After score evaluation of risk (Fig 1a), we tested the efficacy of Ig as supplemental treatment. In contrast to the comparable historical cohort, we found a prompt and marked improvement in disease severity (fall in APACHE II score), especially in the high-risk group (Fig 1b; IgG: p<0.05; IgGMA: p=0.08). Immunoglobulin therapy also led to significantly (p<0.05) higher score response rates and a reduction in mortality (Fig 2), which was close to statistical significance for the IgG group (p=0.08; before Yates’ correction: 0.04). Exploratory analysis for Ig treatment as a whole (IgG and IgGMA) vs standard therapy (control) revealed a statistically significant (p<0.05) improvement in mortality rates. In the Ig group, the mean survival time of the nonsurvivors was 18.3 (1.0 to 35.6) days as opposed to 8.3 (4.0 to 12.6) days in the control group (p=NS). Expectedly, for the total risk population (risk plus high-risk), differences between treatment and control patients were not as distinct as in the high-risk group (Fig 2; nonsurvivors’ mean survival times: Ig: 17.4 (2.7 to 32.1) days; controls: 12.6 (4.8 to 20.4) days; (p=NS). No Ig treatment side effects were recorded. In both the control groups (standard therapy) and the Ig-treated patients, the separation into “responders” and “nonresponders” on the base of a fall in APACHE II score (see “Methods”) correlated significantly with mortality (Table 2).
Patient Groups’ Comparability
Treatment and historical control patients were comparable in most relevant parameters (Table 1). This also applied to the high-risk groups (data not shown). For the few imbalances recorded, jc statistics revealed no significant association with response or mortality rates. buy antibiotics online
Serum Ig Levels
Postoperative pretreatment serum Ig levels (IgG, IgM) were borderline low to subnormal (Fig 3). Both IgG and IgGMA treatment led to higher IgG levels that persisted until day 5. Responders to IgG, but not IgGMA, therapy had significantly (p<0.05) higher IgG levels (days 2 and 5) compared with nonresponders. IgM levels rose after IgGMA therapy, with a tendency toward higher levels in the nonresponder group.
Figure 3. Serum Ig levels during therapy according to response in the total study population. Upper panel: IgG treatment (n = 33). Lower panel: IgGMA treatment (n = 20). Asterisk = significant changes within groups against baseline. Two asterisks = significant differences between responder and nonresponder groups.