行气润肠法治疗便秘型肠易激综合征的临床研究
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摘要
研究目的：
通过规范、科学的临床试验,观察行气润肠法治疗便秘型肠易激综合征的临床疗效、安全性及远期疗效。
研究方法：
选取符合纳入标准的患者60例,随机分为试验组30例,对照组30例,对照组有1例脱落。试验组患者服用行气润肠方,每日1剂,分两次煎服,每次煎取200ml,早、晚餐后1-2小时温服。对照组给予聚乙二醇4000散剂(福松),每次10g,每日2次,溶于一大杯水中后口服。试验组及对照组均以4周为一疗程。疗程结束后进行临床疗效比较、安全性项目观察；停药1月后进行远期疗效比较。
研究结果：
1、试验组30例中,临床痊愈9例,显效11例,有效8例,无效2例,愈显率66.67%,总有效率为93.33%；对照组29例中,临床痊愈3例,显效8例,有效10例,无效8例,愈显率37.93%,总有效率为70.00%。经Wilcoxon秩和检验,试验组和对照组相比有显著统计学差异(Z=-2.625,P=0.009<0.01)。说明试验组的总体临床疗效优于对照组。
2、试验组对腹痛或腹部不适、腹部作胀、大便性状、大便天数、排便不畅、排便不尽感、粘液便、口干欲饮均有明显改善(P<0.05),对照组除口干欲饮外,其余症状均有明显改善(P<0.05),且试验组对腹痛或腹部不适、大便性状、大便天数、口干欲饮的改善程度优于对照组(P<0.05),对腹部作胀、排便不畅、排便不尽感、粘液便的改善程度与对照组相当(P>0.05)。
3、试验组对腹部作胀、腹痛或腹部不适、排便不尽感的起效时间快于对照组(P<0.05)；试验组对大便性状、大便次数、排便不畅、粘液便的起效时间与对照组无差异(P>0.05)。
4、在观察过程中,两组均未发现明显的不良反应。
5、停药1个月后随访,试验组远期疗效优于对照组(P<0.05)。
结论：行气润肠法能有效消除或改善便秘型肠易激综合征患者临床症状并具有良好的安全性及远期疗效。
Objectives:To observe the clinical effects in treating the Irritable bowel syndrome with constipation caused by Qi stagnation, intestinal dryness by the method of Xing Qi Run Chang.
Methods:This research was based on 60 cases of outpatients with Qi stagnation, intestinal dryness and were randomly divided into two groups. One group was the treatment group,30 patients of which were treated with Xing Qi Run Chang Fang. The other group was the control group, with 30 patients being treated with Macrogol 4000 powder for oral solution, but 1 case fell off. These patients all met the diagnosis criterion. Both groups were treated for four weeks. The changes of clinical symptoms before and after treatment and after one month of untreatment were detected respectively to evaluate the therapeutic effects, safety inspection and long-term clinical efficacy.
Results:
1. In the treatment group,9 cases recovered and 11 cases significantly improved,8 cases improved,2 ineffectual cases. The total effective rate in the treatment group is 93.33%.In the control group 3 cases recovered and 8 cases significantly improved,10 cases improved,8 ineffectual cases. The total effective rate in the control group is 70.00%. There is a significant difference in the total effective rate between the treatment group and control guoup in the statistics (P=0.009<0.01).The effective rate from the treatment group is clearly superior.
2. The efficacy of the treatment group is improved obviously in abdominal distension, abdominal pain, defecation state, stool frequency, defecate impeded, unsatisfied feeling of defecation, mucous stool and dry mouth(P<0.05), and the control group, except dry mouth, the rest are obviously improve symptoms (P<0.05); The degree of improvement about the treatment group is better than the control group in abdominal pain, defecation state, stool frequency and dry mouth (P<0.05), and is equivalent to the control group in abdominal distension, defecate impeded, unsatisfied feeling of defecation and mucous stool (P>0.05)
3. The time of Xing Qi Run Chang Fa on alleviating the abdominal distension, abdominal pain unsatisfied feeling of defecation is faster than Macrogol 4000 powder for oral solution(P<0. 05). But is same in defecation state, stool frequency, defecate impeded and mucous stool (P>0.05)
4. In the observation, the two groups were not found significant side effects.
5. After one month of untreatment, the long-term clinical efficacy of the treatment group is better than the control group's(P<0.01).
Conclusions:Xing Qi Run Chang Fa has the significant, safe and good long-term clinical efficacy in the treating the irritable bowel syndrome with constipation caused by Qi stagnation, intestinal dryness.
通过规范、科学的临床试验,观察行气润肠法治疗便秘型肠易激综合征的临床疗效、安全性及远期疗效。
研究方法：
选取符合纳入标准的患者60例,随机分为试验组30例,对照组30例,对照组有1例脱落。试验组患者服用行气润肠方,每日1剂,分两次煎服,每次煎取200ml,早、晚餐后1-2小时温服。对照组给予聚乙二醇4000散剂(福松),每次10g,每日2次,溶于一大杯水中后口服。试验组及对照组均以4周为一疗程。疗程结束后进行临床疗效比较、安全性项目观察；停药1月后进行远期疗效比较。
研究结果：
1、试验组30例中,临床痊愈9例,显效11例,有效8例,无效2例,愈显率66.67%,总有效率为93.33%；对照组29例中,临床痊愈3例,显效8例,有效10例,无效8例,愈显率37.93%,总有效率为70.00%。经Wilcoxon秩和检验,试验组和对照组相比有显著统计学差异(Z=-2.625,P=0.009<0.01)。说明试验组的总体临床疗效优于对照组。
2、试验组对腹痛或腹部不适、腹部作胀、大便性状、大便天数、排便不畅、排便不尽感、粘液便、口干欲饮均有明显改善(P<0.05),对照组除口干欲饮外,其余症状均有明显改善(P<0.05),且试验组对腹痛或腹部不适、大便性状、大便天数、口干欲饮的改善程度优于对照组(P<0.05),对腹部作胀、排便不畅、排便不尽感、粘液便的改善程度与对照组相当(P>0.05)。
3、试验组对腹部作胀、腹痛或腹部不适、排便不尽感的起效时间快于对照组(P<0.05)；试验组对大便性状、大便次数、排便不畅、粘液便的起效时间与对照组无差异(P>0.05)。
4、在观察过程中,两组均未发现明显的不良反应。
5、停药1个月后随访,试验组远期疗效优于对照组(P<0.05)。
结论：行气润肠法能有效消除或改善便秘型肠易激综合征患者临床症状并具有良好的安全性及远期疗效。
Objectives:To observe the clinical effects in treating the Irritable bowel syndrome with constipation caused by Qi stagnation, intestinal dryness by the method of Xing Qi Run Chang.
Methods:This research was based on 60 cases of outpatients with Qi stagnation, intestinal dryness and were randomly divided into two groups. One group was the treatment group,30 patients of which were treated with Xing Qi Run Chang Fang. The other group was the control group, with 30 patients being treated with Macrogol 4000 powder for oral solution, but 1 case fell off. These patients all met the diagnosis criterion. Both groups were treated for four weeks. The changes of clinical symptoms before and after treatment and after one month of untreatment were detected respectively to evaluate the therapeutic effects, safety inspection and long-term clinical efficacy.
Results:
1. In the treatment group,9 cases recovered and 11 cases significantly improved,8 cases improved,2 ineffectual cases. The total effective rate in the treatment group is 93.33%.In the control group 3 cases recovered and 8 cases significantly improved,10 cases improved,8 ineffectual cases. The total effective rate in the control group is 70.00%. There is a significant difference in the total effective rate between the treatment group and control guoup in the statistics (P=0.009<0.01).The effective rate from the treatment group is clearly superior.
2. The efficacy of the treatment group is improved obviously in abdominal distension, abdominal pain, defecation state, stool frequency, defecate impeded, unsatisfied feeling of defecation, mucous stool and dry mouth(P<0.05), and the control group, except dry mouth, the rest are obviously improve symptoms (P<0.05); The degree of improvement about the treatment group is better than the control group in abdominal pain, defecation state, stool frequency and dry mouth (P<0.05), and is equivalent to the control group in abdominal distension, defecate impeded, unsatisfied feeling of defecation and mucous stool (P>0.05)
3. The time of Xing Qi Run Chang Fa on alleviating the abdominal distension, abdominal pain unsatisfied feeling of defecation is faster than Macrogol 4000 powder for oral solution(P<0. 05). But is same in defecation state, stool frequency, defecate impeded and mucous stool (P>0.05)
4. In the observation, the two groups were not found significant side effects.
5. After one month of untreatment, the long-term clinical efficacy of the treatment group is better than the control group's(P<0.01).
Conclusions:Xing Qi Run Chang Fa has the significant, safe and good long-term clinical efficacy in the treating the irritable bowel syndrome with constipation caused by Qi stagnation, intestinal dryness.
引文
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