scores of the experimental group were markedly lower than those of the placebo group(FAS:mean difference1.67,95%CI:e2.66 to0.69,P Z 0.001;PPS:mean difference1.55,95%CI:2.56 to0.54,P Z 0.003).Lung function in the experimental group was significantly higher than in the placebo group(FEV1,FAS:mean difference 0.12,95%CI:0.06 to 0.18;P<0.001;PPS:mean difference 0.12,95%CI 0.05 to 0.18;P<***:FAS:mean difference 0.16,95%CI:0.06 to 0.26;P Z 0.002;PPS:mean difference 0.16,95%CI 0.05 to 0.26;P Z ***1%,FAS:mean difference 5.95,95%CI:3.36 to 8.53;P<0.001;PPS:mean difference 5.92,95%CI 3.28 to 8.56;P<0.001.).PaO2,PaCO2,as well as serum inflamm

关键词： Traditional Chinese medicine COPD Phlegm-heat obstructing the lung syndrome Rhubarb randomized controlled trial

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Acupuncture for Rheumatoid Arthritis: A randomized, Sham-controlled Clinical trial

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Journal of Acupuncture and Tuina Science 2011年第3期9卷 168-172页

作者： Zukow W Kalisz Z Muszkieta R Napierala M University of Economy Bydgoszcz University Kazimierz Wielki University

Objective： To assess the clinical effects of acupuncture in treating rheumatoid arthritis. Methods： Seventy patients fulfilled at least 4 items of the diagnostic criteria for rheumatoid arthritis of the American College of Rheumatology （ACR）. All patients were instructed not to receive other relevant therapies during research. Patients were randomized into a treatment group and a control group by computer generated assigned codes to receive real acupuncture and sham acupuncture respectively. The codes of randomization were hidden from doctors and patients. Patients were studied before and after the whole acupuncture treatment sessions （36 treatments）.The results were assessed according to changes of ESR mm/h, CRP mg/L, rheumatoid factor （RF）, the radiological changes （the erosion and osteoporosis of hand or wrist joint）, the intensity of pain by visual analogue scale （VAS）, the modified questionnaire according to Laitinen and Zytkowski （the intensity of pain, frequency of pain, medicines, limitation of motive activity）. Results： No significant differences in comparison of any parameters were shown before treatment. After treatment, the results of VAS and modified questionnaire were far better in the treatment group than in the control. Conclusion： Acupuncture can achieve a positive result compared with the sham, and it is effective in treating rheumatoid arthritis.

关键词： Acupuncture Therapy Arthritis, Rheumatoid randomized controlled trial

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Chinese herbs in treatment of influenza:a randomized,double-blind,placebo-controlled trial

Chinese herbs in treatment of influenza:a randomized,double-...

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第六届全国中西医结合基础理论研究学术研讨会暨第二届湖南省中西医结合学会肝病专业学术年会

作者： Wang Lei~a Zhang Rui-Ming~a Liu Gui-Ying~b Wei Bao-Lin~c Wang Yang~d Cai Hong-Yan~e Li Feng-Sen~f Xu Yan-Ling~g Zheng Sr-Ping~h ang Gang~(a,*) a Pneumology Group,Department of Integrated Traditional Chinese and Western Medicine,West China Hospital,Sichuan University,Chengdu 610041,P.R.China. b Department of Respiratory Medicine,The First Affiliated Hospital,Tianjin University of Traditional Chinese Medicine,Tianjin 300193,P.R.China. c Department of Respiratory Medicine,The Second Affiliated Hospital,Tianjin University of Traditional Chinese Medicine,Tianjin 300150,P.R.China. d Department of Respiratory Medicine,Shanxi Academy of Traditional Chinese Medicine,Taiyuan 030012,P.R.China. e Department of Respiratory Medicine,Jilin Academy of Traditional Chinese Medicine,Changchun 130021,P.R.China. f Department of Respiratory Medicine,Traditional Chinese Medical Hospital of Xinjiang Uygur Autonomous Region,Urumqi 830000,P.R.China. g Department of Respiratory Medicine,The Affiliated Hospital to Liaoning University of Traditional Chinese Medicine,Shenyang 110032,P.R.China. h Department of Respiratory Medicine,The Affiliated Hospital,Changchun University of Traditional Chinese Medicine,Changchun 130051,P.R.China.

Objective:To investigate the efficacy and safety of Antiwei,a traditional Chinese prescription,in the treatment of ***:In a multi-centre,randomized, double-blind,placebo-controlled trial,we recruited 480 adults aged 18 to 65 years within 36 hours of onset of influenza-like *** were 225 patients with confirmed *** patients were randomly assigned 6 grams of Antiwei(n=360) or placebo (n=120) twice daily for three *** patients recorded their temperature and symptoms on diary cards during *** were performed in both the influenza-like population and the influenza-confirmed ***:Antiwei increased patients’ recovery by 17%(P<0.001),and reduced the severity of illness measured by the median symptom score by 50%(P<0.001) in both the influenza-like and the influenza-confirmed populations,compared to *** influenza-confirmed patients reported reductions in the severity of fever(P=0.002),cough(P=0.023) and expectoration(P=0.004) after one-day of treatment with Antiwei,compared to *** adverse event profiles were similar for Antiwei and ***:Antiwei was effective and well-tolerated in treatment of natural influenza infection in *** represents a clinically valuable intervention in the management of influenza.

关键词： traditional Chinese herb influenza randomized controlled trial

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Meta-analysis and sequential analysis of acupuncture compared to carbamazepine in the treatment of trigeminal neuralgia

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World Journal of Clinical Cases 2024年第22期12卷 5083-5093页

作者： Li Wei Hui Han Jie Meng Xin Li Qing-Ping Yao Department of Encephalopathy Tianjin Beichen Traditional Chinese Medicine HospitalTianjin 300400China Department of Acupuncture First Teaching Hospital of Tianjin University of Traditional Chinese MedicineTianjin 300193China Bio-engineering Institute Tianjin Modern Vocational Technology CollegeTianjin 300350China

BACKGROUND In this randomized controlled trial(RCT)comparing current acupuncture with carbamazepine for trigeminal neuralgia,meta-and sequential analyses were *** To guide clinical decision making regarding the treatment of trigeminal neuralgia with *** The RCT literature on needle comparison was searched in various Chinese biomedical databases including Chinese Biomedical Literature Database,Wanfang Data,VIP Database,as well as international databases such as Excerpt Medica Database,Cochrane Library,PubMed,and Web of Science,along with related clinical registration platforms such as World Health Organization International Clinical trial Registry Platform,ChiCTR,and Clinical trials up to 1 April *** of bias was evaluated using the Cochrane Collaborative Risk Bias tool,primary outcome measures(pain reduction)were analyzed using STATA metaanalysis,outcome measures were analyzed using trial sequential analysis 0.***.5.10 Beta sequential analysis,GRADE was used to assess the evidence,and adverse reactions were *** This study analyzed 16 RCTs with a total of 1231 *** meta-analysis revealed a statistically significant difference in pain reduction between acupuncture and carbamazepine[standardized mean difference(SMD)=1.47;95%confidence interval(CI):0.99-1.95],although the quality of evidence was deemed to be of extremely low *** meta-analysis based on the year of publication indicated that carbamazepine treatment first demonstrated a statistically significant difference in pain reduction in 2014 and remained relatively stable over time[SMD=1.84;95%CI:0.22-3.47].Additionally,the number of adverse events associated with acupuncture was significantly lower compared to *** Acupuncture for trigeminal neuralgia is better than analgesia and safer than carbamazepine;however,firm conclusions still require a high-quality,multicenter,large-sample RCT to confirm these findings.

关键词： Trigeminal neuralgia Acupuncture Carbamazepine Meta-analysis randomized controlled trial

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A meta-analysis on the clinical efficacy of fire dragon cupping in the treatment of lumbar disc herniation

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Integrative Medicine Discovery 2024年第11期8卷 1-7页

作者： Hai-Xia Ma Dan Ma Bin Lin Juan-Xia Zheng Department of Rehabilitation Shenzhen Bao’an Traditional Chinese Medicine HospitalGuangzhou University of Chinese MedicineShenzhen 518000China Department of Rheumatology and Immunology Shenzhen University Affiliated South China HospitalShenzhen 518000China Department of Nutrition Shenzhen Hospital of Southern Medical UniversityShenzhen 518000China.

Background:The incidence of lumbar disc herniation(LDH)is notably *** among experts highlights non-surgical treatments as the primary therapeutic approach for *** medicine frequently employs pharmacotherapy and epidural injections in such treatments,which are associated with numerous adverse *** use can severely impair the liver and kidney functions of ***,the role of safe and effective traditional Chinese medicine techniques becomes *** various traditional Chinese medicine approaches for treating LDH,fire dragon cupping,renowned for its remarkable efficacy,cost-effectiveness,and ease of application,is extensively utilised in clinical settings for managing ***,there is a scarcity of systematic and standardised evidence from evidence-based medicine ***,conducting a meta-analysis is ***:A comprehensive computerised search was conducted in databases including China National Knowledge Infrastructure,WanFang Data,VIP,China Biology Medicine disc,PubMed,EMbase,The Cochrane Library,Web of Science,and *** search aimed to gather randomised controlled trials on fire dragon cupping therapy for LDH,spanning from the inception of these databases until December *** researchers independently screened the literature according to inclusion and exclusion criteria,extracted data,and assessed the methodological quality of the studies included,utilising RevMan 5.3 software for ***:The results show that the fire dragon cupping therapy group had better clinical effectiveness(relative risk=1.23,95%confidence interval(CI)(1.14,1.33),P<0.00001),less pain(standardized mean difference=–1.33,95%CI(–1.49,–1.16),P<0.00001),and some improvement in lumbar function(Japanese Orthopaedic Association scores:mean difference=3.37,95%CI(2.31,4.43),P<***:The fire dragon cupping therapy significantly alleviates LDH,warranting its extensive ***,consid

关键词： fire dragon cupping therapy lumbar disc herniation lumbar spine meta-analysis randomized controlled trial

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Efficacy and safety of acupoint application for allergic rhinitis: a systematic review and Meta-analysis of randomized controlled trials

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Journal of Traditional Chinese Medicine 2022年第6期42卷 858-868页

作者： SHEN Mengxia SHANG Wenfang WU Jiangxia YU Zelin XUAN Lihua The First School of Clinical Medicine of Zhejiang Chinese Medical University Hangzhou 310053China Department of acupuncture and moxibustion the First Affiliated Hospital of Zhejiang Chinese Medical UniversityHangzhou 310006China

OBJECTIVE: To use evidence-based medicine to explore the efficacy of acupoint application(AA) for allergic rhinitis(AR) at different time points and its safety. METHODS: We searched 7 databases(Pub Med, Cochrane, Embase, China National Knowledge Infrastructure, Wanfang Database, China Science and Technology Journal Database, and China Biology Medicine disc) as well as the international clinical trial registration platform from January 2010 to March 2020 for randomized controlled trials(RCTs) comparing the efficacy of AA versus placebo, Western Medicine or other alternative therapies on AR. Risk of bias was assessed according to the Cochrane handbook, and statistical analysis was performed using Rev Man 5.3. Outcomes included the total effective rate, recurrence rate, total nasal symptom score(TNSS), visual analogue scale(VAS), quality of life measured by the Rhinitis Quality of Life Questionnaire(RQLQ) or Short Form-36(SF-36), adverse events, and biomarkers including immunoglobulin E(Ig E), peripheral blood eosinophil count(EOS), interleukin-4(IL-4), and interferon gamma(INF-γ). RESULTS: Twenty-eight RCTs involving 3282 participants were included. The short-term and long-term efficacy of AA was significantly better than placebo, including better total effective rate [RR: 3.05, 95%CI(1.84, 5.07), after treatment;RR: 9.29, 95%CI(2.57, 33.66), at 6 months], lower recurrence rate [RR: 0.55, 95%CI(0.45, 0.66), at 6 months;RR: 0.65, 95%CI(0.57, 0.74), at 1 year], lower TNSS [MD:-3.09, 95%CI(-3.58,-2.61), after treatment], and lower RQLQ [MD:-14.79, 95%CI(-21.49,-8.10), after treatment;MD:-11.92, 95%CI(-17.40,-6.45), at 4-6 months]. Compared with Western Medicine, AA had better long-term total effective rate [RR: 1.33, 95%CI(1.05, 1.69), at 3 months;RR: 1.49, 95%CI 1.22 to 1.81, at 1 year) and lower recurrence rate [RR: 0.48, 95%CI(0.39, 0.58), at 6 months;RR: 0.45, 95%CI(0.33, 0.60), at 1 year]. AA had better long-term total effective rate versus acupuncture [RR: 2.06, 95

关键词： rhinitis allergic acupoint application systematic review Meta-analysis randomized controlled trial

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