1.Advances in Xpert MRSA/SA technology for colonisation and decolonisation of methicillin-anti staphylococcus aureus
Shasha FENG ; Shixin REN ; Yanan LI ; Wenshuang ZHANG
Clinical Medicine of China 2024;40(2):139-144
		                        		
		                        			
		                        			Methicillin-anti staphylococcus aureus(MRSA) is one of the common pathogenic bacteria in hospital infection. Many asymptomatic MRSA carriers have been found in clinical practice, which can not only transmit the strain to others, but also cause secondary infection due to their own reasons. Decolonization measures can reduce the number of MRSA colonizers, thereby reducing the risk of endogenous infection and secondary transmission. Early identification is the first step to prevent transmission and secondary infection, which requires high accuracy and sensitivity of detection methods. Xpert MRSA/SA assay (Cepheid, Sunnyvale, CA, USA) may be a better choice, which can shorten the time of traditional methods, and has high specificity and sensitivity. Unlike other rapid detection methods, the Xpert MRSA/SA assay may be more suitable for MRSA colonisation detection.
		                        		
		                        		
		                        		
		                        	
2.Clinical research of intrathecal baclofen in improving spasticity
Wenshuang ZENG ; Yongjie LI ; Zhenyu ZHANG ; Fuyong CHEN ; Huiting LIN ; Zhaoxiang HONG
Chinese Journal of Neurology 2024;57(11):1199-1205
		                        		
		                        			
		                        			Objective:To investigate the specific method, efficacy and safety of intrathecal baclofen (ITB) in the treatment of moderate and severe spasticity.Methods:The clinical features, response to ITB trial, clinical outcomes and treatment-related complications after baclofen pump implantation surgery were retrospectively analyzed in patients with moderate to severe spasticity who received ITB treatment in Hong Kong University Shenzhen Hospital from August 2022 to August 2023.Results:The study included 22 patients with moderate to severe spasticity, of whom 18 patients (81.8%) were effective in ITB trial. For these patients with effective trial, the lowest mean Modified Ashworth Scale (MAS) score of lower extremity muscle groups after ITB bolus injection was decreased significantly compared with the baseline mean value before injection (1.29±0.81 vs 3.31±1.18 , t=11.364, P<0.001), and the M/H amplitude ratio of soleus H-reflex at 4 hours after ITB bolus injection was significantly higher than the baseline value (9.61±4.66 vs 3.83±2.69, t=7.780, P<0.001). Among the 18 patients with effective ITB trial, 10 patients received baclofen pump implantation surgery with the informed consent of the patients or their guardians. Compared with the 8 patients without surgery, the baseline mean MAS score of lower extremity muscle groups of the 10 patients who received surgery was higher (3.71±1.06 vs 2.83±1.16, F=5.645, P<0.05), the maximum reduction of mean MAS score of lower extremity muscle groups of the 10 patients who received surgery was greater (2.61±0.99 vs 1.30±0.64, F=20.696, P<0.001). In 10 patients who received baclofen pump implantation surgery, the mean MAS score of lower limb muscle groups was significantly decreased in the first and sixth months after surgery compared with the baseline mean value before surgery (1.64±0.91, 1.16±0.89 and 3.71±1.06, F=39.946, P<0.001). Among them, 2 patients were followed up to 12 months after surgery, 2 patients were followed up to 18 months after surgery, and the mean MAS score of their lower limb muscle groups showed continuous improvement, and 1 patient with cerebral palsy combined with lower urinary tract hyperactive syndrome also showed significant improvement of urgent urinary incontinence after surgery. Up to the last follow-up, the daily dose of baclofen in 10 patients receiving baclofen pump implantation was (143.60±96.24) μg, and no treatment-related complications occurred. Conclusions:ITB can effectively relieve spasticity symptoms and other related neurological dysfunction in patients with moderate and severe spasticity, and the efficacy can be maintained for a long time, and treatment-related complications are rare. Preoperative ITB trial is helpful to screen out patients more suitable for baclofen pump implantation. Patients with higher grade of spasticity at baseline and better efficacy of ITB trial are more suitable for baclofen pump implantation. The soleus H reflex can effectively reflect the change of stretch reflex of lower limb muscle groups in patients with spasticity treated by ITB, and can be used to evaluate the treatment effect of ITB.
		                        		
		                        		
		                        		
		                        	
3.Clinical Comprehensive Evaluation of Biantong Capsules and Biantong Tablets in Treatment of Constipation
Zeqi DAI ; Chuchuan WAN ; Wenshuang LI ; Qingran SUN ; Xudong TANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(19):160-167
		                        		
		                        			
		                        			ObjectiveTo carry out the clinical comprehensive evaluation of Biantong capsules and Biantong tablets in the treatment of constipation guided by the clinical value of drugs, and to provide a scientific basis for the rational pricing, rational use, and cataloging of Biantong capsules/tablets. MethodThe available evidence and survey data were used for the clinical comprehensive evaluation of Biantong capsules/tablets and three control drugs in the treatment of constipation in terms of the six dimensions including effectiveness, safety, economics, innovation, suitability, and accessibility. ResultIn terms of effectiveness, Biantong capsules/tablets can improve the response rate, with clear pharmacological mechanism. In terms of safety, the absence of toxic reaction, the mild adverse reactions, and the favorable prognosis indicate high safety. In terms of economics, the average daily cost of Biantong capsules/tablets is the lowest among the tested drugs, which indicates a cost-effectiveness advantage. In terms of innovation, Biantong capsules/tablets have been authorized patents in China and listed as members in the third category of new drugs of traditional Chinese medicine/ninth new drugs of traditional Chinese medicine. In terms of suitability, Biantong capsules/tablets are convenient to store and take and have good suitability in terms of drug technical characteristics and drug usage. In terms of accessibility, Biantong capsules/tablets have a wide coverage in hospitals, sufficient capacity, low patient burden, extensive drug catalogue coverage, and no major environmental risk for long-term application. The comprehensive values of the tested drugs follow a descending order of control drug B (84.27 score), Biantong capsules/tablets (82.47 score), control drug A (70.47 score), and control drug C (59.46 score). The recommendations of the expert panel are Class A (18/18), which can be directly converted into decision-making. ConclusionBiantong capsules/tablets demonstrate a high clinical comprehensive value in the treatment of constipation, providing a reference for the rational pricing, rational use, and cataloging of drugs. 
		                        		
		                        		
		                        		
		                        	
4.Quality evaluation of the research literature on the pharmacoeconomics of traditional Chinese medicines in China from 2018 to 2022
Wenshuang LI ; Zeqi DAI ; Qingran SUN ; Chuchuan WAN ; Xing LIAO ; Xiaoyu XI
China Pharmacy 2023;34(19):2378-2384
		                        		
		                        			
		                        			OBJECTIVE To evaluate the quality of research literature on pharmacoeconomics of traditional Chinese medicine (TCM) in China from 2018 to 2022, to understand the development status and problems of TCM pharmacoeconomic research in China, and to provide a reference for future standardized research on this field. METHODS The systematic search of relevant databases at home and abroad was conducted to obtain the published literature on TCM pharmacoeconomic research in China from January 1, 2018 to November 21, 2022 to summarize the basic information of the literature, the research profile, the method and content of pharmacoeconomic evaluation and to evaluate the quality of the literature by using the CHEERS 2022 checklist; calculate the total literature score by counting the scores of the specific entries of each piece of literature and classifying the quality of the literature as excellent, good, qualified, and unqualified. RESULTS A total of 71 studies were included, involving 60 in Chinese and 11 in English, and 53.52% of the literature was supported by grants; the most studied TCM dosage form was injection (31.03%); less than half (46.48%) of the literature reported the study angle; short-term economic evaluation was predominantly used (69.01%); the Chinese studies were dominated by cost-effectiveness analyses (70.00%), and the English studies were dominated by cost-utility analysis (54.55%). The average score of literature quality evaluation was 11.02, with two (2.82%) of the literature being of good quality, nine (12.68%) of the literature being of qualified quality, and the majority of the literature (84.51%) being of unqualified quality. The average score of Chinese literature was 9.98, and the average score of English literature was 16.73, with the quality of the latter being significantly better than that of the former. CONCLUSIONS At present, the pharmacoeconomic researches of TCM mainly has problems such as lack of scientific selection of intervention in the control group, nonstandard cost measurement, unreasonable selection of research time limit, quality of evidence for health output indicators to be improved, selection of evaluation methods to be improved, and lack of scientific basis for threshold selection. In order to support the implementation and development of high-level pharmacoeconomics research on TCM, policymakers need to create a favorable policy environment and formulate pharmacoeconomic evaluation guidelines that meet the characteristics of TCM, so as to promote the application and transformation of evaluation results.
		                        		
		                        		
		                        		
		                        	
5.Current Situation on Clinical Comprehensive Evaluation of Chinese Patent Medicines in China
Wenshuang LI ; Zeqi DAI ; Qingran SUN ; Chuchuan WAN ; Xing LIAO ; Xiaoyu XI
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(24):155-162
		                        		
		                        			
		                        			ObjectiveTo clarify the development and methodological research status of clinical comprehensive evaluation of Chinese patent medicines in China and identify the problems and difficulties in the evaluation, so as to provide a reference for promoting the subsequent evaluation. MethodFirstly, we analyzed the current situation of clinical comprehensive evaluation in China by reviewing the articles about the process of clinical comprehensive evaluation of drugs and the process of clinical comprehensive evaluation of Chinese patent medicines. Secondly, we comprehensively summarized the formulation background and key points of policies related to clinical comprehensive evaluation of Chinese patent medicines and then show the development status in this field at the national and provincial levels. ResultThe comprehensive clinical evaluation of Chinese patent medicines is still in its infancy in China, and 32 articles of specific evaluation of Chinese patent medicines were included in the study. The dosage forms were mainly capsules (15 articles, 46.88%) and injections (28.13%). The evaluation mainly involved diseases such as the nervous system (10 articles, 31.25%), digestive system (5 articles, 15.63%), and respiratory system (5 articles, 15.63%). The research results of clinical comprehensive evaluation of Chinese patent medicines were mainly from relevant societies and research institutions. Different research teams have developed technical guidelines or specifications for the evaluation, while the government-leading evaluation guidelines remained to be formulated at the national and provincial levels. In addition, the research articles in this field mainly concentrated on the application of evaluation methods, the building of evaluation index systems, and completed evaluation reports. ConclusionTo reflect the unique value and advantages of Chinese patent medicines, the government needs to build technical guidelines for the clinical comprehensive evaluation of Chinese patent medicines on the basis of the clinical comprehensive evaluation of drugs and create a favorable policy environment for the evaluation work. 
		                        		
		                        		
		                        		
		                        	
6.A multi-center survey on the application of antibacterial agents in Chinese children in 2019
Jiaosheng ZHANG ; Xiang MA ; Lanfang TANG ; Daiyin TIAN ; Li LIN ; Yanqi LI ; Jing QIAN ; Wenshuang ZHANG ; Wei LI ; Gen LU ; Ligang SI ; Ping JIN ; Liang ZHU ; Keye WU ; Jikui DENG ; Yuejie ZHENG ; Yonghong YANG
Chinese Journal of Applied Clinical Pediatrics 2022;37(14):1074-1081
		                        		
		                        			
		                        			Objective:To analyze the patterns of antibacterial agents in Chinese children surveyed by the China multi-center monitoring network for the application of antibacterial agents in children and neonates in 2019 by using World Health Organization (WHO) Access, Watch, Reserve and Not-recommended (AWaRe) and typical anatomical/therapeutic/chemical (ATC) in this study.Methods:The cross-sectional method was adopted.A multi-center cross-sectional survey was conducted on one day from September to December 2019.The information of all inpatients taking antibiotics was uploaded to the network-based data collection system (https: //garpec-31.mobilemd.cn/login.aspx? relogin=true). This study covered 13 hospitals from 10 provinces and cities in China.All hospitalized children in the Respiratory Department, Infectious Disease Department, General Surgery Department, Pediatric Intensive Care Units, Neonatal Intensive Care Units and Neonatology joined in this survey.The clinically used antibacterial agents were classified by AWaRe and ATC, and the AWaRe and ATC distributions of antibacterial agents prescribed for Chinese children and neonates were described.Results:Of the 2 644 antibiotic prescriptions included from 13 hospitals, 2 134 (80.71%) were for children and 510 (19.29%) were for neonates.Of all antibiotic prescriptions, there were 368 (13.92%) Access antibiotics prescriptions, 1 973 (74.62%) Watch prescriptions, 60 (2.27%) Reserve prescriptions and 243 (9.19%) Not-recommended prescriptions.The top-five antibiotics prescribed for children and neonates were third-generation cephalosporins (1 056, 39.94%), macrolides (492, 18.61%), carbapenems (275, 10.40%), beta lactam-beta lactamase inhibitors (246, 9.30%), and second-generation cephalosporins (136, 5.14%). The use ratios of Access, Watch, Reserve and Not-recommended antibiotics in each center ranged from 0 to 30.00%, 36.67% to 97.20%, 0 to 17.02% and 0 to 33.33%, respectively.In 1 360 antibiotic prescriptions for children and neonates with pneumonia, there were 152 (11.18%) Access antibiotics, 1 051 (77.28%) Watch antibiotics, 37 (2.72%) Reserve antibiotics, and 120 (8.82%) Not-recommended antibiotics.The top-five antibiotics prescribed for children with pneumonia were third-generation cephalosporins (522, 38.38%), macrolides (388, 28.53%), beta lactam-beta lactamase inhibitors (141, 10.37%), carbapenems (117, 8.6%) and penicillins (49, 3.60%).Conclusions:Watch antibiotics and broad spectrum antibiotics such as third-generation cephalosporins and macrolides prone to induce resistance are the main antibacterial agents used in Chinese children and neonates with pneumonia.Broad-spectrum antibiotics may be overused in Chinese children and neonates.
		                        		
		                        		
		                        		
		                        	
7.Retrospective analysis of clinical characteristics of 18 pregnant women infected with dengue virus in Ruili City, Yunnan Province
Wenshuang JIA ; Man LI ; Jiayuan SHEN ; Zhongping YANG ; Jiarong MAO ; Xiaoxiong YIN ; Yonghua LIU ; Yangsiqi LI ; Hongning ZHOU
Chinese Journal of Endemiology 2021;40(9):752-755
		                        		
		                        			
		                        			Objective:To understand the clinical characteristics of pregnant women infected with dengue virus (DENV) in Ruili City, Yunnan Province, so as to provide basis for formulating effective diagnosis and treatment protocol of dengue fever in pregnant women.Methods:A total of 18 pregnant women infected with DENV hospitalized in Ruili People's Hospital in 2017 and 2018 were selected as observation group, and 18 non-pregnant women infected with DENV were selected as control group according to the age range of the observation group, and epidemiological and clinical data of patients in the two groups were retrospectively collected. Epidemiological characteristics, clinical symptoms and laboratory biochemical indexes of the two groups were compared and analyzed.Results:There were no significant differences ( t = - 0.032, 0.495, P > 0.05) in age [(27.9 ± 5.3) vs (27.9 ± 5.1) years old] and hospitalization stay [(6.8 ± 1.6) vs (6.6 ± 2.0) d] between the observation group and control group. One pregnant woman in observation group had early pregnancy abortion. Patients of both groups had fever in 18 cases (100.0%), headache, muscle aches, and chills in 14 cases (77.8%), anorexia in 15 cases (83.3%), and nausea and vomiting in 5 cases (27.8%); fatigue in 14 cases (77.8%) and 16 cases (88.9%), respectively; there was 1 case of rash in observation group (5.6%), and no rash in control group. There were no significant differences in the above mentioned clinical symptoms distribution between the two groups ( P > 0.05). On the first day of admission, the reduction proportions in red blood cells [61.1% (11/18) vs 5.6% (1/18)], hemoglobin [50.0% (9/18) vs 16.7% (3/18)], and hematocrit [61.1% (11/18) vs 16.7% (3/18)] in observation group were significantly higher than those in control group ( P < 0.05); on the fifth day of admission, the reduction proportions in hemoglobin [33.3% (6/18) vs 5.6% (1/18)] and hematocrit [33.3% (6/18) vs 5.6% (1/18)] in observation group were significantly higher than those in control group ( P < 0.05). Conclusions:The red blood cells, hemoglobin and hematocrit of pregnant women infected with DENV are significantly reduced, and there is a risk of miscarriage in early pregnancy. It is suggested that relevant departments should strengthen the training of medical staff to diagnose and treat pregnant women infected with DENV early.
		                        		
		                        		
		                        		
		                        	
8.Establishment of HPLC Fingerprint ,Chemical Pattern Recognition Analysis and Content Determination of the Leaves of Toricellia angulata from Different Regions
Zhongyao HAN ; Jun XIANG ; Jianyu CHEN ; Yiyong SONG ; Shiwai LI ; Wenshuang TANG ; Zujun YE ; Linsu ZHANG ; Hao TIAN ; Wanle WANG
China Pharmacy 2021;32(10):1224-1229
		                        		
		                        			
		                        			OBJECTIVE:To provide reference for the quality control of the leaves of Toricellia angulata . METHODS :HPLC method was adopted. The determination was performed on Agela Promosil C 18 column with 0.2% phosphoric acid solution-acetonitrile(gradient elution )as mobile phase at the flow rate of 1.0 mL/min. The detection wavelength was set at 210 nm,and column temperature was 35 ℃. The sample size was 10 μL. HPLC fingerprint of 10 batches of the leaves of T. angulata was established and similarity evaluation was conducted by using Similarity Evaluation System of TCM Chromatographic Fingerprint(2004 edition). The chromatographic peak was identified by comparing with the chromatogram of reference substance. Cluster analysis ,PCA and PLS-DA were used to identify chemical patterns ,and the quality differential markers were screened. The contents of hyperoside and isoquercitrin were determined by the same HPLC. RESULTS :The similarities of HPLC fingerprint of 10 batches of the leaves of T. angulata with control fingerprint were 0.923-0.983. A total of 11 common peaks were identified ,and the peaks 4 and 5 were hyperoside and isoquercitrin ,respectively. Results of cluster analysis ,PCA and PLS-DA showed that 10 batches of leaves of T. angulata could be divided into two categories ,Y10 was clustered into one category ,and others were clustered into one category. PLS-DA analysis showed that 6 common peaks (peaks 4,3,10,2,6 and 11) with variable importance projection (VIP)greater than 1 were selected. Average contents of hyperoside and isoquercitrin in 10 batches of the leaves of T. angulata were 0.47-6.97,0.21-1.87 mg/g,respectively. CONCLUSIONS :Established HPLC fingerprint and the method for content determination are stable and reliable ,and can be used for the quality control of the leaves of T. angulata from different areas. Six quality differential markers including  hyperoside in the leaves of T. angulata from different areas are qnyz202034) preliminarily screened.
		                        		
		                        		
		                        		
		                        	
9.The application values of MR quantitative susceptibility mapping in differentiation between knee meniscus degeneration and tear
Ye LI ; Aocai YANG ; Tao GONG ; Sai SHAO ; Xianyun CAI ; Cong SUN ; Tuantuan WANG ; Wenshuang ZHANG ; Weibo CHEN ; Guangbin WANG
Chinese Journal of Radiology 2021;55(5):522-527
		                        		
		                        			
		                        			Objective:To evaluate the feasibility and the application values of quantitative susceptibility mapping (QSM) for the assessment of meniscal injury and in distinguishing meniscus degeneration and tears.Methods:The clinical and imaging data of 70 patients suspected of meniscus injury and scheduled for arthroscopy in Shandong Medical Imaging Research Institute, Cheeloo College of Medicine, Shandong University from November 2019 to June 2020 were analyzed retrospectively. Thirty age-and sex-matched healthy subjects were also examined as controls. All subjects received knee joint QSM and routine MR imaging. According to the results of arthroscopy, the patients was divided into meniscus degeneration and meniscus tear groups, respectively. The conventional MR was evaluated by two radiologists. The meniscus injury area was delineated on the original QSM magnitude images (the central area of the posterior corner of the lateral meniscus was selected in the healthy controls) and mapped to the corresponding QSM maps, and the magnetic susceptibility values were measured. Kruskal-Wallis H test was used to analyze the magnetic sensitivity values of meniscal degeneration, meniscal tear and healthy control groups; and Bonferroni was used to correct the pairwise comparison. ROC curve was established to evaluate the threshold and efficacy of magnetic susceptibility value in the diagnosis of meniscal tear. The results were compared with those of conventional MRI. Results:The magnetic susceptibility values of meniscus of healthy controls, meniscal degeneration and meniscal tear groups were (0.035±0.016)ppm, -0.031(-0.040,-0.005)ppm, and(-0.122±0.115)ppm, respectively, with significant difference found among the three groups (χ2=44.419, P<0.05). The magnetic susceptibility values of meniscus of healthy controls was significantly higher than those of meniscus degeneration patients and meniscus tear patients (χ2=-23.843, -48.253, P<0.05). The magnetic susceptibility values of meniscus of meniscus tear group was significant lower than those of meniscus degeneration group (χ2=-24.410, P<0.05). Taking magnetic susceptibility values of -0.062 5 ppm as threshold, the area under the ROC curve for the diagnosis of meniscal tears was 0.949, with the sensitivity as 87% and the specificity as 100%. The sensitivity and specificity of conventional MRI in the diagnosis of meniscal tears were 86.8% and 87.5%, respectively. Conclusion:QSM can quantitatively evaluate meniscus injury and can be used as an effective supplement method to conventional MRI, which is helpful to improve the diagnosis of meniscus tear.
		                        		
		                        		
		                        		
		                        	
10.The value of MRI anterior cartilaginous acetabulum-head-index to evaluate hip function after treatment of developmental dysplasia of the hip
Wenshuang ZHANG ; Yanzhou WANG ; Tianyou LI ; Cong SUN ; Qinhua LUAN ; Yongguang BAN ; Yufan CHEN ; Aocai YANG ; Ye LI ; Guangbin WANG
Chinese Journal of Radiology 2021;55(10):1076-1081
		                        		
		                        			
		                        			Objective:To evaluate the feasibility of high resolution MRI for the measurement of anterior cartilaginous acetabulum-head-index (A-CAHI) and the value of A-CAHI for predicting hip clinical function after treatment in developmental dysplasia of the hip (DDH).Methods:The imaging data of 92 hips from 61 children with treated DDH were retrospectively reviewed in Shandong Medical Imaging Research Institute from January 2019 to January 2020. All children underwent conservative treatments or surgical interventions 3 years ago. Hip function after treatment was evaluated clinically based on the modified MacKay criteria. The hips were divided into satisfactory clinical function group (McKay rating excellent or good, n=46) and unsatisfactory group (McKay rating fair or poor, n=46). All patients were imaged with conventional MRI, high resolution fat suppressed proton density weighted image (FS-PDWI) of the unilateral hip joint in oblique sagittal view, and anteroposterior hip radiographs. A-CAHI and lateral cartilaginous acetabulum-head-index (L-CAHI) were measured respectively on high-resolution oblique sagittal PDWI and conventional coronal T 1WI. Acetabulum head index (AHI) was also measured on anteroposterior hip radiograph. Mann-Whitney U test or independent-samples t test was used to compare the difference of A-CAHI, L-CAHI and AHI between satisfactory and unsatisfactory clinical function groups. The diagnostic value using A-CAHI, L-CAHI, AHI, or A-CAHI combined with L-CAHI for unsatisfactory clinical function were investigated by the ROC curve. The area under the curve (AUC) and the Z statistic were used to compare diagnostic performance. Results:The values of A-CAHI, L-CAHI and AHI were significantly higher in satisfactory clinical function group compared with the unsatisfactory group ( Z=-7.746, -7.735, t=-7.199, all P<0.001).A-CAHI combined with L-CAHI had the significant highest diagnostic accuracy compared with A-CAHI, L-CAHI and AHI (AUC were 0.994, 0.969, 0.968, 0.861, respectively), with significant differences ( Z=1.975, 2.006, 3.553, P=0.048, 0.051,<0.001). The sensitivity and specificity of A-CAHI combined with L-CAHI for the diagnosis of prognosis were 95.7% and 97.8%, respectively. Conclusions:A-CAHI measured by high resolution MRI was found to have the highest diagnostic accuracy for prediction of hip clinical function in the treated DDH, and combined with L-CAHI can improve the diagnostic accuracy significantly.
		                        		
		                        		
		                        		
		                        	
            
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