Prostaglandin生成阻害剤LM-001の尿路結石による痛ならびに膀胱・前立腺術後の膀胱切迫感に対する臨床疼効果

Abstract

膀胱乳剤にフェルビナクのエチルエステルを封入させたLM-001静注剤を尿路結石による疼痛と膀胱・前立腺手術後の膀胱切迫感に対する有効性ならびに安全性について検討した.1)尿路結石による疼痛に対しては53例中49例に効果がみられた.有効例49例中41例までが本剤投与15分以内に効果が発現した.また26例において効果が24時間以上持続した.2)膀胱・前立腺手術後の膀胱切迫感に対しても29例中25例に効果がみられた.有効例25例中16例までが15分以内に効果発現した.また13例において効果が24時間以上持続した.3)副作用として血管痛, 熱感, 視力軽度低下, 血圧の一時低下がみられたが, いずれもきわめて軽度で何ら処置することもなく短期間に消失した.また, 3例に白血球増多, 1例にA1-pの上昇がみられたが, その程度は軽度であり, すぐに正常化した.4)LM-001は尿路結石による疼痛の緩和と膀胱・前立腺手術後の膀胱切迫感に対し, 速効性で高い有効率を示し, かつ作用時間が長いこと, また副作用がきわめて少ないことから優れた薬剤と評価し得た

Clinical effect of LM-001, a prostaglandin synthetic inhibitor developed from a drug delivery system, was evaluated in 54 patients with pain from urinary tract stones (stone pain) and 32 with vesical urgency after an operation on bladder or prostate. LM-001, felbinac ethyl incorporated in lipid microsphere, wes intravenously administered at the onset of stone pain or vesical urgency. Of 54 with stones and 32 with urgency, 53 and 29 were eligible for response, respectively. The symptoms improved or disappeared in some cases just after the administration and in the majority of patients within 15 minutes, in 49 of 53 patients with stone pain. Further, the effectiveness lasted over 24 hours in 26 of the 49 responding to this agent. On one hand, improvement or disappearance of vesical urgency was recognized in 25 of 29 patients, and the effectiveness was observed shortly after injection in 16 and lasted over 24 hours in 13 cases. Toxicities of this drug were investigated in 54 patients with stone pain and 32 with urinary urgency. Side effects consisted of pain at the injection site in 4, a slight fall of blood pressure in 1, slight visual disturbance in 1, body heat sensation in 1, leukocytosis in 3 and elevation of alkaline phosphatase in 1. These symptoms were transient and disappeared without use of any agent. LM-001 is concluded to be a useful drug for controlling stone pain and vesical urgency since an immediate effect, long durability and high response rates were obtained without severe side