Jiang Zhu-Ming, Cao Jin-Duo
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100730, China.
Curr Med Res Opin. 2006 Jun;22(6):1141-7. doi: 10.1185/030079906X104803.
To evaluate the efficacy and the tolerability of micronized purified flavonoid fraction (MPFF) on symptoms and signs of acute haemorrhoidal disease (HD).
Patients experiencing an acute HD episode for less than 48 h were enrolled in this randomized, double-blind, placebo-controlled study (n = 90 in two hospital-based study centres in Beijing). One group received MPFF, six tablets per day for 4 days followed by four tablets per day for 3 days and the other a placebo. Symptoms and signs of HD were assessed by blinded observers at day 0 (D0), day 4 (D4), and day 7 (D7) on a 4-point severity grading scale (from 1 = absent to 4 = severe). A two-way variance analysis was performed for comparison between groups.
Forty-nine patients (49) in the MPFF group and 41 in the placebo group (mean age 43.2 years [range 18-76 years]), percentage of male gender 54.4%, mean time from onset of acute episode 45.3 h (range 16-48 h) were included in this analysis. No significant differences between groups were seen at baseline in terms of age, gender, and frequency and intensity of symptoms, except for oedema, whose frequency and severity was significantly greater in the MPFF group (p = 0.024). During the 7-day treatment, there was a significant difference in favour of MPFF in the evolution of pain and oedema (p < or = 0.001 at D7) and in bleeding (p = 0.021 at D4, and p = 0.047 at D7). The appreciation of global efficacy by patients (p = 0.007) or investigators (p = 0.006) also favoured MPFF. Blood pressure, heart rate and laboratory parameters remained within normal ranges and were not modified during the study in either group. No patient had to stop the treatment owing to adverse events and only one patient reported gastrointestinal discomfort.
MPFF significantly reduced the extent of pain and bleeding in the selected subjects of this study with acute haemorrhoids. The tolerability was similar in patients receiving MPFF to that in patients receiving a placebo during the 7-day duration of the treatment.MPFF can be considered an effective and well-tolerated agent in the treatment of acute episodes of haemorrhoids.
评估微粉化纯化黄酮类化合物（MPFF）对急性痔病（HD）症状和体征的疗效及耐受性。
纳入急性HD发作少于48小时的患者，进行这项随机、双盲、安慰剂对照研究（北京两个医院研究中心共90例）。一组接受MPFF，每天6片，服用4天，随后每天4片，服用3天；另一组接受安慰剂。由盲法观察者在第0天（D0）、第4天（D4）和第7天（D7），采用4级严重程度分级量表（从1 = 无到4 = 严重）评估HD的症状和体征。进行双向方差分析以比较组间差异。
MPFF组纳入49例患者，安慰剂组纳入41例患者（平均年龄43.2岁[范围18 - 76岁]），男性比例54.4%，急性发作开始后的平均时间为45.3小时（范围16 - 48小时）。除水肿外，两组在年龄、性别、症状频率和强度方面基线时无显著差异，MPFF组水肿的频率和严重程度显著更高（p = 0.024）。在7天治疗期间，MPFF在疼痛和水肿的改善方面（第7天p≤0.001）以及出血方面（第4天p = 0.021，第7天p = 0.047）有显著优势。患者（p = 0.007）或研究者（p = 0.006）对总体疗效的评价也更倾向于MPFF。两组患者的血压、心率和实验室参数均保持在正常范围内，且在研究期间未发生变化。没有患者因不良事件而停止治疗，仅有1例患者报告有胃肠道不适。
在本研究中，MPFF显著减轻了急性痔患者的疼痛和出血程度。在7天治疗期间，接受MPFF治疗的患者与接受安慰剂治疗的患者耐受性相似。MPFF可被认为是治疗急性痔发作的一种有效且耐受性良好的药物。
