电针结合隔姜灸治疗单纯性肥胖症的临床研究
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摘要
目的
本课题采用随机对照研究,以单纯电针治疗为对照组,观察电针结合隔姜灸组治疗单纯性肥胖症的临床疗效,旨在探讨电针结合隔姜灸组治疗单纯性肥胖症的临床疗效及其作用机理,为临床治疗单纯性肥胖症提供依据。
方法
研究对象为单纯性肥胖患者。选取2009年10月至2010年10月期间在台湾中医诊所接受治疗的门诊病人为研究的目标人群,将其中符合病例筛选标准的72例单纯性肥胖症患者,按1：1的比例随机分配至电针结合隔姜灸组和电针组,每组各有36例。4周为一疗程,共治疗两个疗程。每两周测量身高、体重、三围(胸围、腰围、臀围)、体重指数(BMI),体脂百分率(F%)等肥胖性指标,并测量空腹血糖(GLU)、胰岛素(Ins)、血总胆固醇(TC)、血甘油三酯(TG)、高密度脂蛋白(HDL-C)、低密度脂蛋白(LDL-C)等血生化指标,及临床疗效。治疗前后进行安全性检测。
用EPIDATA3.01软件建立数据库,用STATA10.0软件进行统计分析。计量资料组间比较采用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。分类资料组间比较采用X2检验,等级资料组间比较采用Wilcoxon秩和检验。统计图形的制作采用软件Graph Pad Prism 5.0完成。
结果
本研究采用随机对照试验方法进行临床试验,共有合格受试者72例。电针结合隔姜灸试验组36例；电针对照组36例。均为门诊病人。两组可比性检查：两组年龄、性别、病程、中医辨证分型比较,差别均无显著性意义。两组治疗前病情程度比较,差别无显著性意义。
治疗前两组的性别、年龄、病程、肥胖程度、中医辨证分型、体重指数、体脂百分率、三围、胰岛素、血糖、胆固醇、甘油三酯等血生化指标经分析均无统计学意义,说明二组间的临床基线资料具有可比性。
疗效比较：试验组中医证候疗效,试验组临床痊愈率为33.3%,显效率为47.2%,有效率为13.8%,试验组总有效率(临床痊愈%+显效%+有效%)为94.5%；对照组临床痊愈率为22.2%,显效率为27.7%,有效率为25.0%,对照组总有效率(临床痊愈%+显效%+有效%)为75.0%。两组总有效率比较(确切概率法检验,P=0.04),差异有统计学意义(P<0.05)。二组治疗后临床疗效的等级比较(秩和检验检验z=2.39,P=0.016),差异有显著学意义(P<0.05)。提示试验组的临床疗效优于对照组。
安全性检测表明,治疗前血、尿、大便常规、肝肾功能、心电图正常者,治疗后未见异常改变,表明该临床应用安全。
结论
试验组对单纯性肥胖症有比较显著的疗效,能明显降低患者的体重指数、体脂百分率、腰围、臀围；对空腹胰岛素、胆固醇、甘油三酯、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇具有良性的调整作用；试验组的总有效率显著高于对照组,在改善上述肥胖指标和血生化指标方面较单纯电针疗法具有更大的优势。
综上所述,电针结合隔姜灸治疗单纯性肥胖症的疗效比单纯电针疗法好,而且更能改善患者的临床症状。
Objective
This randomized controlled clinical research adopts the clinical epidemiological methods, clinical research methods and statistical methods. This subject adopts randomized controlled studies the effect of electroacupuncture combined with Gejiangjiu therapy (indirect moxibustion by placing a slice of fresh ginger between patient's skin and moxa) treatment of simple obesity treatment, aims to explore the clinical efficacy of combination of reviews electroacupuncture combined with Gejiangjiu therapy treatment and the clinical curative effect of simple obesity for clinical treatment effect mechanism, and provide basis for overweight and obesity.It discusses the difference of the clinical effect and functional mechanism of the therapies and provides the basis for the clinical treatment of simple obesity.
Methods
The research has 72 patients of simple obesity who were treated in Chinese Medicine clinic in Taiwan from October 2009 October 2010 and who met the case selection standards. Divide the patients into 2 groups with 36 in each group at the rate of 1:1. Four weeks make a period of treatment, and there are 2 periods in total. After every two weeks, measure patients'height, weight, BWH (bust, waist and hips),BMI, F% and other obese indexes. Measure blood and biochemical indexes like GLU, Ins, TC, TG, HDL-C, and LDL-C, etc and the curative effect. Before and after the treatment, check the safety indexes.
Use software EPIDATA 3.1 to set up the database and use software SPSS 15.0 for statistics and analysis. The measurement material is expressed by x±s and the numeration material by constituent percentage. For the interclass comparison of the measurement material, take F test (for heterogeneity, take Kruskal-Wallis H rank sum test); for the interclass multiple comparison, take q test (Newman-Keuls); for self circa comparison, take the t pair test or Wilcoxon pair rank sum test. For the interclass comparison of the classified material, takeχ2 test. For the interclass comparison of the ranked material, use Kruskal-Wallis H rank sum test. Draw the statistics graphs with software Graph Pad Prism 5.0. Results
This research collects 72 cases. The trial Group has 36 cases, the Acupuncture Therapy control Group 36 cases. This study used a randomized controlled trial methods were ongoing clinical trials 72 cases qualified participants. Cupping combined with 36 cases of every ginger moxibustion group; Cupping 36 cases of control group. Are all clinic patients. Two groups of comparability check:two sets of age, gender, duration, Chinese medicine typification comparison, there are no significant difference in meaning. The two groups before treatment condition degree, inappetence degree, no significant difference compared significance. The two groups before treatment fatigue, shortness of breath, fatigue, drowsiness, good hunger feed more, constipation, abdominal distension, white, Dan zi grain, khan more afraid of clinical symptoms such as heat, no significant difference compared significance. Two groups of tongue compared qualitative, coating on the tongue, pulses, no significant significance difference. Before treatment two group of gender, age, duration, obesity, TCM syndrome differentiations, body mass index, body fat percentage, measurements, insulin, blood sugar and cholesterol, triglyceride blood biochemical indexes such as there were no statistically significant by analysis between the groups that two clinical baseline material comparable.
Curative effect Comparison:4.75%more curative effect, syndromes group, while clinical cure rate for significant efficiency for 47.2% of efficient group total effectiveness (13.8%, clinical cure%+powerfully%+effective%) for 94.5 percent; Clinical cure rate for control of 22.2%, significant efficiency, effective for 27.7% 25.0% compared, the comparison group total effectiveness (clinical cure%+powerfully%+effective%) for 75.0%. Two group total effectiveness is exact probability method inspection, P=0.04), there is a significant difference significance (P<0.05). Two groups after treating clinical therapeutic level comparison (rank and inspection inspection z=2.39, P=0.016), there is a significant difference learning significance (P<0.05). Tip the clinical curative effect of 4.75%more than control group.
Safety test indicated, before treatment stool blood and urine and kidney function, electrocardiogram routine and normal, not seen abnormal changes after treatment, show that the clinical application security. Conelusion
Based on the clinical results, simple obesity has housed notable curative effect, can significantly reduce the body mass index, patients with body fat percentage and waist, hip circumference; On fasting insulin, cholesterol, triglyceride and high-density lipoprotein cholesterol and low density lipoprotein cholesterol with benign adjust action; Experimental significantly higher than control group, and the total effective rate in improving the obesity index and blood biochemical indexes is purer cupping therapy have greater advantages.
To sum up, electroacupuncture combined with Gejiangjiu therapy with reviews the curative effect of simple obesity is good, it can improve the clinical symptoms.
本课题采用随机对照研究,以单纯电针治疗为对照组,观察电针结合隔姜灸组治疗单纯性肥胖症的临床疗效,旨在探讨电针结合隔姜灸组治疗单纯性肥胖症的临床疗效及其作用机理,为临床治疗单纯性肥胖症提供依据。
方法
研究对象为单纯性肥胖患者。选取2009年10月至2010年10月期间在台湾中医诊所接受治疗的门诊病人为研究的目标人群,将其中符合病例筛选标准的72例单纯性肥胖症患者,按1：1的比例随机分配至电针结合隔姜灸组和电针组,每组各有36例。4周为一疗程,共治疗两个疗程。每两周测量身高、体重、三围(胸围、腰围、臀围)、体重指数(BMI),体脂百分率(F%)等肥胖性指标,并测量空腹血糖(GLU)、胰岛素(Ins)、血总胆固醇(TC)、血甘油三酯(TG)、高密度脂蛋白(HDL-C)、低密度脂蛋白(LDL-C)等血生化指标,及临床疗效。治疗前后进行安全性检测。
用EPIDATA3.01软件建立数据库,用STATA10.0软件进行统计分析。计量资料组间比较采用t检验或Wilcoxon秩和检验,自身前后比较用配对t检验或Wilcoxon配对秩和检验。分类资料组间比较采用X2检验,等级资料组间比较采用Wilcoxon秩和检验。统计图形的制作采用软件Graph Pad Prism 5.0完成。
结果
本研究采用随机对照试验方法进行临床试验,共有合格受试者72例。电针结合隔姜灸试验组36例；电针对照组36例。均为门诊病人。两组可比性检查：两组年龄、性别、病程、中医辨证分型比较,差别均无显著性意义。两组治疗前病情程度比较,差别无显著性意义。
治疗前两组的性别、年龄、病程、肥胖程度、中医辨证分型、体重指数、体脂百分率、三围、胰岛素、血糖、胆固醇、甘油三酯等血生化指标经分析均无统计学意义,说明二组间的临床基线资料具有可比性。
疗效比较：试验组中医证候疗效,试验组临床痊愈率为33.3%,显效率为47.2%,有效率为13.8%,试验组总有效率(临床痊愈%+显效%+有效%)为94.5%；对照组临床痊愈率为22.2%,显效率为27.7%,有效率为25.0%,对照组总有效率(临床痊愈%+显效%+有效%)为75.0%。两组总有效率比较(确切概率法检验,P=0.04),差异有统计学意义(P<0.05)。二组治疗后临床疗效的等级比较(秩和检验检验z=2.39,P=0.016),差异有显著学意义(P<0.05)。提示试验组的临床疗效优于对照组。
安全性检测表明,治疗前血、尿、大便常规、肝肾功能、心电图正常者,治疗后未见异常改变,表明该临床应用安全。
结论
试验组对单纯性肥胖症有比较显著的疗效,能明显降低患者的体重指数、体脂百分率、腰围、臀围；对空腹胰岛素、胆固醇、甘油三酯、高密度脂蛋白胆固醇和低密度脂蛋白胆固醇具有良性的调整作用；试验组的总有效率显著高于对照组,在改善上述肥胖指标和血生化指标方面较单纯电针疗法具有更大的优势。
综上所述,电针结合隔姜灸治疗单纯性肥胖症的疗效比单纯电针疗法好,而且更能改善患者的临床症状。
Objective
This randomized controlled clinical research adopts the clinical epidemiological methods, clinical research methods and statistical methods. This subject adopts randomized controlled studies the effect of electroacupuncture combined with Gejiangjiu therapy (indirect moxibustion by placing a slice of fresh ginger between patient's skin and moxa) treatment of simple obesity treatment, aims to explore the clinical efficacy of combination of reviews electroacupuncture combined with Gejiangjiu therapy treatment and the clinical curative effect of simple obesity for clinical treatment effect mechanism, and provide basis for overweight and obesity.It discusses the difference of the clinical effect and functional mechanism of the therapies and provides the basis for the clinical treatment of simple obesity.
Methods
The research has 72 patients of simple obesity who were treated in Chinese Medicine clinic in Taiwan from October 2009 October 2010 and who met the case selection standards. Divide the patients into 2 groups with 36 in each group at the rate of 1:1. Four weeks make a period of treatment, and there are 2 periods in total. After every two weeks, measure patients'height, weight, BWH (bust, waist and hips),BMI, F% and other obese indexes. Measure blood and biochemical indexes like GLU, Ins, TC, TG, HDL-C, and LDL-C, etc and the curative effect. Before and after the treatment, check the safety indexes.
Use software EPIDATA 3.1 to set up the database and use software SPSS 15.0 for statistics and analysis. The measurement material is expressed by x±s and the numeration material by constituent percentage. For the interclass comparison of the measurement material, take F test (for heterogeneity, take Kruskal-Wallis H rank sum test); for the interclass multiple comparison, take q test (Newman-Keuls); for self circa comparison, take the t pair test or Wilcoxon pair rank sum test. For the interclass comparison of the classified material, takeχ2 test. For the interclass comparison of the ranked material, use Kruskal-Wallis H rank sum test. Draw the statistics graphs with software Graph Pad Prism 5.0. Results
This research collects 72 cases. The trial Group has 36 cases, the Acupuncture Therapy control Group 36 cases. This study used a randomized controlled trial methods were ongoing clinical trials 72 cases qualified participants. Cupping combined with 36 cases of every ginger moxibustion group; Cupping 36 cases of control group. Are all clinic patients. Two groups of comparability check:two sets of age, gender, duration, Chinese medicine typification comparison, there are no significant difference in meaning. The two groups before treatment condition degree, inappetence degree, no significant difference compared significance. The two groups before treatment fatigue, shortness of breath, fatigue, drowsiness, good hunger feed more, constipation, abdominal distension, white, Dan zi grain, khan more afraid of clinical symptoms such as heat, no significant difference compared significance. Two groups of tongue compared qualitative, coating on the tongue, pulses, no significant significance difference. Before treatment two group of gender, age, duration, obesity, TCM syndrome differentiations, body mass index, body fat percentage, measurements, insulin, blood sugar and cholesterol, triglyceride blood biochemical indexes such as there were no statistically significant by analysis between the groups that two clinical baseline material comparable.
Curative effect Comparison:4.75%more curative effect, syndromes group, while clinical cure rate for significant efficiency for 47.2% of efficient group total effectiveness (13.8%, clinical cure%+powerfully%+effective%) for 94.5 percent; Clinical cure rate for control of 22.2%, significant efficiency, effective for 27.7% 25.0% compared, the comparison group total effectiveness (clinical cure%+powerfully%+effective%) for 75.0%. Two group total effectiveness is exact probability method inspection, P=0.04), there is a significant difference significance (P<0.05). Two groups after treating clinical therapeutic level comparison (rank and inspection inspection z=2.39, P=0.016), there is a significant difference learning significance (P<0.05). Tip the clinical curative effect of 4.75%more than control group.
Safety test indicated, before treatment stool blood and urine and kidney function, electrocardiogram routine and normal, not seen abnormal changes after treatment, show that the clinical application security. Conelusion
Based on the clinical results, simple obesity has housed notable curative effect, can significantly reduce the body mass index, patients with body fat percentage and waist, hip circumference; On fasting insulin, cholesterol, triglyceride and high-density lipoprotein cholesterol and low density lipoprotein cholesterol with benign adjust action; Experimental significantly higher than control group, and the total effective rate in improving the obesity index and blood biochemical indexes is purer cupping therapy have greater advantages.
To sum up, electroacupuncture combined with Gejiangjiu therapy with reviews the curative effect of simple obesity is good, it can improve the clinical symptoms.
引文
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