针灸联合柳氮磺胺吡啶治疗强直性脊柱炎的临床研究
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摘要
目的:
通过临床试验研究,观察电针夹脊穴及隔附子饼温和灸对柳氮磺胺吡啶(SASP)的增效减毒作用及其治疗强直性脊柱炎(AS)的机理,进一步探索中西医结合治疗强直性脊柱炎的安全有效方案。
方法:
1临床资料:所有强直性脊柱炎患者均来源于武汉市中医院风湿科专科门诊及住院部。自2007年5月至2008年2月,共收治强直性脊柱炎患者60例,采用随机、阳性药物平行对照的设计方法,分为试验组和对照组,其中试验组30例,对照组30例。
2治疗方法:①对照组(SASP组):30例,给予柳氮磺胺吡啶口服,第一周每次0.25g,第二周起为0.5g,第三周起为0.75g直至疗程结束,每日3次,共12周。②试验组(SASP+针灸组):30例,在对照组治疗之上再给予电针及隔物温和灸,治疗12周后观察疗效。③个别病人关节疼痛难忍时,酌情临时加服洛索洛芬钠,每次60mg,每日三次,不作常规治疗(症状减轻则停药)。此外,不使用与治疗本病相关的其他的中、西药物。
3观测指标:安全性指标包括一般体检、心、肺、肝、肾功能及血、尿、便常规等检查;疗效指标包括①主要症状:腰骶疼痛、脊背疼痛、腰脊活动受限、腰背晨僵、关节疼痛、关节肿胀、腰膝酸软困重、发热。⑦主要体征:疼痛10cm数值表、枕墙距、指地距、Schober试验、胸廓活动度、“4”字试验、骨盆挤压、分离试验。④实验室指标:HLA-B27、ESR、CRP、IgA、ALP。④放射学检查:双侧骶髂关节X线正位片。
4统计方法:采用SPSS13.0软件包进行数据统计分析,计量资料组内比较采用配对均数t检验,组间比较采用两独立样本均数t检验;等级资料用Ridit检验,分类资料采用X~2检验,P＜0.05被认为所检验的差别具有统计学意义。
结果:
两组共60例患者均完成疗程,依从性良好,未出现脱落、剔除病例。
1两组患者治疗后总疗效经分析,试验组总有效率93.33%,控显(近期控制和显效)率66.67%;对照组总有效率76.67%,控显率40%,两组总疗效比较有统计学意义(P＜0.05)。
2两组患者治疗后中医证候疗效经分析,试验组总有效率86.67%,控显率56.67%;对照组总有效率76.67%,控显率22.22%,两组中医证候疗效比较有统计学意义(P＜0.05)。
3临床症状疗效方面,试验组治疗前后比较均有显著性差异(P＜0.05);对照组除外周关节肿胀一项积分值治疗前后比较无显著性差异(P＞0.05)外,其余各项主、次症积分治疗前后比较均有显著性差异(P＜0.05);治疗后组间比较,均有显著性差异(P＜0.05)。
4主要体征比较,两组患者的疼痛10cm数值表、枕墙距、指地距、Schober试验及胸廓活动度方面,试验组治疗前后比较有显著性差异(P＜0.05),对照组治疗前后比较亦有显著性差异(P＜0.05),且治疗后两组患者组间比较有显著性差异(P＜0.05);“4”字试验、骨盆挤压、分离试验方面,治疗后两组患者组间比较有显著性差异(P＜0.05)。
5实验室指标方面,以ESR、CRP、IgA、ALP作为观察指标,试验组治疗前后ESR、CRP、IgA数值有显著性差异(P＜0.05),ALP有非常显著性差异(P＜0.01);对照组治疗前后ESR、CRP、IgA、ALP数值有显著性差异(P＜0.05);治疗后组间比较ESR、CRP、IgA亦有显著性差异(P＜0.05),ALP有非常显著性差异(P＜0.01)。
6骶髂关节X线正位片方面,治疗后两组骶髂关节X线正位片改变无明显差异(P＞0.05)。
7治疗后不良反应方面,试验组5例患者出现短暂性轻度消化道不适;对照组2例患者出现中度不良反应,12例患者出现轻度消化道不适。两组不良反应情况比较有显著性差异(P＜0.05)。
结论:
本次临床试验研究表明,电针夹脊穴及隔附子饼温和灸联合柳氮磺胺吡啶(SASP)组治疗强直性脊柱炎疗效优于柳氮磺胺吡啶组,且副作用的发生率明显降低,有很好的协同作用,确为本病治疗安全有效的方法。对于针灸治疗本病的机理及其远期疗效值得进一步的深入研究。
Objective:
Through the clinical trial research, the observation of electro-acupuncture (EA) JIAJI points and Aconite cake-separated temperate moxibustion can reduce the poison and increase the efficiency of salicylazosulfapyridine (SASP) ,and it treats the ankylosing spondylitisis's mechanism .Further explores the cooperation of Chinese and Western medicine to treat the ankylosing spondylitisis's security effective scheme.
Methods:
1 clinical material: All ankylosing spondylitisis(AS) patient originates from the Wuhan Chinese medicine hospital Rheumatism Branch special clinic and in-patient department. From May, 2007 to February, 2008, altogether admits AS patient 60 examples, uses stochastically,the masculine medicine parallel comparison design method, divides into the experimental group and the control group, experiments the group 30 examples, control group 30 examples.
2 methods of treatment:①Control group (SASP group): 30 examples, give the salicylazosulfapyridine oral administration, first week each time 0.25g, the second week is 0.5g, the third week was 0.75g finishes until the treatment course, daily 3 times, altogether 12 weeks.②Experimental group (SASP+acupuncture group): 30 examples, above the control group treats gives the electro-acupuncture again and Aconite cake-separated temperate moxibustion, treats 12 weeks later observes the curative effect.③When the few patient joint ache is hard to endure, uses judgment the temporary oral administration loxoprofen, each time 60mg, daily three times, does not make the conventional treatment (symptom to reduce, then stops medicine). In addition, does not use the medicine that treats this sickness related other traditional Chinese medicines and the western medicine.
3 observation targets: Secure target including common physical examination, heart, lung, liver, kidney function and blood, urine, stool routine and so on ;The curative effect target includes①Cardinal symptoms: The waist shinbone ache, the back ache, the waist keel activity is limited, the lumbodorsal region early morning to be stiff, the joint ache, the joint swelling, the waist knee worn out and aching sleepy heavy, gives off heat.②Main symptom: Visual Analogue Scale, the pillow wall is apart from, refers to is apart from, the Schober experiment, the chest gallery activity, " 4 " the character experiment, the pelvis extrusion, the separation experiment.③Laboratory target: HLA - B27、ESR、CRP、IgA、ALP.④Radioactivity inspection: Two-sided sacroiliac joint X normal position piece.
4 statistical methods: Uses the SPSS13.0 software package to carry on the data statistical analysis, in the measurement dataset compares uses the pair mean value T-test, the group compares uses two independent sample mean value T-test; The ranked data examines with Ridit, the grouped data uses the chi-square test, P<0.05 was considered examines the difference has statistics significance.
Results:
the two group of altogether 60 example patients complete the treatment course, the compliance are good, has not appeared falls off, the rejection case.
1 After two group of patients treat, the total curative effect passes through the analysis,experimental group total effectiveness 93.33%, will control obviously (near future to control and appearance) rate 66.67%; Control group total effectiveness 76.67%, control obviously leads 40%, two group of total curative effect comparisons have statistics significance (P<0.05).
2 After two group of patients treat, the Chinese medicine card period of five days curative effect passes through the analysis, the experimental group is always effective is 86.67%, controls obviously leads 56.67%; Control group total effectiveness 76.67%, control obviously leads 22.22%, two group of card period of five days curative effect comparison has statistics significance (P<0.05).
3 Around the clinical symptoms curative effect aspect, the experimental group treats is quite even has the significance difference (P<0.05); The control group compares the non-significance difference besides the circumference joint swelling item of integral valve treatment around (P>0.05), other each item of host, around the time sickness integral treatment is quite even has the significance difference (P<0.05); After the treatment, the group the comparison, has the significance difference (P<0.05).
4 Around the main symptom comparison, two group of patient's Visual Analogue Scale, the pillow wall is apart from, refers to is apart from, the Schober experiment and the chest gallery activity aspect, the experimental group treats the comparison to have the significance difference (P<0.05), around the control group treats compares also has the significance difference (P<0.05), and treats the latter two group of patient group the comparison to have the significance difference (P<0.05); "4" the character experiment, the pelvis extrusion, the separation experiment aspect, treats the latter two group of patient group the comparison to have the significance difference (P<0.05).
5 Around the laboratory target aspect, by ESR, CRP, IgA, ALP takes the observation target, the experimental group treats ESR, CRP, the IgA value to have significance difference (P<0.05), ALP to have the unusual significance difference (P<0.01); Around the control group treats ESR, CRP, IgA, the ALP value to have the significance difference (P<0.05); After the treatment, the group compares ESR, CRP, IgA also to have significance difference (P<0.05), ALP to have the unusual significance difference (P<0.01).
6 The sacroiliac joint X normal position piece aspect, treats the latter two group of sacroiliac joint X normal position piece change not obvious difference (P>0.05).
7 After the treatment, the untoward effect aspect, the experimental group 5 example patients present the temporary mild digestive tract to be ill; The control group 2 example patients present the moderate untoward effect, 12 example patients present the mild digestive tract to be ill. Two group of untoward effect situation comparison has the significance difference (P<0.05).
Conclusion:
This clinical trial research indicated, the electro-acupuncture (EA) JIAJI points and Aconite cake-separated temperate moxibustion union salicylazosulfapyridine (SASP) the group to treat ankylosing spondylitisis curative effect to surpass salicylazosulfapyridine group, And the side effect formation rate reduces obviously, has the very good synergism, firmly for this sickness treatment safe effective method. Are worth the further deep research regarding the acupunture therapy this sickness's mechanism and the forward curative effect.
通过临床试验研究,观察电针夹脊穴及隔附子饼温和灸对柳氮磺胺吡啶(SASP)的增效减毒作用及其治疗强直性脊柱炎(AS)的机理,进一步探索中西医结合治疗强直性脊柱炎的安全有效方案。
方法:
1临床资料:所有强直性脊柱炎患者均来源于武汉市中医院风湿科专科门诊及住院部。自2007年5月至2008年2月,共收治强直性脊柱炎患者60例,采用随机、阳性药物平行对照的设计方法,分为试验组和对照组,其中试验组30例,对照组30例。
2治疗方法:①对照组(SASP组):30例,给予柳氮磺胺吡啶口服,第一周每次0.25g,第二周起为0.5g,第三周起为0.75g直至疗程结束,每日3次,共12周。②试验组(SASP+针灸组):30例,在对照组治疗之上再给予电针及隔物温和灸,治疗12周后观察疗效。③个别病人关节疼痛难忍时,酌情临时加服洛索洛芬钠,每次60mg,每日三次,不作常规治疗(症状减轻则停药)。此外,不使用与治疗本病相关的其他的中、西药物。
3观测指标:安全性指标包括一般体检、心、肺、肝、肾功能及血、尿、便常规等检查;疗效指标包括①主要症状:腰骶疼痛、脊背疼痛、腰脊活动受限、腰背晨僵、关节疼痛、关节肿胀、腰膝酸软困重、发热。⑦主要体征:疼痛10cm数值表、枕墙距、指地距、Schober试验、胸廓活动度、“4”字试验、骨盆挤压、分离试验。④实验室指标:HLA-B27、ESR、CRP、IgA、ALP。④放射学检查:双侧骶髂关节X线正位片。
4统计方法:采用SPSS13.0软件包进行数据统计分析,计量资料组内比较采用配对均数t检验,组间比较采用两独立样本均数t检验;等级资料用Ridit检验,分类资料采用X~2检验,P＜0.05被认为所检验的差别具有统计学意义。
结果:
两组共60例患者均完成疗程,依从性良好,未出现脱落、剔除病例。
1两组患者治疗后总疗效经分析,试验组总有效率93.33%,控显(近期控制和显效)率66.67%;对照组总有效率76.67%,控显率40%,两组总疗效比较有统计学意义(P＜0.05)。
2两组患者治疗后中医证候疗效经分析,试验组总有效率86.67%,控显率56.67%;对照组总有效率76.67%,控显率22.22%,两组中医证候疗效比较有统计学意义(P＜0.05)。
3临床症状疗效方面,试验组治疗前后比较均有显著性差异(P＜0.05);对照组除外周关节肿胀一项积分值治疗前后比较无显著性差异(P＞0.05)外,其余各项主、次症积分治疗前后比较均有显著性差异(P＜0.05);治疗后组间比较,均有显著性差异(P＜0.05)。
4主要体征比较,两组患者的疼痛10cm数值表、枕墙距、指地距、Schober试验及胸廓活动度方面,试验组治疗前后比较有显著性差异(P＜0.05),对照组治疗前后比较亦有显著性差异(P＜0.05),且治疗后两组患者组间比较有显著性差异(P＜0.05);“4”字试验、骨盆挤压、分离试验方面,治疗后两组患者组间比较有显著性差异(P＜0.05)。
5实验室指标方面,以ESR、CRP、IgA、ALP作为观察指标,试验组治疗前后ESR、CRP、IgA数值有显著性差异(P＜0.05),ALP有非常显著性差异(P＜0.01);对照组治疗前后ESR、CRP、IgA、ALP数值有显著性差异(P＜0.05);治疗后组间比较ESR、CRP、IgA亦有显著性差异(P＜0.05),ALP有非常显著性差异(P＜0.01)。
6骶髂关节X线正位片方面,治疗后两组骶髂关节X线正位片改变无明显差异(P＞0.05)。
7治疗后不良反应方面,试验组5例患者出现短暂性轻度消化道不适;对照组2例患者出现中度不良反应,12例患者出现轻度消化道不适。两组不良反应情况比较有显著性差异(P＜0.05)。
结论:
本次临床试验研究表明,电针夹脊穴及隔附子饼温和灸联合柳氮磺胺吡啶(SASP)组治疗强直性脊柱炎疗效优于柳氮磺胺吡啶组,且副作用的发生率明显降低,有很好的协同作用,确为本病治疗安全有效的方法。对于针灸治疗本病的机理及其远期疗效值得进一步的深入研究。
Objective:
Through the clinical trial research, the observation of electro-acupuncture (EA) JIAJI points and Aconite cake-separated temperate moxibustion can reduce the poison and increase the efficiency of salicylazosulfapyridine (SASP) ,and it treats the ankylosing spondylitisis's mechanism .Further explores the cooperation of Chinese and Western medicine to treat the ankylosing spondylitisis's security effective scheme.
Methods:
1 clinical material: All ankylosing spondylitisis(AS) patient originates from the Wuhan Chinese medicine hospital Rheumatism Branch special clinic and in-patient department. From May, 2007 to February, 2008, altogether admits AS patient 60 examples, uses stochastically,the masculine medicine parallel comparison design method, divides into the experimental group and the control group, experiments the group 30 examples, control group 30 examples.
2 methods of treatment:①Control group (SASP group): 30 examples, give the salicylazosulfapyridine oral administration, first week each time 0.25g, the second week is 0.5g, the third week was 0.75g finishes until the treatment course, daily 3 times, altogether 12 weeks.②Experimental group (SASP+acupuncture group): 30 examples, above the control group treats gives the electro-acupuncture again and Aconite cake-separated temperate moxibustion, treats 12 weeks later observes the curative effect.③When the few patient joint ache is hard to endure, uses judgment the temporary oral administration loxoprofen, each time 60mg, daily three times, does not make the conventional treatment (symptom to reduce, then stops medicine). In addition, does not use the medicine that treats this sickness related other traditional Chinese medicines and the western medicine.
3 observation targets: Secure target including common physical examination, heart, lung, liver, kidney function and blood, urine, stool routine and so on ;The curative effect target includes①Cardinal symptoms: The waist shinbone ache, the back ache, the waist keel activity is limited, the lumbodorsal region early morning to be stiff, the joint ache, the joint swelling, the waist knee worn out and aching sleepy heavy, gives off heat.②Main symptom: Visual Analogue Scale, the pillow wall is apart from, refers to is apart from, the Schober experiment, the chest gallery activity, " 4 " the character experiment, the pelvis extrusion, the separation experiment.③Laboratory target: HLA - B27、ESR、CRP、IgA、ALP.④Radioactivity inspection: Two-sided sacroiliac joint X normal position piece.
4 statistical methods: Uses the SPSS13.0 software package to carry on the data statistical analysis, in the measurement dataset compares uses the pair mean value T-test, the group compares uses two independent sample mean value T-test; The ranked data examines with Ridit, the grouped data uses the chi-square test, P<0.05 was considered examines the difference has statistics significance.
Results:
the two group of altogether 60 example patients complete the treatment course, the compliance are good, has not appeared falls off, the rejection case.
1 After two group of patients treat, the total curative effect passes through the analysis,experimental group total effectiveness 93.33%, will control obviously (near future to control and appearance) rate 66.67%; Control group total effectiveness 76.67%, control obviously leads 40%, two group of total curative effect comparisons have statistics significance (P<0.05).
2 After two group of patients treat, the Chinese medicine card period of five days curative effect passes through the analysis, the experimental group is always effective is 86.67%, controls obviously leads 56.67%; Control group total effectiveness 76.67%, control obviously leads 22.22%, two group of card period of five days curative effect comparison has statistics significance (P<0.05).
3 Around the clinical symptoms curative effect aspect, the experimental group treats is quite even has the significance difference (P<0.05); The control group compares the non-significance difference besides the circumference joint swelling item of integral valve treatment around (P>0.05), other each item of host, around the time sickness integral treatment is quite even has the significance difference (P<0.05); After the treatment, the group the comparison, has the significance difference (P<0.05).
4 Around the main symptom comparison, two group of patient's Visual Analogue Scale, the pillow wall is apart from, refers to is apart from, the Schober experiment and the chest gallery activity aspect, the experimental group treats the comparison to have the significance difference (P<0.05), around the control group treats compares also has the significance difference (P<0.05), and treats the latter two group of patient group the comparison to have the significance difference (P<0.05); "4" the character experiment, the pelvis extrusion, the separation experiment aspect, treats the latter two group of patient group the comparison to have the significance difference (P<0.05).
5 Around the laboratory target aspect, by ESR, CRP, IgA, ALP takes the observation target, the experimental group treats ESR, CRP, the IgA value to have significance difference (P<0.05), ALP to have the unusual significance difference (P<0.01); Around the control group treats ESR, CRP, IgA, the ALP value to have the significance difference (P<0.05); After the treatment, the group compares ESR, CRP, IgA also to have significance difference (P<0.05), ALP to have the unusual significance difference (P<0.01).
6 The sacroiliac joint X normal position piece aspect, treats the latter two group of sacroiliac joint X normal position piece change not obvious difference (P>0.05).
7 After the treatment, the untoward effect aspect, the experimental group 5 example patients present the temporary mild digestive tract to be ill; The control group 2 example patients present the moderate untoward effect, 12 example patients present the mild digestive tract to be ill. Two group of untoward effect situation comparison has the significance difference (P<0.05).
Conclusion:
This clinical trial research indicated, the electro-acupuncture (EA) JIAJI points and Aconite cake-separated temperate moxibustion union salicylazosulfapyridine (SASP) the group to treat ankylosing spondylitisis curative effect to surpass salicylazosulfapyridine group, And the side effect formation rate reduces obviously, has the very good synergism, firmly for this sickness treatment safe effective method. Are worth the further deep research regarding the acupunture therapy this sickness's mechanism and the forward curative effect.
引文
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