BACKGROUND:The incidence rate of chronic non-specific neck pain is high and the etiology is unknown.Myofascial pain and deep cervical flexor atrophy are the key factors.Extracorporeal shockwave therapy can improve microcirculation,relieve local pain,and delay the degenerative development of the cervical spine,while motion control training can significantly improve neck muscle strength and endurance and reduce neck pain.However,both methods have limited effectiveness when applied individually.OBJECTIVE:To explore the therapeutic efficacy of extracorporeal shock wave intervention combined with motion control training at the upper trapezius muscle on chronic non-specific neck pain.METHODS:Forty-two patients with chronic non-specific neck pain recruited from Shenyang Sport University were randomly divided into three groups:a shock wave group(n=14),in which extracorporeal shockwave intervention at the upper trapezius muscle was given for 10-15 minutes,once a week for 4 weeks;a training group(n=14),in which motion control training was given for 40-50 minutes,three times a week for 4 weeks;and a combination group(n=14),in which extracorporeal shockwave intervention at the upper trapezius muscle combined with motion control training was performed for 4 weeks.Patients were assessed for pain intensity,cervical spine function,upper trapezius muscle thickness,hemodynamic parameters,and serum interleukin 6 and tumor necrosis factor α levels before intervention,1 week and 4 weeks after intervention.RESULTS AND CONCLUSION:(1)Compared with the pre-intervention period,the visual analogue scale scores and neck disability index in the three groups were lower after 1 and 4 weeks of intervention(P＜0.05),and the visual analogue scale scores and neck disability index in the combination group were lower than those of the shock wave group and the training group(P＜0.05).(2)Compared with the pre-intervention period,the upper trapezius thickness increased in the training group and the combination group after 4 weeks of intervention(P＜0.05);the upper trapezius thickness was greater in the combination group than in the shock wave group and the training group after 4 weeks of intervention(P＜0.05).(3)The shock wave group and the combination group had an increase in the peak systolic velocity of the ascending segment of the transverse carotid artery(P＜0.05)and a decrease in the resistance index(P＜0.05)after 1 and 4 weeks of intervention,while the training group showed an increase in the peak systolic velocity of the ascending segment of the transverse carotid artery(P＜0.05)and a decrease in the resistance index(P＜0.05)after 4 weeks of intervention.The peak systolic velocity of the ascending segment of the transverse carotid artery in the combination group was higher(P＜0.05)and the resistance index was lower(P＜0.05)than those in the shockwave group and the training group after 1 and 4 weeks of intervention.(4)Compared with the pre-intervention period,the levels of interleukin 6 and tumor necrosis factor α were reduced in the shock wave and combination groups after 1 and 4 weeks of intervention(P＜0.05),and in the training group after 4 weeks of intervention(P＜0.05).After 1 and 4 weeks of intervention,the levels of interleukin 6 and tumor necrosis factor α were lower in the combination group than in the shock wave group and the training group(P＜0.05).To conclude,extracorporeal shock wave combined with motion control training for chronic non-specific neck pain significantly reduces pain and improves neck function,and the mechanism of action may be to promote the blood flow velocity at the trigger point,reduce blood flow resistance,reduce the serum levels of interleukin 6 and tumor necrosis factor α,and increase the thickness of the upper trapezius muscle.

BACKGROUND:The incidence rate of chronic non-specific neck pain is high and the etiology is unknown.Myofascial pain and deep cervical flexor atrophy are the key factors.Extracorporeal shockwave therapy can improve microcirculation,relieve local pain,and delay the degenerative development of the cervical spine,while motion control training can significantly improve neck muscle strength and endurance and reduce neck pain.However,both methods have limited effectiveness when applied individually.OBJECTIVE:To explore the therapeutic efficacy of extracorporeal shock wave intervention combined with motion control training at the upper trapezius muscle on chronic non-specific neck pain.METHODS:Forty-two patients with chronic non-specific neck pain recruited from Shenyang Sport University were randomly divided into three groups:a shock wave group(n=14),in which extracorporeal shockwave intervention at the upper trapezius muscle was given for 10-15 minutes,once a week for 4 weeks;a training group(n=14),in which motion control training was given for 40-50 minutes,three times a week for 4 weeks;and a combination group(n=14),in which extracorporeal shockwave intervention at the upper trapezius muscle combined with motion control training was performed for 4 weeks.Patients were assessed for pain intensity,cervical spine function,upper trapezius muscle thickness,hemodynamic parameters,and serum interleukin 6 and tumor necrosis factor α levels before intervention,1 week and 4 weeks after intervention.RESULTS AND CONCLUSION:(1)Compared with the pre-intervention period,the visual analogue scale scores and neck disability index in the three groups were lower after 1 and 4 weeks of intervention(P＜0.05),and the visual analogue scale scores and neck disability index in the combination group were lower than those of the shock wave group and the training group(P＜0.05).(2)Compared with the pre-intervention period,the upper trapezius thickness increased in the training group and the combination group after 4 weeks of intervention(P＜0.05);the upper trapezius thickness was greater in the combination group than in the shock wave group and the training group after 4 weeks of intervention(P＜0.05).(3)The shock wave group and the combination group had an increase in the peak systolic velocity of the ascending segment of the transverse carotid artery(P＜0.05)and a decrease in the resistance index(P＜0.05)after 1 and 4 weeks of intervention,while the training group showed an increase in the peak systolic velocity of the ascending segment of the transverse carotid artery(P＜0.05)and a decrease in the resistance index(P＜0.05)after 4 weeks of intervention.The peak systolic velocity of the ascending segment of the transverse carotid artery in the combination group was higher(P＜0.05)and the resistance index was lower(P＜0.05)than those in the shockwave group and the training group after 1 and 4 weeks of intervention.(4)Compared with the pre-intervention period,the levels of interleukin 6 and tumor necrosis factor α were reduced in the shock wave and combination groups after 1 and 4 weeks of intervention(P＜0.05),and in the training group after 4 weeks of intervention(P＜0.05).After 1 and 4 weeks of intervention,the levels of interleukin 6 and tumor necrosis factor α were lower in the combination group than in the shock wave group and the training group(P＜0.05).To conclude,extracorporeal shock wave combined with motion control training for chronic non-specific neck pain significantly reduces pain and improves neck function,and the mechanism of action may be to promote the blood flow velocity at the trigger point,reduce blood flow resistance,reduce the serum levels of interleukin 6 and tumor necrosis factor α,and increase the thickness of the upper trapezius muscle.

Objective To investigate the status and developmental trends of clinical trials for weight control drugs in China,and to provide data support for sponsors,researchers,and regulatory authorities.Methods The drug clinical trial registration and information platform of the National Medical Products Administration was utilized to search for registered clinical trials of weight control drugs from November 2012 to June 2024.The search employed"overweight","obesity",and"weight loss"as keywords.The information collected included project registration time,drug name,dosage form,drug classification,indications,trial staging,study progress,design type,lead unit,and sponsor.Microsoft Office Excel software was employed for data entry,organization,and extraction.Results A total of 95 registered clinical trials of weight control drugs were identified,comprising 40 domestic multicenter trials,47 domestic single-center trials,and 8 international multicenter trials.Regarding trial phasing,46(48.4％)were phase Ⅰ clinical trials,17(17.9％)were phase Ⅱ clinical trials,19(20.0％)were phase Ⅲ clinical trials,and 13(13.7％)were bioequivalence trials.The drug categorization encompassed 22 chemical drugs,20 biological products,and 1 traditional Chinese medicine/natural drug.Concerning drug dosage forms,there were 32 items of injectable dosage forms,8 items of tablets,2 items of capsules,and 1 item of chewable tablets.Conclusions Registered clinical trials for weight-loss medications in China are predominantly concentrated in regions with developed medical resources.Injectable biologics constitute most test drugs,with most drugs in the early stages of research and development.The examination of the safety and efficacy of these drugs remains to be substantiated,and it is anticipated that a considerable period will elapse before their approval and market introduction.

Objective:To assess any effect of combining kinesio taping with Baduanjin in the management of upper cross syndrome (UCS).Methods:Thirty-nine college students with UCS were randomly divided into a kinesio taping group ( n=14), a Baduanjin group ( n=12) and a combined treatment group ( n=13). The kinesio taping and Baduanjin groups received taping and underwent Baduanjin training, respectively, while the combined treatment group received both interventions for 6 weeks. Before, as well as 3 and 6 weeks after the intervention, all were evaluated using a visual analogue scale (VAS), a neck disability index (NDI), and for forward head extension (FHA), round shoulder angle (FSA) and vital capacity (VC). Results:A significant decrease in the average VAS ratings and NDI scores, and better average FHA and FSA was observed in both groups after the experiment. There was also a significant increase in VC. At 6 weeks, all of the indicators were significantly better than three weeks earlier. The kinesio taping and Baduanjin groups showed significantly smaller average improvements than the combined group.Conclusions:Kinesio taping combined with Baduanjin can effectively alleviate pain associated with UCS, relieve cervical dysfunction, correct abnormal posture and increase lung capacity. Its efficacy is superior to that achieved through single interventions.

Objective:To assess any effect of combining kinesio taping with Baduanjin in the management of upper cross syndrome (UCS).Methods:Thirty-nine college students with UCS were randomly divided into a kinesio taping group ( n=14), a Baduanjin group ( n=12) and a combined treatment group ( n=13). The kinesio taping and Baduanjin groups received taping and underwent Baduanjin training, respectively, while the combined treatment group received both interventions for 6 weeks. Before, as well as 3 and 6 weeks after the intervention, all were evaluated using a visual analogue scale (VAS), a neck disability index (NDI), and for forward head extension (FHA), round shoulder angle (FSA) and vital capacity (VC). Results:A significant decrease in the average VAS ratings and NDI scores, and better average FHA and FSA was observed in both groups after the experiment. There was also a significant increase in VC. At 6 weeks, all of the indicators were significantly better than three weeks earlier. The kinesio taping and Baduanjin groups showed significantly smaller average improvements than the combined group.Conclusions:Kinesio taping combined with Baduanjin can effectively alleviate pain associated with UCS, relieve cervical dysfunction, correct abnormal posture and increase lung capacity. Its efficacy is superior to that achieved through single interventions.

Objective To investigate the status and developmental trends of clinical trials for weight control drugs in China,and to provide data support for sponsors,researchers,and regulatory authorities.Methods The drug clinical trial registration and information platform of the National Medical Products Administration was utilized to search for registered clinical trials of weight control drugs from November 2012 to June 2024.The search employed"overweight","obesity",and"weight loss"as keywords.The information collected included project registration time,drug name,dosage form,drug classification,indications,trial staging,study progress,design type,lead unit,and sponsor.Microsoft Office Excel software was employed for data entry,organization,and extraction.Results A total of 95 registered clinical trials of weight control drugs were identified,comprising 40 domestic multicenter trials,47 domestic single-center trials,and 8 international multicenter trials.Regarding trial phasing,46(48.4％)were phase Ⅰ clinical trials,17(17.9％)were phase Ⅱ clinical trials,19(20.0％)were phase Ⅲ clinical trials,and 13(13.7％)were bioequivalence trials.The drug categorization encompassed 22 chemical drugs,20 biological products,and 1 traditional Chinese medicine/natural drug.Concerning drug dosage forms,there were 32 items of injectable dosage forms,8 items of tablets,2 items of capsules,and 1 item of chewable tablets.Conclusions Registered clinical trials for weight-loss medications in China are predominantly concentrated in regions with developed medical resources.Injectable biologics constitute most test drugs,with most drugs in the early stages of research and development.The examination of the safety and efficacy of these drugs remains to be substantiated,and it is anticipated that a considerable period will elapse before their approval and market introduction.

Objective To standardize the management of clinical trials in our hospital,reduce the incidence of protocol deviations,and provide a reference for improving the quality of clinical trials.Methods The healthcare failure mode and effect analysis(HFMEA)method was used to determine the potential failure modes of the current protocol deviation.The frequency,severity and detectability of failure modes were quantified and evaluated.The risk priority number(RPN)was calculated and the corresponding improvement measures were proposed.The RPN values before and after the implementation of HFMEA were statistically analyzed to evaluate the improvement effect.Results After the implementation of HFMEA activities,the RPN values of 14 potential failure modes decreased significantly(P<0.05);The risk level of 12 potential failure modes decreased.The HFMEA team members'ability in finding and solving problems,communication and cooperation were significantly improved.Conclusions The implementation of HFMEA activities contributes to the management of protocol deviation in clinical trials,can effectively reduce the occurrence of protocol deviation,and provides experience for improving the quality of drug clinical trials.

OBJECTIVE： To establish a method for determination of fluconazole concentration in human plasma. METHODS： UPLC-MS/MS method was adopted to determine plasma after precipitated with acetonitrile. Using isotope fluconazole-d4 as internal standard， the determination was performed on ACQUITY UPLC BEH C18 column with mobile phase consisted of 0.1％ formic acid-acetonitrile （gradient elution） at the flow rate of 0.3 mL/min. The column temperature was 40 ℃， and the sample size was 3 μL. ESI was used for positive ion scanning by multiple reaction monitoring mode. The ion pairs for quantitative analysis were m/z 307.1→220.0 （fluconazole） and m/z 311.1→223.0 （internal standard）. RESULTS： The linear range of fluconazole was 10-5 000 ng/mL （r＝0.998 1）. The limits of quantitation was 10 ng/mL. RSDs of intra-day and inter-day were less than 8％； accuracy ranged 95.8％-106.7％. The extraction recovery ranged 97.3％-107.3％ （RSD＜5.0％， n＝6）， and matrix effect， dilution effect and residual effect didn’t influence quantitative analysis of the substance to be measured. CONCLUSIONS： The method is simple， rapid， specific and accurate， which can be used for therapeutic drug monitoring and pharmacokinetic study of fluconazole.

Objective:To determine and investigate the stability of ginkgo biloba extract injection from three different manufactur-ers respectively in 0.9% NaCl infusion and 5% glucose infusion under different conditions (room temperature, high temperature and light). Methods:Ginkgo biloba extract injection was mixed with the two kinds of infusions,and then divided into the normal tempera-ture group,the high temperature group and the light group. The appearance,insoluble particles,pH and content of flavonoids after the relevant treatment were investigated. The appearance and insoluble particles were tested according to the characteristics of the inspec-tion method described in Chinese Pharmacopoeia(2015 edition,volume IV,the general rule),and the content of flavonoids was detec-ted by HPLC-UV. Results:All the mixed solutions were yellow. No significant changes were found in the appearance,pH value,in-soluble particles and contents of quercetin and isorhamnetin in all the mixed solutions in 24 h. The pH value of the mixed solution with 5% glucose infusion was lower than that with 0.9% NaCl infusion,and all the pH values met the standard in Chinese Pharmacopeias. The kaemphenol content in the injection from Shenwei pharmaceutical company was higher than that from the other manufacturers, while the content of kaemphenol in all the injections was within the standard range. Conclusion:The quality of Ginkgo biloba extract injection from the three different manufacturers is stable under different conditions.

OBJECTIVE:To investigate drug combination in outpatient prescriptions of hypertension patients in our hospital, provide reference for rational drug use in clinic. METHODS:The outpatient prescriptions of patients diagnosed as hypertension dur-ing Jan. 1st to Feb. 1st in 2015 were collected from the hospital. The prescriptions of two or more than two drugs were screened, and the prescriptions of drug combination containing CYP enzyme substrate,inhibitor or inducer were recorded. Guided by metabol-ic enzymology theory,the potential metabolic drug interactions in prescriptions were evaluated on the basis of relevant literature and data reports. RESULTS:Totally 1042 prescriptions were consulted. The prescriptions of the combined medication were 551, and the potential metabolic drug-drug interactions were detected at 249 prescriptions,accounting for 45.2％. Main CYP enzyme sub-types were CYP3A4,CYP2C9,CYP2C19 and CYP2D6. Totally 214 prescriptions were correlated with CYP3A4,accounting for 85.9％ of drug interaction prescriptions;CYP3A4 substrate combined with substrate in 199 prescriptions,with inhibitor in 27 pre-scriptions,and with inducer in 11 prescriptions. Totally 27 prescriptions were correlated with CYP2C9,accounting for 10.8％ of drug interaction prescriptions;CYP2C9 substrate combined with substrate in 8 prescriptions,and with inhibitor in 20 prescriptions. Totally 27 prescriptions were correlated with CYP2D6,accounting for 10.8％ of drug interaction prescriptions;CYP2D6 substrate combined with substrate in 15 prescriptions,and with inhibitor in 12 prescriptions. Totally 4 prescriptions were correlated with CYP2C19,accounting for 1.6％ of drug interaction prescriptions;CYP2C9 substrate combined with inhibitor in 2 prescriptions, and with inducer in 2 prescriptions. CONCLUSIONS:Many metabolic drug-drug interactions are detected in the outpatient prescrip-tions of hypertension patients in our hospital. In order to improve the rationality and safety of the prescription,clinicians and phar-macists should pay attention to the drug combinations with drug-drug interactions which have been reported in the existing litera-ture,and choose similar drugs without or with little interactions.