地塞米松穴位注射减轻妇科肿瘤化疗不良反应前瞻性随机对照研究

发布时间：2018-02-11 10:48

  本文关键词： 穴位注射 地塞米松 足三里 妇科肿瘤 化疗 不良反应　出处：《第二军医大学》2014年硕士论文　论文类型：学位论文

【摘要】：研究目的：本研究采用前瞻性随机对照临床研究方法，评估妇科恶性肿瘤患者化疗期间同步予地塞米松足三里穴位注射治疗以减轻骨髓抑制及恶心、呕吐等化疗不良反应的疗效，同时观察其对患者生存质量的影响，以及安全性验证。 研究方法：本次临床试验共收集病例77例，均为2013年01月至2014年01月就诊于上海长海医院中医妇科，符合纳入标准的妇科恶性肿瘤患者。通过分层随机方法分为治疗组与对照组。治疗组（37例）患者化疗期间同步进行足三里穴位注射地塞米松5mg，操作时间为每日上午7-9时，连用三日；对照组（40例）采用安慰剂对照，穴位注射相同体积生理盐水。所有患者在治疗前均签署知情同意书。比较两组患者化疗结束后骨髓抑制程度的差异，骨髓抑制率的不同，化疗期间恶心呕吐及不良反应情况，并予患者进行化疗后MDASI症状量表评估。患者出院后进行随访，记录其化疗后1周、2周、1月的血常规及骨髓抑制情况，通过QLQ-C30生存质量量表，，比较患者化疗前与化疗1月后的生存质量情况。 研究结果：（1）化疗后骨髓抑制程度：患者化疗后隔日复查血常规，治疗组与对照组比较骨髓抑制程度差异具有统计学意义，P＜0.05；对各层患者的骨髓抑制率进行相应对比，2组比较差异无统计学意义，P≥0.05。共随访到43例患者，治疗组23例，对照组20例。两组随访患者化疗后1周、2周、1月骨髓抑制程度，均无明显统计学差异。（2）恶心：自化疗日起，第1日两组患者恶心程度无明显差异，而第2-5日治疗组与对照组的恶心程度差异则有明显的统计学意义，P＜0.01。且治疗组第2-5日的恶心发生率也明显低于对照组。（3）呕吐：化疗第2、3、4日治疗组与对照组比较，呕吐程度差异具有统计学意义（P＜0.01），两组的呕吐发生率差异明显。（4）MDASI症状评估量表：对比治疗组与对照组化疗后的各项症状评分，其中疲乏、睡眠不安、昏昏欲睡等3项差异具有统计学意义，P＜0.05；而恶心、苦恼、胃口差、呕吐等4项，2组比较统计学差异明显，P＜0.01。（5）QLQ-C30生存质量量表：对43例随访病人进行各自的生存质量前后对照，两组患者各自治疗前与化疗后1月生存质量差异均不存在统计学差异，P≥0.05。（6）不良反应：化疗期间，除少部分患者出现便秘、血糖升高、血压升高等，未出现其他明显、严重的不良反应。比较治疗组与对照组患者在治疗期间的不良反应发生率，差异无明显统计学意义。 研究结论：足三里穴位注射地塞米松与化疗同步使用，能够在减轻化疗后骨髓抑制程度的同时，防治化疗所致的恶心呕吐反应，改善患者围化疗期的生活质量，且用药安全，无明显副作用。
[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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