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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

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Chinese Journal of Integrative Medicine 2021年第6期27卷 408-416页

作者： CUI Xue-jun SUN Yue-li ZHANG Chang-qing WU Tao TAN Jun ZHU Zhen-an CHEN Yong-qiang WANG Qiu-gen LI Ming WANG Yong-jun Spine Research Institute Longhua HospitalShanghai University of Traditional Chinese MedicineShanghai(200032)China Department of Orthopedics Shanghai Sixth People's HospitalShanghai Jiao Tong University School of MedicineShanghai(200233)China Department of Orthopedics Huadong HospitalFudan UniversityShanghai(200040)China Department of Orthopedics Shanghai East HospitalTongji UniversityShanghai(200120)China Department of Orthopedics Shanghai Ninth People's HospitalShanghai(200011)China Department of Orthopedics Shanghai Hospital of Traditional Chinese MedicineShanghai University of Traditional Chinese MedicineShanghai(200071)China Department of Orthopedics Shanghai First HospitalShanghai(200080)China Department of Orthopedics Shanqhai Chanqhai HospitalNavy Medical UniversityShanghai(200435)China

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： neck pain pain assessment post-marketing surveillance qishe pill Chinese medicine complementary and alternative medicine

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Effects of qishe pill,a Compound Traditional Chinese Herbal Medicine,on Cervical Radiculopathy:a Multicenter,Double-blind,Randomized Placebo-controlled Trial

Effects of Qishe Pill,a Compound Traditional Chinese Herbal ...

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第十四届全国中药和天然药物学术研讨会

作者： Yue-Li Sun Min Yao Sheng-Fu You Wen Mo Sheng Lu Qi Shi Xue-Jun Cui Yong-Jun Wang Shanghai University of Traditional Chinese Medicine

Background Neck pain is a common symptom in most patients suffering from cervical radiculopathy.However,some conservative treatments are limited by their modest effectiveness.Many patients use complementary and alternative medicine,including traditional Chinese medicine,to address their symptoms.The purpose of the present study is to examine the efficacy and safety of qishe pill,a compound traditional Chinese herbal medicine,for neck pain and related disability in patients with cervical radiculopathy.Objective To determine the relative efficacy and safety of qishe pill for cervical radiculopathy by large scale and munlti-centres.Methods A multicenter,double-blind,randomized,placebo-controlled trial to evaluate the efficacy and safety of the qishe pill is proposed.The study will include 144 patients from three sites across China and diagnosed with cervical radiculopathy,according to the following inclusion criteria:age 18 to 65 with pain or stiffness in the neck for at least 2 weeks（neck disability index score25 or more） and accompanying arm pain that radiates distally from the elbow.Qualified participants will be randomly allocated into two groups（1:1）:qishe pill group and placebo group.The prescription of the trial medications（qishe.pill/placebo） are 3.75 g each twice a day for 28 consecutive days.The primary outcome is pain severity.Secondary outcomes are functional status,patient satisfaction,and adverse events as reported in the trial.Date was collectedafter 4 weeks in treatment and 5 months in follow-up.Results For pain,self-reported disability and general health status（Short Form-36）,qishe pill had a statistically significant advantage over placebo after 4 weeks in treatment and 5 months in follow-up（P＜ 0.05）.There was no adverse event that reported in the groups.Conclusion The relative efficacy and safety of qishe pill for neck pain and related disability could be determined.

关键词： Cervical radiculopathy qishe pill Traditional Chinese medicine RCT.

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Pharmacokinetics,Pharmacodynamics,Tolerability and Safety of qishe pill in Healthy Chinese Subjects:Study Protocol for a Phase Ⅰ Trial

Pharmacokinetics,Pharmacodynamics,Tolerability and Safety of...

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第十四届全国中药和天然药物学术研讨会

作者： Yue-li Sun Ting Hou Shu-fen Liu Zhong-liang Zhang Ning Zhang Min Yao Long Yang Qi Shi Xue-jun Cui Yong-jun Wang Shanghai University of Traditional Chinese Medicine

To assess pharmacokinetics,pharmacodynamics,tolerability and safety of oral medication of qishe pill,a compound traditional Chinese herbal medicine,in healthy Chinese subjects.Methods/design The study will take place at the Phase I Unit of Longhua Hospital,Shanghai University of TCM in Shanghai from September 2014 to December 2014.Firstly,20 subjects will be equally and successively divided into 2 groups(7.5g;15g) in separate two week.For the 7.5g and 15 g oral medication dose groups,samples will be collected at dosing(time 0) and at 15,30,45,60,90,120,150,180,240,360,480,600,720,1440,2160 and 2880 min after dosing.For the PK analysis,5 ml blood samples will be collected.The Pharmacokinetic Parameters assessed include area under the plasma concentration-time curve(AUC

关键词： Cervical radiculopathy Neck pain qishe pill Traditional Chinese medicine healthy Chinese subject Pharmacokinetics Pharmacodynamics Tolerability

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Pharmacokinetics,Pharmacodynamics,Tolerability and Safety of qishe pill in Healthy Chinese Subjects

Pharmacokinetics,Pharmacodynamics,Tolerability and Safety of...

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第八届中医/中西医结合循证医学方法研讨会

作者：孙悦礼候停刘书芬张忠亮张宁姚敏杨龙施祀王拥军崔学军 Longhua Hospital Shanghai University of Traditional Chinese Medicine Spine Institute Shanghai University of Traditional Chinese Medicine Shanghai University of Traditional Chinese Medicine

Purpose:To assess pharmacokinetics,pharmacodynamics,tolerabilityand safety of oral medication of qishe pill,a compound traditional Chinese herbal medicine,in healthy Chinese subjects.Methods/design:The study will take place at the phase I unit of Longhua Hospital Shanghai University of TCM in Shanghai from September 2014 to December 2014.Firstly,20 subjects will be equally and successively divided into 2 groups(7.5g;15g)in separate two week.For the 7.5g andl5 g oral medication dose groups,samples will be collected at dosing(time 0) and at 15,30,45,60,90,120,150,180,240,360,480,600,720,1440,2160 and2880 min after dosing.For the PK analysis,5ml blood samples will be collected.The Pharmacokinetic Parameters assessed include area under the plasma concentration-time curve(AUC,AUC,maximum plasma concentration(C),terminal half-life(t,clearance(CL),apparent volume of distribution during the terminal phase(Vz),and mean residence time(MRT).Pharmacodynamic analyses include the determination of ACT,PT and APTT.Safety and tolerability will beassessed subjectively and objectively.20 subjects will be equally divided into 2 groups(7.5g,per 24 hour for 6 days;or 3.75 g,per 12 hour for 6days).Samples will be collected at 15,30,45,60,90,120,150,180,240,360,480,600,720,1440,2160 and 2880 min after the6 day dosing.Subjective tolerability was assessed by questioning subjects about any adverse events(AE).Objective tolerability will be assessed at scheduled intervals by physical examination,safety laboratory tests,vital sign measurements(blood pressure and pulse rate,body temperature),electrocardiogram(ECG)recordings and fecal occult blood testing(FOBT).Discussion:qishe pill is composed of processed Radix Astragali,Muscone,Szechuan Lovage Rhizome,Radix Stephaniae Tetrandrae,Ovientvine,and Calculus Bovis Artifactus.According to modern research and preparation standards,qishe pill is developed to improve on the various symptoms of cervical radiculopathy,especially for neck pain.This is the first comprehensive evaluation of the safety,tole

关键词： Cervical radiculopathy Neck pain qishe pill Traditional Chinese medicine healthy Chinese subject Pharmacokinetics Pharmacodynamics Tolerability

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