冬病夏治穴位贴敷疗法防治儿童支气管哮喘临床疗效及影响因素的研究
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摘要
本研究借鉴循证医学理念,运用现代医学临床流行病学的研究方法,对冬病夏治穴位贴敷疗法防治儿童支气管哮喘进行了文献回顾性研究和临床观察性研究,在全面收集文献报道、临床观察研究和专家共识的基础上,分析冬病夏治穴位贴敷疗法临床疗效与影响因素的关系,为临床疗效评价寻找科学证据,并为冬病夏治穴位贴敷疗法技术操作规范研究提供了依据。研究内容共分为两部分：
一、冬病夏治穴位贴敷疗法防治儿童支气管哮喘的文献研究
二、冬病夏治穴位贴敷疗法防治儿童支气管哮喘的临床观察研究
目的
通过冬病夏治穴位贴敷疗法治疗儿童支气管哮喘的现代文献和临床观察研究,探讨贴敷方法中药物、制备方法、穴位、贴敷时机、贴敷时间、贴敷皮肤反应等应用规律,为筛选治疗方案中影响临床疗效的相关因素提供客观依据。
方法
借鉴循证医学文献系统评价的思路和方法,结合中医针灸学科的文献特点,以冬病夏治、穴位贴敷、儿童支气管哮喘为关键词,应用SinoMed等全文数据库进行计算机和手工检索获取文献,录入数据表格统计分析。采用临床观察性研究方法,前瞻性队列研究设计,在辽宁、湖北、成都三地的三所Ⅲ级甲等中医院,以哮喘缓解期的患儿为3个队列,通过随访对三所医院不同的治疗方案进行观察与初步分析。
结果一、文献研究
检索纳入合格文献45篇,对患儿的一般资料和临床观察相关信息的分析结果如下。
1、一般资料：男性患儿多于女性,年龄2个月至17岁,平均年龄7.5岁；病程2个月至10年,平均病程3年；64.4%的论文报道了哮喘患儿病情分期,临床观察支气管哮喘缓解期的占55.6%。
2、中药使用频次：由高至低排在前10位的是白芥子、细辛、延胡索、甘遂、麝香、麻黄、皂荚、丁香、肉桂、苏子。药物性味多辛、温,归肺经。组方配伍比例按照白芥子：延胡索：甘遂：细辛以2：2：1：1居多；75.6%选用姜汁制备药膏。
3、腧穴使用频次：由高至低排在前10位的是肺俞、定喘、膏肓、膈俞、膻中、心俞、脾俞、大椎、肾俞、天突；腧穴归经多属足太阳膀胱经、任脉、督脉和经外奇穴；穴性以背俞穴居多。
4、贴敷时机：77.3%在夏季三伏贴敷,11.3%在三伏、三九天均贴,8.9%在夏季或7-8月贴敷,2.2%在非三伏和三九贴敷。
5、贴敷时间：24.4%小于或等于2小时；20.0%大于或等于2小时；6.7%在1-3小时。以2小时界定居多,最短的0.5小时,最长达24小时。
6、贴敷皮肤反应：42.2%未提及皮肤反应；13.3%提及局部皮肤潮红；11.1%提及疼痛；8.9%提及灼热感、细小水泡或其他说明；6.7%提及起泡。
7、研究方法：77.8%是临床观察或临床报道,22.2%报道采用数字表法随机、随机化表和电脑随机。观察病例在300例以下的占88.9%。
二、临床观察研究
1、一般资料
初诊符合支气管哮喘缓解期诊断标准、纳入标准的患儿共609例,其中,入组辽宁328例,湖北139例,成都142例。平均年龄辽宁6.89±2.82岁,湖北6.55±2.77岁,成都6.77±3.23岁；男性多于女性；平均病程2至3年。经统计学处理,患儿的年龄、性别、病程没有显著差异(P>0.05)。
2、初诊情况
(1)临床症状：按症状出现的频次由高至低排序,辽宁哮喘、咳嗽、喘憋、咳痰、气短；湖北和成都均哮喘、咳嗽、咳痰、喘憋、气短。经卡方检验,三所医院初诊哮喘患儿临床症状差异非常显著(P<0.01)。数据合并后排序为哮喘、咳嗽、喘憋、咳痰、气短。
(2)疾病发作或加重的季节性：疾病发作或加重随四季变化由高至低排序,辽宁无明显季节性最高、其次冬季、春季、秋季、夏季；湖北和成都均以冬季最高、其次春季、无季节性、秋季、夏季。经卡方检验,三所医院哮喘患儿急性发作有无季节性有非常显著的差异(P<0.01)。
(3)病情分析：三所医院贴敷患儿治疗前疾病急性发作或加重次数比较有显著性差异(P<0.05)。其中,患儿哮喘发作次数每月≤1次的比例最高,每月2-3次的次之,每周1-2次的较少,每周≥3次的极少。
(4)患儿自评和医生评价：三所医院贴敷患儿或监护人初诊时叙述病情严重程度,依据患者自我感受病情严重程度1-10分尺度表,经秩和检验,没有显著性差异(P>0.05)。初诊时医生诊断哮喘患儿的病情,以中度的最多,轻度的次之、重度的极少。经CMH卡方检验,三所医院医生诊断哮喘患儿的病情程度有显著性差异(P<0.05)。
(5)贴敷皮肤反应：三所医院不同的治疗方案三伏贴敷后,患儿皮肤反应以无反应、或呈痒感、灼热感为主。经CMH卡方检验,三所医院不同的治疗方案贴敷后患儿的皮肤反应有显著性差异(P<0.05)。
3、随访患儿哮喘再发的影响因素分析
(1)单因素分析：①患儿年龄、性别、病程对哮喘再发无统计学差异(P>0.05)。但概率图显示随着患儿年龄增长,哮喘再发概率呈下降趋势。②患儿哮喘急性发作或加重有无季节性对哮喘再发有非常显著的差异(P<0.01),患儿发病有季节性的哮喘再发概率高。③患儿哮喘急性发作次数对哮喘再发有非常显著的差异(P<0.01),急性发作每月少于1次的患儿哮喘再发概率明显低于每月超过1次的患儿。患儿贴敷前病情严重程度的不同等级对哮喘再发有显著性差异(P<0.05),轻度病情的哮喘再发概率低。④患儿贴敷后皮肤反应对哮喘再发经卡方检验,第1次贴敷有非常显著性差异(P<0.01),第2次贴敷有显著性差异(P<0.05),均显示皮肤无反应的哮喘再发概率低；第3次贴敷没有显著性差异(P>0.05)。⑤观察贴敷时机和时间对哮喘再发的影响,经卡方检验,有非常显著性差异(P<0.01)。选择三伏和三九均贴,贴敷0.5-2小时的哮喘再发概率低。⑥从三所医院不同的治疗方案中,提取中药组方中的不同药物,经卡方检验,有非常显著性差异(P<0.01)。组方中有延胡索的哮喘再发概率低,有甘遂、皂角和细辛的哮喘再发概率高。⑦从三所医院不同的治疗方案中,提取穴位处方中的不同穴位,经卡方检验,有非常显著性差异(P<0.01)。选用定喘和天突、膻中的哮喘再发概率低,选用大椎和复合穴位(即指肾俞、脾俞、关元、神阙、内关)的哮喘再发概率高。⑧从三所医院不同的治疗方案中,提取制备方法中的不同药物,经卡方检验,有非常显著性差异(P<0.01)。姜汁加麝香的哮喘再发概率低,加蒸馏水的次之,加蒜汁的最高。
(2)多因素分析：采用多元和多层Logistic回归模型,经SAS软件程序,模型入选的自变量是贴敷时机和时间、疾病发作或加重的季节性,结果显示无明显季节性,在三伏三九均贴,贴敷时间为0.5-2小时的哮喘再发概率低。“三伏”贴敷后,3次随访患儿的哮喘再发及病情,经过两水平分层筛选拟合模型,综合分析哮喘发作次数、发病季节、制备方法、贴敷时机和时间、皮肤反应等因素,提示随着随访时间的延长,三所医院患儿哮喘再发概率均呈下降趋势。数据合并处理结果显示,每隔三个月随访1次,哮喘再发概率下降0.7431倍；在三伏三九贴敷,时间为0.5-2小时的哮喘再发概率下降0.5166倍。
结论
文献分析统计结果,提示穴位贴敷疗法的中药组方、药物比例、制备方法、穴位处方、贴敷时机、贴敷时间、皮肤反应等因素与临床疗效相关。中药使用白芥子、细辛、延胡索、甘遂的频次较高,按照白芥子：延胡索：甘遂：细辛的配伍比例以2：2：1：1居多,制备方法主要采用鲜姜汁或姜汁,药性辛温,多归肺经。腧穴使用肺俞、定喘、膏肓、膈俞、膻中、心俞的频次较高,腧穴多归属足太阳膀胱经,背俞穴居多。三伏贴多于三伏和三九均贴,贴敷时间以2小时为界定的较多,多数报道认为贴敷后皮肤不发泡,以潮红为度。本研究按照循证医学中文献证据级别划分方法,虽然级别不高,但仍可说明以上诸因素可能与疗效有关。由于文献以临床观察或临床报道较多,样本量较少,采用数字表法的随机对照试验较少,缺乏大样本的随机对照试验结果,从循证医学的角度,判断冬病夏治穴位贴敷疗法对儿童哮喘缓解期的治疗作用证据不足,有待于今后进一步通过多中心、大样本的临床随机试验观察提供科学的证据。
2008年夏季“三伏”期间,三所医院观察1-14岁的贴敷患儿共计609例,一般资料基线均衡,具有可比性。初诊资料显示,接受冬病夏治穴位贴敷疗法的门诊患儿症状多表现为哮喘、咳嗽,以轻中度病情多见。患儿哮喘发作或病情与环境气候有关,不同的地域有其特殊性。位于我国东北地区的辽宁,患儿哮喘发作季节性不明显,可能与北方虽然气候寒冷,但室内供暖有关；而位于华中地区的湖北、西南地区的成都患儿哮喘发作有季节性,以冬季发病多见,可能与冬季寒冷、夏季炎热,四季温差较大有关。三所医院的贴敷时机均选择夏季“三伏”,在“头伏”、“中伏”、“末伏”的第1天各贴敷1次,辽宁同时还在“三九”贴敷。贴敷时间辽宁0.5-2小时,湖北和成都2-4小时。患儿贴敷后皮肤均以无反应,或痒感、灼热感多见。
通过贴敷后的3次随访,分析患儿哮喘再发的影响因素,提示年龄、病情、发作或加重有无季节性、贴敷方法均可能影响哮喘再发。通过对三所医院不同治疗方案中不同药物、穴位、制备方法的比较分析,提示中药组方的核心药物是白芥子、延胡索；穴位处方的核心腧穴是肺俞、膏肓、定喘、天突、膻中；药物制备方法选用姜汁加麝香调制最佳。选择三伏三九均贴,贴敷时间0.5-2小时的哮喘再发概率最低。从目前的数据分析表明,冬病夏治穴位贴敷疗法的中药组方、制备方法、穴位处方、贴敷时机和时间、贴敷皮肤反应均可能影响疗效,临床疗效是这些因素综合作用的结果。
本研究的先进性在于采用了前瞻性队列研究设计,系统观察了大样本的数据,揭示了冬病夏治穴位贴敷疗法是综合的复杂干预措施,其治疗作用是通过激发人体阳气,提高机体抵抗力,达到控制疾病发作的目的。体现了抓住哮喘缓解期治疗时机“已病早治”的预防思想,为中医治未病的典型案例。其结论今后将在随机对照试验中进一步验证。
In the present project, the author reviews the related papers and recent clinical researches on the prevention and treatment of infant bronchial asthma (usually occurring during winter) with acupoint-application therapy in summer in the past 40 years and conducted clinical observation by using principles and thoughts of evidence-based medicine and methods of clinical epidemiology of modern medicine. On the basis of comprehensive collection of the related reports, clinical observation and experts' consensus, the author makes an analysis on the relationship between the clinical effects and the influential factors, so as to seek some scientific evidence for assessing its clinical efficacy and to provide valuable references for the operative methods and standards of the acupoint-application therapy.
The study includes two parts:
1. Literature research about the winter disease treated in summer with acupoint-application therapy for infant bronchial asthma;
2. Clinical research on the curative effect of acupoint-application therapy for winter disease (infant bronchial asthma) treated in summer.
Objective:Though collecting of modern literature and observing the clinical effect of acupoint application therapy fro treating child bronchial asthma in summer; we analyzed the relevant influential factors and make a preliminary analysis on the influential factors, such as:selection the effective medicinal herbs, acupoint prescriptions, preparation methods, and the opportunity and duration of intervention. The research will provide a scientific basis for. the therapy.
Methods:According to the concepts and methods of Evidence-based Medicine, and combining characteristics of Chinese acupuncture academic literature, we selected winter-disease treated in summer, acupoint, and child bronchial asthma as keywords to retrieve full text databases, such as SinoMed etc., with computer and manual operation, to make a data table and conducted a statistical analysis. By adopting prospective clinic observation method and cohort study design, the present study was conducted in three top-class Chinese medicine hospitals of Liaoning Province, Hubei Province and Chengdu City. The bronchial asthma children during remission stage in three series of groups were observed, and the related data were analyzed preliminarily in the way of follow-up.
Results:
1. Literature research
The author of the present paper collected a total of 45 qualified papers. General information and analysis about the children and clinical observation results are shown as follows:
1) General information:The sick boys were more than sick girls, with an age from 2 month to 17 years,7.5 years at an average. The duration of disease was from 2 months to 10 years, averaging 3 years. Sixty-four point four percent of the papers described the asthma stages, and 55.6% of them belong to clinical reports in which the infant bronchial asthma was treated during the remission period.
2) Herbal medicine application:The frequently used top 10 medicinal herbs, in sequence, were Sinapis alba, Asarum, Fumitory, Euphorbia kansui, Musk, Chinese ephedra, Chinese honey locust, Clove, Chinese Cinnamcn, and Perilla seed. The ratios of the components of the prescription, Sinapis alba, Fumitory, Euphorbia kansui, Asarum were mostly 2:2:1:1,75.6% of them selected the fresh ginger juice to be processed into ointment.
3) Acupoint selection:The frequently used top 10 acupoint, in sequence, were Feishu (BL13), Dingchuan (EXB1), Gaohuang (BL43), Geshu (BL17), Shanzhong (CV17), Xinshu (BL15), Pishu (BL20), Dazhui (GV14), Shenshu (BL23) and Tiantu (CV22). Most of them belong to the Bladder Meridian of Foot-Taiyang, Conception Vessel, Governor Vessel, and extra-points, and were Back-shu acupoints.
4) The opportunity of acupoint application:Seventy-seven point three percent of the infant patients were treated in dog days,11.3% treated in dog days and the coldest days in winter,8.9% treated in summer or between July and August, and 2.2% treated in other days.
5) The duration of acupoint application in a treatment session: Twenty-four point four percent of the cases received treatment for 2h or more in a session,20.0% treatment for 2h or more than 2h; and 6.7% treatment for 1-3h. The shortest duration of treatment in one session was 0.5h, and the longest 24h, and mostly 2h.
6) Skin reactions:Forty-two point two percent of the papers did not describe the skin reactions; 13.3% mentioned the local erubescence; 11.1% mentioned the pain; 8.9% reported burning sensation, tiny vesicles or other reactions, and 6.7% mentioned blisters.
7) Research methods:Seventy-seven point eight percent of papers were clinical observation or clinical reports; 22.2% adopted numeral table, randomization table or computer-aided randomization for grouping. The number of the observed patients was fewer than 300 cases in 88.9% of the papers.
2. Clinical research
1) General Data
There were 609 children with bronchial asthma who meet the standards in the remission stage, including 328 cases from Liaoning Province,139 from Hubei Province, and 142 from Chengdu City. The average age of the cases was 6.89±2.82 years from Liaoning Province,6.89±2.82 years from Hubei Province, and 6.77±3.23 years from Chengdu City respectively. Boys were more than girls in number. And the average duration of disease was 2-3 years. No significant differences were found in the age, sex, and duration of disease (P>0.05).
2) First diagnosis
(1) Clinic symptoms:According to the frequency (from high to low), clinical symptoms were asthma, cough, wheeze, expectoration, short of breath in infant cases from Liaoning Province, asthma, cough, expectoration, wheeze, and short of breath in those from Hubei Province, and asthma, cough, expectoration, wheeze, and short of breath in those from Chengdu City. Chi-Square Tests showed a very significant difference in clinical primary symptoms among the 3 groups (P<0.01). The sorted order of the aforementioned symptoms was asthma, cough, wheeze, expectoration, and short of breath.
(2) Attack frequency and attack seasons:Infant patients from Liaoning Province group had no obvious seasonality in both the winter and spring; those of Hubei Province group and Chengdu City group were often seen in winter, spring and no obvious seasonality respectively. Chi-Square Tests showed a very significant difference among the 3 groups in the seasonality (P <0.01).
(3) Disease condition analysis:It shows a very significant difference in acute onset or aggravation times of disease among the three hospital groups (P <0.05). And the average highest asthmatic attack or aggravation times who came to visit hospital was≤1 time a month,2-3 times a month, and 1-2 times a week, separately, and the fewest is≥3 times a week.
(4) Self-evaluation and doctors'evaluation:No significant difference was found in the degree of severity of patients' condition in the light of children or their guardians'narration in the first diagnosis according to a sheet with 1-10 points about patients, self-feelings of the degree of severity by rank sum test (P>0.05). Doctor's conclusion on patient's condition for the first diagnosis, moderate is the most, mild is the second and severe condition is the last in the three hospital groups. It showed a significant difference in doctor's diagnosis about children's disease condition by CMH Tests (P<0.05)
(5) Reaction of application skin:The dominating reactions of skin were itching, local hotness after application in dog days according to different therapeutic schedules of the three hospitals. A great significant difference was found in the reactions after CMH Tests (P<0.05)
3) Analysis of influential factors
(1) Analysis of individual factor:①There were no statistical significances in the children's age, sex, and duration of disease (P> 0.05). But the probability of asthma's reoccurrence declined with the increase of age.②A statistical significance was found in the seasonal variation of asthma's occurrence or aggravation (P<0.01)and the occurrence of asthma was higher with seasonal variation.③A statistical significance was found in the different levels of the number of occurrence of asthma in the first diagnosis (P< 0.01). The probability of asthma reoccurrence that children's acute occurrence was less than one time a month was much lower than that in those whose asthma acute occurred below one time a month. A statistical significance was found in different levels of periods of illness severity (P<0.05) and the children with mild type had a low probability of asthma reoccurrence.④A very significant difference was found on the first time between skin reactions and asthma reoccurrence by Chi-Square Tests (P<0.01), and on the second time the difference was significant (P<0.05). No significant difference was found in the skin reactions on the third time (P>0.05).⑤No statistical significance was found in the relationship between the time and the opportunity of application by Chi-Square Tests (P<0.01). The asthma children with 0.5-2h application in both dog days and cold days had a lower probability of asthma reoccurrence.⑥A statistical significance was found among the different treatment regimens of three hospital groups by chi-square test. (P<0.01) Prescription containing Corydalis had a lower probability of reoccurrence of asthma, and those containing Euphorbia kansui, Chinese honey locust and Asarum had a bigger probability of recurrence of asthma.⑦The three hospitals had different treatment acupoint prescriptions. Prescriptions containing Dingchuan (EX-B1) and Tiantu (CV22), and Shanzhong (CV17) had a smaller probability of recurrence of asthma (P<0.01). The reoccurrence of infant asthma by using acupoints Dazhui (GV14) and group points (i.e. Shenshu (BL23), Pishu (BL20), Guanyuan (CV4), Shenque (CV8) also had a bigger probability (P< 0.01).⑧The three different treatment programs using different drugs had a significant difference in the probability of reoccurrence of asthma by the Chi-Square Test (P<0.01). Ginger plus musk had a lower recurrence of asthma, followed by Ginger plus distilled water and Ginger plus garlic.
(2) Multi-factor analysis:By using diverse and multi-Logistic regression model, and by the SAS software program, it was found that the independent variables were the application opportunity and seasonality of the reoccurrence. Results showed no obvious seasonality, and the application duration of 0.5-2h had a smaller probability of recurrence. After acupoint application in Dog days, three times'follow-up and two-level hierarchical filtering fitting model derived from the severity of recurrence, the number of attacks, application opportunity, skin reactions, the onset season, preparation methods and other factors showed that the reoccurrence probability of infant asthma from data of the 3 hospital groups presented a decline tendency along with the extension of follow-up period. Results of every 3 months'follow-up showed the probability of asthma decreased by 0.7431-fold. The acupoint application in Dog Days and the coldest days in winter with duration of 0.5-2 hours had a lower probability of 0.5166-fold of reoccurrence.
Conclusion:
The results of literature analysis indicate that in acupoint application, the prescription, ratio, and preparation method of Chinese medicinal herbs, acupuncture prescription, the opportunity and the duration of application, and the quantity of the skin stimulation are all related to its clinical efficacy. The herbal medicines as Sinapis alba, Asarum, Fumitory, Euphorbia kansui, etc., are used more frequently. Ginger juice is the major one of the prepared drugs. Most of the prescriptions are mainly composed of Sinapis alba, Fumitory, Euphorbia kansui, Asarum in proportion of 2:2:1:1. The frequently used acupoints are Feishu (BL13), Dingchuan(EXB1), Gaohuang (BL43), Geshu (BL17), and Tanzhong (CV17), Xinshu (BL15), most of which belong to the Bladder Meridian of the Foot-Taiyang and Bach-shu points. The application of the therapy is more frequently in dog days than in both dog days and the coldest days in winter, and the suitable duration of application is 2h till appearance of erubescence and without occurrence of blisters on the skin. This study adopted classification method of literature classification according to evidence-based medicine. Although the level is not high, it still shows that the above mentioned factors are related to clinical effects. Also most of literatures are clinical reports, the sample is small, and the papers adopting random number table method, randomization table or computer-aided randomization controlled trials are rare. In accordance with evidence-based medicine, these papers lack enough evidence to prove the definite effectiveness of acupoint application. For this reason, we still need more studies adopting multi-centers, large sample observation of clinical randomized trials to provide scientific evidence for this therapy in the future.
In 2008, a total 609 cases of 1-14-year-old asthma children were observed in "Dog Days" in three top-class hospitals. Their general clinical information in sex, ages and duration of disease were compared. First visit data showed that the onset of asthma was closely related with the environment, different regions had their own peculiarities. In northern China's Liaoning children, spasm occurred in any seasons, probably due to cold climate. However, in the south or southwest Hubei Province and Chengdu, the asthma children had a larger temperature difference in the incidence, being higher in winter and lower in summer. Winter sickness treating in summer with acupoint application therapy is more frequently used for children with mild to moderate asthma, cough-based disease. Acupoint application is conducted in the Dog Days on the 1st day of the first 10 days, the second 10 days and the last 10 days of summer. In Liaoning Province, they usually conduct acupoint application for 0.5-2h in Dog Days and the coldest days in winter, in Hubei and Chengdu provinces, they give the treatment for 2-4h in Dog Days. No apparently unfavorable reactions or only a mild itching was found at the skin in infant asthma patients from the 3 hospital groups.
After acupoint application, we had a follow-up three times. We analyzed the impact of asthma in children with recurrent factors, such as the age, severity, seasonal factors, the amount of skin stimulated, etc. The major medicinal herbs of this treatment were Sinapis alba and Fumitory, and the acpoints used were Feishu (BL13), Gaohuang (BL43), Dingchuan (EX-B1), Tiantu (CV22), and Shanzhong (CV17). The best preparations of herbs were ginger and musk. The best time of acupoint application is the Dog Days and the coldest days in winter, and the application duration 0.5h to 2h. From analysis of the current data, it shows that all the factors may affect the clinical efficacy. And the therapeutic result was affected by the combination of these factors.
The innovation point of this study is the using of a prospective formation study design. It contained a large sample of data, and revealed the complexity of the integrated intervention for winter disease treated in summer for children with bronchial asthma. This therapy can stimulate the yang-qi, enhance the resistance of body and control the onset of disease. This is the classic case of TCM for preventing diseases. The conclusion of the present research will be further confirmed in a series of randomized controlled trials in the future.
一、冬病夏治穴位贴敷疗法防治儿童支气管哮喘的文献研究
二、冬病夏治穴位贴敷疗法防治儿童支气管哮喘的临床观察研究
目的
通过冬病夏治穴位贴敷疗法治疗儿童支气管哮喘的现代文献和临床观察研究,探讨贴敷方法中药物、制备方法、穴位、贴敷时机、贴敷时间、贴敷皮肤反应等应用规律,为筛选治疗方案中影响临床疗效的相关因素提供客观依据。
方法
借鉴循证医学文献系统评价的思路和方法,结合中医针灸学科的文献特点,以冬病夏治、穴位贴敷、儿童支气管哮喘为关键词,应用SinoMed等全文数据库进行计算机和手工检索获取文献,录入数据表格统计分析。采用临床观察性研究方法,前瞻性队列研究设计,在辽宁、湖北、成都三地的三所Ⅲ级甲等中医院,以哮喘缓解期的患儿为3个队列,通过随访对三所医院不同的治疗方案进行观察与初步分析。
结果一、文献研究
检索纳入合格文献45篇,对患儿的一般资料和临床观察相关信息的分析结果如下。
1、一般资料：男性患儿多于女性,年龄2个月至17岁,平均年龄7.5岁；病程2个月至10年,平均病程3年；64.4%的论文报道了哮喘患儿病情分期,临床观察支气管哮喘缓解期的占55.6%。
2、中药使用频次：由高至低排在前10位的是白芥子、细辛、延胡索、甘遂、麝香、麻黄、皂荚、丁香、肉桂、苏子。药物性味多辛、温,归肺经。组方配伍比例按照白芥子：延胡索：甘遂：细辛以2：2：1：1居多；75.6%选用姜汁制备药膏。
3、腧穴使用频次：由高至低排在前10位的是肺俞、定喘、膏肓、膈俞、膻中、心俞、脾俞、大椎、肾俞、天突；腧穴归经多属足太阳膀胱经、任脉、督脉和经外奇穴；穴性以背俞穴居多。
4、贴敷时机：77.3%在夏季三伏贴敷,11.3%在三伏、三九天均贴,8.9%在夏季或7-8月贴敷,2.2%在非三伏和三九贴敷。
5、贴敷时间：24.4%小于或等于2小时；20.0%大于或等于2小时；6.7%在1-3小时。以2小时界定居多,最短的0.5小时,最长达24小时。
6、贴敷皮肤反应：42.2%未提及皮肤反应；13.3%提及局部皮肤潮红；11.1%提及疼痛；8.9%提及灼热感、细小水泡或其他说明；6.7%提及起泡。
7、研究方法：77.8%是临床观察或临床报道,22.2%报道采用数字表法随机、随机化表和电脑随机。观察病例在300例以下的占88.9%。
二、临床观察研究
1、一般资料
初诊符合支气管哮喘缓解期诊断标准、纳入标准的患儿共609例,其中,入组辽宁328例,湖北139例,成都142例。平均年龄辽宁6.89±2.82岁,湖北6.55±2.77岁,成都6.77±3.23岁；男性多于女性；平均病程2至3年。经统计学处理,患儿的年龄、性别、病程没有显著差异(P>0.05)。
2、初诊情况
(1)临床症状：按症状出现的频次由高至低排序,辽宁哮喘、咳嗽、喘憋、咳痰、气短；湖北和成都均哮喘、咳嗽、咳痰、喘憋、气短。经卡方检验,三所医院初诊哮喘患儿临床症状差异非常显著(P<0.01)。数据合并后排序为哮喘、咳嗽、喘憋、咳痰、气短。
(2)疾病发作或加重的季节性：疾病发作或加重随四季变化由高至低排序,辽宁无明显季节性最高、其次冬季、春季、秋季、夏季；湖北和成都均以冬季最高、其次春季、无季节性、秋季、夏季。经卡方检验,三所医院哮喘患儿急性发作有无季节性有非常显著的差异(P<0.01)。
(3)病情分析：三所医院贴敷患儿治疗前疾病急性发作或加重次数比较有显著性差异(P<0.05)。其中,患儿哮喘发作次数每月≤1次的比例最高,每月2-3次的次之,每周1-2次的较少,每周≥3次的极少。
(4)患儿自评和医生评价：三所医院贴敷患儿或监护人初诊时叙述病情严重程度,依据患者自我感受病情严重程度1-10分尺度表,经秩和检验,没有显著性差异(P>0.05)。初诊时医生诊断哮喘患儿的病情,以中度的最多,轻度的次之、重度的极少。经CMH卡方检验,三所医院医生诊断哮喘患儿的病情程度有显著性差异(P<0.05)。
(5)贴敷皮肤反应：三所医院不同的治疗方案三伏贴敷后,患儿皮肤反应以无反应、或呈痒感、灼热感为主。经CMH卡方检验,三所医院不同的治疗方案贴敷后患儿的皮肤反应有显著性差异(P<0.05)。
3、随访患儿哮喘再发的影响因素分析
(1)单因素分析：①患儿年龄、性别、病程对哮喘再发无统计学差异(P>0.05)。但概率图显示随着患儿年龄增长,哮喘再发概率呈下降趋势。②患儿哮喘急性发作或加重有无季节性对哮喘再发有非常显著的差异(P<0.01),患儿发病有季节性的哮喘再发概率高。③患儿哮喘急性发作次数对哮喘再发有非常显著的差异(P<0.01),急性发作每月少于1次的患儿哮喘再发概率明显低于每月超过1次的患儿。患儿贴敷前病情严重程度的不同等级对哮喘再发有显著性差异(P<0.05),轻度病情的哮喘再发概率低。④患儿贴敷后皮肤反应对哮喘再发经卡方检验,第1次贴敷有非常显著性差异(P<0.01),第2次贴敷有显著性差异(P<0.05),均显示皮肤无反应的哮喘再发概率低；第3次贴敷没有显著性差异(P>0.05)。⑤观察贴敷时机和时间对哮喘再发的影响,经卡方检验,有非常显著性差异(P<0.01)。选择三伏和三九均贴,贴敷0.5-2小时的哮喘再发概率低。⑥从三所医院不同的治疗方案中,提取中药组方中的不同药物,经卡方检验,有非常显著性差异(P<0.01)。组方中有延胡索的哮喘再发概率低,有甘遂、皂角和细辛的哮喘再发概率高。⑦从三所医院不同的治疗方案中,提取穴位处方中的不同穴位,经卡方检验,有非常显著性差异(P<0.01)。选用定喘和天突、膻中的哮喘再发概率低,选用大椎和复合穴位(即指肾俞、脾俞、关元、神阙、内关)的哮喘再发概率高。⑧从三所医院不同的治疗方案中,提取制备方法中的不同药物,经卡方检验,有非常显著性差异(P<0.01)。姜汁加麝香的哮喘再发概率低,加蒸馏水的次之,加蒜汁的最高。
(2)多因素分析：采用多元和多层Logistic回归模型,经SAS软件程序,模型入选的自变量是贴敷时机和时间、疾病发作或加重的季节性,结果显示无明显季节性,在三伏三九均贴,贴敷时间为0.5-2小时的哮喘再发概率低。“三伏”贴敷后,3次随访患儿的哮喘再发及病情,经过两水平分层筛选拟合模型,综合分析哮喘发作次数、发病季节、制备方法、贴敷时机和时间、皮肤反应等因素,提示随着随访时间的延长,三所医院患儿哮喘再发概率均呈下降趋势。数据合并处理结果显示,每隔三个月随访1次,哮喘再发概率下降0.7431倍；在三伏三九贴敷,时间为0.5-2小时的哮喘再发概率下降0.5166倍。
结论
文献分析统计结果,提示穴位贴敷疗法的中药组方、药物比例、制备方法、穴位处方、贴敷时机、贴敷时间、皮肤反应等因素与临床疗效相关。中药使用白芥子、细辛、延胡索、甘遂的频次较高,按照白芥子：延胡索：甘遂：细辛的配伍比例以2：2：1：1居多,制备方法主要采用鲜姜汁或姜汁,药性辛温,多归肺经。腧穴使用肺俞、定喘、膏肓、膈俞、膻中、心俞的频次较高,腧穴多归属足太阳膀胱经,背俞穴居多。三伏贴多于三伏和三九均贴,贴敷时间以2小时为界定的较多,多数报道认为贴敷后皮肤不发泡,以潮红为度。本研究按照循证医学中文献证据级别划分方法,虽然级别不高,但仍可说明以上诸因素可能与疗效有关。由于文献以临床观察或临床报道较多,样本量较少,采用数字表法的随机对照试验较少,缺乏大样本的随机对照试验结果,从循证医学的角度,判断冬病夏治穴位贴敷疗法对儿童哮喘缓解期的治疗作用证据不足,有待于今后进一步通过多中心、大样本的临床随机试验观察提供科学的证据。
2008年夏季“三伏”期间,三所医院观察1-14岁的贴敷患儿共计609例,一般资料基线均衡,具有可比性。初诊资料显示,接受冬病夏治穴位贴敷疗法的门诊患儿症状多表现为哮喘、咳嗽,以轻中度病情多见。患儿哮喘发作或病情与环境气候有关,不同的地域有其特殊性。位于我国东北地区的辽宁,患儿哮喘发作季节性不明显,可能与北方虽然气候寒冷,但室内供暖有关；而位于华中地区的湖北、西南地区的成都患儿哮喘发作有季节性,以冬季发病多见,可能与冬季寒冷、夏季炎热,四季温差较大有关。三所医院的贴敷时机均选择夏季“三伏”,在“头伏”、“中伏”、“末伏”的第1天各贴敷1次,辽宁同时还在“三九”贴敷。贴敷时间辽宁0.5-2小时,湖北和成都2-4小时。患儿贴敷后皮肤均以无反应,或痒感、灼热感多见。
通过贴敷后的3次随访,分析患儿哮喘再发的影响因素,提示年龄、病情、发作或加重有无季节性、贴敷方法均可能影响哮喘再发。通过对三所医院不同治疗方案中不同药物、穴位、制备方法的比较分析,提示中药组方的核心药物是白芥子、延胡索；穴位处方的核心腧穴是肺俞、膏肓、定喘、天突、膻中；药物制备方法选用姜汁加麝香调制最佳。选择三伏三九均贴,贴敷时间0.5-2小时的哮喘再发概率最低。从目前的数据分析表明,冬病夏治穴位贴敷疗法的中药组方、制备方法、穴位处方、贴敷时机和时间、贴敷皮肤反应均可能影响疗效,临床疗效是这些因素综合作用的结果。
本研究的先进性在于采用了前瞻性队列研究设计,系统观察了大样本的数据,揭示了冬病夏治穴位贴敷疗法是综合的复杂干预措施,其治疗作用是通过激发人体阳气,提高机体抵抗力,达到控制疾病发作的目的。体现了抓住哮喘缓解期治疗时机“已病早治”的预防思想,为中医治未病的典型案例。其结论今后将在随机对照试验中进一步验证。
In the present project, the author reviews the related papers and recent clinical researches on the prevention and treatment of infant bronchial asthma (usually occurring during winter) with acupoint-application therapy in summer in the past 40 years and conducted clinical observation by using principles and thoughts of evidence-based medicine and methods of clinical epidemiology of modern medicine. On the basis of comprehensive collection of the related reports, clinical observation and experts' consensus, the author makes an analysis on the relationship between the clinical effects and the influential factors, so as to seek some scientific evidence for assessing its clinical efficacy and to provide valuable references for the operative methods and standards of the acupoint-application therapy.
The study includes two parts:
1. Literature research about the winter disease treated in summer with acupoint-application therapy for infant bronchial asthma;
2. Clinical research on the curative effect of acupoint-application therapy for winter disease (infant bronchial asthma) treated in summer.
Objective:Though collecting of modern literature and observing the clinical effect of acupoint application therapy fro treating child bronchial asthma in summer; we analyzed the relevant influential factors and make a preliminary analysis on the influential factors, such as:selection the effective medicinal herbs, acupoint prescriptions, preparation methods, and the opportunity and duration of intervention. The research will provide a scientific basis for. the therapy.
Methods:According to the concepts and methods of Evidence-based Medicine, and combining characteristics of Chinese acupuncture academic literature, we selected winter-disease treated in summer, acupoint, and child bronchial asthma as keywords to retrieve full text databases, such as SinoMed etc., with computer and manual operation, to make a data table and conducted a statistical analysis. By adopting prospective clinic observation method and cohort study design, the present study was conducted in three top-class Chinese medicine hospitals of Liaoning Province, Hubei Province and Chengdu City. The bronchial asthma children during remission stage in three series of groups were observed, and the related data were analyzed preliminarily in the way of follow-up.
Results:
1. Literature research
The author of the present paper collected a total of 45 qualified papers. General information and analysis about the children and clinical observation results are shown as follows:
1) General information:The sick boys were more than sick girls, with an age from 2 month to 17 years,7.5 years at an average. The duration of disease was from 2 months to 10 years, averaging 3 years. Sixty-four point four percent of the papers described the asthma stages, and 55.6% of them belong to clinical reports in which the infant bronchial asthma was treated during the remission period.
2) Herbal medicine application:The frequently used top 10 medicinal herbs, in sequence, were Sinapis alba, Asarum, Fumitory, Euphorbia kansui, Musk, Chinese ephedra, Chinese honey locust, Clove, Chinese Cinnamcn, and Perilla seed. The ratios of the components of the prescription, Sinapis alba, Fumitory, Euphorbia kansui, Asarum were mostly 2:2:1:1,75.6% of them selected the fresh ginger juice to be processed into ointment.
3) Acupoint selection:The frequently used top 10 acupoint, in sequence, were Feishu (BL13), Dingchuan (EXB1), Gaohuang (BL43), Geshu (BL17), Shanzhong (CV17), Xinshu (BL15), Pishu (BL20), Dazhui (GV14), Shenshu (BL23) and Tiantu (CV22). Most of them belong to the Bladder Meridian of Foot-Taiyang, Conception Vessel, Governor Vessel, and extra-points, and were Back-shu acupoints.
4) The opportunity of acupoint application:Seventy-seven point three percent of the infant patients were treated in dog days,11.3% treated in dog days and the coldest days in winter,8.9% treated in summer or between July and August, and 2.2% treated in other days.
5) The duration of acupoint application in a treatment session: Twenty-four point four percent of the cases received treatment for 2h or more in a session,20.0% treatment for 2h or more than 2h; and 6.7% treatment for 1-3h. The shortest duration of treatment in one session was 0.5h, and the longest 24h, and mostly 2h.
6) Skin reactions:Forty-two point two percent of the papers did not describe the skin reactions; 13.3% mentioned the local erubescence; 11.1% mentioned the pain; 8.9% reported burning sensation, tiny vesicles or other reactions, and 6.7% mentioned blisters.
7) Research methods:Seventy-seven point eight percent of papers were clinical observation or clinical reports; 22.2% adopted numeral table, randomization table or computer-aided randomization for grouping. The number of the observed patients was fewer than 300 cases in 88.9% of the papers.
2. Clinical research
1) General Data
There were 609 children with bronchial asthma who meet the standards in the remission stage, including 328 cases from Liaoning Province,139 from Hubei Province, and 142 from Chengdu City. The average age of the cases was 6.89±2.82 years from Liaoning Province,6.89±2.82 years from Hubei Province, and 6.77±3.23 years from Chengdu City respectively. Boys were more than girls in number. And the average duration of disease was 2-3 years. No significant differences were found in the age, sex, and duration of disease (P>0.05).
2) First diagnosis
(1) Clinic symptoms:According to the frequency (from high to low), clinical symptoms were asthma, cough, wheeze, expectoration, short of breath in infant cases from Liaoning Province, asthma, cough, expectoration, wheeze, and short of breath in those from Hubei Province, and asthma, cough, expectoration, wheeze, and short of breath in those from Chengdu City. Chi-Square Tests showed a very significant difference in clinical primary symptoms among the 3 groups (P<0.01). The sorted order of the aforementioned symptoms was asthma, cough, wheeze, expectoration, and short of breath.
(2) Attack frequency and attack seasons:Infant patients from Liaoning Province group had no obvious seasonality in both the winter and spring; those of Hubei Province group and Chengdu City group were often seen in winter, spring and no obvious seasonality respectively. Chi-Square Tests showed a very significant difference among the 3 groups in the seasonality (P <0.01).
(3) Disease condition analysis:It shows a very significant difference in acute onset or aggravation times of disease among the three hospital groups (P <0.05). And the average highest asthmatic attack or aggravation times who came to visit hospital was≤1 time a month,2-3 times a month, and 1-2 times a week, separately, and the fewest is≥3 times a week.
(4) Self-evaluation and doctors'evaluation:No significant difference was found in the degree of severity of patients' condition in the light of children or their guardians'narration in the first diagnosis according to a sheet with 1-10 points about patients, self-feelings of the degree of severity by rank sum test (P>0.05). Doctor's conclusion on patient's condition for the first diagnosis, moderate is the most, mild is the second and severe condition is the last in the three hospital groups. It showed a significant difference in doctor's diagnosis about children's disease condition by CMH Tests (P<0.05)
(5) Reaction of application skin:The dominating reactions of skin were itching, local hotness after application in dog days according to different therapeutic schedules of the three hospitals. A great significant difference was found in the reactions after CMH Tests (P<0.05)
3) Analysis of influential factors
(1) Analysis of individual factor:①There were no statistical significances in the children's age, sex, and duration of disease (P> 0.05). But the probability of asthma's reoccurrence declined with the increase of age.②A statistical significance was found in the seasonal variation of asthma's occurrence or aggravation (P<0.01)and the occurrence of asthma was higher with seasonal variation.③A statistical significance was found in the different levels of the number of occurrence of asthma in the first diagnosis (P< 0.01). The probability of asthma reoccurrence that children's acute occurrence was less than one time a month was much lower than that in those whose asthma acute occurred below one time a month. A statistical significance was found in different levels of periods of illness severity (P<0.05) and the children with mild type had a low probability of asthma reoccurrence.④A very significant difference was found on the first time between skin reactions and asthma reoccurrence by Chi-Square Tests (P<0.01), and on the second time the difference was significant (P<0.05). No significant difference was found in the skin reactions on the third time (P>0.05).⑤No statistical significance was found in the relationship between the time and the opportunity of application by Chi-Square Tests (P<0.01). The asthma children with 0.5-2h application in both dog days and cold days had a lower probability of asthma reoccurrence.⑥A statistical significance was found among the different treatment regimens of three hospital groups by chi-square test. (P<0.01) Prescription containing Corydalis had a lower probability of reoccurrence of asthma, and those containing Euphorbia kansui, Chinese honey locust and Asarum had a bigger probability of recurrence of asthma.⑦The three hospitals had different treatment acupoint prescriptions. Prescriptions containing Dingchuan (EX-B1) and Tiantu (CV22), and Shanzhong (CV17) had a smaller probability of recurrence of asthma (P<0.01). The reoccurrence of infant asthma by using acupoints Dazhui (GV14) and group points (i.e. Shenshu (BL23), Pishu (BL20), Guanyuan (CV4), Shenque (CV8) also had a bigger probability (P< 0.01).⑧The three different treatment programs using different drugs had a significant difference in the probability of reoccurrence of asthma by the Chi-Square Test (P<0.01). Ginger plus musk had a lower recurrence of asthma, followed by Ginger plus distilled water and Ginger plus garlic.
(2) Multi-factor analysis:By using diverse and multi-Logistic regression model, and by the SAS software program, it was found that the independent variables were the application opportunity and seasonality of the reoccurrence. Results showed no obvious seasonality, and the application duration of 0.5-2h had a smaller probability of recurrence. After acupoint application in Dog days, three times'follow-up and two-level hierarchical filtering fitting model derived from the severity of recurrence, the number of attacks, application opportunity, skin reactions, the onset season, preparation methods and other factors showed that the reoccurrence probability of infant asthma from data of the 3 hospital groups presented a decline tendency along with the extension of follow-up period. Results of every 3 months'follow-up showed the probability of asthma decreased by 0.7431-fold. The acupoint application in Dog Days and the coldest days in winter with duration of 0.5-2 hours had a lower probability of 0.5166-fold of reoccurrence.
Conclusion:
The results of literature analysis indicate that in acupoint application, the prescription, ratio, and preparation method of Chinese medicinal herbs, acupuncture prescription, the opportunity and the duration of application, and the quantity of the skin stimulation are all related to its clinical efficacy. The herbal medicines as Sinapis alba, Asarum, Fumitory, Euphorbia kansui, etc., are used more frequently. Ginger juice is the major one of the prepared drugs. Most of the prescriptions are mainly composed of Sinapis alba, Fumitory, Euphorbia kansui, Asarum in proportion of 2:2:1:1. The frequently used acupoints are Feishu (BL13), Dingchuan(EXB1), Gaohuang (BL43), Geshu (BL17), and Tanzhong (CV17), Xinshu (BL15), most of which belong to the Bladder Meridian of the Foot-Taiyang and Bach-shu points. The application of the therapy is more frequently in dog days than in both dog days and the coldest days in winter, and the suitable duration of application is 2h till appearance of erubescence and without occurrence of blisters on the skin. This study adopted classification method of literature classification according to evidence-based medicine. Although the level is not high, it still shows that the above mentioned factors are related to clinical effects. Also most of literatures are clinical reports, the sample is small, and the papers adopting random number table method, randomization table or computer-aided randomization controlled trials are rare. In accordance with evidence-based medicine, these papers lack enough evidence to prove the definite effectiveness of acupoint application. For this reason, we still need more studies adopting multi-centers, large sample observation of clinical randomized trials to provide scientific evidence for this therapy in the future.
In 2008, a total 609 cases of 1-14-year-old asthma children were observed in "Dog Days" in three top-class hospitals. Their general clinical information in sex, ages and duration of disease were compared. First visit data showed that the onset of asthma was closely related with the environment, different regions had their own peculiarities. In northern China's Liaoning children, spasm occurred in any seasons, probably due to cold climate. However, in the south or southwest Hubei Province and Chengdu, the asthma children had a larger temperature difference in the incidence, being higher in winter and lower in summer. Winter sickness treating in summer with acupoint application therapy is more frequently used for children with mild to moderate asthma, cough-based disease. Acupoint application is conducted in the Dog Days on the 1st day of the first 10 days, the second 10 days and the last 10 days of summer. In Liaoning Province, they usually conduct acupoint application for 0.5-2h in Dog Days and the coldest days in winter, in Hubei and Chengdu provinces, they give the treatment for 2-4h in Dog Days. No apparently unfavorable reactions or only a mild itching was found at the skin in infant asthma patients from the 3 hospital groups.
After acupoint application, we had a follow-up three times. We analyzed the impact of asthma in children with recurrent factors, such as the age, severity, seasonal factors, the amount of skin stimulated, etc. The major medicinal herbs of this treatment were Sinapis alba and Fumitory, and the acpoints used were Feishu (BL13), Gaohuang (BL43), Dingchuan (EX-B1), Tiantu (CV22), and Shanzhong (CV17). The best preparations of herbs were ginger and musk. The best time of acupoint application is the Dog Days and the coldest days in winter, and the application duration 0.5h to 2h. From analysis of the current data, it shows that all the factors may affect the clinical efficacy. And the therapeutic result was affected by the combination of these factors.
The innovation point of this study is the using of a prospective formation study design. It contained a large sample of data, and revealed the complexity of the integrated intervention for winter disease treated in summer for children with bronchial asthma. This therapy can stimulate the yang-qi, enhance the resistance of body and control the onset of disease. This is the classic case of TCM for preventing diseases. The conclusion of the present research will be further confirmed in a series of randomized controlled trials in the future.
引文
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