Post-Marketing Surveillance of Qishe Pill(芪麝丸) Use for Management of Neck Pain in a Chinese Patient Cohort to Determine Its Safety,Tolerability and Effectiveness

• 作者: CUI Xue-jun SUN Yue-li ZHANG Chang-qing WU Tao TAN Jun ZHU Zhen-an CHEN Yong-qiang WANG Qiu-gen LI Ming WANG Yong-jun
• 来源期刊: 中国结合医学杂志（英文版）
• 年，卷（期）: 2021,（6）
• 所属期刊栏目: Original Articles
• 页码范围: 408-416
• 页数: 9页
• 语种: 英文
• DOI: 10.1007/s11655-021-2868-x

摘要

Objective:To evaluate the safety and effectiveness of Qishe Pill(芪麝丸) on neck pain in real-world clinical practice.Methods:A multi-center,prospective,observational surveillance in 8 hospitals across Shanghai was conducted.During patients receiving 4-week Qishe Pill medication,Visual Analogue Scale (VAS)and Neck Disability Index (NDI) assessments have been used to assess their pain and function,while safety monitoring have been observed after 2 and 4 weeks.Results:Results from 2,023 patients (mean age 54.5 years)suggest that the drug exposure per unit of body mass was estimated at 3.41 + 0.62 g/kg.About 8.5％ (172/2,023)of all participants experienced adverse events (AEs),while 3.8％ (78/2,023) of all participants experienced adverse reaction.The most common AEs were gastrointestinal events and respiratory events.The VAS score(pain) and NDI score (function) significantly decreased after 4-week treatment.An effect-quantitative analysis was also conducted to show that the normal clinical dosage may be consider as 3-4 g/kg,at which dosage the satisfactory pain-relief effect may achieve by 40-mm reduction in VAS.Conclusion:These findings showed that patients with cervical radiculopathy who received Qishe Pill experienced significant improvement on pain and function.(Registration No.NCT01875562)