Chubarovsky V V, Vanchakova N P, Zun S A, Parashchenko A F, Kolyago O O, Potapov I V, Savchenkov V A, Ushkalova A V
Sechenov First Moscow State Medical University (Sechenov University), Moscow, Russia.
Pavlov First Saint Petersburg State Medical University, St. Petersburg, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2023;123(10):81-87. doi: 10.17116/jnevro202312310181.
An observational non-interventional study was conducted to obtain data on the efficacy and safety of Prospekta in the treatment of postpsychotic asthenia in patients with cognitive impairment (CI).
We selected 69 patients aged 18-75 years with asthenic disorders that developed after suffering psychotic conditions and CI, who were prescribed Prospekta. At four visits (at baseline, after 2, 4 and 8 weeks), the doctor collected complaints, anamnesis, examined the patient, assessed the severity of asthenia on the MFI-20 (The Multidimensional Fatigue Inventory-20) scale, CI - on the MMSE (The Mini-mental state examination). Concomitant diseases and maintenance therapy of the underlying disease were recorded, and the safety of treatment with Prospect was evaluated. At the last visit, the doctor's clinical impression was assessed using the CGI-I (Clinical Global Impression - Global Improvement Scale).
The analysis included data from 69 patients (mean age 45.7 years), of which 27 (33.4%) were women. Prospekta reduced the severity of asthenia on the MFI-20 scale from 85.7±6.6 to 51.6±7.1 points, including general asthenia, mental and physical asthenia, and contributed to an increase in activity and motivation (<0.001). 8-week treatment with Prospekta improved cognitive function on the MMSE scale from 25.7±3.7 to 28.8±1.5 points (<0.001). There was no effect of the drug on blood pressure, heart rate. 76 adverse events (AEs) were detected in 22 patients, of which 62 AEs (82%) were of mild severity, 14 AEs (18%) were of moderate severity. A causal relationship of AEs with taking Prospekta, according to doctors, was absent in 48 (63%) cases.
Prospekta is an effective and safe drug for the treatment of asthenic disorders that have developed after suffering psychotic conditions in patients with CI.
开展一项观察性非干预研究,以获取关于Prospekta治疗认知障碍(CI)患者精神病后虚弱症的疗效和安全性数据。
我们选取了69例年龄在18至75岁之间、患有精神病后出现的虚弱症且伴有CI的患者,并为他们开具了Prospekta。在四次就诊时(基线时、2周后、4周后和8周后),医生收集患者主诉、病史,对患者进行检查,使用MFI - 20(多维疲劳量表 - 20)评估虚弱症严重程度,使用MMSE(简易精神状态检查表)评估CI。记录伴随疾病及基础疾病的维持治疗情况,并评估使用Prospekta治疗的安全性。在最后一次就诊时,使用CGI - I(临床总体印象 - 总体改善量表)评估医生的临床印象。
分析纳入了69例患者(平均年龄45.7岁)的数据,其中27例(33.4%)为女性。Prospekta使MFI - 20量表上的虚弱症严重程度从85.7±6.6分降至51.6±7.1分,包括全身虚弱、精神和身体虚弱,并有助于提高活动能力和动力(<0.001)。Prospekta治疗8周使MMSE量表上的认知功能从25.7±3.7分提高到28.8±1.5分(<0.001)。该药物对血压、心率无影响。在22例患者中检测到76例不良事件(AE),其中62例AE(82%)为轻度,14例AE(18%)为中度。据医生判断,48例(63%)AE与服用Prospekta不存在因果关系。
Prospekta是治疗CI患者精神病后出现的虚弱症的一种有效且安全的药物。