Objective To observe the clinical efficacy and the possible mechanism of Chang Qin Ⅰ in patients with severe craniocerebral injury at acute stage with syndrome of intermin-gled phlegm

blood stasis and accumulated heat. Methods Fifty-eight patients with severe craniocerebral injury at acute stage with syndrome of intermin-gled phlegm

blood stasis and accumulated heat were randomly divided into control group and treatment group

with 29 cases in each group. Thirty healthy subjects from physical examination center were used as normal group. Both control group and treatment group were given western medicine conventional therapy. In addition to it

treatment group was also given Chang Qin Ⅰ

one dose a day for 14 consecutive days. The Glasgow Coma Scale（ GCS） was observed before and on the 7 th and 14 th day after treatment in two groups. The prognosis was evaluated according to the Glasgow Outcome Scale（ GOS） one month after the end of treatment. The serum levels of glial fibrillary acidic protein（ GFAP）

ubiquitin C-terminal hydrolase L1（ UCH-L1） and insulin-like growth factor 1（ IGF-1） in two groups before and on the 7 th and 14 th day after treatment

and in normal group were detected with enzyme-linked immunosorbent assay（ ELISA）. Results The rate of good prognosis was 58. 62%（ 17/29） in the treatment group

while31. 03%（ 9/29） in the control group. The rate of good prognosis in treatment group was higher than that in control group（ P < 0. 05）. Before treatment

levels of GFAP and UCH-L1 in the two groups were higher and level of IGF-1 was lower than those in normal group（ P < 0. 01）. Compared with those in the same group before treatment

the GCS score and the level of IGF-1 increased and the level of GFAP and UCH-L1 decreased（ P < 0. 01） in treatment group on the 7 th and 14 th day after treatment

while the level of GFAP and UCH-L1 decreased and the level of IGF-1 increased in control group on the 7 th and 14 th day after treatment

and the GCS score increased in treatment group on the 14 th day after treatment（ P < 0. 01）. After 7 and 14 days of treatment

the GCS score and the level of IGF-1 in treatment group were higher than those in control group and the level of GFAP in treatment group was lower than that in control group（ P < 0. 05）. Conclusion Chang Qin Ⅰ could improve consciousness disorder degree and prognosis and decrease secondary injury in the patients with severe craniocerebral injury at acute stage with syndrome of intermin-gled phlegm

blood stasis and accumulated heat. Decreasing the serum level of GFAP and UCH-L1 and increasing the level of IGF-1 may be one of its mechanisms.