BOS, J.D.; MEINARDI, M.M. Exp. Dermatol. 2000, 9 3 ; , 165-169 2 ; HUEBER, F.; BESNARD, M.; SCHAEFER, H.; WEPIERRE, J. Skin Pharmacol. 1994, 7 5 ; , 245-256 3 ; PAUS, R.; BOTCHKAREV, V.A.; BOTCHKAREVA, N, V.; MECKLENBURG, L.; LUGER, T.; SLOMINSKI, A. Ann. N. Y. Acad. Sci. 1999, 885, 350-63 ; HADLEY, M.E.; HASKELL-LUEVANO, C. Ann. N. Y. Acad. Sci. 1999, 885, 1-21 ; HAGGAG, A.; EKLUND, B.; LINAKER, O.; GOTESTAM, K.G. Acta Psychiatr. Scand. 1990, 81 2 ; , 141-145 6 ; GLOTH, F.M. 3rd; ALAM, W.; HOLLIS, B.; J. Nutr. Health Aging 1999, 3 1 ; , 5-7 7 ; MICHELSON, D.; STRATAKIS, C.; HILL, L.; REYNOLDS, J.; GALLIVEN, E.; CHROUSOS, G.; GOLD, P. N. Engl. J. Med. 1996, 335 16 ; , 1176-81 8 ; BLAKEMORE, S.J.; WOLPERT, D.; FRITH, C. Neuroreport 2000, 11 ; , R11-6 9 ; KATOU, F.; OHTANI, H.; SAARISTO, A.; NAGURA, H.; MOTEGI, K. Am. J. Pathol. 2000, 156 2 ; , 519 527 10 ; XIE, Y.; LI, Y.; ZHANG, Q.; STILLER, M.J.; WANG, C.L, STREILEIN, J.W. J. Dermatol. Sci. 2000, 24 1 ; , 25-37. 11 ; BECKER, Y. Acta Microbiol. Immunol. Hung. 1996, 43 1 ; , 1-17 1, for example, beta blocker. Drug name description flavored to improve palatability.
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All trials were described as double-blind. In the study by Targan et al the infliximab and placebo solutions were prepared by a pharmacist at each site who was aware of treatment assignments. The investigators, all other study personnel and patients, were blinded to treatment assignment during the double-blind phase of the trial. 70 The same was true for the re-treatment phase of this study.77 In the fistulising Crohn's disease study by Present et al, all study personnel including pharmacists ; and patients were masked from treatment. Data on blinding are not clearly presented for the ACCENT I trial. Intention to treat analysis was only clearly used in the study by Present et al.64 The study by Rutgeerts et al68 does not specify whether intention-to-treat analysis was used. In this trial, for continuous variables, patients who discontinued regularly scheduled follow-up or underwent a surgical procedure or change in medication related to their Crohn's disease not permitted by the trial protocol, had their last observation carried forward.68 The Targan study70 was not analysed by intention-to-treat. Two patients assigned to treatment did not receive it and were not included in the analysis. The remaining patients were analysed according to the treatment to which they were randomised. 70 A total of 24 patients did not complete the re-treatment trial conducted by Rutgeerts et al; 68 14 assigned to placebo and 10 assigned to infliximab. Reasons for discontinuation were lack of efficacy 12 placebo, 4 infliximab ; , adverse events 0 placebo, 6 infliximab ; and other 2 placebo, withdrawal of consent and non-compliance ; . In the fistulising Crohn's disease trial conducted by Present et al, six patients completed only two of the planned three infusions 4 placebo, 1 infliximab 5mg kg, 1 10mg kg ; . Reasons for discontinuation of treatment were lack of efficacy 3 placebo ; , adverse events 1 infliximab 10mg kg ; , other 1 placebo, administration reasons; 1 infliximab 5mg kg, withdrawal of consent ; . The ACCENT I trial is still ongoing, details on, methods of analysis and number of patient withdrawals are not yet available. Interventions and comparators The three fully completed trials incorporated into this review all had a placebo comparator arm and a 10mg kg infliximab treatment arm. The other doses evaluated are shown in Table 5. The Targan study allowed patients who had not achieved a response to their initial infusion at week 4 to receive an additional open-label infusion of infliximab at a dose of 10mg kg. In the ACCENT I study all patients received an initial 5mg kg dose of infliximab and were randomised to continued dosing with infliximab 5mg kg or 10mg kg ; or placebo. Infliximab was administered by slow intravenous infusion over a 2-hour period in all the trials and cefaclor. 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Maternal Lifestyle Study Institutions and Investigators Brown University, Providence, RI: Barry M. Lester, PhD; Linda LaGassee, PhD; Susan Schibler, RN; Melissa Ambrosia, RN. University of Miami, Miami, Fla: Charles R. Bauer, MD; Wendy Griffin, RN; Elizabeth Jacque, RN. University of Tennessee, Memphis: Henrietta S. Bada, MD; Marilyn Williams, MSW; Tina Hudson, BSN. Wayne State University, Detroit, Mich: Seetha Shankaran, MD; Eunice Woldt, MSN; Jay Ann Nelson, BSN. The George Washington University Biostatistics Center, Rockville, Md: Joel Verter, PhD; Heidi Krause-Steinrauf, MS. Research Triangle Institute International, Research Triangle Park, NC: W. Kenneth Poole, PhD; John Langer, MSc; Jane Hammond, MA; Ann Bowler, MS. National Institute on Child Health and Human Development, Bethesda Md: Linda L. Wright, MD. National Institute on Drug Abuse, Bethesda: Vincent L. Smeriglio, PhD. Administration on Children, Youth and Families, Washington, DC: Penelope L. Maza, PhD. 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14. Hoffman RM. The multiple uses of fluorescent proteins to visualize cancer in vivo. Nat Rev Cancer 2005; 5: 796-806. Kanda T, Sullivan KF, Wahl GM. Histone-GFP fusion protein enables sensitive analysis of chromosome dynamics in living mammalian cells. Curr Biol 1998; 8: 377-85. Yamamoto N, Jiang P, Yang M, Xu M, Yamauchi K, Tsuchiya H, Tomita K, Wahl GM, Moossa AR, Hoffman RM. Cellular dynamics visualized in live cells in vitro and in vivo by differential dual-color nuclear-cytoplasmic fluorescent-protein expression. Cancer Res 2004; 64: 4251-6. Yamauchi K, Yang M, Jiang P, Yamamoto N, Xu M, Amoh Y, Tsuji K, Bouvet M, Tsuchiya H, Tomita K, Moossa AR, Hoffman RM. Real-time in vivo dual-color imaging of intracapillary cancer cell and nucleus deformation and migration. Cancer Res 2005; 65: 4246-52. Yamauchi K, Yang M, Jiang P, Xu M, Yamamoto N, Tsuchiya H, Tomita K, Moossa AR, Bouvet M, Hoffman RM. Development of real-time subcellular dynamic multicolor imaging of cancer-cell trafficking in live mice with a variable-magnification whole-mouse imaging system. Cancer Res 2006; 66: 4208-14. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked "advertisement" in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. To whom correspondence should be addressed: Laboratory of Cell Regulation and Carcinogenesis, NCI, Bldg. 41, Rm. C629, 41 Library Dr., MSC 5055, National Institutes of Health, Bethesda, MD 208925055. Tel.: 301-496-8350; Fax: 301-496-8395; E-mail: Kims mail. nih.gov. 1 The abbreviations used are: SERM, selective estrogen receptor modulator; ERs, estrogen receptors; FBS, fetal bovine serum; cFBS, charcoal-stripped FBS; HA, hemagglutinin; RT, reverse transcriptase; TUNEL, dUTP nick-end labeling; IL, interleukin; Z, benzyloxycarbonyl; fmk, fluoromethyl ketone; CMX-Ros, chloromethyl-X-rosamine; PP2A, protein phosphatase 2A; WT, wild type and citalopram.
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