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高脂血症“温灸和之”有效性及不同灸治时程对调脂效应的影响
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摘要
随着生活方式及饮食结构的变化,高脂血症的发病率逐年攀升,并且已成为动脉粥样硬化与冠心病最重要的危险因素,对人类健康构成巨大威胁。目前高脂血症的治疗主要为药物,药物在有效降低血脂的同时,存在不可避免的毒副作用,使得高脂血症患者望而生畏,高脂血症未能得到有效控制,为冠心病等心脑血管疾病的发生埋下隐患。由于人们养生保健意识的逐年增强,中医药的应用受到越来越多的关注,中医药在高脂血症调治方面具有一定优势,突出表现为其不良反应少,对肝肾功能无不良影响,但随着中草药种植加工成本的提高,长期应用价格较为昂贵,且其对血脂调控也需要一个长期过程。鉴于高脂血症的高发病率以及对人类健康的潜在而严重的危害性,寻找一种安全、有效、价格低廉而容易操作的调节血脂的方法成为亟待解决的问题。
     针灸以其效、验、便、廉等特点,以及绿色、安全、无任何毒副作用的优势成为人们关注的焦点。针灸在高脂血症的防治方面发挥了越来越重要的作用,相关报道日益增多。针和灸作用互为补充而又各有所长,针刺在疏通经络、调和气血方面具有较大优势,而艾灸在温补阳气、温通经络、温化痰饮、温运血行方面具有针刺所不及的优势。针对高脂血症属痰属瘀的病理性质以及本病中年以后发病人数激增所反映出的阳气渐虚,肝、脾、肾三脏功能失调的病理基础,艾灸所具有的生温熟热的性质及其温补阳气、温化痰饮、温运血行的功能正中其病机。用艾灸调治高脂血症可谓从标本兼顾的角度治疗。论标,其温化痰饮、温运血行的作用可以帮助祛除高脂血症患者体内的痰瘀等代谢产物,从而有利于脂质的清除。论本,其温补阳气、温通经络、促进代谢的作用有利于脏腑功能的调整和提升。脏腑功能强健后,自然能发挥各自作用,将体内多余的痰浊、瘀血代谢出去。因此说用艾灸来调节血脂可谓直中病机,标本兼治。
     目前相关报道日益增多,但以单穴治疗或固定选穴的报道居多,针对高脂血症复杂的病因及不同临床分型、表现,高脂血症的治疗也应该选穴多样化,针对不同体质类型选用不同穴位。同时在影响艾灸调治高脂血症的相关因素研究中,不同组别的间隔时间相对较短,过于细微的时间差别不利于艾灸疗效差异的发掘。针对上述问题,本研究分为两部分,第一部分从高脂血症的中医学发病机理、艾灸的性质和效用等方面对艾灸调治高脂血症的可行性进行论述,提出高脂血症当以“温灸和之”的立论,并从临床角度加以验证。其主要特点是将经典理论用于高脂血症辨证施灸过程中。第二部分是根据前期研究基础及相关临床报道在穴位相对固定的前提下,设立不同艾灸时程组,通过不同艾灸时程的调脂疗效差异为高脂血症艾灸调治提供较优的艾灸时程方案,为艾灸调脂的时效、量效关系研究作初步探索。
     第一部分
     1研究目的
     通过辨证施灸与药物组的降脂疗效差异,验证高脂血症“温灸和之”的有效性及其优势,并明确其作用特点及效应趋势。
     2研究方法
     2.1随机对照原则的应用
     本研究采用区组随机的方法,并设立口服西药组进行对照。将入组患者首先按就诊先后顺序编号入组,每6例为一个区组,随机分至艾灸治疗组、西药对照组两组,艾灸组32例,药物组33例。两组资料在性别、年龄、病情等方面比较差异均无统计学意义(P>0.05),具有可比性。
     2.2治疗方法
     艾灸组参照《中药新药临床研究指导原则》中设立的三个常见证型,将患者分为气虚痰阻证、阴虚阳亢证及脾肾阳虚证。选取足三里、神阙、三阴交作为基本穴方。气虚痰阻加丰隆、阴虚阳亢加太溪,脾肾阳虚加关元。用清艾条温和灸,每穴每次艾灸10分钟,隔日1次,每周3次,12次为一个疗程。共灸两个疗程。西药对照组口服非诺贝特片,每次100mg,每日3次,饭后服用。
     2.3观察时点
     治疗前及2个月治疗后。
     2.4观察指标
     2.4.1血脂指标
     总胆固醇(TC)
     甘油三酯(TG)
     高密度脂蛋白胆固醇(HDL-C)
     低密度脂蛋白胆固醇(LDL-C)
     2.4.2临床症状、体征
     对治疗前后的临床症状、体征等进行评价,以明确艾灸调脂对患者生存质量的影响。
     2.4.3安全性指标
     对治疗前后患者肝功(谷草转氨酶、谷丙转氨酶)、肾功(尿素氮、肌酐)进行测定。
     2.5数据统计学处理
     使用SPSS13.0统计软件对数据进行统计分析。根据本研究中的临床资料特点,依据相关统计学原理,对治疗组和对照组的基线可比性、疗效评价、安全性评价等三个方面进行分析。在数据统计中,计数资料采用x2检验或Fisher精确卡方检验;等级资料采用秩和检验;对于计量资料首先进行正态性检验,符合正态分布的计量资料采用方差分析,不符合正态分布的计量资料先进行正态转换,经转换符合正态分布的数据采用参数检验;经转换仍不符合正态分布的数据采用秩和检验。计量指标以均数±标准差的形式表示,假设检验统一使用双侧检验。
     3研究结果
     3.1血脂指标
     3.1.1两组总体有效性
     艾灸组32例,有效(包括临床治愈、显效及有效)23例,有效率达71.88%,药物组33例,有效30例,总体有效率90.91,艾灸组与药物组在降低血脂的总体疗效方面差异无统计学意义(P>0.05)。
     3.1.2单个血脂指标的变化
     艾灸与药物治疗后均可使血脂各指标有所下降,艾灸组降低总胆固醇、低密度脂蛋白胆固醇作用明显,而药物组在降低甘油三酯方面疗效更明显,但差异无统计学意义(P>O.05)。
     3.2临床症状
     艾灸组与药物组在改善高脂血症患者临床症状总体积分方面差异极显著(P<0.001)。治疗后两组在缓解乏力、纳呆、腹胀、腰膝酸软、烦躁易怒、形寒怕冷这6项症状方面有统计学差异(P<0.05),艾灸组在缓解症状方面疗效明显优于药物组,说明艾灸可以有效改善高脂血症患者临床症状,提高其生存质量。
     3.3其它相关指标
     两组治疗后疼痛均有不同程度下降,艾灸组下降程度优于药物组,差异具有统计学意义(P<0.05)。两组治疗后血糖均略有下降,但差异无统计学意义(P>0.05)。
     3.4安全性指标
     艾灸组治疗后谷草转氨酶及谷丙转氨酶较治疗前略有下降,药物组治疗后谷草转氨酶及谷丙转氨酶略有升高,表明药物对肝功略有影响,但两组差异无统计学意义(P>O.05)。艾灸治疗后患者尿素氮略有下降,药物组治疗后尿素氮略有上升,两组治疗后肌酐均有不同程度上升,药物组上升更为明显,但两组差异无统计学意义(P>0.05)。艾灸组与药物组治疗后收缩压及舒张压差异无统计学意义(P>0.05),艾灸与药物治疗后心率均有不同程度下降,但两组间差异无统计学意义(P>0.05),艾灸与药物治疗对血常规、尿常规、心电图等无不良影响,治疗后无统计学差异(P>0.05)。
     4研究结论
     4.1“温灸和之”调治高脂血症,可以起到与药物类似的调节血脂作用,对血脂各指标均具有良性调节作用,且对胆固醇及低密度脂蛋白作用更明显;
     4.2“温灸和之”调治高脂血症,可以有效缓解与高脂血症相关的临床症状,提高患者生存质量,作用明显优于药物组。
     4.3“温灸和之”调治高脂血症,对安全性指标无不良影响,安全可靠。
     第二部分
     1研究目的
     通过设立不同艾灸时程组,比较不同艾灸时程对调脂疗效的影响,为高脂血症艾灸调治择选出最优的艾灸时程方案,为艾灸时效、量效关系的深入研究作有益探索。
     2研究方法
     2.1随机对照原则的应用
     本研究收集2009年11月至2011年12月在针灸医院就诊并符合课题要求的高脂血症患者76例,所有病例均经饮食宣教不能理想地控制血脂。采用区组随机方法,随机分至10分钟艾灸组、20分钟艾灸组及30分钟艾灸组三组。10分钟组25例,20分钟组25例,30分钟组26例。三组资料在性别、年龄、病情等方面比较差异无统计学意义(P>0.05),具有可比性。
     2.2具体治疗方案
     依据高脂血症患者脾肾阳虚、痰瘀互结的体质及病理基础,并结合相关临床报道进行选穴。选择丰隆、足三里、神阙、三阴交四穴作为固定穴组。10分钟艾灸组,选取上述四穴,用清艾条温和灸,每穴每次艾灸10分钟,隔日1次,每周3次,12次为一个疗程。共灸两个疗程。20分钟和30分钟组施灸方法同10分钟组,只是施灸时间不同,20分钟组施灸20分钟,30分钟组施灸30分钟。
     2.3观察时点
     治疗前及2个月治疗后。
     2.4观察指标
     2.4.1血脂指标
     总胆固醇(TC)
     甘油三酯(TG)
     高密度脂蛋白胆固醇(HDL-C)
     低密度脂蛋白胆固醇(LDL-C)
     2.4.2临床症状、体征
     对治疗前后的临床症状、体征等进行评价,以明确艾灸调脂对患者生存质量的影响。
     2.4.3安全性指标
     对治疗前后患者肝功(谷草转氨酶、谷丙转氨酶)肾功(尿素氮、肌酐)进行测定。
     2.5数据统计学处理
     同第一部分。
     3研究结果
     3.1血脂指标
     3.1.1三组艾灸治疗前后总体有效性
     10分钟组25例,有效(包括临床治愈、显效及有效)13例,有效率达52.00%,20分钟组25例,有效21例,总体有效率84.00%,30分钟组26例,有效23例,有效率88.46%。三组疗效有极显著性差异(P>0.01)。
     3.1.2单个血脂指标的变化
     胆固醇、甘油三酯及低密度脂蛋白胆固醇艾灸治疗前后差异极显著(P<0.001),高密度脂蛋白胆固醇艾灸前后变化不大(P>0.05)。说明艾灸治疗后可使各项指标趋于正常。
     30分钟艾灸组与10分钟艾灸组在调节总胆固醇和低密度脂蛋白胆固醇方面,差异显著(P<0.05),与20分钟艾灸组相比,无显著性差异(P>0.05)。同时发现,随着艾灸时间的延长,有效指标的下降均数也呈递增趋势,即总胆固醇和低密度脂蛋白胆固醇治疗前后差值的均数比较,30分钟艾灸组>20分钟艾灸组>10分钟艾灸组。而在甘油三酯及高密度脂蛋白胆固醇的调节方面,不同艾灸时程无显著性差异(P>0.05)。说明艾灸调脂对血脂指标中的总胆固醇及低密度脂蛋白胆固醇疗效更好。
     3.2临床症状
     艾灸治疗前后临床症状积分差异极显著(P<0.001),说明艾灸可明显改善高脂血症患者临床症状,提高其生存质量。且不同艾灸时程比较,10分钟组与30分钟组在改善临床症状方面差异显著(P<0.05)。30分钟组临床症状积分低于20分钟组低于10分钟组。说明随着时间推移,艾灸对高脂血症患者临床症状的改善程度越来越好。
     3.3其它相关指标
     艾灸治疗前后高脂血症患者的空腹血糖值也随之下降,且治疗前后差异显著(P<0.001),说明艾灸对高脂血症患者的空腹血糖也具有良好的调节作用。但不同艾灸时程三组之间差异无统计学意义(P>0.05)。艾灸治疗前后患者的疼痛情况有极显著差异(P<0.001)。说明通过艾灸温通经脉、温运血行,可以起到疏通经络、散寒止痛的作用,从而有效缓解高脂血症患者的疼痛症状。不同时程艾灸对高脂血症疼痛的缓解无显著性差异(P>0.05)。但从疼痛缓解的程度来讲,30分钟组>10分钟组>20分钟组。
     3.4安全性指标
     艾灸治疗前后谷草转氨酶、谷丙转氨酶变化无显著差异(P>0.05)。说明艾灸调脂对肝功无不良影响。艾灸治疗前后尿素氮差异显著(P<0.05),治疗后的均值较治疗前有所下降,说明艾灸可以促进蛋白质的终末代谢产物的清除,有利于机体排毒。治疗前后肌酐无显著性差异(P>0.05)。不同时程艾灸治疗前后血压无显著差异(P>0.05)。三组患者艾灸治疗前后心率差异显著(P<0.01),说明艾灸可以有效降低高脂血症患者心率。但组间无显著性差异(P>0.05)。艾灸治疗前后血常规、尿常规及心电图无显著差异(P>0.05)。说明艾灸调脂对三者无任何不良影响。
     4研究结论
     4.1不同艾灸时程对高脂血症的调节,30分钟组总体疗效明显优于20分钟组及10分钟组。不同艾灸时程对单个血脂指标的调节作用,30分钟组优于10分钟组,与20分钟组作用无差异。
     4.2不同艾灸时程对高脂血症患者临床症状改善方面,30分钟组明显优于10分钟组。随着艾灸时间延长,临床症状的改善程度越来越好。
     4.3不同时程艾灸对高脂血症患者的安全性指标无不良影响,三个时程均安全可靠。
     5本研究特色与创新之处
     5.1明晰高脂病机,提出温灸立论
     进一步明晰高脂血症与痰饮的关系,针对高脂血症的病机,提出“温灸和之”的立论,从而为阐述高脂血症病机,并为临床治疗和治疗原则确立提供一定的依据。
     5.2重视辨证选穴,彰显灸疗优势
     将“温灸和之”的立论和原则细化,落实到艾灸调脂的临床实践应用之中。筛选了针对高脂血症艾灸的辨证处方,通过辨证施灸的应用,使艾灸调脂更具有中医针灸学特色。
     5.3优化灸调时程,探究时效关系
     在艾灸时程的设立上,考虑到艾灸量效积累的需要及临床可操作性,通过延长每组治疗时间及扩大不同组别的时程差异,以最大限度突显不同艾灸时程的疗效差异。
Part I
     Objective
     To verify the efficiency and advantage of moxibustion on hyperlipidemia and to investigate its action characters and effect trends through the comparison between lipid-lowering effects of syndrome differentiation moxibustion and drug.
     Methods
     Randomization and control:
     In this randomized block trial, all the enrolled cases were divided into the treatment group (moxibustion group, n=32) and the control group (western medicine group, n=33) randomly with block size of6according to their visiting sequence. There were no statistical differences in gender, age, disease and other aspects between two groups (all P>0.05), and they were comparable.
     Treatment methods:
     In moxibustion group, all the cases can be divided into qi-deficiency-with-phlegm type, yin-deficiency-with-yang-hyperactivity type and yang-deficiency-of-spleen-and-kidney type referring to Guidelines for Clinical Research of Traditional Chinese Medicine. The basic point formula was composed by Zusanli (ST36), Shenque (RN8) and Sanyinjiao (SP6). Fenglong (ST40) was used in qi-deficiency-with-phlegm type, Taixi (KI3) was used in yin-deficiency-with-yang-hyperactivity type, and Guanyuan (RN4) was used in yang-deficiency-of-spleen-and-kidney type. The treatment in pure moxa stick was used for10min on each point every time. The frequency was3times a week in once two days.12times were a course, and the treatment last for2courses. Fenofibrate tablet was taken in the dosage of100mg3times a day after dinner in western medicine group.
     Observation and evaluation time points:
     All the indexes were recorded before treatment and evaluated2months after treatment.
     Observation indexes:
     The observation indexes include serum lipids indexes, clinical symptoms and signs, and safety indexes. The serum lipids indexes include TC, TG, HDL-C and LDL-C. The purpose of evaluation on clinical symptoms and signs is to investigate the influence of moxibustion on QOL during lipid regulation. The safety indexes include GOT, GPT, UN and CR.
     Data statistics processing:
     Analyse the basal levels, therapeutic effects and safety of two groups according to the characters of clinical datum and related statistics principle using SPSS13.0. During the statistics, enumeration data is analysed by x2test or Fisher exact chi-square test, while ranked data is analysed by rank sum test. Test of normality is given first to enumeration data, variance analysis is used if it is normal. Normal transformation is given first if the data is non normal. Parametric test is used for data in accordance with normal distribution after transformation, while rank num test is used for that in non normal distribution after transformation. Measurement data is represented by Mean±SD. All the hypothesis tests use two-side test.
     Results
     Serum lipids indexes:
     For serum lipids indexes, the total therapeutic effect in moxibustion group was71.88%(23/32), while that in western medicine group was90.91%(30/33). The statistical difference between the total therapeutic effects of two groups on regulating lipid was insignificant (P>0.05).
     All the serum lipid indexes in two groups decreased after treatment. The effect of moxibustion on decreasing TC and LDL-C was better, while the effect of western medicine on decreasing TG was better, but the differences were both insignificant (P>0.05).
     Total clinical symptom integrals:
     The statistical difference between total clinical symptom integrals in two groups was very significant (P<0.001). The differences on relieving fatigue, poor appetite, abdominal distension, lassitude in loin and legs, dysphoria and aversion to coldness in two groups after treatment were statistically significant (P<0.05). The effect on relieving clinical symptoms of moxibustion was obviously better than that of western medicine, so moxibustion can relieve clinical symptoms and improve the QOL of hyperlipidemia patients obviously.
     Serum lipids related indexes:
     Pain in two groups relieved in different degree after treatment, and the relieving degree in moxibustion group was higher than that in western medicine group with significant difference (P<0.05). Blood glucose in two groups both decreased after treatment, but the difference between two groups was statistically insignificant (P>0.05).
     Safety indexes:
     GOT and GPT in moxibustion group both decreased after treatment, while those in western medicine group both increased after treatment. It shows that western medicine can injure hepatic function. But the difference in changes of two groups was statistically insignificant (P>0.05). UN in moxibustion group decreased, while that in western medicine group increased after treatment. CR in two groups both increased after treatment, and the increase in western medicine group was more obvious. The differences of these two indexes in two groups were both statistically insignificant (P>0.05). There was no statistical difference on systolic pressure and diastolic pressure in two groups after treatment (P>0.05). Heart rate in two groups decreased in different degree after treatment, but the difference was statistically insignificant (P>0.05). There was no harmful effect on blood routine, urine routine, electrocardiogram and so on in two groups after treatment, and the difference was statistically insignificant (P>0.05).
     Conclusion
     1The effect of moxibustion on regulating serum lipid is similar to that of western medicine. Moxibustion can produce benign regulation in all of the serum lipid indexes especially in TC and LDL-C.
     2Moxibustion can relieve clinical symptoms related to the hyperlipidemia and improve the QOL of patients effectively. The effect is better than that of western medicine group obviously.
     3Moxibustion is safe in regulating serum lipid without harmful effect on safety indexes.
     Part II
     Objective
     To screen the best time course scheme for hyperlipidemia treated by moxibustion through setting different time course groups and comparing the effects on lipid regulation of moxibustion in different groups. To lay foundation for further studies on time-effect and dose-effect relationships of moxibustion.
     Methods
     Randomization and control:
     Seventy six cases visiting Acupuncture and Moxibustion Hospital was fit into this study from Nov2009to Dec2011. All these cases couldn't control their serum lipid to normality through diet control. In this randomized block trial, all these cases were divided into10min group (n=25),20min group (n=25) and30min group (n=26). There were no statistical differences in gender, age, disease and other aspects among three groups (all P>0.05), and they were comparable.
     Treatment method:
     Acupoints were selected according to patients'constitutions and pathological basis of yang-deficiency-of-spleen-and-kidney type and phlegm-and-blood-stasis type combined with related clinical reports. The basic point formula was composed by Fenglong (ST40), Zusanli (ST36), Shenque (RN8) and Sanyinjiao (SP6). Moxibustion with pure moxa stick was applied for10minutes in10min group,20minutes in20min group and30minutes in30min group. The frequency was3times a week in once two days.12times were a course, and the treatment last for2courses.
     The observation and evaluation time points, observation indexes and data analysis methods are all the same to Part I
     Results
     Serum lipids indexes:
     For serum lipids indexes, the total therapeutic effect in10min group was52.00%(13/25), in20min group was84.00%(21/25), and in30min group was88.46%(23/26). There were obviously statistical differences between the total therapeutic effects of3groups on regulating lipid effect (all P<0.01).
     The differences between the levels of TC, TG and LDL-C before and after treatment in3groups were all obviously significant in statistics (all P<0.001), while that of HDL-C was statistically insignificant (P>0.05). The result shows that moxibustion can regulate all related indexes to be normal.
     The difference between the effects on decreasing TC and LDL-C in30min group and10min group was statistically significant (P<0.05), while that between30min group and20min group was statistically insignificant (P>0.05). At the same time, the time of moxibustion and the decreasing mean number of effective indexes was positively related. Comparing the mean numbers of differences of TC and LDL-C before and after treatment, the30min group was the best, and the lOmin group was the worst. The differences between effects on regulating TG and HDL-C in3groups were statistically insignificant (P>0.05). The result shows that the regulating effect of moxibustion on TC and LDL-C is better than on the other serum lipid indexes.
     Total clinical symptom integrals:
     The differences between total clinical symptom integrals before and after treatment in3groups were all obviously statistically significant (all P<0.001). It shows moxibustion can relive patients'clinical symptoms and improve their QOL obviously. Comparing the integrals of clinical symptoms among different groups, the difference between10min group and30min group was statistically significant (P<0.05). The integrals in30min groups were the lowest, and in10min group were the highest. It shows that the treatment time and the effect on relieving clinical symptoms of moxibustion are positive related.
     Serum lipids related indexes:
     Patients'fasting blood glucose decreased after moxibustion, and the differences before and after treatment in all3groups were statistically significant (P<0.001). It shows that moxibustion can also regulate patients'fasting blood glucose effectively. The differences on this aspect among3groups were statistically insignificant (P>0.05). The differences of pain before and after treatment in all3groups were statistically significant (P<0.001). It shows that moxibustion can relieve patients'pain effectively through warming and dredging meridians, promoting blood circulation, dispelling coldness and killing pain. The differences of relieving pain effect among3groups were statistically insignificant (P>0.05). The pain relieving degree in30min group was the best, and in20min group was the worst.
     Safety indexes:
     The differences between GOT and GPT before and after treatment in3groups were statistically insignificant (P>0.05). It shows that there isn't harmful influence on hepatic function in the course of regulating lipid in moxibustion. The difference between UN before and after treatment in3groups was statistically significant (P<0.05), the UN decreased after moxibustion. It shows that moxibustion can promote the clearance of protein's end products and is good for metabolism. The differences between CR and BP before and after treatment in3groups were all statistically insignificant (P>0.05). The difference between heart rate before and after treatment in all3groups was statistically significant (P<0.05), but the differences between different groups after moxibustion were all insignificant (all P>0.05). It shows that moxibustion can decrease patients'heart rate effectively. There was no statistical difference between blood routine, urine routine and electrocardiogram before and after treatment in3groups (P>0.05). It shows that there is no harmful effect on these three aspects during moxibustion.
     Conclusion
     1The effect on regulating serum lipid of moxibustion in30min group is better than that in other two groups obviously. The effect on regulating single lipid index of moxibustion in30min group is better than that in10min group, but similar to20min group.
     2The effect on relieving clinical symptoms of moxibustion in30min group is better than that in10min group obviously. The time of moxibustion and the relieving degree of clinical symptoms is positively related.
     3These three time courses of moxibustion are all safe without harmful effect on safety indexes.
     Distinctive and Innovative Points
     1Clarify the pathogenesis of hyperlipidemia and propose the theory of warm moxibustion in treating hyperlipidemia.
     Clarify the relationship between hyperlipidemia and phlegm, and propose the theory of warm moxibustion in treating hyperlipidemia aiming at its pathogenesis. Provide evidence for discussion of the pathogenesis, clinical treatment and establishment of treatment principle.
     2Propose the view that points should be selected according to syndrome differentiation and reveal the advantage of moxibustion.
     Make the theory and principles of moxibustion detailed, and increase the clinical practicality of moxibustion in treating hyperlipidemia.Screened out points descriptions according to syndrome differentiation, and make moxibustion on regulating lipid more accord with TCM features through using these descriptions.
     3Screen the best time course and discuss the time-effect relationship of moxibustion on regulating lipid.
     In the setting of different time courses, this study verifies the differences between effects of different time courses through prolonging treatment time in each group and enlarging the time difference between different groups according to the accumulate effect of moxibustion and clinical maneuverability.
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