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           score approach based on their demographics,and received a two-round Bigu trial:in the first round,group A received 10-
           day diet-restriction type of Bigu,while group B received 10-day medicine-qi intake in combination with diet-restriction type
           of Bigu. Then,after one-month washout period,the second round was conducted,during which group A received 10-day
           medicine-qi intake in combination with diet-restriction type of Bigu,while group B received 10-day diet-restriction type of Bigu.
           Comparisons were performed between two groups in terms of incidence of adverse reactions and number of dropouts in two rounds
           of Bigu,and subjective hunger sensation,weight,BMI,morning blood pressure,and fasting fingerstick glucose on the first
           and 10th days of two rounds of Bigu. Results After being assigned by PSM,there were 72 males and 80 females in group A;
           61 males and 67 females in group B. In the first round,the incidence of adverse reactions in group A was 65.7%(92/140),
           and the trial discontinuation rate was 48.6%(68/140);the incidence of adverse reactions in group B was 42.9%(60/140),
           and the trial discontinuation rate was 20.0%(28/140). The incidence of adverse reactions and trial discontinuation rate in
           group A were higher than those in group B,and the difference was statistically significant(P<0.05). In the second round,the
           incidence of adverse reactions in group A was 29.2%(41/140),and the trial discontinuation rate was 13.6%(19/140);the
           incidence of adverse reactions in group B was 60.0%(84/140),and the trial discontinuation rate was 42.1%(59/140). The
           incidence of adverse reactions and trial discontinuation rate in group A were lower than those in group B,and the difference was
           statistically significant(P<0.05). The subjective hunger sensation score at the end of the first round was higher than that before
           the beginning,and the subjective hunger sensation score in group B at the end was lower than that before the beginning,and the
           difference was statistically significant(P<0.05). The subjective hunger sensation score at the end in the second round of group
           A was lower than that before the beginning,and the difference was statistically significant(P<0.05). The body weight,BMI,
           systolic blood pressure,diastolic blood pressure,and fasting blood glucose of groups A and B at the end of the 2-round test were
           all lower than those before the start of the test,and the difference was statistically significant(P<0.05). Conclusion This
           real-world trial demonstrates that the medicine-qi intake type of Bigu may reduce the subjective hunger sensation,and incidence
           of adverse reactions as well as enhanced the completion rate of Bigu in healthy population,which may be used as a recommended
           scheme for the promotion of Bigu.
               【Key words】 Fasting;Medicine,traditional;Science health maintenance;Healthy volunteers;Bigu;Real world study



               辟谷,又有“去谷”“断谷”等说法,指练习者通                           本研究创新点:
           过各种方式减少食物的摄入,从而延年益寿的一种养生                                 “服药 - 服气”且配合“隔日限食”的辟谷方法
           方法。辟谷在我国古代较为盛行,练习者众多,且影响                             不仅能达到单纯辟谷疗法带来的降低体质量、体质指
           深远。《魏书》《隋书》《北史》《明史》等史书及《千                            数、血糖、血压的效果,还能明显减少受试者在试验
           金方》《太平圣惠方》《本草纲目》等医书中均有相应                             中的饥饿强度和不良反应发生率,进而提高辟谷完成
           记载  [1] 。辟谷“限制进食”的理念也与西方社会的限                         率,能为推广辟谷疗法提供一定借鉴。
           食疗法(calorie restriction,CR)、隔日限食疗法、轻断                本研究局限性:
           食(the fast diet,FD)等疗法的基本理念不谋而合            [2] 。         (1)本研究用于评价受试者饥饿强度的自觉饥
           研究证实,限食能有效抑制机体炎性反应,而炎性反应                             饿强度评分较为主观,可能影响试验数据的准确性;
           是众多疾病发病机制的始动环节               [3] 。现如今,国内外            (2)真实世界中,能影响受试者饥饿程度的因素众
           的诸多研究者已把 CR 广泛运用于治疗肿瘤、心脑血管                           多。即便能通过倾向性评分匹配消除部分混杂因素,
           疾病、衰老等研究中         [4-6] 且收效良好。由此可见,辟谷                在一定程度保持协变量的平衡,但仍可能存在一定偏
           限食在肥胖、高血压等疾病高发的当今社会中应用前景                             倚;(3)本研究招募的受试者均来自四川省成都市,
           广阔。多数辟谷限食研究均将动物作为研究对象                     [7-8] ,    存在地域局限性,不同地区人群对辟谷试验的反应可
           而为便于精确记录进食量,受试动物的食物摄入量受到                             能不同。
           了严格控制。动物实验的目的是为了在随后的人体试验
           中保障受试者的安全,然而部分研究者在把先前应用于                            为保障受试者安全,研究者只能被迫中止试验。本研究
           受试动物中并被证实可行的限食疗法应用于人类时遇到                            团队在前期研究基础上          [9] 采用“服药 - 服气”辟谷养
           了困难:首先,部分处于饥饿状态的受试者限食依从性                            生技术(即采用辅助服药食饵保障机体功能,再配合能
           差,常因饥饿感过于强烈而违背要求、主动进食,导致                            抑制饥饿感的“服气”功法)并采取“隔日限食”、辟
           试验失败;其次,部分受试者在限食试验中出现了低血                            谷日服食辅助服药食饵等更温和的手段,研究辟谷对真
           糖、低血压、晕厥、休克等影响自身健康的不良反应,                            实世界健康人群的影响,以期为未来将辟谷养生术安全
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