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Objective and subjective results of a randomized, double-blind, placebo-controlled trial using cisapride to treat gastroparesis (1993)

Richards, Robert D. ; Valenzuela, Gregg A. ; Davenport, Karen G. ; [et al.]

Springer

Digestive diseases and sciences 38 (1993), S. 811-816

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ISSN: 1573-2568

Keywords: cisapride ; gastroparesis ; gastric emptying

Source: Springer Online Journal Archives 1860-2000

Topics: Medicine

Notes: Abstract Cisapride, a relatively new gastrointestinal prokinetic agent, has been reported to increase gastric emptying and improve symptoms of gastroparesis. We investigated these effects of cisapride in patients with severe idiopathic and diabetic gastroparesis during an eight-week trial. The study design was a two-week single-blind placebo run in period to exclude placebo responders, followed by a six-week randomized, double-blind, placebo-controlled treatment phase. Delayed gastric emptying of solids on radionuclide scan and a minimum symptom intensity score were inclusion criteria. Forty-three patients were entered: four placebo responders and one other patient were excluded, leaving 19 patients randomized to cisapride (20 mg per os three times a day before meals), and 19 patients to placebo. Seven individual symptoms of gastroparesis were scored in a daily diary and reviewed at two-week visits. Sixteen patients in the cisapride group were able to complete the trial compared to 12 on placebo. The gastric emptying study was repeated at the end of treatment or at the time of withdrawal for those who dropped out. Cisapride significantly increased solid gastric emptying relative to baseline (P=0.005) whereas placebo did not (P〉0.10). Cisapride did not significantly improve any symptom of gastroparesis relative to baseline or to placebo. We conclude that in a population of severe, refractory gastroparetic patients cisapride significantly accelerates gastric emptying of a solid meal without significantly reducing symptoms during a short-term treatment trial compared to placebo. Further trials of cisapride in less advanced and “end-stage” gastroparetics than studied here or combining cisapride with other prokinetic agents or antiemetics, are warranted.

Type of Medium: Electronic Resource

URL: http://dx.doi.org/10.1007/BF01295905

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Biosynthesis and function of membrane bound and secreted forms of recombinant CD11b/CD18 (Mac-1) (1993)

Berman, Phillip W. ; Nakamura, Gerald R. ; Riddle, Lavon ; [et al.]

New York, N.Y. : Wiley-Blackwell

Journal of Cellular Biochemistry 52 (1993), S. 183-195

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ISSN: 0730-2312

Keywords: integrin ; CD11b/CD18 ; Mac-1 ; Leu-CAM ; neutrophil ; Life and Medical Sciences ; Cell & Developmental Biology

Source: Wiley InterScience Backfile Collection 1832-2000

Topics: Biology , Chemistry and Pharmacology , Medicine

Notes: Full-length (membrane bound) and truncated (secreted) forms of the beta 2 integrin heterodimer, CD11b/CD18 (Mac-1), were expressed in a human kidney cell line (293) that normally does not express leukocyte adhesion molecules (Leu-CAMs). The biosynthesis of recombinant Mac-1 in 293 cells differed from that reported for leukocytes in that heterodimer formation was not required for CD11b to be exported to the cell surface. A stable cell line was constructed that constitutively secreted the recombinant, truncated Mac-1 heterodimer into growth conditioned cell culture medium. A novel monoclonal antibody that enabled an immunoaffinity method for the selective purification of recombinant Mac-1 heterodimers was identified. Sufficient protein was purified to allow the first measurement of the 50% inhibitory concentration (IC50) for CD11b/CD18 and for the direct comparison of the inhibitory activity of recombinant soluble Mac-1 with that of various CD18 and CD11b specific monoclonal antibodies. Purified recombinant soluble Mac-1 inhibited the binding of neutrophils, activated by opsonized zymosan or fMet-Leu-Phe peptide, to human umbilical vein endothelial cells. Similarly, the recombinant integrin was effective in inhibiting the binding of unactivated neutrophils to tumor necrosis factor (TNF-alpha) activated endothelial cells. The availability of an abundant source of purified, biologically active Mac-1 will enable direct physical and chemical investigations into the relationship between the structure and function of this leukocyte adhesion molecule.

Additional Material: 9 Ill.