穴位敷贴治疗脾胃湿热证慢性胃炎临床优化方案研究
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摘要
穴位贴敷疗法在临床运用简便易行,疗效明确显著。通过文献回顾发现目前的研究存在诸多问题,对影响疗效的主要因素,如药物的选择、辅料的选择等关键问题无系统研究及解决方案,造成结果可比性不强,多局限于经验的总结。
本研究首次将穴位贴敷治疗慢性浅表性胃炎的整个过程分解开来,分成对疗效造成影响的六个因素,针对此六个因素,将整个研究分成六个临床试验,每个临床试验在三个试验组中统一其它五个因素,对其中一个因素进行试验,可以在避免其它五个因素影响的情况下,确定出该试验因素的最佳方案。最后将结论中最佳的六个方案统一就形成临床优化方案。
影响疗效的六个因素具体为：药物的选择、穴位的选择、敷贴持续时间、具体的疗程、辅料的运用、透皮促进剂的运用。按此形成六个临床试验。
试验一：目的：比较最常用的三组敷贴药物的疗效,选出最佳者。
方法：将符合标准的49例病例分为三个试验组,组1为毕拔为主药物组,组2为黄连为主药物组,组3为栀子为主药物组。在所有病人均给予相同的基础治疗的同时,三个组的病人按组别不同给予不同药物进行穴位敷贴。从安全性指标、疗效性指标、临床症状积分以及中医生存质量等综合评价方案去评估三个组病人穴位贴敷疗法的临床疗效。
结果：通过临床症状积分项目比较,对于“症状总分”,组1和组2、组2和组3都有差别。通过治疗后,组2改善的分数是最高的。通过PRO量表评分比较,除了“心理领域”、“社会领域”外,组1和组2、组1和组3都有差别。通过治疗后,组2、组3改善的PRO分数高于组1。
结论：第二组：黄连、木香、元胡、栀子(1：1：1：1)的疗效是最佳的。
试验二：目的：比较常用的三组敷贴穴位组成的疗效,选出最佳者。
方法：将符合标准的54例病例分为三个试验组,组1为神阙为主穴位组,组2为梁门为主穴位组,组3为中脘为主穴位组。余治疗方案和评价方法同试验1。
结果：通过临床症状积分项目比较,对于“症状总分”和“胃痛”,组3和组1、组3和组2都有差别。通过治疗后,组3改善的分数是最高的。通过PRO量表评分比较,治疗后,组3改善的PRO分数高于组1和组2。
结论：第三组：(中脘、内关、公孙、足三里、合谷)的疗效是最佳的。
试验三：目的：比较常用的三种不同敷贴持续时间取得的疗效,选出最佳者。
方法：将符合标准的42例病例分为三个试验组,组1为敷贴2小时组,组2为敷贴4小时组,组3为敷贴12小时组。余治疗方案和评价方法同试验1。
结果：通过临床症状积分项目比较,组1和组2、组1和组3都有差别。通过治疗后,细1改善的分数是最高的。通过PRO量表评分比较,治疗后,组1改善的PRO分数高于组2和组3。对“生理领域”和“社会领域”,通过治疗后,组1改善的PRO分数高于组2和组3。所以第一组的疗效好。
结论：第一组：敷贴持续时间2小时的疗效是最佳的。考虑存在最佳诱导期和半衰期,敷贴时间长使穴位产生疲劳而降低疗效。
试验四：目的：比较三种常用的不同敷贴疗程的疗效,选出最佳者。
方法：将符合标准的56例病例分为三个试验组,组1为敷贴2周组,组2为敷贴4周组,组3为敷贴6周组。余治疗方案和评价方法同试验1。
结果：通过临床症状积分项目比较,组2、组3改善的分数高于组1。两组之间无差异,但都优于第一组。通过PRO量表评分比较,组2、组3改善的PRO分数高于组1。但两组之间无差异。
结论：组2和组3效果好,无显著差异。组2的疗程是4周,组3的疗程是6周,治疗时间长短不同,但疗效接近,所以选择在实际临床中选用短疗程的组2,疗程4周。考虑有口服西药和中药汤剂的基础治疗,该推荐疗程只适用于联合治疗。
试验五：目的：比较三种常用的辅料的疗效,选出最佳者。
方法：将符合标准的57例病例分为三个试验组,组1为姜汁组,组2为黄酒组,组3为醋组。余治疗方案和评价方法同试验1。
结果：通过临床症状积分项目比较,组1和组2、组1和组3都有差别。通过治疗后,组1改善的分数是最高的。通过PRO量表评分比较,通过治疗后,组1改善的PRO分数高于组2和组3。
结论：在姜汁、黄酒、醋做为辅料的比较中,姜汁的效果是最佳的。考虑姜汁可和胃止呕,作为辅料又可缓解黄连和栀子苦寒,免伤胃气。
试验六：目的：比较三种常用透皮促进剂的疗效,选出最佳者。
方法：将符合标准的40例病例分为三个试验组,组1为川芎提取物组,组2为丁香挥发油组,组3为薄荷醇组。余治疗方案和评价方法同试验1。
结果：通过临床症状积分项目和PRO量表的评分差值比较,得到所有的P值都大于0.05,没有统计学意义,说明各组改善值无显著性差异。
结论：在川芎提取物、丁香挥发油、薄荷醇为透皮促渗剂的试验中。三个组的疗效无显著性差异。考虑黄连和姜汁本身就有一定促渗作用,对结果有一定影响。
Acupoint application is an effective therapy in clinical work. But the literature review on exsisting studies show that there is no evaluation or solution about the main factors which affect the effect, such as drug choice, the selection of herbs and adjuvants. This makes the results of these studies not strongly commeasurable, and most of them are only the summaries on their own experience.
This study is to decompose the entire treatment process of acupoint application on chronic superficial gastritis for the first time. It is devided into six trials by the effect influencing factors. Each trial studies on just one of the influencing factors while the other five factors are same. Every trial is devided into 3 groups. It could identify the preferred plan of the factors separately. Finally, the clinical optimization plan on acupoint application was made from the preferred plan of the six trials.
The six effect influencing factors are:selection of herbs, selection of acupoints, duration of apllication, course of treatment, selection of adjuvant, selection of cutaneous permeable agents. The six trials are:
Trial 1:
Objective:To compare the effect of three commonly used herbal formula of the acupoint application.
Methods:49 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 treated with the fomula of Bi Bo(long pepper)as the chief herb, group 2 with the fomula of Huang Lian(Coptis chinensis) as the chief herb, and group 3 with the fomula of Zhi zi(Gardenia) as the chief herb. All patients were treated with different fomulas, but the basic treatment were same. The therapeutic effects were evaluated by the safety, effect, clinical symptom score, endoscopy evaluation, and quality of life score in TCM, etc.
Results:According to the scores of clinical symptom, there were differences both between group 1 and group 2, group 2 and group 3. Scores of group 2 improved most after treatment. According to PRO scale score, there were differences both between group 1 and group 2, group 1 and group 3 in addition to the "psychological field" and "social field". Scores of group 2 and group 3 improved more than thoses of group 1 after treatment.
Results:the effect of Group two (Copt is, Mu Xiang, Yuan Hu, Gardenia (1:1:1:1)) was the best.
Trial 2:
Objective:To compare the effect of three commonly used acupoints fomula of the acupoint application.
Methods:54 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 treated with the fomula of Shenque as main point, group 2 with Bian Men as main point, group 3 with Zhongwan as the main point. The treatment course and effect evaluation were similar to Trial 1.
Results:According to the scores of clinical symptom, there were differences both between group 1 and group 3, group 2 and group 3 on the total scores and the scores of stomach symptom. Scores of group 3 improved most after treatment. According to PRO scale score, scores of group 3 improved more than group 1 or group 2 after treatment.
Result:the effect of Group three (in the epigastric, internal relations, Gongsun, Zusanli, gu, under the giant virtual) was the best.
Trial 3:
Objective:To compare the effect of three durations of acupoint application. Methods:42 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 was treated for 2 hours each time, group 2 for 4 hours, and group 3 for 12 hours. The herbs, acupoints, course of application and effect evaluation were similar to Trial 1.
Results:According to the scores of clinical symptom, there were differences both between group 1 and group 2, group 1 and group 3. Scores of group 1 improved most after treatment. According to PRO scale score, scores of group 1 improved more than group 2 or group 3 after treatment. On the "physical field" and "social field", through therapy, scores of group 1 improved more than those of Group 2 and Group 3.
Result:the effect of Group one was the best. Considering the better induction period and half time, longer time for application made the acupoints less reactive and the effect decreased.
Trial 4:
Objective:To compare the effect of three different courses of acupoints application.
Methods:56 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 was treated for 2 weeks, group 2 for 4 weeks, and group 3 for 6 weeks. The herbs, acupoints, durations of application and effect evaluation were similar to Trial 1.
Results:According to the scores of clinical symptom, group 2 and group 3 improved more than group 1. But it showed no difference between the two groups, but better than the group 1. According to PRO scale score, scores of group 2 and group 3 improved more than group 1. However, there was no difference between group 2 and group 3.
Result:It showed that Group 2 and Group 3 got better effect, and that no significant difference between them. The effect of the two groups was similar, though the courses were different. In clinical practice, course of 4 weeks worked shorter and better. Considering the basic treatment including oral western medicine and Chinese herbal decotion, the recommended course could not be used separately.
Trial 5:
Objective:To compare the effect of three different adjuvant.
Methods:57 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 was treated with ginger juice as adjuvant, group 2 with, yellow rice wine and group 3 with vinegar. The treatment course and effect evaluation were similar to Trial 1.
Results:According to the scores of clinical symptom, there were differences both between group 1 and group 2, group 1 and group 3. Scores of group 1 improved most after treatment. According to PRO scale score, scores of group 1 improved more than group 2 or group 3 after treatment.
Result:the effect of ginger juice was the best. Because ginger could regulate stomach and allevieate vomitting. It could relieve the bitter and cold of Huang Lian and Zhi Zi, and avoid injury to stomache qi.
Trial 6:
Objective:To compare the effect of three different cutaneous permeable agents.
Methods:40 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 was treated with Chuan Xiong extract as cutaneous permeable agent, group 2 with clove and group 3 with menthol. The treatment course and effect evaluation were similar to Trial 1.
Result:According to the comparison on scores of clinical symptom and PRO scale score, all P values were larger than 0.05. There were no significant differences in all groups.
Conclusion:In trial 6, it showed there were no significant differences on the effect. The result could be affected by the promoting permeation effect of Coptis and ginger.
本研究首次将穴位贴敷治疗慢性浅表性胃炎的整个过程分解开来,分成对疗效造成影响的六个因素,针对此六个因素,将整个研究分成六个临床试验,每个临床试验在三个试验组中统一其它五个因素,对其中一个因素进行试验,可以在避免其它五个因素影响的情况下,确定出该试验因素的最佳方案。最后将结论中最佳的六个方案统一就形成临床优化方案。
影响疗效的六个因素具体为：药物的选择、穴位的选择、敷贴持续时间、具体的疗程、辅料的运用、透皮促进剂的运用。按此形成六个临床试验。
试验一：目的：比较最常用的三组敷贴药物的疗效,选出最佳者。
方法：将符合标准的49例病例分为三个试验组,组1为毕拔为主药物组,组2为黄连为主药物组,组3为栀子为主药物组。在所有病人均给予相同的基础治疗的同时,三个组的病人按组别不同给予不同药物进行穴位敷贴。从安全性指标、疗效性指标、临床症状积分以及中医生存质量等综合评价方案去评估三个组病人穴位贴敷疗法的临床疗效。
结果：通过临床症状积分项目比较,对于“症状总分”,组1和组2、组2和组3都有差别。通过治疗后,组2改善的分数是最高的。通过PRO量表评分比较,除了“心理领域”、“社会领域”外,组1和组2、组1和组3都有差别。通过治疗后,组2、组3改善的PRO分数高于组1。
结论：第二组：黄连、木香、元胡、栀子(1：1：1：1)的疗效是最佳的。
试验二：目的：比较常用的三组敷贴穴位组成的疗效,选出最佳者。
方法：将符合标准的54例病例分为三个试验组,组1为神阙为主穴位组,组2为梁门为主穴位组,组3为中脘为主穴位组。余治疗方案和评价方法同试验1。
结果：通过临床症状积分项目比较,对于“症状总分”和“胃痛”,组3和组1、组3和组2都有差别。通过治疗后,组3改善的分数是最高的。通过PRO量表评分比较,治疗后,组3改善的PRO分数高于组1和组2。
结论：第三组：(中脘、内关、公孙、足三里、合谷)的疗效是最佳的。
试验三：目的：比较常用的三种不同敷贴持续时间取得的疗效,选出最佳者。
方法：将符合标准的42例病例分为三个试验组,组1为敷贴2小时组,组2为敷贴4小时组,组3为敷贴12小时组。余治疗方案和评价方法同试验1。
结果：通过临床症状积分项目比较,组1和组2、组1和组3都有差别。通过治疗后,细1改善的分数是最高的。通过PRO量表评分比较,治疗后,组1改善的PRO分数高于组2和组3。对“生理领域”和“社会领域”,通过治疗后,组1改善的PRO分数高于组2和组3。所以第一组的疗效好。
结论：第一组：敷贴持续时间2小时的疗效是最佳的。考虑存在最佳诱导期和半衰期,敷贴时间长使穴位产生疲劳而降低疗效。
试验四：目的：比较三种常用的不同敷贴疗程的疗效,选出最佳者。
方法：将符合标准的56例病例分为三个试验组,组1为敷贴2周组,组2为敷贴4周组,组3为敷贴6周组。余治疗方案和评价方法同试验1。
结果：通过临床症状积分项目比较,组2、组3改善的分数高于组1。两组之间无差异,但都优于第一组。通过PRO量表评分比较,组2、组3改善的PRO分数高于组1。但两组之间无差异。
结论：组2和组3效果好,无显著差异。组2的疗程是4周,组3的疗程是6周,治疗时间长短不同,但疗效接近,所以选择在实际临床中选用短疗程的组2,疗程4周。考虑有口服西药和中药汤剂的基础治疗,该推荐疗程只适用于联合治疗。
试验五：目的：比较三种常用的辅料的疗效,选出最佳者。
方法：将符合标准的57例病例分为三个试验组,组1为姜汁组,组2为黄酒组,组3为醋组。余治疗方案和评价方法同试验1。
结果：通过临床症状积分项目比较,组1和组2、组1和组3都有差别。通过治疗后,组1改善的分数是最高的。通过PRO量表评分比较,通过治疗后,组1改善的PRO分数高于组2和组3。
结论：在姜汁、黄酒、醋做为辅料的比较中,姜汁的效果是最佳的。考虑姜汁可和胃止呕,作为辅料又可缓解黄连和栀子苦寒,免伤胃气。
试验六：目的：比较三种常用透皮促进剂的疗效,选出最佳者。
方法：将符合标准的40例病例分为三个试验组,组1为川芎提取物组,组2为丁香挥发油组,组3为薄荷醇组。余治疗方案和评价方法同试验1。
结果：通过临床症状积分项目和PRO量表的评分差值比较,得到所有的P值都大于0.05,没有统计学意义,说明各组改善值无显著性差异。
结论：在川芎提取物、丁香挥发油、薄荷醇为透皮促渗剂的试验中。三个组的疗效无显著性差异。考虑黄连和姜汁本身就有一定促渗作用,对结果有一定影响。
Acupoint application is an effective therapy in clinical work. But the literature review on exsisting studies show that there is no evaluation or solution about the main factors which affect the effect, such as drug choice, the selection of herbs and adjuvants. This makes the results of these studies not strongly commeasurable, and most of them are only the summaries on their own experience.
This study is to decompose the entire treatment process of acupoint application on chronic superficial gastritis for the first time. It is devided into six trials by the effect influencing factors. Each trial studies on just one of the influencing factors while the other five factors are same. Every trial is devided into 3 groups. It could identify the preferred plan of the factors separately. Finally, the clinical optimization plan on acupoint application was made from the preferred plan of the six trials.
The six effect influencing factors are:selection of herbs, selection of acupoints, duration of apllication, course of treatment, selection of adjuvant, selection of cutaneous permeable agents. The six trials are:
Trial 1:
Objective:To compare the effect of three commonly used herbal formula of the acupoint application.
Methods:49 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 treated with the fomula of Bi Bo(long pepper)as the chief herb, group 2 with the fomula of Huang Lian(Coptis chinensis) as the chief herb, and group 3 with the fomula of Zhi zi(Gardenia) as the chief herb. All patients were treated with different fomulas, but the basic treatment were same. The therapeutic effects were evaluated by the safety, effect, clinical symptom score, endoscopy evaluation, and quality of life score in TCM, etc.
Results:According to the scores of clinical symptom, there were differences both between group 1 and group 2, group 2 and group 3. Scores of group 2 improved most after treatment. According to PRO scale score, there were differences both between group 1 and group 2, group 1 and group 3 in addition to the "psychological field" and "social field". Scores of group 2 and group 3 improved more than thoses of group 1 after treatment.
Results:the effect of Group two (Copt is, Mu Xiang, Yuan Hu, Gardenia (1:1:1:1)) was the best.
Trial 2:
Objective:To compare the effect of three commonly used acupoints fomula of the acupoint application.
Methods:54 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 treated with the fomula of Shenque as main point, group 2 with Bian Men as main point, group 3 with Zhongwan as the main point. The treatment course and effect evaluation were similar to Trial 1.
Results:According to the scores of clinical symptom, there were differences both between group 1 and group 3, group 2 and group 3 on the total scores and the scores of stomach symptom. Scores of group 3 improved most after treatment. According to PRO scale score, scores of group 3 improved more than group 1 or group 2 after treatment.
Result:the effect of Group three (in the epigastric, internal relations, Gongsun, Zusanli, gu, under the giant virtual) was the best.
Trial 3:
Objective:To compare the effect of three durations of acupoint application. Methods:42 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 was treated for 2 hours each time, group 2 for 4 hours, and group 3 for 12 hours. The herbs, acupoints, course of application and effect evaluation were similar to Trial 1.
Results:According to the scores of clinical symptom, there were differences both between group 1 and group 2, group 1 and group 3. Scores of group 1 improved most after treatment. According to PRO scale score, scores of group 1 improved more than group 2 or group 3 after treatment. On the "physical field" and "social field", through therapy, scores of group 1 improved more than those of Group 2 and Group 3.
Result:the effect of Group one was the best. Considering the better induction period and half time, longer time for application made the acupoints less reactive and the effect decreased.
Trial 4:
Objective:To compare the effect of three different courses of acupoints application.
Methods:56 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 was treated for 2 weeks, group 2 for 4 weeks, and group 3 for 6 weeks. The herbs, acupoints, durations of application and effect evaluation were similar to Trial 1.
Results:According to the scores of clinical symptom, group 2 and group 3 improved more than group 1. But it showed no difference between the two groups, but better than the group 1. According to PRO scale score, scores of group 2 and group 3 improved more than group 1. However, there was no difference between group 2 and group 3.
Result:It showed that Group 2 and Group 3 got better effect, and that no significant difference between them. The effect of the two groups was similar, though the courses were different. In clinical practice, course of 4 weeks worked shorter and better. Considering the basic treatment including oral western medicine and Chinese herbal decotion, the recommended course could not be used separately.
Trial 5:
Objective:To compare the effect of three different adjuvant.
Methods:57 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 was treated with ginger juice as adjuvant, group 2 with, yellow rice wine and group 3 with vinegar. The treatment course and effect evaluation were similar to Trial 1.
Results:According to the scores of clinical symptom, there were differences both between group 1 and group 2, group 1 and group 3. Scores of group 1 improved most after treatment. According to PRO scale score, scores of group 1 improved more than group 2 or group 3 after treatment.
Result:the effect of ginger juice was the best. Because ginger could regulate stomach and allevieate vomitting. It could relieve the bitter and cold of Huang Lian and Zhi Zi, and avoid injury to stomache qi.
Trial 6:
Objective:To compare the effect of three different cutaneous permeable agents.
Methods:40 patients diagnosied with chronic superficial gastritis/meet the standards were divided into three groups. Group 1 was treated with Chuan Xiong extract as cutaneous permeable agent, group 2 with clove and group 3 with menthol. The treatment course and effect evaluation were similar to Trial 1.
Result:According to the comparison on scores of clinical symptom and PRO scale score, all P values were larger than 0.05. There were no significant differences in all groups.
Conclusion:In trial 6, it showed there were no significant differences on the effect. The result could be affected by the promoting permeation effect of Coptis and ginger.
引文
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[16]宋春辉,李桂,崔树星,等.中药敷脐疗法对经腹术后患者胃肠功能恢复及T细胞亚群变化的影响[J].辽宁中医药大学学报,2008；10(1)：5-6.
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[18]王宝玲,于智芬.中药穴位贴敷治疗慢性支气管炎56例[J].时珍国医国药,2007；18(12)：3103-3104.
[19]罗明.三伏天穴位敷贴法治疗支气管哮喘缓解期60例临床观察[J].云南中医中药杂志,2007；28(12)：26-27.
[20]陈默野,张春珍.穴位贴敷对高血压病患者血压的影响[J].时珍国医国药, 2007：18(11)：2788-2789.
[21]张贤武.穴位贴敷治疗慢性咽炎219例[J].浙江中医杂志,2007；42(11)：622.
[22]袁保丰,秦黎虹.穴位贴敷次数对缓解期哮喘患者临床疗效的影响[J].吉林中医药,2007；27(8)：46-47.
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[29]李忠,苏淑茵,金容完,等.中药透皮吸收研究现状与展望[J].北京中医药大学学报,2000；23(6)：70-73.
[30]袁久荣,王爱武,荆淑红,等.中医经皮给药与中药透皮吸收研究进展[J].中国医药学报,2003；18(4)：243-246.
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