Precision medicine is an individualized clinical research model established according to gene, environment, lifestyle and other information. As an innovative method of clinical trials, the main scheme design breaks the barriers of traditional randomized controlled trials to the evaluation of targeted therapies in precision medicine and improves the efficiency of clinical research. This paper will systematically introduce the types, concepts and principles of the main scheme design of the new method of precision medicine clinical trial design, and summarize the advantages and limitations of the main scheme design combined with classic cases, aiming at providing scientific and rigorous methodological guidance and clinical practice experience for precision medicine scientific research design.
Objective To evaluate correlation between –765G>C polymorphism of cyclooxygenase-2 (COX-2) gene and susceptibility to colorectal cancer. Methods The PubMed, Embase, The Cochrane Library, CNKI, CBM, VIP, and Wanfang databases were searched from inception to May 2016 to collect case-control studies about the –765G>C polymorphism of COX-2 gene and the susceptibility to colorectal cancer. Two reviewers independently screened the literatures and extracted data of included studies. The meta-analysis was performed using Stata 12.0 software. Results A total of 13 studies involving 4 998 cases and 7 750 controls were included in this meta-analysis. The overall meta-analysis showed that all the genotypes of the –765G>C polymorphism of COX-2 gene were not associated with the susceptibility to colorectal cancer 〔GGvs. GC: OR=0.98, 95% CI (0.89, 1.07), P=0.590; GC vs. CC: OR=0.85, 95% CI (0.65, 1.11), P=0.236; GG vs. CC: OR=0.86, 95% CI (0.66, 1.12), P=0.275; GG+GC vs. CC:OR=0.87, 95% CI (0.67, 1.13), P=0.288; GG vs. GC+CC:OR=0.97, 95% CI (0.89, 1.05), P=0.425〕. The stratification analysis by ethnicity showed that, the GG vs. GC and GG vs. GC+CC modes of COX-2 gene –765G>C polymorphism might be associated with the susceptibility to colorectal cancer in Asians 〔GGvs. GC: OR=0.70, 95%CI (0.58, 0.86), P=0.001; GG vs. GC+CC: OR=0.71, 95% CI (0.58, 0.87), P=0.001〕, but the other modes were not associated with it 〔GC vs. CC: OR=1.74, 95% CI (0.61, 5.00), P=0.301; GG vs. CC: OR=1.18, 95% CI (0.40, 3.45), P=0.762; GG+GC vs. CC: OR=1.50, 95% CI (0.53, 4.23), P=0.440〕. The genotypes of the –765G>C polymorphism of COX-2 gene were not associated with the susceptibility to colorectal cancer in Caucasians 〔GGvs. GC: OR=1.05, 95% CI (0.95, 1.16), P=0.321; GC vs. CC: OR=0.80, 95% CI (0.61, 1.01), P=0.129; GG vs. CC: OR=0.85, 95% CI (0.64, 1.11), P=0.228; GG+GC vs. CC: OR=0.83, 95% CI (0.64, 1.09), P=0.198; GG vs. GC+CC: OR=1.03, 95% CI (0.94, 1.13), P=0.526〕. Conclusion Current evidence shows that –765G>C polymorphism of COX-2 gene might be a genetic risk factor for colorectal cancer in Asians, but not in Caucasians.
This paper introduces the background and research design (including site of investigation, study population, baseline survey and follow-up monitoring), which belongs to the Precision Medicine Project of the National Key Research and Development Program of China.
ObjectiveTo evaluate the clinical efficacy of flupentixol and melitracen tablets on the treatment of chronic obstructive pulmonary disease (COPD) with anxiety and/or depression.MethodsRandomized controlled trials of flupentixol and melitracen tablets in the treatment of COPD with anxiety and/or depression were retrieved from PubMed, Sciencedirect Database, China National Knowledge Infrastructure, Wanfang Database, and CQVIP Journal Database, with retrieval time from January 2010 to December 2019. Two researchers screened literature and extracted data independently, and meta-analyzed the results using RevMan 5.3 software.ResultsA total of 9 articles with 1 123 patients were included. There were 567 patients in the trial group receiving flupentixol and melitracen tablets plus symptomatic support therapy and 556 patients in the control group receiving simple symptomatic treatment. After treatment, the Hamilton Anxiety Scale score [mean difference (MD)=−5.10, 95% confidence interval (CI) (−7.67, −2.54), P<0.000 1] and Hamilton Depression Scale score [MD=−3.94, 95%CI (−6.64, −1.23), P=0.004] in the trial group were lower than those in the control group, while the forced expiratory volume in one second as percentage of predicted volume [MD=4.89%, 95%CI (0.59%, 9.19%), P=0.03] and COPD Assessment Test score [MD=−3.21, 95%CI (−3.76, −2.66), P<0.000 01] in the trial group were better than those in the control group.ConclusionFlupentixol and melitracen tablets plus symptomatic support therapy has a better effect than simple symptomatic support treatment on COPD with anxiety and/or depression.
The "All of Us" research program is a research project supported by the National Institutes of Health. By recruiting over 1 million volunteers residing in the United States, the project builds a strong research resource to promote the exploration of biological, clinical, social, and environmental determinants of health and disease. This paper introduced the design plan of the "All of Us" research program systematically and provided information that can be used for the construction of a million natural population cohort of precision medicine in China.
Objective To investigate the change of N-terminal pro-B-type natriuretic peptide ( NT-proBNP) levels in plasma of patients with stable chronic obstructive pulmonary disease ( COPD) at exertion. Methods Pulmonary function testing, increamental and constant cycle ergometer exercise testing were performed in 19 patients with stable COPD and 10 healthy subjects. Arterial blood gas analysis were measured at rest and maximal exertion in incremental testing. Venous blood samples were drawn both at rest and maximal exercise in constant-load exercise testing and NT-proBNP levels were measured. Results NT-proBNP levels did not change significantly during exercise in the patients with stable COPD[ ( 4803. 86 ±1027. 07 ) ng/L vs ( 4572. 39 ±1243. 33 ) ng /L, P = 0. 542 ] and the control group [ ( 4303. 18 ±771. 74) ng/L vs ( 4475. 71 ±1025. 50) ng /L, P = 0. 676] . NT-proBNP levels were not correlated with parameters of cardiopulmonary exercise testing. Conclusion The factors other than cardiac function may contribute to the exercise intolerance in stable COPD patients without heart failure.
Objective To evaluate the relationship between genetic polymorphism of ApoE and Alzheimer’s disease in Chinese population. Methods Such databases as PubMed, EBSCO, CNKI, CBM, and WangFang Data were searched from their establishment to December 2010 to collect the literature about the relationship between genetic polymorphism of ApoE and Alzheimer’s disease in Chinese population. RevMan 5.0 was adopted to conduct consistency check and data merging, and to evaluate publication bias. Results ApoEε4 was the risky allele (Plt;0.05) in Chinese population, and its pooled odds ratios and 95%CI was 3.53 (2.49 to 5.00). ApoEε3 was the protective alleles (Plt;0.05) in Chinese population, and its pooled odds ratios and 95%CI was 0.52 (0.40 to 0.68). ApoEε4/ε4, ApoEε4/ε3, and ApoEε4/ε2 were the risky genotypes (all Plt;0.05) in Chinese population, and their pooled odds ratios and 95%CI were 10.17 (4.25 to 24.19), 2.57 (2.04 to 3.25), and 1.94 (1.13 to 3.34), respectively. ApoEε3/ε3 was the protective genotype (Plt;0.05) in Chinese population, and its pooled odds ratios and 95%CI was 0.67 (0.57 to 0.77). Conclusion In Chinese population, some ApoE alleles and genotypes are associated with Alzheimer’s disease.
目的:建立登革病毒的荧光定量PCR检测技术。方法:针对1～4型登革病毒3′端非编码区的一段高度保守序列设计引物和探针,建立登革病毒实时荧光PCR 检测方法及定量的检测方法。并对10例ELISA法检测为登革病毒阳性的病例,取其发热1～2天的临床血清标本进行荧光定量PCR 检测。结果:实时荧光PCR 检测1～4 型登革病毒均为阳性,该探针和引物是登革病毒检测的通用探针和引物。实时荧光PCR检测10份临床血清,6份为阳性,阳性率为60%。结论:实时PCR方法是一个快速、特异性强、敏感性高的检测登革病毒的方法,适用于登革热的临床早期诊断,具有很好的社会效益和经济效益。