Safety of ciprofloxacin in children: Worldwide clinical experience based on compassionate use. Emphasis on joint evaluation

Summary Six hundred and thirty four adolescents and children aged three days to 17 years treated with ciprofloxacin on a compassionate basis were analysed for drug safety. 62% of the ciprofloxacin courses were given to patients with respiratory tract infection, primarily those with acute pulmonary exacerbation of cystic fibrosis. The mean daily oral dose was 25.2 mg/kg body weight. The duration of treatment ranged from one to 880 days (mean 22.8 days). Because of the arthropathogenic potential of quinolones in juvenile animals special emphasis was placed on the evaluation of musculoskeletal adverse events. Arthralgia considered by the treating physicians to be related to ciprofloxacin was reported in eight children, all of whom were females. Arthralgia resolved in all children. Some of these children were given subsequent courses of ciprofloxacin with no complaints of arthralgia. Overall, the safety profile of ciprofloxacin in children is not substantially different from that of adults.

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Verträglichkeit von Ciprofloxacin bei Kindern unter besonderer Beachtung der Gelenke. Auswertung weltweit dokumentierter Problemfälle

Zusammenfassung Die Verträglichkeit des Ciprofloxacin nach Anwendung bei 634 Jugendlichen und Kindern im Alter von drei Tagen bis 17 Jahren wurde analysiert. 62% der Behandlungen mit Ciprofloxacin erhielten Patienten mit Atemwegsinfektionen, insbesondere mit akuter pulmonaler Exazerbation der Mukoviszidose. Der Mittelwert der oralen Tagesdosis war 25,2 mg/kg Körpergewicht. Die Therapiedauer variierte zwischen 1 und 880 Tagen (Mittelwert 22,8 Tage). Wegen der gelenkknorpelschädigenden Wirkung der Chinolone bei juvenilen Versuchstieren wurde besondere Aufmerksamkeit der Beurteilung der mit Gelenken verbundenen Nebenerscheinungen gewidmet. Arthralgie, die von den behandelnden Ärzten als Folge der Ciprofloxacin-Behandlung beurteilt wurde, ist bei acht Kindern berichtet worden. Alle waren weiblich. Die Arthralgie verschwand bei allen Kindern. Einige dieser Kinder erhielten nachträgliche Behandlungen mit Ciprofloxacin ohne Auftreten arthralgischer Beschwerden. Generell unterschied sich das Verträglichkeitsprofil bei Kindern nicht wesentlich von dem der Erwachsenen.

     

Abstracts

Ohne Zusammenfassung

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Abstracts

     

Bordetella pertussis Filamentous Hemagglutinin Enhances the Immunogenicity of Liposome-Delivered Antigen Administered Intranasally

In an attempt to increase the immunogenicity of mucosally delivered antigens, we incorporated the Bordetella pertussis filamentous hemagglutinin (FHA) adhesin into liposomes containing the glutathione S-transferase of Schistosoma mansoni (Sm28GST) as a model antigen. Outbred mice immunized twice intranasally with liposomes containing a constant suboptimal dose of Sm28GST and increasing doses of FHA produced anti-Sm28GST antibodies in a FHA dose-dependent manner. The addition of 3 μg of FHA to the liposomes induced more than 10-fold-higher anti-Sm28GST antibody titers, compared to those induced by liposomes without FHA. The presence of FHA did not alter the nature of the humoral immune response, and the sera contained anti-Sm28GST immunoglobulin G1 (IgG1), IgG2a, and IgG2b. However, anti-Sm28GST IgA was only detected when at least 3 μg of FHA was added to the preparation. These results show a promising potential for FHA to enhance the immunogenicity of mucosally administered antigens incorporated into liposomes.     

A 3 year retrospective review of intrauterine insemination, using cryopreserved donor spermatozoa and cycle monitoring by urinary or serum luteinizing hormone measurements

Insemination with donor spermatozoa is an integral part of infertility treatment. For the last 3 years in our unit, intrauterine insemination with donor spermatozoa (IUID) has been used in preference to vaginal insemination. In this retrospective study, patients were offered an initial course of five single intrauterine inseminations with cryopreserved donor spermatozoa and treatment was then reviewed. A total of 389 patients received 1465 inseminations. In all, 1119 cycles were monitored using luteinizing hormone serum analyses and 346 cycles using the urine home test kits. The clinical pregnancy rate per insemination for the cycles monitored by the serum assay was 18.0% (202/1119) compared with the urine cycles (13.7%, 46/346) (P <05). The pregnancy loss rate was not significantly different (14.4%, 29/202 and 21.7%, 10/46) (serum and urine cycles respectively). The viable clinical pregnancy rate was significantly higher (P <03) for the serum cycles than for the cycles using the urinary monitoring (15.5%, 173/1119 and 10.4%, 36/346 respectively). The cycles monitored by serum assay had a significantly higher cumulative viable clinical pregnancy rate (P <0001) of 70.2% after nine inseminations compared with the urine monitored cycles of 54.8%. The majority of patients opted for the serum cycles, with a minority self-selecting the urine cycles mainly for travelling convenience. The explanation for the significant differences between the viable clinical pregnancy rates per insemination and the cumulative viable clinical pregnancy rates may be due to the sensitivity of the urine home test kit or the patients' interpretation of the result.      

脾内血管的应用解剖学研究盐酸喹那普利治疗原发性高血压的临床应用观察

目的　探讨盐酸喹那普利 (QuinaprilHydrochloride)治疗轻、中度原发性高血压的有效性和安全性。方法　全国 6家医院参加的一项多中心、随机、双盲、平行组间对照研究。结果　 113例原发性高血压病人治疗 8周后 ,总有效率达 85 84% ,统计学有显著性差异。盐酸喹那普利副反应较轻 ,对肾脏、肝脏、造血系统和心脏未见有害作用。结论　盐酸喹那普利是一种安全、疗效好、副反应小的治疗轻、中度原发性高血压的有效药物。     

Synthesis and biological activity of new HMG-CoA reductase inhibitors. 3. Lactones of 6-phenoxy-3,5-dihydroxyhexanoic acids.

A group of 43 optically active sodium carboxylates (11a-qq and the corresponding lactones 4 were prepared from respective phenols 8 according to Schemes I-III. Phenols 8 were synthesized from commercially available compounds according to Schemes IV-IX. A number of these HMG-CoA reductase inhibitors 11 exceeded mevinolin's activity in vitro (Tables II and III). Selected lactones 4 effectively inhibited hepatic "de novo" cholesterol synthesis in rats in vivo (Table IV). After po administration to rabbits, 4ff(11ff), 4hh, and notably 11jj reduced plasma cholesterol levels more potently than mevinolin (Table V). Whereas 4ff(11ff) displayed the slight superiority expected according to in vitro data, 4hh and 11jj were considerably more potent than expected. Each of these compounds had only moderate activity after po administration to dogs (Table VI). Compound di-11ii, a hybrid of the structural elements of probucol and HMG-CoA reductase inhibitors, after po administration to rats decreased serum lipoproteins and increased HDL/LDL ratio better than probucol (Table VII). HMG-CoA reductase inhibitor 11ll and phenolic building blocks 8, notably 8jj and 8kk, inhibited LDL oxidation in vitro (Table VIII). Chemical structure-activity relationships (Table IX) and the pharmacological profile of phenoxy-type inhibitors 11 diverged from those of known HMG-CoA reductase inhibitors.