针刺改善癌性厌食恶病质综合征的临床研究

发布时间：2018-01-06 07:25

本文关键词：针刺改善癌性厌食恶病质综合征的临床研究　出处：《成都中医药大学》2016年博士论文　论文类型：学位论文

【摘要】：背景：癌症是我国第一大致死性疾病,已成为影响国民健康和公共卫生安全的重大问题,针对癌症及并发症的防治策略意义重大。癌性厌食恶病质综合征(CACS)是癌症患者最常见伴发病症,缺乏高效安全的治疗手段。针灸在CACS相关症状的控制方面已显现出一定的优势,可能是治疗本病的有效手段,值得深入研究。目的：评价针刺治疗癌性厌食恶病质综合征的有效性和安全性,为针灸干预该综合征提供证据支撑。方法：本研究采用分期临床试验的方法对针刺改善癌性厌食恶病质综合征的安全性和有效性进行评估。1.工期临床研究采用小样本开放对照试验的方法研究针刺改善CACS的安全性和可行性。20名合格受试者,接受每天一次,至少7次针刺治疗。采用药片计数法评估受试者依从性。通过比较基线及针刺治疗结束后受试者基本生命征、食欲症状、疲劳症状、生活质量、针刺相关事件问卷等变化评估针刺方案治疗CACS的可行性。2.Ⅱ期临床研究采用多中心单盲双模拟随机对照试验的设计思路,评估针刺治疗CACS的有效性和安全性。129名合格受试者按照1：1：1比例,随机分配到针灸组(Acupuncture group, AG)、甲地孕酮组(Megestrol acetate group, MAG)和安慰治疗组(Placebo group, PG)。分别接受针刺+安慰剂、甲地孕酮+安慰针刺、安慰针刺+安慰剂的干预方案。针刺或安慰针刺每天1次,治疗7天；甲地孕酮分散片或安慰剂160mg口服,2次／天,连续7天。治疗前、第4天和治疗结束时,对首要结局指标食欲状态进行评估。体重、简明食欲问卷等次要结局指标,伴随症状控制、生活质量的评估,基线和治疗结束时进行。基线期或治疗结束时对受试者疗效期望值、安全性、依从性以及治疗满意度进行评估。结果： 1.Ⅰ期临床试验结果：(1)本研究按照药片计数法计算受试者依从性为94.3%。(2)受试者治疗前后基本生命征指标变化差异无统计学意义(P0.05);食欲症状、疲劳症状评分以及生活质量等差异具有统计学意义(P0.05)；针刺相关事件问卷主要有针刺疼痛、出血、瘀斑、弯针,未出现严重不良事件。2.Ⅱ期临床试验结果：(1)107名受试者完成对应方案的治疗,三组在人口学特征、疾病构成、治疗期望值和疗效指标基线期比较差异无统计学意义(P0.05),组间均衡一致,具有可比性。(2)首要结局指标：治疗第4天,三组整体食欲、早中餐食欲积分比较差异有统计学意义(P0.05),AG分别与PG、MAG两组成对比较差异均有统计学意义(P0.05)。治疗完成后,AG和MAG成对比较食欲评分差异无统计学意义(P0.05),AG和MAG分别与PG两组成对比较治疗后食欲积分差异均有统计学意义(P0.05)。(3)治疗后,三组体重、疲劳状况差异无统计学意义(P0.05),且组内治疗前后差异比较无统计学意义(P0.05)；简明食欲问卷评估组间比较AG较MAG差异无统计学意义(P0.05),AG较PG差异具有统计学意义(P0.05)。(4)埃德蒙顿症状量表积分AG在恶心、便秘症状治疗前后及与PG比较差异有统计学意义(P0.05),其他症状如疼痛、失眠、咳嗽、气急等无统计学差异(P0.05)；生活质量评估方面AG自身治疗前后比较以及与PG比较差异有统计学意义(P0.05)。(5)针刺主要不良反应有针刺疼痛、出血、瘀斑和心慌乏力,不良反应发生机率小且症状非常轻微,未见严重不良反应发生,依从性为81.1%；疗效满意度组间、两组成对比较差异均有统计学意义(P0.05)。结论：本研究结果提示：1.针刺治疗与甲地孕酮均可显著提高癌性厌食恶病质综合征患者食欲,两者疗效相当,针刺具有起效迅速的特点。2.针刺治疗能够缓解癌症厌食恶病质综合征患者营养恶化的趋势,能显著改善其生活质量、恶心和便秘症状。针刺对伴随疲劳、失眠、焦虑、咳嗽、气急等症状控制无效,不能逆转患者体重下降。3.针刺改善癌性厌食恶病质综合征具有安全性好、依从性高和满意度好,值得深入研究和临床推广。
[Abstract]:Background: cancer is the first deadly disease, has become the major problems affecting the national health and public health safety, according to the significance of prevention strategies for cancer and major complications. Cancer anorexia cachexia syndrome (CACS) is the most common complication in patients with cancer, the lack of efficient and safe treatment method. The control of acupuncture and moxibustion in CACS related symptoms have shown some advantages, may be an effective method to cure the disease, it is worthy of further study. Objective: To evaluate the efficacy and safety of acupuncture in treating cancer anorexia cachexia syndrome, acupuncture intervention of the syndrome to provide evidence support. Methods: This study used for staging and clinical trial safety and the effectiveness of cancer anorexia cachexia syndrome and improve the assessment period.1. acupuncture clinical study using small sample control test method to study acupuncture to improve the security of CACS Safety and feasibility of.20 qualified subjects, for once a day, at least 7 times. The acupuncture treatment pills counting method was assessed by comparison of compliance. The end of baseline and after acupuncture treatment, the subjects of basic life syndrome, appetite symptoms, fatigue symptoms, quality of life, evaluation of design feasibility of.2. II clinical study on acupuncture treatment of CACS with multi center single blind randomized controlled trials of acupuncture related events questionnaire and other changes, evaluate the safety and efficacy of acupuncture treatment of.129 CACS qualified subjects according to the proportion of 1:1:1, were randomly divided into acupuncture group (Acupuncture group, AG), Megestrol acetate (megestrol group group, MAG) and placebo treatment group (Placebo group, PG). Respectively received acupuncture plus placebo, megestrol + placebo acupuncture and placebo acupuncture intervention plus placebo. Acupuncture or placebo acupuncture 1 times a day for 7 days. ; megestrol tablets or placebo 160mg orally, 2 times / day for 7 days. Before the treatment, and the end of the fourth day of treatment, to evaluate the primary outcome of appetite state. Body weight, appetite and other secondary outcomes concise questionnaire, with symptom control, quality of life was assessed for baseline and end of treatment. The end of the baseline or treatment of subjects efficacy expectations, safety, compliance and treatment satisfaction were assessed. Results: 1. phase I clinical trial results: (1) this study in accordance with the pill counting method to calculate the subjects' compliance for 94.3%. (2) subjects before and after treatment of basic vital signs changes there was no statistically significant difference (P0.05); appetite symptoms, the difference was statistically significant fatigue symptom score and quality of life (P0.05); acupuncture related events questionnaire are acupuncture pain, bleeding, bruising, curved needle, no serious adverse events .2. phase II clinical trial results: (1) 107 subjects completed the corresponding treatment scheme, the three groups in demographic characteristics, disease, treatment and curative effect of baseline expectations index was no significant difference between groups (P0.05), consistent and comparable. (2) the primary outcome index for fourth days, the three groups overall appetite, early in the meal had significant difference compared to the integral (P0.05), AG and PG respectively, MAG two composition of the differences were statistically significant (P0.05). After treatment, no statistical significance of AG and MAG score between the paired comparison of appetite (P0.05), AG and MAG with PG two on the integral had significant differences in appetite after treatment (P0.05). (3) after treatment, three groups of weight, there was no significant difference in fatigue (P0.05), and the difference between the group before and after treatment were not statistically significant (P0.05); a concise questionnaire assessment group appetite There was no significant difference between AG MAG (P0.05), AG is PG. The difference was statistically significant (P0.05). (4) Edmonton symptom scale scores was statistically significant in AG nausea, constipation symptoms before and after treatment and the difference compared with PG (P0.05), other symptoms such as pain, insomnia, cough, shortness of breath, no significant difference such as (P0.05); to evaluate the quality of life of AG before and after treatment and compared with PG, the difference was statistically significant (P0.05). (5) the main adverse reactions of Acupuncture Acupuncture pain, bleeding, bruising and palpitation fatigue, adverse reaction rate and vigor symptoms are very mild, and no serious adverse events occurred, for compliance 81.1%; the curative effect satisfaction between groups, two group differences were statistically significant (P0.05). Conclusion: the results suggest: 1. acupuncture treatment and megestrol acetate can significantly improve the appetite of cancer anorexia cachexia syndrome patients, two The curative effect of acupuncture, acupuncture treatment of.2. has the characteristics of rapid onset can alleviate the cancer anorexia cachexia syndrome in patients with nutritional deterioration, can improve the quality of life significantly, nausea and constipation symptoms. With acupuncture on fatigue, insomnia, anxiety, cough, shortness of breath control is invalid, can not reverse the decline of.3. weight with acupuncture to improve cancer anorexia cachexia syndrome has good safety, high compliance and satisfaction, it is worthy of further study and clinical application.

【学位授予单位】：成都中医药大学
【学位级别】：博士
【学位授予年份】：2016
【分类号】：R246.5

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