腹针治疗功能性室性早搏的随机对照研究
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摘要
目的:
     通过观察治疗前后功能性室性早搏患者在中医临床症状、室性早搏次数、心率变异性及生活质量等指标的变化,评价腹针在改善中医症状、减少室性早搏次数、调节心脏自主神经功能及改善患者生活质量方面的疗效及安全性,并初步探讨其作用机理,为腹针治疗功能性室性早搏提供理论依据。
     方法:
     本研究采用随机对照方法,以非经非穴位浅刺作为对照组,将纳入的患者以1:1的比例随机分为治疗组和对照组。治疗组给予腹针治疗,对照组给予非经非穴位点针刺治疗,隔日1次,每周3次,每次留针30分钟,一共治疗12次,治疗结束后并随访1月。观察治疗前后及随访1月时功能性室性早搏患者的中医临床症状、心悸发作次数、心悸发作程度、室性早搏次数、心率变异性指标、生活质量的变化,探寻腹针治疗功能室性早搏的取穴规律,并监测相关的安全性指标。
     结果:
     1、综合疗效比较:治疗后腹针治疗组总有效率为64.6%,对照组总有效率为13.3%,两组间相比差异有显著性统计学意义(P<0.05),腹针治疗对功能性室性早搏患者的综合疗效优于对照组。
     2、中医症状疗效比较:两组患者在治疗后及随访1月时中医症状积分与治疗前相比均有减少(P<0.05),两组间不同观察时点比较差异亦有统计学意义(P<0.05);治疗后治疗组中医症状改善总有效率达87.1%,对照组为43.3%,两组间差异有显著统计学意义(P<0.05)。
     3、中医单项症状疗效比较:两组患者在治疗后及随访1月时7个单项中医症状积分均有所降低,治疗组各个单项症状积分治疗后及随访1月时与治疗前相比差异均有显著统计学意义(P<0.05);对照组仅心悸、乏力积分在治疗后及随访1月时与治疗前相比差异有统计学意义(P<0.05)。两组患者在心悸、心烦、乏力、气短、失眠单项症状疗效上比较上差异有显著性统计学意义,治疗组改善上述症状疗效优于对照组。
     4、心悸症状发作程度比较:两组患者治疗后及随访1月时在心悸发作次数评分、每周心悸发作次数及心悸持续时间上均较治疗前有好转,治疗组在不同观察时点与治疗前比差异均有统计学意义(P<0.05),对照组在随访1月时每周心悸发作次数及心悸持续时间与治疗前比较有统计学意义(P<0.05),两组在不同时间组间比较心悸发作次数评分、每周心悸发作次数及心悸持续时间差异均有统计学意义(P<0.05)。
     5、中医症状即刻缓解及明显缓解时点比较:两组患者在中医症状即刻缓解上比较差异无明显统计学意义(P>0.05),症状缓解持续时间上比较差异有统计学意义;两组患者在中医症状明显缓解上比较差异有统计学意义,而明显缓解时间点上相比差异无统计学意义。
     6、室性早搏变化比较:治疗后治疗组24h室性早搏次数明显减少(P<0.05),而对照组较前无明显变化(P>0.05);两组患者室性早搏减少数目相比差异有统计学意义(P<0.05);室性早搏疗效上治疗组总有效率67.8%,对照组总有效率13.3%,二者相比差异有显著性统计学意义(P<0.05);在室性早搏二联律数比较上,治疗组治疗后室性早搏二联律阵数与治疗前相比有明显减少,差异有统计学意义(P=0.007),对照组治疗前后差异无明显统计学意义(P>0.05),两组患者在室性早搏二联律减少数上比较差异有统计学意义(P=0.03);两组患者在室性早搏三联律及成对室性早搏数比较少差异无统计学意义(P>0.05)。腹针减少24h室性早搏次数和室性早搏总疗效方面优于非经非穴位针刺治疗。
     7、心率变异性指标比较:治疗前两组患者SDNN、SDANN、SDNNI、PNN50、 HF、LF均低于正常参考值,rMSSD及LF/HF高于正常参考值。两组患者在治疗后时域指标均有所升高,治疗组SDNN、SDANN、rMSSD、PNN50变化与治疗前相比差异有显著性统计学意义(P<0.05),而对照组各时域指标变化与治疗前相比差异无显著性统计学意义(P>0.05)。在频域指标上,治疗组治疗后HF、LF均较治疗前有所升高,HF与治疗前相比差异有显著统计学意义(P<0.05),而对照组治疗后两指标与治疗前相比无明显变化(P>0.05),两组患者LF/HF值均有所降低,治疗组与治疗前相比差异有统计学意义(P<0.05),对照组差异无统计学意义,两组间比较频域指标变化差异均无统计学意义(P>0.05)。
     8、生活质量比较:两组患者在治疗后及随访1月时生活质量均较治疗前有所提高,治疗组在生活质量各维度评分与治疗前相比差异均有显著性意义(P<0.05),对照组在社会功能及健康变化维度与治疗前相比差异有统计学意义(P<0.05),两组患者在总体健康、生理职能、情感职能、精神健康及健康变化维度方面比较差异有显著性统计学意义(P<0.05)。
     9、腹针取穴规律:经频数统计中脘、下脘、气海、关元、水分、左水分旁、左气旁、左气穴是腹针治疗功能性室性早搏的高频穴位,使用频率均为100%;根据穴位聚类及结合不同类别之间患者的共性及特异性证候信息,腹针穴位配伍具有一定的规律:湿盛者,加双大横;肩关节痛者,加同侧滑肉门;虚甚者,加右气穴;夜尿频者,加双水道;有内热者,加双下风湿点;大便干或便秘者,加天枢或左下风湿点;颈部不适或颈部引起的头部不适者,加双商曲,甚者加建里。
     10、安全性比较:治疗组在治疗过程中2例出现小范围皮下瘀斑,嘱患者用生土豆片外敷散瘀后能坚持治疗,两组患者在治疗前后及随访时均未出现心率、血压等生命体征的异常,治疗过程中亦未出现晕针、感染、断针、不能忍受疼痛等针刺相关的不适。
     结论:
     1、腹针治疗能够明显改善功能性室性早搏患者的中医临床症状,减少心悸发作次数,缩短心悸持续时间。
     2、腹针治疗能明显减少功能性室性早搏患者室性早搏次数并且疗效优于非经非穴位针刺治疗。
     3、腹针能提高功能性室性早搏患者的心率变异性,调节心脏自主神经功能。
     4、腹针治疗能明显提高功能性室性早搏患者的生活质量,尤其在总体健康、生理职能、情感职能、精神健康及健康变化维度更明显。
     5、腹针治疗功能性室性早搏基本穴位有中脘、下脘、气海、关元、水分、左水分旁、左气旁、左气穴,在此基础上根据辨病和辨证而进行穴位加减。
     6、腹针治疗安全、有效、无明显毒副作用,值得在临床上进一步推广应用。
Objective:
     To investigate the change on patients with functional premature ventricular contractions in clinical symptoms, premature ventricular contractions numbers, heart rate variability and quality of life before and after treatment, evaluate the effectiveness and safety of abdominal acupuncture on improving the clinical symptoms, reducing the numbers of premature ventricular contractions, regulating cardiac autonomic nervous function and improving the patient's quality of life. And to provide therory basis for abdominal acupuncture in treating with functional premature ventricular contractions by discussing its mechanism.
     Methods:
     This study used a randomized controlled method, We divided the patients into a treatment group and a control group in a ratio of1:1. the treatment group as abdominal acupuncture treatment, the control group as minimal acupuncture points acupuncture treatment, the treating was every other day, three times a week,30minutes each time, The treatment process was12times. And followed up for one month after treatment. Observe the change on clinical symptoms, Palpitation number, Palpitation duration, premature ventricular contractions numbers, heart rate variability and quality of life. Explore the regularity of abdominal acupuncture acupoint selection on functional premature ventricular contractions patients, and monitor security indicators.
     Results:
     1.The comparison of comprehensive efficacy:After treatment, The total effective rate was64.6%%in abdominal acupuncture group, The total effective rate was13.3%in the controlled group, the difference between the two groups was significant (P<0.05), the comprehensive efficacy of abdominal acupuncture treatment on patients with premature ventricular contractions was better than the controlled group.
     2.The comparison of clinical symptoms efficacy:After the treatment and one month after the treatment, two groups of patients clinical symptom score decreased compared with before treatment (P<0.05). There also was significant difference between two groups (P<0.05). The total effective rate was87.1%in treatment group and43.3%in controlled group, There was significant difference between two groups (P<0.05).
     3. The comparison of Chinese single sympotom efficacy:After the treatment and one month after the treatment, seven single Chinese sympotoms core were reduced. In two groups, There were significantly difference compared with before treatment in treatment group (P<0.05). The palpitation and fatigue score were significantly difference compared with before treatment in the controlled group (P<0.05). The efficacy of palpitation, irritability, fatigue, shortness of breath and insomnia were significant difference between two groups, The treatment group has better efficacy in improving Chinese clinical syndrome.
     4.The extent of palpitation:After the treatment and one month after the treatment, The Palpitation score, Palpitations episodes per week and Palpitation duration were reduced. The treatment group in the different observation points were significant difference compared with before treatment (P<0.05). The Palpitation score and Palpitation duration were difference compared with before treatment in the controlled group at one month after the treatment (P<0.05). There were significant difference between two groups in the different observation points (P<0.05).
     5. The comparison of Chinese clinical symptoms immediately and obviously relieve:There were no significant difference in Chinese clinical symptoms immediately relieve betweent two groups (P>0.05). duration of symptoms is statistically significant between two groups. There were no significant difference in Chinese clinical symptoms obviously relieve betweent two groups. But significant difference in clinical symptoms obviously relieve points.
     6. The comparison of premature ventricular contractions:The premature ventricular contractions of24hours significant reduced after treatment in treatment group (P<0.05), the control group compared with before treatment no significant change (P>0.05). There was significant difference in the number of premature ventricular contractions reduced between two groups (P<0.05). the total effective rate of premature ventricular contractions was67.8%in treatment group and13.3%in control group. There was significant difference between two groups (P<0.05). abdominal acupuncture treatment reduce the number of premature ventricular contractions and the efficacy is better than minimal acupuncture points acupuncture treatment.
     7.The comparison of heart rate variability:before treatment, The SDNN、 SDANN、SDNNI、PNN50、HF、LF were lower than the normal reference values. rMSSD and LF/HF were higher than the normal reference values. The time domain indexes were increased after treatment. There were significant difference on SDNN、 SDANN、rMSSD、PNN50in treatment group compared with before treatment. But the control group have no difference compared with before treatment. On frequency domain indexes, The HF and LF were increased after treatment in treatment group, the change of HF have significant difference compared with before treatment (P<0.05). but the control group have no significant difference copmpared with before treatment (P>0.05). after treatment, the LF/HF was reduced both of two groups. The treatment group have difference compared with before treatment (P<0.05), but the control group have no. The comparison of two groups have no difference (P>0.05).
     8. The comparison of quality of life:After the treatment and one month after the treatment, the quality of life was improved both of two groups. The treatment group in every dimensions of quality of life score compared with before had significant difference (P<0.05). the control group in social function and health function compared with before had significant difference (P<0.05). There were significant difference on general healthurole physicals role emotional, mental health and change of health function between two groups (P<0.05).
     9. the regularity of abdominal acupuncture acupoint selection:by frequency statistics, the ZhongWan、XiaWan、QiHai、GuanYuan、ShuiFen、left ShuiFen pang、left QiPang、left QiXue were high frequence points of abdominal acupuncture acupoint, used frequency was100%. According to acupuncture points clustering and combined with the commonality and specific syndrome between different types patients, abdominal acupuncture acupoint selection has a certain regularity:Phlegm wet serious, add two sides of DaHeng; Shoulder joint pain, add HuaRouMen; deficiency serious, add right QiXue; Frequent Night
     urination, add two sides of ShuiDao; Abdominal gas impassability, add two sides of XiaFengShidian; Dry stool or constipation, add TianShu or left XiaFengShidian; neck discomfort or head discomfort caused by neck, add two sides of ShuangQu, mores erious, add JianLi.
     10. Security Comparison:In treatment group, two patients appeared small range subcutaneous ecchymosis, instruct patients with raw potato chips after topical scattered stasis can adhere to the treatment, at the time of before and after treatment and one month after treatment, two groups of patients were on present heart rate、blood pressure and other signs of abnormalities. In the process of treatment, two groups of patients have no Needlesickness、 infection、Broken needle and can't stand pain related to acupuncture.
     Conclusion:
     1. Abdominal acupuncture treatment can significantly improve the Chinese clinical symptoms of functional premature ventricular contractions patients, reduce the times of palpitations episodes and shorten the duration of the palpitations.
     2. Abdominal acupuncture treatment can significantly reduce the number of premature ventricular contractions of patients, and the efficacy is better than minimal acupuncture points acupuncture treatment.
     3. Abdominal acupuncture treatment can improve the heart tate variability of functional premature ventricular contractions patients, and regulation of cardiac autonomic nerve function.
     4. Abdominal acupuncture treatment can significantly improve the quality of life in patients with functional premature ventricular contractions, especially on general health role physicaK role emotionaK mental health and change of health function.
     5. ZhongWan、XiaWan、QiHai、GuanYuan、ShuiFen、left ShuiFen pang、left QiPang、 left QiXue are basic points for functional premature ventricular contractions patients, On the basic points according to the disease and syndrome differentiation plus or minus points.
     6. Abdominal acupuncture therapy is safe, effective, and no significant side effects, It is worth further promote the use of clinical.
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