Background: Cardiac surgery can cause similar inflammatory reactions with infection; antibacterial treatment may be inappropriately used. Early and accurate diagnosis of infection still is a difficult problem worldwide. Procalcitonin (PCT) helps to identify sepsis caused by bacterial infections. However, its application in the diagnosis of pulmonary infections after off-pump coronary artery bypass grafting (OPCABG) has not been well studied. We investigated the early predictive value of PCT for the diagnosis of pulmonary infections after OPCABG. Methods: We retrospectively analyzed the clinical data, including conditions in the intensive care unit, postoperative complications, mortality rate, plasma PCT in the morning on the first postoperative day, routine white blood cell (WBC) count, and high-sensitivity C-reactive protein (hs-CRP) levels of patients who underwent elective OPCABG. Patients were divided into an infection group and a noninfection group, according to the occurrence of pulmonary infections. A receiver operating characteristic (ROC) curve was used to analyze the predictive value of PCT for the diagnosis of postsurgical infections. Results: In total, 131 patients who underwent OPCABG were included, of whom 23 (17.6%) developed pulmonary infections. The plasma PCT level significantly was higher in the infection group than in the noninfection group (6.0 ± 6.3 ng/ml vs. 2.0 ± 2.2 ng/ml, P = 0.007). WBC and hs-CRP values were not significantly different between the infection group and the noninfection group (12.3 ± 3.9×109/L vs. 11.1 ± 2.8×109/L, P = 0.171 and 12.4 ± 0.7 mg/L vs. 12.4 ± 0.8 mg/L, P = 0.903, respectively). The area under the ROC for predicting pulmonary infections after OPCABG by plasma PCT was 0.783 (P < 0.001, with a 95% confidence interval of 0.674–0.893), with a cut-off value of 3.55 ng/ml, a sensitivity of 0.609, and a specificity of 0.861. Conclusion: From our study results, we postulate that PCT has a high early predictive value for the diagnosis of pulmonary infections after OPCABG.
IntroductionPsoriasis vulgaris is a common skin disease that is characterised by persistent localised erythematous scaly plaques. Yinxieling is a Chinese herbal formula for psoriasis that has been used for more than 20 years in China. To facilitate application, PSORI-CM01 was developed based on the optimisation and simplification of Yinxieling tablets performed in a previous study and in clinical practice. However, the scientific evidence regarding whether PSORI-CM01 is more effective for psoriasis than the original Yinxieling remains insufficient. Therefore, we designed a randomised clinical trial to investigate the effect, safety and cost-effectiveness of PSORI-CM01 granules compared with those of Yinxieling tablets for the treatment of patients with psoriasis.Methods and analysisThis ongoing study is a two-arm parallel, randomised, double-blind, double-dummy clinical trial. Five hundred and fifty-six participants with psoriasis will be recruited and then randomly allocated into two groups in a 1:1 ratio. Participants in PSORI-CM01 group will receive a 5.5 g granule of PSORI-CM01 two times daily and five placebo tablets three times daily for 12 weeks. The participants in the Yinxieling group will receive five Yinxieling tablets three times daily and a placebo granule two times daily for 12 weeks. The primary outcome is the reduction of the Psoriasis Area and Severity Index. The secondary outcomes include relapse rate, Visual Analogue Scale scores, body surface area and the Dermatology Life Quality Index. Cost-effectiveness analysis will be performed from a health and community care provider perspective.Ethics and disseminationThis research protocol had been reviewed and approved by the institutional review boards of three trial centres (Guangdong Provincial Hospital of Chinese Medicine (B2014-026-01), Affiliated Hospital of Tianjin Chinese Medicine Academy (2014-KY-001) and Third Hospital of Hangzhou (B2014-026-01)). The findings will be disseminated to the public through conference presentations and open-access journals.Trial registration numberChinese Clinical Trial Registry (ChiCTR-TRC-14005185); Pre-results.
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