Clinical, Manometric, and Ultrasonographic Results of Pneumatic Balloon Dilatation vs. Lateral Internal Sphincterotomy for Chronic Anal Fissure: A Prospective, Randomized, Controlled Trial

Purpose This prospective, randomized, controlled trial was designed to compare the clinical, functional, and morphologic results of pneumatic balloon dilatation with lateral internal sphincterotomy for the treatment of chronic anal fissure. Methods All patients with symptomatic chronic anal fissure were randomly assigned to pneumatic balloon dilatation or lateral internal sphincterotomy and invited to complete a standardized questionnaire inquiring about their symptoms. Anal ultrasonography and anal manometry were performed before and six months after surgery. A proctologic examination was performed between the fifth and sixth postoperative weeks. Anal continence, scored by using a validated continence grading scale, was evaluated preoperatively at 1 and 6 weeks and at 12 and 24 months. Results Fifty-three patients, who satisfied selection criteria, were enrolled in the trial. Four patients (7.5 percent) were lost to follow-up. Twenty-four patients (11 males; mean age, 42 ± 8.2 years) underwent pneumatic balloon dilatation and 25 patients (10 males; mean age, 44 ± 7.3 years) underwent lateral internal sphincterotomy. Fissure-healing rates were 83.3 percent in the pneumatic balloon dilatation and 92 percent in the lateral internal sphincterotomy group. Recurrent anal fissure was observed in one patient (4 percent) after lateral internal sphincterotomy. At anal manometry, mean resting pressure decrements obtained after pneumatic balloon dilatation and lateral internal sphincterotomy were 30.5 and 34.3 percent, respectively. After pneumatic balloon dilatation, anal ultrasonography did not show any significant sphincter damage. At 24-month follow-up, the incidence of incontinence, irrespective of severity, was 0 percent in the pneumatic balloon dilatation group and 16 percent in the lateral internal sphincterotomy group (P < 0.0001). Conclusions As lateral internal sphincterotomy, pneumatic balloon dilatation grants a high anal fissure-healing rate but with a statistically significant reduction in postoperative anal incontinence. Reprints are not available.     

Eradication of Helicobacter pylori Compared with Long-Term Acid Suppression in Duodenal Ulcer Disease: A Randomized Trial with 2-Year Follow-up

Background: Trials evaluating long-term management of duodenal ulcer disease have mainly been focused on recurrence of ulcers, disregarding effects on dyspeptic and reflux symptoms. Profound acid inhibition with a proton pump inhibitor is the gold standard therapy in acid-related diseases. We aimed to compare the symptomatic effects of eradication therapy with those of long-term omeprazole treatment in a design with periods both with and without acid inhibition. Methods: Patients with active duodenal ulcer were randomized either to omeprazole, 20 mg twice daily until healing, followed by omeprazole, 20 mg/day for 1 year, or to eradication therapy (metronidazole, amoxicillin, and omeprazole for 2 weeks) followed by placebo for 1 year. All patients were followed up passively for an additional year. Clinical controls were performed every 2 months the 1st year (maintenance phase) and every 6 months during the passive follow-up phase. The study was multicentric and double-blind. The primary end-point was discontinuation of treatment, irrespective of reason. Results: Two hundred and seventy-six patients were randomized (139 in the eradication treatment group). In the maintenance phase there were no differences in the reporting of dyspeptic symptoms or in premature withdrawal. In the passive follow-up phase only five patients in the eradication therapy group discontinued owing to relapse of dyspeptic symptoms or ulcer, compared with 51 patients initially randomized to long-term omeprazole. There were no differences in reflux symptoms or in the development of reflux oesophagitis. Conclusions: Eradication therapy and long-term omeprazole are equally effective in controlling dyspeptic symptoms and reflux in duodenal ulcer patients with healed ulcers. One-quarter of the duodenal ulcer patients who start eradication therapy continue to be symptomatic or fail therapy for other reasons over a 2-year period. Eradication therapy does not increase the risk of reflux in ulcer patients.     

Remifentanil Compared with Midazolam and Pethidine Sedation During Colonoscopy: A Prospective, Randomized Study

Purpose The objective of our study was to compare the safety and efficacy of remifentanil during colonoscopy with those of the standard combination of midazolam and pethidine. Methods One-hundred and sixteen consecutive patients scheduled for colonoscopy were randomly assigned to groups A or B. Patients in group A (n = 56) received intravenous (IV) midazolam and pethidine. Patients in group B (n = 60) received IV remifentanil. Results Recovery was faster in group B (0 min) than in group A (56 ± 11.3 min) (P < 0.001). There was a marked difference between groups B and A with regard to the time of hospital discharge—28.7 ± 4.3 and 148.9 ± 34 min, respectively (P < 0.001). Patients in group A rated the procedure as comfortable, as also did those in group B. A combination of midazolam and pethidine had a greater affect on patients’ cardiorespiratory characteristics. Conclusion Remifentanil during colonoscopy provides sufficient pain relief with better hemodynamic stability, less respiratory depression, and significantly faster recovery and hospital discharge than moderate sedation with midazolam and pethidine.     

Open <Emphasis Type="Italic">vs</Emphasis>. Closed Lateral Internal Sphincterotomy for Idiopathic Fissure-in-Ano: A Prospective,Randomized, Controlled Trial

PURPOSE: Internal sphincterotomy remains the gold standard for treatment of anal fissure but is associated with a risk of imperfect continence. Recent studies have suggested that surgical technique (open vs. closed) may influence incontinence rates after sphincterotomy. This study was designed to assess the short-term and long-term incidence of incontinence after open and closed internal sphincterotomy.METHODS: Seventy-nine patients were randomly assigned to open or closed internal sphincterotomy, performed in standardized fashion by trainee staff. Standardized questionnaires assessing continence (modified Wexner score) were administered preoperatively and at 1, 6, and 52 weeks. Postoperative stay, pain scores, complications, and fissure healing were prospectively assessed by an independent observer.RESULTS: Three patients were lost to follow-up, leaving 36 closed (16 males; mean age, 45.1 years) and 40 open (21 males; mean age, 47.9 years) internal sphincterotomy patients for assessment. All operations were performed as day case procedures with no readmissions. At six weeks postoperative, 96 percent of fissures had healed. There were no significant differences in pain scores between closed and open internal sphincterotomy at Day 1 or Day 3 postoperative. New incontinence of any grade was seen in 6.8 percent of patients at 52-week follow-up. Three patients (4.1 percent, 1 closed, 2 open) suffered major incontinence at 52 weeks. There were no significant differences in continence at 1, 6, or 52 weeks, although more open patients experienced minor imperfections at 1 week.CONCLUSIONS: Incontinence after internal sphincterotomy is not insignificant. The technique (closed vs. open) does not seem to influence incontinence rates.Presented at the Colorectal Tripartite Meeting, Melbourne, Australia, October 28 to 31, 2002.     

Comparison of Fresh Frozen Plasma with a Standardized Serum Protein Solution Following Therapeutic Plasma Exchange in Patients with Autoimmune Disease: A Prospective Controlled Clinical Trial

abstract: The aim of the study was the comparison of the influence of fresh frozen plasma (FFP) (Freiburg, Germany) and Biseko, Biotest Pharma GmbH (Dreieich, Germany), as a plasma substitute (a standardized, virus inactivated human serum protein solution) on the coagulation factors, inhibitors, proteins, and complement factors in the plasma of autoimmune disease patients following membrane plasma separation. Patients (n = 24) with autoimmune disease were randomized to receive either FFP or Biseko for membrane plasma separation therapy. During each plasma exchange, 100% of the plasma volume was replaced by the respective substitute. Plasma exchange volume was performed once daily for 3 days. Target test parameters of the coagulation system were fibrinogen, fibrinopeptide A, factor VIII (FVIIIC), von Willebrand factor antigen (vWFAg), partial thromboplastin time (PTT), thromboplastin time (Quick value), and antithrombin (AT III). The immunoglobulins were IgG, IgA, and IgM and C‐reactive protein (CRP). The thrombocytes were platelet factor 4 (PF4), and complement factors were C3 and C4. Biseko was well tolerated with 1 mild adverse drug reaction (ADR) (n = 1) while FFP gave rise to ADR on 7 occasions (n = 4). Statistically significant differences in the 2 groups were observed for fibrinogen, PTT, Quick value, and AT III. From the clinical point of view, all fluctuations and differences in parameter levels remained clinically silent. The differences had no clinical consequences. Reflecting on a potential decrease in the risk of infections in comparison to FFP therapy and the lower rate of adverse drug reactions, it is possible to postulate an advantage of Biseko for plasma exchange therapy.     

Detection of Colorectal Neoplasms Using Linked Color Imaging: A Prospective,Randomized, Tandem Colonoscopy Trial

Background and aimsA higher adenoma detection rate (ADR) has been shown to be related to a lower incidence and mortality of colorectal cancer. We analyzed the efficacy of linked color imaging (LCI) by assessing the detection, miss, and visibility of various featured adenomas as compared with white light imaging (WLI).MethodsThis was a prospective, randomized, tandem trial. The participants were randomly assigned to 2 groups: first observation by LCI, then second observation by WLI (LCI group); or both observations by WLI (WLI group). Suspected neoplastic lesions were resected after magnifying image-enhanced endoscopy. The primary outcome was to compare the ADR during the first observation. Secondary outcomes included evaluation of adenoma miss rate (AMR) and visibility score.ResultsA total of 780 patients were randomized, 700 of whom were included in the final analysis. The ADR was 69.6% and 63.2% in the LCI and WLI groups, respectively, with no significant difference. However, LCI improved the average ADR in low-detectors compared with high-detectors (76.0% vs 55.1%; P < .001). Total AMR was 20.6% in the LCI group, which was significantly lower than that in the WLI group (31.1%) (P < .001). AMR in the LCI group was significantly lower, especially for diminutive adenomas (23.4% vs 35.1%; P < .001) and nonpolypoid lesions (25.6% vs 37.9%; P < .001) compared with the WLI group.ConclusionAlthough both methods provided a similar ADR, LCI had a lower AMR than WLI. LCI could benefit endoscopists with lower ADR, an observation that warrants additional study. (UMIN Clinical Trials Registry, Number: UMIN000026359).     

A Planned Prospective, Randomized, Placebo-Controlled Multicenter Trial Assessing the Effect of Helicobacter pylori Eradication on the Healing of Iatrogenic Ulcer after Endoscopic Resection of Gastric Neoplasm

Background/Aims

Helicobacter pylori eradication may facilitate the healing of iatrogenic ulcer after endoscopic resection of gastric neoplasm. This study involved designing a randomized, double-blinded, placebo-controlled, multicenter trial, performed by the Korean College of Helicobacter and Upper Gastrointestinal Research and the Medical Research Collaboration Center, Seoul National University Hospital.

Methods

We intend to enroll up to 232 patients H.-pylori-positive patients who have gastric adenoma or early gastric cancer after endoscopic resection. The enrolled patients are being randomly allocated to the H.-pylori-eradication-plus-proton-pump-inhibitor group or the placebo-plus-proton-pump-inhibitor group based on their histology results and the size of the resected specimen. After random allocation, the iatrogenic ulcer size and stage are evaluated at 4- and 8-week follow-ups (with a window of ±7 days). The primary end point is the healing rate of the ulcer by stage, and the secondary end point is the rate of ulcer size reduction, relief rate from ulcer-related symptoms, and adverse-event rates.

Results

More than 90% of the target subjects have already been enrolled into the study and are receiving ongoing periodic monitoring by the Medical Research Collaboration Center.

Conclusions

Completion of the study should reveal whether H. pylori eradication can facilitate the healing of ulcer after endoscopic resection in Korea.     

Evaluation of Two Beta-Tricalcium Phosphates with Different Particle Dimensions in Human Maxillary Sinus Floor Elevation: A Prospective,Randomized Clinical Trial

This study aimed to compare two beta-tricalcium phosphates with different particle sizes in human maxillary sinuses lifting. The immunolabeling of cells for RUNX2 and VEGF were performed to evaluate the osteoblast precursor cells and the vascular formation after 6 months of bone repair. Ten maxillary sinuses were grafted with autogenous bone graft (Group 1), 10 were grafted with ChronOs^® (Group 2), and 10 were grafted with BETA-TCP^® (Group 3). After 6 months of bone healing, biopsies were obtained to assess the new bone formed by histomorphometric and immunohistochemical evaluation for RUNX2 and VEGF. The mean bone formation for Group 1 was 51.4 ± 17.4%. Group 2 presented 45.5 ± 9.9%, and Group 3 conferred 35.4 ± 8.0% of new bone formation. The RUNX2 offered low for Groups 1 and 2 with high cellular activity for osteoblast in Group 3. The VEGF immunolabeling was moderate for Groups 1 and 2 and intense for Group 3. In conclusion, it was possible to show that the bone substitutes evaluated in the present study presented suitable outcomes for bone regeneration, being an alternative for the autogenous bone graft in maxillary sinus bone height reconstruction.     

Prevalence of Anal Cytologic Abnormalities in a French Referral Population: A Prospective Study with Special Emphasis on HIV, HPV, and Smoking

Purpose Studying anal cytology to detect intraepithelial neoplasia has been demonstrated to be useful in highly selected populations. This study was designed to determine the frequency of abnormal smears in a wide sample of patients consulting for anorectal symptoms. Methods An anal smear was proposed during each consultation during a three-month period. Results A total of 205 patients (112 females) were included. After the consultation, visible condylomas were detected in 12 (6 percent) of the cases. Two hundred three (99 percent) smears were able to be analyzed. No case of high-grade squamous intraepithelial lesion was found. Four cases of low-grade squamous intraepithelial lesion were found, all in HIV patients with a history of condylomatous lesions. Forty smears were interpreted as atypical squamous cells of undetermined significance and 159 were normal. The prevalence in this population of low-grade squamous intraepithelial lesion was 19 percent (4/21) in HIV seropositive males, and 15 percent (4/26) in the case of a past history of condyloma. The factors associated with an abnormal smear (low-grade squamous intraepithelial lesion or atypical squamous cells of undetermined significance) were a history of anal condylomatous lesions (odd ratio, 4.9; range, 2.1–11.5), HIV seropositivity (odd ratio, 4; range, 1.6–9.9), and smoking (odd ratio, 2.1; range, 1.1–11.5). Conclusions This work confirms that the frequency of low-grade squamous intraepithelial lesion is raised in HIV-seropositive males and also where there is a history of condyloma, which corroborates the necessity for regular monitoring and screening of these patients at risk. This study also suggests that the use of tobacco is associated with anal cytologic abnormalities. Podium presentation at the meeting of the “Journées de la Société Nationale de Colo-Proctologie,” Paris, France, November 25, 2005, and at Digestive Diseases Week, Los Angeles, California, May 21 to 24, 2006. Supported by a grant from Beaufour Ipsen Pharma. Paris, France     

Efficacy and Safety of TJP-008 Compared to 2 L PEG with Ascorbate in Colon Cleansing: A Randomized Phase 3 Trial

Background/AimsPolyethylene glycol (PEG)-based bowel preparations are effective cleansing agents for colonoscopy. However, they require relatively large volumes to be used even with agents such as 2 L PEG with ascorbate (2LPEG). This phase 3, randomized, single-blinded, multicenter, parallel-group study compared the efficacy of 1 L PEG with high-dose ascorbate, TJP-008, to 2LPEG.MethodsPatients undergoing colonoscopy were randomized (111) to receive TJP-008 as 1-day split dose (TJP-008-1) or 2-day split dose (TJP-008-2) regimen or to receive 2LPEG as a 2-day split dose regimen. Cleansing efficacy was evaluated using the Harefield Cleansing Scale. The primary endpoint was overall bowel cleansing success. Full analysis set (FAS) and per protocol set (PPS) analyses were performed.ResultsOf the 314 screened patients, efficacy was assessed in the following patient numbers (FAS/PPS) total (293/285), TJP-008-1 (98/94), TJP-008-2 (97/95), and 2LPEG (98/96). FAS revealed noninferiority between TJP-008 and 2LPEG with regard to overall success (TJP-008-2, 99.0%; TJP-008-1, 95.9%; 2LPEG, 94.9%; p=0.100 and p=0.733, respectively). PPS also showed noninferiority (p=0.721 and p=0.211, respectively). However, the PPS analyses showed a higher bowel cleansing score for TJP-008-2 for high-quality cleansing in the right colon (TJP-008-2 83.2% vs 2LPEG 62.5%; p=0.005).ConclusionsTJP-008 is a new low-volume cleansing agent with a colon cleansing efficacy comparable to that of standard 2LPEG that exhibits significant safety and tolerability.     

Adsorptive Granulocyte/Monocyte Apheresis for the Maintenance of Remission in Patients with Ulcerative Colitis: A Prospective Randomized, Double Blind, Sham-Controlled Clinical Trial

Background/Aims

Weekly granulocyte/monocyte adsorption (GMA) to deplete elevated and activated leucocytes should serve as a non-pharmacological intervention to induce remission in patients with ulcerative colitis (UC). This trial assessed the efficacy of monthly GMA as a maintenance therapy to suppress UC relapse.

Methods

Thirty-three corticosteroid refractory patients with active UC received 10 weekly GMA sessions as a remission induction therapy. They were then randomized to receive one GMA session every 4 weeks (True, n=11), extracorporeal circulation without the GMA column every 4 weeks (Sham, n=11), or no additional intervention (Control, n=11). The primary endpoint was the rate of avoiding relapse (AR) over 48 weeks.

Results

At week 48, the AR rates in the True, Sham, and Control groups were 40.0%, 9.1%, and 18.2%, respectively. All patients were steroid-free, but no statistically significant difference was seen among the three arms. However, in patients who could taper their prednisolone dose to <20 mg/day during the remission induction therapy, the AR in the True group was better than in the Sham (p<0.03) or Control (p<0.05) groups.

Conclusions

Monthly GMA may potentially prevent UC relapse in patients who have achieved remission through weekly GMA, especially in patients on <20 mg/day PSL at the start of the maintenance therapy.     

Randomized,prospective trial comparing 0.2 percent isosorbide dinitrate ointment with sphincterotomy in treatment of chronic anal fissure: A two-year follow-up

PURPOSE The aim of this trial was to compare lateral internal sphincterotomy with local 0.2 percent isosorbide dinitrate in the treatment of chronic anal fissure to minimize surgical complications such as minor fecal incontinence.METHODS Fifty-four patients with chronic anal fissure were randomized in a prospective trial to either sphincterotomy or local 0.2 percent isosorbide dinitrate. All patients had anal function tests before and 5 weeks after treatment.RESULTS In the ointment group, 18 patients (67 percent) healed at 5 weeks and 24 (89 percent) healed at 10 weeks of treatment. Maximum resting anal pressure was reduced 30 percent. Eight patients (30 percent) had minor side effects. In the surgical group, 26 patients (96 percent) healed at 5 weeks and 100 percent healed at 10 weeks after treatment, with 33 percent reduction in maximum resting anal pressure. Forty-four percent of patients had minor fecal incontinence, which remained in 15 percent after 24 months follow-up. No statistical difference in maximum resting anal pressure was found between groups (P = 0.16), but the percentage of healing at 5 weeks was greater in the surgical group (P < 0.001).CONCLUSIONS Isosorbide dinitrate ointment must be considered as the first choice of treatment in patients with chronic anal fissure. Surgery should be indicated if chemical sphincterotomy fails.Reprints are not available.Presented at the ACPGBI Annual Meeting, Harrogate, United Kingdom, June 24 to 27, 2001.     

Bleeding Outcomes After Left Atrial Appendage Closure Compared With Long-Term Warfarin: A Pooled,Patient-Level Analysis of the WATCHMAN Randomized Trial Experience

ObjectivesThe purpose of this study was to compare the relative risk of major bleeding with left atrial appendage (LAA) closure compared with long-term warfarin therapy.BackgroundLAA closure is an alternative approach to chronic oral anticoagulation for the prevention of thromboembolism in patients with atrial fibrillation (AF).MethodsWe conducted a pooled, patient-level analysis of the 2 randomized clinical trials that compared WATCHMAN (Boston Scientific, Natick, Massachusetts) LAA closure with long-term warfarin therapy in AF.ResultsA total of 1,114 patients were included, with a median follow-up of 3.1 years. The overall rate of major bleeding from randomization to the end of follow-up was similar between treatment groups (3.5 events vs. 3.6 events per 100 patient-years; rate ratio [RR]: 0.96; 95% confidence interval [CI]: 0.66 to 1.40; p = 0.84). LAA closure significantly reduced bleeding >7 days post-randomization (1.8 events vs. 3.6 events per 100 patient-years; RR: 0.49; 95% CI: 0.32 to 0.75; p = 0.001), with the difference emerging 6 months after randomization (1.0 events vs. 3.5 events per 100 patient-years; RR: 0.28; 95% CI: 0.16 to 0.49; p < 0.001), when patients assigned to LAA closure were able to discontinue adjunctive oral anticoagulation and antiplatelet therapy. The reduction in bleeding with LAA closure was directionally consistent across all patient subgroups.ConclusionsThere was no difference in the overall rate of major bleeding in patients assigned to LAA closure compared with extended warfarin therapy over 3 years of follow-up. However, LAA closure significantly reduced bleeding beyond the procedural period, particularly once adjunctive pharmacotherapy was discontinued. The favorable effect of LAA closure on long-term bleeding should be considered when selecting a stroke prevention strategy for patients with nonvalvular AF. (WATCHMAN Left Atrial Appendage System for Embolic PROTECTion in Patients With Atrial Fibrillation; NCT00129545; and Evaluation of the WATCHMAN LAA Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy [PREVAIL]; NCT01182441)     

Efficacy of Octreotide and Sclerotherapy in the Treatment of Acute Variceal Bleeding in Cirrhotic Patients: A Prospective,Multicentric, and Randomized Clinical Trial

Background: Sclerotherapy is the most widely used method for treatment of acute variceal bleeding. Previous reports have suggested that octreotide infusion is as effective as sclerotherapy. Our aim was to investigate the efficacy and safety of octreotide in comparison with sclerotherapy in controlling variceal bleeding. Methods: Seventy-six cirrhotic patients were randomized to receive either sclerotherapy (n = 37) or octreotide (n     

Effects of a Renal Rehabilitation Exercise Program in Patients with CKD: A Randomized,Controlled Trial

Background and objectives

Patients with CKD have a high prevalence of cardiovascular disease associated with or exacerbated by inactivity. This randomized, controlled study investigated whether a renal rehabilitation exercise program for patients with stages 3 or 4 CKD would improve their physical function and quality of life.

Design, setting, participants, & measurements

In total, 119 adults with CKD stages 3 and 4 were randomized, and 107 of these patients proceeded to usual care or the renal rehabilitation exercise intervention consisting of usual care plus guided exercise two times per week for 12 weeks (24 sessions). Physical function was determined by three well established performance-based tests: 6-minute walk test, sit-to-stand test, and gait-speed test. Health-related quality of life was assessed by the RAND 36-Item Short Form Health Survey.

Results

At baseline, no differences in self-reported level of activity, 6-minute walk test, and sit-to-stand test scores were observed between the usual care (n=48) and renal rehabilitation exercise (n=59) groups, although baseline gait-speed test score was higher in the renal rehabilitation exercise group (P<0.001). At follow-up, the renal rehabilitation exercise group but not the usual care group showed significant improvements in the 6-minute walk test (+210.4±266.0 ft [19% improvement] versus −10±219.9 ft; P<0.001), the sit-to-stand test (+26.9±27% of age prediction [29% improvement] versus +0.7±12.1% of age prediction; P<0.001), and the RAND-36 physical measures of role functioning (P<0.01), physical functioning (P<0.01), energy/fatigue levels (P=0.01), and general health (P=0.03) and mental measure of pain scale (P=0.04). The renal rehabilitation exercise regimen was generally well tolerated.

Conclusions

A 12-week/24-session renal rehabilitation exercise program improved physical capacity and quality of life in patients with CKD stages 3 and 4. Longer follow-up is needed to determine if these findings will translate into decreased mortality rates.     

Effect on Mode of Death of Heart Failure Treatment Started with Bisoprolol Followed by Enalapril,Compared to the Opposite Order: Results of the Randomized CIBIS III Trial

Background: Mode of death in chronic heart failure (CHF) may be of relevance to choice of therapy for this condition. Sudden death is particularly common in patients with early and/or mild/moderate CHF. β‐Blockade may provide better protection against sudden death than ACE inhibition (ACEI) in this setting. Methods: We randomized 1010 patients with mild or moderate, stable CHF and left ventricular ejection fraction ≤35%, without ACEI, β‐blocker or angiotensin‐receptor‐blocker therapy, to either bisoprolol (n = 505) or enalapril (n = 505) for 6 months, followed by their combination for 6–24 months. The two strategies were blindly compared regarding adjudicated mode of death, including sudden death and progressive pump failure death. Results: During the monotherapy phase, 8 of 23 deaths in the bisoprolol‐first group were sudden, compared to 16 of 32 in the enalapril‐first group: hazard ratio (HR) for sudden death 0.50; 95% confidence interval (CI) 0.21–1.16; P= 0.107. At 1 year, 16 of 42 versus 29 of 60 deaths were sudden: HR 0.54; 95% CI 0.29–1.00; P= 0.049. At study end, 29 of 65 versus 34 of 73 deaths were sudden: HR 0.84; 95% CI 0.51–1.38; P= 0.487. Comparable figures for pump failure death were: monotherapy, 7 of 23 deaths versus 2 of 32: HR 3.43; 95% CI 0.71–16.53; P= 0.124, at 1 year, 13 of 42 versus 5 of 60: HR 2.57; 95% CI 0.92–7.20; P= 0.073, at study end, 17 of 65 versus 7 of 73: HR 2.39; 95% CI 0.99–5.75; P= 0.053. There were no significant between‐group differences in any other fatal events. Conclusion: Initiating therapy with bisoprolol compared to enalapril decreased the risk of sudden death during the first year in this mild systolic CHF cohort. This was somewhat offset by an increase in pump failure deaths in the bisoprolol‐first cohort.     

宝乐安散剂治疗急慢性腹泻61例随机双盲双模拟对照试验

目的观察宝乐安散剂治疗急慢性腹泻的临床疗效和安全性。方法采用多中心随机双盲、双模拟对照试验。宝乐安散剂61例,po,1.0g(10×108cfu),tid;对照药米雅片65例,po,0.7g(7.0×108cfu),tid。疗程急性腹泻3～7d,慢性腹泻14～21d。结果宝乐安散剂治疗急性腹泻有效率为100.0%(29/29),慢性腹泻有效率为100.0%(32/32);对照药米雅片分别为100.0%(32/32)和100.0%(33/33)。两药疗效间差异均无显著性(χ2=0.0,P>0.05),均未出现不良反应。结论宝乐安散剂是治疗急性、慢性腹泻安全有效的微生态制剂,其疗效和安全性均相当于进口药米雅片。     

Effects of Intensive Low-Salt Diet Education on Albuminuria among Nondiabetic Patients with Hypertension Treated with Olmesartan: A Single-Blinded Randomized,Controlled Trial

Background and objectives

The antiproteinuric effect of a renin-angiotensin-aldosterone system blockade can be magnified by dietary salt restriction. This study sought to determine the effect of intensive low-salt diet education on BP and urine albumin excretion in nondiabetic patients with hypertension and albuminuria.

Design, setting, participants, & measurements

This study was conducted between March of 2012 and March of 2013 as an open-label, randomized, controlled trial. After a run-in period of 8 weeks, all patients received the angiotensin II receptor blocker olmesartan (40 mg daily). Patients were then divided into two groups. One group was treated for another 8 weeks with angiotensin II receptor blocker plus conventional low-salt diet education, and the other group was treated for 8 weeks with angiotensin II receptor blocker plus intensive low-salt diet education. The final analyses was performed with 245 completed patients.

Results

The amount of daily albuminuria was significantly decreased from 0 (566.0 [25.0–5398.6] mg/d) to 8 weeks (282.5 [16.1–4898.5] mg/d; P<0.001). From 8 to 16 weeks, the 24-hour urinary sodium excretion was decreased by 36.0±5.9 mmol/d in the intensive education group and 8.8±4.9 mmol/d in the conventional education group (interaction P<0.001). Patients who completed intensive low-salt diet education exhibited greater decreases in urinary albumin excretion than the control group (change in albuminuria from 8 to 16 weeks, −154.0 versus 0.4 mg/d; P=0.01). Urinary albumin excretion tended to decrease as the 24-hour urinary sodium excretion amount decreased (R=0.32; 95% confidence interval, 0.20 to 0.43; P<0.001).

Conclusions

The 24-hour urinary albumin excretion was decreased more in patients in the intensive low-salt diet education group than patients in the conventional education group. Weekly intensive education on a low-salt diet would be a suitable method for clinical practice.