OBJECTIVE To identify whether sarsasapogenin, a sapogenin from the Chinese medicinal herb Anemarrhena Asphodeloides Bunge, would augment the efficacy of risperidone and significantly improve cognitive functions in patients with negative symptoms dominated schizophrenia. METHODS The trial was a double-blind, placebo-controlled, parallel-group design. The eligible patients were randomized into 2 treatment groups: sarsasapogenin group (sarsasapogenin plus risperidone for 8 weeks, n = 41) and placebo group (risperidone only for 8 weeks, n = 39). At the baseline, as well as at weeks 2, 4 and 8 of treatment, the therapeutic response was measured by using scales including Positive and Negative Symptoms Scale (PANSS), Wechsler Memory Scale (WMS), modified Chinese Wechsler Adult Intelligence Scale (mWAIS), Clinical Global Impression (CGI) and Brief Psychiatry Rating Scale (BPRS). The study period for each subject was 8 weeks and duration of overall trial was 2 years. RESULTS Patients treated with sarsasapogenin plus risperidone demonstrated no statistically significant differences in changes in PANSS, WMS or mWAIS score at the end-point of the trial compared with patients treated with placebo plus risperidone. The incidence of treatment-emergent adverse events in patients treated with sarsasapogenin was not different from that observed in placebo group. CONCLUSION Sarsasapogenin did not augment the efficacy of risperidone in treating negative symptoms dominated schizophrenia. Sarsasapogenin at a dosage of 200 mg per day added to a flexible dosage of risperidone at 2-4 mg per day is safe and well tolerated by patients with negative symptoms dominated schizophrenia.
目的: 探讨知母皂甙元是否能增强利培酮的治疗作用, 以及两者联用是否能显著提高阴性症状为主的精神分裂症病人的认知功能。
方法: 本研究采用双盲、 安慰剂对照的平行设计方案。 研究对象随机分为知利培酮合并母皂甙组(n = 41)和利培酮合并安慰剂组(n = 39), 在治疗前及治疗第2、 4、 8周, 分别对患者进行阳性与阴性症状量表(Positive and Negative Symptoms Scale, PANSS)、 韦氏记忆量表(Wechsler Memory Scale, WMS)、 韦氏简式智力量表(modified Chinese Wechsler Adult Intelligence Scale, mWAIS)、 简明精神量表(Brief Psychiatry Rating Scale, BPRS)和临床疗效总评量表(Clinical Global Impression, CGI)评定。 每位患者共随访8周, 整个研究持续2年。
结果: 在治疗结束时, 两组在PANSS、 WMS及mWAIS的减分上无统计学差异, 两组间不良事件发生率亦无明显差异。
结论: 知母皂甙不会增强利培酮对阴性症状为主的精神分裂症的治疗作用。 给予知母皂甙(200 mg/d)合并利培酮(2–4 mg/d)对治疗阴性症状为主的精神分裂症是安全及能够被耐受的。