Post-Marketing Surveillance of Qishe Pill () Use for Management of Neck Pain in a Chinese Patient Cohort to Determine its Safety, Tolerability and Effectiveness.
Chin J Integr Med
; 27(6): 408-416, 2021 Jun.
Article
em En
| MEDLINE
| ID: mdl-33881718
ABSTRACT
OBJECTIVE:
To evaluate the safety and effectiveness of Qishe Pill () 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).Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Vértebras Cervicais
/
Cervicalgia
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Screening_studies
Limite:
Humans
/
Middle aged
País como assunto:
Asia
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article