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.

《Real World Ecology:Large-scale and Long-term Case Studies and Methods》简介

如今人类的生存环境正迅速恶化,可持续发展需求日益迫切。在这双重因素的驱动下,生态学得到了空前的发展,经历了史无前例的研究目标和方法的变革与飞跃——将理论与应用生态学紧密结合,更加关注实际环境问题和回答真实的生态学现象。

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.

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.

The applications of Bayesian models in real-world studies of traditional Chinese medicine:a primer

真实世界研究适用于中医药领域.目前,尚无公认的用于真实世界研究的统计分析方法.随着计算机技术的发展,贝叶斯统计越来越受到生物医学领域的重视.本文在介绍贝叶斯统计和真实世界研究的基础上,讨论了在中医药领域的真实世界研究中使用贝叶斯模型的注意事项和面临的挑战.

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.

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.

The Islamic Studies in China:Research in the Field of History

A history of the Islamic studies in China,not only includes studies on world Islam,it also includes research on Islam and Muslims in China.Before the Reform and Opening Up,China did not achieve much in this field,since then,the research field of Islam and Muslim in China has been expanding and the results have been published,forming a new trend.In this field,scholars such as Jin Yijiu,Li Xinghua,Qin Huibin,Zhou Guoli,Sha Qiuzhen,Zhou Xiefan,Wu Yungui,and Yang Huaizhong have made the most outstanding achievements.Especially in the collation of reference books and historical materials,in the past 20 years,The Encyclopedia of the history of Islam,The Chinese Encyclopedia of Islam have emerged,and the Chinese and World Encyclopedia of Islamic Law and other important historical books have been published.This paper focuses on the field of historical research and divided into academic research history at home and abroad,which is discussed from several fields such as general history,special history,national history,and regional history.

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.

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.

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.

Dapagliflozin in Heart Failure with Reduced Ejection Fraction:A Real-World Study

Aims:We aimed to observe the improvements in cardiac function indexes and the occurrence of adverse events in patients with heart failure with reduced ejection fraction(HFrEF)after dapagliflozin administration in a real-world setting.Methods:We retrospectively included 201 patients with HFrEF who were treated at a tertiary hospital in Zhengzhou and started to take dapagliflozin(10 mg/d)from March 2020 to June 2021.Their New York Heart Association(NYHA)functional class,cardiac ultrasound indexes,laboratory indexes,and vital signs between baseline and the last follow-up visit were compared,and their adverse events during the follow-up period were recorded.Results:The follow-up period was 173(67–210)days.The cardiac function indexes of patients at follow-up,com-pared with baseline,indicated significant improvement(proportion of NYHA functional class I and II:40.8%vs.56.2%;left ventricular ejection fraction:28.4±5.3%vs.34.7±5.9%;left ventricular end-diastolic diameter:70.1±6.4 mm vs.64.7±5.6 mm;N-terminal pro-B-type natriuretic peptide:5421.9±2864.4 pg/mL vs.2842.8±1703.4 pg/mL at baseline vs.at follow-up;all P<0.05).The rates of hypotension,deterioration of renal function,and genital infection during the follow-up period were 6.5%,4.0%,and 3.5%,respectively.Conclusions:We believe that dapagliflozin is safe and effective in patients with HFrEF in the real world.

Association rules analysis of Fufang Kushen injection in combination with traditional Chinese medicine or modern medications in treating Cervical cancer: real-world retrospective study

Objective: The present study aimed to analyze the association rules of Fufang Kushen injection in combination with other traditional Chinese medicine ( TCM) or modern medications in treating cervical cancer (CC) based on the electrical medical records extracted from real-world hospital information system. Methods: The clinicians’ prescriptions regarding to the combination of with TCM or modern medications were from hospital information system electronic medical data integration warehouse established by the Institute of Basic Medical Research of Chinese Medicine, China Academy of Chinese Medical Sciences, which integrated the hospital information system data of 22 hospitals. The association rules of the drug characteristics were analyzed through Apriori algorithm. Results: A total of 839 patients with CC were included. We found that is often combined with prescriptions which could clear heat, remove toxicity, supplement Qi. also combined with chemotherapeutic drugs, immunomodulatory drugs, 5-HT receptor blockers, and glucocorticoids. The combination presents a specific law. Conclusion: Fufang Kushen injection combined with hepatoprotective drugs, immunomodulators and glucocorticoids is often used to treat cervical cancer.

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.

Assessing acupuncture effect in the real world study

近年来,中医针灸以其独特的理论体系和显著的临床疗效正引领中医走向世界,然而机遇与挑战并存,尽管针灸疗法已经被公众广泛接受,但仍有西方研究者认为对于针灸疗法的有效性仍缺乏有力证据.本文通过回顾针灸临床试验研究的现状、分析其存在问题、结合真实世界临床研究方法学特点,提出针灸临床试验研究应把握针灸的理论和特点、遵循临床实际、借鉴真实世界研究方法学的研究思路,是深化针灸临床试验研究、评价针灸疗效、切实提高针灸疗效公信力,使针灸走向国际、为更多的地区和国家所接受的必要条件.

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.

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.

Is the Mortality Trend of Ischemic Heart Disease by the GBD2013 Study in China Real?

To determine the reason for the different mortality trends of ischemic heart disease （IHD） for China between Global Burden of Disease （GBD） 2010 and GBD2013, and to improve garbage code （GC） redistribution. All data were obtained from the disease surveillance points system, and two proportions for assigning chronic pulmonary heart disease （PHD） as GC to IHD were from GBD2010 and GBD2013,

Real-world vehicle emission factors in Chinese metropolis city—Beijing

The dynamometer tests with different driving cycles and the real-world tests are presented. Results indicated the pollutants emission factors and fuel consumption factor with ECE15+EUDC driving cycle usually take the lowest value and with real world driving cycle occur the highest value, and different driving cycles will lead to significantly different vehicle emission factors with the same vehicle. Relative to the ECE15+EUDC driving cycle, the increasing rate of pollutant emission factors of CO, NOx and HC are -0.42—2.99, -0.32 —0.81 and -0.11—11 with FTP75 testing, 0.11—1.29, -0.77—0.64 and 0.47—10.50 with Beijing 1997 testing and 0.25—1.83, 0.09—0.75 and -0.58—1.50 with real world testing. Compared to the carburetor vehicles, the retrofit and MPI+TWC vehicles' pollution emission factors decrease with different degree. The retrofit vehicle(Santana) will reduce 4.44%—58.44% CO, -4.95%—36.79% NOx, -32.32%—33.89% HC, and -9.39%—14.29% fuel consumption, and especially that the MPI+TWC vehicle will decrease CO by 82.48%—91.76%, NOx by 44.87%—92.79%, HC by 90.00%—93.89% and fuel consumption by 5.44%—10.55%. Vehicles can cause pollution at a very high rate when operated in high power modes; however, they may not often operate in these high power modes. In analyzing vehicle emissions, it describes the fraction of time that vehicles operate in various power modes. In Beijing, vehicles spend 90% of their operation in low power modes or decelerating.

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].