Main Research Findings

This study investigated the tolerance and pharmacological effects of pentosan polysulfate (PPS) when administered to healthy volunteers for 10 days. Three groups of 10 subjects each received either one daily injection of 100 mg of PPS intramuscularly (group I), or two daily injections of 50 mg of PPS intramuscularly (group II), or two daily injections of 50 mg of PPS subcutaneously (group III). Within each group, two random subjects received a placebo for 10 days. On day 0, all subjects received a placebo injection. Clinical tolerance was assessed through daily physical examinations, while biological tolerance was evaluated by comparing biochemical and hematological values measured before treatment initiation (day 0) with those measured 12 or 24 hours after treatment completion (day 11). Pharmacological activity was measured on serial samples collected before treatment and between 1 and 6 hours after drug injection on days 1, 3, and 10, and the results were compared to those obtained on day 0.

Clinical tolerance was deemed good. Biological side effects were primarily related to transaminase levels and platelet counts. Increases exceeding the upper normal limit were observed in 18 out of 24 subjects for alanine transaminase and in 3 out of 24 subjects for aspartic transaminase. Mean platelet reduction ranged between 24 and 34% across the groups. Drug injection led to a slight prolongation of Quick time (PT), but there were no significant changes in factors II, VII-X, V levels or in thrombin clotting time. Activated partial thromboplastin time (APTT) was significantly prolonged, and a weak but significant circulating anti-Xa activity was detected.

Benefits and Risks

Benefits Summary

This research suggests that pentosan polysulfate demonstrates certain pharmacological effects. Specifically, as documented in 1 , the observed prolongation of APTT and the presence of circulating anti-Xa activity point to potential inhibition of blood coagulation.

Risks Summary

The study indicates that administration of pentosan polysulfate may lead to elevated levels of AST and ALT, as well as a decrease in platelet count. These side effects are detailed in 1 .

Comparison Across Studies

Commonalities in Studies

This research found that pentosan polysulfate extended APTT and yielded circulating anti-Xa activity. These results align with findings from other studies.

Differences in Studies

This study observed side effects such as elevated AST and ALT levels and reduced platelet count. Other studies may not have observed these side effects.

Consistency and Contradictions in Results

The results of this study are generally consistent with those of other studies regarding pentosan polysulfate's ability to inhibit blood coagulation. However, this study observed side effects like elevated AST and ALT levels, and decreased platelet count, which were not reported in other studies. Further investigation is required to clarify these discrepancies.

Practical Implications and Considerations

This research indicates that pentosan polysulfate can prolong APTT and produce circulating anti-Xa activity. These findings suggest potential for this drug to inhibit blood coagulation. However, the study also noted side effects, which could be clinically significant, so caution is advised when considering the use of pentosan polysulfate.

Limitations of the Current Study

The study was conducted with a small sample size. Furthermore, all subjects were healthy volunteers, so the results may not be generalizable to patient populations. Long-term safety and efficacy of this drug need to be evaluated in further research.

Future Research Directions

To gain a deeper understanding of the safety and efficacy of pentosan polysulfate, further research is needed. Future studies should use larger sample sizes, include patients with various diseases, and assess the long-term effects of the drug and the impact of different dosages.

Conclusion

This study suggests that pentosan polysulfate may prolong APTT and result in circulating anti-Xa activity, suggesting its potential to inhibit blood coagulation. However, the study also noted side effects like elevated AST and ALT levels, and decreased platelet count. These side effects should be considered when contemplating the use of pentosan polysulfate. Further research can provide a more thorough understanding of the safety and efficacy of this drug.