王氏保赤丸治疗儿童功能性消化不良的随机双盲多中心临床研究
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摘要
目的:评价王氏保赤丸治疗儿童功能性消化不良症状与积滞脾虚夹积证候改善作用,以及临床应用的安全性。方法:采用随机、双盲、阳性药平行对照、多中心、非劣效检验的设计方法。11家中心共入选236例患者,试验组、对照组各118例。两组分别服用王氏保赤丸+双歧杆菌三联活菌散模拟剂、双歧杆菌三联活菌散+王氏保赤丸模拟剂,疗程2周。结果:试验组和对照组功能性消化不良(FD)症状综合有效率分别为90. 27%和86. 73%(FAS),率差的95%CI为3. 54%(-4. 78%,11. 86%),提示试验组不劣于对照组(P=0. 436)。其他次要指标包括中医证候疗效、FD单项症状疗效的组间比较差异均无统计学意义。本次研究共报告7例次临床不良事件,试验组3例(2. 56%),对照组4例(3. 39%),两组不良事件发生率比较差异无统计学意义。结论:王氏保赤丸治疗FD疾病症状的综合有效率非劣于对照药双歧杆菌三联活菌散,且能改善中医证候,临床应用安全性较好。
Objective: To evaluate the efficacy and clinical safety of WangshiBaochi Pills in the treatment of functional dyspepsia and stagnant spleen deficiency with food retention syndrome in children. Methods:Random,double-blind,positive-drug parallel control,multi-centered design and non-inferiority test were used inthis study. A total of 236 patients from 11 centers were divided into two groups,with 118 in each. The control group was given WangshiBaochi Pills for 2 weeks,while the experimental group was given Bifid Triple Viable powder for the same duration. Results: The effective rates of the experimental and control group were 90. 27% and86. 73%( FAS),respectively,and the difference between groups was 3. 54%( 95% CI:-4. 78%,11. 86%),which indicated that the efficacy of the experimental group was not inferior to that of the control group( P =0. 436). There was no significance difference in the TCM syndrome curative effect and individual syndromes curative effect between the two groups. Seven adverse events were reported,including 3 cases( 2. 56%) in the experimental group and 4 cases( 3. 39%) in the control group. There was no significant difference in AE occurrence rates. Conclusion: WangshiBaochi pills is not inferior to Bifid Triple Viable Powder in effective rate for functional dyspepsia in children and can improve the TCM syndromes,with desirable safety in clinical use.
Objective: To evaluate the efficacy and clinical safety of WangshiBaochi Pills in the treatment of functional dyspepsia and stagnant spleen deficiency with food retention syndrome in children. Methods:Random,double-blind,positive-drug parallel control,multi-centered design and non-inferiority test were used inthis study. A total of 236 patients from 11 centers were divided into two groups,with 118 in each. The control group was given WangshiBaochi Pills for 2 weeks,while the experimental group was given Bifid Triple Viable powder for the same duration. Results: The effective rates of the experimental and control group were 90. 27% and86. 73%( FAS),respectively,and the difference between groups was 3. 54%( 95% CI:-4. 78%,11. 86%),which indicated that the efficacy of the experimental group was not inferior to that of the control group( P =0. 436). There was no significance difference in the TCM syndrome curative effect and individual syndromes curative effect between the two groups. Seven adverse events were reported,including 3 cases( 2. 56%) in the experimental group and 4 cases( 3. 39%) in the control group. There was no significant difference in AE occurrence rates. Conclusion: WangshiBaochi pills is not inferior to Bifid Triple Viable Powder in effective rate for functional dyspepsia in children and can improve the TCM syndromes,with desirable safety in clinical use.
引文
[1]中华医学会儿科学分会消化组《中华儿科杂志》编辑委员会.中国儿童功能性消化不良诊断和治疗共识[J].中华儿科杂志,2012,50(6):423-424.
[2]于意,许春娣.儿童功能性消化不良研究现状及诊疗共识解读[J].现代实用医学,2014,26(11):1329-1331.
[3]方秀才,侯晓华主译.罗马Ⅳ功能性胃肠病肠-脑互动异常[M].北京:科学出版社,2016.
[4]赵卫东,娄莹,朱玲.思连康治疗儿童功能性消化不良临床分析[J].中国微生态学杂志,2009,21(5):453-455,457.
[5]周亚兵,吴敏,阎秀菊,等.王氏保赤丸治疗儿童功能性消化不良临床研究[J].中华中医药杂志,2014,29(11):3652-3654.
[6]中华中医药学会.中医儿科常见病诊疗指南[S].北京:中国中医药出版社,2012.
[7]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002.
[8]袁莉娟,刘爱民,李艺,等.微生态制剂的应用研究进展[J].临床合理用药杂志,2018,11(15):178-181.
[9]邹月新.微生态制剂在儿科消化疾病治疗中的临床应用[J].临床医学研究与实践,2018,3(26):85-86.
[10]严裕育,巫伟生,岳喜峰.益生菌联合复方阿嗪米特肠溶片治疗儿童功能性消化不良的临床观察[J].包头医学院学报,2018,34(4):39-41.
[11] YOSHIHISA U,MAYU G,TOSHIYASU W,et al. Continuous consumption of fermented milk containing Bifdobacterium bifdum YIT 10347 improves gastrointestinal and psychological symptoms in patients with functional gastrointestinal disorders[J]. Biosci Microb Food Health,2015,34(2):37-44.
[12] TOSHIHIRO O,ATSUSHI T,NAOMI U,et al. The ameliorating effect of lactobacillus gasseri OLL2716 on functional dyspepsia in helicobacter pylori-Uninfected individuals:a randomized controlled study[J]. Digestion,2017,96:92-102.
[13]符珍珠,莫壮婵,彭颖.四磨汤联合微生态制剂金双歧对小儿功能性消化不良的临床疗效[J].中国中西医结合消化杂志,2015,23(9):637-638,641.
[14]季晓军.双歧杆菌三联活菌胶囊联合莫沙必利治疗功能性消化不良的疗效及预防复发作用[J].中国微生态学杂志,2014,26(5):555-557.
[15]廖毅敏.王氏保赤丸治疗儿童功能性消化不良的临床效果观察[J].临床合理用药杂志,2014,7(33):128-129.
[16]王爱云,陆健,刘竞天.王氏保赤丸对实验性“脾虚证”小鼠治疗作用的研究[J].上海中医药杂志,2004,38(8):53-54.
[17]朱荃.胃肠动力药的研究进展及王氏保赤丸的开发前景[J].北京中医,2000,19(2):65.
[18]鲍志祥.王氏保赤丸的药理研究及临床应用概况[J].上海中医药杂志,2001,35(12):42-44.
[2]于意,许春娣.儿童功能性消化不良研究现状及诊疗共识解读[J].现代实用医学,2014,26(11):1329-1331.
[3]方秀才,侯晓华主译.罗马Ⅳ功能性胃肠病肠-脑互动异常[M].北京:科学出版社,2016.
[4]赵卫东,娄莹,朱玲.思连康治疗儿童功能性消化不良临床分析[J].中国微生态学杂志,2009,21(5):453-455,457.
[5]周亚兵,吴敏,阎秀菊,等.王氏保赤丸治疗儿童功能性消化不良临床研究[J].中华中医药杂志,2014,29(11):3652-3654.
[6]中华中医药学会.中医儿科常见病诊疗指南[S].北京:中国中医药出版社,2012.
[7]郑筱萸.中药新药临床研究指导原则(试行)[M].北京:中国医药科技出版社,2002.
[8]袁莉娟,刘爱民,李艺,等.微生态制剂的应用研究进展[J].临床合理用药杂志,2018,11(15):178-181.
[9]邹月新.微生态制剂在儿科消化疾病治疗中的临床应用[J].临床医学研究与实践,2018,3(26):85-86.
[10]严裕育,巫伟生,岳喜峰.益生菌联合复方阿嗪米特肠溶片治疗儿童功能性消化不良的临床观察[J].包头医学院学报,2018,34(4):39-41.
[11] YOSHIHISA U,MAYU G,TOSHIYASU W,et al. Continuous consumption of fermented milk containing Bifdobacterium bifdum YIT 10347 improves gastrointestinal and psychological symptoms in patients with functional gastrointestinal disorders[J]. Biosci Microb Food Health,2015,34(2):37-44.
[12] TOSHIHIRO O,ATSUSHI T,NAOMI U,et al. The ameliorating effect of lactobacillus gasseri OLL2716 on functional dyspepsia in helicobacter pylori-Uninfected individuals:a randomized controlled study[J]. Digestion,2017,96:92-102.
[13]符珍珠,莫壮婵,彭颖.四磨汤联合微生态制剂金双歧对小儿功能性消化不良的临床疗效[J].中国中西医结合消化杂志,2015,23(9):637-638,641.
[14]季晓军.双歧杆菌三联活菌胶囊联合莫沙必利治疗功能性消化不良的疗效及预防复发作用[J].中国微生态学杂志,2014,26(5):555-557.
[15]廖毅敏.王氏保赤丸治疗儿童功能性消化不良的临床效果观察[J].临床合理用药杂志,2014,7(33):128-129.
[16]王爱云,陆健,刘竞天.王氏保赤丸对实验性“脾虚证”小鼠治疗作用的研究[J].上海中医药杂志,2004,38(8):53-54.
[17]朱荃.胃肠动力药的研究进展及王氏保赤丸的开发前景[J].北京中医,2000,19(2):65.
[18]鲍志祥.王氏保赤丸的药理研究及临床应用概况[J].上海中医药杂志,2001,35(12):42-44.