Therapeutic Research

近年，世界的にうつ病という疾患がもたらす問題が社会的課題になっている。わが国においても当該疾患関連の罹患者による自殺は毎年一定数存在しており，改善の傾向はみられていない。本研究では，自己申告に基づいて疾患保有が登録されているアンケートモニターの情報に基づき，うつ病患者およびその家族を対象としてうつ病の診療実態を把握するとともに，うつ症状の寛解に影響する要因を抽出することを目的に調査を行った。主にうつ病患者，うつ病寛解者各1000 サンプルの計2000 サンプルの回答結果について，単変量および多変量解析を行った。その結果，うつ病患者にとって家族の後押しがあるなどの通院を始めやすい環境，うつ病患者自身および家族も含めた疾患への理解があると，治療コントロールが向上することが示唆された。また，そのためには主治医との信頼関係の構築と関係継続が重要と考えられた。

欠伸（あくび）が多発し，運動療法の継続困難な心不全患者に対し，治療方針を決定する目的で心肺運動負荷試験（CPX）と心エコー図検査（心エコー）を同時に実施した症例を経験した。症例は80 歳代の男性。基礎心疾患に虚血性心疾患，弁膜症（大動脈弁閉鎖不全症と僧帽弁閉鎖不全症）がある。心不全（左室駆出率64％，BNP 218.5 pg/mL）の運動療法中に欠伸の多発と血圧低下により治療の継続が困難であった。CPX と心エコーの同時評価を行ったところ，負荷時に弁膜症の悪化，嫌気性代謝閾値以降の拡張能の増悪を認めた。血圧低下ならびに欠伸出現時，心エコーから推定した体血管抵抗は低下していた。β遮断薬をカルベジロールからビソプロロールに変更したところ症状の改善，運動療法の継続が可能となった。CPX と心エコーによる同時評価は限界もあるが，運動療法の継続困難な症例の評価の方法の一つと考えられた。

Lusutrombopag has been covered by national health insurance in Japan, and now has been widely available for severe thrombocytopenia in the chronic liver disease patients. We experienced two cases of repeated treatment using lusutrombopag. Both of two patients had hepatocellular carcinoma with severe thrombocytopenia, and received repeated invasive treatments such as radiofrequency ablation and transcatheter arterial chemoembolization successfully, without severe bleeding, thrombosis or any serious adverse events. Repetitive administration of lusutrombopag was efficient and safe.

Background：Tiotropium soft mist inhaler（Spiriva® Respimat®；Tio‒R）is the first long‒acting muscarinic antagonist approved in Japan for the treatment of persistent asthma of all severities. Objective：To investigate the safety and effectiveness of Tio‒R in patients with mild‒to‒moderate persistent asthma under general clinical practice.Method：This post‒marketing surveillance（NCT03188120）was a 12‒week non‒interventional observational study. Patients who received Tio‒R for the first time for treatment of mild‒to‒moderate persistent asthma on top of at least ICS maintenance therapy were enrolled. Primary outcomes were the absolute and relative frequencies of patients with adverse drug reactions（ADRs）over a 12‒week period. The secondary outcome was the change from baseline in asthma control status at Week 12；further outcomes included Asthma Control Questionnaire‒6（ACQ‒6）score at Week 12 etc. Results：Of 193 patients enrolled, 180 and 159 were included in the safety and effectiveness analysis sets, respectively. Five （2.78％［5/180］）patients in the safety analysis set reported ADRs, including thirst （1.67％［3/180］）, dysphonia（1.11％［2/180］）, and cough（0.56％［1/180］）. One （0.56％）patient reported a serious adverse event（herpes zoster）. Tio‒R was judged effective in 68.53％（98/143）of patients who had available data for baseline and Week 12. The mean ACQ‒6 score at Week 12 significantly improved compared to that at baseline（－0.93±0.80, mean change±standard deviation ［95％ confidence interval；－1.12, －0.73］）. Conclusion：This survey detected no new safety concerns or precautions for use and confirmed the effectiveness of Tio‒R in patients with mild‒to‒moderate persistent asthma under general clinical practice.

Patient centricity is one of the most important concept whenever we conduct clinical trials. In recent years, several publications about patient insight have been reported and referred to improve patient experience and clinical trial process in the world. We conducted the web‒based survey with patients who have experienced to participate in Japanese clinical trials to understand their insight /feeling /satisfaction /expectations and real circumstance around clinical trials. 1364 patients participate the web‒survey. 83.4％ of the total was completed the clinical trials while 16.6％ was dropout before completion. Total satisfaction（score 0：worst―score 10：best）of clinical trial was 35.2％ for high（score：10‒8）, 54.9％ for middle（score：7‒4）and 9.9％ for low（score：3‒0）. As the advantage of the clinical trial, compensation was 50.7％ and medical expense deduction was 45.6％ while time commitment was 23.4％ and transportation burden was 22.3％ as the disadvantage. As the expectations for future clinical trials, to have personal medical record during the clinical trial was 81.4％（very helpful and helpful）and to see clinical trial outcome was 76.4％.This survey showed that there are various types of burden, needs and expectations at any stage from before to after the clinical trial. In order to make Japanese clinical trials more accessible and improve patient enrollment and retention at minimum study drop‒out, it is important to establish the work flow to continuously incorporate participants’ voice into the study improvement process and proactively support them.