Real world effectiveness of PCSK-9 inhibitors combined with statins versus statins-based therapy among patients with very high risk of atherosclerotic cardiovascular disease in China(RWE-PCSK study)

BACKGROUND The efficacy and safety of proprotein convertase subtilisin/kexin type 9(PCSK-9) inhibitors were confirmed by several clinical trials, but its effectiveness in routine clinical practice in China has not been evaluated. This study aims to describe the real world effectiveness of PCSK-9 inhibitors combined with statins compared with statins-based therapy among patients with very high risk of atherosclerotic cardiovascular disease(ASCVD).METHODS This is a multi-center observational study, enrolled patients from 32 hospitals who underwent percutaneous coronary intervention(PCI) from January to June in 2019. There are 453 patients treated with PCSK-9 inhibitors combined with statins in PCSK-9 inhibitor group and 2,610 patients treated with statins-based lipid lowering therapies in statins-based group. The lipid control rate and incidence of major adverse cardiovascular events(MACE) over six months were compared between two groups.A propensity score-matched(PSM) analysis was used to balance two groups on confounding factors. Survival analysis using Kaplan-Meier methods was applied for MACE.RESULTS In a total of 3,063 patients, 89.91% of patients had received moderate or high-intensity statins-based therapy before PCI, but only 9.47% of patients had low-density lipoprotein cholesterol(LDL-C) levels below 1.4 mmol/L at baseline. In the PSM selected patients, LDL-C level was reduced by 42.57% in PCSK-9 inhibitor group and 30.81%(P < 0.001) in statins-based group after six months. The proportion of LDL-C ≤ 1.0 mmol/L increased from 5.29% to 29.26% in PCSK-9 inhibitor group and 0.23% to 6.11% in statins-based group, and the proportion of LDL-C ≤ 1.4 mmol/L increased from 10.36% to 47.69% in PCSK-9 inhibitor group and 2.99% to 18.43% in statins-based group(P < 0.001 for both). There was no significant difference between PCSK-9 inhibitor and statins-based treatment in reducing the risk of MACE(hazard ratio = 2.52, 95% CI: 0.49-12.97, P = 0.250).CONCLUSIONS In the real world, PCSK-9 inhibitors combined with statins could significantly reduce LDL-C levels among patients with very high risk of ASCVD in China. The long-term clinical benefits for patients received PCSK-9 inhibitor to reduce the risk of MACE is still unclear and requires further study.

Optimal scheme of Shengmai Injection in the treatment of angina pectoris of coronary heart disease based on Louvain algorithm: A real world study

Objective:To explore the optimal scheme of Shengmai Injection combined with other drugs for clinical doctors.Methods:Based on the large-scale data warehouse established by the institute of Clinical Basic Medicine,Chinese Academy of Traditional Chinese Medicine,the hospital information system of 22 large-scale tertiary hospitals in China was collected and 1751 patients with angina pectoris who were treated with Shengmai Injection were selected.Louvain algorithm and complex network analysis are used to build the model to summarize the rule of Shengmai Injection in the treatment of angina pectoris of coronary heart disease.Results:On the basis of Shengmai Injection,according to the symptom treatment of angina pectoris of coronary heart disease,nitrates or Suxiao Jiuxin Pill was used to dilate coronary artery;for the treatment of risk factors of angina pectoris,a combination of"insulin+acarbose+bisoprolol+nifedipine+captopril+estazolam"was used to control blood glucose and blood pressure;"Ganmao Qingre Granule+levofloxacin"to treat upper respiratory tract infection and other medication regimens were used as well.For the complications of angina pectoris of coronary heart disease,"furosemide+spironolactone+potassium chloride+magnesium sulfate"was used to reduce edema and“isosorbide nitrate+metoprolol+Shenmai injection+Wenxin Granule"was used to improve symptom of heart failure of qi and yin deficiency type.Conclusion:The therapeutic regimen of Shengmai Injection combined with traditional chinese medicine and western medicine is basically consistent with the current guidelines,but more clinical studies are still needed to explore more effective combination therapy.

Intravitreal triamcinolone acetonide： a ＂real world＂ analysis of visual acuity, pressure and outcomes

Dear Sir,Triamcinolone acetonide（TA）is worldwide available therapeutic agent that is commonly used throughout medicine.TA remains a safe and important ophthalmic therapeutic agent even after the advent of angiogenesis inhibitors[1-2].

The choice of a neoadjuvant chemotherapy cycle for breast cancer has significance in clinical practice: results from a population-based, real world study

Objective:Neoadjuvant chemotherapy(NAC)is currently used in both early stage and locally advanced breast cancers.The survival benefits of standard vs.non-standard NAC cycles are still unclear.This study aimed to investigate the relationship between NAC cycles and survival based on real world data.Methods:We identified patients diagnosed with invasive primary breast cancers who underwent NAC followed by surgery.Patients who received at least 4 NAC cycles were defined as having received standard cycles,while patients who received less than 4 NAC cycles were defined as having received non-standard cycles.Kaplan-Meier curves and Cox proportional hazard models were used to estimate the disease-free survival(DFS)and overall survival(OS).Results:Of the 1,024 included patients,700 patients received standard NAC cycles and 324 patients received non-standard NAC cycles.The DFS estimates were 87.1%and 81.0%(P=0.007)and the OS estimates were 90.0%and 82.6%(P=0.001)in the standard and non-standard groups,respectively.Using multivariate analyses,patients treated with standard NAC cycles showed significant survival benefits in both DFS[hazard ratio(HR):0.62,95%confidence interval(CI):0.44–0.88]and OS(HR:0.54,95%CI:0.37–0.79).Using stratified analyses,standard NAC cycles were associated with improved DFS(HR:0.59,95%CI:0.36–0.96)and OS(HR:0.49,95%CI:0.28–0.86)in the HER2 positive group.Similar DFS(HR:0.50,95%CI:0.25–0.98)and OS(HR:0.45,95%CI:0.22–0.91)benefits were shown for the triple negative group.Conclusions:Standard NAC cycles were associated with a significant survival benefit,especially in patients with HER2 positive or triple negative breast cancer.

Real world studies are essential for drug therapy in Parkinson's disease

Prospective real-world data from large patient samples, which re- port on the long-term effectiveness of the employed different drug therapies, are rare in Parkinson＇s disease （PD）. The non interven- tional ＂Transdermal Rotigotine User Surveillance Study＂ （TRUST） trial represents such a real-world study. It investigated long-term treatment with different dopamine substituting treatment regimens in 2195 PD patients （Mfiller et al., 2018）. Participation in TRUST meant that the treating neurologists were only asked to document and modify the dopaminergic drug regimen without any prior PD patient selection criteria. Thus this unique trial design reflects the real world of patient maintenance.

Assessing acupuncture effect in the real world study

Acupuncture,with its unique set of theories and its evident results in clinical practice is an important part of traditional Chinese medicine(TCM),and gaining recognition worldwide for the past few years.Although acupuncture treatment is generally accepted by the public,a few western researchers believe that sufficient evidence of its efficiency is still currently lacking,therefore creating a challenge of its acceptance on a wider scale.This article suggests the concepts of acupuncture behind clinical researches by reviewing the clinical researches done,analyzing the existing problems,and integrating real life acupuncture into the research process.By increasing the credibility of acupuncture,its reach can be extended globally and to more countries and regions.

Clinical characteristics of Danshen Ligustrazine injection in the treatment of coronary heart disease with hypertension-A real world study

Objective:To explore the characteristics and rules of Danshen Ligustrazine Injection in the treatment of coronary heart disease with hypertension.Methods:From the information systems of 12 tertiary tier-one hospitals across the country,we extracted the medical data of the application of Danshen Ligustrazine Injection in the treatment of patients with coronary heart disease and hypertension.After normalization,the model was established by Apriori algorithm,and the association rules were analyzed by Clementine 12.0 software.Results:Most of the 1928 patients were between 75 and 90 years old(54.26%).There were more males than females,most with type 2 diabetes,cerebral infarction,etc.Each dose was more than 10 mL(52.78%).Aspirin enteric-coated tablets(67.63%),L-carnitine injection(58.77%),and atorvastatin calcium capsules(50.93%)were often used in combination with safflower yellow pigment(22.20%),Shexiang Baoxin Pill(16.55%),Suxiao Jiuxin Pill(15.09%);the most commonly used combination of western medicine was anticoagulant thrombolytic and antiplatelet drugs(85.84%),and the type of Chinese medicine was Huoxuehuayu(72.98%);The most common combination of two western medicines was L-carnitine injection+aspirin enteric-coated tablets,with a support of 41.9%;The most common combination of two Chinese and western medicines is western medicine·anti-anginal medicine+western medicine·anticoagulant thrombolytic and antiplatelet drugs with a support of 67.6%.Conclusion:Danshen Ligustrazine injection is mainly used in elderly patients with coronary heart disease and hypertension,with many comorbidities.The dosage standard needs to be optimized.The combination of drugs and guidelines should coordinate with each other,which provide clues for clinical diagnosis and treatment and optimization of medication.

Real world analysis on renal impairment of elemene emulsion injection based on propensity score matching

Objective:To explore the main factors of renal function injury caused by the combination of elemene emulsion injection in the real world.Methods:Based on the hospital information system medical database constructed by the Institute of Clinical Basic Medicine of Chinese Academy of Traditional Chinese Medicine,taking the patient information of elemene emulsion injection used in 21 top three hospitals in China as the research object,the nested case control study method was used to compare the combined medication of patients with renal function injury group and control group,The main factors that may lead to renal function injury were screened by MCP variable selection method,and the above main factors were further analyzed by classical logistic regression and propensity score logistic regression method.Results:The analysis found that the combined use of potassium chloride within 7 d before the use of elemene emulsion injection or the combined use of furosemide during the use of elemene emulsion injection may be the main factor leading to renal function injury.Conclusion:The combination of elemene emulsion injection and the above main factors that may lead to renal injury should be avoided.If it must be used,clinical monitoring should be strengthened,and abnormal reactions should be treated immediately.The results of this study have certain clinical significance,and the clinical mechanism can be further studied and explored in the future.

Real world epidemiological characteristics of acute ischemic stroke in young people in northwest Hubei Province

Objective:acute ischemic stroke is oc-curing in younger and younger individuals.This paper aims to explore the real-world epidemiological characteristics of young stroke patients in northwest Hubei.Methods:the information of acute stroke patients under 50 years old in northwest Hubei Province was collected,including age,gender,region,education level,smoking and drinking,onset season,etc,and epidemiological analysis was carried out.Results:a total of 344 patients with acute ischemic stroke were surveyed.The males accounted for 69.19%,and the average age was 44.94±5.61 years old;the females accounted for 30.18%,and the average age was 45.22±5.02 years old.The distribution of patients varied,with most living in urban areas.There were more male patients than female patients.The proportion of patients with an education level below junior high school was higher than that of patients with an education level above junior high.Twenty-nine point thirty-six percent of all young people with stroke smoked and drank.Stroke occurred in all seasons,but the incidence of stroke was relatively high in summer and autumn.There was a significant difference in the ratio of males to females(P<0.001).Conclusion:the incidence rate of acute stroke in young people in northwest Hubei Province is unique.With the increase of age,men in all ages are more prone to strokes than women.The incidence of stroke among young people in urban areas is higher than in surrounding counties.The incidence rate decreases with the increase of education level.More strokes occur in summer and autumn than in winter and spring.Smoking and drinking do not show obvious effects on the incidence rate.

A Comparative Study Of New Criticism&Semiotic Criticism——In Terms Of Their View Of The Relationship Between The Fictional World&The Real World

As we know,new criticism is the post—world school of critical theory insists onthe intrinsic value of work of art and focusses on the individual work alone asan independent unit of meaning.It is opposed to the critical practice of bringing histori-cal of brographical data to bear on the anterpretation of a work.To the new critocs,poet-.ry was a special kind of discourse,a means of communicating feeling and thought thatwould not be expressed in any other kind of language.It differed qualitatively from thelanguage of science,or philosophy,but it converyed valid meanings.Such critics set outto define and formalize the qualities of poetic thought and languagege,using the techniqueof close reading with special emphasis on the implicative values of works and on the vari-ous function of figurative language—imagery,metaphor and symbol—in the work.

Analysis on Clinical Characteristics and Combination Medications of Elemene Injection in the Treatment of Esophageal Cancer in Real World Research

Objective:To explore the clinical characteristics of Elemene Injection in the treatment of patients with esophageal cancer.Methods:A total of 310 patients diagnosed with esophageal cancer from the Hoptital Information System(HIS)of 21 hospitals across the country were selected in the study,and these patients all had been treated with Elemene Injection.In this study,the clinical general medication record information,diagnosis scheme information,general treatment information and combined medications information were analyzed by frequency statistics and association rules.Results:Elemene Injection was used most in patients aged 46-65(177 cases,57.10%);male patients were more than female.Among the main diagnoses of the most seasons and solar terms in hospitalization,the top three diagnoses were esophageal malignant tumor,malignant tumor,and hypertension.In terms of combination medication,the combination of western medicine blood substitutes and perfusion fluids,general nutritional drugs,vitamins,antibacterial drugs,and immune-promoting drugs were the main ones;the combination of traditional Chinese medicine was mainly anti-tumor drugs(48.71%).In addition,among the combination medications,the highest frequency of Elemene Injection combined with western medicine and traditional Chinese medicine were Xiaoaiping Injection(消癌平注射液)and ascorbic acid.Conclusion:The main susceptible people of esophageal cancer was middle-aged around 46-65,and there were more male patients than female;through the first diagnosis of western medicine,it can be found that in addition to patients suffering from esophageal cancer or other cancers,patients with high blood pressure,heart disease,and diabetes could use Elemene Injection.Therefore,when receiving such patients,attention should be paid to checking whether the patient had such diseases.At the same time,when using Elemene Injection,it's necessary to pay attention to certain combined medications to avoid adverse reactions.

Study on the Connotation and Application of Real World Evidence

Objective To define the concepts and characteristics of real world data(RWD),real world research,real world evidence(RWE)and other related terms so as to better apply RWE to serve the whole life cycle monitoring of pharmaceutical products.Besides,some reference can be provided for drug supervision and medical services to further standardize the clinical application of drugs.Methods Through literature retrieval at home and abroad,the development process of exploring RWE in Europe and America was briefly introduced,and its development status in China was compared and analyzed as well.The application fields of RWE were explored based on the whole life cycle of drugs.Results and Conclusion RWE can provide proof for drug life cycle regulatory evaluation.Some European countries and the United States gradually apply RWE to regulatory decision-making and related policy research.Due to its bright prospect,China is also strengthening the expansion of RWE application fields and exploring its use in-depth.

BRAIN INJURY BIOMECHANICS IN REAL WORLD VEHICLE ACCIDENT USING MATHEMATICAL MODELS

This paper aims at investigating brain injury mechanisms and predicting head injuries in real world accidents. For this purpose, a 3D human head finite element model （HBM-head） was developed based on head-brain anatomy. The HBM head model was validated with two experimental tests. Then the head finite element（FE） model and a multi-body system （MBS） model were used to carry out reconstructions of real world vehicle-pedestrian accidents and brain injuries. The MBS models were used for calculating the head impact conditions in vehicle impacts. The HBM-head model was used for calculating the injury related physical parameters, such as intracranial pressure, stress, and strain. The calculated intracranial pressure and strain distribution were correlated with the injury outcomes observed from accidents. It is shown that this model can predict the intracranial biomechanical response and calculate the injury related physical parameters. The head FE model has good biofidelity and will be a valuable tool for the study of injury mechanisms and the tolerance level of the brain.

Smear-Negative Multidrug-Resistant Tuberculosis a Significance Hidden Problem for MDR-TB Control: An Analysis of Real World Data

Purpose: The drug resistance pattern in tuberculosis (TB) is still under investigated. We analyzed the clinical data from the patients with smear positive TB and applied the model to predict the patients with smear-positive TB. Materials and Methods: Medical records information of 6977 cases was included from 11,950 inpatients from January 2009 to November 2013. The cases data were divided into a training set, test set and prediction set. Logistic regression analysis was applied to the training set data to establish a prediction classification model, the effect of which was then evaluated using the test set by receiver operating characteristic (ROC) analysis. The model was then applied to the prediction set to identify incidence of snMDR-TB. Results: Sixteen factors which correlate with MDR-TB-including frequency of hospitalization, province of origin, anti-TB drugs, and complications, were identified from the comparison between SP-TB and spMDR-TB. The area under the ROC curve (AUC) of the prediction model was 0.752 (sensitivity = 61.3%, specificity = 83.3%). The percentage of all inpatients with snMDR-TB (snMDR-TB/Total) was 28.7% ± 0.02%, while that of all SN-PTB with snMDR-TB (snMDR-TB/SN-PTB) was 26.5% ± 0.03%. The ratio of snMDR-TB to MDR-TB (snMDR-TB/MDR-TB) was 2.09 ± 0.33. Conclusion: snMDR-TB as an important source of MDR-TB is a significant hidden problem for MDR-TB control and can be identified by the prediction model. A kind of vicious circle with a certain delay effect exists between snMDR-TB and MDR-TB. To better control MDR-TB, it is necessary to pay greater attention to snMDR-TB, conduct further research and develop targeted therapeutic strategies.

Study on syndrome distribution and medication characteristics of patients with rectal cancer in the real world

Objective:To explore the general characteristics,traditional Chinese medicine(TCM)syndromes and medication of patients with rectal cancer in China.Methods:The clinical data of inpatients with rectal cancer from the information system of 17 tertiary A‑level traditional Chinese medicine hospitals in China were collected.After data standardization,descriptive analysis was performed on the general information,syndrome distribution and medication characteristics of the included patients,and association rule analysis was performed on the drug usage.Results:A total of 15424 hospitalized patients with rectal cancer were included.The ratio of male to female patients was 1.6:1,the average age was 60.87 years old,and the age was mainly in the range of 50 to 79 years old.Among the 12146 patients with rectal cancer,the top 5 TCM syndromes were Qi and Yin deficiency syndrome(25%),phlegm and blood stasis syndrome(19%),spleen deficiency syndrome(14%),Qi stagnation and blood stasis syndrome(7%)and Qi and blood deficiency syndrome(6%).After excluding the anti‑tumor western medicine recommended by the guidelines,adrenal corticosteroids(43.55%),antibiotics(42.94%)and immunomodulatory drugs(42.66%)ranked the top three in the frequency of western medicine use.Dexamethasone(38.15%),metoclopramide tablets(20.51%)and furosemide injection(19.71%)were the three most commonly used western medicines.Among the three western medicines combined,cimetidine,granisetron hydrochloride dextrose injection+dexamethasone were the most common(support 8.23%,confidence 96.4%,and improvement 2.48%).Heat‑clearing and detoxifying agents(53.72%),Yiqi‑fuzheng agents(49.76%)and blood‑activating and stasis‑removing agents(15.68%)ranked the top 3 in the frequency of use of traditional Chinese medicine.Shenqi Fuzheng injection,Shenqi Fuzheng injection(21.59%),Compound Kushen injection(17.52%)and Aidi injection(11.96%)were the three most commonly used Chinese patent medicines.Conclusion:The main syndromes of patients with rectal cancer may be Qi and Yin deficiency syndrome,phlegm and blood stasis syndrome,and spleen deficiency syndrome,etc.The treatment needs to focus on the supplementation of vital essence,combination of dredging and tonifying method,and the integration of traditional Chinese and western medicine.

Using real world data to assess cardiovascular outcomes of two antidiabetic treatment classes

AIM To evaluate the effect on cardiovascular outcomes of sodium-glucose co-transporter-2(SGLT2) inhibitors in a real world setting by analyzing electronic medical records.METHODS We used Tri Net X, a global federated research network providing statistics on electronic health records(EHR). The analytics subset contained EHR from approximately 38 Million patients in 35 Health Care Organizations in the United States. The records of 46,909 patients who had taken SGLT2 inhibitors were compared to 189,120 patients with dipeptidyl peptidase(DPP) 4 inhibitors. We identified five potential confounding factors and built respective strata: elderly, hypertension, chronic kidney disease(CKD), and co-medication with either insulin or metformin. Cardiovascular events were countedas stroke(ICD10 code: I63) or myocardial infarction(ICD10: I21) occurring within three years after the first instance of the respective medication in the patients' records.RESULTS Of the 46909 patients with SGLT2 inhibitors in their EHR, 1667 patients(3.6%) had an ICD code for stroke or for myocardial infarction within the first three years after the first instance of the medication. In the control group, there were 10680 events of 189120 patients(5.6%), which represents a risk ratio of 0.63(95%CI: 0.60-0.66). The overall incidence of stroke or myocardial infarction in the strata with a potential confounding risk factor reached from 4.9% in patients taking metformin to 12.5% in the stratum with the highest risk(concomitant CKD). In all strata, the difference in risk of experiencing a cardiovascular event was similarly in favor of SGLT2 vs control, with Risk Ratio ranging from 0.62 to 0.81.CONCLUSION Real world data replicated the results from randomized clinical trials, confirmed the cardiovascular advantages of SGLT2 inhibitors, and showed its applicability to the US population.

Real-World Evidence in Localized Pancreatic: Coping with Uncertainty in Unselected Populations

Background: Localized pancreatic cancer, including resectable (R), borderline resectable (BR) and locally advanced unresectable disease (LAU), is considered in clinical guidelines for diverse treatment options based on clinical trials in selected populations. Hence, exploring with real world evidence (RWE) clinicians’ preferences for treatment options and their results seems pertinent. Methods: In a set of consecutive patients with localized pancreatic cancer assisted in a third level hospital from January 2013 to December 2022, medical records, symptoms, diagnostic process, distribution between subtypes, and treatment plans, with safety and efficacy results, were assessed. Results: A total of 152 patients with localized disease were included (43.4% R, 21.0% BR, 33.6% LAU). The population characteristics exemplified differences between daily practice and clinical trials. Tumor location and symptoms were as expected. Treatment plan was conditioned by PS or comorbidities in 23.0% of patients. In patients with R disease, surgery followed by different adjuvant chemotherapy (CT) regimes was the antineoplastic treatment of choice (64.8%) with efficacy results (OS 37.5 months;95% CI 18.4 - 56.7), in the range of contemporary standards. The common use of neoadjuvant CT for BR disease (94.4%), with surgery in 50% of them, and its results (OS 30.8 months;95% CI 10.5 - 51.2) reflected current controversies of treatment recommendations and evolution in this scenario. Paliative CT with or without radiotherapy was the standard specific treatment in LAU disease (95.1%) with survival results (PFS: 10.8 months;95% CI 8.8 - 12.7. OS: 20.3 months;95% CI 13.5 - 27.2) that justify the distinct character and the specific study of this entity. Conclusion: RWE for localized pancreatic cancer aroused from the analysis of this population confirms the distinct nature of patients assisted in daily practice, as well as mirrors the complexity of decision making in clinical assumptions in which achieving stronger evidence should be paramount.

Integrated strategies for chemotherapy cycles in nasopharyngeal carcinoma patients: Real-world data from two epidemic centers guiding decision-making

objective:Two cycles of induction chemotherapy(IC)followed by 2 cycles of platinum-based concurrent chemoradiotherapy(CCRT)(2IC+2CCRT)for locoregionally advanced nasopharyngeal carcinoma(LA-NPC)is widely adopted but not evidence-confirmed.This study aimed to determine the clinical value of 2IC+2CCRT regarding efficacy,toxicity and cost-effectiveness.Methods:This real-world study from two epidemic centers used propensity score matching(PSM)and inverse probability of treatment weighting(IPTW)analyses.The enrolled patients were divided into three groups based on treatment modality:Group A(2IC+2CCRT),Group B(3IC+2CCRT or 2IC+3CCRT)and Group C(3IC+3CCRT).Long-term survival,acute toxicities and cost-effectiveness were compared among the groups.We developed a prognostic model dividing the population into high-and low-risk cohorts,and survivals including overall survival(OS),progression-free survival(PFS),distant metastasis-free survival(DMFS)and locoregional relapse-free survival(LRRFS)were compared among the three groups according to certain risk stratifications.Results:Of 4,042 patients,1,175 were enrolled,with 660,419,and 96 included in Groups A,B and C,respectively.Five-year survivals were similar among the three groups after PSM and confirmed by IPTW.Grade 3-4 neutropenia and leukocytopenia were significantly higher in Groups C and B than in Group A(52.1%vs.41.5%vs.25.2%;41.7%vs.32.7%vs.25.0%)as were grade 3-4 nausea/vomiting and oral mucositis(29.2%vs.15.0%vs.6.1%;32.3%vs.25.3%vs.18.0%).Cost-effective analysis suggested that 2IC+2CCRT was the least expensive,while the health benefits were similar to those of the other groups.Further exploration showed that 2IC+2CCRT tended to be associated with a shorter PFS in high-risk patients,while 3IC+3CCRT potentially contributed to poor PFS in low-risk individuals,mainly reflected by LRRFS.Conclusions:In LA-NPC patients,2IC+2CCRT was the optimal choice regarding efficacy,toxicity and costeffectiveness;however,2IC+2CCRT and 3IC+3CCRT probably shortened LRRFS in high-and low-risk populations,respectively.

Clinical data quality problems and countermeasure for real world study

Real world study （RWS） has become a hotspot for clinical research. Data quality plays a vital role in research achievement and other clinical research fields. In this paper, the common quality problems in the RWS of traditional Chinese medicine are discussed, and a countermeasure is proposed.

Analysis of the Real-world Efficacy of Lianhua Qingwen Capsule(莲花清瘟胶囊)in the Treatment of Upper Respiratory Tract Infection

Objective:To explore the efficacy of Lianhua Qingwen Capsule(莲花清瘟胶囊)on upper respiratory tract infection,to understand the impact of Lianhua Qingwen Capsule(莲花清瘟胶囊)on the treatment outcome of upper respiratory tract infection,and provide reference for rational clinical drug use.Methods:The HIS database based on 18 large third-grade class-A hospitals was selected to match 1:1 for upper respiratory tract infection patients using and without Lianhua Qingwen Capsule(莲花清瘟胶囊)according to certain standards.The recombination of treatment outcome as"recovery"and"improvement"in the database was defined as effective treatment,"ineffectiveness","death"and"other"as ineffectivetreatment populations,and the effectiveness of treatment outcomes in the remerged 2 groups was compared by propensity score method.Results:After matching,454 cases were in both the patients treated by(experimental group)and without(control group)Lianhua Qingwen Capsule(莲花清瘟胶囊).Analysis was performed by three Logistic regression methods,all showing regression coefficients greater than 0 and statistically significant differences(P<0.05).Conclusion:Patients with upper respiratory tract infection treated by Lianhua Qingwen Capsule(莲花清瘟胶囊)are more effective than that without Lianhua Qingwen Capsule(莲花清瘟胶囊),it can improve the clinical efficacy of patients with upper respiratory tract infection。