本文關(guān)鍵詞：針刺改善癌性厭食惡病質(zhì)綜合征的臨床研究　出處：《成都中醫(yī)藥大學(xué)》2016年博士論文　論文類型：學(xué)位論文

  更多相關(guān)文章： 癌性厭食惡病質(zhì)綜合征 針灸治療 臨床對(duì)照試驗(yàn) Ⅰ期臨床研究 Ⅱ期臨床研究

【摘要】：背景：癌癥是我國第一大致死性疾病,已成為影響國民健康和公共衛(wèi)生安全的重大問題,針對(duì)癌癥及并發(fā)癥的防治策略意義重大。癌性厭食惡病質(zhì)綜合征(CACS)是癌癥患者最常見伴發(fā)病癥,缺乏高效安全的治療手段。針灸在CACS相關(guān)癥狀的控制方面已顯現(xiàn)出一定的優(yōu)勢(shì),可能是治療本病的有效手段,值得深入研究。目的：評(píng)價(jià)針刺治療癌性厭食惡病質(zhì)綜合征的有效性和安全性,為針灸干預(yù)該綜合征提供證據(jù)支撐。方法：本研究采用分期臨床試驗(yàn)的方法對(duì)針刺改善癌性厭食惡病質(zhì)綜合征的安全性和有效性進(jìn)行評(píng)估。1.工期臨床研究采用小樣本開放對(duì)照試驗(yàn)的方法研究針刺改善CACS的安全性和可行性。20名合格受試者,接受每天一次,至少7次針刺治療。采用藥片計(jì)數(shù)法評(píng)估受試者依從性。通過比較基線及針刺治療結(jié)束后受試者基本生命征、食欲癥狀、疲勞癥狀、生活質(zhì)量、針刺相關(guān)事件問卷等變化評(píng)估針刺方案治療CACS的可行性。2.Ⅱ期臨床研究采用多中心單盲雙模擬隨機(jī)對(duì)照試驗(yàn)的設(shè)計(jì)思路,評(píng)估針刺治療CACS的有效性和安全性。129名合格受試者按照1：1：1比例,隨機(jī)分配到針灸組(Acupuncture group, AG)、甲地孕酮組(Megestrol acetate group, MAG)和安慰治療組(Placebo group, PG)。分別接受針刺+安慰劑、甲地孕酮+安慰針刺、安慰針刺+安慰劑的干預(yù)方案。針刺或安慰針刺每天1次,治療7天；甲地孕酮分散片或安慰劑160mg口服,2次／天,連續(xù)7天。治療前、第4天和治療結(jié)束時(shí),對(duì)首要結(jié)局指標(biāo)食欲狀態(tài)進(jìn)行評(píng)估。體重、簡(jiǎn)明食欲問卷等次要結(jié)局指標(biāo),伴隨癥狀控制、生活質(zhì)量的評(píng)估,基線和治療結(jié)束時(shí)進(jìn)行�；�期或治療結(jié)束時(shí)對(duì)受試者療效期望值、安全性、依從性以及治療滿意度進(jìn)行評(píng)估。結(jié)果： 1.Ⅰ期臨床試驗(yàn)結(jié)果：(1)本研究按照藥片計(jì)數(shù)法計(jì)算受試者依從性為94.3%。(2)受試者治療前后基本生命征指標(biāo)變化差異無統(tǒng)計(jì)學(xué)意義(P0.05);食欲癥狀、疲勞癥狀評(píng)分以及生活質(zhì)量等差異具有統(tǒng)計(jì)學(xué)意義(P0.05)；針刺相關(guān)事件問卷主要有針刺疼痛、出血、瘀斑、彎針,未出現(xiàn)嚴(yán)重不良事件。2.Ⅱ期臨床試驗(yàn)結(jié)果：(1)107名受試者完成對(duì)應(yīng)方案的治療,三組在人口學(xué)特征、疾病構(gòu)成、治療期望值和療效指標(biāo)基線期比較差異無統(tǒng)計(jì)學(xué)意義(P0.05),組間均衡一致,具有可比性。(2)首要結(jié)局指標(biāo)：治療第4天,三組整體食欲、早中餐食欲積分比較差異有統(tǒng)計(jì)學(xué)意義(P0.05),AG分別與PG、MAG兩組成對(duì)比較差異均有統(tǒng)計(jì)學(xué)意義(P0.05)。治療完成后,AG和MAG成對(duì)比較食欲評(píng)分差異無統(tǒng)計(jì)學(xué)意義(P0.05),AG和MAG分別與PG兩組成對(duì)比較治療后食欲積分差異均有統(tǒng)計(jì)學(xué)意義(P0.05)。(3)治療后,三組體重、疲勞狀況差異無統(tǒng)計(jì)學(xué)意義(P0.05),且組內(nèi)治療前后差異比較無統(tǒng)計(jì)學(xué)意義(P0.05)；簡(jiǎn)明食欲問卷評(píng)估組間比較AG較MAG差異無統(tǒng)計(jì)學(xué)意義(P0.05),AG較PG差異具有統(tǒng)計(jì)學(xué)意義(P0.05)。(4)埃德蒙頓癥狀量表積分AG在惡心、便秘癥狀治療前后及與PG比較差異有統(tǒng)計(jì)學(xué)意義(P0.05),其他癥狀如疼痛、失眠、咳嗽、氣急等無統(tǒng)計(jì)學(xué)差異(P0.05)；生活質(zhì)量評(píng)估方面AG自身治療前后比較以及與PG比較差異有統(tǒng)計(jì)學(xué)意義(P0.05)。(5)針刺主要不良反應(yīng)有針刺疼痛、出血、瘀斑和心慌乏力,不良反應(yīng)發(fā)生機(jī)率小且癥狀非常輕微,未見嚴(yán)重不良反應(yīng)發(fā)生,依從性為81.1%；療效滿意度組間、兩組成對(duì)比較差異均有統(tǒng)計(jì)學(xué)意義(P0.05)。結(jié)論：本研究結(jié)果提示：1.針刺治療與甲地孕酮均可顯著提高癌性厭食惡病質(zhì)綜合征患者食欲,兩者療效相當(dāng),針刺具有起效迅速的特點(diǎn)。2.針刺治療能夠緩解癌癥厭食惡病質(zhì)綜合征患者營養(yǎng)惡化的趨勢(shì),能顯著改善其生活質(zhì)量、惡心和便秘癥狀。針刺對(duì)伴隨疲勞、失眠、焦慮、咳嗽、氣急等癥狀控制無效,不能逆轉(zhuǎn)患者體重下降。3.針刺改善癌性厭食惡病質(zhì)綜合征具有安全性好、依從性高和滿意度好,值得深入研究和臨床推廣。
[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.

【學(xué)位授予單位】：成都中醫(yī)藥大學(xué)
【學(xué)位級(jí)別】：博士
【學(xué)位授予年份】：2016
【分類號(hào)】：R246.5

【相似文獻(xiàn)】

相關(guān)期刊論文 前10條

1 崔廣奇;崔紅玉;曹志然;李月霞;;肝1號(hào)對(duì)荷瘤小鼠惡病質(zhì)綜合征影響的實(shí)驗(yàn)研究[J];中國現(xiàn)代醫(yī)生;2008年18期

2 馬婷;;癌癥食欲不振惡病質(zhì)綜合征從脾虛論治探討[J];中醫(yī)藥信息;2009年03期

3 王旭東;梁昱;;癌癥厭食惡病質(zhì)綜合征的研究進(jìn)展[J];實(shí)用醫(yī)學(xué)雜志;2008年16期

4 陳振東,張林杰;癌癥食欲不振/惡病質(zhì)綜合征發(fā)病機(jī)制及其治療的研究進(jìn)展[J];國外醫(yī)學(xué)(腫瘤學(xué)分冊(cè));1997年04期

5 張長征;;通降法治療癌癥厭食惡病質(zhì)綜合征驗(yàn)案舉隅[J];中醫(yī)藥臨床雜志;2013年10期

6 孟令占;童亞西;;晚期腫瘤惡病質(zhì)綜合征的中醫(yī)藥治療現(xiàn)狀[J];中國中醫(yī)急癥;2011年12期

7 虞群;心臟性惡病質(zhì)綜合征50例臨床分析[J];浙江醫(yī)學(xué);1998年07期

8 黃廣優(yōu);甲孕酮治療癌癥食欲不振/惡病質(zhì)綜合征20例[J];右江民族醫(yī)學(xué)院學(xué)報(bào);2001年01期

9 蔡紅兵,羅榮城,楊傳標(biāo),潘春華,左強(qiáng),王月剛;補(bǔ)中益氣湯治療癌癥食欲不振-惡病質(zhì)綜合征30例療效觀察[J];新中醫(yī);2003年03期

10 毛琳;心臟性惡病質(zhì)綜合征36例報(bào)告[J];醫(yī)學(xué)綜述;1996年05期

相關(guān)博士學(xué)位論文 前1條

1 趙朝庭;針刺改善癌性厭食惡病質(zhì)綜合征的臨床研究[D];成都中醫(yī)藥大學(xué);2016年

相關(guān)碩士學(xué)位論文 前1條

1 楊萬全;補(bǔ)腎填精法治療晚期癌癥厭食惡病質(zhì)綜合征的研究[D];廣州中醫(yī)藥大學(xué);2007年

，

本文編號(hào)：1386870