Delirium in Older Patients after Combined Epidural-General Anesthesia or General Anesthesia for Major Surgery: A Randomized Trial.

BACKGROUND: Delirium is a common and serious postoperative complication, especially in the elderly. Epidural anesthesia may reduce delirium by improving analgesia, reducing opioid consumption, and blunting stress response to surgery. This trial therefore tested the hypothesis that combined epidural-general anesthesia reduces the incidence of postoperative delirium in elderly patients recovering from major noncardiac surgery. METHODS: Patients aged 60 to 90 yr scheduled for major noncardiac thoracic or abdominal surgeries expected to last 2 h or more were enrolled. Participants were randomized 1:1 to either combined epidural-general anesthesia with postoperative epidural analgesia or general anesthesia with postoperative intravenous analgesia. The primary outcome was the incidence of delirium, which was assessed with the Confusion Assessment Method for the Intensive Care Unit twice daily during the initial 7 postoperative days. RESULTS: Between November 2011 and May 2015, 1,802 patients were randomized to combined epidural-general anesthesia (n = 901) or general anesthesia alone (n = 901). Among these, 1,720 patients (mean age, 70 yr; 35% women) completed the study and were included in the intention-to-treat analysis. Delirium was significantly less common in the combined epidural-general anesthesia group (15 [1.8%] of 857 patients) than in the general anesthesia group (43 [5.0%] of 863 patients; relative risk, 0.351; 95% CI, 0.197 to 0.627; P < 0.001; number needed to treat 31). Intraoperative hypotension (systolic blood pressure less than 80 mmHg) was more common in patients assigned to epidural anesthesia (421 [49%] vs. 288 [33%]; relative risk, 1.47, 95% CI, 1.31 to 1.65; P < 0.001), and more epidural patients were given vasopressors (495 [58%] vs. 387 [45%]; relative risk, 1.29; 95% CI, 1.17 to 1.41; P < 0.001). CONCLUSIONS: Older patients randomized to combined epidural-general anesthesia for major thoracic and abdominal surgeries had one third as much delirium but 50% more hypotension. Clinicians should consider combining epidural and general anesthesia in patients at risk of postoperative delirium, and avoiding the combination in patients at risk of hypotension.

Long-term Survival after Combined Epidural-General Anesthesia or General Anesthesia Alone: Follow-up of a Randomized Trial.

BACKGROUND: Experimental and observational research suggests that combined epidural-general anesthesia may improve long-term survival after cancer surgery by reducing anesthetic and opioid consumption and by blunting surgery-related inflammation. This study therefore tested the primary hypothesis that combined epidural-general anesthesia improves long-term survival in elderly patients. METHODS: This article presents a long-term follow-up of patients enrolled in a previous trial conducted at five hospitals. Patients aged 60 to 90 yr and scheduled for major noncardiac thoracic and abdominal surgeries were randomly assigned to either combined epidural-general anesthesia with postoperative epidural analgesia or general anesthesia alone with postoperative intravenous analgesia. The primary outcome was overall postoperative survival. Secondary outcomes included cancer-specific, recurrence-free, and event-free survival. RESULTS: Among 1,802 patients who were enrolled and randomized in the underlying trial, 1,712 were included in the long-term analysis; 92% had surgery for cancer. The median follow-up duration was 66 months (interquartile range, 61 to 80). Among patients assigned to combined epidural-general anesthesia, 355 of 853 (42%) died compared with 326 of 859 (38%) deaths in patients assigned to general anesthesia alone: adjusted hazard ratio, 1.07; 95% CI, 0.92 to 1.24; P = 0.408. Cancer-specific survival was similar with combined epidural-general anesthesia (327 of 853 [38%]) and general anesthesia alone (292 of 859 [34%]): adjusted hazard ratio, 1.09; 95% CI, 0.93 to 1.28; P = 0.290. Recurrence-free survival was 401 of 853 [47%] for patients who had combined epidural-general anesthesia versus 389 of 859 [45%] with general anesthesia alone: adjusted hazard ratio, 0.97; 95% CI, 0.84 to 1.12; P = 0.692. Event-free survival was 466 of 853 [55%] in patients who had combined epidural-general anesthesia versus 450 of 859 [52%] for general anesthesia alone: adjusted hazard ratio, 0.99; 95% CI, 0.86 to 1.12; P = 0.815. CONCLUSIONS: In elderly patients having major thoracic and abdominal surgery, combined epidural-general anesthesia with epidural analgesia did not improve overall or cancer-specific long-term mortality. Nor did epidural analgesia improve recurrence-free survival. Either approach can therefore reasonably be selected based on patient and clinician preference.

Effect of transcutaneous electrical stimulation treatment on lower urinary tract symptoms after class III radical hysterectomy in cervical cancer patients: study protocol for a multicentre, randomized controlled trial.

BACKGROUND: Class III radical hysterectomy (RH III)_plus pelvic lymphadenectomy is the standard surgery for early stage cervical cancer (CC) patients, the 5 year survival rate is about 90%, but pelvic floor disorders especially bladder dysfunction are common due to damaged vessels and nerve fibers following surgery. Transcutaneous electrical stimulation (TENS) treatment has been used to treat bladder disorders for many years, but its effect on cervical cancer patients, the best treatment time point and stimulated protocol, had never been assessed. The aim of this study is to investigate the efficacy of TENS treatment on lower urinary tract symptoms (LUTS) after RH III in CC patients. METHODS/DESIGN: The study will be conducted as a clinical, multicentre, randomised controlled trial with balanced randomisation (1:1). The planned sample size is 208 participants (at 1:1 ratio, 104 subjects in each group). At 5-7 days after RH III, patients are screened according to operative and pathological findings. Enrolled participants are randomised into an intervention group (TENS plus conventional clinical care) or control group (conventional clinical care), with stratification by menopausal status (menopause vs. non-menopause) and surgical modality (laparoscopic RH or abdominal RH). Participants in both groups will be followed up at 14 days, 21 days, 28 days, 3 months, 6 months, 12 months, 18 months and 24 months after surgery. The primary endpoint is improvement rate of urination function which is defined as recovery (residual urine ≤50 ml) or improvement (residual urine 50-100 ml). Secondary endpoints include urodynamic parameter, urinary incontinence, anorectal function, pelvic function, quality of life (QOL), disease-free survival and adverse events. Primary endpoint analyses will be carried out by Cochran-Mantel-Haenszel tests taking into center effect. DISCUSSION: To our knowledge this is the first trial to investigate the effect of TENS treatment on bladder function recovery after RH III among CC patients. This study will provide new information on TENS efficacy for bladder function recovery. Once confirmed, it may help to provide a new, non-invisive treatment for those postoperative CC patients with poor pelvic function, which would help improve their quality of life. TRIAL REGISTRATION: The study is registered to Clinical Trials.gov ( NCT02492542 ) on June 25, 2015.

The efficacy of iodine-125 permanent brachytherapy versus intensity-modulated radiation for inoperable salivary gland malignancies: study protocol of a randomised controlled trial.

BACKGROUND: Radiation therapy is the method of choice for subjects with inoperable salivary gland malignancies. I-125 brachytherapy, delivering a high radiation dose to a tumor but sparing surrounding normal tissues, is supposed to be ideal modality for the treatment of salivary gland malignancies. We designed a randomised controlled clinical trial to compare the efficacy of I-125 permanent brachytherapy (PBT) versus intensity-modulated radiation therapy (IMRT) for inoperable salivary gland malignancies. METHODS/DESIGN: In this study, inclusion criteria are subjects with inoperable salivary gland malignancies, aged 18-80 years, have provided informed consent, with at least one measurable tumor focus, be able to survive ≥3 months, Karnofsky performance status ≥60, have adequate hematopoietic function of bone marrow, have normal liver and kidney function, and are willing to prevent pregnancy. Exclusion criteria include a history of radiation or chemotherapy, a history of other malignant tumors in the past 5 years, receiving other effective treatments, participating in other clinical trials, with circulatory metastasis, cognitive impairment, severe cardiovascular and cerebrovascular diseases, acute infection, uncontrolled systemic disease, history of interstitial lungdisease, and being pregnant or breast feeding. The study will be conducted as a clinical, prospective, randomised controlled trial with balanced randomisation (1:1). The planned sample size is 90 subjects. Subjects with inoperable salivary gland malignancies are randomised to receive either I-125 PBT or IMRT, with stratification by tumor size and neck lymph node metastasis. Participants in both groups will be followed up at 2, 4, 6, 9, 12, 15, 18, 21 and 24 months after randomization. The primary outcome is local control rate of the primary site (based on imaging findings and clinical examination, RECIST criteria) in 1 year. Secondary outcomes are progression-free survival, overall survival, quality of life (QOL) measured with the European Organization for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C30 and QLQ-H&N35) of Chinese version, and safety of treatment. Chi-squared test is used to compare the local control rates in both groups. The survival curves are estimated by the Kaplan-Meier method, and log-rank test is used to test the significant difference. DISCUSSION: Only few observational studies have investigated the effect of I-125 PBT on inoperable salivary gland malignancies. To our knowledge, this is the first randomised controlled trial to investigate the efficacy of I-125 PBT for subjects with inoperable salivary gland malignancies, and will add to the knowledge base for the treatment of these subjects. TRIAL REGISTRATION: The study is registered to Clinical Trials.gov ( NCT02048254 ) on Jan 29, 2014.

Effects of decompressive cervical surgery on blood pressure in cervical spondylosis patients with hypertension: a time series cohort study.

BACKGROUND: Patients with cervical spondylosis myelopathy (CSM) and complicated with hypertension are often experiencing a blood pressure decrease after taking cervical decompressive surgery in clinical observations, but how this blood pressure reduction is associated with the surgery, which cut cervical sympathetic nervous, has never been rigorously assessed. Thus, the purpose of this study is to investigate the effect of cervical decompressive surgery on blood pressure among CSM patients with hypertension. METHODS/DESIGN: The study will be a time series cohort study. Fifty eligible patients will be selected consecutively from the Peking University First Hospital. Two 24-h ambulatory blood pressure measurement (ABPM) will be taken before the surgery, apart by at least 3 days. The patients will be followed up for another two ABPMs at 1 and 3 months after the surgery. We will recruit subjects with cervical spondylosis myelopathy meeting operation indications and scheduled for receiving cervical decompressive surgery, aged 18-84 years, have a history of hypertension or office systolic blood pressure ≥140 mmHg on initial screening, and willing to participate in the study and provide informed consent. Exclusion criteria includes a history of known secondary hypertension, visual analogue scale (VAS) score ≥4, and unable to comply with study due to severe psychosis. The change in systolic ABPs over the four times will be analyzed to observe the overall pattern of the blood pressure change in relation to the surgery, but the primary analysis will be the comparison of systolic ABP between the 2(nd) and 3(rd), 4(th) measurements (before and after the surgery). We will also calculate the regression-to-the-mean adjusted changes in systolic ABP as sensitivity analysis. Secondary endpoints are the changes in 24 h ABPM diastolic blood pressure, blood pressure control status, the use and dose adjustment of antihypertensive medication, and the incidence of operative complications. Primary outcome analyses will be carried out using analysis of covariance, as well as the first secondary endpoint. DISCUSSION: This study will inform us the important knowledge about cervical sympathetic nervous system (SNS) and blood pressure. Once confirmed, it may help to produce new method for control of hypertension, which is the leading cause of death in the world. TRIAL REGISTRATION: The study is registered to Clinical Trials.gov (NCT02016768).

Effects of two different anesthesia-analgesia methods on incidence of postoperative delirium in elderly patients undergoing major thoracic and abdominal surgery: study rationale and protocol for a multicenter randomized controlled trial.

BACKGROUND: Delirium is a common complication in elderly patients after surgery and associated with increased morbidity and mortality. Studies suggest that deep anesthesia and intense pain are important precipitating factors of postoperative delirium. Neuraxial block is frequently used in combination with general anesthesia for patients undergoing major thoracic and abdominal surgery. Compared with general anesthesia alone and postoperative intravenous analgesia, combined epidural-general anesthesia and postoperative epidural analgesia decreases the requirement of general anesthetics during surgery and provided better pain relief after surgery. However, whether combined epidural-general anesthesia plus epidural analgesia is superior to general anesthesia plus intravenous analgesia in decreasing the incidence of postoperative delirium remains unknown. METHODS/DESIGN: This is a multicenter, open-label, randomized, parallel-controlled clinical trial. One thousand eight hundred elderly patients (age range 60-90 years) who are scheduled to undergo major thoracic or abdominal surgery are randomized to receive either general anesthesia plus postoperative intravenous analgesia or combined epidural-general anesthesia plus postoperative epidural analgesia. The primary outcome is the 7-day incidence of postoperative delirium. Secondary outcomes include the duration of postoperative delirium, the intensity of pain during the first three days after surgery, the 30-day incidences of postoperative non-delirium complications, the length of stay in hospital after surgery and 30-day all-cause mortality. DISCUSSION: Results of the present study will provide information to guide clinical practice in choosing appropriate anesthesia-analgesia method for elderly patients undergoing major thoracic and abdominal surgery. TRIAL REGISTRATION: The study is registered on ClinicalTrials.gov NCT01661907 and Chinese Clinical Trial Registry ChiCTR-TRC-12002371 .

[Relationship of genetic variants and cardiovascular risk factors with interleukin-6 and interleukin-10 secreted by monocytes].

OBJECTIVE: To examine the relationship of interleukin (IL)-6 and IL-10 genetic variants and cardiovascular factors [oxygenized low density lipoprotein (ox-LDL), lower physical activity, overweight, etc.] with IL-6 and IL-10 secreted by monocytes. METHODS: In the study, 40 health persons, aged from 51 to 80 years, without stroke and myocardial infarction, were randomly sampled from a community-based population in Beijing in 2010. Their data on smoking, drinking, blood pressure, fasting glucose, and lipid were collected. The single nucleotide polymorphisms (SNPs) of IL-6 (rs1800796, rs1524107, rs2066992) and IL-10 (rs1800872, rs1554286, rs3021094) were genotyped. The human monocytes were cultivated in RPMI 1640 medium for 24 h; then divided into two equal parts, in which ox-LDL (50 mg/L) and phosphate buffer solution (PBS) were added for another 48 h. Finally, the secretions of IL-6 and IL-10 in the culture supernatants were measured with ELISA. RESULTS: Paired Wilcoxon tests showed that the IL-6, IL-10, and IL-6/IL-10 were significantly higher in ox-LDL medium than in PBS one (all P < 0.01). The concentrations in PBS/ox-LDL taken as repeated measurements, and adjusted for age and gender, the repeated general linear models showed: IL-10 was significantly lower for those overweight (BMI ≥ 26 kg/m(2)) than for those normal weight (P = 0.007), and IL-6/IL-10 was significantly higher in those overweight (P = 0.003). The IL-6/IL-10 was significantly higher in those with lower physical activity [metabolic equivalent of energy, METS < 166 kJ/(kg.d)] than those with higher physical activities (P = 0.046). IL-6 and IL-10 were significantly higher in alcohol drinkers (P = 0.049 and P = 0.006). IL-6 was significantly higher in those with higher high-density lipoprotein-cholesterol (HDL-c, ≥ 56.4 mg/dL, P = 0.027). There were significant interactions between IL-10 SNPs and ox-LDL on IL-10 (all P < 0.05), but no significant interactions between IL-6 gene SNPs and ox-LDL on IL-6. CONCLUSION: The ox-LDL together with lower physical activity and overweight shifts the balance of pro-inflammatory and anti-inflammatory in the direction of pro-inflammatory. The interaction between IL-10 gene and ox-LDL is intensively correlated with the secretion of the anti-inflammatory cytokine IL-10.

Prevalence of atrial fibrillation in China and its risk factors.

OBJECTIVE: To study the prevalence of atrial fibrillation (AF) and the relation with its risk factors in China. METHODS: A total of 19 363 participants (8635 males and 10 728 females) aged ⋝35 years in geographically dispersed urban and rural regions of China were included in this cross-sectional survey. All participants received questionnaire, physical and blood examination. Echocardiography were performed for AF patients found in the survey. RESULTS: Of the 19 363 participants, 199 were diagnosed with AF. The estimated age-standardized prevalence of AF was 0.78% in men and 0.76% in women. The prevalence of AF in participants aged <60 years was 0.41% in men and 0.43% in women, and was 1.83% in both men and women aged ⋝60 years. About 19.0% of males and 30.9% of females with AF were diagnosed with valve disease. Age- and sex-adjusted multivariable logistic regression analysis revealed that myocardial infarction, left ventricular hypertrophy (LVH), obesity, and alcohol consumption were associated with a increased risk of AF(P<0.05). CONCLUSION: The age standardized prevalence of AF is 0.77% in the participants enrolled in the present study. The number of AF cases aged ⋝35 years is 5.26 million according to 2010 Chinese Census. Most risk factors for AF, identified mainly in Western countries, are also detected in China.

[The optimal cut-off value of waist-to-height ratio for detecting severe central obesity and low body weight adult Chinese population].

OBJECTIVE: To explore the optimal cut-off values of waist-to-height ratio (WHtR) for detecting the severe central obesity and low body weight in adult Chinese population. METHODS: A total of 30 630 participants aged 35-59 years from different areas in mainland China were surveyed for cardiovascular diseases risk factors in two independent cross-sectional studies that carried out in 1992-1994 and 1998, respectively. Indices, such as sensitivity, specificity for hypertension, abnormal glucose, high serum total cholesterol, low serum high density lipoprotein cholesterol and clustering of risk factors (number ≥ 2) were calculated to evaluate the efficacy individual cut-off point of WHtR. The cut-off point value for obvious central obesity was fixed on the point whose specificity of the point was gathered more than 90%. And the cut-off point value to indicate low weight was determined by the percentile distribution of WHtR, at which the 5th percentile of point, both in male and female population. Based on the principle of convenient and practical for use, the optimal cut-off point values of WHtR for low weight and obvious central obesity were determined. RESULTS: The cut-off values of WHtR to detect severe central obesity were 0.54 and 0.57 for men and women, respectively. Additionally, the cut-off points of WHtR for each of the 4 cardiovascular risk factors to evaluate the severity separately ranged from 0.54 to 0.55 in male, and ranged from 0.57 to 0.58 in female. The 5th percentile of WHtR, which was the point value of WHtR to indicate low body weight, was 0.40 in both male and female population. CONCLUSION: Our data suggest that the optimal cut-off value of WHtR for defining severe central obesity and low body weight should be 0.57 and 0.40, respectively.

[Short-term impact of modified blood-lipid reports on physicians' lipid lowering drug prescribing behavior and knowledge improvement on dyslipidemia].

OBJECTIVE: To compare the physicians' lipid lowering drug prescribing behavior and knowledge on dyslipidemia before and at 8 months after new-issued blood-lipid reports in our hospital. METHOD: Blood-lipid reports in our hospital is newly modified in that the classification of dyslipidemia and lipid-lowering guideline and target lipid level are listed on the back of lipid report besides the normal lipid value listed immediately after the measured lipid levels. Physicians' lipid lowering drug prescribing behavior and knowledge on dyslipidemia before and at 8 months after new-issued blood-lipid reports were examined in 143 doctors from various departments before and at 8 months after new-issued lipid reports. RESULTS: At 8 months after the new issued lipid reports, doctors' cognition rate about the guideline was significantly increased [83.9% (120/143) vs. 67.1% (96/143), P < 0.001] and the guideline was considered more helpful on daily practice [75.3% (58/77) vs. 55.8% (43/77), P = 0.005] compared to baseline. However, the prescription rate of dyslipidemia therapy did not change significantly (69.2% vs. 63.2%, P = 0.117) at 8 months after the new issued lipid reports. CONCLUSIONS: The modification of the blood-lipid reports improved doctors' knowledge on dyslipidemia and on the "Chinese guidelines on prevention and treatment of dyslipidemia in adults". However, the lipid lowering drug prescribing behavior remained unchanged at 8 months after the modification of the lipid reports. Further investigation is warranted to see if the lipid lowering drug prescribing behavior could be changed in the long-term.

Effectiveness of a Multifaceted Intervention for Prevention of Obesity in Primary School Children in China: A Cluster Randomized Clinical Trial.

Importance: A rapid nutritional transition has caused greater childhood obesity prevalence in many countries, but the repertoire of effective preventive interventions remains limited. Objective: To determine the effectiveness of a novel multifaceted intervention for obesity prevention in primary school children. Design, Setting, and Participants: A cluster randomized clinical trial was conducted during a single school year (from September 11, 2018, to June 30, 2019) across 3 socioeconomically distinct regions in China according to a prespecified trial protocol. Twenty-four schools were randomly allocated (1:1) to the intervention or the control group, with 1392 eligible children aged 8 to 10 years participating. Data from the intent-to-treat population were analyzed from October 1 to December 31, 2019. Interventions: A multifaceted intervention targeted both children (promoting healthy diet and physical activity) and their environment (engaging schools and families to support children's behavioral changes). The intervention was novel in its strengthening of family involvement with the assistance of a smartphone app. The control schools engaged in their usual practices. Main Outcomes and Measures: The primary outcome was the change in body mass index (BMI; calculated as weight in kilograms divided by height in square meters) from baseline to the end of the trial. Secondary outcomes included changes in adiposity outcomes (eg, BMI z score, prevalence of obesity), blood pressure, physical activity and dietary behaviors, obesity-related knowledge, and physical fitness. Generalized linear mixed models were used in the analyses. Results: Among the 1392 participants (mean [SD] age, 9.6 [0.4] years; 717 boys [51.5%]; mean [SD] BMI, 18.6 [3.7]), 1362 (97.8%) with follow-up data were included in the analyses. From baseline to the end of the trial, the mean BMI decreased in the intervention group, whereas it increased in the control group; the mean between-group difference in BMI change was -0.46 (95% CI, -0.67 to -0.25; P < .001), which showed no evidence of difference across different regions, sexes, maternal education levels, and primary caregivers (parents vs nonparents). The prevalence of obesity decreased by 27.0% of the baseline figure (a relative decrease) in the intervention group, compared with 5.6% in the control group. The intervention also improved other adiposity outcomes, dietary, sedentary, and physical activity behaviors, and obesity-related knowledge, but it did not change moderate- to vigorous-intensity physical activity, physical fitness, or blood pressure. No adverse events were observed during the intervention. Conclusions and Relevance: The multifaceted intervention effectively reduced the mean BMI and obesity prevalence in primary school children across socioeconomically distinct regions in China, suggesting its potential for national scaling. Trial Registration: ClinicalTrials.gov Identifier: NCT03665857.

Effects of Decompressive Cervical Surgery on Blood Pressure in Cervical Spondylosis Patients With Hypertension: A Time Series Cohort Study.

BACKGROUND: The blood pressure of cervical spondylosis (CS) patients with hypertension often returns to normal after decompressive cervical surgery (DCS). However, the effect of DCS on the blood pressure of patients with CS has not been rigorously studied. METHODS: We recruited 50 consecutive CS patients with hypertension from 2014-2017 and investigated the changes in blood pressure after DCS using a time series design. Ambulatory blood pressure monitoring (ABPM) was performed at 3 and 0 days before DCS and at 30 and 90 days after DCS. The primary outcome was mean 24-hour systolic blood pressure (SBP). Secondary outcomes included mean 24-hour diastolic blood pressure (DBP), office blood pressure, and the percentage of patients on antihypertensive medication. Paired t test was used for assessing the changes in blood pressure over time and a McNemar test was used for comparison among different medication groups. RESULTS: The mean 24-hour SBP did not vary significantly among 4 time points (134.5 ± 14.7, 132.8 ± 14.7, 131.5 ± 13.3, and 133.2 ± 14.6, respectively; P = .42). The mean 24-hour DBP showed a similar trend. However, mean office SBP/DBP decreased significantly from 142.5/82.0 mm Hg before surgery to 127.3/76.6 mm Hg after surgery (both P < .01). The corresponding percentage of patients on antihypertensive medication decreased significantly, from 84% to 54% (P < .01). CONCLUSIONS: This study confirmed previous findings of reduction in office blood pressure associated with DCS among CS patients with hypertension. However, this was not confirmed by multiple-time series of 24-hour ABPM. LEVEL OF EVIDENCE: 3.

Association between coronary artery calcification and cognitive function in a Chinese community-based population.

BACKGROUND: Coronary atherosclerosis and cognitive impairment are both age-related diseases, with similar risk factors. Coronary artery calcium (CAC), a marker of coronary atherosclerosis, may play a role in early detection of individuals prone to cognitive decline. This study aimed to investigate the relationship between CAC and cognitive function, and the capability of CAC to identify participants with a high risk of dementia in a Chinese community-based population. METHODS: A total of 1332 participants, aged 40-80 years and free of dementia from a community located in Beijing were included. All participants completed neurocognitive questionnaires and noncontrast CT examinations. Cognitive performance tests (including verbal memory, semantic fluency, executive function, and global cognitive function tests), the Cardiovascular Risk Factors, Aging, and Incidence of Dementia (CIDE) risk score, and the CAC score (CACS) were evaluated by questionnaires and CT. A CAIDE score ≥ 10 was considered to indicate a high risk of dementia in late-life. Participants were divided into three groups according to CACS (0, 1-399, ≥ 400). RESULTS: After adjusting for risk factors, CACS was significantly associated with verbal memory (r = -0.083, P = 0.003) and global cognitive function (r = -0.070, P = 0.012). The prevalence of a high risk of dementia in the subgroups of CACS = 0, 1-399, and ≥ 400 was 4.67%, 13.66%, and 24.79%, respectively (P < 0.001). Individuals with CACS ≥ 400 had a higher risk of CAIDE score ≥ 10 [OR = 2.30 (1.56, 4.56), P = 0.014] than those with CACS = 0. The receiver-operating characteristic curves showed that the capability of CACS to identify participants with a high risk of dementia was moderate (AUC = 0.70, 95% CI: 0.67-0.72,P < 0.001). CONCLUSIONS: CAC, a marker of subclinical atherosclerosis, was significantly associated with cognitive performance in verbal memory and global cognitive function. CAC had a moderate capability to identify participants with a high risk of dementia, independent of age, education, and other risk factors.

Achieving WHO's Goal for Reducing Cesarean Section Rate in a Chinese Hospital.

Background: To address the worldwide dramatically increased Cesarean section (CS) rate in the past decades, WHO has recommended the CS rate should not be higher than 10-15%. Whether it is achievable remains unknown. Methods: We collected the data of delivery from 2008 to 2017 in two typical regional hospitals in China: Longhua Hospital (national policies rigorously implemented) and Dongguan Hospital (national policies not rigorously implemented). We compared between the two hospitals the 10 years trend in annual rate of CS, standardized by age, education level, parity, and CS history, against the time of issuing relevant national, local, and hospital policies. Results: In 10 years, 42,441 women in Longhua and 36,935 women in Dongguan have given birth. China's first national policy on CS reduction was issued in 2010 and the formal relaxation of one-child policy was issued in 2015-2016. In Longhua, the standardized annual CS rate was around 35% in 2008-2009, which declined sharply since 2010 down to 13.1% in 2016 (p < 0.001) and then leveled off. In contrast, in Dongguan, the rate stayed around 25% at the beginning, increased to 36% in 2011, decreased sharply to 27% in 2012, and leveled off until 2015 (p < 0.001), and then bounced back to 35% in 2017. The proportion of women with the history of CS increased significantly in the two hospitals (both roughly from 6% before 2010 to 20% after 2015). Analyses stratified by modified Robson classification showed that CS rates reduced in all risk classes of delivery women in Longhua but only in the Robson class 2 group in Dongguan. Major complications did not differ by hospital. Conclusion: With vigorously implementing national policies at micro levels, the WHO-recommended CS rate could be achieved without increase in major complications.

Treatment and Survival Outcomes Associated With Platinum Plus Low-Dose, Long-term Fluorouracil for Metastatic Nasopharyngeal Carcinoma.

Importance: The treatment of metastatic nasopharyngeal carcinoma (mNPC) is a major challenge because of drug resistance and the toxic effects of chemotherapy. Objective: To evaluate the survival and toxicity outcomes and safety associated with the use of a modified low-dose fluorouracil protocol compared with standard regimens recommended in current guidelines for treatment of mNPC. Design, Setting, and Participants: This retrospective cohort study was based on data retrieved from electronic medical records from Sun Yat-sen University Cancer Center in China for 1397 patients with mNPC diagnosed from January 1, 2006, to December 31, 2017. Data analyses were conducted from October 1, 2020, to May 1, 2021. Exposures: Patients received chemotherapy, including platinum plus low-dose, long-term fluorouracil (PFLL); cisplatin plus standard dose, short-term fluorouracil (PFSS); cisplatin plus gemcitabine (GP); cisplatin plus taxane (TP); and cisplatin plus taxane plus fluorouracil (TPF). Main Outcomes and Measures: The main outcomes included overall survival (OS); subsequent-line, treatment-free survival (sTFS), defined as the period from metastasis to the date requiring subsequent-line treatment or death; and the survival to toxicity ratio (STR), defined as person-year rate of OS divided by person-year rate of severe hematologic toxic effects. Cox regression models were used to compare the outcomes of patients receiving PFLL vs other regimens, adjusting for baseline characteristics. Results: Of 1397 patients with mNPC included in this study (1152 men; median age, 46 years [range, 18-70 years]) 134 received PFLL, 203 received GP, 330 received PFSS, 366 received TP, and 364 received TPF. A total of 764 patients died (75 in treatment group PFLL; 107 in group GP; 204 in group PFSS; 207 in group TP; and 171 in group TPF), and 979 patients had subsequent-line treatment or died, whichever occurred first (PFLL, 77; GP, 144; PFSS, 262; TP, 269; and TPF, 227). The median follow-up was 46.9 months (IQR, 25.4-82.4 months), and the 5-year OS rate among patients who received PFLL was 25.4% (95% CI, 16.7%-38.8%), which was not significantly different from that among patients who did not receive PFLL (30.2%; 95% CI, 27.1%-33.5%; P = .13) or who received GP (25.1%; 95% CI, 18.1%-35.0%; P = .81), PFSS (23.6%; 95% CI, 18.5%-30.0%; P = .80), or TP (28.1%; 95% CI, 22.8%-34.7%; P = .99) but was lower than that for patients who received TPF (40.4%; 95% CI, 34.7%-47.1%; P = .001). The 5-year sTFS among patients who received PFLL (24.1%; 95% CI, 15.4%-37.6%) was significantly higher than that among patients who did not receive PFLL (18.5%; 95% CI, 16.1%-21.3%; P = .005) or who received GP (14.3%; 95% CI, 9.1%-22.5%; P = .001) but similar to that for patients who received TPF (28.0%; 95% CI, 23.0%-34.0%; P = .74). The STR of PFLL was 0.81, substantially better than that of GP (0.41) and TPF (0.65). Conclusions and Relevance: The results of this cohort study suggest that, compared with the use of standard treatment regimens, administration of PFLL was associated with similar OS but prolonged sTFS. PFLL also had better STR than other regimens, which could indicate less severe toxic effects. Thus, PFLL may be an option for first-line treatment of mNPC.

Long-term effects of Xuezhikang on blood pressure in hypertensive patients with previous myocardial infarction: data from the Chinese Coronary Secondary Prevention Study (CCSPS).

Several previous trials from Western population studies have showed that statins may help reduce blood pressure (BP). However, randomized clinical data is limited. Xuezhikang, a partially extract of red yeast rice, contains a family of naturally occurring statins, and has a marked impact on lipids, but it is unknown whether Xuezhikang has any effect on BP during long-term follow-up in the Chinese population. This is a post-hoc subgroup analysis of a randomized, double-blinded, placebo-controlled, parallel group clinical trial, Chinese Coronary Secondary Prevention Study (CCSPS). A total of 2704 hypertensive patients with previous myocardial infarction (MI) were assigned either to placebo (n = 1341) or to Xuezhikang (n = 1363) daily for an average of 4.5 years. The primary outcome was the unadjusted changes in mean arterial pressure (MAP) from baseline to 6 months. We also assessed systolic blood pressure (SBP), diastolic blood pressure (DBP), and pulse pressure. Analysis of covariance was used to calculate the adjusted effects of treatment on changes in these outcomes at 6, 12, 24, and 48 months post-randomization, after controlling for potential confounders. This analysis included 2704/4870 (55.5%) hypertensive patients for whom BP was measured at baseline and at least one follow-up visit after randomization. Median duration of the follow-up was 4.5 years (54 months), and 25 patients (0.92%) were lost to the last follow-up because of adverse effects. The results showed that the unadjusted and adjusted changes in MAP, SBP, DBP, or pulse pressure from baseline were not significantly different for Xuezhikang or placebo recipients at 6, 12, 24, and 48 months after randomization. In this post-hoc subgroup analysis, we failed to demonstrate any significant reducing effects of Xuezhikang on BP in Chinese hypertensive patients with previous MI, suggesting that further prospective study on the effects of statins on BP would be needed, especially in high-risk patients.

[Hypertension and peripheral arterial diseases].

OBJECTIVE: To explore the relationship between different blood pressure levels and peripheral arterial disease (PAD) assessed by ankle-brachial index (ABI). METHODS: Data including ABI,blood pressure, health history, medication use, blood biochemistry and physical examinations derived from 15 817 subjects from 9 areas throughout China were analyzed. Univariate and multivariate adjusted Logistic regression analyses were used for the data analyses. RESULTS: Blood pressure levels were classified into 5 levels as normal blood pressure, high normal blood pressure, primary hypertension, secondary hypertension and the third grade of hypertension. With the increasing of blood pressure levels, the risk of PAD gradually increased (Ptrend<0.05). In comparison with normal blood pressure group, the ORs of PAD for the other groups were 1.10 (95%CI: 0.93-1.29), 1.17 (95% CI: 0.97-1.40), 1.91 (95% CI: 1.55-2.37), and 2.64 (95% CI: 1.99-3.49), respectively. After adjusting for gender(only for total population), age, urban/rural, smoke, obesity/overweight, the history of hypercholesterolemia and diabetes, the ORs were 1.11 (95%CI: 0.94-1.32), 1.13 (95% CI: 0.93-1.38), 1.85(95% CI: 1.47-2.33), and 2.66 (95% CI: 1.98-3.57) (Ptrend<0.05). CONCLUSION: PAD risk increases in proportion with the increasing blood pressure level.

[Usability of the laboratory report and knowledge of lipid-lowering in out-patients from dyslipidemia-related departments].

OBJECTIVE: To investigate the usability of laboratory test report from the angle of patients and understand to what degree the patients master the knowledge of lipid-lowering. METHODS: A total of 508 outpatients, selected from a Grade III-A general hospital, were queried by a questionnaire, their medical records and test reports were reviewed and their heights and weights were measured. In the study, 431 of them fulfilled the inclusion criteria and their information about lipid lowering treatment and treatment compliance were collected. RESULTS: Of the 508 subjects, 90.2% (458/508) read the report seriously; however, only 47.4% (240/508) took drugs according to the doctor's prescription even if the tests were "normal". Of the 431 lipid-lowering therapy related patients, only 26.4% (112/431) chose right in their cardiovascular risk classification, and less than 37.1% (160/431) agreed that "different people had different lipid lowering target". Of the 381 patients who needed the lipid-lowering treatment, 71.7% (273/381) recognized the need for treatment, but 98.7% (376/381) answered a wrong target for treatment; 60.9% (232/381) recognized that the reference values given in the laboratory test reports should be the target for treatment. Of the 246 patients under the lipid-lowering treatment, 35.4% (87/246)had reached their treatment goals, and only 52.0% (128/246) had a good compliance. CONCLUSION: Most patients read and trusted the laboratory test reports. However, dyslipidemia patients scarcely knew their lipid lowering treatment goals and their cardiovascular risk levels. The compliance of patients was poor, and the goal attainment was low. The laboratory medicine department should find out a simple and intuitional way to change the current situation.

[The relationship between occupational physical activity intensity and peripheral arterial disease].

OBJECTIVE: to explore the relationship between occupational physical activity and peripheral arterial disease (PAD)assessed by ankle-brachial index (ABI). METHODS: data including ABI, occupational physical activity intensity, health history, medication use, blood biochemistry and physical examinations derived from 16 446 subjects from 9 areas throughout China were analyzed. Univariate and multivariate adjusted logistic regression analysis were used for the data analyses. RESULTS: occupational physical activity intensity was classified into 5 levels as jobless, very light, light, moderate and heavy intensity. With the increasing of physical activity intensity, the risk of PAD gradually decreased (P(trend) < 0.05). In comparison with jobless group, the ORs of PAD for other groups were 0.65 (95%CI: 0.52, 0.82), 0.70 (95%CI: 0.56, 0.87), 0.57 (95%CI: 0.44, 0.73), 0.65 (95%CI: 0.53, 0.80) respectively. After adjusting for gender, age, smoke, obesity/overweight, the history of hypertension, hypercholesterolemia, diabetes, cardiovascular disease and stroke, the ORs were 1.02 (95%CI: 0.80, 1.31), 0.91 (95%CI: 0.72, 1.15), 0.92 (95%CI: 0.70, 1.19), 0.90 (95%CI: 0.72, 1.12) (P(trend) < 0.05). CONCLUSION: PAD risk reduced in proportion with increasing occupational physical activity.

[Prediction value of blood lipid levels on newly identified carotid plaque in middle-aged and elderly Chinese population].

OBJECTIVE: To evaluate the prediction value of blood lipid levels on the newly-identified carotid plaque in middle-aged and elderly Chinese population. METHODS: All study subjects were recruited from two cohorts from 2002 to 2007 [the People's Republic of China/United States of America collaborative study (USA-PRC study) and the Chinese multi-provincial cohort study (CMCS)]. The baseline examination including cardiovascular disease risk factors and B-mode ultrasound of carotid artery was performed in 2002 and the second examination was made in September to October, 2007. The relationship between baseline lipids and carotid plaque incidence was analyzed in a total of 2000 subjects aged 47 to 79 years (mean 63 years). RESULTS: (1) During these 5 years, the prevalence of carotid plaque increased from 30.3% to 62.2% and from 21.5% to 51.5% for men and women, respectively. The newly-identified carotid plaque incidence was 41.8% for men and 34.1% for women. (2) The incidence of artery plaque significantly increased in both sexes in proportion to increase of baseline total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), and total to high-density cholesterol ratio (TC/HDL-C) levels (P < 0.05 or P < 0.01). (3) Cross-stratification analysis of LDL-C, triglyceride (TG) and HDL-C for carotid plaque incidence indicated the existence of conjoint effects between LDL-C and HDL-C, LDL and TG, as well as between TG and HDL-C, on the increased incidence of carotid plaque. (4) Multi-factorial analysis showed that higher LDL-C, non-HDL-C and TC/HDL-C were independent risk factors for development of new carotid plaque [OR = 1.44 (95%CI = 1.07 - 1.94), OR = 1.45 (95% CI = 1.08 - 1.96), OR = 1.59(95% CI = 1.14 - 2.23) in men;OR = 1.47 (95% CI = 1.13 - 1.92), OR = 1.35 (95% CI = 1.04 - 1.75), OR = 1.64 (95% CI = 1.20 - 2.23) in women]. CONCLUSIONS: The prevalence of carotid plaque increased rapidly in this cohort between 2002 and 2007. Elevated LDL-C, non-HDL-C and TC/HDL-C levels were independent predictors of newly developed carotid plaque.