防风通圣散治疗精神分裂症104例临床研究

A clinical study on the effects of Fang Feng Tong Sheng San in treating 104 patients with schizophrenia.

目的 探讨古方一防风通圣散对精神分裂症的临床疗效、副反应及其作用机理。方法 采用多中心开放随机对照研究,对104例精神分裂症患者用常规抗精神病药加服防风通圣散煎剂结合治疗,与126例单用常规抗精神病药治疗的精神分裂症患者对照。以简明精神病评定量表(BPRS)和阳性症状评定量表(SAPS)、阴性症状评定量表(SANS)、临床疗效总评量表(CGI)和副反应量表(TESS)、锥体外系副反应量表(RSESE)综合评定。结果 治疗后防风通圣散组(治疗组)患者的CGI-SI与CGI-GI分值和BPRS、SAPS、SANS量表的总分及因子分均低于单用常规抗精神病药治疗组(对照组)患者,差异均有显著性(P<0.01)。TESS总分与RSESE总分在整个治疗过程中均低于对照组,差异有显著性(P<0.01)。结论 治疗组对精神分裂症的疗效较好;对阳性、阴性症状的改善明显优于对照组;副反应显著较少,安全度较好。调畅各脏腑机能与气机的运动形式,内通外达是其作用的机理。

Objiective To observe the clinical effects and side effects of Fang Feng Tong Sheng San in treating 104 patients with schizophrenia.Methods Multicentre open controlled trial was adopted 104 cases in the study group were received antipsychotic drugs plus Fang Feng Tong Sheng San, and 126 cases in the control group were received antipsy-chotic drugs alone. The clinical effects were assessed by BPRS, SAPS, SANS and CGI. TESS and RSESE were used to evaluate the side effects . Results The improvement on scores of CGI - SI, CGI - CI, BPRS, SAPS, SANS in the study group were better than those in the control group (p < 0.01). Scores of TESS and RSESE were lower in the study group than that in the control group (p<0.01). Conclusion Fang Feng Tong Sheng San has significant therapeutic effect in treating schizophrenia and reduce side effects,when added to the regular treatment of schizophrenia with antipsychotics.