Introduction: Severe sepsis is associated with a high mortality rate despite implementation of guideline recommendations. Adjunctive treatment may be efficient and require further investigation. In light of the crucial role of immunologic derangement in severe sepsis, thymosin alpha 1 (Tα1) is considered as a promising beneficial immunomodulatory drug. The trial is to evaluate whether Tα1 improves 28-day all-cause mortality rates and immunofunction in patients with severe sepsis. Methods: We performed a multicenter randomized controlled trial in six tertiary, teaching hospitals in China between May 12, 2008 and Dec 22, 2010. Eligible patients admitted in ICU with severe sepsis were randomly allocated by a central randomization center to the control group or Tα1 group (1:1 ratio). The primary outcome was death from any cause and was assessed 28 days after enrollment. Secondary outcomes included dynamic changes of Sequential Organ Failure Assessment (SOFA) and monocyte human leukocyte antigen-DR (mHLA-DR) on day 0, 3, 7 in both groups. All analyses were done on an intention-to-treat basis. Results: A total of 361 patients were allocated to either the control group (n = 180) or Tα1 (n = 181) group. The mortalities from any cause within 28 days in the Tα1 group and control group were 26.0% and 35.0% respectively with a marginal P value (nonstratified analysis, P = 0.062; log rank, P = 0.049); the relative risk of death in the Tα1 group as compared to the control group was 0.74 (95% CI 0.54 to 1.02). Greater improvement of mHLA-DR was observed in the Tα1 group on day 3 (mean difference in mHLA-DR changes between the two groups was 3.9%, 95% CI 0.2 to 7.6%, P = 0.037) and day 7 (mean difference in mHLA-DR changes between the two groups was 5.8%, 95% CI 1.0 to 10.5%, P = 0.017) than in the control group. No serious drug-related adverse event was recorded. Conclusions: The use of Tα1 therapy in combination with conventional medical therapies may be effective in improving clinical outcomes in a targeted population of severe sepsis. Trial registration: ClinicalTrials.gov NCT00711620.
1 September 2015 in International Journal of Surgery
The aim of this study was to estimate the prevalence and risk factors of hypothermia under general anesthesia in a large domestic hospital. All of the consecutive 1840 patients who underwent scheduled surgery between August and December 2013 were admitted to the study. The nasopharyngeal temperature was measured, and the following variables were also recorded: sex, age, type of surgery, duration of anesthesia, active warming devices and type of operating room. Univariate and multiple regression binary logistic analyses with odds ratios (ORs) and 95% confidence intervals (95% CIs) were used to assess the relationship between each clinical risk factor and hypothermia. The prevalence of hypothermia under general anesthesia was 25.7%. In the univariate analysis, the risk factors of hypothermia were age, the duration of anesthesia, the type of operating room and the type of surgery. Sex was not included. In the multiple logistic regression analysis, the significant risk factors of hypothermia were advanced age, laminar airflow operating rooms and general surgeries. Intraoperative hypothermia is still common and should therefore receive serious attention. Advanced age, the use of a laminar airflow operating room and general surgeries are high risk factors of hypothermia.
With the rapid and widespread adoption of mobile devices, mobile phones offer an opportunity to deliver cardiovascular disease (CVD) interventions. This study evaluated the efficacy of a mobile phone-based lifestyle intervention aimed at reducing the overall CVD risk at a health management center in Guangzhou, China. We recruited 589 workers from eight work units. Based on a group-randomized design, work units were randomly assigned either to receive the mobile phone-based lifestyle interventions or usual care. The reduction in 10-year CVD risk at 1-year follow-up for the intervention group was not statistically significant (–1.05%, p = 0.096). However, the mean risk increased significantly by 1.77% (p = 0.047) for the control group. The difference of the changes between treatment arms in CVD risk was –2.83% (p = 0.001). In addition, there were statistically significant changes for the intervention group relative to the controls, from baseline to year 1, in systolic blood pressure (–5.55 vs. 6.89 mmHg; p < 0.001), diastolic blood pressure (–6.61 vs. 5.62 mmHg; p < 0.001), total cholesterol (–0.36 vs. –0.10 mmol/L; p = 0.005), fasting plasma glucose (–0.31 vs. 0.02 mmol/L; p < 0.001), BMI (–0.57 vs. 0.29 kg/m2; p < 0.001), and waist hip ratio (–0.02 vs. 0.01; p < 0.001). Mobile phone-based intervention may therefore be a potential solution for reducing CVD risk in China.
Although evidence suggests that lifestyle interventions can reduce blood pressure (BP) and glucose levels, there is little information about the feasibility of such interventions when implemented in community settings. This study evaluated the effectiveness of a community-based lifestyle intervention on BP and glucose in the middle-aged and older Chinese population. By using a cluster randomisation approach, 474 participants from two communities were assigned to the intervention group which received intensive health education and behavioural intervention, or the control group which received conventional education. Linear mixed models were used to compare between-group differences on change in BP and fasting glucose after 6, 12 and 24 months. At the 12-month follow-up, the intervention group experienced significantly reductions in systolic BP (−4.9 vs. 2.4 mmHg; mean difference [MD] −7.3 mmHg; p < 0.001), diastolic BP (−1.9 vs. 1.9 mmHg; MD −3.8 mmHg; p < 0.001) and fasting glucose (−0.59 vs. 0.08 mmol/L; MD −0.67 mmol/L; p < 0.001). These differences were sustained at the 24-month follow-up. With only two communities, it was not possible to adjust for potential clustering by site. This approach of lifestyle interventions conducted through primary care services may be a potential solution for combating hypertension and diabetes in a resource-limited country context in China.
Background: Many injection drug users (IDUs) in China have high risk sexual behaviors that contribute to the spread of HIV infection. Although many IDUs in China move through drug rehabilitation centers, this opportunity for sexual health education has largely been overlooked. Methods: A convenience sample of 667 drug users from two rehabilitation centers in South China was recruited in the study. Two hundred and forty seven drug users from a single Guangdong Province rehabilitation center received the peer-based education intervention, while 420 drug users from another rehabilitation center received routine HIV/STI education and was used as the control. One hundred and eighty nine (22.1%) individuals refused to participate in the study. HIV/STI behavioral and knowledge domains were assessed at 3 months in rehabilitation centers after the intervention (first follow-up) and at 2-23 months in the community after release (second follow-up). Results: Drug users who completed the intervention reported more frequent condom use with casual sex partners (60.0% vs. 12.5% condom use every time, p = 0.011) and less frequent injection (56.7% vs. 26.4% no injection per day, p = 0.008) at the second follow-up compared to those in the routine education group. Loss to follow up was substantial in both control and intervention groups, and was associated with living far from the detention center and having poor HIV knowledge at baseline. Conclusions: This study shows that rehabilitation centers may be a useful location for providing behavioral HIV/STI prevention services and referral of individuals to community-based programs upon release. More research is needed on behalf of detained drug users in China who have complex social, medical, and legal needs.