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61.

Objective

To evaluate the efficiency of single-tablet regimens (STR) and multiple-tablet regimens (MTR) with exactly the same or different components.

Methods

A study was conducted on HIV-1-infected antiretroviral-naïve patients from 6 Spanish or French centers, who were started on treatment with STR-Atripla®, or the same components separately (MTR-SC), or a different MTR (MTR-Other). Effectiveness was measured as percentage of HIV-RNA <50 copies/mL at 48 weeks (ITT). Efficiency was the ratio between costs (direct cost of antiretrovirals plus outpatient visits, hospital admissions, and resistance tests) and effectiveness.

Results

The study included a total of 2773 patients (759 STR-Atripla®, 483 MTR-SC, and 1531 MTR-Other). Median age was 37 years, 15% were HCV co-infected, 27% had a CD4+ count <200 cells/μL, and 30% had viral load ≥100.000 copies/mL. The duration of the assigned treatment was longer for STR-Atripla® (P < .0001). Response rates (adjusted for CD4+ count, viral load, and clustered on hospitals) at 48 weeks were 76%, 74%, and 62%, respectively (P < .0001). Virological failure was more common in MTR patients (P = .0025), and interruptions due to intolerance with MTR-Other (P < .0001). Cost per responder at 48 weeks (efficiency) was €12,406 with STR-Atripla®, €11,034 with MTR-SC (0.89 [0.82, 0.99] times lower), and €18,353 (1.48 [1.38, 1.61] times higher) with MTR-Other.

Conclusions

STR-Atripla® and MTR-SC regimens showed similar effectiveness, but virological failure rate was lower with STR-Atripla. MTR-SC, considered less convenient, had a marginally better efficiency, mainly due to lower direct costs. MTR-Other regimens had both a worse effectiveness and efficiency. Similar efficiency analyses adjusting for baseline characteristics should be recommended for new STRs.  相似文献   
62.
目的评价国产抗结核固定剂量复合剂(FDC)的临床效果、安全性和可行性。方法将184例初治涂阳肺结核患者分为研究组(FDC)和对照组(组合药),并进行临床应用对比分析研究。结果研究组与对照组:治愈率分别为96.7%、89.1%,停药率为2.2%、9.8%(均P﹤0.05);治疗依从性在药物接受程度、服药感受和方式方面,研究组均优于对照组(前两者P﹤0.01,后者P﹤0.05);痰检转阴率、X线胸片改变率和不良反应发生率两组差异均P﹥0.05。药品总用量FDC比组合药在强化期减少42.14%,继续期却增加86.96%。治愈1例病人平均成本FDC比组合药增加99.7%。结论 FDC在治愈率、停药率和治疗依从性以及减少耐药方面比组合药更显优势,可以在国内推广应用,但也需要做一些改进。  相似文献   
63.
目的 评价复方替米沙坦在替米沙坦单药治疗无充分反应时中国高血压患者中的有效性和安全性.方法 多中心、随机、双盲、双模拟临床试验.经1周安慰剂筛选期,699例符合入选标准的轻、中度高血压患者进入80 mg替米沙坦单药开放治疗期.345例对替米沙坦单药开放治疗8周无充分反应[平均坐位舒张压≥90 mm Hg(1 mm Hg=0.133 kPa)]的患者进入为期8周的随机双盲治疗期.175例患者进入复方替米沙坦治疗组(80 mg替米沙坦加12.5 mg氢氯噻嗪),170例进入80 mg替米沙坦单药治疗组.每次随访测量坐位和立位的收缩压和舒张压谷值,记录不良事件.筛选期以及开放和随机双盲治疗期结束时进行实验室和心电图检查.结果 (1)与开放治疗期结束(基线)比较,随机双盲治疗8周后,复方替米沙坦组坐位舒张压谷值平均下降10.1 mm Hg,替米沙坦单药组平均下降7.7 mm Hg,两组间比较P=0.0017.复方替米沙坦组坐位收缩压谷值平均下降14.2 mm Hg,替米沙坦单药组平均下降7.4 mm Hg,两组间比较P<0.0001.(2)与基线比较,随机双盲治疗8周后,复方替米沙坦组立位舒张压和收缩压谷值平均下降幅度大于替米沙坦单药组,两组间比较P=0.0350和P<0.0001.(3)按照平均坐位舒张压谷值<90 mm Hg和(或)与基线值相比降低≥10 mm Hg评价,随机双盲治疗8周后,复方替米沙坦组有效率为74.6%(129例患者),替米沙坦单药组为59.2%(100例患者),两组间比较P=0.0016.(4)在随机双盲期,两组与试验药物有关的不良事件发生率分别为3.5%和3.6%,两组间比较P>0.05.结论 替米沙坦单药治疗无充分反应的中国高血压患者,复方替米沙坦每日口服一次能够进一步降低血压,且安全性良好.  相似文献   
64.
65.
Chronic obstructive pulmonary disease (COPD) is a debilitating lung disease characterized by airflow limitation and chronic inflammation in the lungs. The mainstay of drug therapy for COPD is represented by long-acting bronchodilators, an important aspect of Novartis' development program. Novel once-daily dosing bronchodilators, such as the long-acting muscarinic antagonist (LAMA) glycopyrronium and the LAMA/long-acting β2-agonist (LABA) fixed-dose combination QVA149, have been shown to provide significant benefits to patients with COPD in terms of improvement in lung function, exercise tolerance, health-related quality of life, symptoms and reduction in the rate of exacerbations. Despite the benefits provided by these new treatment options, prevention of disease progression and control of exacerbations in certain patient phenotypes remain key challenges in the treatment of COPD. In order to address these needs and gain new insights into the complexity of COPD, Novartis is, in addition to bronchodilator-only therapies, developing LABA/inhaled corticosteroids (ICS) combinations to target inflammation, such as QMF149, as well as non-steroid based anti-inflammatory agents against key novel targets. These commitments are central to the Novartis' final goal of improving the standard of care in respiratory medicine and offering a better quality of life to patients with COPD.  相似文献   
66.
In about 1 to 2 percent of patients irradiated for abdominal tumors, the bowel is damaged. Months or years later there will be obstruction, bleeding or fistulas. The surgeon must then decide if recurrent tumor or radiation produces the symptoms. If radiation is responsible, he can usually cure the patient by resecting the involved bowel segment.  相似文献   
67.
目的对不同配方的抗结核药固定剂量复合剂的体内外抗结核药效进行评估。方法体外活性用二倍稀释法检测最低抑菌浓度(MIC),体内活性以半数动物存活时间为指标观察药物对实验性结核病的疗效。结果①二药或三药复方中的各药物对结核分枝杆菌H37Rv、牛型结核杆菌(Ravenal)草分枝结核杆菌(M.phlei)的MIC绝大多数都低于药物单独应用时的MIC;②体内抗结核作用显示,二药复方和三药复方及其复方制剂对实验性结核病均表现卅显著的治疗作用并明显优于各配方中相应药物单独应用时的作用。结论抗结核药二药复方和三药固定剂量复合剂在体内外均具有显著抗结核作用。且不同厂家的同一产品的抗结核作用未见显著差异。  相似文献   
68.
配制中西药结合剂型冠周Ⅰ号,采用药捻置入法治疗冠周炎。经临床93例疗放观察,5d治愈率为95.70%,其疗效优于碘酚液治疗组。本药对牙龈拟杆菌等6种厌氧菌及金黄色葡萄球菌和白色念球菌有较强的抗菌作用,且无毒性,无刺激性。  相似文献   
69.
Summary 417 patients suffering from intestinal amoebiasis were randomly allocated to 6 different treatment groups in a controlled study in 3 District Hospitals in Kenya. The patients received either aminosidine (A), etophamide (E), nimorazole (N), or the combinations NA, NE, EA. Treatment in all cases was given twice daily for 5 days. Before and after treatment, rectosigmoidoscopy was done in each patient, and stool examination with characterization of invasive (IF) and non invasive (NIF) forms of amoeba was done daily throughout treatment, and on Days 15, 30 and 60 of follow-up.Clinical cure was good after all the treatments, varying from 90 to 100%; parasitological cure at the end of treatment was 100% in the NA and EA treatments groups, and 98% in A group. The incidence of relapses was nil in the EA group, followed by 3% in NA and 6% in A groups. Anatomical cure (healing of ulcers) was 97.8% in the NA group, 95.5% in the N group and 88.5% in the A group. Drug tolerance was excellent or good after all the treatments, except that the EA combination produced diarrhoea in 76.5% of patients.Overall analysis of the findings, including tolerance of the various treatments, showed that aminosidine either alone or in combination with nimorazole gave the best results.Ulcers seen on rectosigmoidoscopy were more common in patients excreting invasive forms of amoebae in their stools.  相似文献   
70.
A review of the literature examining behavioral and/or physiological effects of combinations of ethanol and stimulants indicated very few complete, well-designed studies. Stimulants selected were amphetamine, caffeine, and nicotine. For ethanol-amphetamine combinations thirteen animal-behavioral studies, four human-behavioral studies, and eleven studies on lethality and physiology were reviewed. For ethanol-caffeine combinations four animal-behavioral studies, five human-behavioral and three studies on lethality and physiology were reviewed. Only two published ethanol-nicotine combination studies were found. Of studies examined, only eight used multiple doses and dose combinations and, of these, only five examined behavioral parameters. While antagonistic effects were sometimes reported, no antagonism and often potentiation effects also were found, particularly with certain dose combinations. Since current information about ethanol-stimulant interactions is clearly incomplete, attempts to formulate a general model to predict behavioral consequences of ethanol-stimulant combinations must await more complete parametric studies.  相似文献   
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