therapeutic trial with syrup of metronidazole in amoebiasis

4
lndian,7. P*dlatr. 4.5 : 24, 1978 TIIERAPEUTIC TB_T_AL WI_TH SYRUP OF METRONIDAZOLE IN AMOEBIAS!" ~ VE~.NA GUI'TA, A.K. RATHI, V.K. GUPTA AND KUSUM ~,UPTA Kanpur Infestation with Entamotba histolytica, a widespread disease in adults in India, till the last few years, was considered relatively uncommon in the paediatric population. It has been only recently recogxtised as being of common occurrence in children. In children as it is in adnlts, the manifestations of amoebialis may be so diverse that its possibility cannot be ruled out without proper investigations. Metronidazole has made an important contribution to the management Of amoe- biasis. It was first observed in the laboratory that metronidazole had anti- amoebic properties, but for several reasons, the clinical application of this observation was delayed until 1966 when Powell et al. (1966) first published their c, bservations on acute amoebic dysentery and, subsequently, on patients with amoebic liver abscess. At present, numerous reports Keighley 1971, Ponwell et al. 1966, Nicol et al. 1966 regard- ing the incidence of amoebiasis in adults and the role of metroiddazole in its manage- ment are available; few such reports, however, have been published in childr/ The incidence of various intestinal para~i~ infestations, as also the efficacy, acceptab'i / and tolerance of metronidazole syrup i / concentration of 40 mg] 5 ml in treat "m~ of amoebiasis in children is summarised ~.~1~ the present communication. Material and Method The study was carried out children's hospitals, B.R.D. Medica Gorakhpur and G.S.V.M. Medical Kanpur. The duration of study year (November 1975 to Novemb The metronidazole syrup (Arist trial in a concentration of 40 mg~ supplied by Aristo Ptlarmaceutical Stools of the patients admitte chi!dren's hospitals were carefully microscopically as well as macro,. Seventy cases having E. h, qotytiea with clinical symptoms were selected fo~] the clinical drug trial. Aristogyl syrup wa~ administered for a period of 10 days, i~ accordance with the following dosag~l regimen, star.daris~d for each age group. Age in years Dosage regimen adopted 1 to 3 years 3 to 7 years 7 to 12 years Two teaspoonfuls four times daily Three teaspoonsfuls four times daily Four teaspoonsfi.,ls four times daily *From the Department of Paediatrics, G.S V.M. Medical College, Kanpur. All corre*ponence to be directed to Dr. (Mrs.) Veena Gupta, Reader in Paediatrics, G.S.V.M. Medical College, Kanpur. Received on July 31, 1977. Stools fi-om the patients were re- examined after 7 days of treatment to assess the response. To determine, the accept- ability of the syrup, the patients wer~

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Page 1: Therapeutic trial with syrup of metronidazole in amoebiasis

lndian,7. P*dlatr. 4.5 : 24, 1978

TIIERAPEUTIC TB_T_AL WI_TH SYRUP OF METRONIDAZOLE IN AMOEBIAS!" ~ VE~.NA GUI'TA, A.K. RATHI, V.K. GUPTA AND KUSUM ~,UPTA

Kanpur

Infestation with Entamotba histolytica, a

widespread disease in adults in India, till the last few years, was considered relatively uncommon in the paediatric population. I t

has been only recently recogxtised as being of common occurrence in children. In

children as it is in adnlts, the manifestations

of amoebialis may be so diverse that its possibility cannot be ruled out without proper investigations.

Metronidazole has made an important

con t r ibu t ion to the management Of a m o e - biasis. I t w a s first observed in the l abora to ry that metronidazole had anti- amoebic properties, but for several reasons, the clinical application of this observation was delayed until 1966 when Powell et al.

(1966) first published their c, bservations on acute amoebic dysentery and, subsequently,

on patients with amoebic liver abscess. At

present, numerous reports Keighley 1971, Ponwell et al. 1966, Nicol et al. 1966 regard- ing the incidence of amoebiasis in adults and the role of metroiddazole in its manage- ment are available; few such reports,

however, have been published in c h i l d r / The incidence of various intestinal p a r a ~ i ~ infestations, as also the efficacy, acceptab'i / and tolerance of metronidazole syrup i / concentration of 40 mg] 5 ml in treat " m ~ of amoebiasis in children is summarised ~.~1~ the present communication.

Materia l and Method The study was carried out

children's hospitals, B.R.D. Medica

Gorakhpur and G.S.V.M. Medical Kanpur . The dura t ion of study year (November 1975 to Novemb

The metronidazole syrup (Arist trial in a concentration of 40 mg~ supplied by Aristo Ptlarmaceutical

Stools of the patients admitte chi!dren's hospitals were carefully

microscopically as well as macro,. Seventy cases having E. h, qotytiea

with clinical symptoms were selected fo~] the clinical drug trial. Aristogyl syrup w a~ administered for a period of 10 days, i~ accordance with the following dosag~l regimen, star.daris~d for each age group.

Age in years Dosage regimen adopted

1 to 3 years 3 to 7 years 7 to 12 years

Two teaspoonfuls four times daily Three teaspoonsfuls four times daily Four teaspoonsfi.,ls four times daily

*From the Department of Paediatrics, G.S V.M. Medical College, Kanpur. All corre*ponence to be directed to Dr. (Mrs.) Veena Gupta, Reader in Paediatrics, G.S.V.M. Medical College, Kanpur. Received on July 31, 1977.

Stools fi-om the patients were re-

examined after 7 days of t reatment to assess

the response. To determine, the accept-

ability of the syrup, the patients wer~

Page 2: Therapeutic trial with syrup of metronidazole in amoebiasis

~UPTA RT AL. ~TIIERAPRUT|O TRIAL WITH IYRUP OF METRONIDAZOL~ ~N AMOgBIASIS ~5

T a b l e 1. Age distribution of the caJes.

Age groups No. of cases

i ii ii i i i

1 to 3 years 6

3 to 5 years 12

5 to 10 years 25

10 to 12 years 27

categorised in three groups on the basis of a history of acceptabnity of drugs.

1, Patients who accepted medicines with- out difficulty.

2. Patients who accepted medicines with some difficulty.

3 Patients who accepted medicines with great difficulty.

O b serv a t io n s Children of all ages were included in

the present study. A majority of the children were of school going age

Most of the patients had more than one

symptom. A majority of the children were admit ted with pain in the abdomen, loose

motions and poor appetite. The symptoms

are listed in Table 2.

T a b l e 2. Symptoms on admis#iotL

Symptoms

1. Pain in abdomen

2. Loose motions

3. Poor appet i te

4. Weakness

5. B loodaRd mucus ins tools

6. Only mucus in stools

7. Constipation

Number of cases

65

58

25

10

8

23

6

Page 3: Therapeutic trial with syrup of metronidazole in amoebiasis

26 INDIAN JOUgNAL OF Pllma~Ttaos VoL. 45, No. 360

Tab le $. !ncidencr of carious parcaitlc inf#stations in 500 stools.

Organisms

E. histolytica

Gtardia intestlnalis

Ascaris lumbricoides

Ankylostome duod#nale

No. of cases

70

30

50

6

Percentage

14.0

6.0

I0.0

1.2

Seven cases were labdled as amoebic hepatitls.., .... ~The. criteria, of diagnosis were an enlarged !ender l iver without other possible causes, stools showing E. histo~tica and response to treatment with Aristogyl syrup.

Out of 500 stool samples examined, 156 (31 .3%)were positive for parasites, while 344 (68.6%) were normal. E. histolytka was the commonest parasite (14%) followed by Ascaris lumbricoides (10%).

Side effects In two instances occasional vomiting

was reported and four children had a reduction in appetite. These symptoms disappeared after di:continuation of

therapy; no other toxic manifestation was observed during the treatment.

Response to drug Initially the response in each child was

assessed by symptomatic improvement including reduction in frequency of stools and abdominal pain, which wa3 later confirmed by disappearance of E. histolylica from the stools on repeated examination. All the patients responded well to the treatment. Response was observed to be very good in 42 cases, good in 25 and satisfactory in 3. The cases with amoebic hepatitis responded well.

Table 4 shows that Aristogyl syrup was well accepted by the children.

T a b l e 4. Acceptability of Aristogyl syrup.

1.

.

3.

Patients who accepted drugs without difficulty.

Patients who accepted drugs with some difficulty.

Patients who accepted drugs with great difficulty.

38

25

These patients accepted Aristogyl syrug without difficulty.

These patients accepted Aristogyl syru g with some difficulty.

These patients accepted Aristogyi syrug with great difficulty.

Page 4: Therapeutic trial with syrup of metronidazole in amoebiasis

OUp~. A' ET AL.--THERAPEUTIC TRIAL WITH SYItUP OF METRONIDAZOLR IN .aMOEBIASlS

D i s c u s s i o n

A total of 500 stools were exarained in .*be present study. E. histol)tka was the commonest parasite (!4%), followed by ~searis (10%), Giardla (6%) and A.nkflostome (1.2%). Our observat~om are in agreement with Sharma and Saxena (1975). However, A3upta (1974) reported giardiasis as having the highest frequency among parasitic Infestation in children, w h i l e Bubo (1971) eeported Ankflo, oma duodtnale to be the commonest parasite (44.5%); E. histol.ytica J~aving been seen in only 0.6% of his cases. Asearis lumbricoides has also been xeported to be the commonest parasite in children $~" Dutta et al. (1974). This variation in the type of infestation may be jttributed to climatic influences, socio- ~c0nomic factors, personal hygiene of the j)opulation and existing sanittary facilities. It also depends to a great exte:~t on whether lhe study has been carried out on the rural 4)r urban population. Metronidazole was admlnisstered for In days id 70 patients with intestinal and extra intestinal amoe- basis. All the patients responded well and E. histolytica disappeared from the stool. No significont side effects of metronidazole syrup in a concentration of 40 rag/5 ml was

observed exeept vomiting in two cases and loss of appetite in four cases which disappeared after diseon~nuatio~ of the -drug.

27

S u m m a r y

A total of 500 chl]dren admitted with gestrointestinal complaints were subjected to stool examination. 31.2% of the children ~howed evidence of parasites, E. histolytica being the commenest (14%) followed by ,Iseari: lumbrir (10.1%). Seventy children with amoebiasis were treated with metroni- dazole syrup in concentrations of 40 rag/5 ml (Aristogyl) which was found to be quite effective, safe and easily acceptable.

Our thanks are due to M/$ Aristo Pharmaceuticals, Pvt. Ltd., for providing us with adequate samples of Aristogyl to conduct the trial.

Ret'erene.el

Bubo, N.O. '1971). ,Prevalence- of intestinal parasites in children seen at Mulago Hospital. Children in Tropics, 78, 27,

Durra, J .K. and Banerjee, R, (1974). Morbidity pattern in relation to parasitic diseases of gastrointesti- nal tract in an outpatients' clinic of rural area. Indian

07. Pediatr. 41, 48. Gupta, S. (1974). The challenge of intestinal

parasitic infestations in children. Indian Prozl. 26, 335. Keighley, E.E. (1971). Trichomonasis in a

closed community Brit. Mtd..7. 1, 207. Powell, S.j . , Macleod, I., Wilmot, A.J . , Ehdon-

Dew, R. (1966). Metronida~ole in amoebic dysentery nnd amo,bic liver diseases, Lancet. 1, 1100.

Nicol, C.S. Me., Fadzean. J .A. , S'quires, S.L. (1966). Trichomonas vaginalis resistance Lancet, 1, I !00.

Sanjaw-a, R.B. (1972). Recent tre_nds in the diagnosis and treatment of amcebiasis. Prob*. 12, 28.

Sharma, U., $axena, $. ~tOY*3). P,u~iii~ "hrfesta- tion during childhood. Indian Med. Ga~:. 14, 9.