枫蓼肠胃康制剂治疗急性胃肠炎有效性及安全性的系统评价与Meta分析

Systematic review and Meta-analysis of efficacy and safety of Fengliao Changweikang prescription in treatment of acute gastroenteritis

该研究系统评价枫蓼肠胃康制剂治疗急性胃肠炎(acute gastroenteritis, AGE)的临床有效性及安全性。计算机检索中国知网(CNKI)、万方(Wanfang)、维普(VIP)、中国生物医学文献服务系统(SinoMed)、Medline、Cochrane Library,以及2个临床试验注册平台,搜集枫蓼肠胃康制剂治疗AGE的随机对照试验(randomized controlled trial, RCT),检索时间从建库至2022年8月30日。按照预先制定的纳入、排除标准独立进行文献筛选、资料提取、偏倚风险评估后,采用RevMan 5.4.1软件进行数据分析。最终纳入18项RCTs, 3 489例患者。Meta分析显示,单用枫蓼肠胃康制剂可提高腹痛缓解率(RR=1.27,95%CI[1.17,1.38],P<0.000 01);枫蓼肠胃康制剂+常规西药可提高治愈率(RR=1.43,95%CI[1.12,1.82],P=0.004),缩短腹泻改善时间(RR=-1.65,95%CI[-2.44,-0.86],P<0.000 1)、腹痛改善时间(RR=-1.46,95%CI[-2.00,-0.92],P<0.000 01)、呕吐改善时间(RR=-2.16,95%CI[-2.51,-1.81],P<0.000 01)和发热改善时间(RR=-2.61,95%CI[-4.00,-1.23],P=0.000 2),降低白细胞介素-8(IL-8)(RR=-1.07,95%CI[-1.26,-0.88],P<0.000 01)、白细胞介素-6(IL-6)(RR=-8.24,95%CI[-8.99,-7.49],P<0.000 01)和超敏C反应蛋白(hs-CRP)(RR=-3.04,95%CI[-3.40,-2.69],P<0.000 01)水平,减少疾病的复发率(RR=0.20,95%CI[0.05,0.90],P<0.04)。综合结果,枫蓼肠胃康制剂临床应用安全性较好,有益于AGE患者腹痛、腹泻、呕吐和发热等临床症状的改善以及部分血清炎症因子水平的降低。然而考虑到目前评估枫蓼肠胃康制剂在AGE患者中有效性和安全性的高质量研究较少,未来还需进一步的证据。

This study systematically evaluated the clinical efficacy and safety of Fengliao Changweikang prescription for treating acute gastroenteritis(AGE).The databases of CNKI,VIP,SinoMed,Wangfang,Medline,Cochra ne Library and two clinical trial registration platforms of ChiCTR and ClinicalTrials.gov were retrieved from inception to August 30,2022,to collect randomized controlled trial (RCT) on Fengliao Changweikang prescription treating AGE. Two researchersindependently conducted literature screening, data extraction, and risk of bias assessment according to pre -establishedinclusion and exclusion criteria. RevMan 5.4.1 was used for data analysis. Finally, 18 RCTs were included, involving 3 489patients. Meta-analysis showed that compared with conventional western medicine, Fengliao Changweikang prescriptionimproved the relief rate of abdominal pain (RR=1.27, 95%CI[1.17, 1.38] , P<0.000 01 );Fengliao Changweikangprescription + conventional western medicine increased the cure rate (RR=1.32, 95%CI[1.01, 1.72], P=0.04), shortened theduration of diarrhoea (RR=-1.65, 95%CI[-2.44, -0.86], P<0.000 1), abdominal pain (RR=-1.46, 95%CI[-2.00, -0.92], P<0.000 01), vomiting (RR=-2.16, 95%CI[-2.51, -1.81], P<0.000 01) and fever (RR=-2.61, 95%CI[-4.00, -1.23], P=0.000 2), down-regulated the level of interleukin-8 (IL-8) (RR=-1.07, 95%CI[-1.26, -0.88], P<0.000 01), IL-6(RR=-8.24, 95%CI[-8.99, -7.49], P<0.000 01) and hypersensitive C-reactive protein (hs-CRP) (RR=-3.04, 95%CI[-3.40, -2.69], P<0.000 01), and reduced the adverse reactions (RR=0.38, 95%CI[0.29, 0.50], P<0.000 01) and recurrence ofAGE (RR=0.20, 95%CI[0.05, 0.90], P<0.04). In conclusion, Fengliao Changweikang prescription was safe in clinicalapplication. It was beneficial to alleviate the clinical symptoms of diarrhea, abdominal pain, vomiting, and fever, and downregulatethe levels of some serum inflammatory factors in AGE patients. However, considering that few high -quality studieshave evaluated the efficacy and safety of Fengliao Changweikang prescription in treatment of AGE, further evidence isneeded in the future.