穴位埋线与针刺结合治疗根性坐骨神经痛的临床研究
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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,观察穴位埋线与针刺结合治疗根性坐骨神经痛的临床疗效和安全性,并进行客观的疗效评价,期望进一步规范临床疗效,获得较好的社会效益。
方法
选取2009年4月至2010年3月期间在台湾六和中医诊所治疗的,符合病例筛选标准的80例根性坐骨神经痛患者。按1：1的比例随机分配至治疗组(穴位埋线+针刺)和对照组(单纯针刺)两组,每组各有40例。隔日治疗1次,10次为1疗程,观察1个疗程。采用VAS评分、BRS-6行为评分、MG-Gill疼痛计分表评分进行评定,进行安全性检测,临床疗效采用中华人民共和国中医药行业标准的《中医病证诊断疗效标准》进行判定。
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 4.03完成。
结果
共收到合格受试者80例,均为门诊病人。男39例,女41例,年龄31-58岁,病程1个月-24个月。其中穴位埋线联合针刺疗法组40例(男16例,女24例),针刺组40例(男23例,女17例),平均年龄分别为47.89岁、45.12岁,平均病程10.37月、9.73月。
患者基线特征的可比性分析中,两组性别、年龄、病程、疼痛程度、中医辨证分型、PRI知觉、PRI感情、PRI总分、VAS评分、疼痛强度、行为疼痛(BRS-6)评分等经分析均无统计学意义,说明两组间的基线资料具有可比性。
疼痛评比情况：一疗程治疗后,两组的PRI知觉、PRI感情、PRI总分、VAS评分、疼痛强度、行为疼痛(BRS-6)评分均较治疗前降低,且均具有统计意义(P<0.05)。说明两组疗法均可降低上述量表评分,都可缓解患者疼痛症状,提高生存质量。通过组间比较,两组间治疗后的PRI知觉、PRI感情、PRI总分、VAS评分、疼痛强度、行为疼痛(BRS-6)评分及治疗前后差值对比均有统计意义(P<0.05)。说明穴位埋线结合针刺疗法治疗根性坐骨神经痛效果显著。
两组治疗后疼痛程度都有所减轻,重度疼痛患者疼痛程度全部转为中度、轻度甚至消失。尤其穴位埋线结合针刺疗法组患者,80%的患者治疗后都处于轻度疼痛以下,37.5%的患者疼痛消失,疗效较为显著。而对照组治疗后60%患者疼痛程度处于轻度以下。两组治疗后疼痛程度比较,具有统计意义(P<0.05)。
临床疗效情况：治疗一疗程后,治疗组40例,治愈22例,好转16例,无效2例,总有效率95.0%；对照组40例患者,治愈10例,好转22例,无效8例,总有效率80.0%。两组临床疗效与总有效率的比较,差异均有统计意义(P<0.05)。而治疗组的总有效总有效率(95.0%)优于对照组(80.0%)。表明穴位埋线结合针刺疗法治疗根性坐骨神经痛疗效肯定。
两组治疗前后血、尿、大便常规,肝、肾功能,心电图检测均无明显异常变化,表明穴位埋线结合针刺疗法安全有效,无毒副作用。
结论
综合以上临床研究结果,初步证明了采用穴位埋线结合针刺的方法治疗根性坐骨神经痛,方便经济,且疗效显著,安全可靠,值得临床进一步推广使用。
Objective
To observe the clinical effectiveness and safety of points catgut embedding combining with acupuncture for nerve root Sciatica and to evaluated abjectly the therapeutic effect, the study adapted the clinical randomized-controlled trial, by using clinical epidemiology、methodology of clinical science and statistics method. Through this study, further standardization clinical effectiveness and better social effect could be obtained.
Methods
All cases were recruited from Taiwan Liu Keyou Chinese Medicine Clinic from April,2009 to March,2010. Eighty patients with Sciatic who met the criteria were randomly divided 1:1 into the treatment group (Acupoint Thread Embed plus acupuncture) and the control group (acupuncture only). All cases received treatment once two days for five times as one course. VAS score、BRS-6 behavior score、MG-Gill pain Scoreboard were used to evaluate the treatment effect and safety test, and clinical effectiveness was judged by the industry standards of Traditional Chinese Medicine in China, which named Effectiveness Standard of Diseases and Syndrome Diagnosis in Traditional Chinese Medicine EPIDATA3.1 software was used to establish database, and SPSS15.0 was applied to make statistics analysis. Measurement data was expressed by mean±standard deviation (χ±S), and count data was showed by constituent ratio(%). Measurement data was analyzed by t test (if variance arrhythmias existed, data would be analyzed by t'test or Rank sum test); before and after self-cooperation was handled by t test or Wilcoxon Paired Rank Sum Test. Categorical data using Chi-Square test, ranked data using two-samples compared Wilcoxon rank sum test (adjusted).Statistical graphic manufacture was finished by Graph Pad Prism 4.03 software.
Results
Eighty cases were recruited totally from outpatient department. Among them, there were thirty nine men and forty one women, aged between 31-58, with course of disease between one month and twenty four months. There were forty cases (sixteen men and twenty four women) in the treatment group and forty cases (twenty three men and seventeen women) in the control group, with the average age of 47.89 years and 45.12 years relatively and the average course of disease of the patients in two groups was 10.37 months and 9.73 months relatively. In two groups, the baseline that including gender、age、course of disease、pain degree、syndrome differentiation type、PRI cognition、PRI emotion、PRI total score、VAS score、pain severity、behavior pain (BRS-6) score was no significance of differences statically, which suggested baseline data in two groups could be comparable.
Comparison of pain condition:after one treatment course, sore of PRI cognition、PRI emotion、PRI total score、VAS score、pain severity、behavior pain (BRS-6) reduced in both groups, with significant difference statistically (P<0.05),which indicated scale score used above could be lowered and pain symptom could be released and quality of life be improved in two groups. By group comparison, sore of PRI cognition、PRI emotion、PRI total score、VAS score、pain severity、behavior pain (BRS-6) reduced more significantly in treatment group (P<0.05),which suggested the effect of points catgut embedding plus acupuncture treating nerve root Sciacca be significant.
After treatment, pain severity of all cases was ease more or less in both groups and the severity of serious pain patients turned to moderate、light or even disappear. Especially in the treatment group, pain degree of 80% patients was under light degree and pain of 37.5% patients disappeared, which showed significant efficacy. Yet pain degree of 60% patients was under light degree. The comparison of pain severity in two groups was different significantly (P<0.05).
Therapeutic effect comparison:after one therapeutic course, in the treatment group,22 cases were sanative,16 cases became better,2 cases failed to improve, and the total effective rate was 95.0%; and in the control group, 10 cases,22 cases,8 cases and 80.0% relatively. Compared with two groups, both the clinical efficacy and total effective rate showed significant difference (P<0.05). The treatment group made better in the total effective rate (95.0% compared with 80.0%), which indicated points catgut embedding plus acupuncture could firmly treat nerve root Sciacca. Before and after treatment, the blood routine、urine routine、stool routine、liver and renal function、electrocardiogram were tested. All the results showed no abnormal, which indicated therapy of points catgut embedding combining with acupuncture could be safe、effective and no adverse effect.
Conclusion
Judging from all the clinical results mentioned above, points catgut embedding plus acupuncture to treat nerve root Sciacca of nerve roots could be convenient and economical, have significant effectiveness and remain safe, which should be applied in clinic.
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,观察穴位埋线与针刺结合治疗根性坐骨神经痛的临床疗效和安全性,并进行客观的疗效评价,期望进一步规范临床疗效,获得较好的社会效益。
方法
选取2009年4月至2010年3月期间在台湾六和中医诊所治疗的,符合病例筛选标准的80例根性坐骨神经痛患者。按1：1的比例随机分配至治疗组(穴位埋线+针刺)和对照组(单纯针刺)两组,每组各有40例。隔日治疗1次,10次为1疗程,观察1个疗程。采用VAS评分、BRS-6行为评分、MG-Gill疼痛计分表评分进行评定,进行安全性检测,临床疗效采用中华人民共和国中医药行业标准的《中医病证诊断疗效标准》进行判定。
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 4.03完成。
结果
共收到合格受试者80例,均为门诊病人。男39例,女41例,年龄31-58岁,病程1个月-24个月。其中穴位埋线联合针刺疗法组40例(男16例,女24例),针刺组40例(男23例,女17例),平均年龄分别为47.89岁、45.12岁,平均病程10.37月、9.73月。
患者基线特征的可比性分析中,两组性别、年龄、病程、疼痛程度、中医辨证分型、PRI知觉、PRI感情、PRI总分、VAS评分、疼痛强度、行为疼痛(BRS-6)评分等经分析均无统计学意义,说明两组间的基线资料具有可比性。
疼痛评比情况：一疗程治疗后,两组的PRI知觉、PRI感情、PRI总分、VAS评分、疼痛强度、行为疼痛(BRS-6)评分均较治疗前降低,且均具有统计意义(P<0.05)。说明两组疗法均可降低上述量表评分,都可缓解患者疼痛症状,提高生存质量。通过组间比较,两组间治疗后的PRI知觉、PRI感情、PRI总分、VAS评分、疼痛强度、行为疼痛(BRS-6)评分及治疗前后差值对比均有统计意义(P<0.05)。说明穴位埋线结合针刺疗法治疗根性坐骨神经痛效果显著。
两组治疗后疼痛程度都有所减轻,重度疼痛患者疼痛程度全部转为中度、轻度甚至消失。尤其穴位埋线结合针刺疗法组患者,80%的患者治疗后都处于轻度疼痛以下,37.5%的患者疼痛消失,疗效较为显著。而对照组治疗后60%患者疼痛程度处于轻度以下。两组治疗后疼痛程度比较,具有统计意义(P<0.05)。
临床疗效情况：治疗一疗程后,治疗组40例,治愈22例,好转16例,无效2例,总有效率95.0%；对照组40例患者,治愈10例,好转22例,无效8例,总有效率80.0%。两组临床疗效与总有效率的比较,差异均有统计意义(P<0.05)。而治疗组的总有效总有效率(95.0%)优于对照组(80.0%)。表明穴位埋线结合针刺疗法治疗根性坐骨神经痛疗效肯定。
两组治疗前后血、尿、大便常规,肝、肾功能,心电图检测均无明显异常变化,表明穴位埋线结合针刺疗法安全有效,无毒副作用。
结论
综合以上临床研究结果,初步证明了采用穴位埋线结合针刺的方法治疗根性坐骨神经痛,方便经济,且疗效显著,安全可靠,值得临床进一步推广使用。
Objective
To observe the clinical effectiveness and safety of points catgut embedding combining with acupuncture for nerve root Sciatica and to evaluated abjectly the therapeutic effect, the study adapted the clinical randomized-controlled trial, by using clinical epidemiology、methodology of clinical science and statistics method. Through this study, further standardization clinical effectiveness and better social effect could be obtained.
Methods
All cases were recruited from Taiwan Liu Keyou Chinese Medicine Clinic from April,2009 to March,2010. Eighty patients with Sciatic who met the criteria were randomly divided 1:1 into the treatment group (Acupoint Thread Embed plus acupuncture) and the control group (acupuncture only). All cases received treatment once two days for five times as one course. VAS score、BRS-6 behavior score、MG-Gill pain Scoreboard were used to evaluate the treatment effect and safety test, and clinical effectiveness was judged by the industry standards of Traditional Chinese Medicine in China, which named Effectiveness Standard of Diseases and Syndrome Diagnosis in Traditional Chinese Medicine EPIDATA3.1 software was used to establish database, and SPSS15.0 was applied to make statistics analysis. Measurement data was expressed by mean±standard deviation (χ±S), and count data was showed by constituent ratio(%). Measurement data was analyzed by t test (if variance arrhythmias existed, data would be analyzed by t'test or Rank sum test); before and after self-cooperation was handled by t test or Wilcoxon Paired Rank Sum Test. Categorical data using Chi-Square test, ranked data using two-samples compared Wilcoxon rank sum test (adjusted).Statistical graphic manufacture was finished by Graph Pad Prism 4.03 software.
Results
Eighty cases were recruited totally from outpatient department. Among them, there were thirty nine men and forty one women, aged between 31-58, with course of disease between one month and twenty four months. There were forty cases (sixteen men and twenty four women) in the treatment group and forty cases (twenty three men and seventeen women) in the control group, with the average age of 47.89 years and 45.12 years relatively and the average course of disease of the patients in two groups was 10.37 months and 9.73 months relatively. In two groups, the baseline that including gender、age、course of disease、pain degree、syndrome differentiation type、PRI cognition、PRI emotion、PRI total score、VAS score、pain severity、behavior pain (BRS-6) score was no significance of differences statically, which suggested baseline data in two groups could be comparable.
Comparison of pain condition:after one treatment course, sore of PRI cognition、PRI emotion、PRI total score、VAS score、pain severity、behavior pain (BRS-6) reduced in both groups, with significant difference statistically (P<0.05),which indicated scale score used above could be lowered and pain symptom could be released and quality of life be improved in two groups. By group comparison, sore of PRI cognition、PRI emotion、PRI total score、VAS score、pain severity、behavior pain (BRS-6) reduced more significantly in treatment group (P<0.05),which suggested the effect of points catgut embedding plus acupuncture treating nerve root Sciacca be significant.
After treatment, pain severity of all cases was ease more or less in both groups and the severity of serious pain patients turned to moderate、light or even disappear. Especially in the treatment group, pain degree of 80% patients was under light degree and pain of 37.5% patients disappeared, which showed significant efficacy. Yet pain degree of 60% patients was under light degree. The comparison of pain severity in two groups was different significantly (P<0.05).
Therapeutic effect comparison:after one therapeutic course, in the treatment group,22 cases were sanative,16 cases became better,2 cases failed to improve, and the total effective rate was 95.0%; and in the control group, 10 cases,22 cases,8 cases and 80.0% relatively. Compared with two groups, both the clinical efficacy and total effective rate showed significant difference (P<0.05). The treatment group made better in the total effective rate (95.0% compared with 80.0%), which indicated points catgut embedding plus acupuncture could firmly treat nerve root Sciacca. Before and after treatment, the blood routine、urine routine、stool routine、liver and renal function、electrocardiogram were tested. All the results showed no abnormal, which indicated therapy of points catgut embedding combining with acupuncture could be safe、effective and no adverse effect.
Conclusion
Judging from all the clinical results mentioned above, points catgut embedding plus acupuncture to treat nerve root Sciacca of nerve roots could be convenient and economical, have significant effectiveness and remain safe, which should be applied in clinic.
引文
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