PMID- 33881718
OWN - NLM
STAT- MEDLINE
DCOM- 20211108
LR  - 20211108
IS  - 1993-0402 (Electronic)
IS  - 1672-0415 (Linking)
VI  - 27
IP  - 6
DP  - 2021 Jun
TI  - Post-Marketing Surveillance of Qishe Pill () Use for Management of Neck Pain in a 
      Chinese Patient Cohort to Determine its Safety, Tolerability and Effectiveness.
PG  - 408-416
LID - 10.1007/s11655-021-2868-x [doi]
AB  - 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).
FAU - Cui, Xue-Jun
AU  - Cui XJ
AD  - Spine Research Institute, Longhua Hospital, Shanghai University of Traditional 
      Chinese Medicine, Shanghai, 200032, China.
FAU - Sun, Yue-Li
AU  - Sun YL
AD  - Spine Research Institute, Longhua Hospital, Shanghai University of Traditional 
      Chinese Medicine, Shanghai, 200032, China.
FAU - Zhang, Chang-Qing
AU  - Zhang CQ
AD  - Department of Orthopedics, Shanghai Sixth People's Hospital, Shanghai Jiao Tong 
      University School of Medicine, Shanghai, 200233, China.
FAU - Wu, Tao
AU  - Wu T
AD  - Department of Orthopedics, Huadong Hospital, Fudan University, Shanghai, 200040, 
      China.
FAU - Tan, Jun
AU  - Tan J
AD  - Department of Orthopedics, Shanghai East Hospital, Tongji University, Shanghai, 
      200120, China.
FAU - Zhu, Zhen-An
AU  - Zhu ZA
AD  - Department of Orthopedics, Shanghai Ninth People's Hospital, Shanghai, 200011, 
      China.
FAU - Chen, Yong-Qiang
AU  - Chen YQ
AD  - Department of Orthopedics, Shanghai Hospital of Traditional Chinese Medicine, 
      Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
FAU - Wang, Qiu-Gen
AU  - Wang QG
AD  - Department of Orthopedics, Shanghai First Hospital, Shanghai, 200080, China.
FAU - Li, Ming
AU  - Li M
AD  - Department of Orthopedics, Shanghai Changhai Hospital, Navy Medical University, 
      Shanghai, 200435, China.
FAU - Wang, Yong-Jun
AU  - Wang YJ
AD  - Spine Research Institute, Longhua Hospital, Shanghai University of Traditional 
      Chinese Medicine, Shanghai, 200032, China. yjwang8888@126.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT01875562
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
DEP - 20210421
PL  - China
TA  - Chin J Integr Med
JT  - Chinese journal of integrative medicine
JID - 101181180
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (qishe)
SB  - IM
MH  - *Cervical Vertebrae
MH  - China
MH  - Drugs, Chinese Herbal
MH  - Humans
MH  - Middle Aged
MH  - *Neck Pain/drug therapy
MH  - Product Surveillance, Postmarketing
MH  - Prospective Studies
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Chinese medicine
OT  - Qishe Pill
OT  - complementary and alternative medicine
OT  - neck pain
OT  - pain assessment
OT  - post-marketing surveillance
EDAT- 2021/04/22 06:00
MHDA- 2021/11/09 06:00
CRDT- 2021/04/21 12:24
PHST- 2020/10/23 00:00 [accepted]
PHST- 2021/04/22 06:00 [pubmed]
PHST- 2021/11/09 06:00 [medline]
PHST- 2021/04/21 12:24 [entrez]
AID - 10.1007/s11655-021-2868-x [pii]
AID - 10.1007/s11655-021-2868-x [doi]
PST - ppublish
SO  - Chin J Integr Med. 2021 Jun;27(6):408-416. doi: 10.1007/s11655-021-2868-x. Epub 
      2021 Apr 21.