Efficacy of Mesalazine in the Treatment of Symptomatic Diverticular Disease

We aimed to improve symptoms by means of mesalazine in symptomatic colonic diverticular disease patients. One hundred seventy outpatients (98 M, 72 F; age, 67.1 years; range, 39–84 years) were assigned to four different schedules: rifaximin, 200 mg bid (Group R1: 39 pts), rifaximin, 400 mg bid (Group R2: 43 pts), mesalazine, 400 mg bid (Group M1: 40 pts), and mesalazine, 800 mg bid (Group M2: 48 pts), for 10 days per month. At baseline and after 3 months we recorded 11 clinical variables (upper/lower abdominal pain/discomfort, bloating, tenesmus, diarrhea, abdominal tenderness, fever, general illness, nausea, emesis, dysuria), scored from 0 = no symptoms to 3 = severe. The global symptomatic score was the sum of all symptom scores. After 3 months in all schedules but Group R1, 3 of the 11 symptoms improved (P < 0.03); the global score decreased in all groups but Group R1 (P < 0.0001). Mesalazine-treated patients had the lowest global score at 3 months (P < 0.001). Mesalazine is as effective as rifaximin (higher dosage schedule) for diminishing some symptoms, but it appears to be better than rifaximin for improving the global score in those patients.This work was carried out under the auspices of the Roberto Farini Foundation for Gastroenterological Research.     

Prevention of Complications and Symptomatic Recurrences in Diverticular Disease with Mesalazine: A 12-Month Follow-up

In uncomplicated diverticular disease, treatment is aimed at relieving symptoms. The aim of the present study was to evaluate the efficacy of mesalazine for symptomatic relief of uncomplicated diverticular disease of the colon. Two hundred sixty-eight consecutive eligible outpatients (122 male, 146 female; age, 66.1 years; range, 31–81 years) were enrolled in four treatment schedules in a randomized fashion: Group R1 (66 patients), rifaximin, 200 mg bid; Group R2 (69 patients), rifaximin, 400 mg bid; Group M1 (67 patients), mesalazine, 400 mg bid; and Group M2 (66 patients), mesalazine, 800 mg bid. Treatments were administered for 10 days every month for 12 months. Clinical evaluations were performed at admission and at 3-month intervals for 12 months considering 12 clinical variables (upper and lower abdominal pain/discomfort, tenesmus, diarrhea, abdominal tenderness, fever, bloating, general illness, nausea, emesis, dysuria, bleeding) graded as 0 = no symptoms, 1 = mild, 2 = moderate, and 3 = severe. The Global Symptomatic Score (GSS) was calculated using the sum of each symptom score. Two hundred forty-four patients completed the 12- month study; 24 were discontinued (14 treated with rifaximin and 10 treated with mesalazine) either as voluntary dropouts or because they developed side effects and/or complications. Group M2 demonstrated a lower frequency of many symptoms after 6 and 12 months of treatment; the mean GSS was significantly lower in Group M2 after 6 and 12 months of therapy by both intention-to-treat and per-protocol analyses. Patients treated with mesalazine (Groups M1+M2) had a lower GSS than subjects treated with rifaximin (Groups R1+R2) during the 12-month follow-up period. We conclude that cyclic administration of mesalazine is effective for symptomatic relief of uncomplicated diverticular disease of the colon. Some symptoms showed greater improvement with mesalazine, 800 mg bid, than with the other treatment schedules.     

Rifaximin improves symptoms of acquired uncomplicated diverticular disease of the colon

BACKGROUND AND AIMS: We examined the efficacy of cyclic long-term administration of rifaximin, a broad spectrum, poorly absorbable antibiotic, in obtaining symptom relief in a large series of patients with uncomplicated diverticular disease, and compared the incidence of episodes of diverticulitis in the group treated with rifaximin to that in a group receiving fiber supplementation only. PATIENTS AND METHODS: In a multicenter, prospective, open trial, 968 outpatients with uncomplicated symptomatic diverticular disease were randomized to either fiber supplementation with 4 g/day glucomannan plus 400 mg rifaximin twice daily for 7 days every month ( n=558) or 4 g/day glucomannan alone ( n=346). Clinical evaluation was performed on admission and at 4-month intervals for 12 months. RESULTS: After 12 months the group treated with glucomannan + rifaximin showed fewer symptoms (abdominal pain/discomfort, bloating, tenesmus, diarrhea, abdominal tenderness) and a lower global symptomatic score. Overall 56.5% of the patients treated with glucomannan + rifaximin and 29.2% of those treated with glucomannan alone were asymptomatic at 12 months ( P<0.001). The rate of complications (diverticulitis and rectal bleeding) was 1.34% in the rifaximin + glucomannan group and 3.22% in the glucomannan alone group ( P<0.05). CONCLUSION: Cyclic administration of rifaximin is effective in obtaining symptom relief in uncomplicated diverticular disease of the colon. The incidence of episodes of diverticulitis in the group treated with rifaximin was lower than that in the group treated with glucomannan alone.     

One year intermittent rifaximin plus fibre supplementation vs. fibre supplementation alone to prevent diverticulitis recurrence: A proof-of-concept study

BackgroundEvidence supporting appropriate medical therapy to prevent recurrence of colonic diverticulitis is limited. Our goal was to evaluate the potential of rifaximin given periodically in addition to fibre for the prophylaxis of recurrences.MethodsWe conducted a multicentre, randomized, open controlled study in patients with a recent episode of colonic diverticulitis, currently in remission. Patients received 3.5 g of high-fibre supplementation b.d. with or without one week per month of the non-absorbable antibiotic rifaximin (400 mg b.d.) for 12 months. Primary endpoint was recurrence of diverticulitis, encompassing acute symptomatic flare with or without complications, analyzed by multivariable logistic regression analysis and by Cox proportional hazard method.ResultsAfter randomizing 165 patients, the study was interrupted since the recruitment rate was largely below the minimum anticipated, and the trial was switched from evidence-gathering to proof-of-concept. Recurrences occurred in 10.4% of patients given rifaximin plus fibres vs. 19.3% of patients receiving fibres alone. The logistic analysis adjusted for sex, age, illness duration, time from last episode, disease localization and centre recruitment rate, yielded a significant treatment effect (odds ratio 3.20; 95% confidence interval: 1.16–8.82; P = 0.025). Patients with diverticulitis diagnosed since ≥1 year receiving rifaximin also had a lower incidence of recurrences (10%; 95% confidence interval: 2–47% vs. 67%; 95% confidence interval: 37–100%). Both treatments were safe.ConclusionsThis study represents a proof-of concept of the efficacy of cyclic rifaximin treatment, added to fibre supplements, to reduce the risk of recurrences of diverticulitis in patients in remission.     

Intermittent treatment with mesalazine in the prevention of diverticulitis recurrence: a randomised multicentre pilot double-blind placebo-controlled study of 24-month duration

Background and aim

Recurrence of diverticulitis is frequent within 5 years from the uncomplicated first attack, and its prophylaxis is still unclear. We have undertaken a multicentre, randomised, double-blind, placebo-controlled pilot study in order to evaluate the role of mesalazine in preventing diverticulitis recurrence as well as its effects on symptoms associated to diverticular disease.

Methods

Ninety-six patients with the recent first episode of uncomplicated diverticulitis were randomised to receive mesalazine 800 mg twice daily for 10 days every month or placebo for 24 months. The primary efficacy end point was the diverticulitis recurrence at intention to treat analysis. Clinical evaluations were performed using the Therapy Impact Questionnaire (TIQ) for physical condition and quality of life at admission and at 3-month intervals. Treatment tolerability and routine biochemistry parameters as well as the use of additional drugs were also evaluated.

Results

Ninety-two patients (mean age, 61.5) completed the study, 45 of whom received mesalazine, and 47, placebo. Diverticulitis relapse incidence in mesalazine-treated group was 5/45 (11 %) at the 12th month and 6/45 (13 %) at the 24th month; in the placebo-treated group, the correspondent rates were 13 % (6/47) and 28 % (13/47), respectively. Mean values of TIQ at 24 months were significantly better in mesalazine-treated group than in placebo-treated group (p?=?0.02); in addition, average additional drug consumption was significantly lower (?20.4 %, p?<?0.03) in mesalazine than in placebo.

Conclusions

Diverticulitis recurrence occurred in as many as 28 % of patients under placebo within 24 months from the initial episode. Intermittent prophylaxis with mesalazine did not significantly reduce the risk of relapse but induced a significant improvement of patients' physical conditions and significantly lowered the additional consumption of other gastrointestinal drugs.     

A randomized double-blind placebo-controlled trial of rifaximin in patients with abdominal bloating and flatulence

AIMS: To study the efficacy of rifaximin, a nonabsorbable antibiotic, in relieving chronic functional symptoms of bloating and flatulence. METHODS: Randomized double-blind placebo-controlled trial consisting of three 10-day phases: baseline (phase 1), treatment with rifaximin 400 mg b.i.d. or placebo (phase 2), and post-treatment period (phase 3). Primary efficacy variable was subjective global symptom relief at the end of each phase. A symptom score was calculated from a symptom diary. Lactulose H2-breath test (LHBT) was performed at baseline and end of study. RESULTS: One hundred and twenty-four patients were enrolled (63 rifaximin and 61 placebo). Baseline characteristics were comparable and none had an abnormal baseline LHBT. Rome II criteria were met in 58.7% and 54.1%, respectively. At the end of phase 2, there was a significant difference in global symptom relief with rifaximin versus placebo (41.3% vs 22.9%, p = 0.03). This improvement was maintained at the end of phase 3 (28.6% vs 11.5%, p = 0.02). Mean cumulative and bloating-specific scores dropped significantly in the rifaximin group (p < 0.05). Among patients with IBS, a favorable response to rifaximin was noted (40.5% vs 18.2%; p = 0.04) persisting by the end of phase 3 (27% vs 9.1%; p = 0.05). H2-breath excretion dropped significantly among rifaximin responders and correlated with improvement in bloating and overall symptom scores (p = 0.01). No adverse events were reported. CONCLUSIONS: Rifaximin is a safe and effective treatment for abdominal bloating and flatulence, including in IBS patients. Symptom improvement correlates with reduction in H2-breath excretion. Future trials are needed to examine the efficacy of long-term or cyclic rifaximin in functional colonic disorders.     

Long-term treatment with mesalazine in patients with symptomatic uncomplicated diverticular disease

The aim of this work was to compare the recurrence of diverticulitis during a 5-year follow-up in a population of patients affected by symptomatic uncomplicated diverticular disease (SUDD), taking either 800 mg of mesalamine b.i.d for 10 days every month or no 5-ASA. Sixty-seven consecutive patients affected by SUDD followed-up every 6 months for 5 years. All patients in this group (M-group) were requested to consume mesalamine 800 mg b.i.d for 10 days every month. A control group (C-group) of 82 subjects with SUDD allocated in an institution for the elderly and taking no 5-ASA medications was also followed-up for the same period. As a result in the M-group 14.9% of patients did not complete the follow-up, and diverticulitis developed in two patients (4%; 95% CI 1.1–13.5). In the C-group 6.1% patients did not complete the follow-up, and diverticulitis developed in 8 patients (10.4%; 95% CI 5.4–19.2). The difference between the two groups was not significant (difference = −6.4%; 95% CI −15.6 to 4.3; log rank test: p = 0.1256). Cyclic treatment with mesalazine seems to be clinical, although not statistically effective in reducing the incidence of diverticulitis. In future well-designed RCTs are necessary to demonstrate the therapeutic gain of the use of mesalazine, if any, in the management of patients with SUDD.     

Retrospective cross‐sectional pilot study of rifaximin dosing for the prevention of recurrent hepatic encephalopathy

Standard treatment for hepatic encephalopathy (HE) includes medications that reduce ammonia and bacterial translocation in the gut. Rifaximin can be used off‐label for the reduction of overt HE. The study purpose was to determine efficacy of traditional rifaximin dosing (400 mg three times daily) compared with newer dosing (550 mg twice daily) via readmission rates for the prevention of recurrent HE. This was a retrospective, observational, cross‐sectional pilot study conducted in a tertiary medical center. A total of 226 patients 18–89 years of age with documentation of HE via ICD‐9 code who started rifaximin therapy while inpatient between April 2009 and June 2014 were evaluated. Data collected included rifaximin dosing, other medications used to treat HE, duration of therapy, time to readmission, and various laboratory values. There were no differences in readmission rates at 30 days, 60 days, or 6 months between treatment groups. Additionally, there was no difference in the odds of readmission between the treatment groups (OR = 0.77, 95% CI: [0.201, 4.365], P = 0.718). Patients had a low overall probability of readmission over the observational period. Based on average wholesale price data, the cost for a 9‐day supply of rifaximin for the 400‐mg dosing regimen is $952.56 versus $605.16 for the 550‐mg dosing regimen. The rifaximin 550‐mg dosing strategy should be utilized in hospitalized patients for the prevention of recurrent HE as there was no difference in readmission rate or time to readmission between dosing groups. The 550‐mg regimen had a lower acquisition cost for a 9‐day duration of treatment in the studied institution.     

Continuous Versus Cyclic Mesalazine Therapy for Patients Affected by Recurrent Symptomatic Uncomplicated Diverticular Disease of the Colon

Forty consecutive patients affected by recurrent attacks of symptomatic uncomplicated diverticular disease of the colon were evaluated to investigate the effectiveness of 2 different mesalazine therapeutic schedules in preventing recurrence of the disease. The patients were randomly enrolled and treated with mesalazine 1.6 g/d (group A) or mesalazine 1.6 g/d 10 days per month (group B). Thirty-four patients completed the study (85%): 3 (7.5%, 1 in group A and 2 in group B) were lost to follow-up, 2 (5%, both group B) were withdrawn from the study for protocol violation, and 1 (2.5%) for hospital admission for stroke (group A). Twenty-three patients (67.65%) were symptom free after 24 months of treatment (overall symptomatic score, 0): 14 of 18 in group A (per-protocol, 77.78%; intention to treat, 70% [95% confidence interval [CI], 61.5–91.8]), 9 of 16 in group B (per protocol, 56.25%; intention to treat, 45% [95% CI, 61.5–91.8]; P < 0.05). Four patients (10%) improved, but were not completely symptom free. Six patients (15%) showed recurrence of symptoms: 1 in group A (5.56%) and 5 in group B (31.25%; P < 0.005; overall symptomatic score, 68). Daily mesalazine supplying seems to be more effective than cyclic supplying in maintaining remission in recurrent symptomatic uncomplicated diverticular disease.     

Effects of killing Helicobacter pyloriquadruple therapy on peptic ulcer： A randomized double-blind clinical trial

AIM: To study the therapeutic efficacy of a Chinese and Western integrated regimen, killing Helicobacter pylori quadruple therapy on H pylori-associated peptic ulcers (PU). METHODS: With prospective and double-blind controlled method, seventy-five active PU patients with H pylori infection were randomized to receive one of the following three regimens: (1) new triple therapy (group A: lansoprazole 30 mg qd, plus clarithromycin 250 mg bid, plus amoxycillin 500 mg tid, each for 10 d); (2) killing Hp quadruple therapy(group B: the three above drugs plus killing H pylori capsule 6 capsules bid for 4 wk) and (3) placebo(group C: gastropine 3 tablets bid for 4 wk). H pylori eradication and ulcer healing quality were evaluated under an endoscope 4 wk after treatment. The patients were followed up for 5 years. RESULTS: Both the healing rate of PU and H pylori eradication rate in group B were significantly higher than those in group C (100% and 96.4% vs20% and 0%, respectively,P<0.005), but there was no significant difference compared to those in group A (88% and 92%, P>0.05). The healing quality of ulcer in group B was superior to that in groups C and A (P<0.05). The recurrence rate of PU in group B (4%) was lower than that in group A (10%) and group C (100%,P<0.01). CONCLUSION: Killing Helicobacter pylori quadruple therapy can not only promote the eradication of H pylori and healing quality of ulcer but also reduce recurrence rate of ulcer.     

Assessment of small intestinal bacterial overgrowth in uncomplicated acute diverticulitis of the colon

AIM: Small intestinal bacterial overgrowth (SIBO) may contribute to the appearance of several gastrointestinal nonspecific symptoms. Acute diverticulitis is affected by some similar symptoms and bacterial colonic overgrowth. We assessed the prevalence of SIBO in acute uncomplicated diverticulitis and evaluated its influence on the clinical course of the disease. METHODS: We studied 90 consecutive patients (39 males, 51 females, mean age 67.2 years, range 32-91 years). Sixty-one patients (67.78%) and 29 patients (32.22%) were affected by constipation-or diarrhea-prevalent diverticulitis respectively. All subjects were investigated by lactulose H_2-breath test at the entry and at the end of treatment. We also studied a control group of 20 healthy subjects (13 males, 7 females, mean age 53 years, range 22-71 years). RESULTS: Oro-cecal transit time (OCTT) was delayed in 67/90 patients (74.44%) (range 115-210 min, mean 120 min). Fifty-three of ninety patients (58.88%) showed SIBO, while OCTT was normal in 23/90 patients (25,56%). In the control group, the mean OCTT was 88.2 min (range 75-135 min). The difference between diverticulitic patients and healthy subjects was statistically significant (P＜0.01). OCTT was longer in constipation-prevalent disease than in diarrheaprevalent disease [180.7 min (range 150-210 min) vs 121 min (range 75-180 min) (P＜0.001)], but no difference in bacterial overgrowth was found between the two forms of diverticulitis.After treatment with rifaximin plus mesalazine for 10d, followed by mesalazine alone for 8 wk, 70 patients (81.49%) were completely asymptomatic, while 16 patients (18.60%) showed only slight symptoms. Two patients (2.22%) had recurrence of diverticulitis, and two other patients (2.22%) were withdrawn from the study due to side-effects. Seventy-nine of eighty-six patients (91.86%) showed normal OCTT (range 75-105 min, mean 83 min), while OCTT was longer, but it was shorter in the remaining seven (8.14%) patients (range 105-115 min, mean of 110 min). SIBO was eradicated in all patients, while it persisted in one patient with recurrence of diverticulitis. CONCLUSION: SIBO affects most of the patients with acute diverticulitis. SIBO may worsen the symptoms of patients and prolong the clinical course of the disease, as confirmed in the case of persistence of SIBO and diverticulitis recurrence. In this case, we can hypothesize that bacteria from small bowel may re-colonize in the colon and provoke recurrence of symptoms.     

Therapy of travelers' diarrhea with rifaximin on various continents

OBJECTIVE: Our aim was to compare the efficacy and safety of rifaximin, a virtually nonabsorbed antibiotic, 600 and 1200 mg per day, with placebo in patients with travelers' diarrhea. METHODS: This was a multicenter, 1:1:1 randomized, parallel-group, double-blind study, conducted in Antigua, Guatemala; Guadalajara and Morelia, Mexico; and the coast of Kenya north and south of Mombasa. Adult patients with acute travelers' diarrhea were recruited; exclusion criteria included primarily medication that could influence the outcome. Subjects were treated for 3 days, three times daily; follow-up lasted 5 days. For each 24-h period, the subjects completed a diary card. Pre- and posttreatment stool, blood, and urine samples were assessed. RESULTS: Among the 380 volunteers, median time to the last unformed stool was 32.5 and 32.9 h in both rifaximin groups, compared with 60.0 h with placebo (p = 0.0001). Also, secondary clinical outcome measures were favorably influenced by the active agent. No relevant side effects were reported. CONCLUSION: Rifaximin is efficacious and safe for treatment of travelers' diarrhea at daily doses of 600 mg or higher.     

Mesalazine and/or Lactobacillus casei in maintaining long-term remission of symptomatic uncomplicated diverticular disease of the colon

BACKGROUND/AIMS: Four different therapeutic schedules with mesalazine and/or probiotics were assessed in preventing recurrence of symptomatic diverticular disease (DD) of the colon. METHODOLOGY: A prospective, dose-finding study was conducted on 75 patients, enrolled in an open fashion: mesalazine 800mg/daily (group M1) or mesalazine 1.6gr 10 days/month (group M2); mesalazine 800mg/daily + Lactobacillus casei DG 16 billion/day for 10 day/month (group LM1) or mesalazine 1.6gr + Lactobacillus casei DG 16 billion/day for 10 day/month (group LM2); Lactobacillus casei DG 16 billion/day for 10 day/month (group L). RESULTS: Seventy one patients completed the study (94.66%). Sixty six patients (88%) were symptom-free after the 24th month of treatment: 11 of group M1 (on i-t-t: 84% [CI 95%: 55.5-98.8]), 8 of group M2 (on i-t-t: 80% [CI 95%: 44.39-97.48]), 15 of group LM1 (on i-t-t: 93.75% [CI 95%: 69.77-99.84]), 12 of group LM2 (on i-t-t: 92.30% [CI 95%: 63.97-99.81]), 20 in group L (on i-t-t: 86.95% [CI 95%: 66.41-97.22]) (p-ns). Four patients (5.33%) suspended the treatment during the follow-up: all experienced recurrence of symptoms (100%), and 2 of them developed diverticulitis (50%). CONCLUSIONS: Mesalazine and/or Lactobacillus casei seem to be effective in maintaining remission of DD for long-time. Moreover, we found recurrence of the disease and complications in all patients suspending treatments.     

Therapeutic and prophylactic role of mesalazine (5-ASA) in symptomatic diverticular disease of the large intestine. 4 year follow-up results

In order to evaluate the efficacy and tolerability of mesalazine (5-ASA) in the prophylaxis of symptomatic relapses, of major complications and of microhemorrhagic phenomena in diverticular disease of the large intestine (MDC), prospective clinical study was conducted on patients with light-moderate symptomatic MDC under treatment with sulbactam-ampicillin 1.5 g/12 h i.m. and rifaximine 400 mg/12 h per os for 7 days. Follow-up period of 5 years with seriated checkups and laboratory and instrumentation controls. End points are represented by the relapse on inflammation and/or by the occurrence of major complications. On enrollment, 166 patients were randomized to receive mesalazine (Pentacol tablets--SOFAR S.p.A.) 400 mg b.i.d. per os for 8 weeks (81 patients; group M) or no supplementary treatment (85 patients; group C). After 4 years of follow-up, 44 patients dropped out of the study (9 because of major complications, 3 for massive hemorrhage, and 32 drop outs). Symptomatic relapses occurred in 51 patients (12 M; 39 C), while minor diverticular hemorrhages occurred in 43 patients (12 M; 31 C), with an estimated probability of remaining free respectively from symptomatic relapse (p=0.00005) and from microhemorrhagic phenomena (p=0.001) decisively in favor of the group treated with mesalazine. The duration of abdominal pain due to diverticolitis was also shorter in patients of group M (p=0.0002), while the incidence of major complications and side effects was comparable in the two groups. In conclusion, supplementary treatment with mesalazine in patients affected with MDC--at a follow-up limited to 48 months--proved to be well tolerated and effective in reducing the frequency of symptomatic relapses and microhemorrhagic phenomena and in reducing the duration of abdominal pain.     

A randomized, double-blind, multicenter study of rifaximin compared with placebo and with ciprofloxacin in the treatment of travelers' diarrhea

Rifaximin was compared with placebo and ciprofloxacin for treatment of travelers' diarrhea in a randomized, double-blind clinical trial. Adult travelers (N = 399) consulting travel clinics in Mexico, Guatemala, and India were randomized to receive rifaximin 200 mg three times a day, ciprofloxacin (500 mg two times a day and placebo once a day), or placebo three times a day for 3 days. Patients recorded in daily diaries the time and consistency of each stool and documented symptoms for 5 days after treatment. Stool samples were collected for microbiologic evaluations before and after treatment. The median time to last unformed stool (TLUS) in the rifaximin group (32.0 hours) was less than one half that in the placebo group (65.5 hours; P = 0.001; risk ratio 1.6; 95% confidence interval 1.2, 2.2; primary efficacy endpoint). The median TLUS in the ciprofloxacin group was 28.8 hours (P = 0.0003 versus placebo; P = 0.35 versus rifaximin). Rifaximin was less effective than ciprofloxacin for invasive intestinal bacterial pathogens. Oral rifaximin is a safe and effective treatment of travelers' diarrhea caused by noninvasive pathogens.     

短程三联疗法对功能性消化不良幽门螺杆菌感染的根除效果

目的　观察短程三联疗法对功能性消化不良 (FD)Helicobacterpylori感染的根除效果。方法　 73例H .pylori阳性的FD患者被随机分为A、B 2个治疗组 ,A组 (n =3 6) :奥美拉唑 2 0mgbid ,阿莫西林 1 0bid ,甲硝唑 0 4bid ,疗程 1周 ;B组 (n =3 7) :雷尼替丁 0 15bid ,阿莫西林 1 0bid ,甲硝唑 0 4bid ,疗程 1周 ;疗程结束时记录每组病人症状缓解情况 ,疗程结束后 1个月复查H .py lori。结果　H .pylori根除率分别为A组 5 2 8% (19/ 3 6)、B组 43 2 % (16/ 3 7) ,两组比较无统计学差异 (P >0 0 5 ) ,疗程结束时症状缓解率分别为A组 66 7% (2 4/ 3 6) ,B组 5 1 3 % (19/ 3 7) ,无统计学差异 (P >0 0 5 )。结论　本实验短程三联疗法对FD的H .pylori根除率及症状缓解率过低 ,不适合用于FD的H .pylori根治治疗     

Efficacy of rifaximin compared with ciprofloxacin for the treatment of acute infectious diarrhea: a randomized controlled multicenter study

Background/Aims

Ciprofloxacin has been widely prescribed for acute infectious diarrhea. However, the resistance to this drug is increasing. Rifaximin is a novel but poorly absorbed rifamycin derivative. This study evaluated and compared the efficacies of rifaximin and ciprofloxacin for the treatment of acute infectious diarrhea.

Methods

We performed a randomized controlled multicenter study in Korea. Patients with acute diarrhea were enrolled and randomized to receive rifaximin or ciprofloxacin for 3 days. The primary efficacy endpoint was the time to last unformed stool (TLUS). Secondary endpoints were enteric wellness (reduction of at least 50% in the number of unformed stools during 24-hour postenrollment intervals), general wellness (subjective feeling of improvement), and proportion of patients with treatment failure.

Results

Intent-to-treat analysis (n=143) showed no significant difference between the rifaximin and ciprofloxacin groups in the mean TLUS (36.1 hours vs 43.6 hours, p=0.163), enteric wellness (49% vs 57%, p=0.428), general wellness (67% vs 78%, p=0.189), or treatment failure rate (9% vs 12%, p=0.841). The adverse events did not differ significantly between the two groups.

Conclusions

These results suggest that rifaximin is as safe and effective as ciprofloxacin in the treatment of acute infectious diarrhea.     

序贯疗法和三联疗法联合益生茵根除幽门螺杆菌感染的临床对照研究

背景：近年来,幽门螺杆菌（Hp）对抗菌药物耐药的问题日益突出,研究者正不断尝试调整根除治疗方案以提高根除率。目的：评估序贯疗法和三联疗法联合益生菌根除Hp感染的疗效和安全性。方法：纳入有消化不良症状、RUT和“C-UBT均阳性且既往未接受过Hp根除治疗的患者,进入不同组别。序贯疗法组（A组,n=127）：前5d雷贝拉唑10mgbid＋阿莫西林1．0gbid,后5d雷贝拉唑10mgbid＋克拉霉素500mgbid＋替硝唑400mgbid;三联疗法＋益生菌组（B组,n=117）：（雷贝拉唑10mgbid＋阿莫西林1．0gbid＋克拉霉素500mgbid）×7d,三联活菌胶囊3粒tid×14d;标准三联疗法组（C组,n=106）：PPI和抗菌药物的剂量、用法、疗程同B组,但不加用益生菌。疗程结束后4周复查“C-UBT,同时评估症状改善和溃疡愈合情况。治疗期间观察不良反应发生情况。结果：A、B两组Hp根除率（ITT分析：82．7％、78．6％对63．2％;PP分析：83．3％、79．3％对65．0％）和症状缓解率（82．7％、84．6％对65．1％）均显著高于C组（P〈0．05）,A、B组问差异无统计学意义。三种方案的消化性溃疡痊愈率无明显差异（72．7％、67．6％和45．5％,P〉0．05）。B组不良反应发生率显著低于A、C两组（4．3％对15．0％和20．8％,P〈0．05）。结论：与标准三联疗法相比,序贯疗法和三联疗法联合益生菌能明显提高Hp根除率,其中三联疗法联合益生菌安全性更高,可能更适用于临床。     

Treatment of Gastroduodenal Ulcers with Cimetidine in Combination with Low-Dose Propantheline

ABSTRACT Fifty-eight adult outpatients with endo-scopically verified gastric, prepyloric or duodenal ulcers completed a double-blind trial of treatment with either Cimetidine, 1 g daily, plus propantheline, 45 mg daily (group A) or Cimetidine, 1 g daily, plus placebo (group B). After neither three nor six weeks of treatment was there any significant difference between the two groups with regard to ulcer healing or symptomatic relief. The ulcers of 22 (79%) of the 28 patients in group A and 25 (83%) of the 30 patients in group B were healed after six weeks, and 93 % of the patients in both groups became painfree. We were thus not able to show any advantage in combining Cimetidine treatment for ulcer healing with low-dose propantheline. In a small open trial the patients with healed ulcers received prophylactic treatment for 12 months with 1) Cimetidine 800 mg daily, 2) Cimetidine 400 mg at bedtime plus propantheline 45 mg daily or 3) propantheline 90 mg daily. No significant differences were found between the ulcer recurrence rates, but it cannot be excluded that a larger number of patients in each group might have yielded real differences.     

布拉氏酵母菌联合标准三联疗法根除幽门螺杆菌的疗效研究

幽门螺杆菌（Hp）感染与慢性活动性胃炎、消化性溃疡、胃癌等疾病的发生密切相关。近年来随着Hp对抗生素耐药率的升高,标准三联疗法根除印的疗效逐年下降。目的：评价布拉氏酵母菌（S．boulardii）联合标准三联疗法根除却的有效性和安全性。方法：135例经胃镜检查诊断为慢性活动性胃炎并经^13C-尿素呼气试验（^13C-UBT）证实坳感染的患者随机分为3组,A组：口服克拉霉素500mgbid＋阿莫西林1gbid＋雷贝拉唑10mgbid＋S．boulardii散剂250mgbid,疗程7d;B组：前7d口服S．boulardii散剂250mgbid,后7d口服克拉霉素500mgbid＋阿莫西林1gbid＋雷贝拉唑10mgbid＋S．boulardii散剂250mgbid;C组：口服克拉霉素500mgbid＋阿莫西林1gbid＋雷贝拉唑10mgbid,疗程7d。治疗结束后4周复查^13C—UBT以评估根除疗效。结果：128例患者按方案完成治疗。A、B、C组按意向治疗（ITT）分析坳根除率分别为75．6％、80．0％、62．2％,按方案（PP）分析印根除率分别为82．9％、83．7％、63．6％,A、B组PP根除率显著高于C组（P〈0．05）,ITT根除率与C组比较差异无统计学意义（P〉0．05）,A组I．IT和PP根除率与B组比较差异无统计学意义（P〉0．05）。A、B组不良反应发生率显著低于C组（39．0％、18．6％对63．6％,P〈0．05）,B组显著低于A组（P〈0．05）。A、B组对药物的耐受程度显著高于C组（P〈0．05）,B组显著高于A组（P〈0．05）。结论：S．boulardii联合标准三联疗法可提高印根除率,且安全性较高。