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

Xue-jun CUI; Yue-li SUN; Chang-qing ZHANG; Tao WU; Jun TAN; Zhen-an ZHU; Yong-qiang CHEN; Qiu-gen WANG; Ming LI; Yong-jun WANG

doi:10.1007/s11655-021-2868-x

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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

Original Article | Updated：2021-09-01

- 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
- 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
- Chinese Journal of Integrative Medicine 2021年27卷第6期页码：408-416
- Affiliations：
  
  1.Spine Research Institute, Longhua Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai (200032), China
  2.Department of Orthopedics, Shanghai Sixth People's Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai(200233), China
  3.Department of Orthopedics, Huadong Hospital, Fudan University, Shanghai (200040), China
  4.Department of Orthopedics, Shanghai East Hospital, Tongji University, Shanghai(200120), China
  5.Department of Orthopedics, Shanghai Ninth People's Hospital, Shanghai (200011), China
  6.Department of Orthopedics, Shanghai Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai(200071), China
  7.Department of Orthopedics, Shanghai First Hospital, Shanghai (200080), China
  8.Department of Orthopedics, Shanghai Changhai Hospital, Navy Medical University, Shanghai(200435), China
- Author bio：
  
  Prof. WANG Yong-jun, E-mail: yjwang 8888@126.com
- Funds：
  
  the National Science Fundation for Young Scholars of China(81804115;81873317;81930116;82074454);the State Key Program of National Natural Science of China(81330085;81930116);Shanghai Sailing Program(18YF1423800);Shanghai TCM Medical Center of Chronic Disease(2017ZZ01010);Municipal Science and Technology Commission of Shanghai-TCM Key Project(16401970100);National Thirteenth Five-Year Science and Technology Major Special Project for New Drug Innovation and Development(2017ZX09304001)
- DOI：10.1007/s11655-021-2868-x
  中图分类号：
- 纸质出版日期：2021-06-01，
  
  网络出版日期：2021-04-21，
  
  录用日期：2020-10-23
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Xue-jun CUI, Yue-li SUN, Chang-qing ZHANG, 等. 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[J]. Chinese Journal of Integrative Medicine, 2021,27(6):408-416.

Xue-jun CUI, Yue-li SUN, Chang-qing ZHANG, et al. 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[J]. Chinese Journal of Integrative Medicine, 2021,27(6):408-416.
Xue-jun CUI, Yue-li SUN, Chang-qing ZHANG, 等. 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[J]. Chinese Journal of Integrative Medicine, 2021,27(6):408-416. DOI： 10.1007/s11655-021-2868-x.

Xue-jun CUI, Yue-li SUN, Chang-qing ZHANG, et al. 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[J]. Chinese Journal of Integrative Medicine, 2021,27(6):408-416. DOI： 10.1007/s11655-021-2868-x.

摘要

Abstract

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)

关键词

Keywords

neck painpain assessmentpost-marketing surveillanceQishe PillChinese medicinecomplementary and alternative medicine

references

MR Ellenberg, JC Honet, WJ Treanor. Cervical radiculopathy. Arch Phys Med Rehabil 1994;75:342-352.

GA Ariens, W van Mechelen, PM Bongers, LM Bouter, G van der Wal. Psychosocial risk factors for neck pain: a systematic review. Am J Ind Med 2001;39:180-193.

GJ Macfarlane, N Pallewatte, P Paudyal, FL Blyth, D Coggon, G Crombez, et al. Evaluation of work-related psychosocial factors and regional musculoskeletal pain:results from a EULAR Task Force. Ann Rheum Dis 2009;68:885-891.

B Shahidi, D Curran-Everett, KS Maluf. Psychosocial, physical, and neurophysiological risk factors for chronic neck pain: a prospective inception cohort study. J Pain 2015;16:1288-1299.

CJ Woolf, RJ Mannion. Neuropathic pain: aetiology, symptoms, mechanisms, and management. Lancet 1999;353:1959-1964.

R Dubner, MA Ruda. Activity-dependent neuronal plasticity following tissue injury and inflammation. Trends Neurosci 1992;15:96-103.

PW Mantyh, DR Clohisy, M Koltzenburg, SP Hunt.Molecular mechanisms of cancer pain. Nat Rev Cancer 2002;2:201-209.

RH Dworkin, M Backonja, MC Rowbotham, RR Allen, CR Argoff, GJ Bennett, et al. Advances in neuropathic pain:diagnosis, mechanisms, and treatment recommendations.Arch Neurol 2003;60:1524-1534.

KY Ho, C Siau. Chronic pain management: therapy, drugs and needles. Ann Acad Med Singap 2009;38:929-930.

XJ Cui, YL Sun, SF You, W Mo, S Lu, Q Shi, et al. Effects of Qishe Pill, a compound traditional Chinese herbal medicine, on cervical radiculopathy: study protocol for a randomized controlled trial. Trials 2013;14:322.

JR Ge, HM Wang, CX Meng, PJ Tong, LM Lei, FY Yang, et al. Phase Ⅲ clinical trial of the Qishe Wan in treatment of cervical radiculopathy. Chin J New Drugs Clin Rem 2014;33:510-514.

D Gould, D Kelly, L Goldstone, J Gammon. Examining the validity of pressure ulcer risk assessment scales:developing and using illustrated patient simulations to collect the data. J Clin Nurs 2001;10:697-706.

BM Auffinger, RR Lall, NS Dahdaleh, AP Wong, SK Lam, T Koski, et al. Measuring surgical outcomes in cervical spondylotic myelopathy patients undergoing anterior cervical discectomy and fusion: assessment of minimum clinically important difference. PLoS One 2013;8:e67408.

LY Carreon, SD Glassman, MJ Campbell, PA Anderson. Neck disability index, short form-36 physical component summary, and pain scales for neck and arm pain: the minimum clinically important difference and substantial clinical benefit after cervical spine fusion. Spine J 2010;10:469-474.

SL Parker, SS Godil, DN Shau, SK Mendenhall, MJ McGirt.Assessment of the minimum clinically important difference in pain, disability, and quality of life after anterior cervical discectomy and fusion: clinical article. J Neurosurg Spine 2013;18:154-160.

X Cui, K Trinh, YJ Wang. Chinese herbal medicine for chronic neck pain due to cervical degenerative disc disease. Cochrane Database Syst Rev 2010:D6556.

PM Coloma, G Trifiro, V Patadia, M Sturkenboom.Postmarketing safety surveillance: where does signal detection using electronic healthcare recordsfit into the big picture? Drug Saf 2013;36:183-197.

V Vlahovic-Palcevski, D Mentzer. Postmarketing surveillance. Handb Exp Pharmacol 2011;205:339-351.

WJ Zhang, P Hufnagl, BR Binder, J Wojta. Anti-inflammatory activity of astragaloside Ⅳ is mediated by inhibition of NF-kappa B activation and adhesion molecule expression.Thromb Haemost 2003;90:904-914.

ZH Pu, M Dai, C Peng, L Xiong. Security and research progress on pharmacology of Ligusticum chuanxiong alkaloids. China Pharm (Chin) 2020;31:1020-1024.

X Sun, XJ Yu, MF Qiu, ZH Xu, WY Gao. Clinical research progress of the pharmacology of ovientvine. Chin J Surg Integr Tradit West Med (Chin) 2005;11:363-364.

X Li, QH Yu, M Ai, YJ Gan, ZW Fu. Anti-inflammatory effects of Calculus Bovis Artifactus: a pilot study. J Shengyang Pharm Univ (Chin) 2000;17:431-433.

QQ Liang, M Zhang, Q Zhou, Q Shi, YJ Wang.Muscone protects vertebral end-plate degeneration by anti-inflammatory property. Clin Orthop Relat Res 2010;468:1600-1610.

YL Sun, T Hou, SF Liu, ZL Zhang, N Zhang, M Yao, et al. Population pharmacokinetic modeling of the Qishe Pill in three major traditional Chinese medicine-defined constitutional types of healthy Chinese subjects: study protocol for a randomized controlled trial. Trials 2015;16:64.

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