Tenoxicam. A preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic efficacy

Tenoxicam is a new non-steroidal anti-inflammatory and analgesic agent of the oxicam class, and therefore closely related to piroxicam. It possesses a long half-life which enables it to be administered once daily. Clinical trials in patients with rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, gout and non-articular rheumatism suggest that tenoxicam 20mg daily is an equally effective anti-inflammatory and analgesic agent compared with piroxicam 20mg daily, and that it is at least as well tolerated. Additionally, a few small studies in rheumatoid arthritis and osteoarthritis suggest that tenoxicam 20mg daily is as effective and as well tolerated as usual therapeutic dosages of diclofenac, ibuprofen, indomethacin and naproxen. Transient mild or moderate gastrointestinal symptoms, in 8% of patients at a dosage of 20mg daily, are the most frequently reported side effects. If further studies confirm the initially favourable efficacy and tolerability findings, particularly the relatively low incidence of adverse effects, tenoxicam can be considered a useful new agent for the symptomatic treatment of rheumatic and inflammatory diseases, and a worthwhile alternative to other non-steroidal anti-inflammatory drugs.     

Double-blind comparison of etodolac SR and diclofenac SR in the treatment of patients with degenerative joint disease of the knee.

An on-going multi-centre, double-blind, parallel-group study is being carried out to compare the efficacy and tolerability of sustained-release (SR) formulations of etodolac and diclofenac in patients with degenerative joint disease (osteoarthritis) of the knee. An interim analysis of the findings has been made for 64 patients from two centres which have now completed their part in the study. Thirty-two patients were randomly assigned to receive 600 mg etodolac SR once daily for 4 weeks; the remaining 32 patients received 100 mg diclofenac SR. Primary efficacy assessments rated on a 5-point categorical scale were patient and physician overall assessments of the patient's condition, night pain and pain intensity. Secondary efficacy parameters included weight-bearing pain, stiffness duration, joint tenderness on pressure, degree of swelling and erythema, degree of knee flexion and time to walk 15 metres. The results showed that for both etodolac SR and diclofenac SR treatment groups there was an improvement from baseline in all efficacy parameters at the last visit and no statistically significant difference was observed between treatments. However, although not statistically significant, the improvement rate in the patient's condition at Week 2 was slightly greater in the etodolac SR treatment group, suggesting that improvement may occur more rapidly with etodolac SR than with diclofenac SR. With regard to tolerability, 5 patients in the etodolac SR treatment group and 3 in the diclofenac SR group withdrew from the study because of adverse reactions. Two events (dyspepsia and mouth ulceration) in the etodolac SR group and 4 events (headache, glossitis, depression and insomnia) in the diclofenac SR group were considered to be definitely drug-related. Dyspepsia was reported by 3 patients (1 withdrawal) treated with etodolac SR and by 4 patients (2 withdrawals) treated with diclofenac SR. A statistically significant decrease was observed in haemoglobin and haematocrit values after 4 weeks of treatment in the diclofenac SR group, but this was not considered to be clinically important. In addition, there were no clinically significant changes in blood chemistry and urinalysis for either treatments. In conclusion, the results of the present study indicate that 600 mg etodolac SR once daily for 4 weeks is effective in the treatment of patients with degenerative joint disease of the knee, as is 100 mg diclofenac SR. In addition, both drugs have comparable tolerability profiles.     

A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis

OBJECTIVE: To evaluate and compare the efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis of the knee or hip. METHODS: In this 6-week double-blind, active comparator controlled, parallel-group study eligible osteoarthritis patients were randomised to receive either etoricoxib 60 mg once daily (n = 256) or diclofenac 50 mg three times daily (n = 260). The primary study endpoint was the Western Ontario McMaster osteoarthritis index (WOMAC) pain subscale. Other endpoints included were the WOMAC stiffness and physical function subscales, and the Patient's Global Assessment of Response to Therapy (PGART) questionnaire. Early efficacy was evaluated using WOMAC first question (pain walking on a flat surface) and PGART 4 h after the morning dose of each drug on days 1 and 2. Rescue medication (paracetamol) used was also recorded. The study was designed to show comparable efficacy between etoricoxib 60 mg once daily and diclofenac 50 mg three times daily with respect to the primary endpoint and was conducted outside the United States at 67 centres in 29 countries. RESULTS: Etoricoxib (60 mg once daily) was comparable in efficacy to diclofenac (150 mg daily) on all the above parameters. The one exception was in the assessment of early efficacy where etoricoxib demonstrated significantly greater benefit within 4 h of taking the first dose on the first day of therapy (p = 0.007) as evaluated by the percentage of patients with good or excellent (PGART) responses. The treatment effects of both drugs were similar by the time day 2 was reached and were sustained throughout the 6 weeks of therapy. Both treatments were generally well tolerated. CONCLUSIONS: Etoricoxib is clinically effective in the therapy of osteoarthritis providing a magnitude of effect comparable to that of the maximum recommended daily dose of diclofenac. The onset of clinical benefit with etoricoxib on day one is more rapid than that of diclofenac. Both drugs were generally well tolerated.     

Double-blind,randomised, comparative trial of etodolac SR versus diclofenac in the treatment of osteoarthritis of the knee

A multi-centre, double-blind, randomised parallel-group study was conducted to compare the efficacy and safety between etodolac SR and diclofenac in treating patients with osteoarthritis of the knee. Thirty-two patients receiving etodolac SR (400 mg/day) and 32 patients receiving diclofenac (100 mg/day) were included for analyses. After receiving the study treatment, etodolac SR and diclofenac were shown to produce comparable improvement in pain relief as measured by a 10-cm visual analogue scale. There was no statistically significant difference observed between groups for the degree of functional impairment or the amount of paracetamol taken. The etodolac SR treatment group showed fewer incidents of adverse event. In addition, fewer gastrointestinal symptoms were observed in the etodolac SR treatment group. A statistically higher percentage of etodolac SR-treated patients were better tolerated to the study treatment compared with the diclofenac-treated patients. Etodolac SR-treated patients also took fewer antacids than the diclofenac-treated patients during the treatment period. In conclusion, etodolac SR is an effective treatment with fewer side-effects than diclofenac for patients with osteoarthritis of the knee.     

Comparison of a new microcrystalline dicoumarol preparation with warfarin under routine treatment conditions.

1 To determine whether two different oral anticoagulants show difference under routine clinical conditions, 71 patients were randomized to treatment with Apekumarol, a microcrystalline dicoumarol preparation, and 72 patients to treatment with warfarin. 2 During the inpatient phase of treatment both drug groups remained for about 94% of their treatment time within prothrombin value limits of 5-25% (Simplastin A). No statistically significant difference was found between the drugs. 3 While under outpatient care, both drug groups remained for about 80% of their treatment time within prothrombin value limits of 5-25%. No statistically significant difference was found between the drugs. 4 The intensity of control and number of prothrombin-determinations did not differ significantly between the groups. 5 Variations in the daily dose did not differ significantly between the groups. 6 The mean daily dose could not be correlated to mean body weight. 7 The mean daily dose decreased with age for the male patients taking warfarin, not for the female patients. There was no such decrease for either male or female patients taking Apekumarol. An additional 137 patients who at the time of the trial were under routine treatment with warfarin were also studied with regard to mean daily dose, age and sex. In this additional group the mean daily dose could be correlated with age in both males and females. 8 No difference between Apekumarol and warfarin could be demonstrated when tested under routine clinical conditions according to the design of the present study. Sensitivity for warfarin, but not for Apekumarol, seems to increase with age, this sensitivity has been demonstrated in both sexes.     

Double-blind,randomised, comparative trial of etodolac SR versus diclofenac in the treatment of osteoarthritis of the knee

SUMMARY

A multi-centre, double-blind, randomised parallel-group study was conducted to compare the efficacy and safety between etodolac SR and diclofenac in treating patients with osteoarthritis of the knee. Thirty-two patients receiving etodolac SR (400?mg/day) and 32 patients receiving diclofenac (100?mg/day) were included for analyses. After receiving the study treatment, etodolac SR and diclofenac were shown to produce comparable improvement in pain relief as measured by a 10-cm visual analogue scale. There was no statistically significant difference observed between groups for the degree of functional impairment or the amount of paracetamol taken. The etodolac SR treatment group showed fewer incidents of adverse event. In addition, fewer gastrointestinal symptoms were observed in the etodolac SR treatment group. A statistically higher percentage of etodolac SR-treated patients were better tolerated to the study treatment compared with the diclofenac-treated patients. Etodolac SR-treated patients also took fewer antacids than the diclofenac-treated patients during the treatment period. In conclusion, etodolac SR is an effective treatment with fewer side-effects than diclofenac for patients with osteoarthritis of the knee.     

A comparison of faecal blood loss caused by tenoxicam and piroxicam in normal healthy male volunteers

Faecal blood loss arising from tenoxicam at a dose of 20 mg/day was compared to that arising from piroxicam at a dose of 20 mg/day in a double-blind, parallel comparative study in 12 healthy male volunteers. Faecal blood loss was measured for a 1-week run-in on placebo, during 4 weeks of treatment and for a 2-week post-treatment period in both groups. Plasma levels for tenoxicam and piroxicam confirmed good compliance in all subjects. Mean blood loss during the placebo run-in period was 0.35 ml/day. Mean blood loss during treatment with tenoxicam was 0.84 ml/day and with piroxicam 0.81 ml/day. There was no significant difference between these measurements. On cessation of treatment, faecal blood loss continued both in the tenoxicam group (mean 1.30 ml/day) and piroxicam group (mean 1.41 ml/day). The difference between these was not statistically significant. No significant haematological or biochemical abnormality resulted from either of the two trial drugs during the period of the study. Urinalysis and NAG/creatinine ratio also remained unaltered in both treatment groups.     

A comparison of faecal blood loss caused by tenoxicam and piroxicam in normal healthy male volunteers

Summary

Faecal blood loss arising from tenoxicam at a dose of 20?mg/day was compared to that arising from piroxicam at a dose of 20?mg/day in a double-blind, parallel comparative study in 12 healthy male volunteers. Faecal blood loss was measured for a 1-week run-in on placebo, during 4 weeks of treatment and for a 2-week post-treatment period in both groups. Plasma levels for tenoxicam and piroxicam confirmed good compliance in all subjects. Mean blood loss during the placebo run-in period was 0.35?mil day. Mean blood loss during treatment with tenoxicam was 0.84 milday and with piroxicam 0.81 milday. There was no significant difference between these measurements. On cessation of treatment, faecal blood loss continued both in the tenoxicam group (mean 1.30 ml/day) and piroxicam group (mean 1.41 milday). The difference between these was not statistically significant. No significant haematological or biochemical abnormality resulted from either of the two trial drugs during the period of the study. Urinalysis and NAG/creatinine ratio also remained unaltered in both treatment groups.     

A comparison of the therapeutic efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis

SUMMARY

Objective: To evaluate and compare the efficacy and tolerability of etoricoxib and diclofenac in patients with osteoarthritis of the knee or hip.

Methods: In this 6-week double-blind, active comparator controlled, parallel-group study eligible osteoarthritis patients were randomised to receive either etoricoxib 60?mg once daily (n?=?256) or diclofenac 50?mg three times daily (n?=?260). The primary study endpoint was the Western Ontario McMaster osteoarthritis index (WOMAC) pain subscale. Other endpoints included were the WOMAC stiffness and physical function subscales, and the Patient's Global Assessment of Response to Therapy (PGART) questionnaire. Early efficacy was evaluated using WOMAC first question (pain walking on a flat surface) and PGART 4?h after the morning dose of each drug on

days 1 and 2. Rescue medication (paracetamol) used was also recorded. The study was designed to show comparable efficacy between etoricoxib 60?mg once daily and diclofenac 50?mg three times daily with respect to the primary endpoint and was conducted outside the United States at 67 centres in 29 countries.

Results: Etoricoxib (60?mg once daily) was comparable in efficacy to diclofenac (150?mg daily) on all the above parameters. The one exception was in the assessment of early efficacy where etoricoxib demonstrated significantly greater benefit within 4?h of taking the first dose on the first day of therapy (p?=?0.007) as evaluated by the percentage of patients with good or excellent (PGART) responses. The treatment effects of both drugs were similar by the time day 2 was reached

and were sustained throughout the 6 weeks of therapy. Both treatments were generally well tolerated.

Conclusions: Etoricoxib is clinically effective in the therapy of osteoarthritis providing a magnitude of effect comparable to that of the maximum recommended daily dose of diclofenac. The onset of clinical benefit with etoricoxib on day one is more rapid than that of diclofenac. Both drugs were generally well tolerated.     

头孢克洛缓释片与头孢丙烯片对照治疗慢性支气管炎急性发作

目的: 比较头孢克洛缓释片与头孢丙烯片治疗慢性支气管炎急性发作(AECB)的有效性和安全性。方法:多中心随机单盲平行对照设计。缓释头孢克洛组予头孢克洛缓释片750mg,bid;头孢丙烯组予头孢丙烯500mg,bid,疗程均为7d。结果:202例AECB病人入选,缓释头孢克洛组102例,头孢丙烯组100例。治疗前2组基础情况、症状、体征和峰流速均具可比性。治疗后按意向性分析(ITT)和按方案分析(PP)缓释头孢克洛组和头孢丙烯组的临床有效率分别为84. 0 %, 74. 5 %和85. 4 %,74. 7 %,细菌学清除率分别为83 %和79 %, 2组间比较差别无显著意义(P>0. 05 );不良事件发生率缓释头孢克洛组7. 8 %,头孢丙烯组为6. 0 %, 2组比较差别无显著意义(P>0. 05)。结论:AECB病人应用头孢克洛缓释片750mg,bid,连续7d治疗,疗效确切,不良反应发生率低,与头孢丙烯相仿。     

依托考昔治疗骨关节炎的疗效及安全性研究

目的评价依托考昔治疗骨关节炎的有效性和安全性。方法采用随机对照研究的方法,将60例患者分为治疗组和对照组各30例。治疗组每天早餐后口服依托考昔60 mg,对照组每天早、午、晚餐后各服双氯芬酸50 mg,治疗6周,对治疗前、治疗3周及治疗6周时两组的VAS评分进行比较,同时观察药物的不良反应。结果治疗组初次服药后4 h VAS评分低于对照组,差异有统计学意义（P〈0.01）,两组在治疗前及治疗后3、6周的VAS评分比较,差异均无统计学意义（P〉0.05）。两组总的不良反应发生率比较,差异无统计学意义（P〉0.05）,但两组胃肠道不良反应发生率比较,治疗组低于对照组（P〈0.05）。结论在骨关节炎治疗上,依托考昔60 mg日1次与双氯芬酸钠50 mg日3次的疗效相当,但依托考昔起效快,且胃肠道不良反应小。     

Long term treatment with omeprazole 20 mg three days a week or 10 mg daily in the prevention of duodenal ulcer relapse

Background: The aim of this study was to compare omeprazole 10 mg o.m. (daily) with omeprazole 20 mg o.m. on Friday to Sunday inclusive (weekend) in the prevention of duodenal ulcer relapse over a 6-month period. Methods: After an open healing phase (4 to 8 weeks) with omeprazole 20 mg o.m., 81 patients entered the follow-up phase. Forty-two were randomized in a double-blind double-dummy technique, to omeprazole 10 mg o.m., and 39 to omeprazole 20 mg at weekends, At 3 and 6 months or on symptomatic relapse the patients underwent endoscopy with gastric biopsies (quantitative assessment of argyrophilic and gastrin cells), symptom evaluation, and laboratory screening with fasting serum gastrin. Results: Five patients in the 10 mg group and four in the weekend group were lost to follow-up. The estimated relapse rates over six months in the two groups receiving 10 mg daily or 20 mg at weekends were 19% and 31%, respectively (95% CI of percentage difference: –33% to 8%; intention-to-treat analysis, P = N.S.). During the follow-up phase, symptoms tended to be milder in the omeprazole 10 mg daily group compared to the weekend group. Gastrin levels increased significantly during the healing phase but then stayed almost constant in the omeprazole 10 mg group, and significantly decreased with weekend treatment. The median number of argyrophilic cells showed a slight but statistically significant increase in the omeprazole 10 mg daily group, but did not change in the weekend group. Both the healing and long-term therapies were well tolerated. Conclusions: Our data do not show a clear difference between the two treatment regimens, but there was a tendency towards a lower recurrence rate with omeprazole 10 mg daily compared with 20 mg weekend therapy.     

Lansoprazole 15 and 30 mg daily in maintaining healing and symptom relief in patients with reflux oesophagitis

Background: In patients with reflux oesophagitis, endoscopic healing and symptom relief are considered important treatment goals in long-term care.
Aim: To compare the effect of lansoprazole 15 and 30 mg daily on maintaining endoscopic healing and symptom relief in patients with moderate reflux oesophagitis.
Patients and methods: In a single-centre, double-blind randomized clinical trial, 103 patients with grade 1 or 2 reflux oesophagitis who were endoscopically healed and asymptomatic after lansoprazole 30 mg daily for 12 weeks, were randomized to maintenance therapy with either lansoprazole 15 mg or 30 mg o.m. Endoscopy was repeated after 3, 6 and 12 months, and symptom relief assessed after 3, 6, 9 and 12 months. Relapse of oesophagitis or symptoms were considered end-points.
Results: After 12 months, 14/50 patients (28%) receiving lansoprazole 15 mg daily had suffered an endoscopic relapse compared to 8/53 patients (15%) treated with lansoprazole 30 mg daily. A life table analysis showed no statistically significant difference between the two groups ( P =0.086). Significantly more patients were kept in complete symptomatic remission in the 30 mg group ( P <0.01). In the 15 mg group, 23/50 (46%) had suffered either an endoscopic or symptomatic relapse on completion of the study, compared to 12/53 (23%) in the 30 mg group. A life table analysis showed this difference to be statistically significant ( P =0.010). Lansoprazole 15 and 30 mg daily were equally well tolerated.
Conclusion: No statistically significant differences were found in endoscopic relapse rate or occurrence of adverse events, while lansoprazole 30 mg proved superior to 15 mg in maintaining patients in symptomatic relief and combined endoscopic and symptomatic remission.     

Slow-release furosemide and hydrochlorothiazide in congestive cardiac failure: a controlled trial

Thirty-eight ambulatory patients with congestive cardiac failure took part in a double-blind clinical trial of 50 mg hydrochlorothiazide orally daily and slow-release formulation of 60 mg furosemide orally daily. Following a one-week period of placebo administration, patients were randomly allocated to the treatment which they continued for six weeks. Other diuretic drugs were discontinued at entry, but antihypertensive drugs and digoxin were continued during the study at constant dosage. A controlled sodium diet was prescribed. Clinical observations and biochemical and hematologic measurements were made before, during, and at the end of the study. There was an improvement in the clinical condition of patients in both treatment groups, but no significant difference between treatments (with or without digitalis) was detected. Both treatments were clinically well tolerated; however, the tendency of hypokalemia was more pronounced in the hydrochlorothiazide group. This could be hazardous in patients who receive a concomitant cardiac glycoside, especially when no clear-cut benefit of concomitant digitalis therapy is demonstrated.     

An open assessment of tenoxicam (Tilcotil) in the treatment of acute gout in general practice

Twenty-nine patients presenting to their general practitioners with acute gout were treated with tenoxicam 40 mg daily for two days then 20 mg daily for five days. The treatment was well tolerated and 79% of participants responded to therapy. Side affects were minor with no patients withdrawing from the treatment course.     

Oxaprozin versus diclofenac in NSAID-refractory periarthritis pain of the shoulder

OBJECTIVE: To evaluate the efficacy and safety of oxaprozin in comparison with diclofenac in patients with periarthritis pain of the shoulder previously unsuccessfully treated with nonsteroidal anti-inflammatory drugs other than diclofenac and oxaprozin. METHODS: In this open, multicentre, randomised, controlled study, eligible patients with periarthritis of the shoulder were randomised to receive either oxaprozin 1200 mg once daily (n = 49) or diclofenac 50 mg three times daily (n = 47). The treatment period was 15 +/- 1 days. The study was planned on a hypothesis of equivalence between the two study drugs. The primary study endpoint was the change from baseline at day 15 in the patient-assessed shoulder pain score. Secondary efficacy variables included investigator-assessed shoulder function, patient-assessed quality of life on the Short-Form-36 (SF-36) Acute Health Survey and both patients' and investigators' overall assessment of efficacy. RESULTS: At day 15, the mean changes in shoulder pain score from baseline in the oxaprozin and diclofenac groups were -5.85 +/- SD 4.62 and -5.54 +/- SD 4.41, respectively. The difference between the two groups was not statistically significant, confirming the hypothesis of the study that oxaprozin is as effective as diclofenac. Investigator-assessed shoulder function improved in both groups but more so in the oxaprozin group (p = 0.028 at day 15). Quality of life as measured by SF-36 total score was also improved in both treatment groups, with a trend toward greater improvement in the oxaprozin group. Furthermore, a significantly more favourable effect on the SF-36 'mental health' item was observed in oxaprozin compared with diclofenac-treated patients at day 15 (p = 0.0202). As assessed by investigators, the overall efficacy of oxaprozin was superior to that for diclofenac at visit 3 (8 +/- 1 days) (p = 0.0067). Patients also assessed the overall efficacy of oxaprozin as superior to that of diclofenac at visits 3 (8 +/- 1 days) (p = 0.0235) and 4 (15 +/- 1 days) (p = 0.0272). Only six adverse events, all of which were mild or moderate in intensity and occurred in four diclofenac recipients, were observed in the study. CONCLUSIONS: As expected, once-daily oxaprozin proved to be as effective as diclofenac three times daily in reducing the primary efficacy variable of patient-assessed shoulder pain score in patients with periarthritis of the shoulder refractory to previous treatments with other NSAIDs. Oxaprozin was shown to be superior to diclofenac in improving shoulder function and was considered by investigators and patients to have greater overall efficacy than diclofenac. In addition, oxaprozin showed a trend toward superior results in improving patients' quality of life compared with diclofenac. A trend towards better tolerability results for oxaprozin compared with diclofenac was also noted.     

Clinical trial on the efficacy and safety of different diclofenac formulations: Multiple-unit formulations compared to enteric coated tablets in patients with activated osteoarthritis

—This double-blind, randomised, multicentre study investigated the efficacy and safety of two different dosages of a diclofenac sodium dual release capsule (150 mg or 75 mg once daily) in comparison to a standard treatment with enteric coated tablets (50 mg t.i.d.) and placebo in patients with activated osteoarthritis. Pain relief as the main efficacy variable was measured through 24 hours by means of a Visual Analogue Scale at baseline and on five assessment days during the 12 weeks of treatment. Efficacy was observed in all treatment groups with a statistically significant difference between the verum groups and placebo. The overall safety and tolerability of the active treatments was good. For the 75 mg group, a lower incidence of liver and biliary system-related side effects was reported. Considering efficacy, safety, and compliance aspects, the once daily administration of diclofenac sodium 75 mg dual release capsule is the appropriate dosage regimen for mid- and long-term treatment of osteoarthritis.     

东方胃药联合标准三联疗法与含铋剂四联疗法治疗Hp相关性胃炎及消化性溃疡患者临床疗效对比分析

目的观察东方胃药联合标准三联疗法对幽门螺杆菌H.pylori(Hp)感染的根除率以及合并Hp感染的消化性溃疡的疗效,并与铋剂四联疗法进行对比。方法采用前瞻性随机对照研究,研究对象为伴有Hp感染的慢性胃炎或消化性溃疡的患者。(1)Hp相关性胃炎共123例:东方胃药组(A组,61例)和铋剂四联组(B组,62例)。A组给予东方胃药4粒/次,3次/d,口服,联合标准三联药物:埃索美拉唑20 mg,阿莫西林1 000 mg,克拉霉素500 mg, 2次/d,口服;B组给予枸橼酸铋钾600 mg,联合标准三联药物。两组疗程均为14 d,治疗结束并停药4周复查¹³C尿素呼气试验。(2)合并Hp感染的消化性溃疡共101例:东方胃药组(a组,51例)和铋剂四联组(b组,50例)。a组给予东方胃药4粒/次,3次/d,口服,联合标准三联药物,14 d,第15天起东方胃药4粒/次,3次/d,埃索美拉唑20 mg, 1次/d,口服;b组给予枸橼酸铋钾600 mg联合标准三联药物,14 d,第15天起瑞巴派特100 mg, 3次/d,埃索美拉唑20 mg, 1次/d,口服。两组疗程均为4周,...     

坎地沙坦酯治疗轻、中度原发性高血压的临床研究

目的 观察坎地沙坦酯片治疗轻、中度原发性高血压的疗效.方法 采用随机、单盲、平行对照试验.将110例原发性高血压患者随机分为治疗组和对照组各55例.治疗组给予坎地沙坦酯片8mg口服治疗,1次/d;对照组给予缬沙坦片80mg口服治疗,1次/d.服用2周后,若舒张压≥12kPa则剂量加倍,疗程为8周.比较2组的降压疗效、幅度及心率变化.结果 治疗组总有效率为90.9%,对照组的87.3%,2组比较无显著差异（P〉0.05）.2组治疗前、后血压降低幅度均有显著差异（P〈0.01）,但2组间比较无显著差异（P〉0.05）.2组治疗前、后心率均无明显变化,组间比较无显著差异（P〉0.05）.结论 坎地沙坦酯片治疗轻、中度原发性高血压疗效确切,不良反应少,患者耐受性良好,临床应用安全,值得临床推广应用