Clinical recommendation on paliperidone extended-release tablets second edition

1 2 3 2 4 5 6 7 8 9 10 11 12 13 14 15 1 1 100083 2 200030 3 110001 4 100096 5 410011 6 430060 7 215008 8 518003 9 610041 10 050030 11 650032 12 710032 13 310013 14 250021 15 430022 paliperidone extended release ER 2009 2011 ER ER ER R971. 41 A 1003-3734 2016 09-1029 - 07 Clinical recommendation on paliperidone extended-release tablets second edition SI Tian-mei 1 HUANG Ji-zhong 2 LI Xiao-bai 3 JIANG Kai-da 2 YANG Fu-de 4 HAO Wei 5 WANG Gao-hua 6 MEI Qi-yi 7 LIU Tie-bang 8 LI Tao 9 WANG Xue-yi 10 XU Xiu-feng 11 TAN Qing-rong 12 SHI Jian-fei 13 JIAO Zhi-an 14 LI Yi 15 YU Xin 1 1 Peking University the Sixth Hospital Institute of Mental Health Beijing 100083 China 2 Shanghai Mental Health Center Shanghai 200030 China 3 The First Hospital of China Medical University Shenyang 110001 China 4 Beijing HuiLongGuan Hospital Beijing 100096 China 5 The Second Xiangya Hospital of Central South University Changsha 410011 China 6 Renmin Hospital of Wuhan University Wuhan 430060 China 7 Suzhou Guangji Hospital Suzhou 215008 China 8 Shenzhen Kangning Hospital Shenzhen 518003 China 9 West China Hospital of Sichuan Chengdu 610041 China 10 The First Hospital of Hebei Medical University Shijiazhuang 050030 China 11 First Affiliated Hospital of Kunming Medical College Kunming 650032 China 12 The First Hospital of The Fourth Military Medical University Xijing Hospital Xian 710032 China 13 Mental Health Center School of Medicine Zhejiang University Hangzhou Seventh People's Hospital Hangzhou 310013 China 14 Shandong Provincial Hospital Jinan 250021 China 15 Wuhan Mental Health Center Wuhan 430022 China AbstractPaliperidone extended-release tablets paliperidone ER is a new type of antipsychotic drug marketed in China in 2009. The Clinical Recommendation on Paliperidone Extended-Release Tablets in schizophrenia therapy published in 2011 was an important guidance for doctors to use the paliperidone ER rationally in clinical 010 82801948 E-mail si. tian-mei@ 163. com 1029 2016 25 9

practice. In recent yearsmore and more research data and practical experience have been accumulated about paliperidone ER. Sowe updated the Recommendation based on the latest research evidence and clinical experience in order to optimize paliperidone ER treatment and improve patients' outcome. Key wordsschizophrenia paliperidone ER clinical recommendation rational medication 1 ER D 2 65% 2011 ER D 2 1 9- EPS 2 5-2A 5-HT 2A DA D 2 2 ER ER 9 2 8-12 α 2 D 3 5-HT 7 13-16 ER 3 Meta 4 114 ER 4 5-HT NE 2 SSRI RR 0. 3295% CI 0. 17 ~ 0. 58 5 RR 0. 3195% CI 0. 14 ~ 0. 67 11 ER CYP ER ER 2 6 ER CYP450 EPS 12 7 ER OROS Osmotic-controlled Release Oral Delivery System 1 ER Positive and Negative Syndrome Scale 12 mg d - 1 PANSS ER 38% 4 P < 0. 001 d 4 mg d - 1 125% PANSS P < D 2 0. 003 ER 18 D 2 ER Personal and Social Performance ScalePSP EPS D 2 80% ~ 85% P < 0. 001 ER D 2 66% ~ 77% 1030 2016 25 9 3 1 306 17

66% ER 17 13 19 ER PANSS ER ER 3. 2 ER 3 ER 6 mg d - 1 5 d 3 mg d - 1 3. 1 3. 2. 1 9 ~ 12 mg d - 113 19 22 ER ER 2 PANSS 23 24 3 mg d - 1 1 ~ 3 d 6 mg d - 1 6 ~ 9 6 ER mg d - 1 6 mg d - 1 12 20-21 ER ER 2 ER 65. 0% Meta 1 /3 14. 3 ± 1 /2 2 /5 12. 0 d 8 1 /5 3. 2. 2 6 6 5% 5 2 1031 2016 25 9

2 9 ~ 12 mg d - 122 3. 2. 3 80% 9 ~ 12 mg d - 113 38% 12 mg d - 1 25 ER 6 54% 9 ~ 12 mg d - 1 8 14 22 37% 6 mg d - 18 90% 3 9 ~ 12 mg d - 1 19 26 3. 2. 5 25 1 1 ~ 2 H1 M1 3 ~ 4 25 ER 6 mg d 1 150 mgd 8 100 mg 2 3 mg 3 ~ 12 mg d - 1 2 ER 9 ~ 12mg d - 1 9 mg d - 1 1 3. 3 1 ER 11 25 ER ER /mg d - 1 /mg d - 1 10 6 4 ~ 6 6 ~ 12 400 6 15 6 3. 2. 4 55. 5% 3. 3. 1 ER 1032 2016 25 9 1 4 1 /mg 12 150 6 75 27 28 5% ER ER

3 37 5% ~ 10% 3 ER mg d - 1 /kg β 6 < 51 3 3 ~ 6 6 3. 3. 2 ER 51 3 3 ~ 12 12 28 4 6 29-30 3. 4. 2 ER ER 1% ~ 2% 28 6 24 113 31 65 70 8. 4 mg 5 ~ 10 mg d - 1 32-33 71% 67% 3. 3. 3 ER 3. 4. 4 ER 3. 4 3. 4. 1 ER 12 ~ 17 6 3. 4. 3 2 FDA 201 C ER 3 6 12 mg 6 d - 1 PANSS 6 35 2 400 66. 7% PANSS 20% 41. 7% 36 9. 3% 36 1033 2016 25 9

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