针刺治疗Bell's面瘫得气、心理因素与疗效关系的临床观察及心理因素与面瘫发病关系的病例—对照研究
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摘要
第一部分:针刺治疗贝尔麻痹得气、心理因素与疗效关系的多中心临床单盲随机对照研究
     目的:观察针灸治疗过程中得气、神经心理因素、疗效三者之间的关系,探讨得气、神经心理因素在针灸治疗中是否发挥着重要的作用。
     方法:选择306例Bell's面瘫患者为研究对象,采用多中心、单盲设计、随机抽样法分为针刺手法组和非手法组。选取临床实践应用最广、疗效最确切的一组穴位进行针刺治疗:阳白(GB 14)、地仓(ST 4)、颊车(ST 6)、下关(ST7)、翳风(SJ 17)、合谷(LI 4)。手法组患者针刺后,针灸医生予以均匀提插补泻手法,患者出现酸、麻、胀、痛、冷、暖、重、放射感等得气感受或医师手下有沉、紧、涩、滞等感受后,留针30mmin,然后出针;非手法组患者针刺后针灸医生不予任何手法,静留针30min,然后出针。治疗中针灸医师均为匀速进针和匀速出针,5d为一个疗程,一周休息、2d,共治疗4个疗程。对患者疗效评估采用House Brackmann (HB)分级量表、面部残疾指数(FDIP、FDIS)、世界卫生组织生存质量简表(WHOQOL-BREF)评分;对患者和施针者得气状况评估采用针刺得气主观感受量表评分(SASS);对患者心理因素进行卡特尔人格因素测试(Catel-16PF)、划消测试、暗示性测试、针灸疗效主观感受量表评分。
     结果:(1)HB评分比较:两组患者治疗前HB评分无统计学差异(P>0.05)治疗后第180天HB评分手法组(1.39±0.65)低于非手法组(1.91±0.88),具有显著性统计学差异(t=-5.87,P<0.0001):(2)FDI得分比较:治疗后第180天,手法组患者FDIP得分(99.77±1.19)明显高于非手法组(97.04±4.69),具有显著性统计学差异(t=7.01,P<0.0001)。手法组FDIS得分(94.83±8.72)明显高于非手法组(88.89±6.67),具有显著性统计学差异(t=6.68,P<0.0001)。(3) WHOQOL-BREF比较:两组患者在治疗后180天生理、心理、社会、环境四个领域得分比较:手法组明显高于非手法组,具有显著性统计学差异(t=7.28,P<0.0001;t=9.15,P<0.0001;t=6.05,P<0.0001;t=6.38,P<0.0001);(4)得气评分比较:两组患者平均得气分值比较,手法组(22.49±3.89)明显高于非手法组(13.45±2.99),差异具有统计学意义(t=22.79,P<0.0001);两组医生平均得气分值比较,手法组(12.39±1.91)明显高于非手法组(9.36±1.54),差异具有统计学意义(t=15.29,P<0.0001);两组医生、患者得气分值和比较,手法组(34.88±5.38)明显高于非手法组(22.82±4.14),具有显著性统计学差异(t=22.0,P<0.0001);(5)16PF得分比较:两组患者16PF各维度得分均无统计学差异(P>0.05);(6)划消测试:两组患者对、错、漏平均分值均无统计学差异(P>0.05);(7)暗示性得分:两组患者暗示性各维度得分及总分均无统计学差异(P>0.05);(8)针灸疗效主观感受得分:两组患者针灸信任度无统计学差异(P>0.05),治疗后回顾问卷平均得分有显著性统计学差异(t=10.66,P<0.0001);(9)得气、心理因素、针刺手法、病情等因素与主要疗效指标HB评分之间的关系:经多元逐步回归分析,手法、患者平均得气、病情、忧虑性人格因素进入了回归方程,偏回归系数分别为:针刺手法(B=0.6322,P<0.0001)患者平均得气(B=-0.1303,P<0.0001)、忧虑性人格(B=-0.0376,P=0.0398)病情(B=0.5034,P<0.0001);心理因素、针刺手法、病情等因素与得气的关系:经多元逐步回归分析,手法、病情、注意力、针灸信任度进入了回归方程,偏回归系数分别为:针刺手法(B=8.988,P<0.0001);病情(B=0.987,P<0.0001);注意力(B=0.256,P=0.013);针灸信任度(B=0.114,P=0.027);(10)得气、心理因素与次要疗效指标之间的关系:经典型相关分析,患者平均得气、医生平均得气指标与疗效指标相关系数均较大,且同向变化,而心理因素指标与疗效指标相关系数均很小
     结论:针灸治疗Bell's面瘫疗效显著,通过施行手法,可使患者和医生得气感增强,得气感越强,疗效越好,针刺手法、得气在针灸治疗中起着重要作用。心理因素在针灸治疗中发挥着一定的作用,但不起主导作用,忧虑性人格因素与针灸治疗面瘫疗效相关,注意力集中、针灸信任度高人群较为容易得气。
     第二部分:Bell麻痹危险因素探讨及心理因素对Bell麻痹发病的影响:病例-对照研究
     目的:本研究的目的是探索贝尔氏麻痹(BP)的危险因素,并检验心理因素是否是BP发生的潜在危险因素。
     方法:我们进行了一项多中心、病例-对照试验。695名受试者被分配到病例组(n=355)和对照组(n=340)。所有的BP患者来自于中国11家公立三甲教学医院,所有相匹配的对照者也来自同一地区。这项研究由同济医院统一调度执行。我们使用House-Brackmann分级系统和面部残疾指数(FDI)评估BP患者面部残损状况,我们采用Catell 16PF量表来评估所有受试者的人格特征。我们将心理压力、人格因素、受凉史、疲劳史、上呼吸道感染、牙龈感染和面瘫家族史等潜在危险因素纳入研究。基线资料比较采用χ2检验或Mann-Whitney检验测试;而瘫的危险因素探讨采用似然比Logistic回归分析。
     结果:通过χ2试验,两组受试者在受凉史、疲劳史、心理压力、上呼吸道感染方面存在显著性差异。Mann-Whitney检验显示,两组受试者16PF人格因素(乐群性、敏感性、怀疑性、忧虑性、紧张性)有显著性差异。Logistic回归分析结果显示:心理压力者(OR=2.81,95%置信区间:1.70-4.65,P<0.001),聪慧性(OR=1.60,95%置信区间:1.10-2.33,P=0.014)、敏感性(OR=1.85,95%置信区间:1.22-2.79,P值0.004)、忧虑性(OR=1.66,95%置信区间:1.05-2.62,P=0.031)、紧张性(OR=1.62,95%CI:1.12-2.33,P=0.010)等心理因素影响了面瘫的发生,此外,受凉史、疲劳史、上呼吸道感染、牙龈感染等因素也进入了Logistic回归方程。
     结论:我们认为:心理因素(心理压力和人格)是BP发生的主要危险因素,本研究中考虑的其他潜在危险因素(受凉史、疲劳史、上呼吸道感染、牙龈感染等因素)也是引起面瘫的重要因素,在今后的面瘫研究中我们应进一步关注它们。
PartⅠ
     Study on Relationship among De Qi, Psychological Factors, and Efficacy in Acupuncture Treatment for Bell's Palsy:A Single-Blind Multi-center Randomized Controlled Clinical Trial
     Objective:To examine the relationship among De Qi, psychological factors, and the efficacy of acupuncture treatment, and to verify the roles of De Qi and neuropsychological factors in acupuncture treatment.
     Methods:306 Bell's palsy patients were enrolled from 11 medical centers in China. All patients were divided into acupuncture Manipulation group and Non-manipulation group by single-blind designing and random sampling. We select the acupoints for treatment which are most widely used in clinical practice and have been proven exact efficacy:Yangbai (GB 14), Dicang (ST 4), Jiache (ST 6), Xiaguan (ST 7), Yifeng (SJ 17), Hegu (LI 4). Patients in manipulation group were acupunctured with lifting, thrusting, and twirling technique by acupuncturists. When De Qi occurred, the patients felt the internal compound sensation of soreness, numbness, distension, pain, cold, warmth, heaviness, and radiation at and around acupuncture points while the acupuncturists felt the sensation of sinking, astringent, stagnancy, and tightness. The stainless steel filiform needles were retained for 30min. Patients in non-manipulation group were just inserted the needles by acupuncturist, without any acupuncture technique with the identical therapy time of 30 min. During the treatment, the insertion and withdrawal were at an stable speed by acupuncturists. It lasts 5 days for a course,2 days off a week and the total treatment were 4 course. The clinical efficacy in patients were evaluated with House Brackmann (HB)grading system scale, Facial Disability Index (FDIP, FDIS), the World Health Organization Quality of Life-Bref (WHOQOL-BREF) scores; The levels of De Qi for patients and acupuncturists were assessed by subjective acupuncture sensation scale (SASS); the psychological factors in patients were test with personality tests cartels (Catell-16PF), cancellation test, and belief in acupuncture.
     Results:(1)There was no statistical difference of HB scores in two groups for patients before treatment (P>0.05); however, on day 180 after treatment, the HB score in manipulation group (1.39±0.65) was significantly less than that in non-manipulation group (1.91±0.88) (t=-5.87, P<0.0001); (2) On day180 after the treatment, the FDIP score in manipulation group (99.77±1.19) was significantly higher than that in non-manipulation group (97.04±4.69) (t=7.01, P<0.0001). FDIS score in manipulation group (94.83±8.72) was also distinctly higher than non-manipulation group (88.89±6.67) (t=6.68, P< 0.0001). (3) Comparison of the WHOQOL-BREF: the scores of four domains (physical domain, psychological domain, social domain, environmental domain) in manipulation group were significantly higher than those in non-manipulation group (t=7.28, P<0.0001; t=9.15, P< 0.0001;t=6.05,P< 0.0001;t=6.38,P<0.0001); (4) Comparison of the SASS scores:the average score of De Qi for patients in manipulation group (22.49±3.89) was significantly higher than non-manipulation group (13.45±2.99) (t=22.79, P<0.0001); the average scores of De Qi for acupuncturists in manipulation group (12.39±1.91) was also significantly higher than non-manipulation group (9.36±1.54) (t=15.29, P<0.0001); the total scores of De Qi for patients and acupuncturists in manipulation group (34.88±5.38) was significantly higher than non-manipulation group (22.82±4.14) (t=22, P< 0.0001); (5) Comparison of 16PF scores:there was no difference in the 16PF scores for patients between the two groups (P>0.05); (6) The cancellation test:there were no significant difference in the scores for patients between two groups (P>0.05); (7) Suggestibility scores:there were no significantl differences in the dimensions and total scores between the two groups (P>0.05); (8) subjective experience of acupuncture efficacy scale score:scores of subjective experience for patients in two groups showed no significant different before treatment (P>0.05) whereas there was a significant difference after treatment (t=10.66, P<0.0001); (9)The relationship among primary outcome measure HB scores and De Qi, psychological factors, acupuncture manipultion, and other factors:Acupuncture manipultion, the average of De Qi for patients, state of illness, and apprehension personality factors were filtered into the regression equation by the multiple stepwise regression analysis, The partial regression coefficients were as follows:acupuncture manipultion (B=0.6322, P< 0.0001); average of De Qi for patients (B=-0.1303, P<0.0001), Apprehension personality (B=-0.0376, P=0.0398); state of illness (B=0.5034, P<0.0001);the relationship among De Qi and psychological factors, acupuncture manipultion, and other factors were assessed by the multiple stepwise regression analysis. Acupuncture manipultion, state of illness, attention, belief in acupuncture were filtered into the regression equation, and the partial regression coefficients were as follows: Acupuncture manipultion (B=8.988, P<0.0001); state of illness (B= 0.987, P< 0.0001); attention (B=0.256, P=0.013); belief in acupuncture(B=0.114, P=0.027); (10)The relationship between the secondary outcomes and De Qi, psychological factors was test by the canonical correlation analysis. The correlation coefficient between average De Qi for patients and the secondary therapeutic indexes were greater than that of average De Qi for acupuncturists and therapeutic indexes although they changed in the similar way; The correlation coefficients for psychological factors and curative effects were very small.
     Conclusions:In patients with Bell's palsy, acupuncture treatment significantly improves facial function and quality of life. The therapeutic effect on Bell's palsy produced by acupuncture were achieved mainly by increasing the level of deqi;. Psychological factors play a limited role in acupuncture treatment:Apprehension personality factor is associated with the efficacy of bell's palsly; patients with high attention and high belief in acupuncture were more prone to obtain De Qi..
     PartⅡ
     Psychological Factors Are Closely Associated with the Occurrence of Bell's Palsy:A Case-Control Study
     Objective:To explore the risk factors for Bell's palsy (BP) and to examine whether psychological factors are the potential risk factors for the occurrence of BP.
     Methods:We conducted a case-control, multi-center trial.695 subjects were assigned to the case group (n=355) and control group (n=340). All the BP patients were enrolled from 11 State Hospitals in China, and all the controls were selected from the same district to match for the patients. The study was coordinated by a tertiary referral centre, Tongji Hospital. We used the House-Brackmann grading system and Facial Disability Index (FDI) to assess the BP patients, and employed Catell 16PF scale to evaluate the personality factors for all subjects. Psychological stress, personality factors, cold wind, fatigue, upper respiratory tract infections, gum infections, and family history of BP have been assessed in the study, which were regarded as the possible risk factors for BP. The baseline characteristics were analyzed byχ2 tests or Mann-Whitney tests; forward likelihood ratio logistic regression analysis was used to explore the risk factors for BP.
     Results:Byχ2 test, there are significant differences in the history of cold wind, history of fatigue, psychological stress, and upper respiratory tract infections. By the Mann-Whitney tests, the comparison of the 16PF (personality factor A, I, L, O, and Q4) scores between two groups are significantly different. By the logistic regression analysis, among the risk factors, psychological stress(OR=2.81,95% CI:1.70-4.65, P<0.001), personality factor B(OR=1.60,95% CI:1.10-2.33,P=0.014), I(OR=1.85, 95% CI:1.22-2.79, P=0.004), O(OR=1.66,95% CI:1.05-2.62, P=0.031), and Q4 (OR=1.62,95% CI:1.12-2.33, P=0.010) were found to influence the onset of BP. In addition, cold wind, fatigue, upper respiratory tract infections, and gum infections were also involved in the logistic equation.
     Conclusions:The results show that psychological factors (psychological stress and personality) are the key risk factors for the occurrence of BP, and other factors (cold wind, fatigue, upper respiratory tract infection, and gum infection) also paly an important role in the occurrence of BP, which should be concerned seriously in the further study.
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