PubMed Health⌕ Search

Biomedical subjects

G V Daftary

Publications and source records attributed to G V Daftary.

10 recordsLinked to original sources
PubMed2002

Efficacy and safety of phlogenzym--a protease formulation, in sepsis in children.

BACKGROUND: Infections are a major cause of hospitalisation wherein the host mounts an inflammatory response against the infecting agent. Administration of proteolytic enzymes could regulate the host's immune system and help early recovery from sepsis. OBJECTIVE: To test the efficacy and safety of an oral enzyme formulation, Phlogenzym (Mucos Pharma GmbH, Geretsried, Germany; constituents of each enteric-coated tablet were bromelain 90 mg, trypsin 48 mg, rutin 100 mg) as adjuvant therapy in treatment of sepsis in children. SUBJECTS AND METHODS: Double-blind, randomised, controlled phase III study at a tertiary care centre wherein 60 eligible children aged one month to 12 years with sepsis were randomised to receive either phlogenzym (n=30; 17 boys) or placebo (n=30; 22 boys) tablets (1 tablet/10 kg body weight up to maximum six tablets a day in two or three divided doses for 14-21 days) along with appropriate antibiotics and supportive treatment. RESULTS: Median time taken for fever to subside was three days (range 1-12; 95% CI--1.14 to 7.14) in the phlogenzym group vs four days (range 1-18; 95% CI--3.52 to 11.52) in the placebo group (p < 0.05); haemodynamic support was needed for two days (range 1-3; 95% CI--0.84 to 3.16) in the phlogenzym group but three days (range 1-8; 95% CI--0.76 to 5.24) in the placebo group (p < 0.05). The modified Glasgow coma scale score normalized in three days (range 1-14; 95% CI--4.62 to 9.62) in the phlogenzym group vs 5.5 days (range 1-18; 95% CI--2.52 to 13.52) in the placebo group (p > 0.05). Oral feeds could be started in four days (range 1-15; 95% CI--1.74 to 9.74) in the phlogenzym group vs five days (range 1-11; 95% CI--1.26 to 11.26) in the placebo group (p > 0.05). Two patients died in the placebo group. CONCLUSION: Phlogenzym is effective as an adjuvant with antibiotics and supportive treatment for early improvement of pediatric patients with sepsis.

Adjuvants, Immunologic↗
PubMed2001

Efficacy of hydrolytic enzymes in preventing radiation therapy-induced side effects in patients with head and neck cancers.

PURPOSE: Based on in vitro and on clinical evidence of protection against acute side effects of radiation, a prospective randomized, open study was performed to determine the efficacy of an oral proteolytic enzyme preparation in patients with head and neck cancer receiving conventional fractionated radiation therapy. METHODS: Patients with stage T3/T4 head and neck cancer were eligible. One hundred patients from two centres were entered into the study. 60Co gamma-radiation was delivered at a standard daily radiation dose of 2 Gy in 25-35 fractions over a period of 6-7 weeks. Two lateral parallel opposing fields were used with a portal area of 10 x 15 cm. Patients assigned to the test group arm additionally received enzyme tablets orally t.i.d. starting 3 days prior to radiation therapy, and continuing up to 5 days after completion of the course of radiation therapy. Patients in the control arm were not given any drug or placebo. Acute radiation side effects were described as mucositis, skin reaction, dysphagia, and were graded at each visit during and after radiation therapy, following RTOG/EORTC criteria. RESULTS: The severity (maximum extent) of acute radiation therapy side effects was significantly less in enzyme-treated patients than in control patients: mucositis (mean: 1.3 vs 2.2, P < 0.001), skin reaction (1.2 vs 2.4, P < 0.001) and dysphagia (1.4 vs 2.2, P < 0.001). The duration of these side effects as well as the sum scores of side effects were also less in the study arm. CONCLUSIONS: Combination of enzyme therapy with conventional fractionated radiation therapy was feasible and well-tolerated. There was significant protection against acute side effects of radiation therapy in the study arm. Not only was the severity of acute side effects less but the duration was shorter and the time to onset was also delayed. Prospective randomized double-blind studies would verify this role of an oral enzyme therapy as standard co-medication with radiation therapy to the head and neck region.

Acute Disease↗
PubMed2001

Co-medication with hydrolytic enzymes in radiation therapy of uterine cervix: evidence of the reduction of acute side effects.

PURPOSE: The use of additional therapy with an oral enzyme preparation containing trypsin, chymotrypsin and papain has been suggested for the reduction of toxicity due to radiation therapy. This study was conducted to test the efficacy and tolerability of this enzyme combination in preventing or reducing the acute side effects of radiation therapy in patients with locally advanced cervical cancer. METHODS: A prospective, randomised, open, clinical trial was carried out on 120 patients (aged 24-85 years) with locally advanced, biopsy-proven carcinomas of the uterine cervix (stages IIa, lIb or IIIb). Patients received 50 Gy of external radiation therapy over a period of 5 weeks, followed by intracavitary brachytherapy (20-30 Gy). Patients assigned to the test group (60 patients) received additional treatment with enzymes. Patients were evaluated at weekly intervals for acute radiation therapy-related side effects, according to the RTOG/EORTC grading criteria, and then after the end of radiation therapy for another 8 weeks. Occurrence of adverse events, if any, was also recorded. RESULTS: The study revealed that the maximum extent of acute radiation side effects was reduced in the enzyme group: skin reactions (mean: 0.97 vs 1.68 in the control group, P < 0.001), vaginal mucosal reactions (0.55 vs 0.85, P = 0.10), genitourinary symptoms (0.93 vs 1.38, P < 0.001) and gastrointestinal reactions (1.12 vs 1.30, P = 0.12). The sum-scores during treatment, expressed as area under the curve, were significantly less in the enzyme treated patients. In the follow-up visits all observed side effects of radiation therapy were of lower intensity in the enzyme group than in the control group. CONCLUSIONS: In patients with locally advanced cancer of the uterine cervix, oral enzyme therapy was found to be effective in significantly reducing radiation therapy-related side effects such as genitourinary symptoms, subcutaneous changes and reactions of the vaginal mucosa.

Acute Disease↗
PubMed2001

Efficacy and tolerability of oral enzyme therapy as compared to diclofenac in active osteoarthrosis of knee joint: an open randomized controlled clinical trial.

OBJECTIVE: To compare the efficacy and tolerability of an oral enzyme preparation (Phlogenzym) with that of an NSAID (diclofenac) in the treatment of active osteoarthrosis. METHODS: Prospective, randomized, controlled, single-blind study of seven weeks duration at a tertiary care centre wherein 50 patients aged 40-75 years, with activated osteoarthrosis of knee joint were randomized to receive phlogenzym tablets (2-3 tablets, bid) or diclofenac sodium 50 mg bid for three weeks. RESULTS: At the end of therapy (three weeks) and at follow-up visit at seven weeks there was reduction in pain and joint tenderness and swelling in both groups, and slight improvement in the range of movement in the study group. The reduction in joint tenderness was greater (p < 0.05) in the study group receiving phlogenzym. CONCLUSION: Phlogenzym is as efficacious and well tolerated as diclofenac sodium in the management of active osteoarthrosis over three weeks of treatment.

Adult↗
PubMed1999

Allergy diagnosis by Pharmacia Cap System.

From September 1995 to September 1998, sera from 959 suspected allergy patients have been tested by the new Pharmacia Cap System. Of these, 80 per cent were diagnosed to suffer from some allergy while 20 per cent reacted negative. It was found that the CAP system gave accurate and clear cut results to the satisfaction of the patient and referring physician.

Humans↗
PubMed1994

Evaluation of ELISA test for serological diagnosis of tuberculosis.

In order to find out the usefulness of this test in the local population, 240 subjects were investigated at Indira Gandhi Medical College, Nagpur. Of these 85 were normal healthy subjects and 40 were sputum AFB positive tuberculosis cases, enabling us to determine the cut-off value. The remaining 115 were suspected cases of pulmonary or extrapulmonary tuberculosis. In proved as well as suspected cases of tuberculosis, the mean optical density was much higher than among normal controls, which was statistically significant. Thus A-60 ELISA test is a useful diagnostic aid in suspected pulmonary and extrapulmonary tuberculosis.

Adolescent↗
PubMed1994

Tuberculosis screening: usefulness of new KREATECH IgA ELISA test.

A total of 71 sera from 15 proved cases of pulmonary tuberculosis, 2 cases with doubtful radiological report and 54 suspected cases, contacts, donors etc. were subjected to Elisa IgG, IgM and IgA tests for tuberculosis, with a view to comparing the merits of IgA test with those of IgG and IgM. Kreatech IgA test which is claimed to indicate presence of active tuberculosis was positive in 13 of the proved cases and negative in both the doubtful cases. These preliminary results indicate that KREATECH IgA is a promising new ELISA test which can be a useful laboratory aid in the diagnosis of active tuberculosis, both pulmonary and extrapulmonary, for screening of suspected cases, and for monitoring cases undergoing therapy.

Double-Blind Method↗
PubMed1994

ELISA test for tuberculosis.

The Elisa test for diagnosis of tuberculosis using highly purified A 60 antigen extracted from mycobacteria was developed by Anda Biologicals, France, during the late 1980s. It is claimed to have about 95% sensitivity and specificity. Both IgG and IgM antibodies can be separately tested. IgM antibodies appear early in the disease and IgG appear later. The test is negative in healthy, normal subjects and is not related to tuberculin test or BCG vaccination status. The A 60 antigen is common to many mycobacteria including M. tuberculosis, M. leprae, M. bovis, and M. avium. Hence, clinical, radiological and other laboratory data must be considered along with the results of Elisa test for final diagnosis. Tuberculosis is still the most important bacterial infection in India. Because of its high prevalence, normal subjects and proved tuberculosis patients were first surveyed to determine the cut off values for IgG and IgM antibodies among local population. Subsequently the test was offered in India for general use. This paper describes our experience of the test since 1990, on samples referred by various practitioners and laboratories in Bombay and other cities. Result on 5840 IgG tests and 2101 IgM tests shows that the A 60 Elisa test is well accepted and is a useful laboratory aid in the diagnosis of pulmonary and extrapulmonary tuberculosis.

Enzyme-Linked Immunosorbent Assay↗