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Experience With Clinical Testing of Dextran Solutions

Experience With Clinical Testing of Dextran Solutions Abstract THE NECESSITY of submitting data to federal agencies in the process of getting approval for marketing led us to conduct studies in medical student volunteers with several batches of dextran solutions. The size of our study—involving 41 healthy young adults in 59 trials—seems to be sufficiently representative to allow some generalization. The observations made in seven cases point to a type of side effect that might be amenable to premedication with an antihistaminic agent. Design of Study. —The quality control of the dextran solutions, as specified in the Defense Medical Purchase Description,1 consisted of the following procedure: (1) measurement of the sublingual temperature; (2) determination of the bleeding time (Ivy method); and (3) thrombocyte count, all being done before intravenous infusion of 500 ml of dextran solution (into an antebrachial vein) over a period of 45 to 60 minutes (approximately 10 ml/min), and again immediately after the infusion, half References 1. Defense Medical Purchase Description, No. 5, Sept 24, 1965, Federal Stock No. 6505-116-1890. 2. Rocha e Silva, M.: Histamine: Its Role in Anaphylaxis and Allergy , Springfield, Ill: Charles C Thomas, 1955. 3. Briot, M., and Halpern, B.N.: Symptomatologie et pathogenie du syndrome oedemateux produit par le dextran chez le rat , C. R. Soc Biol 146:15-20, 1952. 4. Vorhees, A.B.; Baker, H.J.; and Pulaski, E.J.: Reactions of Albino Rats to Injections of Dextran , Proc Soc Exp Biol Med 76:254-256, 1951.Crossref 5. Haining, C.G.: Histamine Release in Rabbit Blood by Dextran and Dextran Sulphate , Brit J Pharmacol 10:87-94, 1955. 6. Briot, M., and Halpern, B.N.: Action inhibitrice de la prométhazine (Phénergan) et de l'adrenaline sur l'oedème du rat par le dextran , C. R. Soc Biol 146:21-24, 1952. 7. Anderson, R., and Hardenbergh, E.: Anaphylactoid Reaction of the Mouse to Dextran , Proc Soc Exp Med 117:565-567, 1964.Crossref 8. Halpern, B.N., and Briot, M.: Hyperhistaminémie provoquée par l'injection du dextran chez le Rat , C. R. Soc Biol 148:1046-1049, 1954. 9. Halpern, B.N.: Histamine release by long chain molecules , in: Histamine, Ciba Foundation Symposium , Boston: Little, Brown and Co., 1956, pp 92-123. 10. Beraldo, W.T.; Dias da Silva, W.; and Lemos Fernandez, A.D.: Inhibitory Effects of Carbohydrates on Histamine Release and Mast Cell Disruption by Dextran , Brit J Pharmacol 19:405-413, 1962. 11. Adamkiewicz, V.W., and Adamkiewicz, L.M.: Glucose and the Dextran "Anaphylactoid" Inflammation , Amer J Physiol 198:51-53, 1960. 12. Morrison, J.L.; Richardson, A.P.; and Bloom, W.L.: The Effects of Antihistaminic Agents on the Reaction of the Rat to Dextran , Arch Int Pharmacodyn 88:98-105, 1951. 13. Kabat, E.A., and Bezer, A.E.: The Effect of Variation of Molecular Weight on the Antigenicity of Dextran in Man , Arch Biochem 78:306-318, 1958.Crossref 14. Pulaski, E.J.: The Clinical Status of Dextran, PVP and Gelatin Products , Quart Rev Med 9:172-179, 1952. 15. Kabat, E.A., et al: Studies on the Immunochemical Basis of Allergic Reactions to Dextran in Man , J Clin Invest 36:1160-1170, 1957.Crossref 16. Paton, W.D.M.: The Mechanism of Histamine Release , in: Histamine, Ciba Foundation Symposium , Boston: Little, Brown and Co., 1956, pp 59-73. 17. Paton, W.D.M.: Histamine Release by Compounds of Simple Chemical Structure , Pharmacol Rev 9:269-328, 1957. 18. Paton, W.D.M.: Histamine Metabolism , Int Arch Allerg 6:203-229, 1955.Crossref 19. Dias da Silva, W., and Lemos Fernandez, A.D.: Study of the Mechanism of Inhibition Produced by Hexoses on Histamine Release Activity of Dextran , Experientia 21:96-97, 1965.Crossref 20. Parrat, J.R., and West, G.B.: 5-Hydroxytryptamine and the Anaphylactoid Reaction in the Rat , J Physiol 139:27-41, 1957. 21. Greef, K., et al: Die Abnahme des Kininogengehaltes des Plasmas beim toxischen, anaphylaktischen und anaphylaktoiden Schock , Naunyn Schmiedeberg Arch Exp Path 253:235-245, 1966. 22. Adamkiewicz, V.W., and Sacra, P.J.: Passive Transfer of Anaphylactoid Reaction in Rats , Amer J Physiol 205:357-359, 1963. 23. Thompson, W.L., and Walton, R.P.: Evaluation of Plasma Histamine Levels in the Dog Following Administration of Muscle Relaxants, Opiates and Macromolecular Polymers , J Pharmacol Exp Therap 143:131-136, 1964. 24. Harris, J.M., and West, G.B.: Rats Resistant to the Dextran Anaphylactoid Reaction , Brit J Pharmacol 20:550-562, 1963. 25. Fearn, H.J., and West, G.B.: Letter to Editor: Reactivity of Rats to Dextran , J Pharm Pharmacol 17:813, 1965.Crossref 26. Seaman, G.V.F., et al: Physicochemical Changes in Blood Arising From Dextran Infusions , Clin Sci 29:293-304, 1965. 27. Eiseman, B., and Bosomworth, P. (eds.): Evaluation of Low Molecular Weight Dextran in Shock: Pharmacology and Pertinent Rheology , Washington, DC: National Academy of Sciences, National Research Council, 1963. 28. Squire, J.R., et al: Dextran: Its Properties and Use in Medicine , Springfield, Ill: Charles C Thomas, 1955. 29. Segal, A.: The Clinical Use of Dextran Solutions , New York: Grune and Stratton, 1964. 30. Klinman, A.: Presently Useful Plasma Volume Expanders , Anaesthesiology 27:417-424, 1966.Crossref 31. Atik, M.: Dextrans: Their Use in Surgery and Medicine , Anaesthesiology 27:425-438, 1966.Crossref 32. Getzen, J.H., and Speiggle, W.: Anaphylactic Reaction to Dextran: A Case Report , Arch Intern Med 112:168-170, 1963.Crossref 33. Shephard, D.A.E., and Vandam, L.D.: Anaphylaxis Associated With the Use of Dextran , Anaesthesiology 25:244-246, 1964.Crossref 34. Bailey, G., et al: Dextran-Induced Anaphylaxis , JAMA 200:889-891, 1967.Crossref 35. Loew, E.R.; MacMillan, R.; and Kaiser, M.E.: The Anti-histamine Properties of Benadryl, β-Dimethylaminoethyl Benzhydryl Ether Hydrochloride , J Pharmacol Exp Therap 86:229-238, 1946. 36. Langsjoen, P.H.: Observations in the Excretion of Low Molecular Weight Dextran , Angiology 16:148-153, 1965.Crossref 37. Morgan, T.O.; Little, J.M.; and Evans, W.A.: Renal Failure Associated With Low-Molecular-Weight Dextran Infusion , Brit Med J 2:737-739, 1966.Crossref http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Surgery American Medical Association

Experience With Clinical Testing of Dextran Solutions

Archives of Surgery , Volume 96 (3) – Mar 1, 1968

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Publisher
American Medical Association
Copyright
Copyright © 1968 American Medical Association. All Rights Reserved.
ISSN
0004-0010
eISSN
1538-3644
DOI
10.1001/archsurg.1968.01330210149029
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Abstract

Abstract THE NECESSITY of submitting data to federal agencies in the process of getting approval for marketing led us to conduct studies in medical student volunteers with several batches of dextran solutions. The size of our study—involving 41 healthy young adults in 59 trials—seems to be sufficiently representative to allow some generalization. The observations made in seven cases point to a type of side effect that might be amenable to premedication with an antihistaminic agent. Design of Study. —The quality control of the dextran solutions, as specified in the Defense Medical Purchase Description,1 consisted of the following procedure: (1) measurement of the sublingual temperature; (2) determination of the bleeding time (Ivy method); and (3) thrombocyte count, all being done before intravenous infusion of 500 ml of dextran solution (into an antebrachial vein) over a period of 45 to 60 minutes (approximately 10 ml/min), and again immediately after the infusion, half References 1. Defense Medical Purchase Description, No. 5, Sept 24, 1965, Federal Stock No. 6505-116-1890. 2. Rocha e Silva, M.: Histamine: Its Role in Anaphylaxis and Allergy , Springfield, Ill: Charles C Thomas, 1955. 3. Briot, M., and Halpern, B.N.: Symptomatologie et pathogenie du syndrome oedemateux produit par le dextran chez le rat , C. R. Soc Biol 146:15-20, 1952. 4. Vorhees, A.B.; Baker, H.J.; and Pulaski, E.J.: Reactions of Albino Rats to Injections of Dextran , Proc Soc Exp Biol Med 76:254-256, 1951.Crossref 5. Haining, C.G.: Histamine Release in Rabbit Blood by Dextran and Dextran Sulphate , Brit J Pharmacol 10:87-94, 1955. 6. Briot, M., and Halpern, B.N.: Action inhibitrice de la prométhazine (Phénergan) et de l'adrenaline sur l'oedème du rat par le dextran , C. R. Soc Biol 146:21-24, 1952. 7. Anderson, R., and Hardenbergh, E.: Anaphylactoid Reaction of the Mouse to Dextran , Proc Soc Exp Med 117:565-567, 1964.Crossref 8. Halpern, B.N., and Briot, M.: Hyperhistaminémie provoquée par l'injection du dextran chez le Rat , C. R. Soc Biol 148:1046-1049, 1954. 9. Halpern, B.N.: Histamine release by long chain molecules , in: Histamine, Ciba Foundation Symposium , Boston: Little, Brown and Co., 1956, pp 92-123. 10. Beraldo, W.T.; Dias da Silva, W.; and Lemos Fernandez, A.D.: Inhibitory Effects of Carbohydrates on Histamine Release and Mast Cell Disruption by Dextran , Brit J Pharmacol 19:405-413, 1962. 11. Adamkiewicz, V.W., and Adamkiewicz, L.M.: Glucose and the Dextran "Anaphylactoid" Inflammation , Amer J Physiol 198:51-53, 1960. 12. Morrison, J.L.; Richardson, A.P.; and Bloom, W.L.: The Effects of Antihistaminic Agents on the Reaction of the Rat to Dextran , Arch Int Pharmacodyn 88:98-105, 1951. 13. Kabat, E.A., and Bezer, A.E.: The Effect of Variation of Molecular Weight on the Antigenicity of Dextran in Man , Arch Biochem 78:306-318, 1958.Crossref 14. Pulaski, E.J.: The Clinical Status of Dextran, PVP and Gelatin Products , Quart Rev Med 9:172-179, 1952. 15. Kabat, E.A., et al: Studies on the Immunochemical Basis of Allergic Reactions to Dextran in Man , J Clin Invest 36:1160-1170, 1957.Crossref 16. Paton, W.D.M.: The Mechanism of Histamine Release , in: Histamine, Ciba Foundation Symposium , Boston: Little, Brown and Co., 1956, pp 59-73. 17. Paton, W.D.M.: Histamine Release by Compounds of Simple Chemical Structure , Pharmacol Rev 9:269-328, 1957. 18. Paton, W.D.M.: Histamine Metabolism , Int Arch Allerg 6:203-229, 1955.Crossref 19. Dias da Silva, W., and Lemos Fernandez, A.D.: Study of the Mechanism of Inhibition Produced by Hexoses on Histamine Release Activity of Dextran , Experientia 21:96-97, 1965.Crossref 20. Parrat, J.R., and West, G.B.: 5-Hydroxytryptamine and the Anaphylactoid Reaction in the Rat , J Physiol 139:27-41, 1957. 21. Greef, K., et al: Die Abnahme des Kininogengehaltes des Plasmas beim toxischen, anaphylaktischen und anaphylaktoiden Schock , Naunyn Schmiedeberg Arch Exp Path 253:235-245, 1966. 22. Adamkiewicz, V.W., and Sacra, P.J.: Passive Transfer of Anaphylactoid Reaction in Rats , Amer J Physiol 205:357-359, 1963. 23. Thompson, W.L., and Walton, R.P.: Evaluation of Plasma Histamine Levels in the Dog Following Administration of Muscle Relaxants, Opiates and Macromolecular Polymers , J Pharmacol Exp Therap 143:131-136, 1964. 24. Harris, J.M., and West, G.B.: Rats Resistant to the Dextran Anaphylactoid Reaction , Brit J Pharmacol 20:550-562, 1963. 25. Fearn, H.J., and West, G.B.: Letter to Editor: Reactivity of Rats to Dextran , J Pharm Pharmacol 17:813, 1965.Crossref 26. Seaman, G.V.F., et al: Physicochemical Changes in Blood Arising From Dextran Infusions , Clin Sci 29:293-304, 1965. 27. Eiseman, B., and Bosomworth, P. (eds.): Evaluation of Low Molecular Weight Dextran in Shock: Pharmacology and Pertinent Rheology , Washington, DC: National Academy of Sciences, National Research Council, 1963. 28. Squire, J.R., et al: Dextran: Its Properties and Use in Medicine , Springfield, Ill: Charles C Thomas, 1955. 29. Segal, A.: The Clinical Use of Dextran Solutions , New York: Grune and Stratton, 1964. 30. Klinman, A.: Presently Useful Plasma Volume Expanders , Anaesthesiology 27:417-424, 1966.Crossref 31. Atik, M.: Dextrans: Their Use in Surgery and Medicine , Anaesthesiology 27:425-438, 1966.Crossref 32. Getzen, J.H., and Speiggle, W.: Anaphylactic Reaction to Dextran: A Case Report , Arch Intern Med 112:168-170, 1963.Crossref 33. Shephard, D.A.E., and Vandam, L.D.: Anaphylaxis Associated With the Use of Dextran , Anaesthesiology 25:244-246, 1964.Crossref 34. Bailey, G., et al: Dextran-Induced Anaphylaxis , JAMA 200:889-891, 1967.Crossref 35. Loew, E.R.; MacMillan, R.; and Kaiser, M.E.: The Anti-histamine Properties of Benadryl, β-Dimethylaminoethyl Benzhydryl Ether Hydrochloride , J Pharmacol Exp Therap 86:229-238, 1946. 36. Langsjoen, P.H.: Observations in the Excretion of Low Molecular Weight Dextran , Angiology 16:148-153, 1965.Crossref 37. Morgan, T.O.; Little, J.M.; and Evans, W.A.: Renal Failure Associated With Low-Molecular-Weight Dextran Infusion , Brit Med J 2:737-739, 1966.Crossref

Journal

Archives of SurgeryAmerican Medical Association

Published: Mar 1, 1968

References