中西医结合治疗溃疡性结肠炎的荟萃分析
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摘要
目的：溃疡性结肠炎(Ulcerative Colitis,UC)是一种病因尚不十分清楚的直肠和结肠慢性非特异性炎症性疾病,在我国呈逐年增多的趋势。近些年,在治疗本病上多采用中、西医相结合的临床疗法,并取得了较好的疗效。本文依据循证医学理论,搜集中西医及单纯西医对本病的临床研究文献,试图应用Meta分析的统计学方法,全面客观地评价在溃疡性结肠炎的治疗方面,中西医结合疗法是否较单纯西医疗法更具优势。
方法：应用计算机系统检索中英文数据库,包括PUBMED、 MEDLINE、EMBASE、 ELSEVIER SCIENCE、中国期刊数据库CNKI、维普、万方中文期刊数据库,结合手工检索及文献追溯的方式,必要时询问作者相关信息,搜集相关文献。制定纳入文献的标准,3位研究人员分别独立搜集及评价纳入文献的质量,提取文献基本信息及数据后,对每组研究进行异质性检验及合并统计量,得出研究结果,利用漏斗图分析研究结果是否存在偏倚,之后采用转换分析模型及排除研究中权重最大、最小文献的方法进行敏感性分析。统计步骤应用Cochrane协作网提供的Revman5.1软件完成。
结果：一共有16篇研究文献纳入本文进行Meta分析,治疗组1019例,对照组878例。分析结果显示,治疗组与对照组在本病的临床疗效方面存在统计学差异,P<0.00001, OR值为4.51,95%CI为[3.29,6.18]；治疗组与对照组在本病的肠黏膜病变改善方面存在统计学差异,P<0.00001,OR值为11.76,95%CI为[4.15,33.3]；治疗组与对照组在本病的肠黏膜充血水肿改善方面存在统计学差异,P=0.001,OR值为20.13,95%CI为[3.29,123.28]；治疗组与对照组在本病的肠黏膜溃疡改善方面存在统计学差异,P<0.00001,OR值为15.16,95%CI为[8.07,28.45]；治疗组与对照组在本病的肠黏膜糜烂改善方面存在统计学差异,P<0.00001,OR值为16.53,95%CI为[7.45,36.66]；治疗组与对照组在本病的腹痛腹泻症状改善方面存在统计学差异,P=0.002,OR值为7.86,95%CI为[2.08,29.76]；治疗组与对照组在本病的粘液脓血便症状改善方面存在统计学差异,P<0.0001,OR值为8.20,95%CI为[3.21,20.97]；治疗组与对照组在本病的里急后重症状改善方面存在统计学差异,P=0.004,OR值为15.84,95%CI为[2.44,102.94]；治疗组与对照组在本病治疗后疾病活动指数评分方面存在统计学差异,P=0.003,MD值为-0.71,95%CI为[-1.71,-0.24]；治疗组与对照组在本病治疗后免疫学指标IgG评分方面不存在统计学差异,P=0.15,MD值为-1.97,95%CI为[-4.63,0.96]；治疗组与对照组在本病治疗后免疫学指标IgM评分方面存在统计学差异,P=0.02,MD值为-0.90,95%CI为[-1.65,-0.16]；治疗组与对照组在本病治疗后免疫学指标IgA评分方面不存在统计学差异,P=0.06,MD值为-1.02,95%CI为[-2.09,0.04]；治疗组与对照组在本病治疗后全血粘度评分方面不存在统计学差异,P=0.16,MD值为-1.03,95%CI为[-2.47,0.42]；治疗组与对照组在本病治疗后血浆粘度评分方面存在统计学差异,P<0.00001,MD值为-0.36,95%CI为[-0.44,-0.28]；治疗组与对照组在本病治疗后血沉评分方面存在统计学差异,P=0.001,MD值为-7.84,95%CI为[-12.61,-3.07]。
结论：在溃疡性结肠炎的总体临床疗效、治疗后疾病活动指数评分、治疗后免疫学指标IgM评分、治疗后血液流变学指标的血浆粘度及血沉评分、肠黏膜病变总体改善情况及肠黏膜的充血水肿、溃疡、糜烂三个方面分别改善情况,以及腹痛腹泻、粘液脓血便、里急后重症状改善情况的研究分析方面,中西医结合治疗本病较单纯西医治疗更具优势。而在本病治疗后免疫学指标IgG、 IgA评分及治疗后血液流变学指标的全血粘度评分的研究分析方面,中西医结合治疗本病较单纯西医治疗是否更具优势尚不十分明确,且免疫学指标垮G评分的研究结果可能存在不可靠性。
Objective: Ulcerative Colitis(UC) is a kind of chronic non-specific inflammatory bowel disease, in rectum and colon,which is in a gradually growing trend in our country,and its etiology is still unclear.In recent years,traditional Chinese medicine with Western medicine have been being taking in clinical treatments, which has been received good results.According to the based-evidence medicine theory,in the collection of abundant clinical reseach on this disease,attempt to apply Meta-analysis statistical methods to obtain a comprehensive and objective evaluation in the treatment of ulcerative colitis, and evaluate wether Western medicine combined traditional Chinese medicine therapy more advantageous than simple Western medicine therapy.
Method:Applicatingof a computer system to retrieve the Chines and English databases, including PUBMED、MEDLINE、EMBASE、ELSEVIER SCIENCE、CNKI、VIP、Wanfang database,and ask authors the necessary information to collect relevant literature, combined with manual searches and literature retrospective approaches.Formulate the literature inclusion criteria, collect literature and evaluate the quality of the literature included independently by three researchers, extract the basic information and data from the literature,make heterogeneity test in each study group and affiliate the statistics,obtain the results, estimate wether there is bias among the results in use of funnel plots,make sensitivity analysis with methods of conversing effect model and excluding the maximum and minimum weight.Applying software Revman5.1provided by Cochrane Collaboration to accomplish the statistical procedures.
Results: A total of16pieces of research papers are carried out by Meta-analysis in this article,including1019cases in the treatment group and878cases in the control group.The results show that,there is statistical difference between treatment group and control group in the clinical efficacy,P<0.00001,OR4.51,95%CI [3.29,6.18];there is statistical difference between treatment group and control group in the improvement of the intestinal mucosal lesions,P<0.00001,OR11.76,95%CI [4.15,33.3];there is statistical difference between treatment group and control group in the improvement of the intestinal mucosa congestion and edema,P=0.001,OR20.13,95%CI [3.29,123.28];there is statistical difference between treatment group and control group in the improvement of the intestinal mucosa ulcer,P<0.00001,OR15.16,95%CI [8.07,28.45];there is statistical difference between treatment group and control group in the improvement of the intestinal mucosa erosion,P<0.00001,OR16.53,95%CI [7.45,36.66];there is statistical difference between treatment group and control group in the improvement of abdominal pain and diarrhea symptoms,P=0.002,OR7.86,95%CI [2.08,29.76];there is statistical difference between treatment group and control group in the improvement of bloody purulent stool symptom,P<0.0001,OR8.20,95%CI [3.21,20.97];there is statistical difference between treatment group and control group in the improvement of tenesmus symptom,P=0.004,OR15.84,95%CI [2.44,102.94];there is statistical difference between treatment group and control group in the disease activity index score,P=0.003,MD-0.71,95%CI [-1.71,-0.24];there is no statistical difference between treatment group and control group in the disease score of immunological parameters IgQP=0.15,MD-1.97,95%CI [-4.63,0.96];there is statistical difference between treatment group and control group in the disease score of immunological parameters IgM,P=0.02,MD-0.90,95%CI [-1.65,-0.16];there is no statistical difference between treatment group and control group in the disease score of immunological parameters IgA,P=0.06,MD-1.02,95%CI [-2.09,0.04];there is no statistical difference between treatment group and control group in the disease score of whole blood viscocity,P=0.16,MD-1.03,95%CI [-2.47,0.42];there is statistical difference between treatment group and control group in the disease score of plasma viscocity,P<0.00001,MD-0.36,95%CI [-0.44,-0.28];there is statistical difference between treatment group and control group in the disease score of erythrocyte sedimentation,P=0.001,MD-7.84,95%CI [-12.61,-3.07].
ConclusionrWestern medicine combined traditional Chinese medicine therapy are more advantageous than simple Western medicine therapy in the following directions:the overall clinical efficacy,the disease activity index score,the score of immunological parameter IgM,the score of whole blood viscocity and erythrocyte sedimentation,the improvement of the intestinal mucosal lesions,the improvement of intestinal mucosa congestion and edema、 intestinal mucosa ulcer、intestinal mucosa erosion and the improvement of bdominal pain and diarrhea symptoms、 bloody purulent stool symptom、tenesmus symptom. But it is uncertain that wether Western medicine combined traditional Chinese medicine therapy more advantageous than simple Western medicine therapy in the following directions:the score of immunological parameters IgG、IgA, the score of blood rheological parameter whole blood viscocity. And the result of the score in immunological parameter IgG maybe not reliable.
方法：应用计算机系统检索中英文数据库,包括PUBMED、 MEDLINE、EMBASE、 ELSEVIER SCIENCE、中国期刊数据库CNKI、维普、万方中文期刊数据库,结合手工检索及文献追溯的方式,必要时询问作者相关信息,搜集相关文献。制定纳入文献的标准,3位研究人员分别独立搜集及评价纳入文献的质量,提取文献基本信息及数据后,对每组研究进行异质性检验及合并统计量,得出研究结果,利用漏斗图分析研究结果是否存在偏倚,之后采用转换分析模型及排除研究中权重最大、最小文献的方法进行敏感性分析。统计步骤应用Cochrane协作网提供的Revman5.1软件完成。
结果：一共有16篇研究文献纳入本文进行Meta分析,治疗组1019例,对照组878例。分析结果显示,治疗组与对照组在本病的临床疗效方面存在统计学差异,P<0.00001, OR值为4.51,95%CI为[3.29,6.18]；治疗组与对照组在本病的肠黏膜病变改善方面存在统计学差异,P<0.00001,OR值为11.76,95%CI为[4.15,33.3]；治疗组与对照组在本病的肠黏膜充血水肿改善方面存在统计学差异,P=0.001,OR值为20.13,95%CI为[3.29,123.28]；治疗组与对照组在本病的肠黏膜溃疡改善方面存在统计学差异,P<0.00001,OR值为15.16,95%CI为[8.07,28.45]；治疗组与对照组在本病的肠黏膜糜烂改善方面存在统计学差异,P<0.00001,OR值为16.53,95%CI为[7.45,36.66]；治疗组与对照组在本病的腹痛腹泻症状改善方面存在统计学差异,P=0.002,OR值为7.86,95%CI为[2.08,29.76]；治疗组与对照组在本病的粘液脓血便症状改善方面存在统计学差异,P<0.0001,OR值为8.20,95%CI为[3.21,20.97]；治疗组与对照组在本病的里急后重症状改善方面存在统计学差异,P=0.004,OR值为15.84,95%CI为[2.44,102.94]；治疗组与对照组在本病治疗后疾病活动指数评分方面存在统计学差异,P=0.003,MD值为-0.71,95%CI为[-1.71,-0.24]；治疗组与对照组在本病治疗后免疫学指标IgG评分方面不存在统计学差异,P=0.15,MD值为-1.97,95%CI为[-4.63,0.96]；治疗组与对照组在本病治疗后免疫学指标IgM评分方面存在统计学差异,P=0.02,MD值为-0.90,95%CI为[-1.65,-0.16]；治疗组与对照组在本病治疗后免疫学指标IgA评分方面不存在统计学差异,P=0.06,MD值为-1.02,95%CI为[-2.09,0.04]；治疗组与对照组在本病治疗后全血粘度评分方面不存在统计学差异,P=0.16,MD值为-1.03,95%CI为[-2.47,0.42]；治疗组与对照组在本病治疗后血浆粘度评分方面存在统计学差异,P<0.00001,MD值为-0.36,95%CI为[-0.44,-0.28]；治疗组与对照组在本病治疗后血沉评分方面存在统计学差异,P=0.001,MD值为-7.84,95%CI为[-12.61,-3.07]。
结论：在溃疡性结肠炎的总体临床疗效、治疗后疾病活动指数评分、治疗后免疫学指标IgM评分、治疗后血液流变学指标的血浆粘度及血沉评分、肠黏膜病变总体改善情况及肠黏膜的充血水肿、溃疡、糜烂三个方面分别改善情况,以及腹痛腹泻、粘液脓血便、里急后重症状改善情况的研究分析方面,中西医结合治疗本病较单纯西医治疗更具优势。而在本病治疗后免疫学指标IgG、 IgA评分及治疗后血液流变学指标的全血粘度评分的研究分析方面,中西医结合治疗本病较单纯西医治疗是否更具优势尚不十分明确,且免疫学指标垮G评分的研究结果可能存在不可靠性。
Objective: Ulcerative Colitis(UC) is a kind of chronic non-specific inflammatory bowel disease, in rectum and colon,which is in a gradually growing trend in our country,and its etiology is still unclear.In recent years,traditional Chinese medicine with Western medicine have been being taking in clinical treatments, which has been received good results.According to the based-evidence medicine theory,in the collection of abundant clinical reseach on this disease,attempt to apply Meta-analysis statistical methods to obtain a comprehensive and objective evaluation in the treatment of ulcerative colitis, and evaluate wether Western medicine combined traditional Chinese medicine therapy more advantageous than simple Western medicine therapy.
Method:Applicatingof a computer system to retrieve the Chines and English databases, including PUBMED、MEDLINE、EMBASE、ELSEVIER SCIENCE、CNKI、VIP、Wanfang database,and ask authors the necessary information to collect relevant literature, combined with manual searches and literature retrospective approaches.Formulate the literature inclusion criteria, collect literature and evaluate the quality of the literature included independently by three researchers, extract the basic information and data from the literature,make heterogeneity test in each study group and affiliate the statistics,obtain the results, estimate wether there is bias among the results in use of funnel plots,make sensitivity analysis with methods of conversing effect model and excluding the maximum and minimum weight.Applying software Revman5.1provided by Cochrane Collaboration to accomplish the statistical procedures.
Results: A total of16pieces of research papers are carried out by Meta-analysis in this article,including1019cases in the treatment group and878cases in the control group.The results show that,there is statistical difference between treatment group and control group in the clinical efficacy,P<0.00001,OR4.51,95%CI [3.29,6.18];there is statistical difference between treatment group and control group in the improvement of the intestinal mucosal lesions,P<0.00001,OR11.76,95%CI [4.15,33.3];there is statistical difference between treatment group and control group in the improvement of the intestinal mucosa congestion and edema,P=0.001,OR20.13,95%CI [3.29,123.28];there is statistical difference between treatment group and control group in the improvement of the intestinal mucosa ulcer,P<0.00001,OR15.16,95%CI [8.07,28.45];there is statistical difference between treatment group and control group in the improvement of the intestinal mucosa erosion,P<0.00001,OR16.53,95%CI [7.45,36.66];there is statistical difference between treatment group and control group in the improvement of abdominal pain and diarrhea symptoms,P=0.002,OR7.86,95%CI [2.08,29.76];there is statistical difference between treatment group and control group in the improvement of bloody purulent stool symptom,P<0.0001,OR8.20,95%CI [3.21,20.97];there is statistical difference between treatment group and control group in the improvement of tenesmus symptom,P=0.004,OR15.84,95%CI [2.44,102.94];there is statistical difference between treatment group and control group in the disease activity index score,P=0.003,MD-0.71,95%CI [-1.71,-0.24];there is no statistical difference between treatment group and control group in the disease score of immunological parameters IgQP=0.15,MD-1.97,95%CI [-4.63,0.96];there is statistical difference between treatment group and control group in the disease score of immunological parameters IgM,P=0.02,MD-0.90,95%CI [-1.65,-0.16];there is no statistical difference between treatment group and control group in the disease score of immunological parameters IgA,P=0.06,MD-1.02,95%CI [-2.09,0.04];there is no statistical difference between treatment group and control group in the disease score of whole blood viscocity,P=0.16,MD-1.03,95%CI [-2.47,0.42];there is statistical difference between treatment group and control group in the disease score of plasma viscocity,P<0.00001,MD-0.36,95%CI [-0.44,-0.28];there is statistical difference between treatment group and control group in the disease score of erythrocyte sedimentation,P=0.001,MD-7.84,95%CI [-12.61,-3.07].
ConclusionrWestern medicine combined traditional Chinese medicine therapy are more advantageous than simple Western medicine therapy in the following directions:the overall clinical efficacy,the disease activity index score,the score of immunological parameter IgM,the score of whole blood viscocity and erythrocyte sedimentation,the improvement of the intestinal mucosal lesions,the improvement of intestinal mucosa congestion and edema、 intestinal mucosa ulcer、intestinal mucosa erosion and the improvement of bdominal pain and diarrhea symptoms、 bloody purulent stool symptom、tenesmus symptom. But it is uncertain that wether Western medicine combined traditional Chinese medicine therapy more advantageous than simple Western medicine therapy in the following directions:the score of immunological parameters IgG、IgA, the score of blood rheological parameter whole blood viscocity. And the result of the score in immunological parameter IgG maybe not reliable.
引文
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