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  • The findings of this meta analysis should be interpreted wit

    2018-10-23

    The findings of this TGF-beta Smad Compound Library meta-analysis should be interpreted with caution because of several limitations. First, we excluded conference abstracts, reviews, editorials, case reports and articles not written in English or Chinese, which may bias our results. In addition, we omitted unpublished studies and studies not indexed in our set of databases. Nevertheless, our funnel plots suggested no significant risk of publication bias. Second, there may have been misclassification bias. The diagnosis of sarcoidosis in the case group was biopsy-confirmed in only 12 studies (11 publications); in the remaining five studies (Lee et al., 2015; Suchankova et al., 2013; Danila et al., 2009a; Fireman et al., 2006; Smith et al., 2006a), sarcoidosis was diagnosed based on the combination of clinical, radiological, pathological and follow-up observation. Some cases lacked histological evidence of non-caseating granulomas. Third, most studies in our meta-analysis did not report blinding, which increases the risk of analytical bias. Future diagnostic studies should avoid these methodological problems. Future studies should also examine the cost-effectiveness of determining BALF lymphocyte ratios relative to more invasive biopsy, as well as compare the ratio with endobronchial ultrasound transbronchial needle aspiration, which has been shown to be a safe and effective diagnostic procedure (Costabel et al., 2010; Agarwal et al., 2012). The following is the supplementary data related to this article.
    Author Contributions
    Declaration of interests
    Acknowledgments This work was supported by grants 81230001 and 81300032 from the National Natural Science Foundation of China.
    Introduction Chronic kidney disease (CKD) is highly prevalent in non-valvular AF patients, ranging from 26% to 32%, especially in the elderly (Apostolakis et al., 2013; Banerjee et al., 2013). The presence of CKD in AF patients is associated with a greater risk of adverse clinical outcomes, including stroke, thromboembolism and bleeding. In the Danish nationwide cohort study, for example, the presence of CKD amongst patients with AF was significantly associated with an increased risk for stroke/systemic embolism (by 1.49-fold), all-cause mortality (by 2.37-fold), myocardial infarction (by 2-fold) and major bleeding (by 1.33-fold) (Olesen et al., 2012). Warfarin use amongst such patients has been associated with a substantial risk reduction in overall event rates, with a positive net clinical benefit (Bonde et al., 2014). Similarly, the Loire Valley Atrial Fibrillation Project confirmed the high risk associated with CKD in patients with AF (Banerjee et al., 2014, 2013). In clinical trial populations, CKD also confers a much higher relative risk for both stroke and bleeding (Apostolakis et al., 2013; Piccini et al., 2013). When Vitamin K Antagonists (VKAs, e.g. warfarin) are used for thromboprophylaxis, good quality anticoagulation control, as reflected by time in therapeutic range (TTR) >70% is recommended (De Caterina et al., 2013). Limited information been reported on the relationship between CKD and TTR in AF patients, but good TTR has been associated with lower risks of thromboembolism and bleeding (Connolly et al., 2008; Friberg et al., 2014; Pokorney et al., 2015).
    Methods For the present analysis, we used the pooled study populations of the Stroke Prevention using an Oral Thrombin Inhibitor in patients with atrial Fibrillation (SPORTIF) III and V trials. The original protocol and principal results have been previously described (Albers et al., 2005; Halperin, 2003; Olsson, 2003). In brief, the SPORTIF trials were two multicentre phase III clinical trials comparing the efficacy and safety of the direct thrombin inhibitor, ximelagatran, against warfarin in patients with non-valvular AF. SPORTIF III was an open label trial, while SPORTIF V was a double blind study (Halperin, 2003). Signed, informed consent was required from each participant in accordance with protocol regulations approved by the local review boards governing research involving human subjects, and the Declaration of Helsinki. In both SPORTIF trials, ximelagatran was non-inferior in efficacy and safety as warfarin for stroke prevention in non-valvular AF patients (Lip, 2005) but due to hepatotoxicity, ximelagatran was withdrawn. For the purpose of this study, we studied only SPORTIF patients assigned to warfarin treatment where complete information on renal function was available.