732
HONG KONG CHEST SERVICE/BMRC
estimated rates for 79 patients with susceptible strains and 21 patients with resistant strains. Be- cause of the relatively small number of patients with resistant strains in each regimen, their fail- ure rate was calculated by combining results for all 3 regimens, irrespective of whether their cul- tures were initially resistant to isoniazid, to streptomycin, or to both drugs.
For the combined population of patients with susceptible strains and patients with resistant strains before treatment, in the proportion in which they occur in Hong Kong, the estimated failure rates during 30 months for patients treated for 6 months were 25 per cent on the SHZ regimen, 30 per cent on the SH,Z, regi- men, and 29 per cent on the SHZ regimen. The corresponding rates for patients treated for 9 months were 13 per cent, 15 per cent, and 18 per cent.
42
3
Adverse Reactions in First 6 Months
The analysis of adverse reactions was based on 174 SHZ, 185 S2HZ, and 182 S2HZ2 patients. The nature, incidence, and month of onset of the main adverse reactions to the regimens are shown in table 4. An indication of their severity was obtained from the modifications to chemo- therapy made in their management, also shown in table 4.
Adverse reactions were reported in 50 (29 per cent) of 174 SHZ patients, 46 (25 per cent) of
185 SHZ patients, and 39 (21 per cent) of 182 SHZ patients, most of them (31, 33, and 30, respectively) starting during the first 3nths of chemotherapy. The majority were su fully managed without any modification to the regi- men, or with a temporary interruption, and only 7 per cent of the SHZ patients, 3 per cent of the SHZ patients, and 5 per cent of the S2HZ patients had one or more drugs terminated.
Cutaneous reactions. Cutaneous reactions were, in general, mild; only 3 per cent of the SHZ patients, 1 per cent of the SHZ patients, and 3 per cent of the SHZ2 patients had one or more drugs terminated. One SHZ patient de- veloped exfoliative dermatitis in the third month. All 3 drugs were terminated, steroids were given, and the patient recovered.
Hepatic reactions. Only 1 patient (SH,Zg) became jaundiced. This occurred during the second month of chemotherapy. The pyrazina- mide was terminated and the hepatitis resolved during the next 2 months.
In the absence of jaundice or symptoms, a hepatic reaction is defined as an increase in the serum alanine transaminase concentration lead- ing to a modification to the regimen; this increase was to more than 60 IU per liter in all cases. Re- actions occurred in 11 (6 per cent) of the SHZ patients, 16 (9 per cent) of the SHZ, patients, and 11 (6 per cent) of the S2H¿Z2 patients dur- ing the first 6 months, including 6, 12, and 6 patients, respectively, during the first 3 months
↓
TABLE 5
DISTRIBUTION OF SERUM ALANINE TRANSAMINASE CONCENTRATIONS*
Alanine Transaminase Concentration, IU per liter
Patients with
Treatment Modified for Raised Alanine
Transaminase (Cumulative)
0-15
16-30
31-45
46-60
61
Patients
Month Assessed (no.) (%)
(no.) (%)
(no.) (%)
(no.) (%) (no.)
(%)
(no.) (%)
0
497
395
79
77
15
15
3
1
5
1
495
315
64
118
24
32
6
12
2
15
3
3
2
495
295
60
126
25
30
6
18
4
11
2
15
491
292
59
135
27
30
2
<1
10
22
487
302
62
127
26
20
01
6
1
27
5
484
309
64
114
24
22
6
29
6
484
313
65
114
24
10
2
6t
220
136
62
55
25
6
3
7+
221
155
70
35
16
81
222
137
62
54
24
gt
219
142
65
47
21
786
3
4
ON NO
3
1
38
2
2
1
19
2
1
19
1346 ∞ ∞ σ σ
6
8
9
9
0
1
<1
22
10
3
1
< 1
0
23
11
*Based on 153 SHZ, 174 S3H3Z3, and 171 S2H2Z2 patients up to 6 months and on 62 SHZ, 72 S3 H3Z3, and 91 S2H2Z2 patients in months 7, 8, and 9, who missed no more than 1 week of treatment for reasons other than a raised serum alanine transaminase concentration.
† Patients who continued to receive chemotherapy up to 9 months.
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