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.

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.

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.

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.

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.

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.