督灸联合四神丸治疗腹泻型肠易激综合征脾肾阳虚证的疗效观察

Observation on the Curative Effect of Du-moxibustion Combined with Sishen Pill(四神丸)in the Treatment of Diarrhea Type Irritable Bowel Syndrome with Spleen Kidney Yang Deficiency Syndrome

目的:探讨督灸联合四神丸治疗腹泻型肠易激综合征脾肾阳虚证的临床疗效。方法:将189例腹泻型肠易激综合征脾肾阳虚证患者随机分为对照组(47例)、四神丸组(47例)、督灸组(47例)与四神丸配合督灸组(48例)。对照组患者予常规西医治疗,四神丸组患者予常规西医+四神丸治疗,督灸组患者予常规西医+督灸治疗,四神丸配合督灸组患者予常规西医+督灸+四神丸治疗,均连续治疗4周。观察治疗前后中医证候积分、大便性状评分、每天排便次数、10 d内大便急迫时间,检测治疗前后血清血管活性肠肽(VIP)、5-羟色胺3受体(5-HT3R)水平变化情况,评价临床疗效并观察安全性。结果:4组患者治疗后中医证候积分、大便性状评分、血清VIP水平及血清5-HT3R水平均低于治疗前(P<0.05),且四神丸组、督灸组、四神丸配合督灸组患者治疗后中医证候积分、大便性状评分、血清VIP水平及血清5-HT3R水平均低于对照组(P<0.05),四神丸配合督灸组患者治疗后中医证候积分、大便性状评分、血清VIP水平及血清5-HT3R水平低于四神丸组、督灸组(P<0.05)。4组患者治疗后每天排便次数、10 d内大便急迫时间均少于治疗前(P<0.05),且四神丸组、督灸组、四神丸配合督灸组治疗后每天排便次数、10 d内大便急迫时间均少于对照组(P<0.05),四神丸配合督灸组患者治疗后每天排便次数、10 d内大便急迫时间均少于四神丸组、督灸组(P<0.05)。四神丸组患者治疗后中医证候积分、大便性状评分、每天排便次数、10 d内大便急迫时间、血清VIP水平及血清5-HT3R水平与督灸组比较,差异均无统计学意义(P>0.05)。对照组总有效率为70.21%(33/47),四神丸组总有效率为80.85%(37/47),督灸组总有效率为78.72%(37/48),四神丸配合督灸组患者总有效率为97.92%(47/48);四神丸配合督灸组总有效率高于对照组、四神丸组、督灸组(P<0.01);对照组总有效率与四神丸组、督灸组比较,差异无统计学意义(P>0.05);四神丸组总有效率与督灸组比较,差异无统计学意义(P>0.05)。治疗期间,4组均未见明显不良事件。结论:在西医常规治疗基础上,应用督灸联合四神丸治疗腹泻型肠易激综合征脾肾阳虚证患者,可明显缓解其临床症状,降低其血清VIP、5-HT3R水平,提升治疗效果,且安全性高。

Objective: To investigate the clinical effect of Du-moxibustion combined with Sishen Pill in the treatment of diarrhea predominant irritable bowel syndrome with spleen and kidney Yang deficiency type. Methods:189 cases of diarrhea predominant irritable bowel syndrome with spleen and kidney Yang deficiency type were randomly divided into control group(47 cases), Sishen Pill group(47 cases), Du-moxibustiongroup(47 cases) and Sishen Pill combined with Du-moxibustiongroup(48 cases). The control group was treated with conventional western medicine treatment, and the Sishen Pill group was treated with conventional western medicine and Sishen Pill treatment, and the Du-moxibustiongroup was treated with conventional western medicine and Du-moxibustion treatment, and Sishen Pill combined with Du-moxibustion group was treated with conventional western medicine, Du-moxibustion and Sishen Pill treatment, and all patients were treated for 4 weeks. The traditional Chinese medicine(TCM) syndrome scores, stool character scores, daily defecation frequency and urgency of defecation in 10 days before and after treatment were observed, and the levels of serum vasoactive intestinal peptide(VIP) and 5-hydroxytryptamine-3 receptor(5-HT3R) before and after treatment were measured, and the clinical efficacy was evaluated and the safety was observed. Results: The TCM syndrome scores, stool character scores, serum VIP and 5-HT3R levels of the four groups after treatment were lower than those before treatment(P <0.05), and the TCM syndrome scores, stool character scores, serum VIP and 5-HT3R levels of the Sishen Pill group, Du-moxibustion group and Sishen Pill combined with Du-moxibustion group after treatment were lower than those in the control group(P<0.05). The TCM syndrome scores, stool character scores, serum VIP and 5-HT3R levels of the Sishen Pill combined with Du-moxibustion group after treatment were lower than those in the Sishen Pill group and Du-moxibustion group(P<0.05). The number of defecation per day and the number of urgent days of defecation within 10 days in the four groups after treatment were less than before treatment(P<0.05).The number of defecation per day and the number of urgent days of defecation within 10 days in the Sishen Pill group, Du-moxibustion group and Sishen Pill combined with Du-moxibustion group after treatment were less than those in control group(P<0.05), and the number of defecation per day and the number of urgent days of defecation within 10 days in the Sishen Pill combined with Du-moxibustion group after treatment were less than those in the Sishen Pill group and Du-moxibustion group(P<0.05). There was no significant difference in TCM syndrome score, stool character score, daily defecation frequency, the number of urgent days of defecation within 10 days and serum VIP and 5-HT3R levels after treatment between the Sishen Pill group and Du-moxibustion group(P>0.05). The total effective rate in the control group was 70.21%(33/47), and the total effective rate in the Sishen pill group was 80.85%(37/47), and the total effective rate in the Du moxibustion group was 78.72%(37/48), and the total effective rate in the Sishen pill combined with Du moxibustion group was 97.92%(47/48).The total effective rate of Sishen pill combined with Du moxibustion group was higher than that of control group, Sishen pill group and Du moxibustion group(P<0.01). Compared the total effective rate of control group between the Sishen Pill group and Du-moxibustiongroup, there was no significant difference(P>0.05). There was no significant difference in the total effective rate between the Sishen Pill group and Du-moxibustion group(P>0.05). During the treatment, there was no obvious adverse events occurred in the four groups. Conclusion: On the basis of conventional treatment of western medicine, the application of Du-moxibustion combined with Sishen Pill in the treatment of patients with spleen and kidney Yang deficiency type of diarrhea predominant irritable bowel syndrome can significantly alleviate the clinical symptoms, reduce the levels of serum VIP and 5-HT3R,and improve the treatment effect, with high safety.