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Early identification and management of treatment failure on highly active antiretroviral therapy (HAART) is crucial in maintaining a sustained response to therapy in HIV infection. However, HIV viral load (VL) and resistance testing, and second-line HAART regimens, are unaffordable to many patients in India, leaving them with limited treatment options. Predictors and reasons for antiretroviral switching, therefore, are likely to differ in settings of varying resources. A one-year, observational study of patients receiving antiretroviral therapy was conducted in a private, non-profit hospital in Bangalore. This paper examines the predictors and consequences of antiretroviral treatment switching in this setting and explores reasons for switching in a subset of patients. Data on demographics, drug regimens, adherence, and physical and psychosocial outcomes were collected quarterly. Tests of VL and CD4 cell counts were performed every six months. One-third of the patients switched therapy during the study period. Baseline predictors of switching included lower CD4 cell counts and more physical symptoms. Contrary to studies in other settings, a high VL did not predict treatment switching, and only a minority of those experiencing drug failure were switched to second-line regimens. Both groups (switchers and non-switchers) improved significantly over time with respect to CD4 counts and psychological well-being, and showed a reduction in physical and depressive symptoms. Any differences between the groups were no longer significant at the end of the study, once we controlled for baseline levels. Clinical, policy, and research implications of these findings are discussed within the context of resource-limited settings. [ABSTRACT FROM AUTHOR]

Sugarcane Press Mud (SPM) is a waste generated from the sugar industry. India generates about 12 million tonnes of SPM annually and hence, needs effective management. The present study delves into the use of SPM as a ternary blend in cement-lime stabilization of an expansive soil. An expansive soil was stabilized using a combination of 4.5% lime (determined from the Eades and Grim pH test) and a fixed cement content of 1%. The effect of the stabilization was studied by casting cylindrical specimens of dimensions 38 mm x 76 mm and curing them for periods of 7, 14 and 28 days. This process was modified by blending it with SPM as a ternary additive up to 5% in increments of 1%. The optimal dosage of SPM was evaluated for enhanced strength gain which was then subjected to a wet-dry cycle to understand the effect of variation in moisture content. The results of the investigation revealed that cement-lime stabilization of the soil was significantly better than lime stabilization alone. 1% SPM was found to be the optimal dosage required for maximum strength gain. Based on the results, it was concluded that ternary blending of SPM can potentially be beneficial in soil stabilization. [ABSTRACT FROM AUTHOR]

• A mathematical procedure for personalized medicine approach to IVF. • Real world patient data is used to validate the model and derive customized models for more than 50 patients. • Significant improvement in quantity of eggs of particular size is obtained by optimal control as compared to the dosage suggested by physicians. • Successful results of a small clinical trial results are also included. In vitro fertilization (IVF) is the most common technique in assisted reproductive technology and in most cases the last resort for infertility treatment. It has four basic stages: superovulation, egg retrieval, fertilization, and embryo transfer. Superovulation is a drug-induced method to enable multiple ovulation per menstrual cycle and key component towards a successful IVF cycle. Although there are the general guidelines for dosage, the dose is not optimized for each patient, and complications, such as overstimulation, can occur. To overcome the shortcomings of this general system, a mathematical procedure is developed which can provide a customized model of this stage regarding the size distribution of eggs (follicles/ oocytes) obtained per cycle as a function of the chemical interactions of the drugs used and the conditions imposed on the patient during the cycle, which provide a basis for predicting the possible outcome. Uncertainty and risk are modeled and included in optimal drug dosage decisions. This paper describes the theory, model, and the optimal control procedure for improving outcomes of IVF treatment for one of the four protocols used in real practice. The validation of the procedure is performed using clinical data from the patients previously undergone IVF cycles. Customized patient-specific model parameters are obtained by using initial two-day data for each patient. Subsequently, this model is used to predict the FSD for the remaining days of the cycle. This procedure was conducted for 49 patients. The results of the customized models are found to be closely matching with the observed FSD. These results thus validate the modeling approach and consequently its use for predicting the customized optimal drug dosage for each patient. Using the customized model and the optimized dosage, the FSD at the end of the cycle was determined. A small double-blind clinical trial was also conducted in India. The results from the trial show that the dosage predicted by using the model is 40% less than the suggestion made by the IVF clinicians. The testing and monitoring requirements for patients using optimized drug dosage is reduced by 72%. Work on the other three protocols and for patients in the USA is started and is showing promising results. [ABSTRACT FROM AUTHOR]

Carbapenem resistance presents severe threat to the treatment of multidrug resistant Pseudomonas aeruginosa infections. The study was undertaken to investigate the role of efflux pumps in conferring meropenem resistance and effect of single dose exposure of meropenem on transcription level of mexA gene in clinical isolates of P. aeruginosa from a tertiary referral hospital of India. Further, in this investigation an effort was made to assess whether different components of MexAB-OprM operon expresses in the same manner and the extent of contributions of those components in meropenem resistance in its natural host (P. aeruginosa) and in a heterologous host (E. coli). Out of 83 meropenem nonsusceptible isolates, 22 isolates were found to possess efflux pump activity phenotypically. Modified hodge test and multiplex PCR confirmed the absence of carbapenemase genes in those isolates. All of them were of multidrug resistant phenotype and were resistant to all the carbepenem drug tested. MexAB-OprM efflux pump was found to be overexpressed in all the study isolates. It could be observed that single dose exposure meropenem could give rise to trivial increase in transcription of mexA gene. Different constructs of MexAB-OprM (mexR-mexA-mexB-OprM; mexA-mexB-OprM; mexA-mexB) could be expressed in both its natural (P. aeruginosa PAO1) and heterologous host (E. coli JM107) but transcription level of mexA gene varied in both the hosts before and after single dose exposure of meropenem. Different components of the operon failed to enhance meropenem resistance in E. coli JM107 and P. aeruginosa PAO1. This study could prove that MexAB-OprM efflux pump can significantly contribute to meropenem resistance in hospital isolates of P. aeruginosa where an acquired resistant mechanism is absent. Thus, equal importance should be given for diagnosis of intrinsic resistance mechanism so as to minimize treatment failure. As meropenem could not enhance mexA transcriptions significantly, there might be a possibility that the increase in expression of efflux pump genes does not mediated by single antibiotic but rather by a combination of antipseudomonal drugs which are used during treatments. Early detection of efflux genes will help in selection of proper therapeutic options. [ABSTRACT FROM AUTHOR]

Introduction: Coronary heart disease is one of the most common cardiac health problem in India. Anti-platelet therapy is the cornerstone in the management of coronary heart disease. The current study was undertaken to compare the effect of different oral anti-platelet regimens on percentage inhibition of platelet aggregation in coronary heart disease patients using chronolog light transmittance aggregometry. Material and Methods: Blood samples of 215 consecutive patients diagnosed of coronary heart disease (Male: Female ratio- 142: 73) with mean age of 55.2 ±10.3 years, who underwent platelet aggregation test were analysed. Patients were either on aspirin, clopidogrel, prasugrel, cilostazol or a combination of these drugs in different dosages. Of the 215 coronary heart disease patients, 35, 115 and 65 patients were on single, dual and triple anti-platelet drug regimen respectively. Results: The Percentage Inhibition of Platelet Aggregation (%IPA) in patients on dual anti-platelet regimen was highest i.e., 65.14 ± 23.23 as compared to 48.89 ± 22.16 in patients on monotherapy and 62.14 ± 21.64 in patients on triple anti-platelet regimen. Percentage of responders (> 40% inhibition of platelet aggregation) were 54.28%, 73.91% and 64.61% in single, dual and triple drug regimens respectively. Among responders on dual anti-platelet regimen, 64.7% were on aspirin + prasugrel and 35.3% were on aspirin + clopidogrel. The Percentage Inhibition of platelet aggregation in diabetics on dual anti-platelet regimen was 71.69 ± 17.54 as compared to 56.14 ± 23.29 in diabetics on triple anti-platelet regimen. Conclusion: Dual anti-platelet therapy containing prasugrel was found to be more effective than dual anti-platelet therapy containing clopidogrel on background aspirin therapy and triple anti-platelet therapy in terms of percentage inhibition of platelet aggregation in coronary heart disease patients especially those with concomitant diabetes, however this conclusion needs to be further confirmed by large-scale randomized clinical trials. [ABSTRACT FROM AUTHOR]

Objective: To evaluate the effect of the second dose of measles vaccine on measles antibody status during childhood. Setting: Immunization centre of Under-five Clinic of the Department of Community Medicine at a tertiary-hospital. Design: Randomized Controlled trial. Methods: Blood samples were collected from all subjects for baseline measles serology by heel puncture at 9-12 months of age. All subjects were given the first dose of measeis vaccine. At second visit (3-5 months later), after collecting the blood sample from all, half the children were randomized to receive the second dose of measles vaccine (study group), followed by collection of the third sample six weeks later in all the subjects. Results: A total of 78 children were enrolled and 30 children in each group could be analyzed. 11(36.6%) children in the study group and 13 (43.3%) children in the control group had protective levels of measles IgG at baseline. Around 93.3 % of children in the study group had protective measles antibody titers as against 50% in the control group at the end of the trial. The Geometric Mean Titre (GMT) of measles IgG increased from 14.8NTU/mLto 18.2 NTU/mL from baseline to six weeks following receipt of the second dose of the vaccine in the study group, as compared to a decrease from 16.8 NTU/mL to 12.8 NTU/mL in the control group. Conclusions: A second dose of measles vaccine boosts the measles antibody status in the study population as compared to those who receive only a single dose. [ABSTRACT FROM AUTHOR]

We evaluated the herd protection conferred by the bivalent killed oral cholera vaccine. The vaccine conferred significant herd protection, suggesting that significant public health impact in cholera control may be achieved even with modest vaccination coverage.Background. We evaluated the herd protection conferred by an oral cholera vaccine using 2 approaches: cluster design and geographic information system (GIS) design.Methods. Residents living in 3933 dwellings (clusters) in Kolkata, India, were cluster-randomized to receive either cholera vaccine or oral placebo. Nonpregnant residents aged ≥1 year were invited to participate in the trial. Only the first episode of cholera detected for a subject between 14 and 1095 days after a second dose was considered. In the cluster design, indirect protection was assessed by comparing the incidence of cholera among nonparticipants in vaccine clusters vs those in placebo clusters. In the GIS analysis, herd protection was assessed by evaluating association between vaccine coverage among the population residing within 250 m of the household and the occurrence of cholera in that population.Results. Among 107 347 eligible residents, 66 990 received 2 doses of either cholera vaccine or placebo. In the cluster design, the 3-year data showed significant total protection (66% protection, 95% confidence interval [CI], 50%–78%, P < .01) but no evidence of indirect protection. With the GIS approach, the risk of cholera among placebo recipients was inversely related to neighborhood-level vaccine coverage, and the trend was highly significant (P < .01). This relationship held in multivariable models that also controlled for potentially confounding demographic variables (hazard ratio, 0.94 [95% CI, .90–.98]; P < .01).Conclusions. Indirect protection was evident in analyses using the GIS approach but not the cluster design approach, likely owing to considerable transmission of cholera between clusters, which would vitiate herd protection in the cluster analyses.Clinical Trials Registration. NCT00289224. [ABSTRACT FROM PUBLISHER]

BACKGROUND: Mass drug administration (MDA), which means once in-a-year administration of diethyl carbamazine (DEC) tablet to all people (excluding children under 2 years, pregnant women and severely ill persons) in identified endemic areas. OBJECTIVES: 1. To study the compliance of MDA and its determinants in rural areas of Bilagi taluk. 2. To study the reasons for non compliance STUDY DESIGN: A cross sectional study STUDY SETTING: Rural areas of Bilagi taluk belonging to Bagalkot district, Karnataka state, identified as endemic areas of Filariasis where MDA 2008 was undertaken SAMPLE SIZE: 10% of families from each cluster totaling to 5512 population from 30 clusters. SAMPLING METHOD : Two stage sampling method (stratified and 30 cluster sampling method) RESULTS: 77.34% of study population consumed the DEC and 22.66% did not consume DEC. 97% of the children in the age group of 6-14 years consumed DEC and 88% of the children in the age group 2-5 years consumed the DEC. Compliance in age group of 15-60 years was 73%. Compliance in females was 79% as compared to males 75.56%. 88.27% of individuals were motivated by the head of the family who consumed DEC. Compliance of DEC consumption was significantly higher when distributed by teacher. [ABSTRACT FROM AUTHOR]

Context: In India, phenytoin is often prescribed as twice daily or thrice daily dosage schedules. In the West, this practice has been changed to a once daily regimen in most of the cases. Can we in India follow suit? Is our physical and genetic make up with regards to the phenytoin pharmacokinetics different? Does this necessitate a multiple dosing regimen to avoid adverse effects or even breakthrough seizures? Aims: This study was aimed at comparing 300mg once daily of phenytoin and 100mg tid of phenytoin in terms of its adverse effects, peak and trough serum concentrations. Settings and Design: Out patients attending the Neurology Department, Christian Medical College, Vellore, India. This was a prospective, randomized, double blinded, crossover study. Methods and Materials: Twenty-four patients were enrolled into the study. An informed consent was taken from them. Their liver and renal functions were checked. Their basal phenytoin levels were also estimated. Once the preliminary tests were found to be normal, the patients were inducted randomly into one of the two treatment arms, either 300mg once daily or 100mg thrice daily. Each arm was given for a 2 week period. Adverse effects were looked for and the peak and trough phenytoin concentrations were estimated. Statistical Analysis Used: The mean, SD and the P values were obtained by the Per Protocol and the ITT (Intention to Treat) analysis of the trough and peak serum levels by using Wilcoxon's signed rank test. Results: One patient experienced an adverse effect in the once daily regimen as compared to no adverse effects in the tid regimen. The adverse effect was not consequential to the patient. Statistically, the trough concentrations were not significantly different between the regimens, although the peak concentrations of the once daily regimen were significantly higher. Conclusions: In conclusion, it can be said that the once daily regimen can be prescribed for Indian patients with epilepsy. [ABSTRACT FROM AUTHOR]

Objective: The aim of the present study was to compare the pharmacokinetic properties, bioavailability and tolerability of artesunate (AS) and amodiaquine (AQ) administered as a fixed-dose combination (Amonate FDC tablets; Dafra Pharma, Turnhout, Belgium) or as a non-fixed dose combination of separate AS tablets (Arsuamoon; Guilin Pharmaceutical Co, Shanghai, China) and AQ tablets (Flavoquine; Sanofi-Aventis, Paris, France). Methods: This was a randomized, open label, two-period, two-treatment, two-sequence, cross-over study in which 60 healthy male Indian volunteers were given a single total oral dose of 100 mg AS and 400 mg AQ hydrochloride either as two tablets of Amonate FDC (AS 50 mg and AQ hydrochloride 200 mg) or as two AS tablets of the co-blister Arsuamoon (50 mg AS) together with two Flavoquine tablets (200 mg AQ hydrochloride). Plasma AS and blood AQ concentrations, as well as those of their respective active metabolites dihydroartemisinin (DHA) and desethylamodiaquine (DEAQ), were measured by high-performance liquid chromatography-tandem spectrometry. The pharmacokinetic parameters of AS, DHA, AQ and DEAQ were determined by non-compartmental analysis. Bioequivalence assessment was performed by analysis of variance (ANOVA), and calculation of the 90% confidence intervals of the geometric mean ratio test (fixed)/reference (non-fixed) for AUC and C for AS, AQ, DHA and DEAQ. Results: Interim analysis showed that both treatments were not bioequivalent; therefore, statistical analysis was carried out on the results of all subjects for whom blood/plasma concentrations were available for all four analytes ( n = 26). The C (maximum plasma/blood concentration) of AS was 67.0 ± 37.1 and 154.8 ± 116.2 ng/mL for the fixed-dose and non-fixed dose administration, respectively. The AUC (area under the plasma concentration-time curve from time zero to the last measurable concentration) of AS was 60.1 ± 27.5 and 81.8 ± 44.3 ng h/mL for the fixed-dose and non-fixed dose administration, respectively. The 90% confidence intervals for C and AUC of AS were outside the 80-125% acceptance range: 37.02-61.62% and 70.10-83.47%, respectively. The C of AQ was 33.8 ± 13.6 and 31.4 ± 14.1 ng/mL for the fixed-dose and non-fixed dose administration, respectively. The AUC of AQ was 332.3 ± 116.6 and 329.8 ± 99.5 ng h/mL for the fixed and non-fixed dose administration, respectively. For AQ, the 90% CIs for C and AUC were within the 80-125% acceptance range: 99.17-121.71 and 89.53-107.35%, respectively. Bioequivalence assessment based on the active metabolite data supported the bioequivalence conclusions based on the parent compound data. Both the fixed-dose and non-fixed dose administration of 100 mg AS and 400 mg AQ were well tolerated. Conclusion: Bioequivalence of the fixed-dose AS/AQ formulation with the non-fixed dose combination of the same drugs was not demonstrated for AS, but it was shown for AQ for both C and AUC. The results obtained on the active metabolites support this conclusion. Overall, the fixed-dose 50 mg AS/200 mg AQ tablets were not technically bioequivalent with 50 mg AS tablets and 200 mg AQ tablets administered separately. The difference cannot be explained by the pharmaceutical properties of the tablets and seems to be biologically related. [ABSTRACT FROM AUTHOR]

Introduction: The outbreak of cholera in Zimbabwe intensified interest in the control and prevention of cholera. While there is agreement that safe water, sanitation, and personal hygiene are ideal for the long term control of cholera, there is controversy about the role of newer approaches such as oral cholera vaccines (OCVs). In October 2009 the Strategic Advisory Group of Experts advised the World Health Organization to consider reactive vaccination campaigns in response to large cholera outbreaks. To evaluate the potential benefit of this pivotal change in WHO policy, we used existing data from cholera outbreaks to simulate the number of cholera cases preventable by reactive mass vaccination. Methods: Datasets of cholera outbreaks from three sites with varying cholera endemicity-Zimbabwe, Kolkata (India), and Zanzibar (Tanzania)-were analysed to estimate the number of cholera cases preventable under differing response times, vaccine coverage, and vaccine doses. Findings: The large cholera outbreak in Zimbabwe started in mid August 2008 and by July 2009, 98,591 cholera cases had been reported with 4,288 deaths attributed to cholera. If a rapid response had taken place and half of the population had been vaccinated once the first 400 cases had occurred, as many as 34,900 (40%) cholera cases and 1,695 deaths (40%) could have been prevented. In the sites with endemic cholera, Kolkata and Zanzibar, a significant number of cases could have been prevented but the impact would have been less dramatic. A brisk response is required for outbreaks with the majority of cases occurring during the early weeks. Even a delayed response can save a substantial number of cases and deaths in long, drawn-out outbreaks. If circumstances prevent a rapid response there are good reasons to roll out cholera mass vaccination campaigns well into the outbreak. Once a substantial proportion of a population is vaccinated, outbreaks in subsequent years may be reduced if not prevented. A single dose vaccine would be of advantage in short, small outbreaks. Conclusions: We show that reactive vaccine use can prevent cholera cases and is a rational response to cholera outbreaks in endemic and non-endemic settings. In large and long outbreaks a reactive vaccination with a two-dose vaccine can prevent a substantial proportion of cases. To make mass vaccination campaigns successful, it would be essential to agree when to implement reactive vaccination campaigns and to have a dynamic and determined response team that is familiar with the logistic challenges on standby. Most importantly, the decision makers in donor and recipient countries have to be convinced of the benefit of reactive cholera vaccinations. [ABSTRACT FROM AUTHOR]

Solasodine (1) was isolated for the first time from the roots of Solanum trilobatum Linn., a member of the Solanaceae, and assessed for its presumed antinociceptive activity using several experimental murine models, viz. the writhing, formalin, and hot plate tests. When used at doses of 2, 4, and 8 mg/kg, this steroidal alkaloid caused a significant and dose-dependent decrease in the nociception induced by an intraperitoneal injection of acetic acid (p < 0.001). It also led to a significant reduction of the painful sensation caused by formalin in both phases of the formalin test (p < 0.001). Furthermore, the alkaloid produced a significant increase in the reaction time in the hot plate test (p < 0.001). These results suggest that solasodine elicited antinociceptive activity through both central and peripheral mechanisms. [ABSTRACT FROM AUTHOR]

This report describes a noninterventional audit of current patient-controlled analgesia (PCA) use in an Indian cancer hospital over a 1-year period. Because there appeared to be an underutilization of PCA in the authors’ hospital, they performed this audit. A major reason to start PCA was inadequate analgesia despite ongoing epidural or standard PRN analgesic regimes, especially in thoracic, major abdominal, and pelvic bone surgeries. PCA was used for an average 52.13 hours. The reason to stop the PCA in 72 patients was minimal usage due to decreased need after the second postoperative day. Multiple triggers at the same time were a common problem encountered in 21 patients. A blocked intravenous (IV) line was encountered in 12 patients. Thirty-one patients ranked their pain relief with PCA as excellent and 39 patients stated it as good. Their protocols shall be suitably amended to ensure that PCA shall be used in immediate postoperative period as a principal modality of pain relief, especially in the above-mentioned group in absence of epidural analgesia. [ABSTRACT FROM AUTHOR]

Background: The present pilot study investigating the minimum dose for short-course single and double-dose treatment of kala-azar with an apparently new liposomal formulation of amphotericin B, Fungisome, led to identification of immunological components for early detection of success and/or failure to cure. Methods: Patients were treated with 5, 7.5 (single-dose) and 10 mg/kg body weight (5 mg/kg double-dose) of Fungisome. Immunological investigations involving plasma cytokines and antigen-specific lymphoproliferation and cytokine responses from PBMCs were carried out before, 1 week after Fungisome treatment, at the time of relapse, and again after conventional amphotericin B treatment. Results: At 1-month follow-up all the patients showed 100% initial cure. However, total doses of 5, 7.5 and 10 mg/kg Fungisome showed 60%, 50% and 90% cure, respectively, at 6-months posttreatment. Patients successfully cured demonstrated downregulation of IL-12 and IL-10 in plasma, and two-fold or more elevation of IFN-c, IL-12 and TNF, and significant down-regulation of IL-10 and TGF-b in culture supernatants 1-week posttreatment irrespective of drug-dose. A differential immune profile, involving insignificant decline in IL-10 and IL-12 in plasma and negligible elevation of IFN-c, IL- 12 and TNF, and persistence of IL-10, despite decline in TGF-b in culture supernatants, in apparently cured individuals, corresponded with relapse within 6-months of treatment. Conclusion: Immunological investigations revealed significant curative and non-curative immunomodulation 1-week posttreatment, correlating with successful cure and relapse, respectively. Although immune-correlation was doseindependent, almost consistent curative response in patients treated with the highest dose 10 mg/kg reflected a definitive impact of the higher-dose on the immune response. [ABSTRACT FROM AUTHOR]

Abstract  A temephos-induced resistance in Aedes aegypti that was developed for 24 generations exhibited 20.3-fold resistance as compared to susceptible strain. The diagnostic dose of temephos 0.02 mg/l exhibited gradual decrease in larval mortality with the progression of generations. An operational dose (1 mg/l) exhibited the LT50 value of 41.42 min in the susceptible population, whereas the value of the resistant population increased to 72.62, 108.86, 122.34, 182.03, 244.82 and 304.86 min in the fourth, eighth, 12th, 16th, 20th and 24th generation, respectively. The study carried out showed 120 min as the cut-off limit for differentiation between susceptible and resistant A. aegypti. Cross-resistance studies showed a varied degree of cross-resistance to fenthion, chlorpyrifos, malathion and DDT, whereas comparatively higher cross-resistance was observed to chlorpyrifos. Study on diagnostic doses of insecticides to A. aegypti females indicated a gradual decrease in adult mortality at every eighth generation as compared to susceptible population when exposed to malathion 0.8%, fenthion 0.25%, DDT 4%, permethrin 0.25% and temephos 6.5%, whereas little or no change in mortality when exposed to λ-cyhalothrin 0.03% and propoxur 0.1%, was observed. Thus, the expression of larval resistance was observed in adult stages also. [ABSTRACT FROM AUTHOR]

Justification: The indications and doses of most drugs used for heart ailments in children are extrapolated from data in adult patients. Separate guidelines are needed for neonates, infants and children because of the differences in underlying heart diseases and metabolic clearance of some of these drugs. Process: Consensus emerged following expert deliberations at the National Meeting on Management of Congenital Heart Diseases in India, held on 13 September 2008, at the All India Institute of Medical Sciences, New Delhi, India, supported by Pediatric Cardiac Society of India. Objectives: To review the literature and frame evidence based guidelines for (i) indications, doses, adverse effects and safety profile of commonly used drugs in pediatric cardiology practice; and (ii) to provide an algorithm for treatment in various clinical settings. Recommendations: Consensus review and recommendations are given for drugs used in children for heart failure, hypertension, thrombosis, supraventricular tachycardia and intensive care. Guidelines are also given for use of intravenous immunoglobulins and sildenafil in children. [ABSTRACT FROM AUTHOR]