蓝芩口服液治疗小儿手足口病有效性和安全性的系统评价

Systematic review on efficacy and safety of Lanqin Oral Liquid in treatment of hand, foot and mouth disease

蓝芩口服液常用于治疗上呼吸道感染,如急性咽炎,但根据中医异病同治的辨治方法,临床亦常用其治疗小儿手足口病。目前未见针对其疗效及安全性的高级别证据。该研究为了系统评价蓝芩口服液治疗小儿手足口病的临床疗效和安全性,以计算机检索中国知网、万方、维普、SinoMed、Cochrane Library、PubMed 6个数据库中关于蓝芩口服液治疗小儿手足口病的随机对照试验(RCT),检索时限为建库至2019年4月26日。采用RevMan 5.3软件进行数据分析,文献质量评价采用Cochrane协作网的ROB工具。最终纳入24篇,总样本量3 491例,试验组1 826例,对照组1 665例。Meta分析结果显示,在疗效方面,蓝芩口服液联合常规治疗优于西药常规治疗差异有统计学意义(RR总有效率=1.20,95%CI[1.16,1.23],P<0.000 01);在不良反应发生率方面,蓝芩口服液联合常规治疗对比单独常规治疗无统计学差异(RR=1.16,95%CI[0.79,1.70],P=0.45);在临床症状改善时间方面,纳入的研究间异质性过大,不满足Meta分析而未得出结论。结果表明,蓝芩口服液在治疗小儿手足口病具有相对疗效,但鉴于所纳入的文献研究质量普遍偏低,有待进一步验证,故需采用大样本、设计严谨、符合国际规范的临床试验方案,以提高证据质量级别,为临床提供可靠的循证证据。

Lanqin Oral Liquid is a Chinese patent medicine which contains Isatidis Radix, Scutellariae Radix, Gardeniae Fructus, Phellodendri Chinensis Cordex and Sterculiae Lychophorae Semen. It is known for the pharmaceutical effect on the upper respiratory tract infection as it is beneficial for relieving the swelling of pharyngeal. In terms of Chinese medicine, it offers a clearing action on heat and toxic materials. According to the principle of Chinese medicine, different diseases can be treated by the same therapy as long as they have the same syndrome. Based on this unique diagnosis and treatment approach, Lanqin Oral Liquid was applicable to diseases with syndrome of excessive heat in lung and stomach. It was therefore commonly be used in the therapeutic approach towards hand, foot and mouth disease as well. However, no systematic evaluation had yet been done to verify this Chinese patent medicine on the efficacy and clinical safety for the disease. In order to achieve the manner of evidence-based medicine, this study had adopted a systematic review and Meta-analysis to evaluate the efficacy and safety of Lanqin Oral Liquid in the treatment of hand, foot and mouth disease. All related randomized controlled trials(RCT) were searched in the following data bases: CNKI, WanFang, VIP, SinoMed, Cochrane Library and PubMed. Based on the method provided by the Cochrane collaboration, the study assessed the quality of papers selected and RevMan 5.3 software was used to perform Meta-analysis. Totally 24 studies were included with 3 491 sample size, which 1 826 cases were treatment group and 1 665 cases were control group. From the results of Meta-analysis, the total effective rate of combination of Lanqin Oral Liquid and Western medicines shown better than Western medicine alone in the treatment for hand, foot and mouth di-sease, but mild adverse event were also found(RR=1.20,95%CI[1.16,1.23],P<0.000 01). Incidence of adverse reaction between experimental and control group was statistically insignificant(RR=1.16, 95%CI[0.79, 1.70], P=0.45). No conclusion was able to made in terms of the remission time of clinical symptoms, as the studies included were not qualified for Meta-analysis. As a matter of fact, the number of existing studies related to the Lanqin Oral Liquid were limited with poor quality as well. In other words, high quality studies were essential to further evaluate the efficacy and safety of Lanqin Oral Liquid.