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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)
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