OBJECTIVETo investigate the effect of Shenqi Fuzheng Injection (SFI) in radiation pneumonitis and its influence on the levels of plasma transforming growth factor beta (TGF-beta), tumor necrosis factor-alpha (TNF-alpha) and interleukin-10 (IL-10) at various stages (pre-, mid- and post-radiation) of radiotherapy (RT).

METHODSFifty-eight patients enrolled in this study were randomized into two groups, all received conventional radio therapy, but the treatment group was intravenously dripped with SFI additionally, once daily, starting 3 days before radiotherapy to 1 week after the end of it. Levels of TGF-beta, TNF-alpha and IL-10 in blood samples collected and frozen at different time point of RT, before radiotherapy (Pre-RT), after received 40-50 Gy radiation (Mid-RT) and in time of terminating RT (Post-RT), were measured with enzyme linked immunosorbent assay (ELISA). And the occurrence of radiation pneumonitis was analyzed according to RTOG acute radiation pneumonitis criteria.

RESULTSLevel of TGF-beta increased in both groups after RT, either Mid- or Post-RT, but in comparing with that at Pre-RT, statistical significant (P < 0.05) only showed in the control group at Post-RT time when it raised to peak, while in inter-group comparing insignificance was shown. Level of TNF-alpha also increased in both groups, but statistical significance only showed in the control groups as compared with that of Pre-RT, accordingly, it was lower in the treatment group than that in the control group at corresponding time points (P < 0.05). Level of IL-10 decreased gradually in the process of RT, as compared with that at Pre-RT, significant difference was shown in both groups at Post-RT but not at Mid-RT, as compared between groups, no significance (P < 0.05) was shown, though the treatment group showed a high tendency. As for the ratio of IL-10/TNF-alpha, significant difference of lowering in the control group after RT was shown as compared with that at Pre-RT (P < 0.05), and also as compared with that in the treatment group at corresponding time point (P < 0.05). The occurrence of radiation pneumonia > or = grade 2 in the treatment group was significantly lower than that in the control group (chi2 = 8.7133, P < 0.01).

CONCLUSIONPlasma level of TNF-alpha and ratio of IL-10/ TNF-a could be the practicable indexes for estimating the susceptibility of acute radiation pneumonia; SFI can regulate the network of cytokine, and thus be effective in preventing and treating radiation pneumonitis.