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1.
AIM: To explore the efficacy and safety of the topically acting steroid beclometasone dipropionate (BDP) in an oral controlled release formulation in the treatment of extensive or left-sided ulcerative colitis. METHODS: In a multicentre, randomised, parallel-group, single-blind study, patients with active mild to moderate ulcerative colitis were randomised to a 4-week treatment with BDP 5 mg/day o.d. vs. 5-ASA 0.8 g t.d.s. The primary efficacy variable was the decrease of Disease Activity Index (DAI) (clinical symptoms and endoscopic appearance of mucosa). Safety was evaluated by monitoring adverse events, vital signs, haematochemical parameters and adrenal function. RESULTS: One hundred and seventy-seven patients were enrolled and randomly treated with BDP (n = 90) or 5-ASA (n = 87). Mean DAI score decreased in both treatments groups (P < 0.0001 vs. baseline for both groups). Clinical remission was achieved in 63.0% of patients in the BDP group vs. 62.5% in the 5-ASA group. A significant DAI score improvement (P < 0.05) in favour of BDP was observed in patients with extensive disease. Both treatments were well tolerated. Mean plasma cortisol levels were significantly reduced vs. baseline in BDP recipients, but without signs of pituitary-adrenal function depletion. CONCLUSION: Oral BDP gave an overall treatment result in patients with active ulcerative colitis without signs of systemic side-effects.  相似文献   

2.
BACKGROUND: Oral and topical mesalazine formulations are effective in active ulcerative colitis, but little is known on the efficacy of combined treatment. AIM: To compare the efficacy of oral mesalazine vs. combined oral and topical mesalazine in mildly to moderately active ulcerative colitis. METHODS: Patients with mildly to moderately active ulcerative colitis (Clinical Activity Index, CAI 4-12) were identified at 15 participating centres. They were randomized to receive either mesalazine 4 g orally plus placebo enema, or mesalazine 2 g orally plus mesalazine 2 g rectally as a liquid enema for 6 weeks. The rate of clinical remission (CAI < 4) or clinical remission/improvement (reduction of CAI of 50% from baseline) at 6 weeks and time to clinical remission/improvement were primary end-points; the rate of endoscopic remission was a secondary end-point. RESULTS: 67 patients were assigned to oral treatment and 63 to combined treatment. One patient in the oral group and 2 in the combined group discontinued the treatment due to adverse events. Following an intention-to-treat analysis, the rate of clinical remission was 82% for oral treatment and 87% for combined treatment (P=0.56); the mean time to remission 22.2 and 20.2 days, respectively (P=0.29); the rate of clinical remission/improvement and the rate of endoscopic remission were 85% and 91% (P=0.503) and 58% and 71% (P=0.21), respectively. CONCLUSIONS: In patients with mild active ulcerative colitis, mesalazine 4 g orally and 2 g orally plus 2 g enema are equally effective in inducing disease remission.  相似文献   

3.
BACKGROUND: The herbal preparation, aloe vera, has been claimed to have anti-inflammatory effects and, despite a lack of evidence of its therapeutic efficacy, is widely used by patients with inflammatory bowel disease. AIM: To perform a double-blind, randomized, placebo-controlled trial of the efficacy and safety of aloe vera gel for the treatment of mildly to moderately active ulcerative colitis. METHODS: Forty-four evaluable hospital out-patients were randomly given oral aloe vera gel or placebo, 100 mL twice daily for 4 weeks, in a 2 : 1 ratio. The primary outcome measures were clinical remission (Simple Clinical Colitis Activity Index /= 3 points; response was defined as remission or improvement), Baron score, histology score, haemoglobin, platelet count, erythrocyte sedimentation rate, C-reactive protein and albumin. RESULTS: Clinical remission, improvement and response occurred in nine (30%), 11 (37%) and 14 (47%), respectively, of 30 patients given aloe vera, compared with one (7%) [P = 0.09; odds ratio, 5.6 (0.6-49)], one (7%) [P = 0.06; odds ratio, 7.5 (0.9-66)] and two (14%) [P < 0.05; odds ratio, 5.3 (1.0-27)], respectively, of 14 patients taking placebo. The Simple Clinical Colitis Activity Index and histological scores decreased significantly during treatment with aloe vera (P = 0.01 and P = 0.03, respectively), but not with placebo. Sigmoidoscopic scores and laboratory variables showed no significant differences between aloe vera and placebo. Adverse events were minor and similar in both groups of patients. CONCLUSION: Oral aloe vera taken for 4 weeks produced a clinical response more often than placebo; it also reduced the histological disease activity and appeared to be safe. Further evaluation of the therapeutic potential of aloe vera gel in inflammatory bowel disease is needed.  相似文献   

4.
BACKGROUND: Repifermin (keratinocyte growth factor-2) has been shown to reduce inflammation in animal models of colitis. AIM: To evaluate repifermin for the treatment of active ulcerative colitis. METHODS: Eighty-eight patients with active ulcerative colitis were enrolled in a 6-week, double-blind trial. Patients were randomized to receive treatment for five consecutive days with intravenous repifermin at a dose of 1, 5, 10, 25 or 50 microg/kg, or placebo. The primary objective of the study was to evaluate the safety of repifermin. The primary efficacy outcome was clinical remission at week 4, defined as a score of zero on the endoscopic appearance and stool blood components of the Mayo score and a score of zero or unity on the stool frequency and physician's global assessment components. RESULTS: At week 4, the rates of clinical remission in the 1, 5, 10, 25 and 50 microg/kg repifermin groups were 19%, 9%, 0%, 0% and 0%, respectively, and 11% for the placebo group (P = 0.32 for repifermin vs. placebo). The frequencies of commonly occurring adverse events and severe adverse events were similar in both groups. CONCLUSIONS: Intravenous repifermin at a dose of 1-50 microg/kg was very well tolerated, but there was no evidence that repifermin was effective for the treatment of active ulcerative colitis at these doses. An additional study to determine the efficacy of repifermin at doses of > 50 microg/kg or for a longer treatment duration may be warranted, as the maximally tolerated dose was not reached in the present study.  相似文献   

5.
Introduction: Beclomethasone dipropionate (BDP) is a second-generation corticosteroid that uses novel drug technologies to ensure colonic targeting and potentially reducing systemic corticosteroid concentrations. It is approved for treatment of patients with mild-to-moderate ulcerative colitis (UC) who do not respond to mesalazine. The gut-selective mechanism of action has the potential to improve the safety profile of BDP compared with other conventional corticosteroids.

Areas covered: We reviewed the mechanism of action, efficacy, and safety of BDP in the treatment of UC. The positioning of BDP in management algorithms is also discussed.

Expert opinion: The highly selective mechanism of action of BDP restricts the steroid-related side effects. BDP is efficacious in the treatment of active UC. Topical formulation is the first choice in distal UC, while oral formulation is used in patients with an extensive involvement of the colon. The rates of adverse events (AE), serious AEs, and steroid-related side-effects are similar to placebo and mesalamine and slightly inferior to traditional corticosteroids.  相似文献   


6.
Seborrheic dermatitis (SD) is a common disorder for which no satisfactory curative treatment exists. Preliminary studies suggest that terbinafine may be effective. The efficacy and tolerability of oral terbinafine was evaluated in multi-site SD in a randomized, double-blind, placebo-controlled study. For this purpose, 174 adult patients with SD lesions involving >or=3 skin areas, each causing >or=2 moderate/severe symptoms according to a pre-defined clinical score, were classified according to the localization of lesions: patients with lesions predominantly involving non-exposed skin areas, such as scalp and hairline and sternum and/or interscapular area (Population A, n=83) or patients with lesions in exposed sites, mainly the face (Population B, n=91). Patients were randomized to oral terbinafine (250 mg/day ) (n=86) or matching placebo (n=88), each given for 6 weeks. Primary efficacy variable was the response rate, defined as >or=50% decrease in baseline total clinical score without rescue medication intake after 6 weeks of treatment. The main secondary assessments were: subject's global assessment of relief and proportion of patients satisfied with treatment. Recurrence rate was assessed in responder patients during a 4-week treatment-free period. In Population A the response rate after 6 weeks of treatment was significantly higher with terbinafine (70% vs 45.4%; p=0.03) and so was the proportion of patients who reported relief (75% vs 41%; p=0.007) and who were satisfied (66% vs 40%; p=0.02). No significant differences were recorded in Population B. Adverse events occurred in 11.5% of terbinafine patients and 8% of placebo patients. One patient discontinued treatment with terbinafine because of adverse events (mild tachycardia and insomnia). In conclusion, our results show that terbinafine is significantly more effective than placebo in reducing the severity of SD lesions in nonexposed sites. Clinical trials comparing terbinafine to standard treatment regimens in different types of patients with SD are warranted.  相似文献   

7.
Crohn's disease and ulcerative colitis are inflammatory bowel diseases characterised by a chronic relapsing course. Corticosteroids represent the mainstay of medical treatment of inflammatory bowel disease for the induction of remission. Despite the high efficacy of systemic steroids, their use is limited by the high incidence of potentially serious adverse effects. The topically acting steroids are synthetic compounds characterised by high anti-inflammatory activity and low systemic effects by virtue of efficient first-pass hepatic inactivation. Budesonide and Beclomethasone Dipropionate are the two most studied topically acting steroids in inflammatory bowel disease. Oral Budesonide has been extensively studied in the treatment of mild to moderate ileo-caecal Crohn's disease but few data are available concerning oral Beclomethasone Dipropionate. This review focuses on the available evidence of efficacy and safety of oral Beclomethasone Dipropionate in the management of ulcerative colitis and Crohn's disease and a possible role of this steroid in clinical practice is suggested.  相似文献   

8.
BACKGROUND: Probiotics are efficacious for treating and maintaining remission of ulcerative colitis. AIM: To conduct a randomized placebo-controlled trial of bifidobacteria-fermented milk supplementation as a dietary adjunct in treating active ulcerative colitis. METHODS: Twenty patients with mild to moderate, active, ulcerative colitis randomly received 100 mL/day of bifidobacteria-fermented milk or placebo for 12 weeks with conventional treatment. RESULTS: Clinical and endoscopic activity indices and histological scores were similar in the two groups before treatment. Although improvements were significant in both groups, the clinical activity index was significantly lower in the bifidobacteria-fermented milk than in the placebo group after treatment. The post-treatment endoscopic activity index and histological score were significantly reduced in the bifidobacteria-fermented milk, but not the placebo group. Increases in faecal butyrate, propionate and short-chain fatty acid concentrations were significant in the bifidobacteria-fermented milk, but not the placebo group. No adverse effects were observed in either group. CONCLUSION: Supplementation with this bifidobacteria-fermented milk product is safe and more effective than conventional treatment alone, suggesting possible beneficial effects in managing active ulcerative colitis. This is a pilot study and further larger studies are required to confirm the result these preliminary results.  相似文献   

9.
Infliximab in the treatment of severe ulcerative colitis: a follow-up study   总被引:3,自引:0,他引:3  
Conventional treatment options for patients with severe steroid-refractory ulcerative colitis (UC) include intravenous cyclosporine, which is frequently burdened by toxicity, or colectomy. Preliminary data suggest a benefit of anti-tumor necrosis factor alpha (Infliximab) therapy in patients with steroid refractory UC. Thirteen patients with severe UC, refractory to therapy with methyl-prednisolone, 60 mg IV daily were treated with a single intravenous infusion of Infliximab 5 mg/kg. Ten out of 13 patients (77%) had a clinical response to therapy defined by a CAI < or = 10 on two consecutive days. Two patients (15%) underwent total colectomy because of clinical worsening; one patient refused surgery and was lost to follow-up. Infusion with Infliximab produced no significant adverse events. The mean time of follow-up was 25.6 months (range 17-24); in this period of time 8 out of 10 patients (80%) maintained clinical remission and were able to discontinue corticosteroids therapy. Infliximab appears to be an effective agent for inducing long standing remission in refractory patients with severe UC.  相似文献   

10.
Background  Ulcerative colitis (UC) pathophysiology is characterized by an imbalance between pro- and anti-inflammatory cytokines. Interferon (IFN)-β-1a has potent immunoregulatory properties, including stimulation of host defence mechanisms and thus represents a potential treatment.
Aim  To extend pilot data and identify a suitable dose of IFN-β-1a to achieve endoscopically confirmed remission (ECR) in patients with moderately active UC and to evaluate safety.
Methods  In this multicentre, double-blind, placebo-controlled trial, adults with moderately active UC were randomized to IFN-β-1a 44 or 66 μg, or placebo, subcutaneously three times weekly for 8 weeks, with a 4-week follow-up.
Results  Endoscopically-confirmed remission was observed in 23.4% [95% confidence interval (CI): 13.8–35.7] of placebo patients, 29.2% (95% CI: 18.6–41.8) of the IFN-β-1a 44 μg group and 20.0% (95% CI: 11.1–31.8) of the 66 μg group ( P  = 0.45). Improvements with IFN-β-1a 44 μg were greater than with placebo for most secondary efficacy outcomes, although significance was not achieved. Placebo response rates were higher than expected from previous trials. Adverse events were similar to the known safety profile of IFN treatment.
Conclusions  Interferon-β-1a was generally well tolerated at the doses tested, but a significant therapeutic benefit in patients with UC was not observed.  相似文献   

11.
Oral methotrexate in ulcerative colitis   总被引:2,自引:0,他引:2  
BACKGROUND: We performed an audit of methotrexate for ulcerative colitis, because efficacy is unclear. Aim : To investigate the role of methotrexate in the management of ulcerative colitis. METHODS: Patients with ulcerative colitis treated with oral methotrexate at the inflammatory bowel disease clinics of Oxford and Wycombe General Hospital, UK, were evaluated. Efficacy was defined by remission (complete steroid withdrawal for >3 months) and response (good, partial or nil, proportionate reduction of steroids). RESULTS: There were 50 patients (42 ulcerative colitis alone; eight had rheumatoid arthritis associated with ulcerative colitis and were analysed separately). Indications for methotrexate in ulcerative colitis alone were azathioprine intolerance (31 of 42) and lack of benefit from azathioprine (11 of 42). The mean dose of methotrexate in ulcerative colitis alone was 19.9 mg/week for a median of 30 weeks (range: 7-395). Remission occurred in 42%. The response was good in 54% and partial in 18%. Side-effects occurred in 23%; 10% stopped treatment because of side-effects. Of those treated with methotrexate because of treatment failure with azathioprine, three of 11 achieved remission, but four came to colectomy within 90 days of starting methotrexate. The colitis remained in remission in seven of eight of those with RA treated with methotrexate and ulcerative colitis (mean dose 15.0 mg/week). CONCLUSION: Oral methotrexate (approximately 20 mg/week) is well-tolerated and moderately effective in steroid-dependent or steroid-refractory patients with ulcerative colitis.  相似文献   

12.

Aim:

To compare beclomethasone dipropionate 3 mg/60 mL enema (BDP) and prednisolone sodium phosphate 30 mg/60mL enema (PP) once daily in patients with active distal ulcerative colitis.

Methods:

One hundred and fifty-seven patients were enrolled in a multicentre, 4-week, randomized, double-blind trial. Patients were assessed at baseline, 2 and 4 weeks.

Results:

Both treatment groups showed statistically significant improvement of clinical activity after 2 and 4 weeks. Endoscopy and biopsy showed a reduction in the activity score at the end of the treatment period in both groups. No statistically significant difference was observed between the two treatment groups. After 4 weeks, 29% of patients in the BDP group and 25% in the PP group were considered to be in clinical remission; an improvement was observed in 40% of patients on BDP and in 47% on PP. Mean morning plasma cortisol levels showed a slight but significant reduction in the PP group, while the ACTH test showed that neither drug interfered with the hypothalamic–pituitary–adrenal (HPA) axis function. No significant changes were observed in the laboratory tests. Finally, there was a low incidence of adverse events in both groups.

Conclusions:

It is concluded that, in the topical treatment of active distal ulcerative colitis, BDP 3 mg enemas are as efficacious as PP 30 mg enemas, without interference with the HPA axis.
  相似文献   

13.
The tricyclic antidepressant drug amitriptyline was evaluated as a short-term treatment of anorexia nervosa patients. In a 5-week double-blind, placebo-controlled study 11 patients were given amitriptyline and 14 received placebo. In addition, 18 patients who refused to participate in the drug trial and received only psychosocial treatment were used as an additional comparison group. Overall, patients in the three groups showed little improvement. No statistically significant differences favoring amitriptyline were found in any of the outcome variables. Plasma levels varied widely among patients receiving similar doses. No association was found between plasma levels and improvement in either psychiatric symptomatology or weight. Amitriptyline patients did not manifest any tendency for a reduction of depressive symptomatology. In addition, amitriptyline treatment was associated with substantial discomfort and adverse affects.  相似文献   

14.
目的观察痰热清注射液联合吸入用丙酸倍氯米松混悬液治疗儿童喘息性支气管炎的临床疗效。方法选取2016年12月—2018年7月在驻马店市中心医院治疗的喘息性支气管炎患儿100例作为研究对象,采用数字表法将患儿随机分为对照组和治疗组,每组各50例。对照组雾化吸入用丙酸倍氯米松混悬液,0.5支/次,1~2次/d。治疗组患儿在对照组治疗的基础上静脉滴注痰热清注射液,0.3~0.5 mL/kg加入到5%葡萄糖注射液100~250 mL中,1次/d。两组均连续治疗5 d。观察两组患者的临床疗效,同时比较两组治疗前后的临床症状消失时间、肺功能指标、血清学指标。结果治疗后,对照组和治疗组的总有效率分别为78.0%、92.0%,两组比较差异具有统计学意义(P0.05)。治疗后,治疗组患儿的咳嗽消失时间、喘息消失时间、肺部啰音消失时间、气促缓解时间和退热时间均显著短于对照组,两组比较差异具有统计学意义(P0.05、0.01)。治疗后,对照组的用力肺活量(FVC)、用力呼吸容积(FEV1)、FVC/FEV1、最大呼气流量(PEF)、肺活量(VC)和最大通气量(MVV)水平均明显上升,呼出气一氧化氮(FeNO)明显下降,同组治疗前后比较差异具有显著性(P0.05);治疗组的FEV1、FVC/FEV1和MVV水平上升,且同组治疗前后比较具有显著差异(P0.05),FVC、PEF、VC水平上升,FeNO下降,同组治疗前后比较具有极显著性差异(P0.01)。治疗后,治疗组患儿的肺功能指标明显优于对照组,两组比较差异具有统计学意义(P0.05)。治疗后,两组患儿的白细胞介素-8(IL-8)、白细胞介素-6(IL-6)和肿瘤坏死因子-α(TNF-α)水平均显著降低,同组治疗前后比较差异具有统计学意义(P0.05);治疗后,治疗组血清学指标显著低于对照组,两组比较差异具有统计学意义(P0.05)。结论痰热清注射液联合丙酸倍氯米松混悬液治疗喘息性支气管炎具有较好的临床疗效,可明显缩短临床症状恢复时间,降低血清炎症因子水平,改善肺功能,具有一定的临床推广价值。  相似文献   

15.
目的 建立了复方倍氯米松橡胶膏剂中丙酸倍氯米松的含量测定方法。方法 RP HPLC外标法 ,Shim packCLC ODSC18柱 ,6 .0mm× 15 0mm ,5 μ ;流动相为 0 .0 5mol·L-1磷酸二氢钠溶液 (用 80 %磷酸溶液调节 pH值至 2 .5 ) 甲醇 ( 2 0∶80 ) ;柱温4 0℃ ;检测波长 2 4 0nm。结果 当进样体积为 5 0 μL时 ,在 0 .10 9~ 4 .34μg·mL-1的浓度范围内 ,线性关系良好 ;其他相似物质峰对丙酸倍氯米松的测定没有任何干扰 ;方法的重复性、回收率、溶液的稳定性均令人满意。结论 本法灵敏、方便、准确 ,可作为复方倍氯米松橡胶膏剂中丙酸倍氯米松的含量测定的首选方法。  相似文献   

16.
AIM: To assess safety and clinical efficacy of granulocyte and monocyte adsorptive apheresis for distal ulcerative colitis. METHODS: Granulocyte and monocyte adsorptive apheresis therapy (five aphereses for 5 consecutive weeks) was performed for 30 consecutive patients with active distal ulcerative colitis. Patient compliance, adverse effects and clinical symptoms were regularly assessed. RESULTS: Adverse effects were noted during nine (6%) apheresis sessions in eight patients; slight headache five, transient abdominal pain with tenesmus two, fever (38 degrees C) one and mild liver dysfunction one. None of these adverse effects was serious and all patients could complete five aphereses. Clinical symptoms (stool frequency and consistency, rectal bleeding, tenesmus and mucus in stools) significantly improved after the third apheresis. Clinical remission (normal stool frequency and no rectal bleeding) was achieved in 21 patients (70%) after five aphereses. The median Disease Activity Index score significantly decreased; from 6 [interquartile range (IQR): 4-7] to 2 (IQR: 1-3) (P < 0.0001). CONCLUSION: In the treatment of active distal ulcerative colitis, granulocyte and monocyte adsorptive apheresis is safe and well-tolerated. Granulocyte and monocyte adsorptive apheresis had a beneficial effect on clinical remission and symptoms. However, randomized-controlled trials would be necessary to assess a definite efficacy of granulocyte and monocyte adsorptive apheresis.  相似文献   

17.
目的 改进无极膏中丙酸倍氯米松薄层鉴别的方法。方法 增加软膏的取样量和滤除基质干扰后进行试验。结果 提高了样品中主药检出的准确性。结论 本改进方法优于原标准。  相似文献   

18.
BACKGROUND: Rectal formulations of mesalazine are the treatment of choice in mildly to moderately active ulcerative colitis. A new foam formulation of mesalazine was developed to improve both drug delivery and patient acceptance. METHODS: In this multicentre, randomized, double-blind, parallel-group study, 111 patients with mildly to moderately active proctitis, proctosigmoiditis, or left-sided ulcerative colitis received mesalazine foam enema or placebo enema (2 g mesalazine per day) for 6 weeks. Disease activity was monitored on the basis of the Clinical Activity Index, Endoscopic Index, Histological Index, and global efficacy assessment by the investigators. Safety assessments included the recording of adverse events, laboratory variables and vital signs. RESULTS: Clinical remission was more frequent in the mesalazine group than the placebo group (65% vs. 40%; P=0.0082), particularly in patients with mild disease and patients with proctosigmoiditis. The frequency of patients with an endoscopic remission was higher in the mesalazine group (57%) than in the placebo group (37%). Similarly, 59% of patients receiving mesalazine but only 41% of those receiving placebo showed an improved Histological Index. The foam enemas were generally well-tolerated, and no treatment-related changes on laboratory variables and vital signs were noted. CONCLUSIONS: Mesalazine foam enema was well-tolerated and was more effective than placebo in the treatment of patients with distal ulcerative colitis.  相似文献   

19.
目的探讨芪倍合剂联合美沙拉嗪肠溶片治疗活动期溃疡性结肠炎的临床疗效。方法选取2019年1月-2019年6月于新乡医学院第一附属医院门诊及住院治疗的96例活动期溃疡性结肠炎患者作为研究对象,将所有溃疡性结肠炎患者随机分为对照组和治疗组,每组各48例。对照组口服美沙拉嗪肠溶片,1 g/次,4次/d;治疗组在对照组治疗的基础上口服芪倍合剂,50 mL/次,3次/d。两组疗程均为8周。观察两组患者的临床疗效,比较两组的临床症状缓解时间、血清白细胞介素-33(IL-33)、可溶性血清基质裂解素(sST2)水平和复发率情况。结果治疗后,对照组、治疗组的临床总有效率分别为79.17%、93.75%,两组比较差异具有统计学意义(P<0.05)。治疗后,治疗组血便消失平均时间、腹泻次数至少降低50%所需时间与对照组相比均显著缩短,差异均具有统计学意义(P<0.05)。治疗2、4、8周后,两组患者血清IL-33、sST2水平同治疗前相比均显著下降(P<0.05);且治疗2、4、8周后,治疗组患者血清IL-33、sST2水平均显著低于同期对照组(P<0.05),差异均具有统计学意义(P<0.05)。随访3个月,对照组和治疗组患者的复发率分别为30.56%、9.30%,差异具有统计学意义(P<0.05)。结论芪倍合剂联合美沙拉嗪肠溶片治疗活动期溃疡性结肠炎的临床疗效较好,能迅速改善患者血便、腹泻症状,降低机体的炎症因子水平,有着良好的临床应用价值。  相似文献   

20.
Supine office blood pressures (SOBP) and 24-hour automated ambulatory blood pressure monitorings (AABPM) showed blood pressure reductions from a stable baseline to active treatment with 120-, 240-, and 480-mg doses of a new verapamil QD capsule (solid-spheroidal-oral once-daily drug-absorption system: (SODAS) in patients with mild-to-moderately severe (diastolic blood pressures 95-119 mm Hg) essential hypertension. Reductions were documented at 24 hours, hourly, and by the 24 hour average, using SOBP and AABPM, after the once-daily verapamil administration. Both SOBP and the 24-hour average by AABPM were significantly reduced from baseline by active verapamil treatment of 120-, 240-, and 480-mg doses. In comparison to verapamil QD (0 mg), blood pressure reductions from baseline to active treatment were significant at the 240- and 480-mg doses but not at the 120-mg dose. There was a significant linear dose response. This verapamil formulation (SODAS) was effective throughout the 24-hour period after once-daily dosing.  相似文献   

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