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Journal of Pharmaceutical Analysis 2019年第2期9卷 108-116页

作者： Subhraseema Das Usharani Subuddhi Department of Chemistry National Institute of Technology Rourkela

Hydrogels composed of poly(vinyl alcohol)(PVA) and poly(ethylene glycol)(PEG) were synthesized using glutaraldehyde as crosslinker and investigated for controlled delivery of the common anti-inflammatory drug, ibuprofen(IBF). To regulate the drug delivery, solid inclusion complexes(ICs) of IBF in β–cyclodextrin(β–CD) were prepared and added to the hydrogels. The ICs were prepared by the microwave irradiation method, which is more environmentally benign. The formation of IC was confirmed by various analytical techniques and the synthesized hydrogels were also characterized. controlled release of drug was achieved from the hydrogels containing the ICs in comparison to the rapid release from hydrogels containing free IBF.The preliminary kinetic analysis emphasized the crucial role of β–CD in the drug release process that influences the polymer relaxation, thereby leading to prolonged release. The cytotoxicity assay validated the hydrogels as non-toxic in nature and hence can be utilized for controlled delivery of IBF.

关键词： Hydrogels Poly(vinyl alcohol) Poly(ethylene glycol) Ibuprofen controlled delivery systems

Clinical efficacy of comprehensive therapy based on traditional Chinese medicine patterns on patients with pneumoconiosis: a pilot double-blind, randomized, and placebo-controlled study

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Frontiers of Medicine 2022年第5期16卷 736-744页

作者： Jiansheng Li Hulei Zhao Yang Xie Jieya Li Qingwei Li Xuexin Chen Weiyu Zhang Collaborative Innovation Center for Chinese Medicine and Respiratory Diseases Co-constructed by Henan Province&Education Ministry of China Henan University of Chinese MedicineZhengzhou 450046China Henan Key Laboratory of Chinese Medicine for Respiratory Disease Henan University of Chinese MedicineZhengzhou 450046China Department of Respiratory Diseases The First Affiliated Hospital of Henan University of Chinese MedicineZhengzhou 450000China Department of Pneumoconiosis Henan Hospital for Occupational DiseasesZhengzhou 450052China Department of Respiratory Diseases Jiaozuo Coal Industry Group Co.Ltd.Central HospitalJiaozuo 454000China Department of Pneumoconiosis Yima Coal Industry Group Co.Ltd.General HospitalYima 472300China

Effective therapy options for pneumoconiosis are lacking.Traditional Chinese medicine(TCM)presents a favorable prospect in the treatment of pneumoconiosis.A pilot study on TCM syndrome differentiation can evaluate the clinical efficacy and safety of TCM and lay a foundation for further clinical research.A double-blind,randomized,and placebo-controlled trial was conducted for 24 weeks,in which 96 patients with pneumoconiosis were randomly divided into the control and treatment groups.Symptomatic treatment was conducted for the two groups.The treatment group was treated with TCM syndrome differentiation,and the control group was treated with placebo.The primary outcomes were the six-minute walking distance(6MWD)and the St.George Respiratory Questionnaire(SGRQ)score.The secondary outcomes were the modified British Medical Research Council Dyspnea Scale(mMRC),Chronic Obstructive Pulmonary Disease Assessment Test(CAT),Hospital Anxiety and Depression Scale(HADS),and pulmonary function.Only 83 patients from the 96 patients with pneumoconiosis finished the study.For the primary outcome,compared with the control groups,the treatment group showed a significantly increased 6MWD(407.90 m vs.499.51 m;95%confidence interval(CI)47.25 to 135.97;P<0.001)and improved SGRQ total score(44.48 vs.25.67;95%CI 27.87 to 9.74;P<0.001).The treatment group also significantly improved compared with the control group on mMRC score(1.4 vs.0.74;95%CI 1.08 to 0.23;P=0.003),CAT score(18.40 vs.14.65;95%CI 7.07 to 0.43;P=0.027),and the total symptom score(7.90 vs.5.14;95%CI 4.40 to 1.12;P<0.001).No serious adverse events occurred.This study showed that TCM syndrome differentiation and treatment had a favorable impact on the exercise endurance and quality of life of patients with pneumoconiosis.

关键词： pneumoconiosis randomized controlled trials traditional Chinese medicine

Effect and Safety of CX-DZ-ⅡIntelligent Electroacupuncture Therapeutic Instrument for Neck Pain Caused by Cervical Spondylos:Study Protocol for A Randomized controlled Trial

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Chinese Journal of Integrative Medicine 2020年第5期26卷 375-381页

作者： CHEN Zhi-han LIANG Fan-rong YANG Ming-xiao LI De-hua ZHANG Ya REN Yu-lan School of Acupuncture Moxibustion and Tuina Chengdu University of Traditional Chinese MedicineChengdu(610075)China School of Chinese Medicine University of Hong Kong Li Ka Shing Faculty of MedicineHong Kong SARChina Department of Acupuncture and Moxibustion A ffiliated Hospital of Chengdu University of Traditional Chinese MedicineChengdu(610075)China School of Chinese Classics Chengdu University of Traditional Chinese MedicineChengdu(610075)China

Background: Neck pain caused by cervical spondylosis(CS) is a chronic pain condition, with an increasingly high incidence in the general population. Electroacupuncture is a common analgesic modality that has been widely applied in neck pain treatment. However, current electroacupuncture instruments used in the clinic have low intelligence levels and obscure parameter standards. We here designed this study for assessing the effect and safety of a new, intelligent electroacupuncture instrument, the CX-DZ-Ⅱ, in treating neck pain. Methods: The present study is a prospective, two-center, randomized, controlled, open-label, non-inferiority trial for CX-DZ-Ⅱ on treating neck pain caused by CS. Totally 160 eligible patients will be included in this trial and randomly assigned to an experimental group and a control group in a 1:1 ratio. A semi-standard acupoint selection strategy will be employed. In the experimental group, selected acupoints will be stimulated by CX-DZ-Ⅱ. Electroacupuncture treatment will be accomplished by a pre-existing electroacupuncture instrument in the control group. The duration of treatment will be 2 weeks. The primary outcome is the change of Visual Analog Scale(VAS) score after one course of treatment. The secondary outcomes include the VAS scores after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the rate of adverse events occurrence, and the performance of instrument. Discussion: This study will evaluate the effect and safety of the CX-DZ-Ⅱ intelligent electroacupuncture therapeutic instrument in comparison with a pre-existing non-intelligent instrument in the treatment of neck pain caused by CS. The results will hopefully demonstrate a more optimal electroacupuncture instrument for the treatment of neck pain.(Trial registration No. gov NCT03005301).

关键词： neck pain electroacupuncture therapeutic instrument translational medicine randomized controlled trial protocol

Acupoint Catgut Embedding Alleviates Insomnia in Different Chinese Medicine Syndrome Types: A Randomized controlled Trial

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Chinese Journal of Integrative Medicine 2019年第7期25卷 543-549页

作者： XU Fu XUAN Li-hua ZHOU Hai-jiang CHEN Fei-yu ZHENG Zhao-jian BI Ying WU Xiang Department of Acupuncture and Moxibustion Zhejiang Hospital of Traditional Chinese Medicine Hangzhou (310006) China First Clinical Medical College Zhejiang Chinese Medical University Hangzhou (310007) China Department of Acupuncture and Moxibustion Zhejiang Wenling First People's Hospital Zhejiang (317500) China

Objective: To investigate the effects and safety of catgut embedding on alleviating insomnia. Methods: Totally 510 patients with insomnia were divided into 5 Chinese medicine(CM) syndrome types: Xin(Heart) and Pi(Spleen) deficiency, yin deficiency with excess fire, Xin and gut qi deficiency, Wei(Stomach) disorder, and qi and blood deficiency, respectively. These 5 types of patients were randomly assigned to a catgut embedding group, an acupuncture group or a medication group(30 cases in Xin and Pi deficiency type, Wei disorder type, Xin and gut qi deficiency type, respectively;40 cases in yin deficiency with excess fire type and qi and blood deficiency type, respectively). In the catgut embedding group, patients were treated by implanting catgut into acupoints once every 10 days for a total of 30 days. In the acupuncture group, patients were treated with acupuncture once per day over 30 days(excluding weekends);and patients in the medication group took 1 mg Eurodin Tablet orally every night for 30 days. Pittsburgh Sleep Quality Index(PSQI) was evaluated before treatment, on 30 and 60 days after the first treatment, respectively. The International Unified Sleep Efficiency Value(IUSEV) was measured at 30 and 60 days. The safety was evaluated after treatment and adverse events were analyzed. Results: The objective PSQI scores including subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbance, daytime dysfunction, and total scores at 30 days were significantly improved compared with pre-treatment in the catgut embedding and acupuncture groups(P<0.01 or P<0.05). At 30 days, the PSQI scores in catgut embedding group were superior to the medication group in the patients with each type of insomnia, with the exception of sleep duration(P<0.01 or P<0.05). At 60 days, significant differences were found between the catgut embedding group and the medication group(P<0.01 for all indices). The IUSEV scores in the catgut embedding group were significantly higher than the acupuncture g

关键词： insomnia acupoint catgut embedding acupuncture therapy medication randomized controlled trial

Fire-needle acupuncture for upper limb spastic paralysis after stroke:Study protocol for a randomized controlled trial

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Journal of Integrative Medicine 2019年第3期17卷 167-172页

作者： Xin-yu Yue Zhuo-qi Feng Xi-yi Yu Jia-min Hu Xiao-Jing He Shi Shu School of Traditional Chinese Medicine Naval Medical University Beijing He's SanTong Acupuncture and Fire-needle Moxibustion Clinic Basic Medical School Shanghai University of Traditional Chinese Medicine

Background: Fire-needle acupuncture, an important kind of acupuncture therapy, has been clinically used to treat upper limb spastic paralysis(ULSP) after stroke. Clinical experience has indicated that fire-needle acupuncture treatment takes less time, requires fewer visits, and has more rapid results and fewer side effects compared to chemical medicine alternatives. This study will evaluate the effects of fire-needle acupuncture for ULSP in the context of standardized clinical research and provide high-quality data to inform clinical procedures and future study design.Methods/Design: A randomized controlled trial will be carried out to evaluate the effects of fire-needle acupuncture therapy in patients with ULSP from stroke. ULSP patients(n = 120) will be recruited at Changhai Hospital in Shanghai, China. Patients will be randomly divided into three groups, including fire-needle acupuncture group(FAG), filiform-needle acupuncture group(FFAG) and rehabilitation treatment group(RTG). During the 3-week treatment, the FAG will be treated every two days, while FFAG and RTG will be treated 5 d in a row and then rest for 2 d. The Simplified Fugl-Meyer Motor Function Scale and Modified Ashworth Scale will be used as the primary outcome measures. Statistical analysis will be conducted by an independent statistician.Discussion: Through this study, the utility of fire-needle acupuncture in treating ULSP after stroke will be tested, and some specific claims of fire-needle acupuncture therapy will be evaluated, such as relieving spasm and muscular tension, improving activities of daily living, rapidity of response and less frequency of treatment compared with other treatments.

关键词： Fire-needle acupuncture Upper limb spastic paralysis Stroke Randomized controlled trial Study protocol

controlled attenuation parameter for evaluating liver steatosis in chronic viral hepatitis

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World Journal of Gastroenterology 2014年第21期20卷 6626-6631页

作者： Giovanna Ferraioli Carmine Tinelli Raffaella Lissandrin Mabel Zicchetti Barbara Dal Bello Gaetano Filice Carlo Filice Department of Infectious Diseases Fondazione IRCCS Policlinico San MatteoMedical School University of Pavia27100 PaviaItaly Clinical Epidemiology and Biometric Unit Fondazione IRCCS Policlinico San Matteo27100 PaviaItaly Department of Pathology Fondazione IRCCS Policlinico San Matteo27100 PaviaItaly

AIM:To assess the performance of controlled attenuation parameter(CAP)in patients with chronic viral hepatitis.METHODS:CAP is a new technique that measures the attenuation in the liver of an ultrasound beam,which is directly related to lipid accumulation.Consecutive patients undergoing liver biopsy for chronic viral hepatitis were studied using the M probe of FibroScan device(Echosens,Paris,France).The device estimates liver st-eatosis in decibel per meter(dB/m).An expert operator performed all measurements.Steatosis was graded according to Kleiner’s classification.Pearson or Spearman rank coefficient was used to test correlation between two study variables.Linear regression was used for multivariate model to assess the association between CAP and other variables.Receiver operating characteristic curve analysis was performed to calculate area under the curve(AUROC)for S0 vs S1-S3 and S0-S1 vs S2-S3.RESULTS:115 subjects(85 males and 30 females)were prospectively studied.The mean values of CAP were 227.1±43.1 for S0;254.6±38.9 for S1;297.8±49.4 dB/m for S2-S3.In univariate analysis CAP showed a significant correlation with age,body mass index(BMI),degree of steatosis,and cholesterol.Multivariate regression analysis confirmed the correlation with the degree of steatosis[coefficient,1.2(0.60-1.83);Pcontrolled attenuation parameter could be a useful tool in the clinic

关键词： Liver steatosis Noninvasive techniques controlled

Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial

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Journal of Integrative Medicine 2019年第3期17卷 161-166页

作者： Ya-ru Huangfu Wei Peng Bao-jun Guo Zhi-fu Shen Li Li Shi-wei Liu Hui Zheng You-ping Hu Acupuncture and Tuina School Chengdu University of Traditional Chinese Medicine

Background: Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of ‘‘stomach disharmony leading to restless sleep." Acupuncture is an effective complementary and alternative medicine therapy to improve gastrointestinal function and restore the normal sleep-wake cycle. However, studies on the effectiveness of acupuncture for insomnia due to spleen-stomach disharmony syndrome are limited to case reports and few randomized controlled trials; deeper research on its mechanism is still lacking. This randomized controlled trial aims to assess the treatment efficacy of ‘‘harmonizing stomach to tranquilize mind"acupuncture for insomnia and its influence on the intestinal microbiome.Methods/design: This is a randomized, single-blind, parallel-group study. Sixty eligible patients with insomnia due to spleen-stomach disharmony syndrome will be randomly divided into two groups(1:1 allocation ratio). The intervention group will use ‘‘harmonizing stomach to tranquilize mind"acupuncture, and the control group will receive sham acupuncture. Participants will receive 5 acupuncture treatment sessions per week for 4 consecutive weeks. The Pittsburgh Sleep Quality Index will be used to evaluate the clinical efficacy of acupuncture treatment by making assessments at baseline, the end of treatment and the end of the follow-up. High-throughput 16 S ribosomal ribonucleic acid gene sequencing will be performed to detect changes in the intestinal microbial composition before and after treatment.Discussion: The results of this trial are expected to confirm that ‘‘harmonizing stomach to tranquilize mind" acupuncture can effectively relieve insomnia and alter the intestinal microbiome.

关键词： Insomnia Gastrointestinal symptoms Acupuncture Intestinal microbiome Randomized controlled trial Study protocol

Burnout in the emergency department: Randomized controlled trial of an attention-based training program

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Journal of Integrative Medicine 2019年第3期17卷 173-180页

作者： Pádraic J.Dunne Julie Lynch Lucia Prihodova Caoimhe O'Leary Atiyeh Ghoreyshi Sharee A.Basdeo Donal J.Cox Rachel Breen Ali Sheikhi áine Carroll Cathal Walsh Geraldine McMahon Barry White Trinity Translational Medicine Institute Trinity College Research Department Royal College of Physicians of Ireland Department of Innovation Fitbit Inc. Health Research Institute Main BuildingUniversity of Limerick Health Service Executive Dr Steevens' Hospital Department of Emergency Medicine St.James' s Hospital National Centre for Hereditary Coagulation Disorders St.James' s Hospital

Background: Burnout(encompassing emotional exhaustion, depersonalization and personal accomplishment) in healthcare professionals is a major issue worldwide. Emergency medicine physicians are particularly affected, potentially impacting on quality of care and attrition from the specialty.Objective: The aim of this study was to apply an attention-based training(ABT) program to reduce burnout among emergency multidisciplinary team(MDT) members from a large urban hospital.Design, setting, participants and interventions: Emergency MDT members were randomized to either a notreatment control or an intervention group. Intervention group participants engaged in a four session(4 h/session) ABT program over 7 weeks with a practice target of 20 min twice-daily. Practice adherence was measured using a smart phone application together with a wearable Charge 2 device.Main outcome measures: The primary outcome was a change in burnout, comprising emotional exhaustion, depersonalization and personal achievement. The secondary outcomes were changes in other psychological and biometric parameters.Results: The ABT program resulted in a significant reduction(P < 0.05; T1 [one week before intervention]vs T3 [follow-up at two months after intervention]) in burnout, specifically, emotional exhaustion, with an effect size(probability of superiority) of 59%. Similar reductions were observed for stress(P < 0.05) and anxiety(P < 0.05). Furthermore, ABT group participants demonstrated significant improvements in heart rate variability, resting heart rate, sleep as well as an increase in pro-inflammatory cytokine expression.Conclusion: This study describes a positive impact of ABT on emergency department staff burnout compared to a no-treatment control group.

关键词： Burnout Emotional exhaustion Meditation Healthcare professional Sleep Stress Cytokines Cortisol Randomized controlled trial

Whether Syndrome Differentiation Affects Treatment Result:Study Protocol of MaZiRenWan(麻子仁丸)for Functional Constipation in A Randomized controlled Trial

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Chinese Journal of Integrative Medicine 2019年第3期25卷 175-181页

作者： CHENG Chung-wah ZHANG Li ZHAO Chen ZHONG Linda LD SHI Li-jie DAI Liang ZHENG Rui CHEN Jing LI Ge ZHAI Jing-bo KUN Wai LU Ai-ping SHANG Hong-cai BIAN Zhao-xiang Hong Kong Chinese Medicine Clinical Study Centre School of Chinese Medicine Hong Kong Baptist University Department of Clinical Pharmacology the Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine Department of Gastroenterology the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine Graduate School Tianjin University of Traditional Chinese Medicine Department of Health Care Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine School of Traditional Chinese Medicine Tianjin University of Traditional Chinese Medicine Research Institute of Traditional Chinese Medicine Tianjin University of Traditional Chinese Medicine Key Laboratory of Chinese Internal Medicine of Ministry of Education and Beijing Dongzhimen Hospital Beijing University of Chinese Medicine

Background: Syndrome is one of the most important concepts in Chinese medicine(CM) theory. However, it was not well accounted in most of randomized controlled trials(RCTs). Objective: To determine whether CM syndrome differentiation affects the treatment results, functional constipation(FC) was selected as a target disease, and MaZiRenWan(麻子仁丸, MZRW), a classic CM formula commonly used for constipation with excessive heat syndrome, was selected for study. Methods: It is an 18-week prospective double-blinded, doubledummy RCT, including 2-week run-in, 8-week treatment and 8-week post treatment follow-up. A total of 120 FC patients diagnosed as excessive heat syndrome will be recruited from the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine and the Baokang Affiliated Hospital of Tianjin University of Traditional Chinese Medicine. Patients will be randomly allocated into fixed MZRW(f_MZRW) granule group, modified MZRW(m_MZRW) granule group or bisacodyl group. For m_MZRW group, no more than two herbal granules can be added according to the syndrome differentiation for individual participants. The primary end point is the mean of complete spontaneous bowel movements(CSBMs) per week during the treatment period. Secondary end points include mean of CSBMs per week during follow-up, stool form, global symptom improvement, constipation and constipation-related symptoms assessment, CM syndrome change, and reported adverse events. Discussion: This trial is designed to evaluate the effectiveness of these three interventions for FC patients with the CM syndrome of excessive heat, and to determine the change of CM syndrome and the progress of disease during the treatment course. The results are important to explore whether syndrome differentiation is important for the therapeutic effect of a formula on a disease.

关键词： functional constipation Chinese herbal medicine syndrome differentiation MaZiRenWan randomized controlled trial

Effect of Zhizhu Kuanzhong Capsules(枳术宽中胶囊) on Treatment of Functional Dyspepsia: A Meta-Analysis of Randomized controlled Trials

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Chinese Journal of Integrative Medicine 2019年第8期25卷 625-630页

作者： WEN Ming-yi ZHANG Fu-cheng WANG Yao-jun Department of Respiratory Shandong Chest HospitalJinan (250013)China Department of Gastroenterology The General Hospital of Jina n Military Comma nd Jinan (250031)China Department of Gastroenterology Sunshine Union Hospital Weifang Shandong Province (261061)China

Objective: To evaluate the effect of Zhizhu Kuanzhong Capsules (枳术宽中胶囊, ZKC) for functional dyspepsia (FD) through meta-analysis. Methods: Online databases, including PubMed, EM base, China National Knowledge Infrastructure, Wanfang Data, VIP database and Cochrane Library, were searched for randomized controlled trials (RCTs) of ZKC for FD from the inception to April, 2016. Trials were selected according to inclusion criteria and were evaluated with quality assessment standards in the Cochrane Handbook for Systematic Reviews of Interventions and Jadad scale. RevMan 5.3 and GRADEprofiler 3.6 were used for statistical analysis and evidence quality assessment. Results: Twenty-three trials with 2,496 patients were included and most of them were of poor methodological quality. ZKC alone or ZKC combined with routine Western medicine (WM) showed a better clinical effect rate compared with the control group of WM [odds ratio (OR)=3.32, 95% confidence interval (2.66, 4.15), Pcontrolled trials with large samples to validate the conclusions.

关键词： Zhizhu Kuanzhong Capsules functional dyspepsia randomized controlled trial meta-analysis Chinese medicine