PubMed · 16423644
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Ed Carlson. 2006. Offshore innovation.. https://doi.org/10.1016/s0197-2510(06)70276-5
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Pyloromyotomy as described by Weber and Ramstedt has been the standard therapy for infantile hypertrophic pyloric stenosis since the 1960's and conservative therapy has been abandoned. The objective of this study was to test the effectiveness of systemic atropine applied intravenously for 7 days as a conservative therapeutic strategy and as an alternative to primary operation. Forty-two consecutive term infants with infantile hypertrophic pyloric stenosis were enrolled in the study over a period of 5 years. After confirmation of the diagnosis they all received intravenous atropine at a dose of 0.04 mg/(kg day) and increased by 0.01 mg/(kg day) up to 0.12 mg/(kg day), given as 6-8 single doses per/day. Nine pairs of parents requested that their child should be operated before completing the 7 days of medical therapy. Surgery was necessary in 8 of the remaining 33 infants (24,.2%) who did not improve after 7 days of conservative treatment. Successful treatment with i.v. atropine sulfate was achieved only in 25/33 term infants at an average maximal dose of 0.11 mg/(kg day), without any major side effects. Intravenous atropine sulfate has been considered as a potential alternative therapeutic strategy in the treatment of infantile hypertrophic pyloric stenosis. Clinical improvement however was often not seen before the 6th or 7th day of intravenous treatment. A success rate for the conservative approach of only 75% at day 7 in our study does not favour atropine therapy, in view of success rates above 95% with surgical repair.
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An oil-in-water microemulsion electrokinetic chromatography (MEEKC) method has been developed and validated for the determination of atropine, its major degradation products (tropic acid, apoatropine and atropic acid) and related substances from plants material (noratropine, 6-hydroxyhyoscyamine, 7-hydroxyhyoscyamine, hyoscine and littorine). Separation of atropine and all impurities was optimized by varying the voltage, the nature of the oil droplet and the buffer, as well as the organic modifier (methanol, 2-propanol or acetonitrile) and the surfactant type and concentration. The optimum O/W microemulsion background electrolyte (BGE) solution consists of 0.8% (w/w) octane, 6.62% (w/w) 1-butanol, 2.0% (w/w) 2-propanol, 4.44% (w/w) SDS and 86.14% (w/w) 10 mM sodium tetraborate buffer pH 9.2. In order to shorten the analysis time a voltage gradient was applied. The validation was performed with respect to specificity, linearity, range, limit of quantification and detection, precision, accuracy and robustness. The established method allowed the detection and determination of atropine sulfate related substances at impurity levels given in the European Pharmacopoeia. Good agreement was obtained between the established MEEKC method and the traditional RP-HPLC method.