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PubMed2002

Efficacy of interferon monotherapy to 394 consecutive naive cases infected with hepatitis C virus genotype 2a in Japan: therapy efficacy as consequence of tripartite interaction of viral, host and interferon treatment-related factors.

BACKGROUND/AIMS: The mechanism of variable response to interferon (IFN) monotherapy in patients infected with HCV genotype 2a is still unclear. Here we investigated the response in a large group of patients infected with genotype 2a. METHODS: We evaluated 394 consecutive non-cirrhotic naive patients infected with genotype 2a who received IFN monotherapy for 24 weeks, including initial aggressive induction therapy. Of these, 97 were also evaluated for early viral kinetics in serum and treatment efficacy. RESULTS: The overall sustained response (SR) rate was 68.3% (viral load <1.0 Meq/ml (82.4%); >/=1.0 (52.4%)). Multivariate analysis identified five independent factors associated with SR; viral load <1.0 Meq/ml, total IFN dose > or =700 million units, hepatocyte steatosis none or mild, albumin > or =3.9 g/dl, and alanine aminotransferase > or =75 IU/l. The kinetic study showed that serum viral clearance at < or =1 week was the best predictor of SR, and persistence at > or = 4 weeks was a predictor of non-SR. CONCLUSIONS: Our study suggests that viral, host and IFN treatment-related factors determine the response to IFN monotherapy in patients infected with HCV genotype 2a. Further, we report that IFN monotherapy is very effective for patients with genotype 2a, especially for those with low viral load; and that early viral kinetics is useful as a predictor of the response.

Adolescent↗

PubMed1999

Efficacy of a potentized homoeopathic drug (Arsenicum Album-30) in reducing genotoxic effects produced by arsenic trioxide in mice: comparative studies of pre-, post- and combined pre- and post-oral administration and comparative efficacy of two microdoses.

OBJECTIVE: To examine the comparative efficacies of Arsenicum Album 30C and 200C and three administrative modes in protecting against the genotoxic effects produced by Arsenic trioxide injection in mice. DESIGN: Healthy mice, Mus musculus, were intraperitoneally injected with a 0.004% solution of As2O3 @1 ml/100 gms of body weight. Genotoxic effects were assessed through chromosome aberrations (CA), micronucleated erythrocytes (MNE), mitotic index (MI) and sperm head anomaly (SHA) studies, keeping suitable succussed alcohol fed (positive) and As2O3 untreated normal (negative) controls. The As2O3 treated mice were divided into three subgroups, which were orally administered with the drug a) prior to, b) after and c) both prior to and after injection of As2O3 at specific fixation intervals. RESULTS: While the CA, MNE and SHA were reduced in the drug fed series as compared to respective controls, the MI showed an apparent increase. The combined pre- and post-feeding of Arsenicum album was found to be most effective in reducing the genotoxic effects of As2O3 i200C was more effective than 30C. CONCLUSION: Arsenicum Album reduces the genotoxic effect of arsenic poisoning.

Administration, Oral↗

PubMed2004

Biochemical basis of polyvalency as a strategy for enhancing the efficacy of P-glycoprotein (ABCB1) modulators: stipiamide homodimers separated with defined-length spacers reverse drug efflux with greater efficacy.

Human P-glycoprotein (Pgp) is as an ATP-dependent efflux pump for a variety of chemotherapeutic drugs. The aim of this study is to evaluate whether Pgp modulators can be engineered to exhibit high-affinity binding using polyvalency. Five bivalent homodimeric polyenes based on stipiamide linked with polyethylene glycol ethers in the range of 3-50 A were synthesized and quantitatively characterized for their effect on Pgp function. The stipiamide homodimers displaced [(125)I]iodoarylazidoprazoin (IAAP), an analogue of the Pgp substrate prazosin. A minimal spacer of 11 A is necessary for inhibition of IAAP labeling, beyond which there is an inverse correlation between the length of the spacer and the IC(50) for the displacement of IAAP. ATP hydrolysis by Pgp on the other hand is stimulated by the dimers with spacers of up to 22 A, whereas dimers with longer spacers inhibit ATP hydrolysis. Finally, the homodimers reverse Pgp-mediated drug efflux in intact cells overexpressing Pgp, and 11 A is a threshold beyond which the effectiveness of the homodimers increases exponentially and levels off at 33 A. We demonstrate that dimerization and identification of an optimal spacer length increase by 11-fold the affinity of stipiamide, and this is reflected in the efficacy with which Pgp-mediated drug efflux is reversed. These results suggest that polyvalency could be a useful strategy for the development of more potent Pgp modulators.

ATP Binding Cassette Transporter, Subfamily B, Mem↗

PubMed2003

A randomized trial to assess the efficacy of interferon alpha in combination with ribavirin in the treatment of interferon alpha nonresponders with chronic hepatitis C: superior efficacy of high daily dosage of interferon alpha in genotype 1.

A randomized trial was conducted to assess the efficacy of daily (QD) or thrice weekly (TIW) administration of interferon-alpha (IFN) in high doses in combination with ribavirin (1.0-1.2 g/day) in patients with chronic hepatitis C (CHC) who were nonresponders to previous IFN monotherapy. Interferon was administered as 10 MU IFN (QD or TIW) for 4 weeks, followed by 5 MU IFN (QD or TIW) for 20 weeks, and then by 3 MU IFN (QD or TIW) for 24 weeks. Sustained virological response (SVR) was evaluated in 142 patients who received at least one dose of medication. One-fourth of the patients achieved SVR, 26% of those treated with IFN QD and 25% of those treated with IFN TIW (P = 0.85). For genotype 1 patients, SVR rates were 32.4 and 15.8% for IFN QD and IFN TIW, respectively, whereas for genotype non-1 patients the corresponding SVR rates were 20.6 and 36.4%, respectively (test of homogeneity: P = 0.031). This finding was further confirmed by multivariate logistic regression analysis where a statistically significant interaction (P = 0.012) was found between treatment and HCV genotype indicating that the IFN QD regimen was superior to IFN TIW among genotype 1 patients whereas, among genotype non-1 patients, the two treatments were similar (odds ratio of SVR in IFN QD vs IFN TIW: 3.33 among genotype 1 patients, 95% CI: 1.00-11.14). In conclusion, re-treatment of patients not responding to previous IFN monotherapy with a combination of high daily dose of IFN with ribavirin may be beneficial for genotype 1 infected patients.

Adolescent↗

PubMed2004

Long-term efficacy of routine access to antiretroviral-resistance testing in HIV type 1-infected patients: results of the clinical efficacy of resistance testing trial.

The long-term efficacy of making resistance testing routinely available to clinicians has not been established. We conducted a clinical trial at 6 US military hospitals in which volunteers infected with human immunodeficiency virus type-1 were randomized to have routine access to phenotype resistance testing (PT arm), access to genotype resistance testing (GT arm), or no access to either test (VB arm). The primary outcome measure was time to persistent treatment failure despite change(s) in antiretroviral therapy (ART) regimen. Overall, routine access to resistance testing did not significantly increase the time to end point. Time to end point was significantly prolonged in the PT arm for subjects with a history of treatment with > or =4 different ART regimens or a history of treatment with nonnucleoside reverse-transcriptase inhibitors before the study, compared with that in the VB arm. These results suggest that routine access to resistance testing can improve long-term virologic outcomes in HIV-infected patients who are treatment experienced but may not impact outcome in patients who are naive to or have had limited experience with ART.

Adult↗

PubMed1996

Concurrent oral poliovirus and rhesus-human reassortant rotavirus vaccination: effects on immune responses to both vaccines and on efficacy of rotavirus vaccines. The US Rotavirus Vaccine Efficacy Group.

Interference between oral poliovirus vaccine (OPV) and monovalent (RRV-S1) and tetravalent (RRV-TV) rhesus-human rotavirus vaccines was evaluated. Serum antibody responses to OPV and rotavirus vaccines and efficacy of rotavirus vaccines were compared among control and vaccine groups stratified by number of concurrent OPV and rotavirus vaccinations received. Neutralizing antibody titers to poliovirus type 1 tended to rise more steeply in placebo than RRV-TV recipients, but there were no significant differences in seroprevalence or in geometric mean titers (GMTs) of antibodies to types 1, 2, or 3 among groups. Concurrent OPV resulted in lower IgA GMTs to rotavirus in RRV-S1 but not RRV-TV recipients. Rotavirus gastroenteritis rates among rotavirus vaccines did not differ by number of concurrent OPV doses received, but the sample sizes were too small to rule out any effect. These results suggest OPV and rhesus-human rotavirus vaccines may be given at the same visit in the United States.

Administration, Oral↗

PubMed1986

Evaluation of the efficacy of split-product trivalent A(H1N1), A(H3N2), and B influenza vaccines: protective efficacy.

A total of 1,995 primary school children (1,464 vaccinees and 531 non-vaccinees) were studied to evaluate the protective efficacy of Tween-ether split trivalent A(H1N1), A(H3N2), and B influenza vaccines by comparison of the incidence of confirmed infection in two groups during 1980 to 1984. During the study period, epidemics caused by antigenically different influenza viruses, that is A(H1N1) epidemics in 1981 and 1984, a B epidemic in 1982 and an A(H3N2) epidemic in 1983, were experienced, and at the same time strains changed by antigenic drift were frequently isolated. In these epidemics, 61% to 87% of the children reported respiratory illnesses and 18% to 48% of the illnesses were influenza confirmed by seroconversion. Throughout these four epidemics, the incidence of confirmed infection among the vaccinees (7.8% to 33.8%) was 6.5% to 34.8% lower than that among the nonvaccinees (35.4% to 51.6%), demonstrating that the vaccine was effective (X2 = 76.34, P less than 0.001). However, this effectiveness was not seen in an epidemic in one of the entrant schools in 1984, possibly caused by a strain with intense antigenic drift. On the basis of data on incidence of various symptoms, duration of fever and the number of days of absence from class, it was considered that clinical symptoms in the vaccinees were milder than those in the nonvaccinees. When the titers of hemagglutination-inhibiting (HAI) antibody against the vaccine strains were measured, the protective level of HAI antibody giving less than or equal to 50% incidence of infection was 1:64, but it increased to 1:256 in the 1984 epidemic, reflecting the high rate of isolates with intense antigenic drift.

Child↗

PubMed2005

Efficacy of combination therapy for systolic blood pressure in patients with severe systolic hypertension: the Systolic Evaluation of Lotrel Efficacy and Comparative Therapies (SELECT) study.

Systolic hypertension is predominant among patients over 50 years of age, is a more important cardiovascular risk factor than diastolic blood pressure, and is more difficult to control than diastolic blood pressure. Consequently, the Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC 7) recommends combination therapy as first-line treatment for patients with stage 2 hypertension. In the Systolic Evaluation of Lotrel Efficacy and Comparative Therapies (SELECT) study, 24-hour ambulatory blood pressure monitoring was used to identify patients with systolic hypertension and to determine the impact of 8 weeks of treatment with either amlodipine besylate/benazepril HCl 5/20 mg combination therapy (n=149), amlodipine besylate 5 mg (n=146), or benazepril HCl 20 mg (n=148). Combination therapy was significantly more effective in reducing systolic blood pressure and pulse pressure than either monotherapy (p<0.0001). Significantly greater percentages of patients in the combination group compared with either monotherapy achieved blood pressure control (p<0.0001). Adverse events were low in all three treatment arms, with less peripheral edema in the combination group than in the amlodipine-treated group. The combination of amlodipine besylate/benazepril HCl given to patients with stage 2 systolic hypertension resulted in significantly greater reductions in blood pressure and pulse pressure than those seen with monotherapy and was at least as well tolerated as the separate components. This data supports the recommendation of the JNC 7 for the use of combination therapy in patients with stage 2 hypertension.

Aged↗

PubMed2004

The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) project: an open-label pragmatic randomised control trial comparing the efficacy of differing therapeutic agents for primary care detoxification from either street heroin or methadone [ISRCTN07752728].

BACKGROUND: Heroin is a synthetic opioid with an extensive illicit market leading to large numbers of people becoming addicted. Heroin users often present to community treatment services requesting detoxification and in the UK various agents are used to control symptoms of withdrawal. Dissatisfaction with methadone detoxification 8 has lead to the use of clonidine, lofexidine, buprenorphine and dihydrocodeine; however, there remains limited evaluative research. In Leeds, a city of 700,000 people in the North of England, dihydrocodeine is the detoxification agent of choice. Sublingual buprenorphine, however, is being introduced. The comparative value of these two drugs for helping people successfully and comfortably withdraw from heroin has never been compared in a randomised trial. Additionally, there is a paucity of research evaluating interventions among drug users in the primary care setting. This study seeks to address this by randomising drug users presenting in primary care to receive either dihydrocodeine or buprenorphine. METHODS/DESIGN: The Leeds Evaluation of Efficacy of Detoxification Study (LEEDS) project is a pragmatic randomised trial which will compare the open use of buprenorphine with dihydrocodeine for illicit opiate detoxification, in the UK primary care setting. The LEEDS project will involve consenting adults and will be run in specialist general practice surgeries throughout Leeds. The primary outcome will be the results of a urine opiate screening at the end of the detoxification regimen. Adverse effects and limited data to three and six months will be acquired.

Adolescent↗

PubMed1988

[Prospective study to assess the clinical efficacy of bone scintigraphy--comparative study of the efficacy in breast carcinoma and prostate carcinoma].

Prospective study of bone scintigraphy was performed on 414 patients with breast carcinoma and 88 patients with prostate carcinoma. In 468 of them, confirmative diagnoses of bone, whether metastasis was existent or not, were made after the observations over a year. Finally, the incidences of bone metastasis were 11 percent for breast carcinoma and 54 percent for prostate carcinoma respectively. The efficacy of preoperative bone scintigraphy in breast carcinoma was comparable to that in prostate carcinoma with regard to improvement of predictive probability of bone metastasis: raising up the probability in the positive cases and bringing down in the negative cases.

Bone Neoplasms↗

PubMed1999

What's the 'best buy' for treatment of constipation? Results of a systematic review of the efficacy and comparative efficacy of laxatives in the elderly.

Constipation is a common cause of general practice consultations in elderly people, and laxative use is common among this group of patients. However, there appears to be little evidence to guide laxative treatment in this population. This paper reports the results of a systematic review of randomized controlled trials of the efficacy of laxatives in the treatment of constipation in the elderly. While the results of the review suggest that laxatives can improve bowel movement frequency, stool consistency, and symptoms of constipation, with a few exceptions, the relevant trials have serious methodological shortcomings. However, the review finds little evidence of marked differences in effectiveness between laxatives and, in particular, there appears to be no evidence to support the current National Health Service (NHS) trend towards prescribing the more expensive stimulant laxatives. This is an area where good quality trial evidence is now needed.

Aged↗

PubMed1975

Investigations on the efficacy of surface disinfection and surface cleaning procedures. 2. Laboratory testing of the efficacy under conditions simulating those of real-life.

Using a standardised method (impression method by means of 'Rodac' plates and glass as well as ceramic surfaces as germ carriers) we tested for the efficacy of 3 surface disinfectants (aldehydes, aldehydes + detergent substances, phenol derivatives) and 3 disinfectant cleaning agents (aldehydes + detergent substances + wax) and 2 per cent soft soap solution on Staphylococcus aureus, Klebsiella pneumoniae and Sarcina lutea. The method enabled us to calculate the actual germ count reduction and also took account of the natural dying-rate of the test organisms. Their resistance to the different types of active substances varied greatly. Thus the 3 disinfectants had a better effect on Klebsiellae and Staphylococci than on Sarcinae. 2 of the 3 disinfectant cleaning agents, on the other hand, turned out to be less suitable for the elimination of Klebsiellae. It thus follows that Sarcina cannot be used as test organism for in-use tests (see Communication 1) unless the resistance of Staphylococci and Klebsiellae to the test preparation has first been established in laboratory experiments. The general question, namely whether in-use tests provide meaningful and accurate results remain to be elucidated. On the basis of our test results, the exclusive use of soap for cleaning floors, as a substitute of disinfection, should definitely be ruled out. Although soap reduces Gram-positive cocci well in actual practice, it is almost ineffective against problem germs such as Klebsiellae. What should be stipulated is the use of broad-spectrum disinfectants, i.e. they should, if possible, act equally well against different types of germs. From the commercially-available preparations that were tested, a phenol-base product gave the best results. On the basis of these results we venture to doubt that the use of aldehyde preparations which is customary at the moment, is the right approach to fight hospital infections.

Aldehydes↗

PubMed1990

A predictive parameter of antibacterial efficacy in vivo, based on efficacy in vitro and pharmacokinetics.

A method is described to predict the efficacy of antibiotics at changing concentrations in vitro or in an experimental thigh infection in granulocytopenic mice from the activity at constant concentrations in vitro, using pharmacokinetic parameters. The combinations studied were erythromycin against Staphylococcus aureus (in vitro and in vivo), four cephalosporins against two Gram-negative rods (in vivo), netilmicin against Pseudomonas aeruginosa (in vitro) and vancomycin against S. aureus (in vivo). The effect in vitro (ER) was defined as the difference between the growth rate without antibiotic and the growth rate in the presence of an antibiotic. The relationship between concentration and ER was described with the Hill equation. Using pharmacokinetic parameters of exponentially declining concentrations in vitro or of a bi-exponential concentration course in vivo together with the parameters of the Hill equation, the corresponding time course of ER was calculated. By integration with respect to time, an estimate, called ERt, was obtained of the effect on bacterial numbers, called EN, defined as the difference between the number of bacteria in the controls and the number in the presence of the antibiotics. For all antibiotics studied the value of ERt was significantly correlated with the actual values of EN.

Animals↗

PubMed1990

[Evaluation of the efficacy of oil chemoembolization for hepatocellular carcinoma by computed tomography: a proposal for altering the criteria to indicate the efficacy].

To evaluate the efficacy of oil chemoembolization for hepatocellular carcinoma (HCC), the authors have investigated computed tomography (CT) and pathological findings of 29 resected HCCs from 24 patients and have reached the following conclusions: (1) HCCs that showed a dense retention of Lipiodol within the whole tumor or showed no enhancement on contrast enhanced CT had a significantly higher necrosis rate (p less than 0.01) but were not always easy to evaluate; and (2) in 18 of the 29 tumors that had been observed by CT for 4 to 8 weeks after oil chemoembolization, 91% of those tumors which had a high necrosis rate (greater than or equal to 90%) showed a significant reduction rate that was 20% or greater (p less than 0.05). Based on these results, we propose altering the criteria to allow for the indication of 'partial response', that is, a decrease of 20% or greater in the size of the tumor, confirmed by CT measurement within 8 weeks after oil chemoembolization, and no new lesions or signs of progression in any existing lesion.

Adult↗

PubMed1984

Distalgesic; safety and efficacy. Efficacy: UK experience.

The UK experience of Distalgesic efficacy is examined, and 18 trials have been reviewed, of which only five were controlled and only three contained a placebo. Three trials are examined in detail and the problems of trial methodology discussed. The assessment of analgesic effect in chronic painful conditions presents considerable problems. Despite the fact that Distalgesic appears to be a useful analgesic in the clinical situation, long-term controlled studies of its effectiveness in chronic pain are still awaited.

Acetaminophen↗

PubMed1995

Comparative attributes for the description of the relative efficacy of therapeutic agents: general concepts and definitions, and application to the American Dental Association guidelines for the comparison of the clinical anticaries efficacy of fluoride dentifrices.

Comparative attributes are terms or phrases commonly employed in the vernacular of the biomedical literature to convey the results of comparative studies. Examples are such terms as "equivalent" or "superior." Recently, there has developed an increasing tendency in certain areas of application toward the institution of guidelines which provide both a uniform set of criteria for defining such attributes and a set of requirements which must be satisfied in order to demonstrate that such attributes may hold in a particular situation. The present paper provides a general discussion of comparative attributes, from which the application of the underlying concepts to any particular context might better be understood. Second, it provides an explicit and comprehensive discussion regarding the American Dental Associations's guidelines concerning the attributions of "superiority," "equivalence," and "at least as good as," as they are applied to the comparison of the clinical anticaries efficacy of fluoride dentifrices.

American Dental Association↗

PubMed1996

Efficacy and tolerability of manidipine hydrochloride in the long-term treatment of mild-moderate hypertension. Manidipine Efficacy in Long-Term Treatment Group.

The aim of this multicenter study was to evaluate the efficacy and tolerability of manidipine hydrochloride, a new calcium-antagonist of the dihydropyridine group, in the long-term treatment of mild to moderate hypertension. After a 2-week run-in period on placebo, 183 patients, 98 males and 85 females, with mean age of 53.8 years, sitting DBP > or = 95 and < or = 115 mmHg and SBP < or = 210 mmHg, were given manidipine 10 mg once daily. Two weeks later, patients whose DBP was > or = 90 mmHg or with a reduction in DBP < 10 mmHg were administered with manidipine 20 mg once daily. Follow-up visits were performed at 6, 10, 14, 26, 38 and 52 weeks after starting manidipine treatment. All BP (by mercury sphygmomanometer, Korotkoff I and V) and heart rate (HR) measures were made 24 h after dosing. Adverse events and laboratory data were recorded. Particular attention was paid to the collection of possible major cardiovascular (angina pectoris, myocardial infarction) and cerebrovascular (IRA, stroke) events, observed during the treatment period. One-hundred-and-fifty-one patients completed the study (79 on a 10 mg dose and 72 on a 20 mg dose), whereas 32 dropped out (11 lost to follow-up, 11 insufficient therapeutic response, 7 ADRs, 3 other causes). Significant reductions of BP values were achieved during the manidipine 10 mg treatment period. Analysis of covariance between doses confirmed a more potent hypotensive effect of manidipine 20 mg as compared to 10 mg on sitting DBP and mean BP and on standing SBP, especially in patients with moderate hypertension. At the end of 1 year of treatment the success rates (defined as sitting DBP > or = 90 mmHg or a reduction of > or = 10 mmHg vs baseline) were similar in the two groups (manidipine 10 mg: 96.1%; manidipine 20 mg: 94.5%). No clinically relevant change in HR was observed. Overall, 28 patients (17 in the manidipine 20 mg and 11 in the manidipine 10 mg treated group) complained of adverse events, the most common being ankle oedema (4.9%), headache (3.8%), palpitation (2.7%) and flushing (2.2%). Neither cardiovascular nor cerebrovascular events or other serious adverse event were reported. In conclusion, a significant and constant reduction of BP values was observed with long-term treatment with manidipine. The reduction in BP was dose-related especially in patients suffering from moderate hypertension. Adverse events were mild and relatively more frequent with the higher manidipine dosage.

Antihypertensive Agents↗

PubMed1998

[Therapeutic efficacy of benzoxazinorifamycin KRM-1648 against experimental murine tuberculosis: (1). A study on the efficacy of short course treatment with the intratracheal and intravenous infection model].

OBJECTIVES: This study aims to compare in vivo activity of benzoxazinorifamycin KRM-1648 (KRM) with those rifampicin (RFP) and rifabutin (RBT) against experimental murine tuberculosis. STUDY DESIGN: Mice were infected with Mycobacterium tuberculosis or M. bovis by the intratracheal (i.t.) or intravenous (i.v.) routes, and treated for 10 days with various doses of each drug starting from the 9th or 11th day after the TB-infection. RESULTS: (A) A rapid test for in vivo evaluation of three rifamycins was conducted by examining the survival days of treated mice infected with 106 cfu of M. bovis Ravenel. Mice treated with KRM exhibited 2.13.7 times longer survival times, in comparison with those treated with RFP or RBT. (B) In the i.t.-model of M. bovis Ravenel infection, three rifamycin derivatives gave "distinctive dose-response curves" in the correlation of dose sizes with the mean survival times or "log10CFU/lungs reductions". (C) In M. tuberculosis Kurono infection models, the ranking of the anti-TB activity of the three rifamycins in each organ was as follows: i.t.-and i.v.-lungs: KRM >> RFP not equal to RBT, i.v.-spleen: KRM not equal to RBT > RFP, i.v.-liver: KRM not equal to RBT > RFP. (D) Based on the results of "log10CFU reduction" in different organs in M. tuberculosis Kurono infection models, "characteristic in vivo activity patterns of each rifamycin" were obtained. (E) The therapeutic efficacy of KRM in lungs was greater than in spleen and liver with any dose. In contrast, RBT exhibited more remarkable in vivo activity in the spleen and liver than in lungs. CONCLUSION: The prominent in vivo activity of KRM may allow small dose for effective therapy; 1/3 dose or less in comparison with those of RFP or RBT, or intermittent therapy of tuberculosis.

Animals↗