Insights into the Volatile Flavor Profiles of Two Types of Beef Tallow via Electronic Nose and Gas Chromatography-Ion Mobility Spectrometry Analysis.

In the current study, an electronic nose (E-nose) and gas chromatography-ion mobility spectrometry (GC-IMS) were employed to investigate the volatile flavor compounds (VFCs) of intense flavor beef tallow (L) and ordinary beef tallow (P). The study results indicate that an E-nose combined with an LDA and GC-IMS combined with an OPLS-DA can effectively distinguish between the two types of beef tallow. Compared with ordinary beef tallow, the E-nose sensors of intense flavor beef tallow have stronger response signals to sulfides, terpenes, and nitrogen oxides. A total of 22 compounds contribute to making the flavor of intense flavor beef tallow more typical and richer; in contrast, ethyl acetate was the main aroma-active compound found in the ordinary beef tallow. Sulfur-containing compounds and terpenoids might be the key substances that cause sensory flavor differences between the two types of beef tallow. In conclusion, the results of this study clarify the characteristics and differences of the two types of beef tallow and provide an enhanced understanding of the differences in the flavors of the two types of beef tallow.

Dynamic Treatment Strategy of Chinese Medicine for Metastatic Colorectal Cancer Based on Machine Learning Algorithm.

OBJECTIVE: To establish the dynamic treatment strategy of Chinese medicine (CM) for metastatic colorectal cancer (mCRC) by machine learning algorithm, in order to provide a reference for the selection of CM treatment strategies for mCRC. METHODS: From the outpatient cases of mCRC in the Department of Oncology at Xiyuan Hospital, China Academy of Chinese Medical Sciences, 197 cases that met the inclusion criteria were screened. According to different CM intervention strategies, the patients were divided into 3 groups: CM treatment alone, equal emphasis on Chinese and Western medicine treatment (CM combined with local treatment of tumors, oral chemotherapy, or targeted drugs), and CM assisted Western medicine treatment (CM combined with intravenous regimen of Western medicine). The survival time of patients undergoing CM intervention was taken as the final evaluation index. Factors affecting the choice of CM intervention scheme were screened as decision variables. The dynamic CM intervention and treatment strategy for mCRC was explored based on the cost-sensitive classification learning algorithm for survival (CSCLSurv). Patients' survival was estimated using the Kaplan-Meier method, and the survival time of patients who received the model-recommended treatment plan were compared with those who received actual treatment plan. RESULTS: Using the survival time of patients undergoing CM intervention as the evaluation index, a dynamic CM intervention therapy strategy for mCRC was established based on CSCLSurv. Different CM intervention strategies for mCRC can be selected according to dynamic decision variables, such as gender, age, Eastern Cooperative Oncology Group score, tumor site, metastatic site, genotyping, and the stage of Western medicine treatment at the patient's first visit. The median survival time of patients who received the model-recommended treatment plan was 35 months, while those who receive the actual treatment plan was 26.0 months (P=0.06). CONCLUSIONS: The dynamic treatment strategy of CM, based on CSCLSurv for mCRC, plays a certain role in providing clinical hints in CM. It can be further improved in future prospective studies with larger sample sizes.

Characteristics of cancer-related fatigue and its correlation with anxiety, depression, and stress-related hormones among Chinese cancer survivors: a cross-sectional study.

Background: Fatigue is a common source of distress for cancer survivors. The severity of cancer-related fatigue varies significantly, which may be due to individual differences in host factors. Aim: This cross-sectional study aims to explore how demographic, oncological, sociological, psychological, and stress-related hormones levels interact to influence the distinct experiences of fatigue (Cancer-related fatigue [CRF] occurrence and fatigue degree). Methods: A cross-sectional study carried out at the oncology outpatient and ward department of Xiyuan Hospital of China Academy of Chinese Medical Sciences recruited 306 cancer patients between January 2021 to December 2021. General information, fatigue, psychological factors was evaluated by general information questionnaire, the Revised Piper's Fatigue Scale-Chinese Version (RPFS-CV), and the self-report Hospital Anxiety and Depression Scale (HADS). Stress-related hormones were measured with chemiluminescent enzyme immunoassay (Zhengzhou Antobio). Results: 306 patients were included, 229 (74.8%) were diagnosed with CRF, including 94 (41.0%) with mild fatigue, 121 (52.8%) with moderate fatigue, and 14 (6.1%) with severe fatigue. Multivariate regression analysis showed that higher depression scores, aldosterone levels may increase the risk of CRF. Patients who are obese (Body mass index ≥ 28 kg/m2) may help to reduce the risk of CRF. Other contributing factors for increased levels of fatigue (p< 0.05) include being female, having anxiety, depression and high aldosterone levels. Conclusion: The research suggested that CRF was a common symptom in cancer survivors and pay attention to these influencing factors may help to better identify patients susceptible to fatigue and provide long-term, targeted interventions.

Effects of Abelmoschus manihot gum content, heating temperature and salt ions on the texture and rheology properties of konjac gum/Abelmoschus manihot gum composite gel.

To improve the gelling property of konjac gum (KGM) and enhance the application value of Abelmoschus manihot (L.) medic gum (AMG), a novel type of gel was prepared using KGM and AMG in this study. The effects of AMG content, heating temperature and salt ions on the characteristics of KGM/AMG composite gels were studied by Fourier transform infrared spectroscopy (FTIR), zeta potential, texture analysis and dynamic rheological behavior analysis. The results indicated that the AMG content, heating temperature and salt ions could affect the gel strength of KGM/AMG composite gels. Hardness, springiness, resilience, G', G* and η* of KGM/AMG composite gels increased when AMG content increased from 0 to 2.0 %, but they decreased when AMG increased from 2.0 % to 3.5 %. High-temperature treatment significantly enhanced the texture and rheological properties of KGM/AMG composite gels. The addition of salt ions reduced the zeta potential absolute value and weakened the texture and rheological properties of KGM/AMG composite gels. Furthermore, the KGM/AMG composite gels could be classified as non-covalent gels. The non-covalent linkages included hydrogen bonding and electrostatic interactions. These findings would help understand the properties and formation mechanism of KGM/AMG composite gels and help improve the application value of KGM and AMG.

Doubly robust estimation of optimal dynamic treatment regimes with multicategory treatments and survival outcomes.

Patients with chronic diseases, such as cancer or epilepsy, are often followed through multiple stages of clinical interventions. Dynamic treatment regimes (DTRs) are sequences of decision rules that assign treatments at each stage based on measured covariates for each patient. A DTR is said to be optimal if the expectation of the desirable clinical benefit reaches a maximum when applied to a population. When there are three or more options for treatments at each decision point and the clinical outcome of interest is a time-to-event variable, estimating an optimal DTR can be complicated. We propose a doubly robust method to estimate optimal DTRs with multicategory treatments and survival outcomes. A novel blip function is defined to measure the difference in expected outcomes among treatments, and a doubly robust weighted least squares algorithm is designed for parameter estimation. Simulations using various weight functions and scenarios support the advantages of the proposed method in estimating optimal DTRs over existing approaches. We further illustrate the practical value of our method by applying it to data from the Standard and New Antiepileptic Drugs study. In this analysis, the proposed method supports the use of the new drug lamotrigine over the standard option carbamazepine. When the actual treatments match the estimated optimal treatments, survival outcomes tend to be better. The newly developed method provides a practical approach for clinicians that is not limited to cases of binary treatment options.

[Analysis of adverse reactions of Xianling Gubao preparation based on real world SRS data].

From January 1, 2004 to July 21, 2016 a total of 2 796 cases of adverse drug reaction/adverse event(ADR/AE) after the use of Xianling Gubao Capsules/Tablets were reported by National Adverse Drug Reaction Monitoring Center. The following results were obtained by analyzing the reports of 2 796 cases of adverse drug reactions/adverse drug events after the use of Xianling Gubao Capsules/Tablets. A total of 75 patients, accounting for 2.68% of the total ADR/AE time, had severe ADR/AE events. Among them, 30 patients were aged 65 and above, accounting for 40.00% of the total number of severe ADR/AE patients. All the patients with ADR/AE were aged 45-64 years, which totaled 1 346 cases and took up 48.14% of the total patients with ADR/AE. All of ADR/AE cases and severe ADR/AE cases were orally given Xianling Gubao Capsules/Tablets. Females accounted for 52.50% and 76.00%, respectively, and the proportion of females was significantly higher than that of males. Among patients with a medical history of ADR/AE, severe ADR/AE was higher than the average, accounting for about 1.33%. The proportion of cases orally given 1-3 tablets of Xianling Gubao Capsules/Tablets in all ADR/AE cases and severe ADR/AE cases was 95.32% and 96.00%, which conformed to the usage in the package insert. All ADR/AE cases and severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets twice daily occupied the highest proportions, or 77.00% and 61.00%, respectively. The proportion of severe ADR/AE cases orally given Xianling Gubao Capsules/Tablets was slightly higher than that of all ADR/AE cases in the medication frequency, which didn't conform to the usage in the package insert. All the symptoms of ADR/AE orally given Xianling Gubao Capsules showed many manifestations, and the top 10 symptoms were nausea, rash, itching, stomach dysfunction, vomiting, abdominal pain, dizziness, diarrhea, anaphylaxis, and reflux heartburn. The symptoms of severe ADR/AE after oral administration of Xianling Gubao Capsules were varied, and the top 10 symptoms were abnormal liver function, rash, suffocation, itching, dizziness, vomiting, anaphylaxis, abdominal pain, weakness, and convulsions. Abnormal liver function accounted for 44.12%. All of ADR/AE cases occurred within 2 days after oral administration of Xianling Gubao Capsules/Tablets, accounting for 54.26%. Severe ADR/AE occurred within 2 days after the use of Xianling Gubao Capsules/Tablets, accounting for 25.34%. The proportion of ADR/AE cases occurring within 15 days after oral administration of Xianling Gubao Capsules/Tablets increased again(57.33%). The overall trend contained two peaks.

Clinical features of Chinese patients in different age groups with spontaneous intracerebral hemorrhage based on multicenter inpatient information.

BACKGROUND: Patients with spontaneous intracerebral hemorrhage (ICH) have poor functional outcomes. This study investigated the status of hospitalized patients with ICH based on multicenter inpatient information. METHODS: We analyzed data from the hospital information systems (HISs) of 14 tertiary hospitals, including 6 Chinese medicine hospitals and 8 western hospitals from 7 provinces and 2 municipalities. The inclusion criteria were age ≥25 years and radiologically confirmed spontaneous ICH within two weeks of symptom onset. Age groups were as follows: 25-44, 45-59, 60-74, 75-89, 90 and over 90 years old. Data are presented as the proportion (%), median (interquartile range) or mean (standard deviation). Descriptive statistical analyses were conducted to analyze demographic features, lengths of hospital stay, hospitalization expenses, hematoma locations, mortality and major comorbid conditions or complications. RESULTS: Patients were recruited from October 2003 to September 2011. A total of 9475 inpatients were recruited from 14 Class III Grade A hospitals. Baseline characteristics included a mean age of 58 (20) years old and 37.2% female (3303). The largest number of ICH patients were in the 44-59-year-old group. The ratio of males to females in the 25-44-year-old age group was 2.36:1, which was the highest of all groups; the lowest male to female ratio was 1.56:1 in the 45-59-year-old age group. The ratios of males to females in the 60-74, 75-89 and ≥90-year-old age groups were 1.60:1, 1.62:1 and 1.64:1, respectively. The proportion of males in all age groups was higher than that of females, significantly greater in the 25-44-year-old age group (P < 0.001). The lengths of hospital stay ranged from 15 to 28 days. The hospitalization expenses of the 25-44-year-old patients were 50,000-100,000 RMB, and the costs of the remaining age groups were 10,000-20,000 RMB. Basal ganglia/thalamic hemorrhage was the most common site of ICH in different age groups. Lobar and multiple locations were higher in those aged >75 years. Hypertension was the primary comorbid condition in all age groups, and it showed a rising trend with increasing age. The second most common comorbidity in the 25-44-year-old age group was vascular abnormality, while in the other age groups, comorbidities included cerebral infarction, dyslipidemia, coronary heart disease, diabetes mellitus and arrhythmia. Mortality increased with age; mortality for those under the age of 74 years fluctuated between 4.09% and 5.93%, whereas in those in the 75-89 and ≥90-year-old age groups, mortality was 13.34% and 34.09%, respectively. CONCLUSIONS: As age increased, the length of hospital stay, financial burden and mortality due to ICH increased. Different age groups had different distributions of neuroimaging features, major comorbid conditions or complications.

An efficacy evaluation method for non-normal outcomes in randomized controlled trials.

Randomized controlled trials (RCT) are widely used in clinical efficacy evaluation studies. Linear regression is a general method to evaluate treatment efficacy considering the existence of confounding variables. However, when residuals are not normally distributed, parameter estimation based on ordinary least squares (OLS) is inefficient. This study introduces an exponential squared loss (ESL) model to evaluate treatment effect. The proposed method provides robust estimation for non-normal data. Simulation results show that it outperforms ordinary least squares regression with contaminated data. In the mild cognitive impairment (MCI) efficacy evaluation study with traditional Chinese medicine, our method is applied to construct a linear efficacy evaluation model for the difference in Alzheimer's disease assessment scale-cognitive (ADAS-cog) scores between the final and baseline records (ADASFA), with the existence of confounding factors and non- normal residuals. The results coincide with existing medical literatures. This proposed method overcomes the limitation of confounding variables and non-normal residuals in RCT efficacy studies. It outperforms OLS on estimation efficiency in situations where the percentage of non-normal contamination reaches 30%. These advantages make it a good method for real-world clinical studies.

Sanjin tablets for acute uncomplicated lower urinary tract infection (syndrome of dampness-heat in the lower jiao): protocol for randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical trial.

BACKGROUND: Acute uncomplicated lower urinary tract infection (UTI) is one of the most common bacterial infections. Patients usually present with dysuria, urinary urgency, urinary frequency, and suprapubic pain or tenderness. Approximately 150 million people are diagnosed with UTI each year worldwide. The high recurrence rate of lower UTI is a common problem of clinical treatment. The misuse of antibiotics has led to the emergence of a number of resistant bacterial strains. Thus, traditional Chinese medicine is considered as an alternative option for treating acute uncomplicated lower UTI. Thus, this study aims to evaluate the efficacy and safety of Sanjin tablets (SJT) for the treatment of acute uncomplicated lower UTI, explore whether SJT can reduce or substitute the use of antibiotics, and reduce the recurrence rate in the treatment of acute uncomplicated lower UTI. METHODS/DESIGN: In this study, a randomized, double-blind, double-dummy, parallel control of positive drug, multicenter clinical study will be established. A total of 252 patients with acute uncomplicated lower UTI (syndrome of dampness-heat in the lower jiao) will be randomly allocated in the ratio of 1:1:1 to three groups: experimental group; control group 1; and control group 2. The experimental group receives Sanjin tablets plus levofloxacin tablets (LT) placebo; the control group 1 receives LT plus SJT placebo; and the control group 2 receives SJT plus LT on the first five days, SJT plus LT placebo on the last two days. Each group will be treated for seven days and followed-up 1-2 times. The primary outcome measures of effective rate and recurrence rate are symptoms. Secondary outcome measures of effective rate and recurrence rate are the urine leukocytes, bacteriology examination, and safety assessment. Outcomes will be assessed at baseline and after treatment. DISCUSSION: This study protocol will provide the research data of efficacy and safety of SJT for the treatment of acute uncomplicated lower UTI. The first aim is to determine whether Sanjin tablets can reduce the use of antibiotics; the second aim is to determine whether Sanjin tablets can substitute the use of antibiotics. The recurrence rate will be assessed after cured to determine whether SJT can reduce the recurrence rate. The results of this study will improve the rational use of drugs, especially the rational application of antibiotics. It will also enable safety evaluation from laboratory indices and adverse events, which will provide reliable evidence for clinical treatment. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03658291 . Registered on 4 September 2018.

[Analysis of Qingkailing Injection in treatment of combined medication features of 2 147 cases of upper respiratory tract infection].

Acute upper respiratory infection is one of the common infectious diseases,especially in the elderly people. Qingkailing Injection has the effect of clearing away heat and detoxifying. It can be used for external wind heat,upper respiratory tract infection,viral cold,etc. Based on 2 147 cases of upper respiratory tract infection patients using Qingkailing Injection in the medical electronic data warehouse of the information system of 16 large class-A hospitals constructed by the Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences,description analysis,Apriori calculation and recurrent network analysis were used to analyze the effect of Qingkailing Injection on upper respiratory tract infection. The clinical characteristics and the law of combined use of drugs can provide reference for the mining of clinical diagnosis and treatment characteristics and the construction of optimal and effective programs and paths. 2 147 patients with upper respiratory tract infection who used Qingkailing Injection were mostly middle-aged and elderly people over 45 years old,often combined with hypertension,ischemic cerebrovascular disease,coronary heart disease,diabetes,etc.; in treatment,it was more common to use Qingkailing Injection in combination with hormones,antipyretics and analgesics,antibiotics,nutritional support agents,antitussive,expectorant and antiasthmatic drugs,as well as traditional Chinese medicine Jiebiao agents and blood management agents. The combination of potassium chloride injection and cephalosporin injection is the most commonly used in combination with two kinds of Western medicine( 33. 2%); the combination of Shuanghuanglian and Ganmao Qingre Granules is the most commonly used in combination with two kinds of traditional Chinese medicine( 9. 13%); through the calculation of complex network group module,it is found that Qingkailing Injection is often associated with antibiotics,antipyretic and analgesic drugs,antitussive,expectorant and antiasthmatic drugs,antiviral drugs and anti infection drugs. Drugs,nutritional support agents,bronchodilators,immunomodulators and other chemical drugs are often used in combination with Chinese medicine,such as Jiebiao agents,expectorants,Qingre agents,resuscitation agents,Qufeng agents,tonics,Liqi agents,which may be related to both the treatment of upper respiratory tract infection and the basic diseases of middle-aged and elderly patients,with the theoretical characteristics of " combination of disease and syndrome,corresponding formula and syndrome". Based on the real world big data complex network group module mining results provide clues for the clinical optimization scheme and path construction,and provide signals and ideas for further causal research.

Cohort Study on Prognosis of Patients with Metastatic Colorectal Cancer Treated with Integrated Chinese and Western Medicine.

OBJECTIVE: To investigate the efficacy of integrated Chinese and Western medicine (IM) in the treatment of metastatic colorectal cancer (mCRC) in a cohort study. METHODS: The survival outcome of patients receiving IM was compared with that of patients receiving Western medicine alone. The study design was adopted with "continuous administration of Chinese medicine for ⩾ 3 months" as the exposure factor. Patients who met this exposure factor were assigned to the IM cohort (Group A, 110 patients). Patients who did not meet this exposure factor were assigned to the Western medicine cohort (Group B, 225 patients). The overall survival (OS), progression-free survival (PFS), and 1st year, 2nd year, and 3rd year survival in the two cohorts were compared. RESULTS: The median OS in Group A and B were 18 months [95% confidence interval (CI) 15-21] and 16 months (95% CI 14-18), respectively, and the median PFS in Group A and B were 6 months (95% CI 4-7) and 5 months (95% CI 4-6), respectively. No statistically significant differences were observed between the groups (P=0.186, P=0.223). Group A demonstrated significantly longer OS and PFS than Group B in the following subgroups: female patients, patients with lesions in the right half of the colon, and those who received first-line treatment (P<0.05). In the subgroup of elderly patients (age>65 years), the OS in Group A was longer than that in Group B (P<0.05). CONCLUSION: IM could prolong the survival of patients with mCRC. (Registry No. ChiCTR-IOR-17010497).

Establishment of Comprehensive Indicators in TCM Pectoral-qi Case Report Based on Experts Diagnosis and Self-test Technology.

RATIONALE: To establish TCM Pectoral-qi comprehensive indicators and highlight the inner structure among different variables in an objective way, the article uses Partial Least Square Second-order Latent Variable Model (PLS-SLVM) and accomplishes 3 different comprehensive indicators based on both experts diagnosis and self-test data. SLVM includes a measurement model that defines the relationship between observed variables and latent variables and a structure model that imputes relationships between latent variables. The article focuses on PLS as the estimation method. Without normal distribution and independence assumptions, PLS uses objective weighting methods based on the data. Bootstrap method (B = 200) is used to calculate the mean value and standard errors of the PLS estimates. The article chooses the percentile interval to obtain the confidence interval of PLS parameters. PATIENT CONCERNS: The patients were diagnosed by the means of experts diagnosis and self-test technology. On the one hand, the patients want to know the effect of self-test by wearing a kind of instrument. On the other hand, we want to establish TCM Pectoral-qi comprehensive indicators and highlight the inner structure among different variables in an objective way. DIAGNOSES: The group of 59 subjects are the same no matter whether they were diagnosed through TCM Pectoral-qi Assessment Questionnaire of self-test technology. INTERVENTIONS: The same group of 59 subjects keep wearing the instrument for hours and get the self-test data consequently. OUTCOMES: As one of comprehensive indicator establishing methods, PLS-SLVM highlights the structure state among variables and improves the evaluation efficiency. Furthermore, it provides a new tool and method in TCM diseases prevention and health security. LESSONS: As expected, PLS-SLVM is a useful tool due to its nonassumption of normal distribution and independence with consideration of correlation among different variables. Thus PLS-SLVM can be applied in ordinal data from assessment questionnaire and continuous data about physicochemical indexes for the same group of people. It displays that PLS-SLVM builds a connection between TCM experts diagnosis and the self-testing technology.

Efficacy and Safety of Quxie Capsule () in Metastatic Colorectal Cancer: A Double-Blind Randomized Placebo Controlled Trial.

OBJECTIVE: To verify the efficacy and safety of Quxie Capsule () in patients with metastatic colorectal cancer (mCRC). METHODS: The present study was a randomized, double-blind, placebo-controlled trial. Sixty patients with mCRC were randomized into two groups at a 1:1 ratio by sealed envelope. The treatment group received conventional therapy combined with Quxie Capsule for 3 months. The control group was treated with conventional therapy combined with placebo for 3 months. Main outcome measures were overall survival (OS) and progression-free survival (PFS). Subgroup analysis was performed according to age, right or left-sided disease, and second-line therapy to determine the differences in PFS and OS between the two groups. Patients were followed up every 3 months until Dec 31st 2016. RESULTS: The median OS was 23 months in the treatment group [95% confidence interval (CI): 15-not calculated] vs. 14 months in the control group (95% CI: 11-22, P=0.060). The OS of the treatment group tended to be longer than that of the control group (P>0.05). In the subgroups of patients <65 years old, left-sided colon, and 2nd-line therapy, the treatment group showed a significant survival benefit compared with the control group (P=0.006, 0.038, 0.013, respectively). There were no significant differences between the two groups in PFS (P>0.05). Safety analysis showed no severe hematological toxicity or liver and renal function injury in the treatment group. CONCLUSIONS: Quxie Capsule showed good safety and efficacy, and could prolong the OS of patients with mCRC. (Registration No. ChiCTR-IOR-16009733).

[Post-marketing safety surveillance of Diemailing Kudiezi injection: real world study in 30 233 cases].

This study was aimed to obtain the incidence of adverse drug reaction (ADR) of Diemailing Kudiezi injection, explore its characteristics, related risk factors and application in real world. A prospective single cohort study was conducted from 25 hospitals (including Chinese medicine hospitals and Western medicine hospitals) for 4 years. 30 233 consecutive inpatients using Diemailing Kudiezi injection were observed. Their general information was analyzed by using statistic frequency description. Association rules were used to analyze the correlation between comorbidities or drug combinations; the influential factors for ADRs were initially screened by using cross contingency method and Chi-square test, and then Group LASSAO method was used for further analysis. 54 patients with adverse drug events and 30 patients with ADRs were reported among 30 233 patients, with a total ADR incidence of 0.099%[95%CI (0.06%, 0.13%)]. There were 27 patients identified as the "general" ADR, one patients with "severe" ADR (anaphylactic shock) and two patients with new ADRs. ADR occurred most in 30 min after using Diemailing Kudiezi injection, in a total of 16 patients. The most ADRs were palpitation, vomiting, chills, pruritus and rash, 6 times for each symptom. Diemailing Kudiezi injection was well tolerated in the general population. The overall incidence of adverse reactions was rare, with high safety. However, the real incidence of ADRs may be underestimated in this study, and the blood samples were not obtained for the patients, so further mechanism studies shall be conducted.

[Intensive hospital monitoring of Shuxuening injection in 30 209 cases].

In order to obtain the characteristics and incidence of adverse reactions of Shuxuening injection (Xingxue), the design method of a multi-center, large sample intensive monitoring in the hospitals was adopted. The hospitalized patients with use of Shuxuening injection from 27 medical institutions were enrolled as the research subjects to monitor their entire process of treatment cycle. The main content of monitoring included the patients' general information, diagnostic information, medication information, and adverse event information. A total of 30 209 patients with Shuxuening injection were enrolled; adverse reactions occurred in 34 cases, with an incidence of 0.113%, which belonged to the rare adverse reactions. Adverse reactions were characterized by headache, dizziness, pruritus, palpitations, nausea, et al. All the above results showed that Xingxue Shuxuening injection had high safety in clinical application.

Differences exist across insurance schemes in China post-consolidation.

BACKGROUND: In China, the basic insurance system consists of three schemes: the UEBMI (Urban Employee Basic Medical Insurance), URBMI (Urban Resident Basic Medical Insurance), and NCMS (New Cooperative Medical Scheme), across which significant differences have been observed. Since 2009, the central government has been experimenting with consolidating these schemes in selected areas. This study examines whether differences still exist across schemes after the consolidation. METHODS: A survey was conducted in the city of Suzhou, collecting data on subjects 45 years old and above with at least one inpatient or outpatient treatment during a period of twelve months. Analysis on 583 subjects was performed comparing subjects' characteristics across insurance schemes. A resampling-based method was applied to compute the predicted gross medical cost, OOP (out-of-pocket) cost, and insurance reimbursement rate. RESULTS: Subjects under different insurance schemes differ in multiple aspects. For inpatient treatments, subjects under the URBMI have the highest observed and predicted gross and OOP costs, while those under the UEBMI have the lowest. For outpatient treatments, subjects under the UEBMI and URBMI have comparable costs, while those under the NCMS have much lower costs. Subjects under the NCMS also have a much lower reimbursement rate. CONCLUSIONS: Differences still exist across schemes in medical costs and insurance reimbursement rate post-consolidation. Further investigations are needed to identify the causes, and interventions are needed to eliminate such differences.

[Correlation Study on Risk Factors and CM Symptoms in Postmenopausal Osteoporosis].

Objective To observe the correlation between risk factors and symptoms of Chinese medicine (CM) in postmenopausal osteoporosis (OP) of females aged between 40 and 65. Methods Registry method was used in this study. Risk factors and information on symptoms of CM collected from 1 823 OP high risk females (40 -65 years old) in Dongcheng District of Beijing and Xuhui District of Shanghai (collected in our previous research). Meanwhile, Cox proportional hazard model was also a- dopted to conduct single-factor and multiple-factor analyses. Risk factors and symptoms of CM were screened and analyzed. Results A total of 1 498 subjects attended follow-up surveys, with the response rate of 82.17%. Of them, 52 had brittle fracture. In Cox single-factor analysis, when taking the time for occurrence of postmenopausal OP as the outcome variable, average age (RR = 1. 083, P = 0. 003 ) , whether menopause (RR = 5. 462, P = 0. 004), average menopausal year (RR = 1. 060, P = 0. 010) , menopausal year ≤10 years (RR =4. 890,P =0. 008), menopausal year >10 year (RR =7. 720,P = 0. 001) , delivery times ≤3 times (RR =5. 870, P =0. 003), dizziness (RR =3. 037, P =0. 001) , spasm of lower limbs (RR =2. 315, P =0. 003) , reduced bone mass in bone mass density (BMD) diagnosis (RR = 2. 376, P =0. 008) , ß >0 and RR >1 in BMD diagnosis (RR =2. 801 ,P =0. 013) indicated they were risk factors for postmenopausal OP fracture. When taking BMD diagnosis, age, menopausal year, delivery times, dizziness, and spasm of lower limbs in multiple-factor analysis, menopausal year <10 years (RR =3. 257,P =0. 032) and dizziness (RR =2. 655,P =0. 005) were associated variables. Conclusion Dizziness and menopausal years were most important factors of OP fracture, and dizziness could be taken as symptoms of CM in early predicting occurrence of OP fracture.

[32 546 intensive hospital monitoring cases of Shuxuetong injection].

This study adopted multi-center and large sample design to understand the incidence, characteristics and other information about adverse reaction of Shuxuetong injection. In 54 medical institutions, use of Shuxuetong injection of entire treatment period was monitored, including patients' general information, diagnostic information, medication, adverse reaction/event information, etc. Sixty four cases of adverse reactions in 32 546 patients was monitored, adverse rate was 0.197%, mainly characterized by skin itching, rash, flu-like, dyspnea, palpitations, headache, chest tightness and other allergic reactions. Adverse reaction occurred mainly in elderly patients and medication was consistent with the instruction. Based on these results, safety of Shuxuetong injection in clinical application is excellent.

[Clinical analysis of Cervus and Cucumis Polypeptide injection based on real world hospital information system].

To analyze the clinical application of Cervus and Cucumis Polypeptide injection in the real world, in order to define the characteristics of clinical drug use and correlation, and provide reference for risk management and further study for Cervus and Cucumis Polypeptide injection. Descriptive analysis and association rules analysis were performed on 37 721 cases using Cervus and Cucumis Polypeptide injection in 26 hospitals nationwide. Cervus and Cucumis Polypeptide injection were mostly adopted by patients aged between 45 and 64(39.84%); mainly used to treat fracture patients in clinic(17 362 cases, 33.97%); 12 mL(41.81%) was the commonest dosage. And the course of treatment mainly lasted for 1-3 days(28 467 cases, 76.26%), which was basically consistent with the description of package insert. In clinic, traditional Chinese medicines, such as blood activating and stasis removing agents and Bushen Zhuanggu agents, were frequently combined with it(rule support degree of 19.38%). Such western medicine as antibiotics and nutritional drugs were frequently combined with it(rule support 39.9%). The main single combined medicine were vitamin C(13 202 cases, 35%), and Jintiange capsule(7 285 cases, 19.31%). The commonly used combined drug pairs were Hulisan capsule and Jintiange capsule (rule support 4.458%), phenobarbital and ceftazidime azole oxazoline(rule support degree of 10.62%). Cervus and Cucumis Polypeptide injection is mainly adopted by elderly patients in clinic, used to treat fracture patients, and often combined with blood activating and stasis removing agents, Bushen Zhuanggu agents, antibiotics, and nutritional medicine to enhance fracture healing. In clinical application, attention shall be paid to drug safety of elderly patients and types of combined medicines and their interaction, so as to prevent adverse reactions.

[Analysis of Diemailing Kudiezi injection use in real world in 7 189 patients with cerebral infarction].

This is a study based on hospital intensive monitoring to explore medication use of Diemailing Kudiezi injection(one Chinese herbal medicine injection) in real word in the patients with cerebral infarction. The active monitoring model was adopted and hospital intensive monitoring on safety of 7 189 cases of patients with cerebral infarction was conducted to obtain the drug use information of Diemailing injection. The results were analyzed by using statistical description and association rule method. The statistical description and association rule analysis were conducted based on patients' basic demographic characteristics, use of Diemailing injection and combined use of drugs. Sixty-two percent(4 437/7 189) of the patients were from traditional Chinese medicine hospitals as compared with 39%(2 752/7 189) from western medicine hospitals; 84%(6 003/7 189) of the patients were from tertiary hospitals as compared with 16%(1 186/7 189) from second-class hospitals. The hospitals were mostly located in north China. Drug related indicators such as a single dripping speed, stash time after allocating transfusion, duration of injection, and injecting room temperature were not noted in instruction manual. It was also found that there were off label use in the practice, for instance, non-intravenous infusion, >14 d treatment course, use of non-designated solvent, and a single dose>40 mL or<10 mL. Analysis of association rules showed that only Edaravone among the most frequent combined drugs was listed in the current guideline in China, and the other three most frequent combined drugs deproteinized calf blood extractive injection, Cinepazide Maleate injection and Alprostadil injection were used with little evidence. Diemailing＋Aspirin＋Alprostadil was the most common combined use in our study, but the recommended clopidogrel＋Aspirin was not found in this study. The drug use situation of Diemailing injection in the real world was obtained by data analysis on large size samples, providing basic reference information for clinicians and researchers. However, efficacy was not concerned in this study, so efficacy-related information could not be explained.