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Rifampicin* GRAHAM POOLE PETER STRADLING SHEILA WORLLEDGE

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Rifampicin* GRAHAM POOLE PETER STRADLING SHEILA WORLLEDGE Postgrad Med J: first published as 10.1136/pgmj.47.553.742 on 1 November 1971. Downloaded from Postgraduate Medical Journal (November 1971) 47, 742-747. Potentially serious side-effects of high-dose twice-weekly rifampicin* GRAHAM POOLE PETER STRADLING SHEILA WORLLEDGE Chest Clinic and Department of Haematology, Royal Postgraduate Medical School, and Hammersmith Hospital, DuCane Road, London, W. 12 Summary cin therapy in the summer of 1969. This preliminary Daily rifampicin in a single dose of 600 mg, combined report on side-effects of rifampicin is made to warn with other drugs, usually streptomycin and isoniazid, others that our experience suggests that rifampicin, was given to forty-nine patients for 3 months. It was when used twice-weekly at a dosage of 1200 mg, can planned to continue for another 15 months with result in an unacceptably high incidence of toxicity. twice-weekly rifampicin 1200 mg plus isoniazid 900 One side-effect encountered (thrombocytopenia) is mg, but the high incidence of side effects led to potentially extremely serious and was first recog- cessation of the intermittent regimen when only two nized by Farga (1970). A case of immune thrombo-Protected by copyright. patients had completed 18 months. cytopenia with rifampicin antibodies detected by Though there was no serious problem with daily reaction with platelets and red cells has already been treatment, eleven patients (22%) were unable to con- reported from this school (Blajchman et al., 1970) tinue rifampicin on the intermittent regimen. In eight and two more have now occurred, together with a (16%) a pyrexial syndrome occurred. In one of these case of transient renal failure. patients there was also temporary renal failure and in another, precipitous thrombocytopenia led to epistaxis Materials and methods and bleeding into the tongue and lips. Symptomless Regimen thrombocytopenia developed in two other patients, The trial regimen planned, and used in most making three cases (6%y) of thrombocytopenia in all. cases, was intra-muscular streptomycin 0 75 g, oral In sixteen (33%°) of the forty-nine patients anti- isoniazid 300 mg, and oral rifampicin 600 mg on 6 bodies to rifampicin were detected in the blood. Side- days a week for 3 months, followed by twice-weekly effects occurred in nine (56%) of these, including the rifampicin 1200 mg, with isoniazid 900 mg, plus three developing thrombocytopenia, but in only two pyridoxin 10 mg, for a further 15 months. Appro- http://pmj.bmj.com/ (6%) of the thirty-three patients with no antibodies priate dosage adjustments were made for the two detected. This association of toxic reactions with anti- children in the series. Administration of all doses to bodies is highly significant (P < 0-001). all patients was fully supervised. Introduction Patients Laboratory reports on rifampicin suggest that it All newly-diagnosed tuberculous patients with is one of the most effective anti-tuberculosis drugs tuberculosis attending the Chest Clinic at Hammer- on September 25, 2021 by guest. yet discovered (Verbist & Gyselen, 1968) and clinical smith Hospital from 1 July, 1969 were considered results are highly encouraging (Gyselen et al., 1969). for inclusion in the trial. Also included in this toxicity The only significant side-effect reportedwhenthedrug study were three patients who received, for retreat- is used on a daily basis is jaundice, which is particu- ment of relapsed disease, regimens including rifam- larly likely to occur in alcoholics (Lesobre et al., 1969; picin plus ethambutol and, as a third drug, either Lees et al., 1970). Laboratory work further suggests isoniazid, streptomycin or capreomycin. New that rifampicin should be highly effective in inter- patients with alcoholism, proved liver disease, or mittent regimens (Batten, 1969; Grumbach, Canetti pregnancy, or who were only temporarily resident & Le Lirzin, 1969; Dickinson & Mitchison, 1970). in the area, were not treated with rifampicin. In We started a clinical trial of intermittent rifampi- addition, two patients were not included because * This article is reprinted from the British Medical Journal they were receiving large doses of steroid and (1971) 3, 343-347, by kind permission of the Editor, immuno-suppressive therapy, after renal transplant Postgrad Med J: first published as 10.1136/pgmj.47.553.742 on 1 November 1971. Downloaded from Side-effects of rifampicin 743 operations, which may well have materially altered Direct antiglobiulin tests the response to rifampicin. These were carried out as a screening procedure The report includes only those patients who had by testing the patient's red blood cells with a broad- completed at least 4 months of treatment, the range spectrum antiglobulin serum used in two dilutions. being from 4 to 18 months: only two patients com- The dilutions chosen were those that had pre- pleted the planned 18 months. viously been determined as optimal for detecting The forty-nine patients in the survey (thirty-three complement and IgG respectively when bound to the males and sixteen females aged 9-84 years) came red cells. Any positive results were further tested by from various racial groups (Tables 1 and 2). Im- standard techniques with an anti-IgG serum, an migrants accounted for 61% (Asians and Negroes, anti-IgM serum, an anti-IgA serum and an anti- 37%4; Caucasians, 24%). complement serum (Dacie & Lewis, 1968). Thirty-seven patients with tuberculosis attending other units and receiving drugs other than rifampicin Indirect antiglobulin tests were used as controls (thirty males and seven These were also carried out as a screening pro- females). The age and racial distribution was similar cedure, the method described by Harris (1956) being to that in the rifampicin group: immigrants again used. A total of 70 mg of purified rifampicin (kindly comprised 61%. supplied by Professor D. A. Mitchison), or the Toxicity precautions rifampicin from the capsules, was dissolved in 100 ml of 0-95%/ sodium chloride and added to an If pregnancy occurred during treatment rifampicin equal volume of the patient's serum. (There was no was stopped. Bilibrubin, alkaline phosphatase and difference in the results when using either of these isocitric dehydrogenase estimations were done two solutions of rifampicin.) The tests were read routinely on pretreatment blood samples, and again with a broad-spectrum antiglobulin serum used in Protected by copyright. 3-4 weeks after treatment had started. Patients the two dilutions described above. In a control test were also warned to report any untoward symptoms, saline was substituted for rifampicin. The pH particularly nausea, itching or aching in the upper activities of the rifampicin solution and the saline abdomen. Inquiries for any possible toxic symptoms were the same. were routinely made by the nurses administering the treatment and the eyes were examined regularly for The serum for all the indirect antiglobulin tests jaundice. Hepato-toxicity is not considered further was separated from the red cells within 4 hr of taking here, except to state that no patients developing the the sample. The serum was either tested at once or side-effects described in this paper suffered hepato- frozen to - 20°C and tested within 24 hr. The nor- toxic reactions. mal red cells used in the screening procedure were the group 0 red cells that are prepared daily in our laboratory for the detection of atypical blood group TABLE 1. Age and sex distribution of the antibodies. patients treated with rifampicin Haematological tests http://pmj.bmj.com/ Age groups Males Females Totals Platelet complement fixation tests were carried out 9-20 2 1 (1) 3 (1) as previously described (Blajchman et al., 1970). 21-30 6 (4) 2 (1) 8 (5) The patients in the rifampicin group had full blood 31-40 8 (2) 3 (1) 1 1 (3) counts, 41-50 7 5 (3) 12 (3) including platelet estimations, done at 51-60 9 (1) 2 (1) 1 1 (2) monthly intervals. Two samples were taken each 61+ 1 3 (2) 4 (2) time; one just before the rifampicin was given and Totals 33 (7) 16 (9) 49 (16) one 6 hr later. on September 25, 2021 by guest. The number of patients developing rif- Results ampicin-dependent antibodies is shown in parentheses. All the patients on rifampicin did remarkably well clinically. There were thirty-seven (76%) from whom Mycobacterium tuberculosis was isolated: thirty- TABLE 2. Country of origin of the patients treated with rifampicin three (89%) converted in 8 weeks, and all in 24 weeks. The majority accepted rifampicin with equi- British Irish Asian African W. Indian Other European nimity on a daily basis during the initial 3 months. The situation became very different, however, during 19 (6) 7 (2) 6 (1) 1 11 (6) 5 (1) the subsequent intermittent regimen. The number of patients developing rifampicin-dependent A total of eleven patients (22%4) were unable to antibodies is shown in parentheses. continue rifampicin because of side-effects develop- Postgrad Med J: first published as 10.1136/pgmj.47.553.742 on 1 November 1971. Downloaded from 744 Graham Poole, Peter Stradling and Sheila Worlledge ing on intermittent treatment. These side-effects as a routine procedure half-way through the investi- were of two types: firstly, a febrile reaction occurring gation. in eight (16%4) patients and secondly, thrombo- cytopenia occurring in three (6%4). (One patient had Indirect antiglobulin test both the febrile reaction and thrombocytopenia.) By using the serum from patients on rifampicin, Another patient complained of persistent nausea and this test gave a positive result in the presence of rif- slight malaise, but did not suffer the febrile reaction ampicin, but not in its absence, in sixteen patients or other symptoms. (33%4). It did not give a similar positive result in any sera from patients in the control group. Further The febrile reaction tests with the sera of patients who gave rifampicin- This clinical syndrome has become clearly recog- dependent positive reactions showed that the posi- nizable and has been established as directly due to tive results were due to complement components rifampicin by administering 600 mg trial doses ofthis bound to the red cell surface.
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