Biometrical evaluation of the performance of the revised OECD Test Guideline 402 for assessing acute dermal toxicity.

A comprehensive biometrical assessment was conducted to compare the performance of multiple test designs for acute dermal systemic toxicity to support the animal welfare update to the original OECD Test Guideline (TG) 402 for acute dermal toxicity. The test designs evaluated included: (1) two, three, or five animals per dose group (2) evident toxicity or lethality endpoints and (3) absence or presence of a one-animal sighting study. The revision of TG 402 respected the 3R principles (replace, reduce, refine) of animal testing. The results demonstrate that the TG 402 test design can be optimised with reduced animal numbers per test group, such that a scenario of two animals per group following a sighting study at a starting dose of 200 mg/kg bw (unless further information is available to better define the starting dose) would provide a classification which in most cases is conservative, without compromising both the statistical ability of the study to assess dermal toxicity, or the relevant classification outcome.

Profile of oral squamous cell cancer in a tertiary level medical college hospital: a 10 yr study.

To know the clinical and epidemiological characteristics & management strategies for the patients who underwent surgery for oral Squamous Cell Cancer (SCC) in a medical college hospital. Data pertaining to clinico-epidemiological factors & surgical management for oral cancer were analyzed in patients admitted to a tertiary level medical college hospital. Records of 139 patients admitted over a period of 10 years (January 1998 to December 2007) were used for data analysis. Only patients with complete records were included in the analysis. M: F ratio was 2.2:1 with average age of patients being 50.4 years. Tobacco chewing & smoking were major predisposing factors identified. Oral ulcer was the most common symptom while buccal mucosa, tongue & lower alveolus were three most common primary tumor sites. Majority of tumors were stage IV at presentation (52 %). Wide excision of tumor was done in 46 % of cases while in 54 % cases commando procedure was done. Reconstruction after either commando or wide excision was done in half of the patients. Pectoralis major myocutaneous (PMMC) flap was used in majority of cases for reconstruction. Neck dissection was done in 67 % patients. Majority (85 %) of these were radical neck dissection (RND). Per operative blood transfusions were required in 64 % patients while 19 % patients needed post operative transfusion. Post operative complications were noted in 34 % of the patients. Of these majority were related to wound infection & orocutaneous fistula formation. Hospital stay varied from 7 to 105 days with the mean duration of 30 days. Two year follow up revealed a recurrence rate of 36 %. Majority of the patients presented at an advanced stage due to self as well as professional delay in diagnosis. This leads to difficulty in resection of the primary tumor as well as reconstruction of the defect. A higher rate of recurrence after surgery is also seen. Post operative complications increase the morbidity which is reflected by an increase in the hospital stay (19 days Vs 46 days).

Does preoperative biliary stenting affect the outcome of pancreatico-duodenectomy?

BACKGROUND: Controversy exists whether preoperative endoscopic biliary stenting to reduce serum bilirubin level affects the outcome of pancreaticoduodenectomy. AIM: To determine whether preoperative endoscopic biliary stenting is associated with altered morbidity or mortality after pancreaticoduodenectomy. METHODS: In 37 consecutive patients with periampullary lesion undergoing pancreaticoduodenectomy over a 6-year period, frequency of septic complications, occurrence of pancreatic leak or bleeding, duration of hospital stay, and mortality were studied; of these, 15 had preoperative biliary stenting and 22 had not. RESULTS: Postoperative infective complications occurred more often in the patients with biliary stent than in those without (26% vs 0%, p=0.04). Postoperative recovery time, hospital stay and mortality were similar in the two groups. CONCLUSION: Preoperative biliary stenting is associated with septic complications, but this does not affect postoperative recovery after pancreaticoduodenectomy.

Intranasal administration of fusidic acid cream in leprosy.

The effect of local treatment of nostrils with fusidic acid cream was investigated in 30 previously untreated lepromatous leprosy patients. The cream was applied in the nostrils after flushing the nostrils with normal saline, twice a day for a period of four weeks. It was found that 20 mg/gm of sodium fusidate was effective in reducing the morphological index of the nose-blow smear to zero in two weeks in majority of the patients. No untoward side effect was seen in any of the patients. Such nasal treatment along with multidrug therapy may help in reducing the patient's level of infectiousness to their contacts, since the nose is recognized to be an important portal of exit of M. leprae.

Comparative efficacy of three measles vaccines in Indian children.

A Comparative study of three types of measles vaccines was undertaken among 1005 children. Of these 527 were vaccinated with the Serum Institute of India (SII) vaccine, 230 with Schwarz (SC) and 248 were vaccinated with Edmonston-Zegreb (EZ) vaccine (imported from Zegreb). Though the majority of children reacted favourably with all the three vaccines (SII: 98.43%; SC: 93.40%; EZ: 93.0%) with a rise in titre, but the percentage of seroconversion was significantly higher with the SII vaccine (p < 0.01). The Schwarz and Edmonston Zagreb vaccines showed significantly less GM titre as compared with the other age group i.e. 9-12 months (p < 0.05). With Serum Institute of India (SII) vaccine the GM titres were almost similar in the different age groups. The overall GM titre obtained with the SII vaccine was significantly higher than the SC vaccine (p > 0.001) as well as the EZ vaccine (p > 0.001). It is of interest to note that among the infants, 22.5% children had measles antibody in them before vaccination.

PIP: This study compares the efficacy of the three types of measles vaccines undertaken among 1005 children at the General Hospital pediatrics department in Pune, India. Of these children, 527 were vaccinated with the Serum Institute of India (SII) vaccine, 230 with Schwarz (SC), and 258 were vaccinated with Edmonston-Zagreb (EZ) vaccine. Results showed that the percentage of seroconversion was significantly higher with SII vaccine (98.43%) when compared with the SC (93.40%) or the EZ vaccines (93.0%). Majority of the children reacted favorably with the 3 vaccines after the rise in titer. The GM titer in the age group less than 9 months of the Schawarz vaccine was significantly less as compared with 9-12 months. The EZ vaccine also showed significantly less GM titer in the age group less than 9 months compared with the 13-18 month group. The SII vaccine and the GM titer were almost similar in different age groups. The overall GM titer obtained in the SII vaccine was significantly higher than the SC and the EZ vaccines. From this study, a direction to the strategy of measles vaccination was enlightened.

A study of pure neuritic leprosy: clinical experience.

Pure neuritic leprosy is a well-recognized clinical entity. Manifestations of leprosy in pure neuritic form accounted for 179 patients out of the total 3853 leprosy patients (4.6%) attending our Poona Urban Leprosy Investigation Centre clinics. Patients with pure neuritic leprosy are prone to develop nerve damage. Eight-seven (48.6%) of our pure neuritic patients presented with deformities. Involvement of upper extremity and right ulnar nerve in particular was the most common clinical feature. Patients presenting with involvement of two nerves of the same extremity was also quite common. None of our patients developed skin lesions while on anti-leprosy treatment. It is important to recognize neuritic symptoms early and suspect leprosy even in the absence of skin lesions.

Wax therapy for dry feet in leprosy.

A comparative study of the effect of wax therapy and foot soaks on dry plantar skin was conducted in patients with leprosy. Thirty patients with varying grades of fissures and callosities were given wax therapy for feet, and 20 similar patients were given foot soaks. Patients given wax therapy felt subjectively much better than those who had soaking. Healing of cracks and fissures and softening of callosities was observed more frequently in patients with wax therapy. These differences are statistically significant. As an institutional method wax therapy has definite advantages for treating patients with fissures and callosities, whereas soaking of the feet is easy and readily available in patients' homes to restore the dry skin to normal.

Study of deformities in children with leprosy: an urban experience.

A study was conducted to assess the deformities in children with leprosy. Eyes, hands and feet were examined for leprosy-related deformities. The influence of age, sex, duration of disease, type of disease, occurrence of leprosy reactions and anti-leprosy treatment on the occurrence of deformities was studied. In our urban leprosy project the percentage of children (0-14 years) suffering from leprosy is 7% of the total number of leprosy patients. The response to multidrug therapy, health education and physiotherapy was good.

Oral zinc therapy in recurrent erythema nodosum leprosum: a clinical study.

Effect of oral zinc as an immunomodulator was studied clinically in patients with recurrent ENL over a period of one year. In this study, 40 leprosy patients with chronic ENL, requiring more than 30-40 mg of prednisolone/day for the control of their reactions, were given oral zinc sulphate for a period of four months, and, marked improvement in the frequency, duration and severity of reactions was observed after zinc therapy. Also evident was marked reduction in the steroid requirement after oral zinc therapy. It appears that zinc may be a good substitute for the present day anti-reaction treatment which is not free from disadvantages. Further investigations to know the precise action of zinc on immune-system may help to understand the role of zinc therapy and its optimum duration.

Comparison of two multidrug regimens in multibacillary leprosy.

One of the technical problems relating to the multidrug therapy of leprosy is the slow decrease in the bacteriological index (BI) in multibacillary patients. In this study we have compared a regimen containing rifampicin given daily for 9 months with the standard WHO multidrug regimen for multibacillary leprosy. We have found, at the end of two years, a significantly greater fall of BI in patients who had received the regimen containing daily rifampicin as compared to those who had received pulsed doses of rifampicin. The doses of dapsone and clofazimine were similar in these two groups. It appears that daily administration of rifampicin may be useful in treating multibacillary patients in whom reduction in the BI is slower than expected. However, in view of its high cost and the very much increased incidence of type-2 lepra reactions and hepatitis, daily rifampicin therapy cannot be recommended for a control programme.

Gelatin particle agglutination assay to detect anti-PGL-I antibodies in leprosy patients and in household contacts: a preliminary study.

A preliminary study of anti-phenolic glycolipid-I (PGL-I) IgM antibody detection using M. leprae gelatin particle agglutination (MLPA) test kit is described. Antibodies were demonstrated in 70% of our leprosy patients taking antileprosy treatment. The percentage of positivity of multibacillary cases was 86.0, whereas that of paucibacillary cases was 30.0. Good correlation was found between bacteriological index and the presence of antibodies. Antibodies were detected in 28% of our patients released from treatment. Fourteen out of 27 household contacts were found to have antibodies but none of the normal controls were seropositive. These preliminary data demonstrate that MLPA test is not applicable as sero-diagnostic test or as a test of cure, but may be useful for epidemiological studies and as a research tool.

Hyperkeratotic and verrucous skin lesions on lower extremities of leprosy patients.

Three morphological varieties of hyperkeratotic and verrucous skin lesions on the anterior aspect of ankle joints in patients with leprosy are described: (i) verrucous lesions with thread-like horny projections similar to filiform warts; (ii) irregular compact hyperkeratotic lesions with deep fissures in between; and (iii) hyperkeratotic lesions with linear fissures corresponding to the transverse creases on the anterior aspect of the ankle. Chemical cautery was useful for the treatment of the first two varieties, and a potent topical corticosteroid with salicylic acid was useful for the third.

Coexistent lepromatous leprosy and reactive perforating collagenosis.

The cases of two young men with coexistent lepromatous leprosy and reactive perforating collagenosis are reported. Although both patients' parents were consanguineous, experimental induction of Koebner's phenomenon by superficial scratching failed to produce the lesions of reactive perforating collagenosis. The lesions of reactive perforating collagenosis showed a satisfactory response to treatment with topical retinoic acid.

Vibration sense and tarsal disintegration.

The extent of loss of vibration and pressure sensations was assessed in 21 leprosy patients with disintegration of the tarsus. Feet which had and did not have tarsal disintegration both showed severe impairment of pressure sensation, but the loss of vibration sense was more severe in feet which had undergone the destructive process. It appears that loss of deep sensation is an important factor in the process of tarsal disintegration in feet which are already anaesthetic. Measurement of vibration sense using a biosthesiometer may be a valuable clinical test in the investigation and follow-up of the patient with the insensitive foot to identify those at risk of developing tarsal disintegration.