Isolation and characterization of degradation impurities in docetaxel drug substance and its formulation

The degradation of docetaxel drug substance and its injection formulation has been investigated. The majority of impurities were observed in a base degradation study and all five degradation products were characterized. These impurities were isolated, enriched and were subjected to mass and NMR spectral studies. Based on the spectral data, these were characterized as 10-deacetyl baccatin III, 7-epi-10-deacetyl baccatin III, 7-epi-10-oxo-10-deacetyl baccatin III, 7-epi docetaxel and 7-epi-10-oxo-docetaxel, respectively. The last two impurities were also detected in the stability study of docetaxel formulation. Out of these degradation impurities two substances have been previously identified while the other three previously unreported.     

白首乌化学成分的研究

自白首乌主要品种耳叶牛皮消(Cynanchum auriculatum Royle ex Wight)根中首次分得三个已知甾体酯型甙元:告达亭(caudatin),开德甙元(kidjolanin),萝藦甙元(Metaplexigenin)和一种新的二苯酮衍生物(Ⅳ),经光谱分析推定其结构为2,6,2′,5′-四羟基,3-乙酰基,6′-甲基二苯酮,命名白首乌二苯酮。     

Interventional Sialendoscopy for Parotid Ductal Calculi: Our Preliminary Experience

With this article we present our initial experience with interventional sialendoscopy of the parotid duct for the parotid calculi. We carried out a prospective study of patients of parotid calculi in a tertiary referral centre. Diagnostic and interventional sialendoscopy was performed in five cases of parotid calculi. The outcome was classified on the basis of clearance of the lumen of the duct and resolution of symptoms. Diagnostic sialendoscopy was able to diagnose the calculus in all cases. Interventional sialendoscopy was done under general anesthesia in all cases and calculus was successfully removed. The average size of sialolith was 8.2 mm. No complications occurred in any of the cases. Check sialendoscopy was done in all cases after a minimum follow up of 6 months, which showed the duct lumen to be free of stone with no stricture of the duct. Sialendoscopy is an optimal technique for removal of intraductal parotid calculi and avoids removal of the gland. In our series there was no associated morbidity and complication.     

Metabolic acidosis due to inhaled salbutamol toxicity: A hazardous side effect complicating management of suspected cases of acute severe asthma

Metabolic acidosis has seldom been reported during treatment of asthma with use of beta agonist but not with much clinical consequence. We report two cases of metabolic acidosis with hyperventilation as a direct effect of salbutamol that caused difficulty in assessment and management of their respiratory symptoms which resolved with appropriate tapering of beta agonist.     

The Effect of Medicaid Primary Care Provider Reimbursement on Access to Early Childhood Caries Preventive Services

Objective

To examine receipt of early childhood caries preventive services (ECCPS) in two states'' Medicaid programs before and after the implementation of reimbursement to medical primary care providers (M-PCPs).

Data Sources

Enrollment and claims data from the Florida and Texas Medicaid programs for children ≤54 months of age during the period 2006–2010.

Study Design

We conducted time trend-adjusted, difference-in-differences analyses by using modified Poisson regressions combined with generalized estimating equations (GEEs) to analyze the effect of M-PCP reimbursement on the likelihood that an enrollee had an ECCPS visit after controlling for age, sex, health status, race/ethnicity, geographic location, and enrollment duration.

Data Extraction Methods

Enrollment data were linked to claims data to create a panel dataset with child-month observations.

Principal Findings

Reimbursement to M-PCPs was associated with an increased likelihood of ECCPS receipt in general and topical fluoride application specifically in both states.

Conclusions

Reimbursement to M-PCPs can increase access to ECCPS. However, ECCPS receipt continues to fall short of recommended care, presenting opportunities for performance improvement.     

Effects of a Brief Case Management Intervention Linking People With HIV to Oral Health Care: Project SMILE

Objectives. Although people with HIV experience significant oral health problems, many consistently identify oral health as an unmet health care need. We conducted a randomized controlled trial to evaluate the impact of a dental case management intervention on dental care use.Methods. We evaluated the intervention according to self-reported dental care use at 6-, 12-, and 18-month follow-ups. Multivariable logistic models with generalized estimating equations were used to assess the effects of the intervention over time.Results. The odds of having a dental care visit were about twice as high in the intervention group as in the standard care group at 6 months (adjusted odds ratio [OR] = 2.52; 95% confidence interval [CI] = 1.58, 4.08) and 12 months (adjusted OR = 1.98; 95% CI = 1.17, 3.35), but the odds were comparable in the 2 groups by 18 months (adjusted OR = 1.07; 95% CI = 0.62, 1.86). Factors significantly associated with having a dental care visit included frequent physician visits and dental care referrals.Conclusions. We demonstrated that a dental case management intervention targeting people with HIV was efficacious but not sustainable over time. Barriers not addressed in the intervention must be considered to sustain its use over time.In the era of antiretroviral therapy, people with HIV are living longer and the treatment of associated medical and oral manifestations of the disease has shifted to a chronic disease model.1 Previous studies have shown that a person living with HIV/AIDS is more likely than a person without the disease to experience oral health problems.2–5 Furthermore, the oral health problems of individuals with HIV can be more severe and difficult to treat than those of the general population and may also contribute to the onset of opportunistic infections.5The oral health complications associated with HIV are well documented,2–6 and oral manifestations are increasingly being recognized as markers for monitoring treatment efficacy and predicting treatment failure.7 Oral manifestations, including Kaposi’s sarcoma, necrotizing ulcerative periodontitis, oral hairy leukoplakia, and candidiasis, may be present in up to 50% of people with HIV and 80% of people diagnosed with AIDS,5,6 and may predict low CD4 counts.8 In addition, individuals living with HIV/AIDS may experience difficulty in maintaining adequate salivary flow, which affects chewing, swallowing, and the ability to take medication.4 Chronic use of highly active antiretroviral therapy can also contribute to diminished salivary flow as well as an increased risk of oral candidiasis and oral hairy leukoplakia.9Throughout the 1990s, a series of study findings highlighted the unmet needs for dental care among people with HIV infection.10–14 This gap in oral health care services was corroborated by findings from the oral health component of the HIV Cost and Services Utilization Study,15 which demonstrated that unmet dental needs were twice as common as unmet medical needs among HIV-positive adults16,17 and led to a national call to action to improve access to oral health care.18 That study also showed that approximately half of people living with HIV had dental insurance, and those without dental insurance had greater unmet needs for dental services.17,19,20Recently published findings suggest that an unmet need still persists. One example is an initiative, funded by the Health Resources and Services Administration, that included 2469 people living with HIV who had not received dental care during the preceding year. Nearly half of these individuals (48%) reported an unmet dental need since their HIV diagnosis, 52% had not seen a dentist in more than 2 years, and 63% rated the health of their teeth and gums as fair or poor.21,22 An earlier investigation involving baseline data from the study presented here showed that oral health problems and symptoms were very prevalent among our study population, with 63% of participants having experienced an oral health impact very often or fairly often in the preceding 4 weeks.23Barriers to dental care use among individuals living with HIV include fear of dental care, HIV-specific stigma, fear of disclosing their HIV status to health care providers, perceived cost barriers, and poor adherence to medical guidance.20,22,24–31 Compounding patient access barriers, dental care providers may be reluctant to treat patients with HIV owing to fears of HIV transmission and associated stigma.32–36Previous research conducted in Florida revealed that more than one third of people with HIV do not discuss oral health with their primary care providers.37 Although clinical guidelines recommend that HIV care providers examine the oral cavity during initial and interim physical examinations of people living with HIV, this still may not be a regular clinical practice.37 To address underuse of oral health care services among individuals with HIV, we evaluated the efficacy of an intervention that linked individuals to dental care. The sample comprised a population of HIV-positive individuals in south Florida who had received HIV primary care but had not received oral health services in the preceding 12 months.     

Efficacy of Autogenous Split Thickness Calvarial Graft in the Management of Residual Cranial Defect

Introduction

The patients with cranial deformity suffer from headache, dizziness, irritability, loss of concentration, depression, anxiety, intolerance to noise and vibration and neuromotor weakness. It is therefore essential to restore the calvarium.

Material and Method

This study was conducted in the Department of Oral and Maxillofacial Surgery, Armed Forces Medical College, Pune between Oct 2010 and Mar 2012. The study population was selected from the outpatient department and from the referred cases. The aim was to study the uptake of split thickness calvarial graft in the management of residual cranial defect. After applying the inclusion and exclusion criterions, ten cases were selected with residual cranial deformity, operated for cranioplasty using split thickness calvarial graft and evaluated.

Conclusion

It was concluded that cranioplasty using autogenous split thickness calvarial graft for restoring cranial defects is a useful technique and this procedure allows the surgeon to reconstruct a moderate-to-large cranial defect, without breaching the inner cortical plate.