润肠方药治疗便秘型肠易激综合征疗效及安全性的系统评价与Meta分析
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摘要
目的对润肠方药治疗便秘型肠易激综合征(IBS-C)的临床疗效及安全性进行系统性评价。方法计算机检索包括Pub Med、Springer Link、EMBASE、中国学术期刊全文数据库(CNKI)、中国生物医学文献数据库(CBM)、万方数据库和维普网(VIP)7个数据库,时限为建库至2017年9月10日。文献质量采用Cochrane手册中Cochrane风险偏倚工具进行评估;质量评价及数据提取均由两名评价员独立完成。纳入研究的数据分析应用Rev Man 5.3软件。结果最终纳入14篇文献共计1114例患者,其中,润肠方药治疗(治疗组)588例,常规西药治疗(西药组)526例。Meta分析结果显示:治疗组临床疗效优于西药组,差异有统计学意义(OR=4.49;95%CI:3.22,6.26;P<0.00001);治疗组中医症候积分较西药组明显下降,差异有统计学意义(OR=-4.64;95%CI:-7.36,-1.91;P=0.0008),且排便及大便性状的改善也均优于西药组,差异有统计学意义(OR=3.61;95%CI:1.25,10.39.P=0.02;OR=3.74;95%CI:1.49,9.39;P=0.005);但针对腹痛则两组疗效相当,差异无统计学意义(OR=1.03;95%CI:0.24,4.51;P=0.97);从远期疗效来看,治疗组优于西药组,差异有统计学意义(OR=3.67;95%CI:1.73,7.78;P=0.0007)。结论润肠方药治疗IBS-C疗效优于常规西药,且安全性较高,远期疗效较好,不良反应少;但仍有待于开展更多大样本、多中心、长期随访高质量临床研究以获得更佳的循证医学证据,从而更好地指导临床。
Objective This meta-analysis analyzed the efficacy and safety of Chinese medicine of Runchang prescription for treatment of irritable bowel syndrome with constipation(IBS-C). Methods We searched sevenelectronic databases including Pub Med,Springer Link,EMBASE,CNKI,CBM,VIP and Wanfang for randomizedcontrolled trials investigating the efficacy of Runchang prescription in the treatment of irritable bowel syndrome withconstipation(IBS-C). The search period was from inception to September 10, 2017. Statistical analyses wereperformed and article quality was evaluated with the Cochrane Risk Bias Tool in the Cochrane Handbook by twoindependent reviewers. Rev Man 5.3 was used for the meta-analysis. Results Fourteen eligible studies comprising atotal of 1114 participants were identified. Among them 588 cases used Runchang prescription treatment(treatmentgroup)and 526 cases used conventional western medicine(western medicine group). In the outcome,treatment groupshowed significant improvement in overall clinical efficacy compared with western medicine group(odds ratio [OR] =4.49; 95% confidence interval [CI]: 3.22, 6.26; P < 0.00001). The scores of TCM syndrome in the treatmentgroup were significantly lower than that in the western medicine group(OR=-4.64;95% CI:-7.36,-1.91;P=0.0008),improved the defecation and stool form(OR=3.74;95% CI:1.49,9.39;P=0.005) in the treatmentgroup as compared to western medicine group,with statistically significant difference(OR = 3.61;95% CI:1.25,10.39. P=0.02;OR=3.74;95% CI:1.49,9.39;P=0.05). No significance was observed in abdominal pain(OR=1.03;95% CI:0.24,4.51;P=0.97) A better long-term efficacy was associated with Runchang prescription ascompared to western medicine(OR=3.67; 95% CI: 1.73, 7.78; P=0.0007). Conclusion Runchang prescriptionshowed greater improvement in terms of clinical efficacy and long-term efficacy in the treatment of IBS-C thanwestern medicine, and had high safety, less adverse reaction. Large multi-center and long-term high-qualityrandomized control trials are needed to obtain more accurate evidence-based medicine and guide the clinical in abetter way.
Objective This meta-analysis analyzed the efficacy and safety of Chinese medicine of Runchang prescription for treatment of irritable bowel syndrome with constipation(IBS-C). Methods We searched sevenelectronic databases including Pub Med,Springer Link,EMBASE,CNKI,CBM,VIP and Wanfang for randomizedcontrolled trials investigating the efficacy of Runchang prescription in the treatment of irritable bowel syndrome withconstipation(IBS-C). The search period was from inception to September 10, 2017. Statistical analyses wereperformed and article quality was evaluated with the Cochrane Risk Bias Tool in the Cochrane Handbook by twoindependent reviewers. Rev Man 5.3 was used for the meta-analysis. Results Fourteen eligible studies comprising atotal of 1114 participants were identified. Among them 588 cases used Runchang prescription treatment(treatmentgroup)and 526 cases used conventional western medicine(western medicine group). In the outcome,treatment groupshowed significant improvement in overall clinical efficacy compared with western medicine group(odds ratio [OR] =4.49; 95% confidence interval [CI]: 3.22, 6.26; P < 0.00001). The scores of TCM syndrome in the treatmentgroup were significantly lower than that in the western medicine group(OR=-4.64;95% CI:-7.36,-1.91;P=0.0008),improved the defecation and stool form(OR=3.74;95% CI:1.49,9.39;P=0.005) in the treatmentgroup as compared to western medicine group,with statistically significant difference(OR = 3.61;95% CI:1.25,10.39. P=0.02;OR=3.74;95% CI:1.49,9.39;P=0.05). No significance was observed in abdominal pain(OR=1.03;95% CI:0.24,4.51;P=0.97) A better long-term efficacy was associated with Runchang prescription ascompared to western medicine(OR=3.67; 95% CI: 1.73, 7.78; P=0.0007). Conclusion Runchang prescriptionshowed greater improvement in terms of clinical efficacy and long-term efficacy in the treatment of IBS-C thanwestern medicine, and had high safety, less adverse reaction. Large multi-center and long-term high-qualityrandomized control trials are needed to obtain more accurate evidence-based medicine and guide the clinical in abetter way.
引文
[1]Chang JY,Talley NJ.Current and emerging therapies in irritable bowel syndrome:from pathophysiology to treatment[J].Trends in pharmacological sciences,2010,31(7):326-334.
[2]Longstreth GF,Thompson WG,Chey WD,et al.Functional bowel disorders[J].Gastroenterology,2006,130(5):1480-1491.
[3]Camilleri M,Lasch K,Zhou W.Irritable bowel syndrome:methods,mechanisms,and pathophysiology.The confluence of increased permeability,inflammation,and pain in irritable bowel syndrome[J].American journal of physiology Gastrointestinal and liver physiology.2012;303(7):G775-785.
[4]Stanghellini V,Tosetti C,Barbara G,et al.Dyspeptic symptoms and gastric emptying in the irritable bowel syndrome[J].The American journal of gastroenterology,2002,97(11):2738-2743.
[5]Tillisch K,Mayer EA,Labus JS.Quantitative meta-analysis identifies brain regions activated during rectal distension in irritable bowel syndrome[J].Gastroenterology,2011,140(1):91-100.
[6]陈婷,唐旭东,王凤云,等.肠易激综合征细胞因子失衡与肠粘膜屏障损伤的相关性[J].世界华人消化杂志,2015,23(10):1597-1602.
[7]Barbara G,Zecchi L,Barbaro R,et al.Mucosal permeability and immune activation as potential therapeutic targets of probiotics in irritable bowel syndrome.Journal of clinical gastroenterology[J],2012,46 Suppl:S52-55.
[8]Enck P,Aziz Q,Barbara G,et al.Irritable bowel syndrome[J].Nature reviews Disease primers,2016,2:16014.
[9]薛丽君,杨怡玲,唐剑,等.肠易激综合征的药物治疗进展[J].医学综述,2016,22(1):118-121.
[10]Shi J,Tong Y,Shen JG,et al.Effectiveness and safety of herbal medicines in the treatment of irritable bowel syndrome:a systematic review[J].World journal of gastroenterology,2008,14(3):454-462.
[11]黄越前,丁飞跃,钟冬梅,等.气滞胃痛颗粒联合乳果糖治疗便秘型肠易激综合征临床研究[J].中医学报,2017,2(32):279-281.
[12]李富增.加味麻仁润肠丸治疗便秘型肠易激综合征40例[J].山西中医,2004,20(3):15-16.
[13]胡珂,张涛,李跃民,等.疏肝润肠方对便秘型肠易激综合征血浆生长抑素及血管活性肠肽水平影响的临床研究[J].中医药通报,2006,5(1):46-48.
[14]宋清照,张蕾,唐尚有.健脾润肠汤治疗肠易激综合征便秘型36例[J].国医论坛,2007,22(6):26-27.
[15]邱光明.车前润肠汤治疗便秘型肠易激综合征的体会[C].全国第二届便秘的基础研究与临床诊治新概念学术会议.郑州:中华胃肠外科杂志编辑部.2008.
[16]李江.通腑润肠汤治疗便秘型肠易激综合征的临床研究[D].陕西中医学院.2010.
[17]李华燕,张颖芹.理气润肠类中药复方颗粒治疗便秘型肠易激综合征随机对照研究[J].浙江中医杂志,2011,46(11):788-789.
[18]严晶.行气润肠法治疗便秘型肠易激综合征的临床与实验研究[D].南京中医药大学.2011.
[19]刘云彦.滋阴润肠方治疗便秘型肠易激综合征31例[J].陕西中医,2013,34(10):1323-1324.
[20]魏旭凤.疏肝润肠缓激汤治疗便秘型肠易激综合征70例[J].中外健康文摘,2013,10(20):382-383.
[21]陆迅.行气润肠法治疗便秘型肠易激综合征的临床与实验研究[D].南京中医药大学.2013.
[22]徐义勇,艾志富,朱丽娟.疏肝理气润肠法治疗便秘型肠易激综合征的疗效及其调节胃肠激素的研究[J].时珍国医国药,2014,25(9):2192-2194.
[23]周慧芬,徐安妗,祝方良.中医治疗便秘型肠易激综合征的临床观察[J].中华中医药学刊,2014,32(3):683-685.
[24]王飞达.三脏调和润肠汤治疗便秘型肠易激综合征的临床研究[D].浙江中医药大学.2015.
[25]陈建科.滋阴润肠方治疗便秘型肠易激综合征31例[J].河南中医,2015,35(8):1932-1934.
[26]国家中医药管理局.中医病症诊断疗效标[M].南京:南京大学出版社,1994:11.
[27]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002:10.
[28]Higgins JP,Thompson SG,Deeks JJ,et al.Measuring inconsistency in meta-analyses[J].British medical journal,2003,327(7414):557-560.
[29]杨倩,王小天,杜姚,等.便秘型肠易激综合征药物研究进展[J].辽宁中医药大学学报,2015,17(6):5-7.
[30]Everhart JE,Ruhl CE.Burden of digestive diseases in the united States Part I:Overall and upper gastrointestinal diseases[J].Gastroenterology,2009,136(2):376-386.
[31]孙建梅,李慧,田耀洲.便秘型肠易激综合征中西医机制研究进展[J].辽宁中医药大学学报,2017,3(19):94-97.
[32]张红敏,侯书杰,陈世伟.生地提取液润肠通便作用的实验研究[J].河南预防医学杂志,2001,12(5):265-266.
[33]杜丽东,吴国泰,牛婷惠,等.当归补血药对对血虚便秘模型大鼠的治疗作用[J].中药药理与临床,2016,32(5):60-64.
[34]范亚楠,黄玉秋,贾天柱,等.肉苁蓉炮制前后对便秘大鼠的通便作用[J].中草药,2016,38(12):2684-2687.
[35]陈万群,胡玲,陈苇菁,等.运脾降浊法治岭南老年性湿热便秘思路探讨[J].广州中医药大学学报,2012,29(6):725-726.
[36]郑学宝,胡玲,王汝俊,等.枳术汤对脾虚便秘小鼠通便作用的实验研究[J].新中医,2003,35(10):75-76.
[37]梅全喜.现代中药药理与临床应用手册[[M].北京:中国中医药出版社,2008.
[38]赵强,李莹,孔令升,等.桃仁化学成分及药理作用研究进展[J].天水师范学院学报,2008,28(2):56-59.
[2]Longstreth GF,Thompson WG,Chey WD,et al.Functional bowel disorders[J].Gastroenterology,2006,130(5):1480-1491.
[3]Camilleri M,Lasch K,Zhou W.Irritable bowel syndrome:methods,mechanisms,and pathophysiology.The confluence of increased permeability,inflammation,and pain in irritable bowel syndrome[J].American journal of physiology Gastrointestinal and liver physiology.2012;303(7):G775-785.
[4]Stanghellini V,Tosetti C,Barbara G,et al.Dyspeptic symptoms and gastric emptying in the irritable bowel syndrome[J].The American journal of gastroenterology,2002,97(11):2738-2743.
[5]Tillisch K,Mayer EA,Labus JS.Quantitative meta-analysis identifies brain regions activated during rectal distension in irritable bowel syndrome[J].Gastroenterology,2011,140(1):91-100.
[6]陈婷,唐旭东,王凤云,等.肠易激综合征细胞因子失衡与肠粘膜屏障损伤的相关性[J].世界华人消化杂志,2015,23(10):1597-1602.
[7]Barbara G,Zecchi L,Barbaro R,et al.Mucosal permeability and immune activation as potential therapeutic targets of probiotics in irritable bowel syndrome.Journal of clinical gastroenterology[J],2012,46 Suppl:S52-55.
[8]Enck P,Aziz Q,Barbara G,et al.Irritable bowel syndrome[J].Nature reviews Disease primers,2016,2:16014.
[9]薛丽君,杨怡玲,唐剑,等.肠易激综合征的药物治疗进展[J].医学综述,2016,22(1):118-121.
[10]Shi J,Tong Y,Shen JG,et al.Effectiveness and safety of herbal medicines in the treatment of irritable bowel syndrome:a systematic review[J].World journal of gastroenterology,2008,14(3):454-462.
[11]黄越前,丁飞跃,钟冬梅,等.气滞胃痛颗粒联合乳果糖治疗便秘型肠易激综合征临床研究[J].中医学报,2017,2(32):279-281.
[12]李富增.加味麻仁润肠丸治疗便秘型肠易激综合征40例[J].山西中医,2004,20(3):15-16.
[13]胡珂,张涛,李跃民,等.疏肝润肠方对便秘型肠易激综合征血浆生长抑素及血管活性肠肽水平影响的临床研究[J].中医药通报,2006,5(1):46-48.
[14]宋清照,张蕾,唐尚有.健脾润肠汤治疗肠易激综合征便秘型36例[J].国医论坛,2007,22(6):26-27.
[15]邱光明.车前润肠汤治疗便秘型肠易激综合征的体会[C].全国第二届便秘的基础研究与临床诊治新概念学术会议.郑州:中华胃肠外科杂志编辑部.2008.
[16]李江.通腑润肠汤治疗便秘型肠易激综合征的临床研究[D].陕西中医学院.2010.
[17]李华燕,张颖芹.理气润肠类中药复方颗粒治疗便秘型肠易激综合征随机对照研究[J].浙江中医杂志,2011,46(11):788-789.
[18]严晶.行气润肠法治疗便秘型肠易激综合征的临床与实验研究[D].南京中医药大学.2011.
[19]刘云彦.滋阴润肠方治疗便秘型肠易激综合征31例[J].陕西中医,2013,34(10):1323-1324.
[20]魏旭凤.疏肝润肠缓激汤治疗便秘型肠易激综合征70例[J].中外健康文摘,2013,10(20):382-383.
[21]陆迅.行气润肠法治疗便秘型肠易激综合征的临床与实验研究[D].南京中医药大学.2013.
[22]徐义勇,艾志富,朱丽娟.疏肝理气润肠法治疗便秘型肠易激综合征的疗效及其调节胃肠激素的研究[J].时珍国医国药,2014,25(9):2192-2194.
[23]周慧芬,徐安妗,祝方良.中医治疗便秘型肠易激综合征的临床观察[J].中华中医药学刊,2014,32(3):683-685.
[24]王飞达.三脏调和润肠汤治疗便秘型肠易激综合征的临床研究[D].浙江中医药大学.2015.
[25]陈建科.滋阴润肠方治疗便秘型肠易激综合征31例[J].河南中医,2015,35(8):1932-1934.
[26]国家中医药管理局.中医病症诊断疗效标[M].南京:南京大学出版社,1994:11.
[27]郑筱萸.中药新药临床研究指导原则[M].北京:中国医药科技出版社,2002:10.
[28]Higgins JP,Thompson SG,Deeks JJ,et al.Measuring inconsistency in meta-analyses[J].British medical journal,2003,327(7414):557-560.
[29]杨倩,王小天,杜姚,等.便秘型肠易激综合征药物研究进展[J].辽宁中医药大学学报,2015,17(6):5-7.
[30]Everhart JE,Ruhl CE.Burden of digestive diseases in the united States Part I:Overall and upper gastrointestinal diseases[J].Gastroenterology,2009,136(2):376-386.
[31]孙建梅,李慧,田耀洲.便秘型肠易激综合征中西医机制研究进展[J].辽宁中医药大学学报,2017,3(19):94-97.
[32]张红敏,侯书杰,陈世伟.生地提取液润肠通便作用的实验研究[J].河南预防医学杂志,2001,12(5):265-266.
[33]杜丽东,吴国泰,牛婷惠,等.当归补血药对对血虚便秘模型大鼠的治疗作用[J].中药药理与临床,2016,32(5):60-64.
[34]范亚楠,黄玉秋,贾天柱,等.肉苁蓉炮制前后对便秘大鼠的通便作用[J].中草药,2016,38(12):2684-2687.
[35]陈万群,胡玲,陈苇菁,等.运脾降浊法治岭南老年性湿热便秘思路探讨[J].广州中医药大学学报,2012,29(6):725-726.
[36]郑学宝,胡玲,王汝俊,等.枳术汤对脾虚便秘小鼠通便作用的实验研究[J].新中医,2003,35(10):75-76.
[37]梅全喜.现代中药药理与临床应用手册[[M].北京:中国中医药出版社,2008.
[38]赵强,李莹,孔令升,等.桃仁化学成分及药理作用研究进展[J].天水师范学院学报,2008,28(2):56-59.