Study on the relationship among dose, concentration and clinical response in Chinese schizophrenic patients treated with Amisulpride.

OBJECTIVE

To provide therapeutic window of amisulpride dose and serum concentration.

METHODS

194 schizophrenics were assessed with PANSS. The concentration of Amisulpride in blood was tested. And relationship with concentration was analyzed.

RESULTS

The dose of amisulpride was 100mg∼1200 mg/d(555+/-218), plasma concentration was 20∼1280 ng/mL(349+/-223) and C/D ratio was 0.07∼1.65 (0.63+/-0.34). The correlation of dose and concentration was significantly correlated (r = 0.55; P < 0.05).It was found that concentration(P < 0.001), C/D ratio(r = 0.383, P < 0.001), rather than dose (-0.042,p > 0.05) related to age significantly.It was found no differences in dose(p > 0.05), concentration (p > 0.05) and C/D ratio(p > 0.05) between male and female patients. The change ratio of positive symptom was 10 %∼90 %, negative symptom was 5∼80 %, general symptoms was 5∼90 %, PANSS was 5∼90 %.The correlation between change ratio of positive symptom, general symptom and PANSS and dose, concentration were significant(P < 0.01), but not related with the change ratio of negative symptom(p>0.05).The both dose and concentration of amisulpride were higher significantly in effective group than that in ineffective group according to change ratio of positive symptom, negative symptom, general symptom and PANSS(P < 0.01).

CONCLUSION

The correlation of dose and concentration of amisulpride was significantly correlated. The recommended range 457∼637 ng/mL was suggested as average therapeutic window.