补中益气汤治疗气虚型慢性功能性便秘的疗效研究
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摘要
目的:
     观察补中益气汤治疗气虚型慢性功能性便秘的临床疗效。
     方法:
     采用前瞻性RCT研究方法,将符合纳入标准的78例气虚型慢性功能性便秘患者随机分为2组,对照组38例,采用乳果糖口服治疗,治疗组40例,采用补中益气汤口服治疗,治疗时间均为3个月。2组治疗前后分别进行便秘评估及相关伴随症状评分,以周排便频率达到1-2d/次的实际病例数、便秘症状积分、伴随症状积分和综合疗效积分作为疗效判定指标进行评价。2组治疗前后的结果用统计学方法分析和处理,并进行组内、组间叫的比较。
     结果:
     主要结局指标(大便频率):治疗3个月后周排便频率达到1-2d/次的实际病例数分别是:对照组26例,治疗组32例,2组间比较差异无统计学意义(P>0.05)。次要结局指标(评分表):①便秘症状评分:治疗组评分减少(9.95±2.23)分(P<0.05),对照组评分减少(8.24±2.79)分(P<0.05);2组间比较P>0.05,2组改善便秘症状疗效无明显差异。治疗组总有效率95.0%,对照组总有效率94.7%,两组总有效率比较无明显差异(P>0.05)。②伴随症状评分:治疗组评分减少(22.83±4.91)分(P<0.05),对照组评分减少(7.68±6.28)分(P<0.05);2组间比较P<0.05,治疗组改善便秘伴随症状疗效明显优于对照组。治疗组总有效率100.0%,对照组总有效率42.1%,治疗组总有效率明显优于对照组(P<0.05)。综合疗效评价:治疗组综合疗效总有效率为100%,对照组综合疗效总有效率为68.4%,治疗组综合疗效总有效率明显优于对照组(P<0.05)。
     结论:
     补中益气汤治疗气虚型慢性功能性便秘疗效确切,改善患者便秘症状可媲美乳果糖,改善患者相关伴随症状及其临床综合疗效明显优于乳果糖。
Objective
     To Observe the clinical curative effect on treatment of chronic functional constipation of qi asthenia by buzhong yiqi tang.
     Methods
     The Prospective RCT research method was adopted in the present study and a total of78patients with chronic functional constipation of qi asthenia which were randomized into2groups. The control group (n=38) was treated with Lactulose Oral. Therapeutic group (n=40) was treated by buzhong yiqi tang. Period of treatment was3months. Constipation symptoms score and other concomitant symptoms score were evaluated before and after treatment of the2groups. The actual number of patients whose defecation frequency per week was up to1or2days per time, the score of constipation symptoms, the score of other concomitant symptoms, and the integrative score of symptoms after the treatment were recorded and evaluated. The2groups pretherapy and post-treatment consequence were compared between interclass and intragroup separately, the results were analyzed and treated using statistical methods.
     Results
     Main outcome index (Defecate frequency):The actual number of patients whose defecation frequency per week was up to1or2days per time after3months:control group (n=26), therapeutic group (n=32);The2groups were not statistically significant difference (P>0.05). The secondary outcome index (rating scale):①Score of constipation symptoms:therapeutic group rating reduce (9.95±2.23)(P<0.05), control group reduce (9.95±2.23)(P<0.05). Comparison among groups (P>0.05), the2groups were not statistically significant difference. Total effective rate (ORR):therapeutic group was95.0%, control group was94.7%, the2groups were not statistically significant difference in improving constipation symptoms (P>0.05).②Score of other concomitant symptoms:therapeutic group rating reduce (22.84±4.91)(P<0.05), control group reduce (7.68±6.28)(P<0.05). Comparison among groups (P<0.05), the2groups were statistically significant difference. Total effective rate (ORR):therapeutic group was100.0%but control group was42.1%, therapeutic group was better than control in improving other concomitant symptoms of constipation symptoms (P<0.05). Evaluation of comprehensive curative effect Total effective rate (ORR) of therapeutic group was100.0%, Total effective rate (ORR) of control group was68.4%, the2groups were statistically significant difference (P>0.05), therapeutic group was better than control in improving total therapeutic effect.
     Conclusion
     It was definite superior effect that treatment of chronic functional constipation of qi asthenia by buzhong yiqi tang. It could rival Lactulose that Buzhong yiqi tang improved constipation symptoms, and it had better effects on the other concomitant symptoms with constipation and clinical comprehensive effect than Lactulose.
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