试论中医汤方治疗理论体系的层次

中医汤方治疗是中医药治疗疾病的最重要的手段,目前相关的用方理论较多,缺乏整合,完全学习及应用有一定的困难。中医学从本质上讲属于一门技术体系,本文在总结前人经验的基础上,将中医汤方理论划分为理念、理论、理论-技术及技术层面4个层次,并简述其要素,为临床及科研提供参考。

消化系统中成药应用指南的编制问题解析

中成药在我国的医疗保健中发挥着重要作用,但其目前在临床应用中仍存在一些问题。中国中药协会为探索中成药在临床中的应用,组织专家开展了中成药治疗优势病种临床应用指南项目,项目本着“循证为主、共识为辅、经验为鉴”的原则,采取统一的方法学设计编制10余种疾病的临床应用指南。本文对指南编制过程中存在的问题如中成药临床应用特点、临床问题的确立、文献检索、证据分级及推荐强度、指标评价、中西医思维转化等方面进行说明和解析,为后续工作提供参考。

试论张仲景思维模式在消化系统疾病中的应用

消化系统疾病是临床常见的一大类疾病,临床患病率较高,多数属于中医的脾胃及肝胆疾病。古代中医在此类疾病的诊疗方面积累了丰富的经验,其中以张仲景著作《伤寒论》与《金匮要略》中对相关疾病的诊治内容尤为丰富,为后世医家提供了许多启迪。文章分析张仲景的临床诊疗思维模式,从“辨-病、脉、证-治”的角度论述张仲景思维模式在消化系统疾病中的应用,为临床医师提供参考。

关于肠易激综合征中医药临床疗效评价指标体系中若干问题的专家共识

在肠易激综合征(IBS)相关中医药临床研究中,如何通过恰当的临床疗效评价指标对其开展临床疗效评价是目前存在的问题之一。受中华中医药学会脾胃病分会委托,编制的《关于肠易激综合征中医药临床疗效评价指标体系中若干问题的专家共识》分为概述、IBS临床疗效评价指标体系的选择与应用、IBS临床疗效评价指标的分析与处理、结果解释4个部分内容,对IBS临床疗效评价指标体系的相关问题进行说明,为相关人员提供参考。

Therapeutic Effect of Chang'an Ⅰ Recipe(肠安Ⅰ号方) on Irritable Bowel Syndrome with Diarrhea: A Multicenter Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective： To evaluate the efficacy and safety of Chinese medicine （CM） decoction Chang＇an I Recipe （肠安 Ⅰ号方） in the treatment of irritable bowel syndrome with diarrhea （IBS-D）. Method： A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed. Based on the order of inclusion, the IBS-D patients were randomly assigned to the treatment group or the placebo control group, administrated with Chang＇an I Recipe or placebo, 150 mL/bag, 3 times daily, for 8 weeks. The primary indices of efficacy included the effective rates of IBS symptom severity score （IBS-SSS） and the differences in adequate relief （AR） responder; the secondary indexes of efficacy included the changes in scores of the IBS Quality of Life （IBS-QOL） and Hospital Anxiety and Depression （HAD） scales. The safety indices included adverse events and related laboratory tests. Results： A total of 216 patients were included, with 109 in the treatment group and 107 in the control group, and finally 206 were included in the full analysis set （FAS）, 191 were included in the per protocol set （PPS）. In FAS, the total effective rate was 67.6% and 40.2% for the treatment and control groups, respectively, with 95% confidence interval （CI） for difference in the effective rates between the two groups of 14.4%-40.2%; while in PPS, the total effective rate was 71.3% and 41.2% for the treatment and control groups, respectively （95% CI 16.6%-43.4%）. The consistent conclusions of FAS and PPS showed a better efficacy in the treatment group. Both FAS and PPS showed higher AR responder in the treatment group （FAS： 59.6% vs. 35.5%; PPS： 62.8% vs. 38.1%）. As for IBS-QOL, the total score and scores in various dimensions of IBS-QOL were not significantly different between the two groups （P〉0.05）. Both anxiety and depression scales of HAD were not significantly different between the two groups （P〉0.05）. No adverse events or laboratory abnormalities were found to be obviously related to the tested drugs or clinically significant. Conclusion： Chang＇an I Recipe was more effective than placebo in the treatment of IBS-D, with no obvious adverse reactions. （No,ChiCTR-TRC-09000328）

A Randomized, Controlled, Double-Blinded and Double- Dummy Trial of the Effect of Tongjiang Granule （通降颗粒） on the Nonerosive Reflux Disease of and Gan （肝）-Wei （胃） Incoordination Syndrome

Objective： To assess the effectiveness of Tongjiang Granule （TJG, 通降颗粒） on the patients with nonerosive reflux disease （NERD） of Gan （肝）-Wei （胃） incoordination syndrome, its impact on their quality of life, and its safety. Method： A randomized, controlled, double-blinded, and double-dummy method was adopted in the trial. There were 120 NERD patients enrolled in the study and randomly divided into the experiment and control groups, each with 60 patients; drugs were distributed according to the drug number by patients＇ inclusion sequences. In the experiment group, patients were given TJG 10 g and mosapdde citrate dummy 5 mg three times a day, and in the control group, patients were given mosapdde citrate 5 mg and TJG dummy 10 g three times a day. The treatment courses of both groups were 4 weeks. Results： Among 120 included patients, 112 were screened for full analysis set （FAS）, and 105 were screened per-protocol set （PPS）. The results were as follows： （1） the improvement of total scores of symptom in the experiment group （0-4 week） were 15.93 ± 7.88 scores by FAS and 16.22 ±7.75 scores by PPS, and they were 10.43± 10.16 scores and 10.79± 10.27 scores in the control group, respectively. The 95% CI of net scores improvement between the two groups were 2.10- 8.90 scores and 1.92-8.94 scores in FAS and PPS; it was significantly better in the experiment group than that in the control group （P〈0.05）. （2） The improvement of scores of major symptom in the experiment group （0-4 week） were 10.68±5.35 by FAS and 10.89±5.29 by PPS and 7.40±7.41 and 7.60±7.46 in the control group, respectively. The 95% CI of net scores improvement in the two groups were 0.85-5.71 and 0.71-5.69 in FAS and PPS separately, and the improvement in the experiment group was significantly better than that in the control group （P〈0.05）. （3） The total effective rates were 86.0% and 61.8% in the experiment and the control group separately, and the Ridit analysis results showed that it was better in the experiment group （P〈0.05）. （4） The improvement quality of life in the domain of physical functioning and general health in the experiment group was better than that in the control group （P〈0.05）. （5） One case of experiment group caught a cold and recovered in six days without drug suspension. No adverse event was found in the other cases. There was no meaningful safety examination indices change in pretreatment and posttreatment periods in both groups. Conclusion： TJG showed a definite effect on the treatment of NERD with Gan-Wei incoordination syndrome, and it could improve the quality of life of NERD patient without obvious toxic and side effects.

Chang'an Ⅱ Decoction(肠安Ⅱ号方)-Containing Serum Ameliorates Tumor Necrosis Factor-α-Induced Intestinal Epithelial Barrier Dysfunction via MLCK-MLC Signaling Pathway in Rats

Objective To investigate the effect of Chang’an Ⅱ Decoction(肠安Ⅱ号方))-containing serum on intestinal epithelial barrier dysfunction in rats.Methods Tumor necrosis factor(TNF)-α-induced injury of Caco-2 monolayers were established as an inflammatory model of human intestinal epithelium.Caco-2 monolayers were treated with blank serum and Chang’an Ⅱ Decoction-containing serum that obtained from the rats which were treated with distilled water and Chang’an Ⅱ Decoction intragastrically at doses of 0.49,0.98,1.96 g/(kg·d)for 1 week,respectively.After preparation of containing serum,cells were divided into the normal group,the model group,the Chang’an Ⅱ-H,M,and L groups(treated with 30 ng/mL TNF-αand medium plus 10%high,middle-,and low-doses Chang’an Ⅱ serum,respectively).Epithelial barrier function was assessed by transepithelial electrical resistance(TER)and permeability of fluorescein isothiocyanate(FITC)-labeled dextran.Transmission electron microscopy was used to observe the ultrastructure of tight junctions(TJs).Immunofluorescence of zonula occludens-1(ZO-1),claudin-1 and nuclear transcription factor-kappa p65(NF-κBp65)were measured to determine the protein distribution.The mRNA expression of myosin light chain kinase(MLCK)was measured by real-time polymerase chain reaction.The expression levels of MLCK,myosin light chain(MLC)and p-MLC were determined by Western blot.Results Chang’an Ⅱ Decoction-containing serum significantly attenuated the TER and paracellular permeability induced by TNF-α.It alleviated TNF-α-induced morphological alterations in TJ proteins.The increases in MLCK mRNA and MLCK,MLC and p-MLC protein expressions induced by TNF-αwere significantly inhibited in the Chang’an Ⅱ-H group.Additionally,Chang’an Ⅱ Decoction significantly attenuated translocation of NF-κBp65 into the nucleus.Conclusion High-dose Chang’an Ⅱ-containing serum attenuates TNF-α-induced intestinal barrier dysfunction.The underlying mechanism may be involved in inhibiting the MLCK-MLC phosphorylation signaling pathway mediated by NF-κBp65.

A Preparation Model of Chinese Medicine Decoction Placebo

Chinese medicine（CM）decoction placebo is one of the key factors restricting the placebo-controlled clinical trial of CM.In this article,based on the analysis of the difficulties in preparing CM placebo,the production requirements for placebo were put forward.Moreover,in accordance with clinical practices,a production method and evaluation process of CM decoction placebo was proposed,to provide a reference for clinical research.