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Background
Severe pneumonia is associated with high mortality and morbidity, and increased antibiotics resistance in the past decades has further deteriorated its prognosis. In view of the limited range of antibiotics, there is an urgent need to develop new non-antibiotics-based strategies to improve the outcome of severe pneumonia. Furthermore, mortality from severe pneumonia has been largely independent of insulting microbes. Xuebijing, a Chinese medicine extract infusion formula, has been shown to have effects on cytokine reduction, anti-coagulation, and neutralisation of released bacterial cytotoxins. Results of clinical studies show improved outcomes after Xuebijing infusion, including increased survival, reduced hospital admissions, and improved clinical presentations.Methods
To confirm previous findings, we did a multicenter, double-blinded, randomised trial. Patients who met criteria of severe pneumonia (on the basis of 2007 ATS/IDSA guidelines) were enrolled from 32 tertiary hospitals in China between Dec 1, 2013, and May 30, 2016, after approval from the Institutional Review Board of Zhongshan Hospital. Consent was obtained from all participants. The trial was registered at the Chinese clinical trial registry (ChiCTR-TRC-13003534).Findings
710 patients were randomly allocated to receive intravenous injections (100 mL) of 0·9% NaCl BID (control) or Xuebijing (in 0·9% NaCl) BID for 5–7 days. Clinical and laboratory parameters were recorded and analysed for efficacy and safety. Xuebijing infusion reduced mortality compared with control solution (25% in the control group vs 16% in the Xuebijing group; p=0·009), and some patients showed an improved pneumonia severity index (46% in the control group vs 61% in the treatment group; p<0·0001). Similar results were obtained for sequential organ failure assessment, lung injury score, multiple organ dysfunction score, and systemic inflammatory response syndrome after Xuebijing infusion. Chest X-ray image analysis showed a greater resolution of infiltration in the treatment group than in the control group.Interpretation
Taken together, Xuebijing infusion combined with standardised treatment could reduce mortality in patients with severe pneumonia, suggesting that Xuebijing could be a potential and promising adjunct therapy in severe pneumonia.Funding
This study was supported by Tianjin Science and Technology committee grant (14ZXLJSY00230) and Tianjin Chase Sun Pharmaceutical. 相似文献3.
Xiaona Liu Hong Fang Qinghua Xia Yingyao Chen Peng Zhou Yujie Yan Junling Gao Yu Jiang Baodong Yao Russell L Rothman Wang Hong Xu 《Lancet》2017
Background
Patients with diabetes in China have low health literacy, which likely leads to poor glycaemic control and clinical outcomes. This study was designed to evaluate the effectiveness of health literacy-focused and exercise-focused interventions on glycated haemoglobin A1c (HbA1c) in the population.Methods
In this cluster-randomised controlled trial conducted from Feb 20, 2015, through April 30, 2017, in Shanghai, China, 799 patients aged 18 years or older with type 2 diabetes from 40 clusters of general practitioner teams were randomised into three intervention arms or a control arm in blocks of eight clusters. The control group received usual care, the health literacy group was supplemented with individualised low literacy communications delivered by trained health-care providers using an interactive diabetes education toolkit, and the exercise group had usual diabetes care but was also asked to walk 3–5 times a week, 30–40 min per day in the first 6 months and 60–70 min per day in the following 6 months. Patients in the comprehensive intervention group were given both the literacy and exercise interventions. Assessments were conducted upon enrolment and after 3, 6, and 12 months of intervention. The study analysed improvement in HbA1c at 12 months as a primary outcome. Ethics approval was obtained from the Medical Ethics Committee of Fudan University (IRB00002408 & FWA00002399, approval no 2013-06-0451). All participants provided written informed consent. This trial is registered with the International Standard Randomized Controlled Trial Number Register (no ISRCTN76130594).Findings
Complete 12-month data were available for 761 (95%) patients, 192 in the control group, 188 in the health literacy group, 188 in the exercise group, and 193 in the comprehensive intervention group. Compared with the control group, the three intervention groups had decreased HbA1c levels and were more likely to achieve goal HbA1c levels (HbA1c ≤7·0%). After 3 months of intervention, the largest decrease was observed in the comprehensive intervention group, with an adjusted β of ?0·47% (95% CI ?0·73 to ?0·20), followed by the health literacy group (?0·35%, ?0·60 to ?0·10) and exercise group (?0·32%, ?0·57 to ?0·06). At the 6-month and 12-month assessments, the effect of the exercise intervention increased, with an adjusted β of ?0·73% (95% CI ?0·98 to ?0·47) and ?0·75% (?1·05 to ?0·45), respectively, while those for the health literacy group were ?0·35% (?0·61 to ?0·10) and ?0·65% (?0·94 to ?0·35), respectively. The decrease in HbA1c was more pronounced in patients with higher literacy or numeracy levels at baseline.Interpretation
Both health literacy-focused and exercise-focused interventions improved glycaemic control in Chinese patients with diabetes, particularly in patients with higher literacy or numeracy levels at baseline. Implementation of these approaches could be helpful at other public health clinics across China.Funding
China Medical Board (CMB) Open Competition Project (No. 13-159) and the Social Science Fund of China National Ministry of Education (No. 14YJAZH092). 相似文献4.
Background
Psychological distress remains a significant challenge for patients with poorly controlled type 2 diabetes. This study aimed to evaluate if an empowerment-based self-management programme would optimise psychological wellbeing in this vulnerable population of patients with diabetes.Methods
Adult patients with poorly controlled type 2 diabetes from two tertiary hospitals in Xi'an city, China, were randomly allocated to intervention or control groups using a computer-generated randomisation list with a block size of four. Participants in the intervention group received the DESIRE programme, which is a patient-centred consultation programme to empower and engage patients in self-management and active coping. The trial's primary outcome was effect on HbA1c. In this secondary analysis, we report findings for diabetes distress measured by the Diabetes Distress Scale [DDS]; patients with a mean score of three or higher were deemed to be those with diabetes distress worthy of clinical attention. Analysis was with a generalised estimating equation model according to the intention-to-treat method. Data were collected at baseline and at 8 and 20 weeks after randomisation by trained nurses who were masked to group assignment. Written consent was obtained from participants before study commencement. This trial is registered with the Chinese Clinical Trial Register, number ChiCTR-IPR-14005492.Findings
Between April, 2014, and October, 2015, 242 patients were enrolled and randomised to control (n=121) or intervention (n=121) groups. Participants had similar social, demographic, and disease characteristics at baseline (mean diabetes duration 8·0 years [SD 6·0]; mean HbA1c 10·0% [SD 1·8]). Compared with participants in the control group, those in the intervention group had a significantly greater reduction in emotional-related distress (from mean score 3·24 [SD 1·19] to 2·54 [1·05] in the intervention group vs 3·45 [1·21] to 3·21 [1·23] in the control group; effect size 0·59, 95% CI 0·45–0·73, p=0·027) and regimen-related distress (from 3·45 [1·28] to 2·97 [0·96] vs 3·68 [1·14] to 3·55 [1·13]; effect size 0·56, 95% CI 0·42–0·69, p=0·011) after 20 weeks of follow-up. These reductions were clinically significant.Interpretation
The empowerment-based, patient-centred DESIRE programme could significantly reduce diabetes distress in patients with poorly controlled type 2 diabetes. Our findings provide a basis for integrating the DESIRE programme into routine care.Funding
No funding. 相似文献5.
Kaiyue Diao Duolao Wang Zhongxiu Chen Xi Wu Min Ma Ye Zhu Li Zhang Hua Wang Mian Wang Sen He Chen Li Qiao Deng Ting Yan Tao Wu Lu Tang Baotao Huang Jiayu Sun Yong He 《Clinical cardiology》2021,44(12):1709
BackgroundAngiotensin receptor neprilysin inhibitor (ARNI) sacubitril‐valsartan has been recommended as one of the first‐line therapies in heart failure with reduced ejection fraction. However, whether ARNI could benefit patients with ST‐segment elevation myocardial infarction (STEMI) by improving left ventricular (LV) remodeling remains unknown. The primary objective of the PERI‐STEMI trial is to assess whether sacubitril‐valsartan is more effective in preventing adverse LV remodeling for patients with STEMI than enalapril.HypothesisWe hypothesize that sacubitril/valsartan is superior to enalapril in preventing adverse LV remodeling evaluated by cardiovascular magnetic resonance imaging at the 6‐month follow‐up.MethodsPERI‐STEMI is an investigator‐initiated, prospective, multi‐center, randomized, open‐label, superiority trial with blinded evaluation of outcomes. A total of 376 first‐time STEMI patients with primary percutaneous coronary intervention (PPCI) within 12 h after symptom onset will be randomized to sacubitril‐valsartan or enalapril treatment. All the patients will receive a baseline cardiovascular magnetic resonance (CMR) examination at 4–7 days post‐PPCI. The primary endpoint is the change of indexed LV mass at the 6‐month follow‐up CMR.ResultsEnrollment of the first patient is planned in November 2021. Recruitment is anticipated to last for 12–18 months and patients will be followed for 5 years after randomization. The study is expected to complete in June 2027.ConclusionsThe results of the PERI‐STEMI trial are expected to provide CMR evidence on whether ARNI could benefit patients with STEMI, so as to facilitate the strategy of CMR‐based risk stratification and therapy selection for these patients. PERI‐STEMI is registered at ClinicalTrials.gov (NCT04912167). 相似文献