Trial of Liv.52 in Infectious Hepatitis in Children in Goa
Harish Mazumdar, M.B., F.A.A.P. (U.S.A.), Professor and Head of the Department, and Mira Mazumdar, M.B.,B.S., F.A.A.P. (U.S.A.), Research Officer, Department of Paediatrics, Goa Medical College, Panaji, Goa.
Liver function tests were repeated every week until full recovery. Liver biopsies were performed before and after treatment in five patients.
The trial group were given Liv.52 in three daily doses of 20-30 drops for infants and 40-60 drops for older children. In the ward, all patients were kept at bed rest. Older children were given a daily diet yielding 2112 calories containing 62.4 g proteins, 68.8 g fats and 297 g carbohydrates. Infants were given adequate milk according to their weights. Vitamin supplements were given to children in both groups. After the jaundice subsided, in the trial group, Liv.52 was continued for periods varying from 3 to 6 months until the patients were normal both clinically and by way of liver function tests.
Patients in the control group (30 males and 20 females) were admitted to the Children's Ward and were not given any specific treatment. The regime of bed rest, vitamin supplements and diet was the same as in the trial group.
In very severe and fulminant cases in both groups patients who were in impending hepatic coma, prednisolone and other measures were used as indicated. Care was taken to ensure that the findings in such patients did not vitiate the comparison of cases in the two groups.
Patients were followed in the out-patient's department after discharge, initially at two weekly intervals, and later, at monthly intervals for 6 months and then twice yearly.
OBSERVATIONS
Seasonal Incidence: The seasonal admission of cases of hepatitis is shown in Table IV. It was seen that the heaviest concentration of admissions was in the months of October, November, December and January. We have observed a similar high incidence of gastroenteritis and cases of enteric fever during these months. The phenomenon seems to be at variance with observations in other parts of the country where the highest incidence of these diseases is recorded during the monsoon months. Goa has an annual rainfall of 120 inches, almost entirely from mid-June to mid-September, and it is not clear why the pattern of food and water borne infections is different from other parts of the country with similar climate.
Table IV: Seasonal incidence (1967-1974) |
||||||||||||
Month |
Jan. |
Feb. |
Mar. |
Apr. |
May |
Jun. |
Jul. |
Aug. |
Sep. |
Oct. |
Nov. |
Dec. |
No. of cases |
9 |
7 |
9 |
4 |
7 |
7 |
8 |
9 |
6 |
10 |
13 |
11 |
|
October-February – 50 (Dry and Cool) |
March-May – 20 (Hot) |
June-September – 30 (Monsoon) |
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Age and Sex Incidence: In this series males predominated over females in the ratio of 60 to 40. The youngest patients were a 6-month-old in the control group and a 5-month-old in the trial group. The largest number of patients was in the age group 3-6 years.
Clinical Manifestations: The average duration of illness before admission was 16.2 days in the control group and 13.8 days in the trial group.
The commonest symptoms on admission (Table II) were fever, anorexia and jaundice. The complaints of nausea and/or vomiting, abdominal pain and passing of dark coloured urine were next in the order of frequency. Oedema of feet was present in four cases and two of the three patients in precoma were drowsy on admission.
Liver was palpable in all cases and was tender in 50% of them. In a small number the liver was firm. Splenic enlargement was present in 27% cases on admission.
In the Liv.52 group the average duration of jaundice after admission was 10.9 days and in the control group it was 14.6 days. Appetite improved within 5 days of starting Liv.52 and in the control group after 7 days. Nausea and vomiting subsided within 3 days in the Liv.52 group and after 5 days in the control group. Tenderness of the liver persisted for 7 days in the trial group and more than 10 days in the control group. The average weight gain was 0.92 kg in 2 weeks in the Liv.52 group. In the control group there was no appreciable weight gain during the same period.
LABORATORY FINDINGS
Serum bilirubin (Maximum recorded – 8.8 mg): In the control group there were 36 patients with initial serum total bilirubin levels of more than 2 mg and after 2 weeks, in 80% of the patients these abnormal levels persisted. In the trial group 32 patients had a level of more than 2 mg initially, and after two weeks only five had levels between 2-5 mg%. In both groups there were approximately 20% of cases who had initial levels of more than 5 mg but at the end of two weeks none in either group had these levels.
Serum total proteins (Minimum recorded – 3.2 g): Almost all patients in both groups who had serum protein values of less than 5 g per 100 ml showed improvement at the end of two weeks.
Serum albumin (Minimum recorded – 1.6 g): Low serum albumin levels (less than 3 g) were seen in over 70% of cases in both groups. At the end of 2 weeks, the level remained less than 3 g% in 80% of the control group and 50% of the trial group.
SGPT (Maximum recorded – 259 units): Almost 80% of patients in both groups showed moderately raised readings initially. At the end of 2 weeks, 70% of the control group continued to have high levels of SGPT, whereas in the trial group only 22% had pathological levels. About 30% of patients in both groups had initial levels of over 100 units but after two weeks no child in either group had SGPT over 100 units.
Alkaline phosphatase (Maximum recorded – 38.4 K.A.U.): Almost 80% of all patients had pathological levels initially. At the end of 2 weeks, 80% of the control group and only 36% of the trial group had abnormal values.
Zinc turbidity (Maximum recorded – 64 units): Eighty per cent patients in both groups had levels more than 6 units. At the end of 2 weeks all 46 survivors in the control group, but only 24% in the trial group showed abnormal levels.
Prothrombin time (Maximum recorded – 64 seconds against 19 seconds for control): Between 40-50% patients in both groups had prolonged prothrombin time initially. After 2 weeks, 20% of the control group and none in the trial group continued to have this abnormal finding.
Bile salts, pigments and urobilinogen in urine: Out of all 100 cases, 56% initially showed the presence of these in the urine. After two weeks none but one in the control group showed their presence in the urine.
Corticosteroids had to be used in 5 and 6 cases respectively in the trial and control groups. These were cases of fulminant hepatitis, hepatic precoma and coma. In the control group all four patients of hepatic coma died, including the one in whom exchange transfusion was performed. In the trial group 2 cases of acute hepatitis who went into coma and 2 of prolonged fever and jaundice had grossly deranged liver function tests. Inadequate response to Liv.52 in these severe cases prompted us to use prednisolone, but Liv.52 was continued throughout the illness. Post-treatment liver biopsies in these 2 latter cases showed reversal to reparative changes (without scarring) from the diagnostic findings of severe acute necrosis of liver cells in the earlier biopsies. All the four children recovered completely. There were no deaths in the trial group.
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