肺康颗粒对COPD稳定期肺肾亏虚证患者生存质量影响的临床研究

发布时间：2019-03-23 15:59

【摘要】：目的:观察评估肺康颗粒对COPD稳定期肺肾亏虚证患者中医证候积分、急性加重次数及程度、肺功能、生存质量及六分钟步行距离的影响,以进一步科学评判肺康颗粒对COPD稳定期的临床疗效。方法:本试验将符合纳入标准的COPD稳定期肺肾亏虚证患者随机分为肺康治疗组及对照组。对照组根据患者病情予以西医常规治疗,肺康治疗组在西医常规治疗基础上给予肺康颗粒冲服,疗程均为6个月。以治疗前、治疗3月、治疗6月为观测节点,观察两组中医证候积分、急性加重次数及程度、肺功能、圣乔治呼吸问卷(St.George Respiratory Questionnaire,SGRQ)、六分钟步行距离(Six Minutes Walking Distance,6MWD)的变化情况。结果:1.经SPSS 21.0统计学分析处理,两组患者一般资料包括年龄、性别、病程及病情严重程度等指标相比较,差异均无统计学意义(P0.05),具有可比性。2.对中医证候积分的影响:经重复测量方差分析显示,两组咳嗽、乏力、腰膝酸软症状积分及总积分的时间变化趋势组间比较,差别有统计学意义(P0.05)。肺康组各个症状积分及证候总分比较,治疗3个月比治疗前下降,差异有统计学意义(P0.016);治疗6个月与治疗前比较,除自汗积分外,其余症状积分下降均有统计学意义(P0.016);治疗6个月与治疗3个月对比,气短、乏力、腰膝酸软及证候总分差别有统计学意义(P0.016)。对照组治疗3个月与治疗前比较,除咳嗽、乏力外,其余症状改变均有统计学意义(P0.016),治疗6个月与治疗前比较,各症状积分改变均有统计学意义(P0.016),治疗6个月与治疗3个月对比,仅咯痰、易感冒及总分的差别具有统计学意义(P0.016)。在不同时点进行组间比较,治疗3月时,肺康组咳嗽、乏力、中医证候总分低于对照组,差异有统计学意义(P0.016);治疗6月时,肺康组咳嗽、乏力、腰膝酸软以及证候总分变化低于对照组,差异有统计学意义(P0.016)。3.对临床疗效的影响:治疗3月后肺康组总有效率为68.97%,对照组总有效率仅13.79%,治疗6月后肺康组总有效率达93.10%,而对照组有51.72%,尽管两组均能改善患者中医证候(P0.05),但对同一时点组间疗效进行对比,提示肺康组要胜过对照组(P0.05)。4.对肺功能的影响:经重复测量方差分析显示FEV1、FEV1%及FEV1/FVC的时间变化趋势没有组间差异(P0.05)。肺康组各项指标与治疗前比较有上升趋势,但差异无统计学意义,而西医对照组中各参数变化趋势不明显,但两组间各指标比较差异仍无统计学意义。5.对急性加重次数及程度的影响:治疗期间肺康组急性加重次数低于对照组,差异有统计学意义(P0.05),治疗期间两组急性加重程度比较,差异无统计学意义(P0.05)。6.对生存质量的影响:经重复测量方差分析显示,SGRQ总分、呼吸症状积分、活动受限积分及疾病影响积分的时间变化趋势没有组间的差异(P0.05)。各时间点上两组对比,治疗3月时两组间差异无统计学意义(P0.016),治疗6月时两组间差异有统计学意义(P0.016),肺康组改善更明显。肺康组在治疗3月和治疗6月后较治疗前改善,差异有统计学意义(P0.016),治疗6个月较治疗3个月改善,差异有统计学意义(P0.016);对照组治疗3个月和治疗6个月后均较治疗前有所改善,差异有统计学意义(P0.016),治疗6月与治疗3月比较无明显改善,差异无统计学意义(P0.016)。7.对六分钟步行距离的影响:经重复测量方差分析显示,6MWD的时间变化趋势组间差异不明显(P0.05)。肺康组治疗3月和治疗6月皆比治疗前显著提高,差异有统计学意义(P0.016),且治疗6月比治疗3月下降更明显,差异具有统计学意义(P0.016),对照组仅在治疗6月的时间结点上较基线水平上升(P0.016)。结论:1.肺康颗粒联合西医常规方案治疗COPD稳定期肺肾亏虚证患者与单纯西药治疗相比,能有效缓解COPD患者的症状表现,尤其在咳嗽、乏力、腰膝酸软等症状方面,缓解更明显。2.肺康颗粒能改善患者生存质量,减轻疾病对患者的影响。3.肺康颗粒一定程度上能延缓肺功能下降趋势、减少急性发作次数及提高日常活动能力。
[Abstract]:Objective: To evaluate the effect of Feikang granule on the syndrome of TCM syndrome, the number of times and the degree of acute exacerbation, the function of the lung, the quality of life and the distance of the six-minute walk in the patients with chronic obstructive pulmonary kidney deficiency of COPD, and to further study the clinical effect of Feikang granule on the stable period of COPD. Methods: The patients with lung and kidney deficiency of the stable period of COPD were randomly divided into the treatment group of the lung and the control group. The control group was treated by western medicine according to the condition of the patient, and the lung-kang treatment group was treated with the lung-kang granules on the basis of the routine treatment of western medicine, and the course of treatment was 6 months. The changes of the two groups of TCM syndrome, the number and degree of acute exacerbation, the lung function, the St. George's Respiratory Questionnaire (SGRQ) and the six-minute walk distance (6MWD) were observed. Results:1. The data of the two groups, including age, sex, course of course and severity of the disease, were not statistically significant (P0.05). The effect of the integration of the syndrome of TCM syndrome: The results of variance analysis showed that there was a significant difference between the two groups of cough, weakness, soft symptom of the waist and knees and the time of total integration (P0.05). The total score of the symptoms and the total score of the symptoms in the treatment group was lower than that of the treatment before treatment (P.016), and the total score of the other symptoms decreased after 6 months (P.016). Compared with the treatment for 3 months, the difference of the total score of short, weak, and soreness of the waist and knees and the total score of the syndrome in the treatment for 6 months was of statistical significance (P.016). The control group was compared with the treatment before and after the treatment for 3 months, except for cough and weakness, the rest of the symptoms were statistically significant (P0.05). The treatment was compared with the treatment before the treatment for 6 months, and the integral change of each symptom was statistically significant (P.016), and the treatment for 6 months was compared with the treatment for 3 months, and only the sputum was obtained. The difference of common cold and total score was of statistical significance (P.016). In the treatment of 3 months, the total score of cough, weakness and TCM syndrome in the lung-kang group was lower than that of the control group at the time of the treatment for 3 months (P.016). In the treatment of June, the total score of cough, weakness, soreness of the waist and knees and the total score of the syndrome was lower than that of the control group. The difference was significant (P0.05). The total effective rate of the treatment group was 68.97% in the treatment group, the total effective rate of the control group was 13.79%, the total effective rate of the lung and kang group was 93.10% after June, and 51.72% in the control group, although both groups could improve the TCM syndrome of the patients (P0.05). However, the curative effect of the group was compared with that of the control group (P0.05). Effects on lung function: The time trend of FEV1, FEV1% and FEV1/ FVC was shown to be no difference between groups (P0.05). The indexes of the lung-kang group were higher than that before treatment, but there was no significant difference in the difference between the two groups, but there was no significant difference between the two groups. The number and degree of acute exacerbations: the number of acute exacerbations of the lung in the treatment period was lower than that of the control group (P <0.05), and the difference between the two groups in the treatment period was not statistically significant (P0.05). The effect of variance analysis of variance, the total score of SGRQ, the integral of respiratory symptoms, the limited integral of the activity and the time of the disease-affected integration was not significantly different between the groups (P0.05). There was no significant difference between the two groups at each time point (P 0.016), and the difference between the two groups was statistically significant at the end of June (P0.05). In the treatment of 3-month and 6-month treatment, the treatment of the lung-kang group was improved and the difference was statistically significant (P0.05). The control group was treated for 3 months and the treatment for 6 months, and the difference was improved. There was no significant difference in the difference between the treatment of June and the treatment in March, and there was no significant difference in the difference (P.016). The effect of six-minute walk distance: The variance of 6MWD was not significant between the two groups (P0.05). The treatment of the patients with Feikang group was significantly higher than that in the treatment group (P.016), and the treatment for June was more obvious than that of the treatment in March. The difference was of statistical significance (P.016). The control group only increased from the baseline in the time node of the treatment for June (P.016). Conclusion:1. Compared with the traditional western medicine, the patients with the lung-kidney-deficiency syndrome in the stable period of COPD can effectively relieve the symptoms of the patients with COPD, especially in the symptoms of cough, weakness, soreness of the waist and knees, and the like. Feikang granule can improve the quality of the patient's life and reduce the influence of the disease on the patient. Feikang granule can delay the function of the lung function to a certain extent, reduce the number of acute attack and improve the daily activity.
【学位授予单位】：广州中医药大学
【学位级别】：硕士
【学位授予年份】：2017
【分类号】：R563.9

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