在所有的受詴者中並沒有發現在血液與尿液常規、肝腎與凝血功能等 生化檢查於治療前後有異常變化的情形， 其中包括了一位輕微腎功能不 佳的患者(creatinine 1.7mg/dl (0.7- 1.4) )。 在使用槐花散與安慰劑治療的 患者中各有一位敘述非特異性的副作用包括服藥後10 分鐘會有倦怠頭暈 的現象，但都迅速消除，受詴者當時血壓心跳並無明顯變化。
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管通透性，凝血機轉與淋巴血流壓力獲得改善有關(Szlavy, Repa et al.
1990; Mentes, Gorgul et al. 2001)。
至於服用藥物去治療痔瘡， 目前文獻可以搜尋到的有MPFF(an oral micronized flavonoid compound (Daflon ， Les Laboratoires Servier， Gidy， France)(Wadworth and Faulds 1992; Cospite 1994;
Godeberge 1994; Meyer 1994; Buckshee, Takkar et al. 1997; Ho and Seow-Choen 2000; Misra and Parshad 2000; La Torre and Nicolai 2004) 與Dobesilate(Szlavy, Repa et al. 1990; Mentes, Gorgul et al. 2001) 兩種。 至於中藥或槐花散則並沒有較完整或證據等級較高的文獻探討。 的調整應是很容易被接受的(Misra and Imlitemsu 2005)。 目前證據醫學針 對痔瘡 流血 的保 守治 療建 議是 增加纖 維攝取 避免 便秘 (Alonso-Coello, Guyatt et al. 2005)而肛門不適與搔癢則可以坐浴來緩解(Shafik 1993) 至於口服藥物， 在Daflon與Dobesilate等藥物之外，我們提供一個新的
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結論
從這一個臨床詴驗， 我們觀察到使用槐花散在保守藥物治療基礎 上去處理有症狀的痔瘡的確是傾向有效而安全的， 而對於防止痔瘡流血 再復發的成效最明顯。 使用此非侵犯性，接受度高的口服藥物治療， 能 得到比傳統治療更有助益的成果。
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參考文獻
Alonso-Coello, P., G. Guyatt, et al. (2005). "Laxatives for the treatment of hemorrhoids." Cochrane Database Syst Rev(4): CD004649.
BACKGROUND: Symptomatic hemorrhoids are a common medical condition, which increase in prevalence in women during pregnancy and postpartum. Although the evidence appears to be inconclusive, narrative reviews and clinical practice guidelines recommend the use of laxatives (and fiber) for the treatment of hemorrhoids and relief of symptoms. This is due to their safety and low cost. OBJECTIVES: To evaluate the impact of laxatives on a wide range of symptoms in people with symptomatic hemorrhoids. SEARCH STRATEGY: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 2, 2005), MEDLINE (1966 to 2005), EMBASE (1980 to 2005), CINAHL (1982 to 2005), BIOSIS, and AMED (Allied and Alternative Medicine Database), for eligible trials (including conference proceedings).
We sought missing and additional information from authors, industry, and experts in the field.
SELECTION CRITERIA: We selected all published and unpublished randomised controlled trials that compared any type of laxative to placebo or no therapy in any patient population. DATA COLLECTION AND ANALYSIS: Two authors independently screened studies for inclusion and retrieved all potentially relevant studies. Data were extracted from studies that met
31
our selection criteria on study population, intervention used, pre-specified outcomes, and methodology. We extracted methodological information for the assessment of internal validity:
existence and method of generation of the randomization schedule, and method of allocation concealment; blinding of caregivers and outcomes assessors; numbers of and reasons for participants lost to follow up; and use of validated outcome measures. MAIN RESULTS: Seven randomised trials enrolling a total of 378 participants to fiber or a non-fiber control were identified. Meta-analyses using random-effects models showed that laxatives in the form of fiber had a beneficial effect in the treatment of symptomatic hemorrhoids. The risk of not improving hemorrhoids and having persisting symptoms decreased by 53% in the fiber group (risk reduction (RR) 0.47, 95% CI 0.32 to 0.68). These results are compatible with large treatment effects regarding prolapse, pain, itching, although the pooled analyses showed a tendency toward no-effect for these parametres. The effect on bleeding showed a significant difference in favour of the fiber (RR 0.50, 95% CI 0.28 to 0.89). Studies including data on multiple follow ups (usually after six weeks and three months) showed consistent results over time.
However, we have to stress two possible limitations of this review: the risk of publication bias, and only moderate study quality. AUTHORS' CONCLUSIONS: The
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use of fiber shows a consistent beneficial effect for relieving overall symptoms and bleeding in the treatment of symptomatic hemorrhoids.
Broader, J. H., I. F. Gunn, et al. (1974). "Evaluation of a bulk-forming evacuant in the management of haemorrhoids." Br J Surg 61(2): 142-4.
Buckshee, K., D. Takkar, et al. (1997). "Micronized flavonoid therapy in internal hemorrhoids of pregnancy." Int J Gynaecol Obstet 57(2): 145-51.
OBJECTIVE: To assess the safety, efficacy and acceptability of a micronized flavonoid formulation in the treatment of internal hemorrhoids of pregnancy.
METHODS: In an open study on hospital outpatients, we studied therapy with micronized diosmin 90% and hesperidin 10% for a median of 8 weeks before delivery and 4 weeks after delivery, in 50 women with acute hemorrhoids. The outcome measures were symptoms and signs of hemorrhoids; adverse effects; and acceptability of treatment. RESULT: On intention to treat analysis, 66% (95% confidence interval, range 79.1-52.9) had relief from acute symptoms by the 4th day; 53.6% (95% confidence interval, range 70-37.1, P < 0.001) fewer patients had relapse in the antenatal period. Treatment was well accepted, and did not affect pregnancy, fetal development, birth weight, infant growth and feeding. CONCLUSION: In the short term, micronized diosmin 90% and hesperidin 10% is
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safe, acceptable, and effective in the treatment of hemorrhoids of pregnancy.
Cospite, M. (1994). "Double-blind, placebo-controlled evaluation of clinical activity and safety of Daflon 500 mg in the treatment of acute hemorrhoids."
Angiology 45(6 Pt 2): 566-73.
One hundred patients with a history of hemorrhoidal disease and suffering from an acute hemorrhoidal attack were randomized into two parallel groups and treated with Daflon 500 mg* (D500) or placebo (PL) under double-blind conditions. Daflon 500 mg was administered at the dosage of three tablets bid the first four days and two tablets bid the following three days. Overall improvement of symptoms was greater in the D500 group than in the PL group, from D2 up to D7. The clinical severity of proctorrhagia, anal discomfort, pain, and anal discharge diminished in both groups but to a greater extent in the D500 group (P < 0.001 for all parameters except protorrhagia, P = 0.006). Inflammation, congestion, edema, and prolapse were more markedly improved in the D500 group than in the PL group. Duration and severity of the current hemorrhoidal episode, as assessed by patient self-evaluation, were less important in the D500 group as compared with previous episodes. Use of analgesics and topical medications diminished in both groups, with a major reduction in the D500 group from D4 (P < 0.001). Acceptability was
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good in both groups: no patient experienced major side effects. In summary, treatment with D500 resulted in a quicker and more pronounced relief of signs and symptoms of acute hemorrhoids than with the placebo.
Godeberge, P. (1994). "Daflon 500 mg in the treatment of hemorrhoidal disease: a demonstrated efficacy in comparison with placebo." Angiology 45(6 Pt 2):
574-8.
Hemorrhoidal disease (HD) is a trophic disorder of the anal canal characterized by recurrent, self-resolving acute episodes. The author reports the results of a double-blind, placebo-controlled trial of the efficacy of Daflon 500 mg in the treatment of acute and chronic symptoms of hemorrhoids. One hundred and twenty outpatients (54 men, 66 women) suffering from an acute episode of HD during the previous two months were included. They received Daflon 500 mg (group D, n = 60) or placebo (group P, n = 60) two tablets daily for two months.
The patients were examined at entry (T0) and at two months (T2). At T0, the two groups did not differ in terms of age, sex, weight, height, history of symptoms of HD; 7 patients were excluded from analysis because of treatment failure (group D, n = 2; group P, n = 3), or lost to follow-up (group P, n = 2). In group D, 40% of patients had an attack during the trial with a mean duration of 2.6 days and
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a mean severity of 1.1 scored on a scale from 1 to 3. These values were significantly different (P <
0.01) from the corresponding values in the P group:
70%, 4.6 days and 1.6 respectively. Each symptom and sign was scored on a scale of severity. The overall symptom score, scored from 0 to 15, decreased from 6.6 (group D) and 6.1 (group P) (NS) to 1.1 and 4.0 respectively (P < 0.01) at the end of treatment.(ABSTRACT TRUNCATED AT 250 WORDS)
Haas, P. A., T. A. Fox, Jr., et al. (1984). "The pathogenesis of hemorrhoids." Dis Colon Rectum 27(7):
442-50.
The structure of the anal canal was examined in histology slides. Hemorrhoids are normal features of the human anatomy. They are pads that bulge into the lumen. Hemorrhoids have three parts: 1) the lining, which can be mucosa or anoderm; 2) the stroma with blood vessels, smooth muscle, and supporting connective tissue; and 3) the anchoring connective tissue system, which secures the hemorrhoids to the internal sphincter and the conjoined longitudinal coat. The anchoring and supporting connective tissue system deteriorates with aging. The hemorrhoids not only bulge, but descend into the lumen. This becomes observable in the third decade of life, with individual differences. The veins become distended as they lose their support. The descended loose lining becomes more sensitive to pressure from
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straining and to trauma from the stool. There can be a stasis in the veins, with clot formations and swelling, or erosions of the lining, with bleeding.
The hemorrhoids become symptomatic.
Hansen, H. H. (1976). "[The importance of the Musculus canalis ani for continence and anorectal diseases (author's transl)]." Langenbecks Arch Chir 341(1):
23-37.
The functional morphology of the M. canalis ani is described. Hitherto this muscle has not been studied in detail. The M. canalis ani is located inside of the M. sphincter ani internus and reaches through the spatium submucosum et subcutaneum of the analcanal.
This muscle is part of a described "organ of continence". Its importance in the course of anorectal disease is shown.
Ho, Y. H. and F. Seow-Choen (2000). "Randomized clinical trial of micronized flavonoids in the early control of bleeding from acute internal haemorrhoids." Br J Surg 87(12): 1732-3.
La Torre, F. and A. P. Nicolai (2004). "Clinical use of micronized purified flavonoid fraction for treatment of symptoms after hemorrhoidectomy: results of a randomized, controlled, clinical trial." Dis Colon Rectum 47(5): 704-10.
PURPOSE: The aim of this study was to evaluate if the
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combination of micronized purified flavonoid fraction with short-term routine antibiotic and anti-inflammatory therapy was better at reducing the intensity of postoperative symptoms and wound bleeding after a Milligan-Morgan's open hemorrhoidectomy than antibiotic and anti-inflammatory treatment alone. METHODS: Fifty patients were randomly assigned to receive routine antibiotic and anti-inflammatory treatment alone (control patients) or a combination of micronized purified flavonoid fraction with identical antibiotic and anti-inflammatory treatment (micronized purified flavonoid fraction patients).
The evolution of symptoms (pain, tenesmus, pruritus, and bleeding) during the postoperative period was assessed by means of patients' self-questionnaires.
Each symptom was scored on a graded severity scale from 0 to 3, daily during the first three days of the immediate postoperative period, then at regular intervals (about every 14 days) until postoperative day 60. A global score for evaluation of each postoperative symptom and bleeding was used. The global score for each symptom was the sum of scores for each patient over the study period. The global score for each symptom was compared between the two groups with the Mann-Whitney U test. RESULTS: No significant differences in age, gender distribution, and stage of disease between the two groups were noticed at baseline. Posthemorrhoidectomy symptoms
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were relieved more rapidly in the micronized purified flavonoid fraction group; during the first three postoperative days, the global score for each symptom was significantly more reduced in the micronized purified flavonoid fraction group. The global scores for each symptom are as follows: pain after 3 days, 6.16 (SD = 1.9) in the control group vs. 3.48 (SD = 1.8) in the micronized purified flavonoid fraction group (P < 0.0001); tenesmus, 5.36 (SD = 1.8) in the control group vs. 1.48 (SD = 1.5) in the micronized purified flavonoid fraction group (P < 0.0001);
pruritus, 4.04 (SD = 1.9) in the control group vs.
1.84 (SD = 1.4) in the micronized purified flavonoid fraction group (P < 0.0001); bleeding, 4.4 (SD = 2.1) in the control group vs. 2.0 (SD = 1.3) in the micronized purified flavonoid fraction group (P <
0.0001). A significant difference (P < 0.0001) between groups was also shown in favor of micronized purified flavonoid fraction patients when global scores were calculated over the entire study period (60 days). CONCLUSION: Micronized purified flavonoid fraction used in combination with short-term antibiotic and anti-inflammatory treatment can reduce both the duration and extent of postoperative symptoms and wound bleeding following hemorrhoidectomy.
Lestar, B., F. Penninckx, et al. (1989). "The composition of anal basal pressure. An in vivo and in vitro study
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in man." Int J Colorectal Dis 4(2): 118-22.
The maximal anal basal pressure (MABP) was measured with probes of 0.3, 1, 2 and 3 cm diameter in 21 subjects, 60 years old, without anal pathology. The components of MABP were analyzed by inducing a maximal internal sphincter (IS) relaxation, taking pressure measurements in the conscious state and during narcosis with curarization. In seven cases pressure measurements were done on isolated anorectum after abdominoperineal rectum amputation.
MABP increases with probe diameter before as well as during anaesthesia with curarization. The contribution of the striated sphincter tonic activity is constant within the range of probe diameters used. At rest, i.e. when the 0.3 cm diameter pressure recording probe is used, 30% of MABP is made up by striated sphincter tonic activity, 45% of it is due to nerve induced IS activity, 10% to purely myogenic IS activity and 15% can be attributed to the expansion of the haemorrhoidal plexuses. Although MABP is mainly based on active forces generated by the smooth and striated sphincter apparatus, the presence of the anal cushions is essential for perfect anal continence, as they have to fill the gap within the IS ring to hermetically close the anal canal. The global IS activity, contributing 50-60%
of MABP at rest, can completely be inhibited by a maximal rectoanal inhibitory reflex. Stretching of passive elements starts at 1 cm anal distension, but
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steeply increases thereafter, accounting for 65% of the MABP at 3 cm anal distension. It is deduced that optimal stool diameter is about 2 cm.
Loder, P. B., M. A. Kamm, et al. (1994). "Haemorrhoids:
pathology, pathophysiology and aetiology." Br J Surg 81(7): 946-54.
Haemorrhoidal disease is the consequence of distal displacement of the anal cushions, which are normal structures with an important role in continence. The causes of haemorrhoidal disease are unknown;
constipation and abnormal bowel habit are commonly blamed despite largely contrary evidence. The most consistently demonstrated physiological abnormality is an increased maximum resting anal pressure. Most evidence points to this being a secondary phenomenon rather than the cause of haemorrhoidal disease. Among the many unexplored areas are the function of the longitudinal muscle in relation to haemorrhoidal disease, the description and pharmacological responsiveness of the anal subepithelial muscle, and the clinical role of specific pharmacological agents that might reverse some of the observed physiological changes.
Mentes, B. B., A. Gorgul, et al. (2001). "Efficacy of calcium dobesilate in treating acute attacks of hemorrhoidal disease." Dis Colon Rectum 44(10):
1489-95.
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PURPOSE: A randomized, double-blind, controlled study was conducted to investigate the efficacy of oral calcium dobesilate therapy in treating acute attacks of internal hemorrhoids. METHODS:
Twenty-nine well-documented adult patients with first- or second-degree internal hemorrhoids were treated with calcium dobesilate for two weeks, while16 patients received only a high-fiber diet to serve as control. Both symptoms and anoscopic inflammation were scored on a scale from 0 to 2 before (T0) and two weeks after treatment (T2). RESULTS: A success rate of 86.21 percent with cessation of bleeding plus lack of severe anitis anoscopically at two weeks were achieved with calcium dobesilate. The pretreatment symptom score of 2 fell significantly to 0.45 +/- 0.13, and the pretreatment anitis score of 1.69 +/- 0.09 fell to 0.55 +/- 0.12 at T2 (P = 0.0001 for both comparisons). The symptom and anoscopic inflammation scores obtained with calcium dobesilate treatment were also significantly better than those with diet only (P = 0.0017 and P = 0.0013, respectively). CONCLUSION: Together with recommendations about diet and bowel discipline, oral calcium dobesilate treatment provides an efficient, fast, and safe symptomatic relief from acute symptoms of hemorrhoidal disease. This symptomatic healing is associated with a significant improvement in the anoscopically observed inflammation.
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Meyer, O. C. (1994). "Safety and security of Daflon 500 mg in venous insufficiency and in hemorrhoidal disease." Angiology 45(6 Pt 2): 579-84.
Daflon 500 mg is a new flavonoid vasoprotector venotonic agent whose active principle is micronized and contains 90% diosmin and 10% flavonoids expressed as hesperidin. In animal studies, the safety of Daflon 500 mg is shown by an LD50 (lethal dose 50) of more than 3 g/kg, ie, 180 times the daily therapeutic dose, as well as by the absence of any toxic effect after repeated oral dosing for thirteen and twenty-six weeks, using a dose representing 35 times the daily dosage, in the rate and primate.
Daflon 500 mg has no mutagenic action nor any significant effect on reproductive function.
Gastrointestinal tolerance is good when administered orally in the rat. Transplacental passage and passage into breast milk are minimal. In the rat, 0.003% of the administered dose has been found in each fetus and 1% in breast milk. Clinical trials fulfill international scientific requirements and have collected more than 2850 patients treated with Daflon 500 mg at the dosage of two tablets per day for six weeks to one year. The proportion of patients with side effects (10% of those treated), essentially of a gastrointestinal or autonomic nature and leading to a rate of only 1.1% trial dropouts, is less than described in 225 patients given a placebo (13.9%) in
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controlled trials. Satisfactory clinical acceptability already confirmed in the short term was equally found in long-term treatment. Hemodynamic parameters (systolic and diastolic blood pressure) as well as laboratory parameters (hematology, liver and renal function, metabolic) were uninfluenced even by prolonged treatment for one year at the dosage of two tablets per day.(ABSTRACT TRUNCATED AT 250 WORDS)
Misra, M. C. and Imlitemsu (2005). "Drug treatment of haemorrhoids." Drugs 65(11): 1481-91.
Drug treatment for various anorectal conditions has been known since ancient times. Today, modern as well as traditional drugs are being increasingly used in all grades of symptomatic haemorrhoids. These drugs (oral and local) are used as a part of conservative management or as an adjuvant to invasive outpatient procedures. Flavonoids, in the new formulation of micronised purified flavonoid fraction (MPFF) or as part of the ancient traditional medicine derivative of the Ginkgo tree, are used for relief of acute symptoms (for control of bleeding and re-bleeding in all grades of haemorrhoids). MPFF has been recommended for control of acute bleeding in patients waiting for a definitive outpatient treatment.
Similarly, better known drugs such as calcium dobisilate (used in diabetic retinopathy and chronic venous insufficiency), nitrates and nifedipine have
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also been effective and well tolerated in the medical
also been effective and well tolerated in the medical