1.Research progress of medication-related patient-reported outcome scales
Panpan LU ; Haixin LI ; Zhiling DENG ; Xujian LIANG ; Yiting LU ; Ming YAN ; Songtao CAI ; Wanchao LI ; Ruifeng ZENG ; Yi GUO ; Zhijie XU
Chinese Journal of Pharmacoepidemiology 2024;33(1):95-105
		                        		
		                        			
		                        			Drug therapy is a common method to cure diseases and relieve symptoms.The value of patient-reported outcome(PRO)in evaluating the effect of drug therapy has been increasingly paid attention.The PRO scale is a standardized questionnaire,which can scientifically evaluate the experiences and subjective effects of drug use from a patient-centered perspective,and help patients and clinicians make more reasonable medication decisions.By reviewing and sorting out relevant global literature,this paper found that the content of the PRO scales relevant to drug therapy focused on five fields:"medication satisfaction""medication adherence""drug treatment burden""medication-related quality of life"and"adverse drug reactions".This paper described the basic information,measurement characteristics and application of common scales in recent years respectively,and summarized and analyzed the problems and enlightenment of scale development,aiming to provide theoretical reference for the selection,application and development of PRO scales.
		                        		
		                        		
		                        		
		                        	
2.Analysis and Efficiency Evaluation of Traditional Chinese Medicine Health Resources Allocation in Shanxi Province
Ruifeng LI ; Juanjuan YAN ; Ruiying LIANG
Chinese Health Economics 2024;43(3):39-43
		                        		
		                        			
		                        			Objective:To study the allocation status of traditional Chinese medicine health resources in Shanxi Province from 2009 to 2021,conduct a vertical evaluation of the operation efficiency of traditional Chinese medicine health resources in Shanxi Province,discuss the related causes,and propose improvement method.Methods:The Gini coefficient method was used to make statistical data of traditional Chinese medicine health resources in Shanxi Province according to population allocation,Lorentz curve was drawn to analyze the equity of resource allocation,and BCC model was used to evaluate the input-output efficiency of resources.Results:The allocation of TCM health resources per population in Shanxi Province was the shortest in 2014,showing a trend of first decreasing and then increasing.The data output of operation efficiency showed that the allocation of TCM health resources in Shanxi Province was DEA effective in 2013,2015,2017-2019 and 2021,weak in 2009-2012 and 2014,and non-DEA effective in 2016 and 2020.Conclusion:The health resources of traditional Chinese medicine invested in Shanxi are not reasonably matched,the utilization of resources is not sufficient,the technical efficiency and scale efficiency of operation need to be improved.The redundancy of health resources and the"increasing return to scale"phenomenon coexist.
		                        		
		                        		
		                        		
		                        	
3.Multicenter evaluation of the diagnostic efficacy of jaundice color card for neonatal hyperbilirubinemia
Guochang XUE ; Huali ZHANG ; Xuexing DING ; Fu XIONG ; Yanhong LIU ; Hui PENG ; Changlin WANG ; Yi ZHAO ; Huili YAN ; Mingxing REN ; Chaoying MA ; Hanming LU ; Yanli LI ; Ruifeng MENG ; Lingjun XIE ; Na CHEN ; Xiufang CHENG ; Jiaojiao WANG ; Xiaohong XIN ; Ruifen WANG ; Qi JIANG ; Yong ZHANG ; Guijuan LIANG ; Yuanzheng LI ; Jianing KANG ; Huimin ZHANG ; Yinying ZHANG ; Yuan YUAN ; Yawen LI ; Yinglin SU ; Junping LIU ; Shengjie DUAN ; Qingsheng LIU ; Jing WEI
Chinese Journal of Pediatrics 2024;62(6):535-541
		                        		
		                        			
		                        			Objective:To evaluate the diagnostic efficacy and practicality of the Jaundice color card (JCard) as a screening tool for neonatal jaundice.Methods:Following the standards for reporting of diagnostic accuracy studies (STARD) statement, a multicenter prospective study was conducted in 9 hospitals in China from October 2019 to September 2021. A total of 845 newborns who were admitted to the hospital or outpatient department for liver function testing due to their own diseases. The inclusion criteria were a gestational age of ≥35 weeks, a birth weight of ≥2 000 g, and an age of ≤28 days. The neonate′s parents used the JCard to measure jaundice at the neonate′s cheek. Within 2 hours of the JCard measurement, transcutaneous bilirubin (TcB) was measured with a JH20-1B device and total serum bilirubin (TSB) was detected. The Pearson′s correlation analysis, Bland-Altman plots and the receiver operating characteristic (ROC) curve were used for statistic analysis.Results:Out of the 854 newborns, 445 were male and 409 were female; 46 were born at 35-36 weeks of gestational age and 808 were born at ≥37 weeks of gestational age. Additionally, 432 cases were aged 0-3 days, 236 cases were aged 4-7 days, and 186 cases were aged 8-28 days. The TSB level was (227.4±89.6) μmol/L, with a range of 23.7-717.0 μmol/L. The JCard level was (221.4±77.0) μmol/L and the TcB level was (252.5±76.0) μmol/L. Both the JCard and TcB values showed good correlation ( r=0.77 and 0.80, respectively) and agreements (96.0% (820/854) and 95.2% (813/854) of samples fell within the 95% limits of agreement, respectively) with TSB. The JCard value of 12 had a sensitivity of 0.93 and specificity of 0.75 for identifying a TSB ≥205.2?μmol/L, and a sensitivity of 1.00 and specificity of 0.35 for identifying a TSB ≥342.0?μmol/L. The TcB value of 205.2?μmol/L had a sensitivity of 0.97 and specificity of 0.60 for identifying TSB levels of 205.2 μmol/L, and a sensitivity of 1.00 and specificity of 0.26 for identifying TSB levels of 342.0 μmol/L. The areas under the ROC curve (AUC) of JCard for identifying TSB levels of 153.9, 205.2, 256.5, and 342.0 μmol/L were 0.96, 0.92, 0.83, and 0.83, respectively. The AUC of TcB were 0.94, 0.91, 0.86, and 0.87, respectively. There were both no significant differences between the AUC of JCard and TcB in identifying TSB levels of 153.9 and 205.2 μmol/L (both P>0.05). However, the AUC of JCard were both lower than those of TcB in identifying TSB levels of 256.5 and 342.0 μmol/L (both P<0.05). Conclusions:JCard can be used to classify different levels of bilirubin, but its diagnostic efficacy decreases with increasing bilirubin levels. When TSB level are ≤205.2 μmol/L, its diagnostic efficacy is equivalent to that of the JH20-1B. To prevent the misdiagnosis of severe jaundice, it is recommended that parents use a low JCard score, such as 12, to identify severe hyperbilirubinemia (TSB ≥342.0 μmol/L).
		                        		
		                        		
		                        		
		                        	
4.Comparative efficacy of vNOTES and LESS in the management of benign uterine lesions in obese patients
Wenyuan LI ; Min WEI ; Jie HAN ; Ruifeng LI ; Zhen WANG ; Hailan LI ; Jing XU ; Dongmei JIN ; Lingyan XU ; Rong PENG ; Yan ZHANG ; Xinhua SUN
The Journal of Practical Medicine 2024;40(22):3184-3189
		                        		
		                        			
		                        			Objective To compare the outcomes of transvaginal natural orifice transluminal endoscopic surgery(vNOTES)and laparoendoscopic single-site surgery(LESS)for total uterine excision in obese patients with benign uterine lesions,and to investigate the utility of vNOTES in this patient population.Methods A total of 100 obese patients(BMI>28.0 kg/m2)diagnosed with benign uterine lesions requiring total uterine and bilateral salpingectomy between January 2022 and January 2023 were included in this study.They were randomly assigned to two groups:the LESS group(n=51)and the vNOTES group(n=49).Patient demographics,surgical duration,intraoperative blood loss,changes in hemoglobin levels,pain scores,time to first flatus postoperatively,length of hospital stay,pelvic floor function,sexual quality of life,and postoperative complications were compared between the two groups.Results The two groups did not show any statistically significant differences in terms of blood loss,pre-and postoperative hemoglobin changes,pelvic floor function,sexual quality of life,or postoperative complications(P>0.05).However,the vNOTES group exhibited shorter surgical durations,time to first flatus postoperatively,and length of hospital stay compared to the LESS group(P<0.05).Additionally,the vNOTES group demonstrated lower intraoperative pain scores than the LESS group.(P<0.05).Conclusions In obese patients with benign uterine lesions,vNOTES total uterine excision surgery demonstrated shorter surgical durations and postoperative hospital stays,lower postoperative pain scores,and better adherence to the principles of en-hanced recovery after surgery(ERAS),indicating its potential for broader application.
		                        		
		                        		
		                        		
		                        	
5.Analysis of risk factors for the failure of endoscopic endonasal skull base reconstruction
Xudong YAN ; Lin WANG ; Ruifeng TAN ; Longgang YU ; Jisheng ZHANG ; Lin HAN ; Shengnan ZHANG ; Yan JIANG
Chinese Journal of Otorhinolaryngology Head and Neck Surgery 2024;59(11):1159-1164
		                        		
		                        			
		                        			Objective:To analyze the influencing factors of skull base reconstruction failure after endoscopic endonasal skull base surgery (EESBS).Methods:A retrospective analysis was performed on 228 EESBS cases at the Affiliated Hospital of Qingdao University from 2018 to 2023. The clinical features associated with skull base reconstruction and postoperative cerebrospinal fluid leakage were collected and analyzed. Lasso regression was initially used for exploratory analysis, and risk factors for reconstruction failure were subsequently evaluated using multifactorial logistic regression.Results:A total of 157 cases of EESBS were included, with an overall reconstruction failure rate of 11.5% (18/157). No patients who underwent second-stage reconstruction with a tipped mucosal flap or multilayered free mucosal and fascial repair experienced further postoperative cerebrospinal fluid leakage. Variables identified through Lasso regression included history of surgery, history of radiotherapy, and site of leakage. Multifactorial logistic analysis showed that history of radiotherapy ( OR=5.96, P=0.021) and site of leakage in the posterior skull base ( OR=8.70, P=0.003) were significant risk factors for failure of skull base reconstruction. Conclusion:In cases with a history of radiotherapy and/or posterior skull base lesions in the operative area, reconstruction strategies should be strengthened to improve the success rate of one-stage repair, in particular, when intraoperative cerebrospinal fluid leakage occurs.
		                        		
		                        		
		                        		
		                        	
6.Detection of avian influenza virus-H5N1 by multiplex reverse transcription and multiple cross displacement amplification combined with lateral flow biosensor technology
Pengfei WANG ; Fan ZHAO ; Linlin YAN ; Jing WANG ; Ruifeng YANG ; Shoukui HU
Chinese Journal of Laboratory Medicine 2024;47(11):1326-1331
		                        		
		                        			
		                        			Objective:To establish of a newmethod:for the rapid detection of H5N1-Avian Influenza virus by combining reverse transcription (RT), multiple cross displacement amplification (MCDA) and nanoparticle-based lateral flow biosensor (LFB).Methods:MCDA primers were designed based on gene sequences specific to Hemagglutinin (HA) and Neuraminidase (NA) in H5N1 avian influenza virus. The target genes HA and NA were amplified through reverse transcription and MCDA in one reaction system. Results were displayed by LFB. The assay was named as H5N1-mRT-MCDA-LFB. The reaction conditions of the H5N1-RT-MCDA-LFB method were optimized, and the sensitivity and specificity were also assessed.Results:The H5N1-RT-MCDA-LFB assay could achieve good amplification effect at a constant temperature of 65 ℃ for 40 minutes. The method had a lower limit of detection of 100 fg per reaction with 100-fold higher sensitivity than that of the RT-qPCR (lower limit of detection 10 pg per reaction). The assay was negative in detecting 28 common viruses, mycoplasmas, chlamydias, bacterias and funguses, except for H5N1. In addition, the H5N1-RT-MCDA-LFB method showed better validation in simulated clinical samples with a lower limit of detection at 1×10 2 copies/ml. Conclusion:The H5N1-RT-MCDA-LFB assay is a valuable molecular diagnostic technique for detecting H5N1 avian influenza virus due to its simplicity, rapidity, sensitivity and specificity.
		                        		
		                        		
		                        		
		                        	
7.Comparative study on the theme of traditional Chinese medicine policies among different provinces of China
Shuang YANG ; Ruifeng LI ; Xinying AN ; Zhihong XIAO ; Hongyun WANG ; Yan WANG ; Huan GOU ; Peng GAO ; Youliang HUANG
China Pharmacy 2023;34(6):653-659
		                        		
		                        			
		                        			OBJECTIVE To clarify the core content of traditional Chinese medicine (TCM) policy in the provinces of China, so as to provide reference for optimizing the structure of the policy system of traditional Chinese medicine in China and assisting the inheritance and innovation of TCM industry in various regions. METHODS The websites of directly affiliated organs in 31 provinces, excluding Hong Kong, Macao and Taiwan, were retrieved to collect the TCM policies released from 2000 to 2021. The importance of keywords in the TCM policies of each province was measured based on term frequency-inverse documentation frequency (TF-IDF) keyword extraction method, and the similarities and differences were analyzed among TCM policies. RESULTS & CONCLUSIONS A total of 99 documents related to TCM policies of various provinces were obtained in this study, most of which were released after 2016. The theme of national TCM policy covered four aspects: building TCM talent team, perfecting TCM service system, strengthening TCM resource management and promoting TCM industry innovation. The TF-IDF values of “medical institutions”“traditional Chinese medicine”“medical treatment” were higher than other keywords in each province, indicating that the provinces paid more attention to the construction of TCM service system and the management of TCM resources than other aspects. Anhui and Jiangsu, Beijing and Henan, Hubei and Jilin, Hubei and Tianjin, and Hubei and Yunnan had the more degree of similarity in TCM policies, which all contained 16 of the same keywords. Therefore, the above regions should be encouraged to strengthen exchanges and cooperation and realize mutual promotion and joint development. Among all the keywords whose importance ratio was greater than 0.2,“ Tibetan medicine” was unique to Qinghai and Tibet,“ disease type” was unique to Guangdong, and the TF-IDF value of “supervision and management” in Beijing was higher, indicating that the emphasis of TCM policy formulation in different provinces was various. Meanwhile, the top 10 keywords of TF- IDF value in all provinces did not have words related to financial input, and the TF-IDF values of “informatization” in most provinces did not rank at the top. It is suggested to increase financial input or encourage social financing, and add “Internet+new business” in the field of TCM.
		                        		
		                        		
		                        		
		                        	
8.Clinical features and genetic analysis of a child with acute form of Tyrosinemia type I due to a novel variant of FAH gene.
Qinghua ZHANG ; Chuan ZHANG ; Yupei WANG ; Weikai WANG ; Ruifeng XU ; Ling HUI ; Xuan FENG ; Xing WANG ; Lei ZHENG ; Binbo ZHOU ; Yan JIANG ; Shengju HAO
Chinese Journal of Medical Genetics 2023;40(2):171-176
		                        		
		                        			OBJECTIVE:
		                        			To analyze the clinical phenotype and genetic basis for a child with acute form of tyrosinemia type I (TYRSN1).
		                        		
		                        			METHODS:
		                        			A child with TYRSN1 who presented at the Gansu Provincial Maternal and Child Health Care Hospital in October 2020 was selected as the subject. The child was subjected to tandem mass spectrometry (MS-MS) and urine gas chromatography-mass spectrometry (GC-MS) for the detection of inherited metabolic disorders, in addition with whole exome sequencing (WES). Candidate variants were validated by Sanger sequencing.
		                        		
		                        			RESULTS:
		                        			The child's clinical features included abdominal distension, hepatomegaly, anemia and tendency of bleeding. By mass spectrometry analysis, her serum and urine tyrosine and succinylacetone levels have both exceeded the normal ranges. WES and Sanger sequencing revealed that she has harbored c.1062+5G>A and c.943T>C (p.Cys315Arg) compound heterozygous variants of the FAH gene, which were inherited from her father and mother, respectively. Among these, the c.943T>C was unreported previously.
		                        		
		                        			CONCLUSION
		                        			Considering her clinical phenotype and result of genetic testing, the child was diagnosed with TYRSN1 (acute type). The compound heterozygous variants of the FAH gene probably underlay the disease in this child. Above finding has further expanded the spectrum of FAH gene variants, and provided a basis for accurate treatment, genetic counseling and prenatal diagnosis for her family.
		                        		
		                        		
		                        		
		                        			Female
		                        			;
		                        		
		                        			Humans
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		                        			Gas Chromatography-Mass Spectrometry
		                        			;
		                        		
		                        			Genetic Testing
		                        			;
		                        		
		                        			Mutation
		                        			;
		                        		
		                        			Phenotype
		                        			;
		                        		
		                        			Prenatal Diagnosis
		                        			;
		                        		
		                        			Tyrosinemias/genetics*
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		                        			Child
		                        			
		                        		
		                        	
9.Expert consensus on clinical practice in perioperative nursing for elderly patients with hip fracture (version 2023)
Mi SONG ; Dan KONG ; Yuan GAO ; Yaping CHEN ; Xiaohua CHEN ; Yi CUI ; Junqin DING ; Leling FENG ; Lili FENG ; Jinli GUO ; Yun HAN ; Jing HU ; Sanlian HU ; Tianwen HUANG ; Yu JIA ; Yan JIN ; Xiangyan KONG ; Haiyan LI ; Hui LI ; Lunlan LI ; Shuixia LI ; Hua LIN ; Juan LIU ; Xuemei LU ; Ning NING ; Lingli PENG ; Lingyun SHI ; Changli WAN ; Jie WANG ; Qi WANG ; Yi WANG ; Ruifeng XU ; Ying YING ; Ping ZHANG ; Shijun ZHANG ; Wenjuan ZHOU
Chinese Journal of Trauma 2023;39(3):214-222
		                        		
		                        			
		                        			Hip fracture is considered as the most severe osteoporotic fracture characterized by high disability and mortality in the elderly. Improved surgical techniques and multidisciplinary team play an active role in alleviating prognosis, which places higher demands on perioperative nursing. Dysfunction, complications, and secondary impact of anaesthesia and surgery add more difficulties to clinical nursing. Besides, there still lack clinical practices in perioperative nursing for elderly patients with hip fracture in China. In this context, led by the Orthopedic Nursing Committee of Chinese Nursing Association, the Expert consensus on clinical practice in perioperative nursing for elderly patients with hip fracture ( version 2023) is developed based on the evidence-based medicine. This consensus provides 11 recommendations on elderly patients with hip fracture from aspects of perioperative health education, condition monitoring and inspection, complication risk assessment and prevention, and rehabilitation, in order to provide guiding advices for clinical practice, improve the quality of nursing and ameliorate the prognosis of elderly patients with hip fracture.
		                        		
		                        		
		                        		
		                        	
10.A multi-center performance evaluation of different hepatitis C virus core antigen assays for clinical infection screening
Ruifeng YANG ; Ning LIU ; Chengrong BIAN ; Juan LIU ; Yan LIU ; Shuping WU ; Bo FENG ; Huiying RAO ; Yanjiao LI ; Bo′an LI ; Jinli LOU ; Hongsong CHEN
Chinese Journal of Laboratory Medicine 2023;46(12):1305-1312
		                        		
		                        			
		                        			Objective:We conducted a real-world multi-center clinical study with a large sample size to comprehensively evaluate the performance of three commercial hepatitis C virus (HCV) core antigen assays. The study aimed to evaluate the performance for their use in HCV infection screening, and to provide clues for further improving the sensitivity and specificity of the assays.Methods:Key performance indicators including the lower limit of detection (LOD), diagnostic sensitivity, and specificity of three HCV antigen assays (the Architect, Laibo, and ChemClin HCV core antigen assays) were evaluated using commercial seroconversion panels reflecting early HCV infection and clinical routine serum samples of outpatients and inpatients from 3 tertiary hospitals from January 2018 to April 2022. Factors that affect the performance indicators were further investigated.Results:The window period for detecting HCV infection with the three antigen assays was equal to or slightly longer than that of the RNA assay, but all are shorter than that of the anti-HCV assay. There was a good linear positive correlation between HCV core antigen and HCV RNA levels in treatment naive patients with hepatitis C ( r=0.90, P<0.01). For the most common genotype 1b strain in China, the LOD of the three HCV assays were equivalent to 531 IU/ml (Architect), 3,698 IU/mL (Laibo), and 4,624 IU/mL (ChemClin) HCV RNA, respectively. Due to the skewed distribution of HCV RNA levels in treatment-naive hepatitis C patients, more than 95% of the patients had viral loads higher than 6 166 IU/ml. Therefore, the three HCV antigens assays still maintained a satisfactory diagnostic sensitivity (94.33%-99.40%). Among 54 immunodeficient patients (leukemia patients) with HCV infection, 9% (5/54) had negative anti-HCV results, while the HCV antigen assays found all these infectors. Through further experiments, we revealed the amino acid polymorphism in the core region of genotype 3 strain impaired the sensitivity of all three HCV antigen assays. In addition, the sensitivity of the two domestic assays was impaired by anti-HCV antibodies in the serum. The specificity of HCV antigen assays for diagnosing hepatitis C is 99.94% to 99.98%. The rheumatoid factors, autoantibodies, and other unknown interference substances can lead to a small number of low level, "false positive" antigen results. Conclusions:HCV core antigen assay may be used as a satisfactory approach of infection screening, especially for the immunodeficient patents. However, the sensitivity and specificity of the assays are influenced by multiple factors, which should be further improved.
		                        		
		                        		
		                        		
		                        	
            
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