良附丸中药配方颗粒治疗胃脘痛临床疗效和安全性的系统评价  

Systematic Review of Clinical Efficacy and Safety of Formula Granules of Liangfu Pill in the Treatment of Epigastric Pain

作　　者：彭丹 杨小娟[2] 杨征 段冬玉 倪睿 刘耀 PENG Dan;YANG Xiaojuan;YANG Zheng;DUAN Dongyu;NI Rui;LIU Yao(Dept.of Pharmacy,Army Specialty Medical Center,Army Medical University,Chongqing 400042,China;Dept.of Respiratory Medicine,the First Affiliated Hospital of Chongqing Medical University,Chongqing 400042,China)

机构地区：[1]陆军军医大学陆军特色医学中心药剂科,重庆400042 [2]重庆医科大学附属第一医院呼吸内科,重庆400042

出　　处：《中国医院用药评价与分析》2022年第9期1122-1126,共5页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：重庆市临床药学重点专科建设项目(渝卫办发〔2020〕68号)。

摘　　要：目的:系统评价良附丸中药配方颗粒治疗胃脘痛的有效性和安全性。方法:检索PubMed、Web of Science、Cochrane Central Register of Controlled Trials(CENTRAL)、MEDLINE、Embase、中国知网、维普数据库和中国生物医学文献数据库等8个数据库,检索时间截至2022年2月10日,纳入良附丸中药配方颗粒治疗胃脘痛的随机对照试验(RCT)。使用Stata 12.0软件对总有效率和痊愈率,胃脘痛的疼痛程度、持续时间和发作次数等结局指标进行Meta分析,并评价安全性。结果:最终纳入11项RCT,共1056例受试者。Meta分析结果表明,与良附丸饮片汤剂相比,良附丸中药配方颗粒能显著提高胃脘痛患者的痊愈率和总体有效率(痊愈率:RR=0.74,95%CI=0.65~0.84;总有效率:RR=0.87,95%CI=0.83~0.91),差异均有统计学意义(P<0.05)。相比于饮片汤剂,良附丸中药配方颗粒在改善患者胃脘痛的疼痛程度、持续时间和发作次数等方面的疗效更加显著(疼痛程度:RR=0.86,95%CI=0.71~1.02;疼痛持续时间:RR=0.89,95%CI=0.74~1.04;疼痛发作次数:RR=0.69,95%CI=0.54~0.84),差异均有统计学意义(P<0.05)。同时,相比于饮片汤剂,良附丸中药配方颗粒能明显降低患者总体不良反应发生率,差异有统计学意义(RR=0.41,95%CI=0.19~0.88,P<0.05)。结论:与良附丸饮片汤剂相比,良附丸中药配方颗粒治疗胃脘痛患者能进一步提高总体疗效和改善疼痛。受限于纳入研究的质量和样本数量,上述结论仍需更多高质量、多中心和大样本的RCT进行验证。OBJECTIVE:To systematically evaluate the efficacy and safety of formula granules of Liangfu pill in the treatment of epigastric pain.METHODS:PubMed,Web of Science,Cochrane Central Register of Controlled Trials(CENTRAL),MEDLINE,Embase,CNKI,VIP and CBM were retrieved to collect the randomized controlled trials(RCT)of formula granules of Liangfu pill in the treatment of epigastric pain till Feb.10th,2022.Stata 12.0 software was used to perform Meta-analysis on outcome indicators such as the total effective rate and recovery rate,the pain degree,duration and number of episodes of epigastric pain,and the safety was evaluated.RESULTS:Totally 11 RCT were enrolled,including 1056 patients.Meta-analysis showed that compared with Liangfu pill decoction,formula granules of Liangfu pill could significantly improve the cure rate and overall effective rate of patients with epigastric pain(cure rate:RR=0.74,95%CI=0.65-0.84;total effective rate:RR=0.87,95%CI=0.83-0.91),the differences were statistically significant(P<0.05).Compared with decoction,formula granules of Liangfu pill was more effective in improving the pain degree,duration and frequency of epigastric pain(pain degree:RR=0.86,95%CI=0.71-1.02;duration of pain:RR=0.89,95%CI=0.74-1.04;frequency of pain:RR=0.69,95%CI=0.54-0.84),the differences were statistically significant(P<0.05).Meanwhile,compared with Liangfu pill decoction,formula granules of Liangfu pill could significantly reduce the overall incidence of adverse drug reactions in patients,the difference was statistically significant(RR=0.41,95%CI=0.19-0.88,P<0.05).CONCLUSIONS:Compared with Liangfu pill decoction,formula granules of Liangfu pill in the treatment of patients with epigastric pain can further improve the overall efficacy and relieve pain.Limited by the quality of the included literature and the number of samples,the above conclusions still need to be verified by more high-quality,multicenter and large-sample RCT.

关 键 词：良附丸 中药配方颗粒 饮片汤剂 META分析 系统评价 

分 类 号：R932[医药卫生—生药学]