Cordeiro N J V, Oniyangi O
Department of Paediatrics, Royal Berkshire and Battle NHS Trust, London Road, Reading, UK, RG1 5AN.
Cochrane Database Syst Rev. 2004(3):CD004448. doi: 10.1002/14651858.CD004448.pub2.
Sickle cell disease (SCD) is a common recessively inherited disorder of haemoglobin affecting peoples originating from sub-Saharan Africa, the Middle East and Mediterranean basin, the Indian subcontinent, the Caribbean and South America. The homozygous state (SS) is associated with complications and a reduced life expectancy. Phytomedicines (medicine derived from plants in their original state) encompass much of what the populations most affected would encounter in terms of plant-remedies from traditional healers. There has been little in the way of systematic appraisal of their benefits.
To assess the benefits and risks of phytomedicines in people with SCD of all types, of any age, in any setting.
We searched the Cochrane Cystic Fibrosis and Genetic Disorders group specialised register of controlled trials of haemoglobinopathies, which comprises references identified from comprehensive electronic database searches, handsearches of relevant journals and abstract books of conference proceedings. We performed an additional search of the bibliographic database of Allied and Complementary Medicine (AMED). Date of most recent search of the trials register: September 2003.
All randomised or quasi-randomised trials with participants of all ages with SCD, in all settings, comparing the administration of phytomedicines, by any mode to placebo or standard treatment, including blood transfusion and hydroxyurea.
Both reviewers independently assessed trial quality and extracted data from the study.
Reports of two trials were found, of which only one, including 82 participants, was eligible for inclusion in this review. This Phase IIB (pivotal) study suggests that a phytomedicine, NIPRISAN, was effective in reducing episodes of SCD crisis associated with severe pain over a six-month period. NIPRISAN did not appear to affect the risk of severe complications or the level of anaemia. No serious adverse effects were reported.
REVIEWERS' CONCLUSIONS: While NIPRISAN, as a phytomedicine, appeared to be safe and effective, over a six-month follow-up period of this study, in reducing crises associated with severe pain, further studies are required to assess its role in the management of people with sickle cell disease. The results of Phase III, multicentre trials are awaited.
镰状细胞病(SCD)是一种常见的血红蛋白隐性遗传性疾病,影响来自撒哈拉以南非洲、中东和地中海盆地、印度次大陆、加勒比地区和南美洲的人群。纯合子状态(SS)与并发症和预期寿命缩短有关。植物药(源自原始状态植物的药物)涵盖了受影响最严重人群在传统治疗师的植物疗法方面会遇到的许多情况。对其益处的系统评估很少。
评估植物药对所有类型、任何年龄、任何环境下的镰状细胞病患者的益处和风险。
我们检索了Cochrane囊性纤维化和遗传疾病小组关于血红蛋白病的对照试验专门登记册,该登记册包括从全面电子数据库检索、相关期刊手工检索以及会议论文摘要集中识别出的参考文献。我们还对联合与补充医学(AMED)的书目数据库进行了额外检索。试验登记册的最新检索日期:2003年9月。
所有随机或半随机试验,参与者为所有年龄的镰状细胞病患者,在所有环境下,比较通过任何方式给予植物药与安慰剂或标准治疗(包括输血和羟基脲)。
两位综述作者独立评估试验质量并从研究中提取数据。
找到两项试验的报告,其中只有一项(包括82名参与者)符合纳入本综述的条件。这项IIB期(关键)研究表明,一种植物药NIPRISAN在六个月期间有效减少了与严重疼痛相关的镰状细胞病危机发作。NIPRISAN似乎未影响严重并发症风险或贫血水平。未报告严重不良反应。
虽然作为植物药的NIPRISAN在本研究的六个月随访期内似乎安全有效,可减少与严重疼痛相关的危机,但需要进一步研究以评估其在镰状细胞病患者管理中的作用。期待III期多中心试验的结果。