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地塞米松穴位注射減輕婦科腫瘤化療不良反應(yīng)前瞻性隨機(jī)對(duì)照研究

發(fā)布時(shí)間:2018-02-11 10:48

  本文關(guān)鍵詞: 穴位注射 地塞米松 足三里 婦科腫瘤 化療 不良反應(yīng) 出處:《第二軍醫(yī)大學(xué)》2014年碩士論文 論文類型:學(xué)位論文


【摘要】:研究目的:本研究采用前瞻性隨機(jī)對(duì)照臨床研究方法,評(píng)估婦科惡性腫瘤患者化療期間同步予地塞米松足三里穴位注射治療以減輕骨髓抑制及惡心、嘔吐等化療不良反應(yīng)的療效,同時(shí)觀察其對(duì)患者生存質(zhì)量的影響,以及安全性驗(yàn)證。 研究方法:本次臨床試驗(yàn)共收集病例77例,均為2013年01月至2014年01月就診于上海長(zhǎng)海醫(yī)院中醫(yī)婦科,符合納入標(biāo)準(zhǔn)的婦科惡性腫瘤患者。通過分層隨機(jī)方法分為治療組與對(duì)照組。治療組(37例)患者化療期間同步進(jìn)行足三里穴位注射地塞米松5mg,操作時(shí)間為每日上午7-9時(shí),連用三日;對(duì)照組(40例)采用安慰劑對(duì)照,穴位注射相同體積生理鹽水。所有患者在治療前均簽署知情同意書。比較兩組患者化療結(jié)束后骨髓抑制程度的差異,骨髓抑制率的不同,化療期間惡心嘔吐及不良反應(yīng)情況,并予患者進(jìn)行化療后MDASI癥狀量表評(píng)估。患者出院后進(jìn)行隨訪,記錄其化療后1周、2周、1月的血常規(guī)及骨髓抑制情況,通過QLQ-C30生存質(zhì)量量表,,比較患者化療前與化療1月后的生存質(zhì)量情況。 研究結(jié)果:(1)化療后骨髓抑制程度:患者化療后隔日復(fù)查血常規(guī),治療組與對(duì)照組比較骨髓抑制程度差異具有統(tǒng)計(jì)學(xué)意義,P<0.05;對(duì)各層患者的骨髓抑制率進(jìn)行相應(yīng)對(duì)比,2組比較差異無統(tǒng)計(jì)學(xué)意義,P≥0.05。共隨訪到43例患者,治療組23例,對(duì)照組20例。兩組隨訪患者化療后1周、2周、1月骨髓抑制程度,均無明顯統(tǒng)計(jì)學(xué)差異。(2)惡心:自化療日起,第1日兩組患者惡心程度無明顯差異,而第2-5日治療組與對(duì)照組的惡心程度差異則有明顯的統(tǒng)計(jì)學(xué)意義,P<0.01。且治療組第2-5日的惡心發(fā)生率也明顯低于對(duì)照組。(3)嘔吐:化療第2、3、4日治療組與對(duì)照組比較,嘔吐程度差異具有統(tǒng)計(jì)學(xué)意義(P<0.01),兩組的嘔吐發(fā)生率差異明顯。(4)MDASI癥狀評(píng)估量表:對(duì)比治療組與對(duì)照組化療后的各項(xiàng)癥狀評(píng)分,其中疲乏、睡眠不安、昏昏欲睡等3項(xiàng)差異具有統(tǒng)計(jì)學(xué)意義,P<0.05;而惡心、苦惱、胃口差、嘔吐等4項(xiàng),2組比較統(tǒng)計(jì)學(xué)差異明顯,P<0.01。(5)QLQ-C30生存質(zhì)量量表:對(duì)43例隨訪病人進(jìn)行各自的生存質(zhì)量前后對(duì)照,兩組患者各自治療前與化療后1月生存質(zhì)量差異均不存在統(tǒng)計(jì)學(xué)差異,P≥0.05。(6)不良反應(yīng):化療期間,除少部分患者出現(xiàn)便秘、血糖升高、血壓升高等,未出現(xiàn)其他明顯、嚴(yán)重的不良反應(yīng)。比較治療組與對(duì)照組患者在治療期間的不良反應(yīng)發(fā)生率,差異無明顯統(tǒng)計(jì)學(xué)意義。 研究結(jié)論:足三里穴位注射地塞米松與化療同步使用,能夠在減輕化療后骨髓抑制程度的同時(shí),防治化療所致的惡心嘔吐反應(yīng),改善患者圍化療期的生活質(zhì)量,且用藥安全,無明顯副作用。
[Abstract]:Objective: to evaluate the efficacy of simultaneous injection of dexamethasone at Zusanli acupoint during chemotherapy in patients with gynecological malignancy by prospective randomized controlled clinical study to reduce bone marrow suppression and nausea. The effect of adverse reactions such as vomiting on the quality of life (QOL) of patients and the safety verification were observed. Methods: a total of 77 cases were collected from January 2013 to January 2014 in Shanghai Changhai Hospital. Patients with gynecologic malignant tumors who met the inclusion criteria were randomly divided into treatment group (n = 37) and control group (n = 37). During chemotherapy, the patients were given simultaneous injection of dexamethasone at Zusanli acupoint at 5 mg, and the operating time was 7-9 am daily. In 3rd, 40 patients in the control group were treated with placebo, the same volume of normal saline was injected at the acupoint. All the patients signed informed consent before treatment. The difference of bone marrow suppression between the two groups after chemotherapy was compared. The difference of bone marrow suppression rate, nausea and vomiting during chemotherapy and adverse reactions were evaluated by MDASI symptom scale after chemotherapy. The patients were followed up after discharge to record their blood routine and bone marrow suppression in 1 week to 2 weeks after chemotherapy and January, respectively. The quality of life (QOL) of patients before chemotherapy was compared with that after January by QLQ-C30. Results: the degree of bone marrow suppression after chemotherapy: the patients' blood routine was reexamined every other day after chemotherapy. Compared with the control group, the degree of bone marrow suppression in the treatment group was significantly different from that in the control group (P < 0.05), and there was no significant difference in the bone marrow suppression rate between the two groups (P > 0.05). A total of 43 patients were followed up, 23 patients in the treatment group, 23 patients in the treatment group, and 23 patients in the treatment group. There was no significant difference in the degree of bone marrow depression between the two groups after one week of chemotherapy and two weeks after chemotherapy. There was no significant difference in the degree of nausea between the two groups since the day of chemotherapy, and on 1st, there was no significant difference in the degree of nausea between the two groups. The incidence of nausea in the treatment group was significantly lower than that in the control group on day 2-5 (P < 0.01). The incidence of nausea in the treatment group was also significantly lower than that in the control group (P < 0.01): the 2nd day of chemotherapy and the comparison between the treatment group and the control group in 4th, the incidence of nausea in the treatment group was significantly lower than that in the control group (P < 0.01). There was significant difference in the degree of vomiting between the two groups (P < 0.01). The incidence of vomiting was significantly different between the two groups (P < 0.01). The MDASI symptom evaluation scale (MDASI) was significantly different between the two groups. The scores of symptoms after chemotherapy were compared between the treatment group and the control group, in which fatigue and restlessness were observed. The difference of three items of lethargy was statistically significant (P < 0.05), while that of nausea, distress, poor appetite and vomiting was significantly different (P < 0.01. 05) QLQ-C30 quality of life (QQQC30) was compared with that of 43 patients followed up before and after follow-up. There was no significant difference in the quality of life between the two groups before treatment and January after chemotherapy (P 鈮

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