摘要
Objective:To evaluate the safety and effectiveness of Qishe Pill(芪麝丸)on neck pain in realworld 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).
基金
Supported by the National Science Fundation for Young Scholars of China(No.81804115,No.81873317,No.81930116 and No.82074454)
the State Key Program of National Natural Science of China(No.81330085 and No.81930116)
Shanghai Sailing Program(No.18YF1423800)
Shanghai TCM Medical Center of Chronic Disease(No.2017ZZ01010)
Municipal Science and Technology Commission of Shanghai-TCM Key Project(No.16401970100)
National Thirteenth Five-Year Science and Technology Major Special Project for New Drug Innovation and Development(No.2017ZX09304001)。
