3种口服中成药治疗儿童抽动障碍的快速卫生技术评估

Three oral Chinese patent medicines for children with tic disorder:a rapid health technology assessment

采用快速卫生技术评估综合评价芍麻止痉颗粒、菖麻熄风片、九味熄风颗粒治疗儿童抽动障碍的临床价值,为医疗卫生决策及临床儿童合理用药提供可能的参考依据。通过检索8个数据库和3个临床试验注册平台,筛选已发表的文献,评估文献质量后,从疾病负担与未满足需求、技术特性、安全性、有效性、经济性等维度开展快速评估,并对结果进行描述性分析。共纳入文献22篇(1篇英文、21篇中文),其中随机对照试验(RCT)18篇、临床对照试验(CCT)4篇,涉及芍麻止痉颗粒5篇(皆为RCT)、菖麻熄风片9篇(RCTs 6篇、CCTs 3篇)、九味熄风颗粒8篇(RCTs 7篇、CCT 1篇)。94.40%的RCTs总体偏倚风险为有一定偏倚风险,仅1篇(5.60%)总体评估结果为高偏倚风险,研究质量总体一般;4篇CCTs评价结果显示研究的评分为5~6分,均低于7分,质量较低。芍麻止痉颗粒单用或联合硫必利片在改善中医证候和抽动症状方面相较单用硫必利片具有明显优势,日均费用79.44~119.16元;菖麻熄风片单用或联合常规西药相对于常规西药或安慰剂,能够提高临床总有效率,改善抽动症状,日均费用22.50~67.50元;九味熄风颗粒单用或联合常规西药相对于常规西药或安慰剂,能够有效缓解抽动症状,日均费用82.42~164.85元。3种中成药不良事件症状主要集中在消化、呼吸与神经系统,均为轻症。芍麻止痉颗粒、菖麻熄风片及九味熄风颗粒能够有效治疗儿童抽动障碍,为目前该疾病领域仅获批准的中成药,其中芍麻止痉颗粒为2019年最新获批,其研究证据时效最新,且有发表于Q1区的高质量RCT。然而这3种中成药的对比分析受到诸多因素的影响,未来应进一步厘清,基于多维度可获得的大样本数据开展3种中成药的综合对比评估,凸显药物之间的优势和劣势,为临床合理使用和药物监管提供决策依据。

This study aims to comprehensively evaluate the clinical value of Shaoma Zhijing Granules(SZG),Changma Xifeng Tablets(CXT),and Jiuwei Xifeng Granules(JXG)in the treatment of children with tic disorder with the method of rapid health technology assessment(RHTA),which is expected to serve as a reference for medical and health decision-making and clinical rational use of drugs in children.To be specific,relevant articles were retrieved from eight databases and three clinical trial registry platforms.After the quality evaluation,rapid assessment was carried out from the dimensions of disease burden and unmet needs,technical characteristics,safety,efficacy and economy,and the results were analyzed and presented descriptively.A total of 22 articles(1 in English,21 in Chinese)were screened out:18 randomized controlled trials(RCTs)and 4 clinical controlled trials(CCTs).Among them,5 were about the SZG(all RCTs)and 9 were on CXT(6 RCTs and 3 CCTs).The rest 8 focused on JXG(7 RCTs and 1 CCT).Moreover,the overall risk of bias for 94.40%RCTs was evaluated as"some concerns"and only one(5.60%)had high risk of bias.In terms of quality,the 4 CCTs scored 5-6 points(7 points),suggesting low quality.SZG alone or in combination with tiapride has obvious advantages in improving traditional Chinese medicine syndromes and tic symptoms compared with tiapride alone,with the average daily cost of CNY 79.44-119.16.Compared with conventional western medicine or placebo,CXT alone or in combination with conventional western medicine can improve the total effective rate and alleviate tic symptoms,and the average daily cost is CNY 22.50-67.50.JXG alone or in combination with conventional western medicine can effectively relieve tic symptoms compared with conventio-nal western medicine or placebo,with the average daily cost of CNY 82.42-164.85.The adverse events related to the three Chinese patent medicines mainly occurred in the digestive,respiratory,and nervous systems,all of which were mild.In general,SZG,CXT,and JXG are effective for children with tic disorder.They have been approved to be used in this field,of which SZG was approved in 2019,with the most up-to-date research evidence and high-quality RCT in Q1 journals.However,the comparative analysis of the three was affected by many factors,which should be further clarified.Based on the large sample data available in multiple dimensions,a comprehensive comparative evaluation of the three Chinese patent medicines should be carried out,thereby highlighting the advantages and disadvantages of them and serving a reference for rational clinical use and drug supervision.