1.Clinical Comprehensive Evaluation of Guanxinjing Capsules in Treating Angina Pectoris of Coronary Heart Disease with Syndrome of Qi Deficiency and Blood Stasis in "6+1" Dimensions
Mengmeng WANG ; Xin CUI ; Jian LYU ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):120-128
ObjectiveTo systematically review the available studies about Guanxinjing capsules in treating angina pectoris of coronary heart disease (syndrome of Qi deficiency and blood stasis), evaluate the evidence quality and comprehensive value of Guanxinjing capsules in 6+1 dimensions involving 9 aspects, and clarify the clinical positioning and advantages of this medicine. MethodsA qualitative combined with quantitative evaluation method was adopted, involving clinical medicine, epidemiology, evidence-based medicine, and pharmacoeconomics. Through public data collection, questionnaire surveys, real-world data collection, and literature comprehensive evaluation, an evaluation system involving 9 aspects in 6+1 dimensions was constructed for Guanxinjing capsules. Experts assigned weights to the criterion layer and indicator layer, and the multi-criteria decision analysis (MCDA) model and CSC (V2.0) were employed to measure each dimension and reveal the clinical value of Guanxinjing capsules. Results①The evaluation results showed that Guanxinjing capsules are safe. According to the adverse reactions in the instructions, the systematic evaluation and meta-analysis of clinical safety, and the data collected by the National Center for Adverse Drug Reaction Monitoring, the adverse reactions of Guanxinjing capsules mainly include chest tightness, dyspnea, dizziness, and digestive system-related symptoms, with a standardized score of 0.75 points, which suggests good safety. ②The meta-analysis results suggest that according to the same efficacy standards, the effectiveness of Guanxinjing capsules alone and Guanxinjing capsules combined with conventional Western medicine or Chinese patent medicines is higher than that of conventional Western medicine or the Chinese patent medicine Shenshao capsules alone in treating coronary heart disease. The standardized score of effectiveness is 0.57, which indicates that the effectiveness still requires evidence support. ③With the individual disposable income in 2020 as the expected payment assumption threshold, compared with conventional treatment alone, combining Guanxinjing capsules with conventional treatment is cost-effective and economical for the patients with angina pectoris of coronary heart disease under certain conditions (higher than 106.91 yuan), which suggests good economy. ④At present, 3 patents for the invention of Guanxinjing capsules have been approved, covering multiple fields such as clinical innovation, service system innovation, and industrial development, which implies good innovation. ⑤In addition, the questionnaire surveys for medical staff involve five different dimensions, and the statistical scores and evaluation results show good suitability of Guanxinjing capsules. ⑥The reimbursement rate of Guanxinjing capsules by residents is high. The sampling survey results show that Guanxinjing capsules are fully equipped in hospitals across China and have good accessibility. ⑦Derived from the theory of activating blood and resolving stasis proposed by Wang Qingren, a famous physician in the Qing Dynasty, Guanxinjing capsules integrate multiple therapies such as replenishing Qi, nourishing Yin, and aromatic warming and unblocking. According to the analysis data in the "6+1" dimensions, the clinical comprehensive evaluation score of Guanxinjing capsules for angina pectoris of coronary heart disease (syndrome of Qi deficiency and blood stasis) was 0.73. ConclusionThe results of comprehensive evaluation of each dimension and clinical value suggest that Guanxinjing capsules in treating angina pectoris of coronary heart disease (syndrome of Qi deficiency and blood stasis) have sufficient clinical evidence, good safety, suitability, and accessibility. It is recommended that Guanxinjing capsules can be included in the documents of basic clinical medication management in accordance with the established procedure.
2.Comprehensive Clinical Evaluation of Duliang Soft Capsules in Treatment of Migraine with Wind-cold Blood Stasis Syndrome
Xiaoxiao ZHAO ; Xuming ZHANG ; Junyu XI ; Zhenkai LU ; Fumei LIU ; Lianxin WANG ; Yuanyuan LI ; Yanming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(8):223-232
ObjectiveTo comprehensively assess the clinical value of Duliang soft capsules in the treatment of migraine with wind-cold blood stasis syndrome, and to provide guidance for national medical decision-making, clinical drug promotion, and pharmaceutical services. MethodThe evaluation of Duliang soft capsules' clinical value was conducted in accordance with the Guidelines for the Management of Comprehensive Clinical Evaluation of Drugs (Trial Version, 2021) using a combination of qualitative and quantitative methods. Utilizing the CSC v2.0 software, this study conducted a comprehensive clinical evaluation of Duliang soft capsules across the "6+1" dimensions, including safety pre- and post-market launch, effectiveness in treating migraine, economy (cost-effectiveness), and innovation, suitability, accessibility, and traditional Chinese medicine (TCM) characteristics in both its technology and clinical applications. ResultSafety: Duliang soft capsules were found to have good safety based on evidence from known adverse reactions (spontaneous reporting system (SRS) data, literature data, etc.), pre-marketing toxicological research, and post-marketing drug monitoring. Effectiveness: A meta-analysis indicated that the combination of Duliang soft capsules and western medicine was more effective than Western medicine alone in the treatment of migraine. The product's effectiveness was rated as "Best" based on the quality and value of the evidence. Economy: Duliang soft capsules are moderately priced and categorized as a Type B medical insurance product. Economic research indicated that the combination of Western medicine and Duliang soft capsules was more cost-effective than Western medicine alone. The product's economy was rated as "Better". Innovation: Duliang soft capsules, with Angelicae Dahuricae Radix and Chuanxiong Rhizoma as the main components, hold one invention patent and have been awarded the China Patent Excellence Award. The pharmaceutical company has introduced innovative extraction (CO2 supercritical extraction technology) and formulation (soft capsule) processes. The product's innovation was rated as "Better". Suitability: A questionnaire survey on Duliang soft capsules showed that it was well-suited for both patients and healthcare professionals. The product received a comprehensive assessment of suitability through the "Evaluation of Chinese Patent Medicine Information Services". The product's suitability was rated as "Best". Accessibility: Duliang soft capsules are moderately priced, making them accessible and affordable. The product's accessibility was rated as "Good" based on evidence from these three aspects. TCM characteristics: The formulation of Duliang soft capsules can be traced back to WANG Qiu's Selected Formulas from the Praiseworthy Studio (Shi Zhai Bai Yi Xuan Fang) from the Song Dynasty, and it was documented in ZHANG Jiebin's The Complete Works of Zhang Jing-yue (Jing Yue Quan Shu) as "Duliangwan". The product has been extensively studied with over 2000 clinical cases since its market launch, and its TCM characteristics were rated as outstanding with sufficient evidence. ConclusionThe comprehensive clinical value evaluation of Duliang soft capsules demonstrated its high effectiveness, suitability, and accessibility, and outstanding TCM characteristics. The product's safety, economy, and innovation received good ratings. In summary, Duliang soft capsules exhibited significant clinical value and outstanding TCM characteristics, the evidence was sufficient, and the result was confirmed, providing crucial references for clinical decision-making and pharmaceutical management.
3.Clinical Comprehensive Evaluation of Zhichuanling Oral Liquid in Treatment of Asthma and Considerations for Cultivating High-value Patents
Shuo YANG ; Haiyan LI ; Yanming XIE ; Lianxin WANG ; Jingming CHENGFENG ; Xin CUI ; Lixun LI
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(18):208-216
ObjectiveThis study conducted a "6 + 1" clinical comprehensive evaluation of the existing research on Zhichuanling oral liquid (ZOL) in the treatment of asthma,so as to clarify the clinical advantages and precise clinical positioning of ZOL in the treatment of asthma, lay a foundation for further research and academic promotion of ZOL, and provide new directions for patent cultivation. MethodAn evaluation method featuring a qualitative and quantitative combination was used, which considered the dimensions of safety,effectiveness,economy,innovation,suitability,accessibility, and traditional Chinese medicine (TCM) characteristics. According to Expert Meeting Law, relevant weights were obtained through voting. CSC_v2.0 software was used to calculate each dimension and convert it into the corresponding grade score. ResultBased on the existing materials,① ZOL instruction indicates the adverse reactions,taboo, and notes. Multiple data of clinical research before and after marketing and spontaneous reporting system shows that ZOL has controllable risk and good safety. Safety is rated as B grade. ② Multiple data of clinical research before marketing, systematic evaluation of clinical effectiveness, and Meta-analysis shows that ZOL has good effectiveness and clinical significance. Effectiveness is rated as a B grade. ③ Analysis of the cost-effectiveness of ZOL combined with conventional treatment shows that the economy of the drug is good and rated as a B grade. ④ ZOL has better innovation, which is rated as an A grade. ⑤ ZOL can basically meet the clinical drug needs based on the result of the questionnaire survey and has good suitability, which is rated as a B grade. ⑥ ZOL has better accessibility, and accessibility is rated as A grade. ⑦ ZOL involves a rich theory of TCM but insufficient experience of human usage. It is thus rated as a C grade in terms of TCM characteristics. Based on the results of "6 + 1" dimension,the clinical comprehensive evaluation of ZOL in the treatment of asthma (cold syndrome and heat syndrome)is rated as B category. ConclusionZOL has good clinical value and outstanding innovation and accessibility in the treatment of asthma (cold syndrome and heat syndrome). It is recommended that ZOL be transformed into the relevant policy results of basic clinical drug management procedurally. At the same time,it is recommended to actively cultivate patents with TCM characteristics.
4.Studies on the Network Toxicology and Immunological Mechanism of Chinese Herbal Medicine-Induced Acute Kidney Injury
Shuo YANG ; Xiangjia LUAN ; Lianxin WANG
Journal of Traditional Chinese Medicine 2024;65(22):2347-2357
ObjectiveTo explore potential herbal components/Chinese herbal medicines (CHM) leading to drug-induced acute kidney injury (DI-AKI) and analyse the possible mechanisms of DI-AKI, and to further explore the correlation between DI-AKI caused by Chinese herbal medicines and the immune system. MethodsUsing network toxicology research methods, DI-AKI-related targets were collected through DisGeNET, MalaCards, TTD, and OMIM databases, and then screened CHM components that caused DI-AKI through HERB database, China National Knowledge Infrastructure (CNKI), Wanfang Data Knowledge Service Platform, Wikipedia Chinese Journal Service Platform, and PubMed, selected with an oral bioavailability (OB) value ≥20%, and screened CHM caused DI-AKI through traditional Chinese medicine system toxicology database. Cytoscape v3.9.1 was used to construct a DI-AKI target-CHM component-CHM network, and the topological properties of the network were calculated to obtain the key targets, DI-AKI-causing CHM components and the corresponding CHM, and the core sub-network targets were subjected to GO function and KEGG pathway enrichment analyses were conducted. The correlation between DI-AKI caused by CHM and the immune system was also explored using immune infiltration analysis and Mendelian randomisation analysis. ResultsThere are 22 CHM components causing DI-AKI with OB ≥ 20% were identified, among which alkaloids are the most abundant contained in 5 CHM components, followed by anthraquinones and diterpenes contained in 3 CHM components each. A total of 21 CHMs causing DI-AKI were finally collected, among which CHMs containing components of aristolochic acid/aristolactam such as Zhusha (Cinnabaris), Guanmutong (Isotrema manshuriense), Guangfangji (Isotrema fangchi) and Qingmuxiang (Inula helenium L.) were the main CHMs leading to DI-AKI. Ten genes including TNF, TP53, IL6, HIF1A, and BCL2 were the pivotal genes in the development of DI-AKI. GO functional enrichment of 29 targets in the core sub-network revealed significant enrichment in epithelial cell proliferation, regulation of apoptotic signalling pathways, angiogenesis, hypoxia and oxidative stress, and angiogenesis. Signal transduction pathways in the KEGG pathway were enriched to 23 targets and 17 pathways. The results of immune infiltration analysis showed that CHMs causing DI-AKI were positively correlated with conventional dendritic cells, macrophages, and neutrophils, and negatively correlated with CD4+ initial T cells, CD8+ initial T cells, and immature dendritic cells. Mendelian randomisation analysis showed that CD64 on CD14+ and CD16+ monocytes may be a risk factor for acute kidney injury, and T-cell-dependent antigen receptor on CD4+ T cells is a protective factor for acute kidney injury. ConclusionNetwork toxicology studies identified 21 potential CHMs associated with DI-AKI, suggesting that their mechanisms may be closely linked to immune system activation through oxidative stress, autophagy, and apoptosis, which lead to inflammatory responses. The immune mechanism of DI-AKI induced by CHMs may involve elevated levels of immune cells, such as conventional dendritic cells, macrophages, and neutrophils, alongside a decline in natural killer T cells, helper T cells (types I and II), and monocytes, which have shown a causal relationship with acute kidney injury.he study provide a theoretical support for the study of CHM causing DI-AKI and also offer references for the CHM safety precise study and pharmacovigilance.
5.A Multicenter, Randomized, Double-blind, and Placebo-parallel Controlled Trial of Tibetan Medicine Ruyi Zhenbaowan in Treatment of Knee Osteoarthritis
Chunquan SUN ; Yanming XIE ; Jinghua GAO ; Weiheng CHEN ; Lianxin WANG ; Shangquan WANG ; Xiangdong TIAN ; Zujian XU ; Yuxin ZHENG ; Mingwang ZHOU ; Chungen LI ; Zhanwang XU ; Jiayi GUO ; Shuangqing DU ; Qigang CHEN ; Quan JI ; Zhiqiang BAI ; Jing XIAO ; Wanli QI ; Weiyi YANG ; Jingxiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(24):57-67
ObjectiveThis study aimed to evaluate the clinical efficacy of Ruyi Zhenbaowan(RYZBW)in the treatment of initial and early knee osteoarthritis (KOA) through a prospective multicenter,randomized,double-blind,and placebo-parallel controlled trial. MethodFrom October 13th, 2021 to December 25th, 2021, 240 KOA subjects meeting the acceptance criteria were enrolled in 15 sub-centers including Wangjing Hospital, Chinese Academy of Chinese Medical Sciences, and they were randomly divided into observation group and control group, with 120 cases in each group. The intervention measures for the observation group were RYZBW + health education, and the intervention measures for the control group were RYZBW placebo + health education. The intervention period in both groups was four weeks, and they were followed up for four weeks after the intervention. The primary outcome measure was the total score of Western Ontario and McMaster University Osteoarthritis Index score (WOMAC score), and the secondary outcome measures were the response rate of visual scale (VAS) pain score, WOMAC sub item scores (joint pain, joint stiffness, and joint function), quality of life (SF-12) score, and traditional Chinese medicine (TCM) syndrome score. Result(1) Efficacy evaluation. The marginal model results showed that the observation group was better than the control group in improving the WOMAC total score and WOMAC pain score in the treatment of KOA with RYZBW, and the difference was statistically significant (P<0.05). There was no significant difference between the two groups in improving VAS score response rate, WOMAC function score, WOMAC stiffness score, SF12-PCS (quality of life-physical health) score, SF12-MCS (quality of life-mental health) score, and TCM syndrome score. (2) Subgroup analysis. ① In terms of VAS score response rate, the response rate of the observation group was higher than that of the control group for subjects with baseline VAS score of (4, 5], and the difference was statistically significant (P<0.05). ② In terms of TCM syndrome score, for subjects aged [56, 60] and [61, 65], the decrease in total TCM syndrome score in the observation group was better than that in the control group, and the difference was statistically significant (P<0.05). ConclusionTibetan medicine RYZBW has good clinical efficacy in improving WOMAC total score, VAS score response rate, WOMAC pain score, WOMAC function score, and TCM syndrome score for patients with initial and early KOA, which can fill the lack of Tibetan medicine RYZBW in the treatment of KOA and make a demonstration study for the inheritance and development of ethnic medicine.
6.Comparison of Runzao Zhiyang capsules and loratadine tablets in drug-induced liver injury:a real-world cohort study
Zilin LONG ; Houyu ZHAO ; Yongqi ZHENG ; Lianxin WANG ; Feng SUN
Chinese Journal of Pharmacoepidemiology 2024;33(3):241-250
Objective To compare the difference in risk of drug-induced liver injury(DILI)between Runzao Zhiyang capsules and loratadine tablets.Methods Based on electronic medical records obtained through active drug safety monitoring in China,a retrospective cohort study was conducted to collect clinical data of patients who took oral Runzao Zhiyang capsules or loratadine tablets between January 1,2004,and December 31,2021.After balancing the confounding factors with a 1∶1 propensity score,the logistic regression model was used to analyze the risk of DILI between the two groups.Additionally,the sensitivity analysis of the data before matching and after inverse probability weighting method was conducted.Results A total of 31 636 patients were included,with 26 840 patients taking Runzao Zhiyang capsules orally.After matching there were 4 072 patients in each group,the risk of DILI in the Runzao Zhiyang capsules group was significantly lower than in the loratadine tablets group(0.12%vs.0.83%),OR=0.15(95%CI 0.06 to 0.38).Before matching and after inverse probability weighting,the incidence of DILI in the Runzao Zhiyang capsules group was still lower than that in the loratadine tablets group,and the difference was statistically significant(P<0.001).Conclusion Runzao Zhiyang capsules have a better safety profile in terms of liver injury compared to the loratadine tablets.The hepatotoxicity of Polygonum multiflorum and its preparations should be scientifically evaluated and rationally treated to ensure medication safety and health.
7.Application value of donor liver autologous portal venous blood rinse in orthotopic liver trans-plantation
Yafei GUO ; Zebin ZHU ; Hao ZHENG ; Ning WANG ; Zhijun XU ; Xuefeng LI ; Wei CAI ; Ruipeng SONG ; Jizhou WANG ; Dalong YIN ; Lianxin LIU ; Shugeng ZHANG
Chinese Journal of Digestive Surgery 2023;22(2):244-250
Objective:To investigate the application value of donor liver autologous portal venous blood rinse in orthotopic liver transplantation (OLT).Methods:The retrospective cohort study was conducted. The clinicopathological data of 35 pairs of donors and recipients who underwent OLT in the First Affiliated Hospital of University of Science and Technology of China from May 2018 to June 2019 were collected. Of the 35 donors, there were 31 males and 4 females, aged (48±9)years. Of the 35 recipients, there were 25 males and 10 females, aged (47±9)years. Of the 35 recipients, 16 recipients undergoing donor liver autologous portal venous blood rinse were allocated into the portal vein group, and 19 recipients undergoing donor liver albumin water rinse were allocated into the albumin group. Observation indicators: (1) surgical situations; (2) postoperative situations; (3) follow-up. Measurement data with normal distribution were represented as Mean± SD, and compari-son between groups was analyzed using the t test. Measurement data of skewed distribution were represented as M(range). Count data were descried as absolute numbers, and comparison between groups was analyzed using the Fisher exact probability. Results:(1) Surgical situations. The anhepatic phase time and arterial blood Ca 2+ concentration within 5 minutes after reperfusion of the recipients were (52±12)minutes and (0.99±0.10)mmol/L in the portal vein group, versus (64±12)minutes and (1.05±0.07)mmol/L in the albumin group, showing significant differences in the above indicators between the two groups ( t=2.94, 2.22, P<0.05). The mean arterial pressure, arterial blood K +concentration and arterial blood pH within 5 minutes after reperfusion of the recipients were (70±24)mmHg (1 mmHg=0.133 kPa), (4.7±1.3)mmol/L and 7.27±0.06 in the portal vein group, versus (71±28)mmHg, (4.6±1.1)mmol/L and 7.30±0.07 in the albumin group, showing no significant difference in the above indicators between the two groups ( t=0.14, 0.30, 1.22, P>0.05). (2) Post-operative situations. Cases with post-reperfusion syndrome (PRS), cases with severe PRS of cardiac arrest, cases with primary graft nonfunction of the recipients were 6, 0, 2 in the portal vein group, versus 8, 1, 1 in the albumin group, showing no significant difference in the above indicators between the two groups ( P>0.05). Total bilirubin on postoperative day 7 of the recipients was (90±52)μmol/L in the portal vein group, versus (166±112)μmol/L in the albumin group, showing a significant difference between the two groups ( t=2.66, P<0.05). International normalized ratio on postoperative day 7, the highest alanine aminotransferase and aspartate aminotransferase within 7 days after operation of the recipients were 2.1±2.0, (1 952±2 813)IU/L and (3 944±6 673)IU/L in the portal vein group, versus 1.8±0.6, (1 023±1 014) IU/L and (2 005±2 910)IU/L in the albumin group, showing no significant difference in the above indicators between the two groups ( t=0.66, 1.23, 1.08, P>0.05). Recipients with hepatic artery complication and biliary complication were 1 and 2 in the portal vein group, versus 0 and 4 in the albumin group, showing no significant difference in the above indicators between the two groups ( P>0.05). There were 3 cases and 2 cases died during the perioperative period in the portal vein group and the albumin group, respectively. (3) Follow-up. Of the 35 recipients, 30 recipients were followed up for 534(range, 28?776)days after operation. During the follow-up, there were 3 patients with postoperative complications in the portal vein group including 2 cases died and 1 case recovered after sympto-matic treatment. There were 5 patients with postoperative complications in the albumin group including 1 case died and 4 cases recovered after symptomatic treatment. Up to the follow-up date, 11 patients in the portal vein group and 16 patients in the albumin group were in good condition. Conclusion:Rinse of the donor liver with autologous portal venous blood during liver transplantation can shorten the time of anhepatic phase, without increasing the occurrence of post-reperfusion syndrome, ischemia re-perfusion injury and biliary tract complications.
8.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.
9.Expert consensus on the accurate diagnosis and treatment of acetabular fractures based on three-column classification (version 2023)
Ruipeng ZHANG ; Hongmin CAI ; Shicai FAN ; Gang LYU ; Yan ZHUANG ; Chengla YI ; Xiaodong GUO ; Longpo ZHENG ; Xianzhong MA ; Hua CHEN ; Dahui SUN ; Guanglin WANG ; Qishi ZHOU ; Weixu LI ; Wei FENG ; Zhangyuan LIN ; Xiaodong QIN ; Jiandong WANG ; Zhanying SHI ; Lianxin LI ; Guangyao LIU ; Shuquan GUO ; Ming LI ; Jianzhong GUAN ; Yingze ZHANG ; Zhiyong HOU
Chinese Journal of Trauma 2023;39(10):865-875
Accurate classification of the acetabular injuries and appropriate treatment plan are great challenges for orthopedic surgeons because of the irregular anatomical structure of the acetabulum and aggregation of important vessels and nerves around it. Letournel-Judet classification system has been widely applied to classify acetabular fractures. However, there are several limitations, including incomplete inclusion of fracture types, difficulty in understanding and insufficient guidance for surgical treatment, etc. Serious complications such as traumatic arthritis are common due to wrong classification and diagnosis and improper selection of surgical strategy, which brings a heavy burden to the society and families. Three-column classification, based on anatomic characteristics, has advantages of containing more fracture types and being easy to understand, etc. To solve the problems existing in the diagnosis and treatment process based on Letournel-Judet classification, achieve accurate diagnosis and treatment of patients with acetabular fractures, and obtain satisfactory prognosis, the Orthopedic Trauma Emergency Center of Third Hospital of Hebei Medical University and the Trauma Orthopedic Branch of the Chinese Orthopedic Association organized experts from relevant fields to formulate the Expert consensus on the accurate diagnosis and treatment of acetabular fractures based on three-column classification ( version 2023) in terms of principles of evidence-based medicine. Based on the three-column classification, 15 recommendations were proposed, covering the diagnosis, treatment, complication prevention and management, etc, so as to provide reference for accurate diagnosis and treatment of acetabular fractures.
10.Minimally invasive technique for tibial plateau bicondylar fracture repair using the double reverse traction repositor
Zhimeng ZHAO ; Fulin TAO ; Dawei WANG ; Lin LI ; Dongsheng ZHOU ; Lianxin LI
Chinese Journal of Orthopaedics 2023;43(22):1509-1516
Objective:To assess the efficacy of a minimally invasive technique for repairing tibial plateau bicondylar fractures utilizing the double reverse traction repositor.Methods:A retrospective analysis was performed of the data of 31 patients (Schatzker V 17 cases, Schatzker VI 14 cases) who had been admitted to trauma center of Shandong provincial hospital affiliated to Shandong first medical university for tibial plateau bicondylar fractures from January 2017 to January 2022. There were 21 males and 10 females, aged from 18 to 67 years (average, 32.4±6.5 years). The intervention strategy comprised the use of a double reverse traction repositor and was augmented by precise screw fixation. A comprehensive set of parameters were measured, including time interval between injury and operation, operation time, blood loss, hospital stay, fracture healing time, incision complications. Postoperative assessments were made immediately and at the 12-month mark, including the evaluation of articular step-off height, medial tibial plateau angle, and posterior tibial slope angle. The evaluation also included thTime interval between injury and operation ranged from 5 to 11 days, with an average of 6.1±1.3 days. The surgical procedures varied in length from 70 to 160 minutes, averaging at 109.2±15.6 minutes. The volume of blood loss was noted to be between 90 to 380 ml, averaging at 176.5±20.8 ml. Hospitalization spanned from 10 to 15 days, with an average stay of 12.2 ±0.8 days. Over a follow-up duration of 12 to 20 months, averaging at 13.5±1.1 months, all patients achieved fracture union within a period of 11 to 20 weeks, with an average time of 14.6±1.5 weeks. The postoperative articular step-off was recorded at 0.45±0.13 mm immediately after surgery and 0.58±0.21 mm at the one-year follow-up. Similarly, the medial tibial plateau angle and posterior tibial slope angle showed marginal changes from the immediate postoperative period to the 12-month evaluation. Knee joint mobility at the one-year mark ranged impressively from 0° to 135°, with an average of 125.6°±2.1°. Functional outcomes as reflected by Rasmussen scores ranged from 18 to 28 points, with an average of 25.4±1.7 points. Pain, as assessed by the VAS, had a low score range of 0 to 2 points, averaging at 0.7±0.2 points. Notably, there were no postoperative complications associated with the incisions, such as fat liquefaction, infection, skin necrosis, or exposure of internal fixations. Additionally, no cases of delayed union or fixation failure were observed. Six patients had traumatic arthritis 1 year after operation.Conclusion:The minimally invasive double reverse traction repositor technique for tibial plateau bicondylar fracture repair is effective, warranting its broader application in orthopedic surgery.

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