《穴位埋线治疗混合痔外剥内扎术后肛门疼痛的临床研究》的立题和设计
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摘要
目的:痔是临床上最常见、最多发的肛门疾病。Ⅰ、Ⅱ度痔通过保守综合治疗一般可取得较好的疗效,无需手术治疗,但Ⅲ、Ⅳ度痔原则上仍需手术治疗。痔的手术方式很多,其中1937年Milligan和Morgan创立了外剥内扎术,开展以来一直沿用至今,经过长期的临床实践证明,此术式有良好的远期疗效以及相对低廉的价格,目前仍是临床上最常用最主流的手术方式。但术后肛门疼痛是混合痔外剥内扎术最常见及最重要的并发症之一,而且疼痛通常要持续近5—7天后才开始逐渐减轻,对患者术后的日常生活及心理影响极大,严重影响患者的康复,同时增加了住院时间及费用。目前有很多不同途径的镇痛方法,但都有各自的缺点。近年来大量报道显示,穴位埋线可用于治疗坐骨神经痛、头痛、三叉神经痛、痛经、脱疽疼痛、胃脘痛,但穴位埋线用于痔术后镇痛尚属空白。于是我们想到:以针灸经络理论作指导,运用祖国医学穴位埋线疗法,在混合痔外剥内扎术后行经络系统穴位埋线治疗,试图利用埋线的持续性穴位刺激作用以达到减轻痔术后持续性疼痛的治疗目的。同时,应用循证医学的方法,选择科学、合理的科研设计和疗效评价指标,希望尽可能客观、真实地评价穴位埋线疗法减轻混合痔外剥内扎术后肛门疼痛的临床疗效。
方法:根据随机、对照的科研设计原则,采用中央随机法将符合试验标准的患者随机分为治疗组(穴位埋线组)和对照组(常规组),围手术期常规处理相同,进行临床操作,严格按照视觉模拟评分法、口述描绘评分法、面部表情评估法,分别在术后4、6、8、24、48、72、96、120小时观察术后肛门疼痛的程度及治疗后的镇痛效果,并随访疼痛消失时间,并进行比较研究。同时记录不良反应、镇痛药物使用量以及次要观察指标。采用SPSS 13.0统计软件进行全部数据结果分析。
结果:本课题为广东省中医院科学技术研究专项项目:中医药疗效评价体系理论模型的论证与研究的子课题之一,其立题和设计经过反复论证与研究后,通过广东省中医院伦理委员会审查,已进入临床试验阶段,目前为止进行了近30例临床观察。
结论:创新的、清晰的立体思路是课题的基础;科学、严密、精湛、详实、合理的设计是课题顺利进展的必要前提。
Objective: Clinical hemorrhoid is the most common, most of the anus of the disease. I, II of hemorrhoids through conservative treatment may generally be made good effect, without Surgical intervention, but III, IV of hemorrhoids in principle be operated on.There are many ways to hemorrhoid surgery, 1937, Milligan and Morgan founded the stripping of Internal Ligation, has been used to date, a long-term clinical practice has proved that this operation a good long-term efficacy and relatively low prices, is still Clinical is the most mainstream of the most common surgical method.But after anal pain is mixed hemorrhoids, stripping Internal Ligation of the most common and one of the most important complications, and nearly pain usually 5-7 days after the beginning gradually reduce, the daily life of patients with psychological and Greatly influenced by, seriously affecting the rehabilitation of patients, while increasing the length of stay and costs. At present, there are many different ways of analgesia, but have their own shortcomings. In recent years numerous reports that point catgut embedding can be used to treat sciatica, headache, trigeminal neuralgia, dysmenorrhea, from Ju pain, Epigastralgia, but the point catgut embedding for hemorrhoids postoperative analgesia is the blank. So we thought:We acupuncture meridians to the guidance of theory, the use of medical therapy Thread Embedding in the mixed hemorrhoids, after stripping Internal Ligation line meridian system Point catgut embedding treatment, trying to use catgut embedding the continuing role to stimulate acupoints to relieve pain after hemorrhoid Therapeutic purposes. At the same time, the method of application of evidence-based medicine, the choice of a scientific and rational research design and efficacy of indicators that as objectively as possible, to evaluate the real point catgut embedding therapy to reduce mixed hemorrhoids, strippingInternal Ligation anal pain after the clinical efficacy.
Methods: According to a randomized, controlled research design principles, use therandom method will be consistent with the test criteria of patients were randomly divided into treatment group (Point catgut embedding) and the control group (the control group), perioperative same as conventional treatment, clinical operations, strict According to visual analog score, score depict oral, facial expressions Assessment Act, in after hours of observation after 4,6,8,24,48,72,96,120 pain and the extent of the analgesic effect after treatment, the follow-up pain disappeared, and a comparative study. The adverse effect and the Use of analgesic drugs were recorded simultaneously. All data were analyzed by SPSS 13.0.
Results: The topic for Chinese medicine hospitals in Guangdong Province special scientific and technological research projects: the Chinese Medicine Clinical Evaluation System theoretical model demonstration and research on the subject of one of its legislature that the design and demonstration and through repeated studies by the Guangdong Provincial Committee of Chinese medicine hospitals ethics review, Has entered the clinical trial stage, so far conducted nearly 30 cases of.
Conclusion: The innovative, clear three-dimensional thinking is the basis of issues; science, tight, exquisite, informative and rational design issue is a necessary prerequisite for the smooth progress.
方法:根据随机、对照的科研设计原则,采用中央随机法将符合试验标准的患者随机分为治疗组(穴位埋线组)和对照组(常规组),围手术期常规处理相同,进行临床操作,严格按照视觉模拟评分法、口述描绘评分法、面部表情评估法,分别在术后4、6、8、24、48、72、96、120小时观察术后肛门疼痛的程度及治疗后的镇痛效果,并随访疼痛消失时间,并进行比较研究。同时记录不良反应、镇痛药物使用量以及次要观察指标。采用SPSS 13.0统计软件进行全部数据结果分析。
结果:本课题为广东省中医院科学技术研究专项项目:中医药疗效评价体系理论模型的论证与研究的子课题之一,其立题和设计经过反复论证与研究后,通过广东省中医院伦理委员会审查,已进入临床试验阶段,目前为止进行了近30例临床观察。
结论:创新的、清晰的立体思路是课题的基础;科学、严密、精湛、详实、合理的设计是课题顺利进展的必要前提。
Objective: Clinical hemorrhoid is the most common, most of the anus of the disease. I, II of hemorrhoids through conservative treatment may generally be made good effect, without Surgical intervention, but III, IV of hemorrhoids in principle be operated on.There are many ways to hemorrhoid surgery, 1937, Milligan and Morgan founded the stripping of Internal Ligation, has been used to date, a long-term clinical practice has proved that this operation a good long-term efficacy and relatively low prices, is still Clinical is the most mainstream of the most common surgical method.But after anal pain is mixed hemorrhoids, stripping Internal Ligation of the most common and one of the most important complications, and nearly pain usually 5-7 days after the beginning gradually reduce, the daily life of patients with psychological and Greatly influenced by, seriously affecting the rehabilitation of patients, while increasing the length of stay and costs. At present, there are many different ways of analgesia, but have their own shortcomings. In recent years numerous reports that point catgut embedding can be used to treat sciatica, headache, trigeminal neuralgia, dysmenorrhea, from Ju pain, Epigastralgia, but the point catgut embedding for hemorrhoids postoperative analgesia is the blank. So we thought:We acupuncture meridians to the guidance of theory, the use of medical therapy Thread Embedding in the mixed hemorrhoids, after stripping Internal Ligation line meridian system Point catgut embedding treatment, trying to use catgut embedding the continuing role to stimulate acupoints to relieve pain after hemorrhoid Therapeutic purposes. At the same time, the method of application of evidence-based medicine, the choice of a scientific and rational research design and efficacy of indicators that as objectively as possible, to evaluate the real point catgut embedding therapy to reduce mixed hemorrhoids, strippingInternal Ligation anal pain after the clinical efficacy.
Methods: According to a randomized, controlled research design principles, use therandom method will be consistent with the test criteria of patients were randomly divided into treatment group (Point catgut embedding) and the control group (the control group), perioperative same as conventional treatment, clinical operations, strict According to visual analog score, score depict oral, facial expressions Assessment Act, in after hours of observation after 4,6,8,24,48,72,96,120 pain and the extent of the analgesic effect after treatment, the follow-up pain disappeared, and a comparative study. The adverse effect and the Use of analgesic drugs were recorded simultaneously. All data were analyzed by SPSS 13.0.
Results: The topic for Chinese medicine hospitals in Guangdong Province special scientific and technological research projects: the Chinese Medicine Clinical Evaluation System theoretical model demonstration and research on the subject of one of its legislature that the design and demonstration and through repeated studies by the Guangdong Provincial Committee of Chinese medicine hospitals ethics review, Has entered the clinical trial stage, so far conducted nearly 30 cases of.
Conclusion: The innovative, clear three-dimensional thinking is the basis of issues; science, tight, exquisite, informative and rational design issue is a necessary prerequisite for the smooth progress.
引文
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