Objective: To explore the curative effects and safety of olanzapine combined with Niuhuang Ningong tablet in treatment-resistant schizophrenia. Method: One hundred and twelve patients of treatment-resistant schizophrenia were randomly divided into observation and control groups. Olanzapine was taken oral in control group(n=56) for 8 weeks

the starting dose was 5 mg·d-1

and added to 10 mg·d-1 in weeks.56 patients of observation group took olanzapine combined with Niuhuang Ningong tablet for 8 weeks

the dose of Niuhuang Ningong tablet were 5 piece/times

tid.Clinical effectiveness and side effects were assessed with positive and negative symptom scale(PANSS)

global assessment scale(GAS)and treatment emergent symptom scale(TESS)before treatment and at the end of 8 weeks of treatment. Result: The total effective rate of control group was 62.50%

and the and the total effective rate of observation group was 75.00%. the treatment TCM of pathogenic fire derived from stagnation of liver-QI

innter disturbance by phlegmatic fire (IDPF) and exuberant fire due to yin-depletion (EFYD) in control group were (2.51±0.27)

(2.68±0.32)

(2.47±0.39);the treatment TCM of pathogenic fire derived from stagnation of liver-QI

innter disturbance by phlegmatic fire (IDPF) and exuberant fire due to yin-depletion (EFYD) in observation group were (1.35±0.21)

(1.28±0.13)

(1.87±0.42).There were more significant difference in the total effective rate and after treatment Chinese Medicine symptom between observation group and the control group(P<0.05 or P<0.01).Compare with the control group

PANSS score

positive symptoms points

negative symptoms points

psychopathological points and CGI-SI total score of the observation group were significantly decreased from the fourth treatment (P<0.05 or P<0.01). The scores of TESS and the recurrence rate of the control group were (0.72±0.23)and 32.43%

and the scores of TESS and the recurrence rate of the observation group were(0.54±0.16)and 21.43%.So the adverse reaction and the recurrence rate of the observation group were significantly lower than the control group(P<0.05 or P<0.01). Conclusion: The results suggest olanzapine together with Niuhuang Ninggong tablet has good efficacy

less side effects and less recurrence rate in the treatment of treatment-resistant schizophrenia.This method deserves extensive application in the clinical.