Efficacy and safety associated with the infusion speed of intravenous immunoglobulin for the treatment of Kawasaki disease: a randomized controlled trial
Fukui S, Seki M, Minami T, Kotani K, Oka K, Yokomizo A, Matsubara D, Sato T, Nozaki Y, Saito M, et al
Pediatric rheumatology online journal. 2021;19(1):107
BACKGROUND High-dose intravenous immunoglobulin (IVIG) is the mainstay of treatment for Kawasaki disease (KD). Usually, 2 g/kg of IVIG is administered over 10-24 h, depending on the institution or physician, but the association between infusion speed and effectiveness has not been reported. In this study, we evaluated the differences in efficacy and safety between two different IVIG administration speeds. METHODS This was a multicenter, unblinded, randomized controlled study. Patients newly diagnosed with KD were randomized into two groups: one who received IVIG over 12 h (12H group, double speed), and one that received IVIG over 24 h (24H group, reference speed). The endpoints included the duration of fever, incidence of coronary artery abnormalities (CAAs) and of adverse events. Laboratory data were evaluated before and after IVIG administration. RESULTS A total of 39 patients were enrolled. There was no difference between groups in fever duration after the initiation of IVIG (21 h vs. 21.5 h, p = 0.325), and no patient experienced CAAs. Two adverse events were observed in the 12H group (elevation of aspartate aminotransferase and vomiting), however no severe adverse events requiring treatments or extension of hospital stay were observed in either group. After initial IVIG administration, the change ratio of inflammatory markers, such as white blood cell counts, neutrophils, C-reactive protein, and albumin, did not show significant differences between the two groups. On the other hand, a greater increase of serum immunoglobulin G from its baseline level was observed in the 24H group compared to the 12H group (3037 ± 648 mg/dl vs. 2414 ± 248 mg/dl, p < 0.01). CONCLUSION The efficacy and safety of IVIG administered over 12 h (double speed) were similar to those administered over 24 h (reference speed). TRIAL REGISTRATION University Hospital Medical Information Network ( UMIN000014665 ). Registered 27 July 2014 - Prospectively registered, https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000017058.
Usefulness of LigaSure for liver resection: analysis by randomized clinical trial
Saiura A, Yamamoto J, Koga R, Sakamoto Y, Kokudo N, Seki M, Yamaguchi T, Yamaguchi T, Muto T, Makuuchi M
American Journal of Surgery. 2006;192((1):):41-5.
BACKGROUND The goal of the present study was to evaluate the efficacy of the novel LigaSure Vessel Sealing System (Valleylab, Boulder, CO) when used for liver resection. METHODS Sixty patients (n = 30 in each group) with liver pathology from a single center were randomized to undergo liver resection with either the LigaSure system or with conventional clamping methods. Patients were stratified according to tumor size (<5 or >5 cm), type of hepatectomy (minor or major), and liver damage (normal or injured). Estimated blood loss during liver transection was used as the primary end point, whereas liver transection speed and morbidity rate were used as secondary end points. RESULTS There were no hospital deaths. The median blood loss during liver transection was less in the LigaSure than in the conventional group (200 vs 322 mL; P = . 185). The amount of blood loss during minor hepatectomy was significantly less in the LigaSure than in the conventional group (186 vs 412 mL, P = . 012). The liver transection speed was significantly faster in the LigaSure than in the conventional group (2. 3 vs 1. 6 cm(2)/min, P < . 001. The number of ties required during liver transection was significantly less in the LigaSure than in the conventional group (6 vs 69 ties, P < . 001). The morbidity rate was similar when comparing the 2 groups, indicating that the LigaSure sealing device and conventional methods had comparable efficacy in sealing the bile duct in the portal triad. Postoperative bile leak was observed in 1 patient (3%) in the LigaSure group and in 3 patients (9%) in the conventional group (P = . 301). CONCLUSIONS The LigaSure system is an effective and safe tool for decreasing liver resection time.