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Examination of Patients Suspected As Having Hypersensitivity to Iodinated

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Examination of Patients Suspected As Having Hypersensitivity to Iodinated 1750 Regular Article Biol. Pharm. Bull. 37(11) 1750–1757 (2014) Vol. 37, No. 11 Examination of Patients Suspected as Having Hypersensitivity to Iodinated Contrast Media with Leukocyte Migration Test Mikio Saito,*,a Manabu Abe,a Tomoyasu Furukawa,b Motohiro Yagi,c Yoshihiro Koike,d Yutaka Wakasugi,e Norihiko Tabuchi,f and Katsuji Uno f a Laboratory of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, Niigata University of Pharmacy and Life Sciences; 265–1 Higashizima, Akiha-ku, Niigata 956–8603, Japan: b Department of Pharmacy, Niitsu Medical Center Hospital; 610 Furuta, Akiha-ku, Niigata 956–0025, Japan: c Department of Pharmacy, Brain Disease Center Agano Hospital; 6317–15 Yasuda, Agano, Niigata 959–2221, Japan: d Department of Pharmacy, Toyoura Hospital; 1611–8 Aramatikou, Shibata, Niigata 959–2311, Japan: e Department of Internal Medicine, Suibarago Hospital; 13–23 Okayama-cho, Agano, Niigata 959–2093 Japan: and f Laboratory of Molecular Microbiology, Faculty of Pharmacy and Pharmaceutical Sciences, Fukuyama University; 1 Gakuen-cho, Fukuyama, Hiroshima 729–0292, Japan. Received May 2, 2014; accepted August 15, 2014 In vivo tests may be used for the diagnosis of allergy to iodinated contrast media (ICM); however, the tests do not provide definitive diagnosis and are associated with risks for patients. Diagnoses based on in vitro tests are limited, and there are almost no relevant studies. Herein, the authors examined involvement of allergic reaction from a multilateral standpoint in 39 patients suspected of having ICM allergies using leukocyte migration test (LMT). The positive rate of LMT was 44%. A comparison with the positive rate of LMT in drugs other than ICM (74%) indicated 30% difference, which was significantly low value, suggesting that there is poor involvement of these drugs in the allergic reaction. In LMT positives, 76% of hypersensi- tivity reactions were skin rash mainly erythema, and 18% was anaphylactic reactions. Cases considered as non-immediate hypersensitivity accounted for about 4 times as many as immediate-type hypersensitivity. In examination of relevancy between a history of drugs or food allergies, the incidence of ICM allergies was 35%. There is a high possibility that these adverse reactions were caused by pseudoallergy to drug. It was suggested that most hypersensitivity reactions were skin rash related to non-immediate hypersensitivity, and approximately 20% of the reaction was immediate anaphylactic reaction. Therefore attention should be paid not only to immediate-type hypersensitivity but also delayed reactions. Moreover, it was considered that patients with past history of drug or food allergies have a high potential for manifestation of the reactions. Key words iodinated contrast media (ICM); leukocyte migration test (LMT); pseudoallergy; non-immediate hypersensitivity; allergic history Since the late 1980 s, a number of hypoosmotic, nonionic have reported a possibility of involvement of a variety of cy- iodinated contrast media (ICM) have been used instead of tokines to date.11–13) Furthermore, LMT is more sensitive than ionic ICM. To meet this trend, development of serious adverse DLST, and is also considered to have a high detection rate as effects, such as pain, sensations of burning and anaphylactoid an in vitro identification method.14) Especially, a chemotaxis symptoms at the time of high-pressure injection, reduced sig- chamber, which was developed by the authors, has a higher nificantly. On the other hand, allergic side effects caused by sensitivity than existing agarose plate methods, and has been nonionic ICM became to attract attention, and not only imme- reported that this method has a high clinical utility.15) diate type hypersensitivity cases, which have a high severity, Therefore, utility of LMT, involvement of allergic reaction, but also delayed hypersensitivity cases have been reported.1–5) and relevancy to hypersensitivity reaction, latency period and However, test methods used when ICM allergy is suspected past history of allergy were examined in patients suspected are in vivo identification tests including patch test, intracu- of being ICM hypersensitivity from a standpoint of in vitro taneous reaction test, prick test and scratch test. As in vitro identification methods by using LMT with high detection sen- identification tests, radio-allergo-solvent test (RAST) using sitivity. specific immunoglobulin E (IgE) antibody, histamine release test (HRT), basophil activation test (BAT) and drug-induced MATERIALS AND METHODS lymphocyte stimulation test (DLST) may be conducted. DLST are often used in clinical practice; however, clinical utility in Subjects This study examined the possibility of hyper- the diagnosis of ICM allergy is not proved yet because of its sensitivity to ICM at Suibarago Hospital over a 20 year period low detection sensitivity. In other words, there is almost no (April 1991 to March 2010), after the matter was brought up research analysis that used in vitro identification methods for by doctors. The pharmaceutical department was tasked with multiple cases to identify ICM allergy, and proved its utility. conducting LMT with a subject group of 49 patients. Of these Authors have reported that leukocyte migration test (LMT) patients, 10 patients, who indicated LMT positive to suspected is effective as a detection and identification method for hyper- drugs other than ICM, were eliminated, and 39 patients (18 sensitivity to drugs including drug eruption.6–10) LMT is not a males, 21 females) were included. The age was ranged from test method to identify cytokines or chemokines; however, we 25 to 79 years old (20’s, 2 cases; 30s, 1 case; 40s, 7 cases, 50s, 10 cases; 60s, 10 cases; 70s, 9 cases), and the average age The authors declare no conflict of interest. was 58.5±13.0 years old (mean±S.D.). * To whom correspondence should be addressed. e-mail: [email protected] © 2014 The Pharmaceutical Society of Japan November 2014 1751 Of the study patients, 9 patients (23%) had a past history buffer added TC-199 medium (Gibco)) (antigen solution with- of allergy, and the breakdown was 7 cases of drug allergy out patient serum; control solution was a mixed solution of (30%) and 2 cases of food allergy (9%). In addition, there was 100 µL of HBSS and 100 µL of culture medium). Another no patient with allergic diseases such as asthma and atopic antigen solution was prepared by mixing 100 µL of the drug dermatitis. solution with 100 µL of patient serum (antigen solution with The most common hypersensitivity reaction was skin rash patient serum; control solution was a mixed solution of 100 µL (28 cases, 72%), and followed by anaphylaxis (including ana- of HBSS and 100 µL of patient serum). Poorly soluble drugs phylactoid symptoms, shock-like symptoms) (10 cases, 26%), were used by dissolving in ethanol or 0.1 N sodium hydroxide and hepatic disorder (1 case, 3%). The LMT was conducted solution, or dissolving in dimethyl sulfoxide (DMSO) and the only with patients who had given consent, and after the sig- diluted with HBSS so that the final concentration of DMSO nificance of the test had been fully explained to the patients becomes 1% or under. Phytohemagglutinin (PHA), which is or their families. After doctors had requested LMT at the a mitogen, was uses at 1 µg/mL of reaction concentration as a pharmaceutical department, patient information was gathered positive control to confirm the responsiveness of the test. from various sources, including medical records held at the Maximum drug concentration (Cmax) of each test drug was pharmaceutical department on hypersensitivity reactions, used as the antigen concentration of the drug. However, if dosage periods and the like, as well as reports from attend- Cmax of the drug was unknown, a concentration of 1/50000/ ing physicians on patients suspected of susceptibility to side mL and 1/10000/mL of a dosage were used for oral and inject- effects from drugs, and direct interviews with patients and able drugs, respectively. The drug antigens were prepared on their families. These steps involved in conducting an LMT are the day of LMT. It was confirmed that concentrations of sol- routinely systematized within the hospital. Informed consent vent and test drugs used do not exert immunological influence satisfied “Ethical Guidelines for Epidemiology Research” of on the responsiveness of LMT induced by PHA stimulation. the Ministry of Education, Culture, Sports, Science and Tech- Separation of Mononuclear Leukocytes and Reaction Cul- nology and Ministry of Health, Labour and Welfare of Japan, ture LMT was conducted between 7 d and 3 months after the and LMT was also obtained approval of the Ethical Commit- discontinuation of test drug administration. In addition, this tee of Suibaragou Hospital. study was conducted such that drugs given during the test pe- Suspected Drugs (Test Drugs) Suspected drugs used for riod or during treatment would not affect immunocompetence; 39 study patients were at least one drug and at most six drugs the drugs used to treat the various hypersensitivity reactions per one case, and 42 types of 85 drugs were used in total. As and the drugs given subsequently did not have an effect on the shown in Table 1, ICM (diagnostic products) include six types LMT’s reactivity. For the reaction between the patient mono- of 39 drugs, which consist of ionic ICM including ioxaglic nuclear leukocytes and test drugs, mononuclear leukocytes acid (8 cases) and meglumine sodium amidotrizoate (1 case), (an intermediate layer) were collected from heparinized pe- and non-ionic ICM including iomeprol (8 cases), iopamidol (6 ripheral blood using specific gravity centrifugal method with cases), ioversol (13 cases), and iotrolan (3 cases). Other drugs Ficoll–Paque solution (Pharmacia Biotech, Uppsala, Sweden), include 8 types of 13 drugs affecting metabolism, which are and the separated mononuclear leukocytes after rinsing with the highest number, and followed by 9 types of 11 drugs af- HBSS were suspended into culture medium at a concentration fecting the central nervous system, 6 types of 7 drugs affect- of 1.25×106 cells/mL.
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