2013年安徽省成年人血脂水平和血脂异常分布特征分析

目的 了解安徽省成年人血脂异常流行水平,为制定血脂异常防治卫生政策提供依据。方法 利用2013年中国成年人慢性病及其危险因素监测项目中安徽省的调查数据,采用多阶段整群随机抽样方法,以面对面询问方式收集调查对象的相关信息,采集空腹静脉血,测定血清总胆固醇（TC）、甘油三酯（TG）、低密度脂蛋白胆固醇（LDL-C）和高密度脂蛋白胆固醇（HDL-C）,并使用事后分层权重调整和复杂抽样设计方法进行统计分析。结果 有效样本量为7120人,成年人血脂异常患病率为29.56%,其中男性为34.91%,女性为24.26%,男性血脂异常率随年龄增加而降低（2=13.907,P=0.000）,女性则随年龄增加而增加（2=73.366,P=0.000）。血清TC、TG、HDL-C和LDL-C水平分别为4.53、1.43、2.73和1.39 mmol/L,男性血清TG和HDL-C水平与文化程度分别呈正相关和负相关（t=5.938,P=0.000;t=-12.641,P=0.000）,女性血清TC、TG和LDL-C水平均随年龄增长而增加（t=10.060,P=0.000;t=12.531,P=0.000;t=8.058,P=0.000）,不同职业间4种指标差异均有统计学意义。高TC血症、高TG血症、高LDL-C血症和低HDL-C血症患病率分别为5.14%、12.36%、5.18%和16.94%,高TC、高LDL-C和低HDL-C血症患病率随年龄增加而升高（2=13.631,P=0.000;2=14.684,P=0.000;2=8.893,P=0.003）,男性高TG和低HDL-C血症患病率与文化程度呈正相关（2=40.386,P=0.000;2=70.480,P=0.000）,不同职业间的高LDL-C血症和低HDL-C血症患病率差异有统计学意义（2=28.783,P=0.000;2=14.687,P=0.040）。结论 血脂异常是安徽省成年人居民中常见的健康危险因素,应根据血脂异常的年龄、性别、文化程度和职业等差异实施针对性的防控措施。     

Rationale, design and methods of the CASHMERE study

Carotid intima-media thickness (IMT) measurement is a noninvasive method used for quantification of early stage of atherosclerosis. Data suggest that the combination of statin and hormone replacement therapy (HRT) might be useful in reducing the early progression of atherosclerosis in postmenopausal women. The main aim of the study is to compare the effects of 12-month therapy with atorvastatin (80 mg/day), HRT (oral 17beta-estradiol 1 or 2 mg/day, plus cyclic dydrogesterone 10 mg) alone and their combination vs. placebo on the progression of carotid IMT by using a high-definition echotracking device. The secondary objectives are to assess the effects of the treatments vs. placebo on arterial stiffness, lipid profile and C-reactive protein. The CASHMERE trial is an European randomized study with a 2 x 2-factorial design, double blinded for atorvastatin and prospective randomized, open blinded endpoint evaluation (PROBE) method applied to HRT. The investigators can adjust the dose of estradiol at any time during follow-up if necessary. A total of 800 postmenopausal women with mild hypercholesterolemia and with no previous history of cardiovascular disease will be included and followed up by their physicians [general practitioners (GPs) or gynecologists] for 1 year. The CASHMERE trial is the first randomized clinical trial to examine the effects of a statin alone or combined with HRT on the structure and the function of carotid artery as early markers of atherosclerosis in postmenopausal women with mild hypercholesterolemia. The results are expected for 2007.     

The Female Athlete Body (FAB) study: Rationale,design, and baseline characteristics

BackgroundEating Disorders (EDs) are serious psychiatric illnesses marked by psychiatric comorbidity, medical complications, and functional impairment. Research indicates that female athletes are often at greater risk for developing ED pathology versus non-athlete females. The Female Athlete Body (FAB) study is a three-site, randomized controlled trial (RCT) designed to assess the efficacy of a behavioral ED prevention program for female collegiate athletes when implemented by community providers. This paper describes the design, intervention, and participant baseline characteristics. Future papers will discuss outcomes.MethodsFemale collegiate athletes (N = 481) aged 17–21 were randomized by site, team, and sport type to either FAB or a waitlist control group. FAB consisted of three sessions (1.3 h each) of a behavioral ED prevention program. Assessments were conducted at baseline (pre-intervention), post-intervention (3 weeks), and six-, 12-, and 18-month follow-ups.ResultsThis study achieved 96% (N = 481) of target recruitment (N = 500). Few group differences emerged at baseline. Total sample analyses revealed moderately low baseline instances of ED symptoms and clinical cases.ConclusionsHealth risks associated with EDs necessitate interventions for female athletes. The FAB study is the largest existing RCT for female athletes aimed at both reduction of ED risk factors and ED prevention. The methods presented and population recruited for this study represent an ideal intervention for assessing the effects of FAB on both the aforementioned outcomes. We anticipate that findings of this study (reported in future papers) will make a significant contribution to the ED risk factor reduction and prevention literature.     

北京市部分职业人员血脂水平及血脂异常流行情况

目的:分析2003年北京部分职业人员血脂水平及高脂血症的患病率,并与国内1984～1986年有关血脂研究资料及日本、美国血脂调查结果比较。方法:以16963名体检者为研究对象,对其进行问卷调查、体检及血脂指标检测,血脂包括总胆固醇(TC)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)、三酰甘油(TG)。结果:由于TC、HDL-C、LDL-C及TG数据呈偏态分布,按百分位数法得出各年龄组的血脂结果,统计血脂异常的不同性别和年龄组的流行率。与20年前相关研究结果比较,男女TC高0.09mmol/L及0.11mmol/L,TG增高明显,男女分别为0.47mmol/L和0.3mmol/L,LDL-C差异无显著性,HDL-C下降0.07mmol/L(男)和0.05mmol/L(女)。高脂血症患病率比20年前明显增高,TC高于合适水平者有27.4%,高TC检出率为14.2%。本统计TC水平比日本低0.55mmol/L,比美国低0.53mmol/L(男)和0.56mmol/L(女),差异均具有显著性(P<0.001)。结论:与20年前资料相比,各型血脂异常检出率明显上升。TG升高幅度较大,而TC水平较稳定。目前我国冠心病血脂危险水平仍低于日本和美国。     

Serum lipid concentrations and prevalence of dyslipidemia in a large professional population in Beijing

BACKGROUND: Lipid abnormalities are major risk factors for premature coronary artery diseases. We investigated serum lipids and the prevalence of dyslipidemia in a professional population in Beijing and compared these data with those obtained in a similar population during 1984-1986. METHODS: We studied 14 963 individuals 20-90 years of age. Health status was determined by questionnaires and physical check-ups. Total cholesterol (TC), LDL-cholesterol (LDL-C), HDL-cholesterol (HDL-C), and total triglycerides (TGs) were measured. TC >5.7 mmol/L, LDL-C >3.6 mmol/L, TGs >1.7 mmol/L, and HDL-C <0.9 mmol/L were defined as abnormal. RESULTS: Mean serum TC, LDL-C, and TG concentrations were increased compared with the values obtained in 1984-1986, with 52.7% of males and 42.9% of females having at least one abnormal lipid concentration. Hypercholesterolemia occurred in 6% of males and 2.8% of females in the younger group (20-39 years) and in 20.2% of males and 38.7% of females in the older group (>60 years). HDL-C was abnormally low in approximately 7% of males and in 1.6% of females. The prevalences of hypercholesterolemia, hypertriglyceridemia, and abnormally low HDL-C, especially the presence of slight hypertriglyceridemia, were higher than in 1984-1986 in all age groups. The increase was most prominent in the middle age group (40-59 years). CONCLUSIONS: Hypercholesterolemia, hypertriglyceridemia, and abnormally low HDL-C have increased considerably over the past 20 years in professional populations in Beijing. Dietary changes and less physical activity resulting from rapid improvements in living conditions may be the causes for the increases. Enhanced preventive measures should be undertaken to modify these situations.     

The PRImary care Screening Methods (PRISM) study: Rationale and design considerations

BackgroundPrimary care is the most frequently visited clinic type immediately prior to suicidal behavior, with nearly half of suicide decedents visiting a primary care provider within a month of their death. Data supporting the efficacy of suicide risk screening in this setting is lacking, however. Improved suicide risk screening in primary care could lead to earlier intervention and treatment.PurposeThe PRImary care Screening Methods (PRISM) study is designed to develop and evaluate the efficacy of an alert algorithm that can be used by military primary care providers to accurately identify high-risk patients, to improve the identification of high-risk patients who deny suicidal thoughts, and to quantify patient subgroups who are more likely to be missed by existing screening methods (i.e., false negatives).MethodsThe rationale of the PRISM study is discussed, along with ethical and design considerations related to the conduct of suicide prevention research. The PRISM study enrolled 2690 patients from six primary care clinics across the U.S. Patients were enrolled during routine visits to a primary care clinic, and completed a battery of self-report scales in clinic waiting rooms. Follow-up phone interviews are conducted 1, 6, and 12 months after enrollment. The primary outcome is suicide attempt.ConclusionsPRISM is the first study to prospectively examine multiple suicide risk screening methods in “real-world” military primary care clinics. Ethical and design issues were considered to ensure that human participants, especially suicidal patients, were adequately protected while minimizing the potential confounding effect of risk management protocols.     

Survival of myocardial infarction long-term evaluation (SMILE) study: Rationale,design, organization,and outcome definitions

The rationale, design, organization, and outcome definitions of the Survival of Myocardial Infarction Long-term Evaluation (SMILE) study are described in detail. Recruitment of a total of 1500 patients (750 per treatment group) has been planned for this multicenter, double-masked, randomized, placebo-controlled trial investigating the effects of oral treatment with zofenopril calcium (7.5-30 mg twice a day) on the combined short-term total mortality and occurrence of severe refractory congestive heart failure in patients with acute anterior myocardial infarction (AMI). Secondary outcomes of the study include recurrent myocardial infarction, angina, and progression of congestive heart failure, as well as long-term mortality. Patients are initially treated in hospital within 24 hr from the onset of symptoms of AMI and their active follow-up is continued for 6 weeks. In addition, the patients will be passively followed for 12 months from the index AMI to assess vital status and the occurrence of congestive heart failure. The trial data are analyzed on an intention-to-treat basis. An international independent policy and safety monitoring board is acting as the overall supervisory body and is responsible for the ethical conduct of the trial. A scientific committee is responsible for the scientific aspects of the trial and for the regular review of the progress of the study.     

Cocaine Use Reduction with Buprenorphine (CURB): Rationale,design, and methodology

BackgroundEffective medications to treat cocaine dependence have not been identified. Recent pharmacotherapy trials demonstrate the potential efficacy of buprenorphine (BUP) (alone or with naltrexone) for reducing cocaine use. The National Institute on Drug Abuse Clinical Trials Network (CTN) launched the Cocaine Use Reduction with Buprenorphine (CURB) investigation to examine the safety and efficacy of sublingual BUP (as Suboxone®) in the presence of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) for the treatment of cocaine dependence. This paper describes the design and rationale for this study.MethodsThis multi-site, double-blind, placebo-controlled study will randomize 300 participants across 11 sites. Participants must meet the DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Participants are inducted onto XR-NTX after self-reporting at least 7 days of abstinence from opioids and tolerating a naloxone challenge followed by oral naltrexone and are then randomly assigned to one of three medication conditions (4 mg BUP, 16 mg BUP, or placebo) for 8 weeks. Participants receive a second injection of XR-NTX 4 weeks after the initial injection, and follow-up visits are scheduled at 1 and 3 months post-treatment. Participants receive weekly cognitive behavioral therapy (CBT). Recruitment commenced in September, 2011. Enrollment, active medication, and follow-up phases are ongoing, and recruitment is exceeding targeted enrollment rates.ConclusionsThis research using 2 medications will demonstrate whether BUP, administered in the presence of XR-NTX, reduces cocaine use in adults with cocaine dependence and opioid use disorders and will demonstrate if XR-NTX prevents development of physiologic dependence on BUP.     

Enhancing cancer screening in primary care: Rationale,design, analysis plan,and recruitment results

Colorectal cancer (CRC) is the third leading type of cancer and the third leading cause of cancer death in the United States. National policy-making organizations recognize and support a variety of CRC screening strategies among average-risk adults aged 50 and older based on strong evidence showing that screening decreases mortality from CRC and can also reduce the incidence of the disease. The goal of this study was to test a multi-level stepped intervention to increase CRC screening rates. We used a group-randomized trial design where the units of assignment were clinics and the units of observation were eligible patients receiving care at those clinics, with stratified random assignment of clinics to study conditions. The primary analysis was planned as a mixed-model logistic regression to account for the expected positive intraclass correlation associated with clinics. Our recruitment experience reflected the difficulties of conducting research in the real world where changes in economic conditions, staff turnover/layoff, inadequate medical records, and poor acceptance of research can significantly impact study plans. It demonstrated the problems that can emerge when procedures used in the study depart from those used in the pilot work to generate parameter estimates for power analysis. It also demonstrated the importance of allowing for attrition at the group and patient levels so that if recruitment falls short, it is possible to maintain adequate power with only a slight increase in the detectable difference. This experience should assist others planning group-randomized trials, whether in cancer screening or in other areas.     

Trial of calcium for preeclampsia prevention (CPEP): Rationale,design, and methods

The results of ten clinical trials suggest that supplemental calcium may prevent preeclampsia. However, methodologic problems and differences in study design limit the acceptance of the results and their relevance to other patient populations. Many of the trials were conducted in countries where, unlike the United States, the usual daily diet contained little calcium. Moreover, none of the trials has reported the outcome of systematic surveillance for urolithiasis, a potential complication of calcium supplementation. In response to the need for a thorough evaluation of the effects of calcium supplementation for the prevention of preeclampsia in the United States, the trial of Calcium for Preeclampsia Prevention (CPEP) was undertaken at five university medical centers. Healthy nulliparous patients were randomly assigned to receive either 2 g supplemental calcium daily (n = 2295) or placebo (n = 2294) in a double-blind study. Study tablets were administered beginning from 13 to 21 completed weeks of gestation and continued until the termination of pregnancy. CPEP employed detailed diagnostic criteria, standardized techniques of measurement, and systematic surveillance for the major study endpoints and for urolithiasis. The nutrient intake of each patient was assessed at randomization and at 32–33 weeks gestation. This report describes the study rationale, design, and methods.     

Rationale and design of the regimen education and messaging in diabetes (REMinD) trial

BackgroundIndividuals with type 2 diabetes manage complex multi-drug regimens, but nearly half of all patients do not consistently take the dose prescribed for them, and therefore may not receive the full potential therapeutic benefit. Both patient and health system factors contribute to achieving and maintaining medication adherence. To determine if patients with type 2 diabetes who are concurrently managing other chronic conditions could improve their adherence, we devised and are testing a multifaceted, primary care-based strategy to provide health literacy-appropriate and language concordant regimen information, guidance and reminders.ObjectiveWe are testing the effectiveness of an electronic health record (EHR) based strategy and short message service (SMS) text reminders to help patients with type 2 diabetes adhere to their medications.MethodsWe are conducting a 3-arm, multi-site trial to test and compare the effectiveness of the EHR, and EHR + SMS text reminder strategies compared to usual care on medication adherence. Our goal is to enroll a total of 900 English or Spanish-speaking patients with type 2 diabetes and hemoglobin A1C value ≥7.5%. Enrolled participants will complete interviews at baseline and 3 and 6 months following their baseline interview.ConclusionsOur trial is evaluating practical, clinic-based, scalable, evidence-based solutions for patients with type 2 diabetes managing complex medication regimens. Our findings will evaluate strategies that can be implemented broadly in primary care practices, and programmed as defaults within EHRs to support appropriate medication adherence to allow the widespread implementation of those strategies.     

Significant increase in the prevalence of erythromycin-resistant,clindamycin- and miocamycin-susceptible (M phenotype) Streptococcus pyogenes in Spain

In 1998 we conducted a multicentre study in Spain on the susceptibility of Streptococcus pyogenes isolates to different 14-, 15- and 16-membered macrolides and clindamycin, in which the number of strains examined was proportional to the number of inhabitants in each geographical area. The aim of the present work was to re-examine the antimicrobial susceptibility of S. pyogenes in 2001, using the same methodology and centres as in 1998, to determine the different susceptibility phenotypes to macrolides-lincosamides, and to compare the results from the 2 years by statistical tests. A total of 529 unique isolates of S. pyogenes, collected in 21 laboratories, were studied. Throat swabs provided 417 isolates (78.8%), and the remaining 112 were from other sources. Four hundred and thirty-five (82.2%) were isolated from children and 94 (17.8%) from adults. One hundred and fifty-seven (29.7%) of the isolates were resistant to erythromycin and azithromycin, whereas resistance to miocamycin, a 16-membered macrolide, was 1.5%. The prevalence of resistance to clindamycin was 1.3%. The majority (98.7%) of the 157 erythromycin-resistant strains presented the M phenotype. When we compared the results obtained in 1998 and 2001, we observed a statistically significant increase in resistance to erythromycin and azithromycin (P = 0.02, chi(2) test), but not to clindamycin or miocamycin (P = 0.47, chi(2) test with Yates' correction). The significant increase in the prevalence of resistance to some macrolides of S. pyogenes in Spain underscores the need for continuous surveillance of antimicrobial resistance in this species.     

北京市石景山区血脂异常知晓率及治疗率和控制率的流行病学研究

目的了解北京市石景山社区血脂异常患病率、知晓率、治疗率、控制率,为制定防治干预措施提供依据。方法在北京市石景山社区采用非随机整群抽样的方法,对社区居民统一进行问卷调查、体格检查和实验室血生化检查,了解血脂异常患病率、知晓率、治疗率、控制率情况,并统计分析不同年龄组、性别、家族史及疾病史居民血脂异常患病率、知晓率、治疗率、控制率情况。结果本研究共纳入3 824例调查对象,女性2 543例(66. 50%),男性1 281例(33. 50%)。血脂异常患病率为68. 04%(2 602/3 824),知晓率52. 50%(1 366/2 602),治疗率37. 82%(984/2 602),控制率17. 10%(445/2 602)。其中男性血脂异常患病率68. 62%(879/1 281),知晓率45. 96%(404/879),治疗率31. 06%(273/879),控制率14. 68%(129/879);女性血脂异常患病率67. 75%(1 723/2 602),知晓率55. 83%(962/1 723),治疗率41. 27%(711/1 723),控制率18. 34%(316/1 723)。女性血脂异常知晓率、治疗率、控制率均在40～50岁组最低。男性血脂异常治疗率、控制率在40～50岁组最低,知晓率在70～≤82岁组最低。患者有血脂异常家族史、高血压家族史、患者本人患有高血压、糖尿病者,其血脂异常知晓率、治疗率和控制率均高于无上述状况者,差异有统计学意义(P 0. 05)。患者有糖尿病家族史,其血脂异常知晓率、治疗率高于无糖尿病家庭史者,差异有统计学意义。结论北京市石景山社区居民的血脂异常知晓率、治疗率和控制率水平仍需进一步提高;男性血脂异常患病率高于女性,但知晓率、治疗率和控制率均低于女性。     

Rationale and design of the Chronic Kidney Disease Antidepressant Sertraline Trial (CAST)

Major Depressive Disorder (MDD) affects one in five patients with Chronic Kidney Disease (CKD) and is an independent risk factor for hospitalization and death before and after dialysis initiation. However, it remains an under-recognized and under-treated problem, in part due to the lack of well-controlled studies that support or refute the efficacy and safety of antidepressant medications in CKD patients. Major trials of antidepressant treatment excluded patients with stages 3–5 CKD, precisely those at higher risk for both depression and increased mortality. The Chronic Kidney Disease Antidepressant Sertraline Trial (CAST) is a randomized, double-blinded, placebo-controlled trial of sertraline, a selective serotonin reuptake inhibitor (SSRI). It will enroll 200 adults with stages 3–5 CKD and MDD excluding kidney transplant and chronic dialysis patients. Sertraline will be administered at an initial dose of 50 mg once daily or matching placebo followed by a dose escalation strategy consisting of 50 mg increments at 2 week intervals (as tolerated) to a maximum dose of 200 mg. The primary outcome is improvement in depression symptom severity measured by the Quick Inventory of Depressive Symptomatology scale. Secondary outcomes include safety endpoints and improvement in quality of life. Changes in cognitive function, adherence to medications, nutritional status, inflammation, and platelet function will be explored as potential mechanisms by which depression may mediate poor outcomes. We discuss the rationale and design of the CAST study, the largest placebo-controlled trial aimed to establish safety and efficacy of a SSRI in the acute phase treatment of CKD patients with MDD.