靳三针结合中药治疗抽动秽语综合征的临床研究
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摘要
目的
本研究采用临床流行病学、临床科研方法学及数理统计分析方法,进行临床随机对照研究,观察靳三针治疗抽动-秽语综合征(Tourette's Syndrome, TS)的临床疗效及其安全性,期望进一步规范临床疗效,获得较好的社会效益。
方法
选取2010年1月至2010年12月期间在台湾朱祺仁中医门诊治疗的,符合病例筛选标准的60例患者。按1：1的比例随机分配至试验组和对照组两组,每组各有30例。隔日治疗1次,15次为1疗程。通过对TS患者的临床症状、体征进行量化,并以此作为疗效评价指标,进行统计学处理。比较临床疗效,并进行安全性检测。
用EPIDATA3.1软件建立数据库,用SPSS15.0软件进行统计分析。计量资料用均数±标准差(x±S)表示,计数资料用构成比(%)表示。计量资料组间比较采用t检验(方差不齐采用t’检验或秩和检验),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χ2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 4.03完成。
结果
本研究采用随机双盲对照试验方法进行临床试验,共有合格受试者60例。治疗组30例；对照组30例。治疗前,三组患者的年龄、性别、病程、眨眼皱眉、手臂抽动、脘腹拘挛、心悸惊恐情况等基线资料比较,差异无统计学意义(P>0.05),即两组基线一致,具有可比性。
经过治疗后,治疗组与对照组的中医证候疗效总有效率分别为93.3%和70.0%,两组间中医证候总疗效等级分布差异有统计学意义(P<0.05)。两组中医证候疗效比较,差异有显著性意义(P<0.05),治疗组疗效优于对照组。
两组治疗后眨眼皱眉、脘腹拘挛、心悸惊恐情况改善程度比较,差异无显著性意义(P>0.05)。说明两组的治疗方法对以上症状的疗效相当。
两组治疗后手臂抽动情况改善程度比较,差异无显著性意义(P>0.05)。说明两组的治疗方法对以上症状的疗效相当。
两组治疗后发声抽动、运动抽动变化比较,差异无显著性意义(P>0.05)。说明两组的治疗方法对以上症状的疗效相当。
两组治疗后综合损伤等情况变化比较,差异有显著性意义(P<0.05)。说明在以上两方面治疗组的疗效比对照组好。
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,表明该疗法临床应用安全。
结论
1.针药结合治疗抽动-秽语综合征的疗效比单刺针灸治疗好。
2.针药结合治疗比单纯针刺治疗更能缓解患者手臂抽动症状。
3.针药结合治疗在运动抽动、综合损伤两方面的疗效比针刺治疗好。
Objective
This randomized controlled clinical trial adopts clinical epidemiological, clinical research methodological and mathematical statistical methods and intends to discuss the clinical efficacy and safety of Tourette's Syndrome (TS) treatment by Jin's Three Needle acupuncture therapy with the hope of further standardizing the clinical curative effect and achieving good social benefits.
Methods
Research objects are 60 patients who met the case selection criteria and were treated from January 2010 to December 2010 in Zhu Qiren's TCM Clinic in Taiwan. They are randomly assigned to the Trial Group and the Control Group with 30 cases in each group at the rate of 1:1. One treatment every other day and 15 times of treatment make a treatment period. Quantitize TS patients' clinical symptoms and signs and take them as curative effect evaluation indexes. Conduct the statistical processing, compare the clinical efficacy and conduct safety examination.
Use EPIDATA 3.1 software to set up a database and analyze with SPSS 15.0 software. The measurement data is expressed by mean±standard deviation (x±s) and the numeration data by constituent ratio (%). The interclass comparison of the measurement data is expressed by the t-test (t'test or rank sum test for heterogeneity of variance), the self AP comparison by pair t test or Wilcoxon pair rank sum test. The interclass comparison of classified data is expressed by theχ2 test and the interclass comparison of ranked data by Wilcoxon rank sum test. Statistical graphs are produced by software Graph Pad Prism 4.03.
Results
This randomized double-blind clinical trial has 60 qualified subjects with 30 in the Trial Group and 30 in the Control Group. In comparing the baseline features of patients, there's no statistical significant difference in two groups'age, gender, disease duration, winking and frowning, arm tic disorder, abdominal contracture, palpitation and panic, etc before treatment, which indicates that the baseline data of two groups are consistent and comparable.
After treatment, the Trial Group and the Control Group's total curative effect rates of TCM syndromes are respectively 93.3% and 70.0% which indicates the distributional difference has statistical significance (P<0.05). Comparison of two groups'TCM syndrome curative effect shows statistical significance (P<0.05) and the Trial Group is superior to the Control Group.
There's no statistically significant difference (P>0.05) in improving symptoms like winking and frowning, abdominal contracture, palpitation and panic which indicates two groups have equivalent curative effect.
There's no statistically significant difference (P>0.05) in improving arm tic disorder which indicates two groups have equivalent curative effect.
There's no statistically significant difference (P>0.05) in improving vocal tic disorder and movement tic disorder which indicates two groups have equivalent curative effect.
There's statistically significant difference (P<0.05) in improving comprehensive trauma conditions which indicates the Trial Groups has better curative effect than the Control Group.
Safety examination demonstrates no abnormal changes occur to those with normal blood, urine, stool, liver and kidney function and electrocardiogram examination results which indicate the safe clinical application of this therapy.
Conclusion
1. Acupuncture plus Chinese Herbal Medicine Therapy has better curative effect than the Simple Acupuncture Therapy in Tourette's Syndrome treatment.
2. Acupuncture plus Chinese Herbal Medicine Therapy has better curative effect than the Simple Acupuncture Therapy in relieving patients'arm tic disorder. 3. Acupuncture plus Chinese Herbal Medicine Therapy has better curative effect than the Simple Acupuncture Therapy in the treatment of movement tic disorder and comprehensive trauma.
本研究采用临床流行病学、临床科研方法学及数理统计分析方法,进行临床随机对照研究,观察靳三针治疗抽动-秽语综合征(Tourette's Syndrome, TS)的临床疗效及其安全性,期望进一步规范临床疗效,获得较好的社会效益。
方法
选取2010年1月至2010年12月期间在台湾朱祺仁中医门诊治疗的,符合病例筛选标准的60例患者。按1：1的比例随机分配至试验组和对照组两组,每组各有30例。隔日治疗1次,15次为1疗程。通过对TS患者的临床症状、体征进行量化,并以此作为疗效评价指标,进行统计学处理。比较临床疗效,并进行安全性检测。
用EPIDATA3.1软件建立数据库,用SPSS15.0软件进行统计分析。计量资料用均数±标准差(x±S)表示,计数资料用构成比(%)表示。计量资料组间比较采用t检验(方差不齐采用t’检验或秩和检验),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χ2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 4.03完成。
结果
本研究采用随机双盲对照试验方法进行临床试验,共有合格受试者60例。治疗组30例；对照组30例。治疗前,三组患者的年龄、性别、病程、眨眼皱眉、手臂抽动、脘腹拘挛、心悸惊恐情况等基线资料比较,差异无统计学意义(P>0.05),即两组基线一致,具有可比性。
经过治疗后,治疗组与对照组的中医证候疗效总有效率分别为93.3%和70.0%,两组间中医证候总疗效等级分布差异有统计学意义(P<0.05)。两组中医证候疗效比较,差异有显著性意义(P<0.05),治疗组疗效优于对照组。
两组治疗后眨眼皱眉、脘腹拘挛、心悸惊恐情况改善程度比较,差异无显著性意义(P>0.05)。说明两组的治疗方法对以上症状的疗效相当。
两组治疗后手臂抽动情况改善程度比较,差异无显著性意义(P>0.05)。说明两组的治疗方法对以上症状的疗效相当。
两组治疗后发声抽动、运动抽动变化比较,差异无显著性意义(P>0.05)。说明两组的治疗方法对以上症状的疗效相当。
两组治疗后综合损伤等情况变化比较,差异有显著性意义(P<0.05)。说明在以上两方面治疗组的疗效比对照组好。
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,表明该疗法临床应用安全。
结论
1.针药结合治疗抽动-秽语综合征的疗效比单刺针灸治疗好。
2.针药结合治疗比单纯针刺治疗更能缓解患者手臂抽动症状。
3.针药结合治疗在运动抽动、综合损伤两方面的疗效比针刺治疗好。
Objective
This randomized controlled clinical trial adopts clinical epidemiological, clinical research methodological and mathematical statistical methods and intends to discuss the clinical efficacy and safety of Tourette's Syndrome (TS) treatment by Jin's Three Needle acupuncture therapy with the hope of further standardizing the clinical curative effect and achieving good social benefits.
Methods
Research objects are 60 patients who met the case selection criteria and were treated from January 2010 to December 2010 in Zhu Qiren's TCM Clinic in Taiwan. They are randomly assigned to the Trial Group and the Control Group with 30 cases in each group at the rate of 1:1. One treatment every other day and 15 times of treatment make a treatment period. Quantitize TS patients' clinical symptoms and signs and take them as curative effect evaluation indexes. Conduct the statistical processing, compare the clinical efficacy and conduct safety examination.
Use EPIDATA 3.1 software to set up a database and analyze with SPSS 15.0 software. The measurement data is expressed by mean±standard deviation (x±s) and the numeration data by constituent ratio (%). The interclass comparison of the measurement data is expressed by the t-test (t'test or rank sum test for heterogeneity of variance), the self AP comparison by pair t test or Wilcoxon pair rank sum test. The interclass comparison of classified data is expressed by theχ2 test and the interclass comparison of ranked data by Wilcoxon rank sum test. Statistical graphs are produced by software Graph Pad Prism 4.03.
Results
This randomized double-blind clinical trial has 60 qualified subjects with 30 in the Trial Group and 30 in the Control Group. In comparing the baseline features of patients, there's no statistical significant difference in two groups'age, gender, disease duration, winking and frowning, arm tic disorder, abdominal contracture, palpitation and panic, etc before treatment, which indicates that the baseline data of two groups are consistent and comparable.
After treatment, the Trial Group and the Control Group's total curative effect rates of TCM syndromes are respectively 93.3% and 70.0% which indicates the distributional difference has statistical significance (P<0.05). Comparison of two groups'TCM syndrome curative effect shows statistical significance (P<0.05) and the Trial Group is superior to the Control Group.
There's no statistically significant difference (P>0.05) in improving symptoms like winking and frowning, abdominal contracture, palpitation and panic which indicates two groups have equivalent curative effect.
There's no statistically significant difference (P>0.05) in improving arm tic disorder which indicates two groups have equivalent curative effect.
There's no statistically significant difference (P>0.05) in improving vocal tic disorder and movement tic disorder which indicates two groups have equivalent curative effect.
There's statistically significant difference (P<0.05) in improving comprehensive trauma conditions which indicates the Trial Groups has better curative effect than the Control Group.
Safety examination demonstrates no abnormal changes occur to those with normal blood, urine, stool, liver and kidney function and electrocardiogram examination results which indicate the safe clinical application of this therapy.
Conclusion
1. Acupuncture plus Chinese Herbal Medicine Therapy has better curative effect than the Simple Acupuncture Therapy in Tourette's Syndrome treatment.
2. Acupuncture plus Chinese Herbal Medicine Therapy has better curative effect than the Simple Acupuncture Therapy in relieving patients'arm tic disorder. 3. Acupuncture plus Chinese Herbal Medicine Therapy has better curative effect than the Simple Acupuncture Therapy in the treatment of movement tic disorder and comprehensive trauma.
引文
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