Tamrakar S M, Nepal M K, Koirala N R, Sharma V D, Gurung C K, Adhikari S R
Norvic International Hospital, Thapathali, Kathmandu.
Kathmandu Univ Med J (KUMJ). 2006 Apr-Jun;4(2):152-60.
In the last decade there have been numerous randomized controlled trials comparing the efficacy and safety of second generation antipsychotics and conventional antipsychotics in the treatment of schizophrenia, but most of them have been conducted in the western population. This study compared the efficacy and safety of risperidone versus haloperidol in the Nepalese context, in order to add on to the very few literatures available on this topic in the South East Asia region and compare them.
Patients with the diagnosis of schizophrenia were randomly assigned to receive risperidone 4-6 milligrams (mg) per day and haloperidol 10-20 mg per day, and were followed up for 6 weeks. Assessment were done on the day of the diagnostic interview and days 7, 14, 28 and 42 (end point). During the assessment periods Positive and Negative Syndrome Scale (PANSS) was administered to monitor the progress in psychopathology and Udvalg for Kliniske Undersogelser (UKU) side effects rating scale was applied to rate the treatment emergent adverse effects.
Both risperidone and haloperidol were associated with substantial baseline- to- endpoint reduction in symptom severity. After one week of treatment, the improvement in schizophrenia with risperidone was significantly better than haloperidol in terms of PANSS- total Score (-45.4 versus -29.5), negative subscale score (-14.3 versus -6.68) and general psychopathology subscale score (-20.9 versus -13.7). At the end point of the study, the benefit was maintained in total score (-52.1 versus -43.1), though the negative subscale score still showed tendency for greater improvement in psychopathology with risperidone. The side effects profile did not show significant differences except in extrapyramidal symptoms. Thirty-eight percent of risperidone treated patients had to resort to anti-parkinsonian treatment compared to 78% in haloperidol treatment group.
Similar to the studies in the western countries, Asia and Indian subcontinent, both risperidone and haloperidol were effective in the reduction of psychopathological symptoms in this group of Nepalese population with the diagnosis of schizophrenia. However, risperidone was quicker and better then haloperidol and risperidone had a better safety profile. This is important, because extrapyramidal side effects of neuroleptics are responsible for non-compliance and increased cost in terms of us of anti-parkinsonian medication.
在过去十年中，已有大量随机对照试验比较第二代抗精神病药物和传统抗精神病药物治疗精神分裂症的疗效和安全性，但其中大多数研究是在西方人群中进行的。本研究比较了利培酮与氟哌啶醇在尼泊尔人群中的疗效和安全性，以补充东南亚地区关于该主题的极少文献并进行比较。
将诊断为精神分裂症的患者随机分配，分别接受每天4 - 6毫克（mg）的利培酮和每天10 - 20毫克的氟哌啶醇治疗，并随访6周。在诊断访谈当天以及第7、14、28和42天（终点）进行评估。在评估期间，使用阳性和阴性症状量表（PANSS）监测精神病理学进展，并应用临床研究不良反应量表（UKU）对治疗中出现的不良反应进行评分。
利培酮和氟哌啶醇均与症状严重程度从基线到终点的显著降低相关。治疗一周后，就PANSS总分（-45.4对-29.5）、阴性分量表评分（-14.3对-6.68）和一般精神病理学分量表评分（-20.9对-13.7）而言，利培酮治疗精神分裂症的改善情况显著优于氟哌啶醇。在研究终点，总分的获益得以维持（-52.1对-43.1），尽管阴性分量表评分仍显示利培酮在精神病理学改善方面有更大改善的趋势。除锥体外系症状外，副作用情况未显示出显著差异。接受利培酮治疗的患者中有38%不得不采用抗帕金森治疗，而氟哌啶醇治疗组这一比例为78%。
与西方国家、亚洲和印度次大陆的研究相似，利培酮和氟哌啶醇在治疗这群诊断为精神分裂症的尼泊尔人群中，均能有效减轻精神病理学症状。然而，利培酮比氟哌啶醇起效更快且效果更好，并且利培酮的安全性更高。这很重要，因为抗精神病药物的锥体外系副作用会导致患者不依从治疗，并增加抗帕金森药物使用方面的成本。
