1.Randomized, Open, Parallel Controlled, Multi-center Study for Efficacy and Safety of Lianhua Qingke Tablets in Treatment of Acute Bronchitis in Children with Syndrome of Phlegm-heat Obstructing Lung
Nan LI ; Shaoyi GENG ; Xiaofang WANG ; Xiaowei ZHANG ; Lixia JIA ; Rongzhen KANG ; Xiangjun DU ; Lichun WU ; Linlin ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(10):90-94
ObjectiveTo evaluate the efficacy and safety of Lianhua Qingke tablets in the treatment of acute bronchitis in children with the syndrome of phlegm-heat obstructing lung. MethodA randomized, open, parallel controlled, and multi-center clinical study was conduted. Children with acute bronchitis (syndrome of phlegm-heat obstructing lung) were randomly assigned to an observation group and a control group. The control group received routine basic treatment, and the observation group was treated with Lianhua Qingke Tablets on the basis of routine basic treatment. After 7 days of treatment, the clinical efficacy, TCM efficacy, time to symptom disappearance, time to cough disappearance, and clinical safety were compared between the two groups. ResultA total of 248 children were included (124 in the observation group and 124 in the control group). After 7 days of treatment, the total response rate in terms of clinical efficacy in the observation group was 96.8% (120/124), which was higher than that (90.3%, 112/124) in the control group (Z=-5.034, P<0.01). The total response rate in terms of TCM syndrome in the observation group was 97.6% (121/124), which was higher than that (93.5%, 116/124) in the control group (χ2=-5.326, P<0.01). The scores of physical signs and TCM symptoms in the observation group were lower than those in the control group at the time of taking medicine for 3 days and 7 days (P<0.01). The time to symptom disappearance and the time to cough disappearance in the observation group were shorter than those in the control group (P<0.01). Drug-related adverse reactions occurred in neither group. ConclusionLianhua Qingke tablets demonstrate a definite effect on acute bronchitis in children with the syndrome of phlegm-heat blocking lung. The tablets can significantly shorten the course of disease and relieve cough and TCM symptoms, with high safety, which is worthy of clinical application and promotion.
2.Discussion on Effects of Electroacupuncture on Intestinal Flora and Serum Inflammation Factors in Rheumatoid Arthritis Rabbits Based on"Gut-joint"Axis
Cui LIU ; Xiaozheng DU ; Weiyao JING ; Chenghong SU ; Limei LIU ; Bo YUAN ; Xinghua ZHANG ; Fengfan ZHANG ; Ping CHEN ; Xiangjun LI ; Haidong WANG
Chinese Journal of Information on Traditional Chinese Medicine 2024;31(4):124-131
Objective To observe the effects of electroacupuncture on intestinal flora and serum inflammatory factors in rabbit model with rheumatoid arthritis(RA);To explore the mechanism of its therapeutic effect on RA.Methods RA model rabbits were established by ovalbumin induction combined with Freund's complete adjuvant,and the rabbits after successful modeling were randomly divided into model group,probiotic group and electroacupuncture group,with 6 rabbits in each group.Another 6 rabbits were set as the normal group.The electroacupuncture group received electroacupuncture at the bilateral"Zusanli"and"Dubi"for 30 minutes,the probiotic group was given probiotic capsules solution(14.5 mg/kg)by gavage,once a day,for two consecutive weeks.The knee joint circumference and pain threshold of rabbits were measured,histopathological morphological changes of colonic tissue and synovial tissue ws observed by HE staining,16S rDNA sequencing was used to analyze structural changes of intestinal flora,the contents of TNF-α,IL-1β and IL-6 in serum were detected by ELISA.Results Compared with the normal group,the circumference of knee joint of rabbits in the model group increased significantly,the pain threshold was significantly decreased(P<0.01);the colonic mucosal damage was serious,the goblet cells were missing,a large number of inflammatory cells were infiltrate;the joint capsule synovial surface was rough,the synovial cell layer was hyperplasia and thickening,the synovial tissue inflammatory cell infiltration was obvious;the number and evenness of gut microbiota species decreased,while the relative abundance of Proteobacteria,Firmicutes,and Bacteroidetes decreased(P<0.05,P<0.01),the relative abundance of Desulfobacteria increased(P<0.01),while the relative abundance of Campylobacter,Lawsonella,and Pseudomonas increased(P<0.01),while the relative abundance of Heshanomonas and Herbaspirillum decreased(P<0.01);the contents of serum TNF-α,IL-1β and IL-6 increased(P<0.01).Compared with the model group,the knee joint circumference of the probiotic group and the electroacupuncture group decreased,the pain threshold increased(P<0.01,P<0.05);the degree of intestinal mucosal damage was reduced,the goblet cells were basically arranged neatly,the inflammatory cell infiltration was reduced;synovial cells proliferation and thickening decreased,with a small amount of inflammatory cell infiltration;the number and evenness of gut microbiota species increased,while the relative abundance of Proteobacteria,Firmicutes,and Bacteroidetes increased(P<0.05,P<0.01),the relative abundance of Desulfobacteria decreased(P<0.01),while the relative abundance of Campylobacter,Lawsonella and Pseudomonas decreased(P<0.01),the relative abundance of Heshanomonas and Herbaspirillum increased(P<0.05,P<0.01);the contents of serum TNF-α,IL-1β and IL-6 significantly decreased(P<0.01).Conclusion Electroacupuncture can significantly improve the symptoms of RA rabbits and reduce the inflammatory reaction in synovial tissue of joint,and the mechanism may be related to the regulation of intestinal flora structure.
3.Design of the key links and implementation path of management in the clinical comprehensive evaluation of drug
Wenwen DU ; Wei XU ; Xiangjun ZHU
China Pharmacy 2024;35(12):1413-1418
OBJECTIVE To design the implementation path around the key links of the management in the clinical comprehensive evaluation of drug in China, and to provide suggestions for optimizing and perfecting the management in the clinical comprehensive evaluation of drug. METHODS Based on the relevant experience of drug evaluation management in typical countries regions at home and abroad, the discussion was performed and the management mechanism was designed from seven aspects, such as funding source, selection of topics, staff management, information management, data management, evaluation process and quality assessment. RESULTS & CONCLUSIONS In terms of funding sources, the financial department can provide funding guarantees or other alternative forms such as performance evaluations to encourage all parties to undertake the clinical comprehensive evaluation of drug projects. In terms of the selection of topics, a “top-down” or “bottom-up” selection mode can be determined according to the project’s nature and actual situation, and a selection process of “forming alternatives-setting up theme selection list-demonstrating and publishing theme selection list” can be formed. In terms of staff management, the specialty of team members should be specified, and the expert team should be established to provide clinical comprehensive evaluation of drug. In terms of information management, the national/provincial basic informational platform should be established, and the registration system should be established. In terms of data management, a regional health data-sharing platform should be formed and the “application-checking-utilization” mechanism should be conducted. In terms of the evaluation process, the evaluation procedures that concern on project implementation plan demonstration system and project closing review system should be constructed. In terms of quality assessment, quality assessment and reward and punishment mechanism for project completion,that consider the quality of management first while focusing on the technical quality, can be established. The management mechanism based on the standardized implementation of the seven key links will standardize the development of clinical comprehensive evaluation of drugs in China to some extent, and help improve the quality of clinical comprehensive evaluation projects for drugs.
4.Chinese expert consensus on emergency surgery for severe trauma and infection prevention during corona virus disease 2019 epidemic (version 2023)
Yang LI ; Yuchang WANG ; Haiwen PENG ; Xijie DONG ; Guodong LIU ; Wei WANG ; Hong YAN ; Fan YANG ; Ding LIU ; Huidan JING ; Yu XIE ; Manli TANG ; Xian CHEN ; Wei GAO ; Qingshan GUO ; Zhaohui TANG ; Hao TANG ; Bingling HE ; Qingxiang MAO ; Zhen WANG ; Xiangjun BAI ; Daqing CHEN ; Haiming CHEN ; Min DAO ; Dingyuan DU ; Haoyu FENG ; Ke FENG ; Xiang GAO ; Wubing HE ; Peiyang HU ; Xi HU ; Gang HUANG ; Guangbin HUANG ; Wei JIANG ; Hongxu JIN ; Laifa KONG ; He LI ; Lianxin LI ; Xiangmin LI ; Xinzhi LI ; Yifei LI ; Zilong LI ; Huimin LIU ; Changjian LIU ; Xiaogang MA ; Chunqiu PAN ; Xiaohua PAN ; Lei PENG ; Jifu QU ; Qiangui REN ; Xiguang SANG ; Biao SHAO ; Yin SHEN ; Mingwei SUN ; Fang WANG ; Juan WANG ; Jun WANG ; Wenlou WANG ; Zhihua WANG ; Xu WU ; Renju XIAO ; Yang XIE ; Feng XU ; Xinwen YANG ; Yuetao YANG ; Yongkun YAO ; Changlin YIN ; Yigang YU ; Ke ZHANG ; Xingwen ZHANG ; Guixi ZHANG ; Gang ZHAO ; Xiaogang ZHAO ; Xiaosong ZHU ; Yan′an ZHU ; Changju ZHU ; Zhanfei LI ; Lianyang ZHANG
Chinese Journal of Trauma 2023;39(2):97-106
During coronavirus disease 2019 epidemic, the treatment of severe trauma has been impacted. The Consensus on emergency surgery and infection prevention and control for severe trauma patients with 2019 novel corona virus pneumonia was published online on February 12, 2020, providing a strong guidance for the emergency treatment of severe trauma and the self-protection of medical staffs in the early stage of the epidemic. With the Joint Prevention and Control Mechanism of the State Council renaming "novel coronavirus pneumonia" to "novel coronavirus infection" and the infection being managed with measures against class B infectious diseases since January 8, 2023, the consensus published in 2020 is no longer applicable to the emergency treatment of severe trauma in the new stage of epidemic prevention and control. In this context, led by the Chinese Traumatology Association, Chinese Trauma Surgeon Association, Trauma Medicine Branch of Chinese International Exchange and Promotive Association for Medical and Health Care, and Editorial Board of Chinese Journal of Traumatology, the Chinese expert consensus on emergency surgery for severe trauma and infection prevention during coronavirus disease 2019 epidemic ( version 2023) is formulated to ensure the effectiveness and safety in the treatment of severe trauma in the new stage. Based on the policy of the Joint Prevention and Control Mechanism of the State Council and by using evidence-based medical evidence as well as Delphi expert consultation and voting, 16 recommendations are put forward from the four aspects of the related definitions, infection prevention, preoperative assessment and preparation, emergency operation and postoperative management, hoping to provide a reference for severe trauma care in the new stage of the epidemic prevention and control.
5.Analysis of risk factors for multiple myeloma combined with radiation-based sarcopenia
Jie REN ; Lei QI ; Xingchen YAO ; Jinzhou WANG ; Xiangjun SHI ; Wenming CHEN ; Xinru DU
Chinese Journal of Orthopaedics 2023;43(9):567-573
Objective:To analyze the risk factors of radiation-based sarcopenia in patients with multiple myeloma (MM).Methods:A total of 185 clinical and imaging data of patients with MM admitted to Beijing Chaoyang Hospital from September 2009 to October 2019 were retrospectively analyzed. The area of the erector spinae muscle and the area of fatty infiltration (FI) in the fascial compartment were measured by Image-pro Ρlus software, and the area of the fat-free erector spinae muscle and the fat infiltration rate (FI%) were calculated. Sarcopenia was defined as an erector spinae area of less than 3 197 mm 2 in males and 2 895 mm 2 in females. The differences in gender, age, body mass index, disease duration, hemoglobin, leukocytes, platelets, albumin, serum calcium, lactate dehydrogenase, serum creatinine, alkaline phosphatase, M-protein, serum β 2-microglobulin, bortezomib chemotherapy, receipt of stem cell transplantation, osteopathy, stage, recurrence and progression of MM between the sarcopenia group and the normal muscle group were compared. Binary logistic regression was used to analyze the independent risk factors of sarcopenia in MM patients. Kaplan-Meier curves were drawn to compare the survival rates between the two groups. Results:53.0% (98/185) of MM patients were complicated with sarcopenia: there were 30 males, whose fat-free erector spinae area was 25.0±6.0 cm 2, the FI of erector spinae was 12.0±4.8 cm 2, and the FI% was 31.5%±12.0%, while there were 68 females, whose fat-free erector spinae area was 22.7±4.2 cm 2, the FI of erector spinae was 10.7±4.1 cm 2, and the FI% was 30.2%±9.8%. 47.0% (87/185) of MM patients had normal muscle mass: there were 62 males, whose fat-free erector spinae area was 40.6±6.5 cm 2, the FI of erector spinae was 9.3±4.8 cm 2, and the FI% was 17.9%±7.4%, while there were 25 females, whose fat-free erector spinae area was 33.6±5.1 cm 2, the FI of erector spinae was 9.9±3.0 cm 2, and the FI% was 21.9%±5.7%. There were statistically significant differences in the gender composition ratio (χ 2=30.47, P<0.001), hemoglobin ( t=-2.73, P=0.007), serum creatinine ( Z=-2.26, P=0.024), receipt of stem cell transplantation (χ 2=4.32, P=0.038), and MM recurrence and progression (χ 2=3.85, P=0.050) between the two groups. However, there were no significant differences in age, body mass index, course of disease, leukocytes, platelets, albumin, alkaline phosphatase, lactate dehydrogenase, serum calcium, M-protein, serum β 2-microglobulin, bortezomib chemotherapy, osteopathy or MM stage ( P>0.05). Binary logistic regression analysis showed that female was an independent risk factor for sarcopenia in MM patients. The survival rates at 2, 3, 4, and 5 years were 87.9%, 71.8%, 64.4%, and 53.7% in the sarcopenia group, and 92.1%, 75.8%, 66.8%, and 66.8% in the normal muscle group, respectively, with no statistically significant differences ( HR=0.71, P=0.364). Conclusion:The incidence of radiation-based sarcopenia in MM patients is 53.0%. Low hemoglobin and blood creatinine levels, not receiving stem cell transplantation, and recurrence or progression of MM are associated with sarcopenia in MM patients, and female is an independent risk factor for sarcopenia in MM patients.
6.Clinical guideline on first aid for blast injury of the chest (2022 edition)
Zhiming SONG ; Jianming CHEN ; Jing ZHONG ; Yunfeng YI ; Lianyang ZHANG ; Jianxin JIANG ; Mao ZHANG ; Yang LI ; Guodong LIU ; Dingyuan DU ; Jiaxin MIN ; Xu WU ; Shuogui XU ; Anqiang ZHANG ; Yaoli WANG ; Hao TANG ; Qingshan GUO ; Yigang YU ; Xiangjun BAI ; Gang HUANG ; Zhiguang YANG ; Yunping ZHAO ; Sheng LIU ; Lijie TAN ; Lei TONG ; Xiaoli YUAN ; Yanmei ZHAO ; Haojun FAN
Chinese Journal of Trauma 2022;38(1):11-22
Blast injury of the chest injury is the most common wound in modern war trauma and terrorist attacks, and is also the most fatal type of whole body explosion injury. Most patients with severe blast injury of the chest die in the early stage before hospitalization or during transportation, so first aid is critically important. At present, there exist widespread problems such as non-standard treatment and large difference in curative effect, while there lacks clinical treatment standards for blast injury of the chest. According to the principles of scientificity, practicality and advancement, the Trauma Society of Chinese Medical Association has formulated the guidance of classification, pre-hospital first aid, in-hospital treatment and major injury management strategies for blast injury of the chest, aiming to provide reference for clinical diagnosis and treatment.
7.Chinese consensus on surgical treatment of traumatic rib fractures (2021)
Lingwen KONG ; Guangbin HUANG ; Yunfeng YI ; Dingyuan DU ; Baoguo JIANG ; Jinmou GAO ; Lianyang ZHANG ; Jianxin JIANG ; Xiangjun BAI ; Tianbing WANG ; Xingji ZHAO ; Xingbo DANG ; Zhanfei LI ; Feng XU ; Zhongmin LIU ; Ruwen WANG ; Yingbin XIAO ; Qingchen WU ; Chun WU ; Liming CHENG ; Bin YU ; Shusen CUI ; Jinglan WU ; Gongliang DU ; Jin DENG ; Ping HU ; Jun YANG ; Xiaofeng YANG ; Jun ZENG ; Haidong WANG ; Jigang DAI ; Yong FU ; Lijun HOU ; Guiyou LIANG ; Yidan LIN ; Qunyou TAN ; Yan SHEN ; Peiyang HU ; Ning TAO ; Cheng WANG ; Dali WANG ; Xu WU ; Yongfu ZHONG ; Anyong YU ; Dongbo ZHU ; Renju XIAO ; Biao SHAO
Chinese Journal of Trauma 2021;37(10):865-875
Traumatic rib fractures are the most common injury in thoracic trauma. Previously,the patients with traumatic rib fractures were mostly treated non-surgically,of which 50%,especially those combined with flail chest presented chronic pain or chest wall deformities and over 30% had long-term disabilities,being unable to retain a full-time job. In the past two decades,thanks to the development of internal fixation material technology,the surgical treatment of rib fractures has achieved good outcomes. However,there are still some problems in clinical treatment,including inconsistency in surgical treatment and quality control in medical services. The current consensuses on the management of regional traumatic rib fractures published at home and abroad mainly focus on the guidance of the overall treatment decisions and plans,and relevant clinical guidelines abroad lacks progress in surgical treatment of rib fractures in recent years. Therefore,the Chinese Society of Traumatology affiliated to Chinese Medical Association and Chinese College of Trauma Surgeons affiliated to Chinese Medical Doctor Association,in conjunction with national multidisciplinary experts,formulate the Chinese Consensus for Surgical Treatment of Traumatic Rib Fractures(2021)following the principle of evidence-based medicine,scientific nature and practicality. This expert consensus puts forward some clear,applicable,and graded recommendations from aspects of preoperative imaging evaluation,surgical indications,timing of surgery,surgical methods,rib fracture sites for surgical fixation,internal fixation methods and material selections,treatment of combined injuries in rib fractures,in order to provide references for surgical treatment of traumatic rib fractures.
8.Application of Essential Anatomy software in the clinical practice teaching of spinal surgery
Zhijun XIN ; Xiangjun XIN ; Sheng YE ; Weijun KONG ; Qian DU ; Jun AO ; Wenbo LIAO
Chinese Journal of Medical Education Research 2020;19(10):1186-1189
In this paper, the current situation and existing problems of spinal surgery practice are analyzed and summarized. Combined with the review of the structure and function of spinal region, we have expounded the application and advantages of Essential Anatomy software in the clinical practice teaching of spinal surgery. This software has a friendly interface, simple operation, real content, intuitive and visual model, and it can provide videos and slice function, which makes the original complex and abstract spinal anatomy practice content become novel and vivid, and greatly deepens doctors' understanding of the structure, function, movement and the disease pathogenesis of spinal region. At the same time, it also greatly mobilizes the learning interest and initiative of the clinical practice doctors, and improves the effect of clinical practice.
9.Association of ApoB/A-1 ratio with type 2 diabetes mellitus in Chinese Han ethnic population:A cross-sectional study
Chang LIU ; Yongming HE ; Xiaojiao DU ; Dongping CAI ; Xiangjun YANG
Chinese Journal of Endocrinology and Metabolism 2017;33(4):321-325
In this cross-sectional study, consecutive Chinese Han ethnic inpatients in the Division of Cardiology, the First Affiliated Hospital of Soochow University from January 1, 2010 to December 31, 2013 were included. According to the exclusion criteria, 9 587 patients [1 604 with type 2 diabetes mellitus (T2DM) and 7 983 without T2DM]were obtained for final analysis. Logistic regression model was used to analyze the association of ApoB/A-1 ratio with T2DM and the possible interactions between ApoB/A-1 ratio and other risk factors. The results showed that the distribution of ApoB/A-1 ratio was positively skewed in Chinese Han ethic population. The median of ApoB/A-1 ratio of female was lower than that of male (0.68 vs 0.73,P<0.01). In all groups, the proportion of T2DM was increased with the raised ApoB/A-1 ratio. By the stratification analyses of sex, age, coronary artery disease, and the use of statins, ApoB/A-1 ratio was still correlated with T2DM. There existed significant interactions between ApoB/A-1 ratio and the smoking status or creatinine in T2DM.
10.In vitro study and molecular modeling on 17-AAG-Ioaded polymethyl methacrylate bone cement for multiple myeloma
Xiangjun SHI ; Boran DU ; Xinru DU ; Wenming CHEN
Chinese Journal of Orthopaedics 2016;36(15):988-994
Objective To explore the possibility of polymethyl methacrylate (PMMA) bone cement as the carrier for lipophilic drugs through in vitro cytotoxicity study and molecular modeling with PMMA and 17-allylamino-17-demethoxy-geldanamycin (17-AAG) loaded PMMA bone cement.Methods The 17-AAG loaded bone cement was made by mixing method.In vitro antitumor activity with MTT assay for PMMA,17-AAG,the 24 h and 48 h released solution of 17-AAG loaded PMMA bone cement were evaluated.Through Material Studio 5.0,the interaction between 17-AAG and PMMA through the model of Amorphous Cell and energy optimization of Forcite was explored.Results The inhibition ratio of MMA for tumor cells is 9.21%±0.06% with 50 μmol/L.The 24 h released solution of 17-AAG loaded PMMA bone cement (17-AAG∶ PMMA=1∶ 4 000) inhibits the tumor cells 66.15%±0.43% which has a quick released influence on 17-AAG.The inhibition of 24 h released solution of 17-AAG-loaded PMMA bone cement (17-AAG∶PMMA=1 ∶ 1 000,1∶2 000) shows no significance compared with PMMA released solution (P<0.05).The 48 h released solution of 17-AAG-PMMA (17-AAG∶ PMMA=1∶ 1 000,1∶2 000,1∶4 000) inhibits U26630.25%±4.47%,30.24%±3.42%,50.52%±5.20%,with a significant difference with PMMA.The molecular model showed that the interaction between 17-AAG and PMMA was van der Waalz bonds,which drove 17-AAG inside or on the surface of PMMA bone cement.Conclusion PMMA bone cement can be used as a carrier for lipophilic drugs.It has antitumor activity and influences the release of 17-AAG with different ratio,for example it has a sustained-released influence on 17-AAG in 17-AAG-PMMA (17-AAG∶PMMA=1 ∶ 1 000,1∶2 000).Molecular model implies that 17-AAG exists inside or on the surface the PMMA bone cement through van der Waalz bonds.

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