|Year : 1983 | Volume
| Issue : 5 | Page : 570-574
Clinical evaluation of non-steroid topical anti-inflammatory agents
YP Singh, S Bharti, Raka Sagar
Deptt. of Ophthal., S.N. Medical College, Agra, India
Y P Singh
Department of Ophthalmology, S.N. Medical College, Agra
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Singh Y P, Bharti S, Sagar R. Clinical evaluation of non-steroid topical anti-inflammatory agents. Indian J Ophthalmol 1983;31:570-4
In clinical practice the etiological agent responsible for ocular inflammation is rarely known. Variations in host response is also significantly responsible for differences in ocular response to such an insult. Nevertheless, the management of the behaviour of an eye exposed to varied inflammatory reactions is our primary interest thus requiring the use of non-specific anti-inflammatory agents in a great majority of cases.
Since the advent of corticosteroids their use as an anti-inflammatory agent has been on the increase but it has aptly been stated that corticosteroid therapy in acute ocular infections should be questioned. Although laboratory studies reveal that ocular infections treated with adequate dosages of effective antibiotics may result in less scarring if corticosteroid therapy is also instituted, the nonavailability of adequate isolation techniques in a good number of centres and the possibility of infection by a resistant bacteria, fungus or virus being a real one, cannot simply be ignored.
Few facts in clinical therapy are more certain than the one that corticosteroid will reduce host resistance to microorganisms. In addition cataract and glaucoma are established complications of corticosteroid therapy.
For therapeutic purposes a non-corticosteroid anti- inflammatory agent without side-effects needs to be brought to practice.
| Material and methods|| |
A total of 80 eyes contributed to our study. 50 eyes had Herpes simplex keratitis (HSK) and 30 eyes were of iridocyclitis. Ocular examination included besides the routine, corneal sensations and corneal staining in HSK and examination for aqueous flare, K.Ps., exudates and iris pattern in iridocyclitis. Taking these as parameters for assessment of severity of inflammation grading was thus done as:
HSK grade 1 Dendritic ulcer < 2 mm
2 Dendritic ulcer 2-4 mm
3 Dendritic ulcer > 4 mm
Iridocyclitis grade 1 Aqueous flare present
2 K.Ps. present
3 Exudates and hypopyon.
A detailed systemic examination was done.
The anti-infiamatory agents used were Indomethacin 1% and 2% and Oxyphenbutazone 10% suspension in saesame oil in the dosage of 2 drops 4 times a day.
In HSK-5 IDU in its usual dosage with anti-in. flammatory agents. In Iridocyclitis-Single application of atropine 1 % eye ointment on first visit and anti-inflammatory agents.
Symptoms and signs of inflammation were observe ed daily for 3 days, on alternate day for next 7 days and then every 4th day till quiescence in all the cases. In a similar way corneal staining and corneal sensations were utilized to explain the effectivity of treatment in HSK.
During this period development of any local or systemic side-effects were looked for.
| Observations|| |
HSK: Indomethacin was used in 30 eyes (1%-24 eyes, 2%-6 eyes) and oxyphenbutazone in 20 eyes. 40 patients had history of fever with rigors and institution of antimalarial therapy 5-15 days before the eye involvement. In 31 eyes the disease had recurring nature.
Severity of inflammation: Severity of inflammation was of grade 3 in 5 eyes of indomethacin group and 3 eyes of oxyphenbutazone croup. (Graph 1).
Corneal Sensations: Corneal sensations were undemonstrable on ulcer area on first day in all the cases and were elicitable after a mean duration of 6 days with IDU-Indomethacin 1% combination, 4 days with IDU-Indomethacin 2% combination and 8 days with IDU-oxyphenbutazone 10% combination. (Graph-II)
Corneal Healing: Total corneal healing was observed over a mean duration of 4.6, 4.0 and 6.6 days with indomethacin 1%, 2% and oxyphenbutazone 100 respectively. (Graph-III)
Response of inflammation to the Anti-inflammation Agents
Severity of inflammation had no bearing on speed of recovery. Marked improvement was observed over a mean duration of 5 days, 4 days and 7.6 days with indomethacin 1%, 2% oxyphenbutazone 10% respectively and for complete remission a mean duration of 10.3 days, 8.5 days and 14.4 days was noted with these agents in that order. (Graph IV)
30 eyes with acute iridocyclitis comprised the study. Indomethacin 1% and oxyphen-butazone 10% were instilled in 15 eye each. Eyes with recurrent disease or with history of prior treatment were not included in the series.
Severity and bilaterality The severity of disease was of grade 3 in 4 eyes, 2 eyes each in indomethacin and oxyphenbutazone group. It was of severity grade 2 in rest of 26 eyes. An increase in severity of inflammation was noted in 2 eyes during the first 4 days of drug administration viz. increased in the number of K.P.s in one eye of indomethacin group and appearance of K.P.s in one eye of oxyphen-butazone group. Later, both these eyes responded well.
Disease was bilateral in I patient and both the eyes reached queiscence with oxyphenbutazone in 15 days.
Vision: Corrected vision recorded on the first visit was less than 6/6 in all the eyes under study. While on the complete remission an improvement in vision to 6/6 was observed. 4 eyes-2 each of oxyphenbutazone group and indomethacin group with pre-existing complicated cataract failed to gain an improvement in vision.
Mean initial TOP recorded in eyes treated with indomethacin was 20.7 mm. of Hg. and of those that were administered oxyphenbutazone was 19.3 mm. of Hg. A mean fall in IOP recorded after complete remission in indome thacia and oxyphenbutazone treated group respectively was 5.15 mm. of Hg. and 0.91 mm. of Hg. (Graph V).
From a clinical stand-point a marked improvement in eyes on therapy was detected after a mean duration of treatment for 7.5 days with indomethacin and 9.5 days with oxyphenbutazone. And a complete remission was achieved in 13.2 days with indomethacin and in 15.5 days with oxyphenbutazone. (Graph VI).
No systemic side-effects were noticed. Local irritation complained of by the patients using the suspension was actually due to the vehicle. The truthfulness of the statement was proved by the fact that an equal amount of irritation was noticed in the fellow eye serving as control where only the vehicle was administered in this eye.
| Discussion|| |
Recently there has been a revision in views regarding the mediators of inflammations after Ambache and Brunner (1968) and many others have shown that prostaglandins are the mediators of inflammation. Substantial amount of prostaglandin like activity has been noticed in rabbit aqueous humour after experimentally induced uveitis (Eakins et al. 1972) and prostaglandins have been used intracamerally to induce inflammatory response and to elevate IOP (Beitch and Eakins, 1974; Kelly and Starr, 1971). Indomethacin and aspirin like drugs have been shown to inhibit prostaglandin synthesis (Eakins, 1972, 1974, Sawa and Masuda, 1976; Perman, 1980) and many studies have confirmed it to date.
This clinical study reproduced the experimental findings available now.
This study has been exclusively confined to the patients of iridocyclitis who had no history of recurrent disease or of any prior treatment. Atropine 1 % ointment was used firstly to assess the response of pupil to topical atropine, mydriasis being proportional to anti-inflammatory activity of the other agent used and secondly, because atropine is a part of treatment of iridocyclitis and is mandatory with due consideration to the fact that study was clinical and was done on human beings.
| Results|| |
Anti-inflammatory activity of indomethacin is more than that of oxyphenbutazone. Recovery of corneal sensations and corneal healing is more rapid with indomethacin as compared to that with oxyphenbutazone in HSK. Ocular inflammation is mediated by prostaglandins and is associated with a rise in IOP. Indomethacin is prostaglandin synthetase inhibitor and controls this in IOP associated with iridocyclitis. Clinical effectivity of indomethacin 1 % suspension is nearly equal to that of 2% suspension. Both oxyphenbutazone and indomethacin are beneficial in ocular conditions respective to corticosteroid therapy. Both are safe when used in concentrations used in this study. They do not enhance the replication of herpes virus, have no effect on lens or IOP and have no local or systemic metabolism side-effects.
[Figure - 1], [Figure - 2], [Figure - 3], [Figure - 4], [Figure - 5], [Figure - 6]
[Table - 1], [Table - 2], [Table - 3], [Table - 4], [Table - 5], [Table - 6]