[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.

[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.

[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.

[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.

[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.

[Practical Diagnostic Criterion of Blood Stasis Syndrome: Introduction, Reliability, and Validity].

OBJECTIVE: To introduce practical diagnostic criterion of blood stasis syndrome (BSS), and to evaluate its reliability and validity. METHODS: By referring to three diagnostic criteria of BSS [practical diagnostic criterion of BSS (criterion A), diagnostic criterion of BSS in 1986 (criterion B), Consensus of Integrative Medicine on BSS Diagnosis in 2011 (criterion C)], 712 patients from different departments of Xiyuan Hospital were recruited. The reliability of criterion A and its consistency with the other two criteria were assessed using Kappa coefficient. A Bayesian approach was also employed to assess the sensitivity and specificity of criterion A. RESULTS: According to the consistency check, criterion A presented good consistency when used by different researchers (the diagnostic accordance rate was 91. 96%, Kappa =0. 82, P <0.001). Meanwhile, there was an acceptable diagnostic consistency among the three diagnostic criteria. Bayesian estimation suggested that criterion A had higher sensitivity but similar specificity, as compared with criterion B or criterion C. Compared with criterion B [the median of sensitivity and specificity were 0. 762 (95% Cl: 0. 731 -0. 790) and 0. 902 (95% Cl: 0. 858 -0. 936) respectively, the median of sensitivity and specificity of criterion A were 0. 911 (95% CI: 0. 888 - 0. 930) and 0. 875 (95% CI: 0. 826 - 0. 915) respectively. Estimating the difference between criterion A and B, the median of sensitivity and specificity were 0. 149 (95% CI: 0. 112 -0.184) and -0. 026 (95% CI:-0. 085 -0. 033) respectively. Compared with criterion C [the median of sensitivity and specificity were 0. 831 (95% Cl: 0. 804 -0. 857) and 0. 892 (95% CI: 0. 848 - 0. 926) respectively], the median of sensitivity and specificity of criterion A were 0. 912 (95% CI: 0. 889 -0. 932) and 0. 880 (95%CI: 0. 833 - 0.919) respectively. Estimating the difference between criterion A and C, the median of sensitivity and specificity were 0. 081 (95% CI: 0.047 - 0.114) and -0.011 (95%CI: -0.070 -0.046) respectively. CONCLUSION: Compared with criterion B and C, criterion A not only had better reliability, but also could significantly improve the sensitivity without obviously lowering the specificity.

[Effect of Naoshuantong capsule on change of SSQOL index in patients with ischemic stroke in six mouths follow-up].

To evaluate the effect of Naoshuantong capsule on the life quality of patients with ischemic stroke in six months of follow-up studies, and observe the adverse events. The results would provide reference for the secondary prevention on the recovery stage of ischemic stroke. 696 patients from 12 Class III Grade I hospitals nationwide were divided into 2 groups by central randomization system. The study group, 344 cases, were treated with Naoshuantong capsule plus Aspirin, and the control group, 352 cases, were treated with Aspirin. The patients were treated for 6 months. At the end of treatment, SS-QOL used for evaluating the quality of life was observed. The safety index was defined by adverse observation event. The incidence of adverse events and laboratory tests results were observed before and after treatment at the same time. The results indicated that compared to the control group, the treatment group had significant statistical difference in the impact of effort, self-care ability and the the work or labor ability of patients (P < 0.05). No serious adverse events were observed. Naoshuantong capsule showed some superiority to Asprin on improving the quality of life on patients with ischemic stroke, and it could be used in secondary prevention on the recovery stage of ischemic stroke. Naoshuantong capsule is safe and effective in the treatment of convalescence ischemic stroke.

[Clinical and medicine characteristics of patients with Parkinson's syndrome].

This study analyze the characteristics and clinical medicine in 17 hospitals all over China, based on hospital information system diagnostic information database, including 4 497 cases of hospitalized patients with Parkinson's syndrome. Results indicate, the most common comorbidities are infarction, hypertension, coronary heart disease, diabetes and lung infections, including cerebral infarction, the combined incidence of hypertension in men reached 33.46% and 30.05%, respectively, it is slightly lower in the females. Men with coronary heart disease are more than women, women with diabetes and bone disease are more than men. Combined incidence of the disease increases with age, vascular factors occupy an important position. The most common combined diseases in patients with 90 years of age or older are coronary heart disease, lung infection, and often accompanied by metabolic disorders and nutritional emergency, critical care. Constipation, depression, anxiety, sleep disorders, cognitive impairment are common non-motor symptoms. The drug categories associated with Parkinson's core symptoms treatment are about 20% to 30% of clinical medicine, the others are associated with the treatment of combined disease, clinical medicine and disease spectrum consistent. Blood circulation topped Chinese agents applied frequency, reaching 44.52%; laxative drugs accounted for 11.66%; detoxification agent representing 9.46%. The first twenty Chinese medicine of the applying frequency reached 56.07% of the total utilization, including 12 kinds of traditional Chinese medicine injections, accounting for 60%. Therefore, in the diagnosis and treatment of Parkinsons syndrome, the treatment of comorbidities is very important, more attentions should be paid to vascular factors of the disease, Chinese medicine should be more concerned to improve the non-motor symptoms, give full play to the pharmaceutical multi-target, the overall regulation of advantages, integrative medicine, and improve the quality of life of patients.

[Analysis of characteristics of using traditional Chinese and western medicine on type 1 diabetes adult patients based on electronic medical records].

To understand the kinds and the characteristics of combination of traditional Chinese medicines and western medicines using on adults with type 1 diabetes in general hospitals,This research brings into 4 602 hospitalized adult patients with type 1 diabetes from hospital information system (HIS) of 13 third class A hospitals. These research objects were hospitalized in December 2003-July 2011. The research analyzes the operating frequency and associated usage of western medicines and traditional Chinese medicines by the method of frequency statistics and association rules. Through the analysis, the research says that in the clinical treatment of adult patients with type 1 diabetes, the western medicine used most frequently is insulin, a total of 1 539 cases, accounted for 8.47%; the traditional Chinese medicine used most frequently is oral agents of pseudo-ginseng, a total of 183 cases, accounting for 6.25%; the combinations of Chinese and western medicines commonly used include Huoxue Huayu Tongmai Shuluo decoction + vasodilator, support degree is 45.93%, followed by Huoxue Huayu Tongmai Shuluo decoction + vasodilator + hypoglycemic drugs, support degree is 45.50%; Huoxue Huayu Tongmai Shuluo decoction + vasodilator + nutritional agent, support degree is 36.29%.

[Analysis of characteristics of traditional Chinese medicine and western medicine clinical use in patients with viral hepatitis based on real world hospital information system data].

Viral hepatitis is clinical multiple strong infectious disease, to know characteristics of traditional Chinese medicine and western medicine clinical use in patients with viral hepatitis, the research object of this study is 41 180 cases of hospitalized patients with viral hepatitis in hospital information system from 17 grade A hospitals, using frequency statistics and association rules method to analyze the traditional Chinese medicine and western medicine clinical use information, the drug kinds analysis results: western medicine of reduced glutathione tablets use frequency is highest, 14 079 cases (34.61%), traditional Chinese medicine of diammonium glycyrrhizinateuse frequency is highest, 14 058 cases (34.56%); traditional Chinese medicine and western medicine drug combination in diammonium glycyrrhizinate combined with reduced glutathione tabletsuse frequency is highest, 8 607 cases (25.09%). The mechanism of drug classification results :both traditional Chinese medicine and western medicine are the sort of educed enzyme medicine that has the highest percentage of drug use, traditional Chinese medicine 10 983 cases (27.01%), western medicine, 9 595 cases (23.59%); traditional Chinese medicine and western medicine combination in a kind of medicine to clear heat and promote diuresis combined with educed enzyme drug use frequency is highest, 5 621 cases (13.82%). Through the analysis above, combine traditional Chinese and western medicine therapy for the treatment of viral hepatitis should be given priority. Traditional Chinese medicine to clear heat and promote diuresis combined with western medicine of educed enzyme drug is the most commonly appear in clinical two drug combination scheme, traditional Chinese medicine to clear heat and promote diuresis combined with western medicine of educed enzyme drug and nucleustide analogsis the most commonly appear in clinical three drug combination scheme.

[Study of clinical character and medicinal therapy of viral hepatitis in hospital based on real world].

Viral hepatitis was the most common infectious disease in china. But the diagnosis and treatment were varied because the viral hepatitis patients were hospitalized in different kinds of hospital such as infectious disease hospital, general hospital and Chinese medical hospital. It was necessary to know clinical characters and information of viral hepatitis patients in different hospitals. The general information, subtype distribution, prognosis, complication, medication and relations of onset with solar term from 41 180 viral hepatitis patients based on HIS data were analyzed. It was found that the age of patients between 18 to 59 years old was most; most patients were males. The national basic medical insurance was the most type of payment. The outcome of viral hepatitis in the youth and female were better than that in the old and male. Acute hepatitis was easer to restore than chronic hepatitis. Liver cirrhosis and hepatocellular carcinoma were the two most complications. The peak of onset was during summer solstice, slight heat and great heat. The most common Chinese medicine was Diammonium glycyrrhizinate and the most common western medicine was reduced glutathione. The combination of D. glycyrrhizinate with reduced glutathione, polyene phosphatidylcholine and thymosin was the main pattern. But It was not knew if the combination of western and Chinese medicine was the most effective therapy to protect liver function. It was necessary to take deeply research of the relationship between the combination therapy and their effectiveness.

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.

[Impact analysis of shuxuetong injection on abnormal changes of ALT based on generalized boosted models propensity score weighting].

OBJECTIVE: To estimate treatment effects of Shuxuetong injection on abnormal changes on ALT index, that is, to explore whether the Shuxuetong injection harms liver function in clinical settings and to provide clinical guidance for its safe application. METHOD: Clinical information of traditional Chinese medicine (TCM) injections is gathered from hospital information system (HIS) of eighteen general hospitals. This is a retrospective cohort study, using abnormal changes in ALT index as an outcome. A large number of confounding biases are taken into account through the generalized boosted models (GBM) and multiple logistic regression model (MLRM) to estimate the treatment effects of Shuxuetong injections on abnormal changes in ALT index and to explore possible influencing factors. RESULT: The advantages and process of application of GBM has been demonstrated with examples which eliminate the biases from most confounding variables between groups. This serves to modify the estimation of treatment effects of Shuxuetong injection on ALT index making the results more reliable. CONCLUSION: Based on large scale clinical observational data from HIS database, significant effects of Shuxuetong injection on abnormal changes in ALT have not been found.

Diagnosis Analysis of 4 TCM Patterns in Suboptimal Health Status: A Structural Equation Modelling Approach.

Background. We illustrated an example of structure equation modelling (SEM) in the research on SHS to explore the diagnosis of the Sub optimal health status (SHS) and provide evidence for the standardization of traditional Chinese medicine (TCM) patterns in SHS. And the diagnosis of 4 TCM patterns in SHS was evaluated in this analysis. Methods. This study assessed data on 2807 adults (aged 18 to 49) with SHS from 6 clinical centres. SEM was used to analyze the patterns of SHS in TCM. Parameters in the introduced model were estimated by the maximum likelihood method. Results. The discussed model fits the SHS data well with CFI = 0.851 and RMSEA = 0.075. The direct effect of Qi deficiency pattern on dampness pattern had the highest magnitude (value of estimate is 0.822). With regard to the construct of "Qi deficiency pattern", "fire pattern", "stagnation pattern" and "dampness pattern", the indicators with the highest load were myasthenia of limbs, vexation, deprementia, and dizziness, respectively. It had been shown that estimate factor should indicate the important degree of different symptoms in pattern. Conclusions. The weights of symptoms in the respective pattern can be statistical significant and theoretical meaningful for the 4 TCM patterns identification in SHS research. The study contributed to a theoretical framework, which has implications for the diagnosis points of SHS.

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.

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).

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).