Gao Wen-yan, Wang Chang-hong, Lin Yi-fan
Department of Traditional Chinese Medine, the General Hospital of Shenyang Military Region, Shenyang 110016.
Zhongguo Zhong Xi Yi Jie He Za Zhi. 2010 Jan;30(1):13-7.
To verify the efficacy of Jianpi Tiaogan Wenshen Recipe (JTWR) in treating diarrhea-predominant irritable bowel syndrome (IBS-D) and to analyze its therapeutic mechanism through observing the effect of JTWR on clinical symptoms and rectal sensibility in patients.
With a prospective, randomized controlled trial adopted, 80 patients with IBS-D were assigned randomly equally and to two groups. The treatment group was treated with JTWR, and the control group was treated with pinaverium bromide tablet (PVB), all for four weeks. Patients' symptoms, such as abdominal discomfort, pain, and distension; frequency of defecation; appearance of stool; and occurrence of tenesmus were recorded before and after treatment by scoring, and the rectal sensitivity was detected as well. Patients with therapeutic effect of cured and markly effective were followed up four weeks after withdrawal of medication.
Three cases in the treatment group and four cases in the control group were dropped. Except the appearing of mucus stool, no statistically significant difference was shown between the two group in all other symptoms, either at before or after treatment; but the end point scores of individual symptoms between pre- and post-treatment were different statistically in both groups (P<0.05). Per-protocol population set (PPS) analysis on comprehensive effect showed that the total effective rate and the cure rate in the treatment group was 81.1% (30/37) and 24.3% (9/37), and those in the control group, 80.6% (29/36) and 19.4% (7/36) respectively; while the full analysis set (FAS) showed a result of 80.0% (32/40) and 22.5% (9/40) vs 77.5% (31/40) and 17.5% (7/40) respectively, all with insignificant difference between groups (P>0.05). Follow-up study showed that relapse or aggravation of disease occurred in four cases in the treatment group and 12 in the control group respectively, showing significant difference between groups (P<0.01). Rectal sensitivity examination showed that the rectal thresholds of sensation, defecation, and maximum tolerable volume were improved in both groups after treatment (P<0.05), but showed no significant difference between groups (P>0.05).
JTWR is effective in treating IBS-D, with the effect better than PVB in improving mucus stool, also in the remote effect. Its therapeutic mechanism is possibly by way of adjusting the sensitivity of rectum.
验证健脾调肝温肾方（JTWR）治疗腹泻型肠易激综合征（IBS-D）的疗效，并通过观察JTWR对患者临床症状及直肠敏感性的影响，分析其治疗机制。
采用前瞻性随机对照试验，将80例IBS-D患者随机均分为两组。治疗组给予JTWR治疗，对照组给予匹维溴铵片（PVB）治疗，疗程均为4周。记录治疗前后患者腹部不适、疼痛、腹胀等症状、排便频率、大便性状及里急后重的发生情况并进行评分，同时检测直肠敏感性。对治疗后疗效为治愈和显效的患者停药4周后进行随访。
治疗组脱落3例，对照组脱落4例。除黏液便出现情况外，两组治疗前后其他各症状比较差异均无统计学意义；但两组各单项症状治疗前后终点评分差异均有统计学意义（P<0.05）。符合方案集（PPS）分析综合疗效显示，治疗组总有效率和治愈率分别为81.1%（30/37）和24.3%（9/37），对照组分别为80.6%（29/36）和19.4%（7/36）；意向性分析集（FAS）结果分别为80.0%（32/40）和22.5%（9/40）对77.5%（31/40）和17.5%（7/40），组间差异均无统计学意义（P>0.05）。随访研究显示，治疗组有4例病情复发或加重，对照组有12例，组间差异有统计学意义（P<0.01）。直肠敏感性检查显示，两组治疗后直肠感觉阈值、排便阈值及最大耐受容量均有改善（P<0.05），但组间比较差异无统计学意义（P>0.05）。
JTWR治疗IBS-D有效，在改善黏液便方面疗效优于PVB，远期疗效亦较好。其治疗机制可能是通过调节直肠敏感性实现的。
