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Background: Caesarean section has been a part of human culture since ancient times. It has been used effectively throughout the 20th century and among the major abdominal surgeries, it is the most common, oldest worldwide surgery performed in obstetrics. Despite the life saving advantages, there are several adverse consequences of caesarean delivery for a woman and to her household. The rate and risk of these complications increases due to the increasing incidence mainly in countries like India. The role of nurse midwife is to act in the best interest of patient and newborn and make the patient independent in carrying out the activities of daily living as soon as possible. This can lead to a faster recovery and shorter hospital stay. Also it can indirectly help in reducing the complications associated with prolonged bed rest and can improve the maternal newborn bonding. Aim and Objectives: The present study was done to evaluate the effect of planned early ambulation on selected biophysiological health parameters of post caesarean patients. Material and Methods: The study included total 500 study subjects, 250 in experimental and 250 in control group. Quasi experimental approach with multiple time series design was adopted for the study. The experimental group was given an early planned recommended ambulation technique starting from the day of surgery. This consisted of deep breathing exercise, cough exercise, leg exercise and early mobilization. Over and above, the routine general health care was given by the doctors and nurses. The control group received only by routine general care by doctors and nurses and mobilization on third post operative day as per strategy adopted by the hospital. The deep breathing exercises, coughing exercises and leg exercises were not given routinely and hence were not given to the control group. Post caesarean biophysiological parameters chart was used to assess the selected parameters for first five post operative days. Result: The significant findings of the study were that there was a significant difference in the proportions of normal observations of selected biophysiological health parameters like incisional pain, condition of breast, condition of abdomen and peristaltic movements of experimental group as compared to that of control group. All these parameters improved significant during first five post caesarean days at 0.05 level of significance. Thus the alternative hypothesis was accepted and null hypothesis was rejected. From the present study it could be concluded that the early planned ambulation is an effective strategy for post operative management of caesarean patient. It can help in avoiding morbidity and can enhance the early recovery of the patient. [ABSTRACT FROM AUTHOR]

Background. Efficacy of standard dose of primaquine (PQ) as antirelapse for P. vivax has decreased. We aimed to assess efficacy of different PQ regimens. Methods. It was an open label, randomized, controlled, parallel group, assessor blind study comparing antirelapse efficacy of 3 PQ regimens (B = 15 mg/day × 14 days, C = 30 mg/day × 7 days, and D = 30 mg/day × 14 days) with no PQ group (A) in P. vivax patients. Paired primary and recurrence samples were subjected to 3 methods: (i) month of recurrence and genotyping, (ii) by PCR-RFLP, and (iii) PCR sequencing, to differentiate relapse and reinfection. The rates of recurrence relapse and reinfection were compared. Methods were compared for concordance between them. Results. The recurrence rate was 16.39%, 8.07%, 10.07%, and 6.62% in groups A, B, C, and D, respectively (P = 0.004). The relapse rate was 6.89%, 1.55%, 4%, and 3.85% as per the month of recurrence; 8.2%, 2%, 4.58%, and 3.68% (P = 0.007) as per PCR-RFLP; and 2.73%, 1.47%, 1.55%, and 1.53% as per PCR sequencing for groups A, B, C, and D, respectively. The concordance between methods was low, 45%. Conclusion. The higher recurrence rate in no PQ as compared to PQ groups documents PQ antirelapse activity. Regimens tested were safe. However, probable resistance to PQ warrants continuous monitoring and low concordance and limitations in the methods warrant caution in interpreting. [ABSTRACT FROM AUTHOR]

BACKGROUND: In patients with persistent fever and netropenia, amphotericin B is administered empirically for early treatment and prevention of systemic fungal infections. Despite this treatment, there are chances of breakthrough fungal infections and drug is also toxic. MATERIALS AND METHODS: A multicentric, randomized, controlled clinical trial was conducted to compare liposomal amphotericin B two doses with conventional amphotericin B as empirical antifungal therapy. RESULTS:The average body weight of patients was 26.4±14.8 (n=22), 32.9±19.4 (n=23) and 37.9±20.0 (n=20) kg in 1 mg, 3 mg Fungisome (liposomal amphotericin B) and 1 mg/kg/day conventional amphotericin B group, respectively. The mean age was 16.2±13.4, 16.0±10.9 and 22.7±16.2 yrs in 1 and 3 mg/kg/day Fungisome and 1 mg/kg/day conventional AMP B group, respectively. The average duration of treatment with 1 mg and 3 mg/kg/day Fungisome and 1 mg/kg/day conventional amphotericin B was 17±9.8, 16.2±8.3, and 14.7±10.7 days, respectively. The time to resolve fever was 13.3±10.2, 10.9±7.1, 10.1±6.7 days, and for absolute neutrophil count (ANC) to be above 500 cells per microliter, it took 13.4±9.6, 10.6±7.6 and 7.3±3.4 days, respectively. Liposomal formulations were well-tolerated compared to conventional amphotericin B. CONCLUSIONS: This small randomized study showed that the indigenous liposomal formulation Fungisome™ appears to be equally efficacious and safer than conventional amphotericin B. Also, the lower dose Fungisome (1 mg/kg/day) appears to be equally efficacious and was well-tolerated as compared to higher dose Fungisome (3 mg/kg/day). Treatment cost would be a major factor for limiting use of higher dose of Fungisome. [ABSTRACT FROM AUTHOR]

Adverse drug reactions (ADRs) are considered as one of the leading causes of death among hospitalized patients. Thus reporting of adverse drug reactions become an important phenomenon. Spontaneous adverse drug reaction reporting form is an essential component and a major tool of the pharmacovigilance system of any country. This form is a tool to collect information of ADRs which helps in establishing the causal relationship between the suspected drug and the reaction. As different countries have different forms, our aim was to study, analyze the suspected adverse drug reaction reporting form of different countries, and assess if these forms can capture all the data regarding the adverse drug reaction. For this analysis we identified 18 points which are essential to make a good adverse drug reaction report, enabling proper causality assessment of adverse reaction to generate a safety signal. Adverse drug reaction reporting forms of 10 different countries were collected from the internet and compared for 18 points like patient information, information about dechallenge-rechallenge, adequacy of space and columns to capture necessary information required for its causality assessment, etc. Of the ADR forms that we analyzed, Malaysia was the highest scorer with 16 out of 18 points. This study reveals that there is a need to harmonize the ADR reporting forms of all the countries because there is a lot of discrepancy in data captured by the existing ADR reporting forms as the design of these forms is different for different countries. These incomplete data obtained result in inappropriate causality assessment. Copyright © 2010 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: There is need to investigate the use of liposomal amphotericin B in cryptococcal meningitis in India. Aims: To compare the efficacy, safety, duration of treatment and cost of two doses of liposomal amphotericin B (Amp B) (Fungisome™) in cryptococcal meningitis in HIV/AIDS patients. Settings and Design: Prospective, randomized, multicenter study in tertiary care hospitals across India. Materials and Methods: Adult patients with culture-proven cryptococcal meningitis with HIV/AIDS were randomized to receive either 1 (Group A) or 3 mg/kg/day of Fungisome (Group B). Clinical efficacy and tolerability, laboratory evaluations and mycological response were assessed daily, twice weekly and weekly respectively. The patients were assessed at four and eight-week follow-up. Statistics: We calculated average and standard deviation for the various parameters. Results: The time to show clinical response was 13.66 days (1 mg) and 9.55 days (3 mg). In Group B (n=6 complete response), 50% patients responded within one week by microbial conversion, 83% in two weeks and 100% in three weeks. Patients with 1 mg dose (n=4 complete response), none showed microbial conversion within one week, 75% responded in two weeks, whereas one patient took four weeks. The average duration of treatment was 36.5±14.4 and 26.5±5.89 (S.D.) days in 1 and 3 mg/kg/day respectively. Drug was tolerated with little renal, hepatic or hematological toxicity. The cost was found to be 3.81 lacs and 1.74 lacs with 3mg/kg/day and 1mg/kg/day respectively. Conclusion: Higher dose showed better efficacy and quicker microbial conversion of Cerebrospinal fluid (CSF) (cerebrospinal fluid) than 1 mg/kg/day. It shortened the duration of treatment in days by 27% while drug cost almost doubled (Clinical trial registration number: ISRTCN 52812742). [ABSTRACT FROM AUTHOR]

A medical system is called traditional, among others, when it is practiced within the country of its origin. The increasing use of Traditional Medicine (TM) worldwide and the growth of the related pharmaceutical industry has led to an activation of research regarding its quality, efficacy and safety. The Ayurveda and Siddha systems of traditional medicine have their origin in India. Of these, Ayurveda is one of the oldest systems of medicine in the world and the most commonly practiced form of traditional medicine in India. Subjects to be discussed comprise of issues related to herb–drug interactions, misuse of TM, variations in the action of a drug due to natural and deliberated reasons and the documentation of adverse drug reaction. Combined efforts, without any bias, by scholars from both traditional and modern medicine to optimize the risk benefit profile and to serve as guards for optimal use of TM, is the prerequisite for global harmonization. [ABSTRACT FROM AUTHOR]

Objective: The primary objective of this study was to investigate the pharmacokinetics of nimesulide 1 mg/kg administered intramuscularly in healthy Indian volunteers. The secondary objective was to compare the tolerability of the formulation versus placebo (vehicle only). Design: A randomised, crossover, assessor-blind study in 13 healthy Indian volunteers. Setting: The study was conducted in a clinical pharmacology ward at the KEM Hospital, a tertiary referral centre, in Mumbai (Bombay), India. Subjects: Healthy male Indian volunteers who satisfied the inclusion/exclusion criteria were enrolled for the study. Interventions: All subjects received a 1 mg/kg single dose of both the active drug (a light yellow-coloured, particle-free liquid with a pH between 3.5 and 5.5) and placebo with a 2-week washout period in between. The intramuscular route was used to obtain rapid onset of action. Blood samples for pharmacokinetic analysis were collected at 0, 15, 30, 45, 60, 75 and 90 minutes and 2.0, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 6.0, 7.0, 8.0, 10.0, 12.0, 18.0, 24.0, 36.0 and 48.0 hours. Safety was measured by pre- and post-drug biochemical investigations, ECG and physical examination, while tolerability was assessed by pain as perceived by the subject. Outcome measures: The pharmacokinetics of nimesulide and its metabolite were calculated by maximum plasma concentration (C), time to reach C(t), area under the concentration versus time curve from time zero to 48 hours (AUC) and from time zero to infinity (AUC), clearance and volume of distribution. Conclusion: The 1 mg/kg dose gave a mean C of 2.36 ± 0.94 mg/L, and t was 2.73 ± 1.07h. The AUC was 22.57 ± 7.67 μg•h/ml and AUC was 23.96 ± 7.59 μg•h/ml. For the 4-hydroxy-nimesulide metabolite, C was 0.76 ± 0.33 mg/L and t was 5.04 ± 1.34h. All 13 subjects experienced pain with the active drug, while 12 of 13 subjects had pain when receiving placebo. This difference was not statistically significant. Parenteral NSAIDs have shown good analgesic efficacy in general surgery coupled with the advantage of an opioid-sparing effect. The 1 mg/kg dose of this nimesulide formulation can be used as the starting dose for Phase II clinical studies. [ABSTRACT FROM AUTHOR]

Therapeutic Drug Monitoring (TDM) was introduced in India in the mid and late 1980s and the last 10 years have seen it grow, together with the growth of separate Clinical Pharmacology departments. The TDM service in the country is broadly of two types: in large teaching hospitals where the service is available through departments of Clinical Pharmacology, and in the private sector, where drug estimations are done by clinical biochemistry departments with minimal interpretation. This article is based on literature review and our own experiences over a 10 year period in a department of Clinical Pharmacology. It focuses on the evolution of TDM, its problems such as lack of funding, special aspects such as the impact of ethnic diff;erences, nutritional defi;ciencies, quality of medicines and availability of generic products; its utility as a research tool and its future. [ABSTRACT FROM AUTHOR]

A total of 40 cases of neonatal convulsions of different nonmetabolic aetiological factors were studied. Patients with kernicterus were included in the study. Peak plasma phenobarbital concentrations after incremental loading doses of phenobarbital i.e. 10 mg/kg, 15 mg/kg, and 20 mg/kg were determined. Diphenylhydantoin was added if phenobarbital alone was unable to control seizures. In three patients, a combination of phenobarbital and diphenylhydantoin was used as the initial loading therapy. Increase in the loading dose of phenobarbital was associated with an increase in its peak plasma concentration. Despite increase in the plasma phenobarbital concentration beyond the 'therapeutic' levels suggested by the Western studies, doses of 15 mg/kg and 20 mg/kg of phenobarbital were unable to score over the traditional regimen of 10 mg/kg. Convulsions were controlled in 50% of the patients with any of these three regimens, irrespective of the aetiology. Convulsions were controlled in 7 out of the 9 cases where diphenylhydantoin was added, because of the failure of phenobarbital in controlling the convulsions as a single drug. Convulsions of all the three patients, in whom a combination of phenobarbital and diphenylhydantoin was used by random selection as the initial bolus, were controlled. Seizure effects were difficult to distinguish from drug effects but major side effects were not encountered despite the fluctuating drug levels in the sick neonate. [ABSTRACT FROM AUTHOR]

Seven children suffering from JRA, eight cases of rheumatic arthritis and nine rheumatic carditis patients were given 100 mg/kg/24 h aspirin for three weeks. In JRA patients creatinine clearance reduced from pretreatment value of 63.2±9.2 (SE) to 38.8±5.25 (SE)/ml/min/1.73 sqm (p<.01). In rheumatic fever patients the corresponding values were 80.9±6.1 (SE) pretreatment and 69.2±5.8 (SE)/ml/min/1.73 sqm. post-treatment. On discontinuing aspirin, creatinine clearance returned to near normal after 4 weeks. Three patients showed a reversible increase in SGPT values. A negative correlation was observed in hemoglobin value and steady state salicylate level. It was concluded that, possibility of reduction in glomerular filteration rate after aspirin treatment in JRA and rheumatic fever patients should be borne in mind particularly in children with an already compromised renal function. [ABSTRACT FROM AUTHOR]

Amphotericin B incorporated into small unilamellar liposomes prepared from soya phosphatidylcholine and cholesterol in a molar ratio of 7:3 was administered to 12 patients with suspected or documented systemic fungal infection. Each patient received 0·1, 0·4 and 1·0 mg/kg dose of liposomal amphotericin B. Liposomal amphotericin B was well tolerated by these patients with no dose-limiting toxicity. Mild to moderate fever with rigors occurred in 3 patients after the higher doses. Peak plasma amphotericin B concentrations, measured by HPLC; were 0·747–1·429 mg/L and 24 h trough concentrations were 0·148–0·363 mg/L. The mean of amphotericin B was 17·2 h with a mean volume of distribution of 2·285 L/kg. While these pharmacokinetic parameters obtained with this liposomal amphotericin B formulation are comparable to the values obtained after conventional amphotericin B therapy, they are strikingly different from values obtained by other workers using small unilamellar liposomes with either positive or negative charge. Yet in animal experiments the distribution of all formulations are comparable. [ABSTRACT FROM PUBLISHER]

Broad ligament is a very uncommon site for presentation of lei-omyoma. On account of their size and nature (pedunculated or sessile), clinically leiomyomas may present variably. We are pre-senting a rare case of leiomyoma of broad ligament in a 52 year old female patient who presented with complaints of lower abdo-minal pain of long duration, associated with menstruation. On clin-ical and radiological examination it was found to be a right sided mass in the pelvic region suspected to be a tubo-ovarian mass. On histopathology, it was confirmed to be a soft tissue tumor-Leiomyoma. We present this case on account of its rarity and the diagnostic difficulties posed. [ABSTRACT FROM AUTHOR]

BACKGROUND: Bevacizumab a recombinant humanized monoclonal antibody was approved in 2004 by US FDA for metastatic colorectal cancer. It is reported to cause potentially serious toxicities including severe hypertension, proteinuria, and congestive heart failure. AIM: To correlate adverse event tetany with the use of bevacizumab. MATERIALS AND METHODS: World Health Organization's Uppsala Monitoring Centre, Sweden, for reporting of adverse drug reactions from all over the world, identified 7 cases with tetany-related symptoms to bevacizumab from four different countries. These 7 patients reported to UMC database developed adverse events described as musculoskeletal stiffness (1), muscle spasm (1), muscle cramps (1), lock jaw or jaw stiffness (4), and hypertonia (1), with hypocalcaemia. RESULTS: After detailed study of the possible mechanism of actions of bevacizumab and factors causing tetany, it is proposed that there is a possibility of tetany by bevacizumab, which may occur by interfering with calcium metabolism. Resorption of bone through osteoclasts by affecting VEGF may interfere with calcium metabolism. Another possibility of tetany may be due to associated hypomagnesaemia, hypokalemia, or hyponatremia. CONCLUSIONS: Tetany should be considered as a one of the signs. Patient on bevacizumab should carefully watch for tetany-related symptoms and calcium and magnesium levels for their safety. [ABSTRACT FROM AUTHOR]

The article discusses the response of public health service by hospital staff and medical students during the flood that occurred in Mumbai, India. The flood came on November 26, 2005. There were around 100 deaths due to drowning and house collapses. The flood was expected to increase the magnitude of the major health threats. To overcome this threat, manpower and materials were deployed at the three tiers of the public health system with greater emphasis on providing primary care.

'The National Health Policy 2002" of India and the "Roll Back Malaria" policy makers have set up an ambitious goal of reducing malaria mortality and morbidity by 25% by 2007, and by 50% by 2010. To achieve these goals, problems should be identified, available evidence analyzed and policy should be changed early. Infection with drug resistant malarial parasites has a tremendous impact on health (prolonged recurrent illness, increased hospital admissions and death), health system (higher cost of treatment) and socioeconomics of the region. In view of the evidence of the economic burden of malaria, it has been suggested that second line treatment could be considered at 10% failure instead of 25%. Effective schizonticidal drugs will not only reduce morbidity and mortality but will also reduce transmission. Studies have shown that prevalence of viable (as tested by exflagellation test) gametocytes is considerably more after the chloroquine or chloroquine + sulphadoxine-pyrimethamine treatment compared to quinine. Unfortunately, the only gametocytocidal drug for Plasmodium falciparum, primaquine, is also loosing its efficacy. 45 mg primaquine reduces gametocyte prevalence by 50% while a new drug, 75 mg bulaquine or 60 mg primaquine reduces it by 90%. Plasmodium vivax forms 60-70% of malaria cases in India. Relapses which occur in 10-20% of cases adds to the burden. Efficacy, as confirmed by polymerase chain reaction-single strand conformational polymorphism to differentiate relapse and re-infection, of standard dose of primaquine (15 mg/day for 5 days, even 15 mg/day for 14 days) for vivax malaria is reducing. Fourteen day treatment is also impractical as compliance is poor. Newer drugs, newer drug delivery systems are thus needed. Slow release formulations with blood levels maintained for one week may be useful. Rationale of giving primaquine in higher doses and different timing need to be considered. The genome of Plasmodium falciparum and genome of Anopheles gambiae have been unraveled in last past 3 years. This has given us an opportunity to develop new tools. Whatever be the tool, educating health care workers as well as lay public and ensuring appropriate use of available drug are essential to achieve our goals of controlling malaria. [ABSTRACT FROM AUTHOR]

Aims To carry out a retrospective pharmacoeconomic analysis of the impact of therapeutic drug monitoring (TDM) in adult patients with generalized tonic-clonic epilepsy in an academic, non profit making organization. Methods Twenty-five patients who had undergone TDM were compared with 25 age, disease and duration of drug therapy matched controls who had not undergone TDM. Only direct costs were calculated. These included cost to the hospital of providing the TDM service, cost to the hospital per seizure saved, and cost to the patient per seizure saved. Results Patients undergoing TDM had much more effective seizure control (P = 0.00032, OR 4.846, 95% confidence interval 1.29,18.3), fewer adverse events, better earning and were more likely to be married than the control group. Conclusions In patients with adult onset epilepsy, a minimum of two drug estimations per year offers significant benefit in terms of better seizure control, fewer adverse events and greater chances of remission. [ABSTRACT FROM AUTHOR]

Ascariasis has been reported to impair the absorption of nutrients, vitamin A, and D-xylose, which is corrected on treatment. The effect of ascariasis and its treatment on the absorption of sulphadimidine and isoniazid has been investigated. There was no difference between drug absorption before and after the treatment or in comparison with a normal population. [ABSTRACT FROM AUTHOR]

The effect of iron deficiency anaemia and its treatment on the absorption of sulphadimidine has been investigated in adult patients. The absorption judged by total % of the dose excreted in urine and C, t, AUC and Kabs in plasma, was not significantly different before and after iron therapy or correction of anaemia. However, sulphadimidine absorption by the anaemic patients was significantly greater than in normals. [ABSTRACT FROM AUTHOR]

The case of a female patient with acute lymphoblastic leukaemia and chronic disseminated candidiasis, who was refractory to 1.8 g conventional amphotericin B therapy, is reported. She experienced severe amphotericin-B-related side-effects in spite of pretreatment, but was subsequently successfully treated with 3 g of a small unilamellar liposome formulation of amphotericin B prepared from soya phosphatidylcholine and cholesterol in a 7∶3 molar ratio at our institute. The patient experienced minimal side-effects with this preparation, although no pretreatment was given. Liposomal amphotericin B prepared in our institute appears to be a safe and effective therapy for systemic fungal infections. However, large controlled studies are required to determine more precisely the potential of liposomal amphotericin B in the treatment of severe systemic fungal infection. [ABSTRACT FROM AUTHOR]

A letter to the editor, accounting to two cases of acute leukemia with refractory hypokalemia following treatment with amphotericin B, is presented.

The article presents information on the drug resistance found in the parasite species of malaria. Mainly four kind of species including P. falciparum, P. vivax and P. malariae are accountable for the most human malaria infections across the world. According to the researches, drug resistance has been found in P. vivax and P. falciparum. The cases that reveal resistance to the first-line drug chloroquine has been reported mainly from Papua New Guinea and Irian Jaya, Indonesia.

A bioequivalence study of three brands of regular diltiazem - Angizem (A), Dilzem (B) and Herbesser (C) has been carried out in 5 healthy, male volunteers. After a single oral dose of 60 mg of each preparation, the mean AUC(0-8 h) and C of preparation B was significantly higher than of brands A and C. The t of A and B was significantly lower than of C. B had a higher dissolution rate in vitro (98.8% dissolved in 45 min) than A and C. Thus, there was bioinequivalence of the three brands of diltiazem, due partly to differences in dissolution and perhaps in part to a first pass effect. [ABSTRACT FROM AUTHOR]