Tác động đến sự hài lòng và mức độ tham gia dịch vụ của Paliperidone Palmitate so với Paliperidone đường uống ở bệnh nhân tâm thần phân liệt: Một thử nghiệm kiểm soát ngẫu nhiên mở

Springer Science and Business Media LLC - Tập 39 - Trang 169-178 - 2018
Paola Bozzatello1, Silvio Bellino1, Irene Mancini2, Luisa Sandei, Enrico Zanalda3, Paola Rocca2,4
1Center for Personality Disorders, Department of Neuroscience, “Rita Levi Montalcini”, University of Turin, Turin, Italy
2Department of Neuroscience “Rita Levi Montalcini”, University of Turin, Turin, Italy
3Department of Mental Health, A.S.L. TO 3, Turin, Italy
4Department of Neuroscience and Mental Health, S.S. D. Coordinamento Assistenziale Psichiatrico Ospedale-Territorio, A.O.U. Città della Salute e della Scienza di Torino-Molinette, Turin, Italy

Tóm tắt

Các hướng dẫn thực hành lâm sàng khuyến cáo sử dụng liệu pháp đơn thuốc antipsychotic, bao gồm cả các dạng đường uống và dạng tác dụng kéo dài, trong điều trị tâm thần phân liệt. Thử nghiệm kiểm soát ngẫu nhiên, mù mở này nhằm đánh giá hiệu quả và khả năng dung nạp ở bệnh nhân tâm thần phân liệt của Paliperidone Palmitate tác dụng kéo dài một lần mỗi tháng (PP1M) so với Paliperidone giải phóng kéo dài đường uống (ER), với trọng tâm đặc biệt vào sự hài lòng, mức độ hạnh phúc chủ quan và mức độ tham gia dịch vụ. Bảy mươi hai bệnh nhân ngoại trú liên tiếp mắc bệnh tâm thần phân liệt (DSM-5) được phân bổ ngẫu nhiên trong 6 tháng vào: (1) PP1M (50–150 mg tương đương) hoặc (2) Paliperidone ER (6–12 mg/ngày). Người tham gia được đánh giá tại thời điểm bắt đầu và sau 6 tháng với Bảng hỏi Sự hài lòng đối với Thuốc (TSQM); Thang đo Hạnh phúc Chủ quan dưới tác động của thuốc chống loạn thần (SWN-K); Thang đo Mức độ Tham gia Dịch vụ (SES); Ấn tượng Toàn cầu Lâm sàng - Tâm thần phân liệt (CGI–SCH); và điểm số về Hiệu suất Cá nhân và Xã hội (PSP). Phân tích ANOVA các đo lường lặp lại được thực hiện. Phân tích theo ý định điều trị với quan sát cuối cùng được thực hiện. Chúng tôi phát hiện một hiệu ứng đáng kể trong các chủ thể (thời gian thử nghiệm) cho tất cả các thang đánh giá ngoại trừ các triệu chứng nhận thức và lĩnh vực “tác dụng phụ” của TSQM. Một hiệu ứng đáng kể giữa các chủ thể (phương thức điều trị) được tìm thấy cho triệu chứng tiêu cực CGI, các lĩnh vực TSQM “sự hài lòng chung” và “sự tiện lợi”, cũng như SES. Có bảy người tham gia rút lui (9,7%): hai do tăng prolactin huyết tương và năm do thiếu tuân thủ. Những khác biệt đáng kể giữa hai loại bào chế đã được tìm thấy. PP1M vượt trội hơn so với Paliperidone ER về sự hài lòng toàn cầu của điều trị và sự tiện lợi, về sự tham gia dịch vụ, và trong việc giảm triệu chứng tiêu cực. Thử nghiệm đã được đăng ký tại Đăng ký Thử nghiệm Lâm sàng Úc và New Zealand (ANZCTR) với mã số: ACTRN12618001113246.

Từ khóa

#tâm thần phân liệt #Paliperidone #sự hài lòng điều trị #tham gia dịch vụ #nghiên cứu ngẫu nhiên

Tài liệu tham khảo

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