1.Preparation and in vitro dissolution behaviors evaluation of silymarin phospholipid complex
Qiping ZENG ; Jianqing LIU ; Li'na YANG ; Zhihong LIU ; Hongtao SONG
Journal of Pharmaceutical Practice and Service 2024;42(3):101-107
Objective To prepare silymarin phospholipids complex(SM-PC) and investigate its physicochemical properties. Methods On the basis of single-factor tests, the drug-lipid ratio, drug concentration and reaction temperature were selected as the factors of the central composite design and response surface methodology in the preparation of SM-PC by solvent volatilization, and the best process was optimized with the compound rate as the index. And its in vitro dissolution was measured. Results The optimum preparation technology of SM-PC was as follows: acetone was used as compound solvent, the concentration of SM was 8.0 mg/ml, the mass ratio of SM to phospholipid was 1∶1.8, the reaction temperature was 56 ℃ and the recombination rate was(95.15±1.55)% with deviation of less than 3%. The in vitro dissolution test showed that the dissolution of SM-PC was close to 90% in 60 min. The dissolution behavior of main component of silybin was similar to that of silymarin capsules(Legalon ®), which was higher than SM-API. Conclusion SM-PC was successfully prepared by central composite design response surface method, which significantly improved the dissolution and laid a foundation for the study of subsequent preparations.
2.Effects of acupuncture combined with Buyang Huanwu Decoction on the cerebral blood flow hypo perfusion model rats with carotid artery stenosis based on high-throughput sequencing
Hongtao YU ; Ruizhu GUO ; Yixiao LIU ; Zhiqiang SONG ; Zhongyang LIU ; Yiping WANG ; Haichun ZHOU
International Journal of Traditional Chinese Medicine 2024;46(3):330-335
Objective:To explore the effects of acupuncture combined with Buyang Huanwu Decoction on intestinal flora in cerebral blood flow hypo perfusion model rats with carotid artery stenosis.Methods:Totally 40 rats were randomly divided into sham-operation group, model group, TCM treatment group and acupuncture and drug combination treatment group, with 10 rats in each group. Except the sham-operation group, the other groups were prepared cerebral ischemia model by needle control and thread embolism method. TCM treatment group received Buyang Huanwu Decoction 100 mg/kg for gavage, once a day, and the intervention lasted for 2 weeks. In the acupuncture and drug combination group, based on the TCM treatment group, Baihui and its left and right sides of 2 mm were selected for acupuncture, once a day, and continuous intervention was performed for 2 weeks. Neurological function evaluation and behavioral function score were performed 7 and 14 days after administration, respectively. 16S rRNA sequencing was used to comprehensively characterize the structure and composition of fecal microflora of rats in each group. Linear discriminant analysis Effect Size (LEfSe) was used to analyze the difference of intestinal bacteria among groups.Result:On the 7th and 14th day after administration, compared with the model group, the neurological function score in the TCM treatment group and the acupuncture and drug combination group decreased ( P<0.05), and the behavioral function score increased ( P<0.05). Compared with model group, the Shannon index of TCM treatment group and acupuncture and drug combination group increased ( P<0.05). The abundance of Firmicutes increased ( P<0.05), and the abundance of Bacteroidetes and Proteobacteria decreased ( P<0.05); the abundance of Clostridia increased ( P<0.05), and the abundance of Gammaproteobacteria decreased ( P<0.05). The abundance of Escherichia-Shigella and Bacteroides decreased ( P<0.05); the abundance of lactobacillus significantly increased ( P<0.05). Conclusion:Acupuncture combined with Buyang Huanwu Decoction can improve the symptoms of cerebral hypoperfusion model rats with carotid artery stenosis, and the mechanism may be to increase the abundance of probiotics.
3.Construction and application evaluation of off-label drug use evaluation system in cancer hospital
Jinglin LIU ; Weiping WANG ; Hongtao WANG ; Ning GAO ; Chao ZHANG ; Xibei ZHOU ; Chunnuan WU ; Lu LU ; Jie ZHANG ; Xiaokun SONG
China Pharmacy 2024;35(17):2082-2087
OBJECTIVE To provide reference for strengthening the standardized management of off-label drug use in cancer hospitals. METHODS The evaluation system for off-label drug use was established to standardize the application, approval, and filing process for off-label drug use in our hospital. The changes in off-label drug application quantity, proportion, disease category and drug category in our hospital were compared before (October 1st, 2021-September 30th, 2022) and after (October 1st, 2022- September 30th, 2023) the establishment of the evaluation system; drug items supported by high-level evidence screened by pharmacy department were analyzed statistically. RESULTS The number of off-label drug use applications in our hospital had gradually increased, from 306 pieces in the fourth quarter of 2021 to 3 828 pieces in the third quarter of 2023. In the year before the construction of the evaluation system, there were a total of 4 482 applications for off-label drug use, and in the year after the construction of the evaluation system, there were 11 840 applications for off-label drug use. After the construction of the evaluation system, the proportion of unregistered off-label drug use significantly decreased, compared to the same period last year (P<0.05). Among them, there were no unregistered applications for off-label drug use for digestive system tumors, head and neck tumors, and radioactive drugs; lymphoma, breast tumors,urogenital system tumors, cytotoxic drugs and new anti-tumor drugs all had a decrease of over 70% in unregistered off-label drug applications. Twenty-seven off-label drug use items related to 19 drugs supported by high-level evidence were screened by the pharmacy department of our hospital, among which 25 items were drug use beyond indication. CONCLUSIONS The establishment of off-label drug use evaluation system in cancer hospital is helpful to the rational use and refined management of clinical anti-tumor drugs.
4.Clinical efficacy of electrophysiological monitoring for patients with cancer-induced brachial plexus injury treated with 125I seeds therapy
Xiaolu PEI ; Zhen GAO ; Linjing SONG ; Yan DI ; Lijuan ZHANG ; Zezhou LIU ; Hongtao ZHANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2024;44(9):545-548
Objective:To explore the clinical efficacy of 125I seeds implantation in treating cancer-induced pain and motor dysfunction caused by brachial plexus compression through neurophysiological monitoring. Methods:A retrospective study was conducted on 8 patients (4 males, 4 females; age 58-63 years) who underwent 125I seeds therapy for cancer-induced brachial plexus injury at Hebei Provincial People′s Hospital from January 2021 to August 2023. Pain severity was assessed by using the numerical rating scale (NRS) and motor function was evaluated by using the Fugl-Meyer (F-M) assessment. Electrophysiological monitoring was used to assess changes in sensory and motor branch conduction velocity (CV) of the musculocutaneous nerve, axillary nerve, median nerve, ulnar nerve, and radial nerve before and 3 months after treatment. Paired t-test was used for data analysis. Results:All 8 patients had moderate to severe pain (6 had motor dysfunction). The preoperative and postoperative NRS scores was 5.9±1.0 and 3.3±1.7, respectively ( t=4.93, P=0.002), while F-M scores was 44.8±7.6 and 54.8±5.7, respectively ( t=-3.52, P=0.017). Electrophysiological results showed that 7 patients had lesion involvement in the lower trunk of the brachial plexus, and 1 patient had involvement in the upper trunk. The preoperative and postoperative motor branch CV of the ulnar nerve was (47.2±2.6) and (59.7±8.2) m/s, respectively ( t=-3.17, P=0.034), while the sensory branch CV was (41.8±1.2) and (56.0±5.7) m/s, respectively ( t=-5.82, P=0.001). The nerve CV increased compared to the preoperative ones. Conclusions:125I seeds implantation has good clinical efficacy in treating cancer-related pain and motor dysfunction caused by brachial plexus compression. Changes in electrophysiology can quantitatively monitor the recovery of sensory and motor functions of the brachial plexus.
5.Translation and validation of Chinese version fear of falling avoidance behaviour questionnaire
Ying SHEN ; Hongtao LIANG ; Yan ZHANG ; Fan WANG ; Yan SONG
Modern Clinical Nursing 2024;23(5):19-24
Objective To introduce and translate the fear of falling avoidance behaviour questionnaire(FFABQ)into a Chinese version and test its reliability and validity.Methods The Brislin translation model was employed to translate and back-translate the original FFABQ.The back-translated FFABQ was modified based on expert consultations and a pre-survey,followed by cultural adaptation evaluation.To assess the reliability and validity of the Chinese version FFABQ(FFABQ-CHN),a convenient sampling method was used to select a total of 269 elderly patients from a general hospital in Xi'an to participate the survey.The item analysis,content validity,exploratory factor analysis,Cronbach α coefficient,split-half reliability,test-retest reliability and paired t-test were employed in the evaluation of the reliability and validity of FFABQ-CHN.Results The Chinese version FFABQ comprised 3 dimensions of walking,daily activities and work/leisure activities,with 14 items in total.A total of 254 patients had responded to the survey.Item analysis revealed that CR values of the 14 items ranged from 3.978 to 11.755(all P<0.05),with correlation coefficients between each item and the total score of the questionnaire from 0.473 to 0.930(all P<0.001).The content validity index at the item level ranged from 0.834 to 1.000,while the content validity index at the scale level was 0.968.Exploratory factor analysis extracted three common factors,with a cumulative variance contribution rate of 85.347%.The Cronbach α coefficient,half-half reliability and test-retest reliability of the questionnaire were 0.929,0.877,and 0.954,respectively.Paired t-test indicated no significant difference between the scores(all P>0.05).Conclusions The Chinese version FFABQ demonstrates strong a reliability and validity in the assessment of activity restriction related to fear of falling in the elderly.Thus,it serves as an effective tool for medical practitioners in evaluation of the restrictions in fear-of-falling-related activities of the elderly.
6.In vivo pharmacokinetics and in vitro-in vivo correlation of silymarin phospholipid complex microporous osmotic pump controlled-release tablets in beagle dogs
Qiping ZENG ; Lina YANG ; Jianqing LIU ; Hongtao SONG
Journal of Pharmaceutical Practice 2023;41(12):741-746
Objective To evaluate the release characteristics in vitro, pharmacokinetics in rabbits and in vivo-in vitro correlation of silymarin phospholipid complex microporous osmotic pump controlled release tablets(SM-PC MPOP). Methods The release characteristics of SM-PC MPOP in vitro were detected by HPLC in the artificial gastric fluid. Six beagle dogs were subjected to double cycle cross control, which were given SM-PC MPOP and Legalon(30 mg/kg). The concentration of silybin in plasma was determined by HPLC and the data were processed by software. Results The cumulative release rate of SM-PC MPOP in vitro was over 85% in 12 h. The pharmacokinetics in beagle dogs showed that SM-PC MPOP and legalon conformed to double compartment first-order absorption model and the pharmacokinetic parameters were obtained: tmax:(3.2±0.4)and(0.9±0.1)h, Cmax:(0.298 6±0.068 9)and(0.629 9±0.076 5)μg/ml, AUC0→24:(2.996 8±0.583 3)and(2.268 9±0.432 8)h·μg /ml. The relative bioavailability of SM-PC MPOP was(162.21 ± 30.82)%. Conclusion SM-PC MPOP could release slowly, which could increase the relative bioavailability significantly. The correlation between the absorption in vivo and release in vitro was fine(r = 0.839 0).
7.Risk factors for early acute kidney injury after classic orthotopic liver transplantation
Jiahong CHEN ; Ying XU ; Songzhe HE ; Tao LI ; Yunhao BAI ; Xiangqin SONG ; Tiantian ZHAO ; Wei LI ; Hongtao JIANG ; Yi WANG
Chinese Journal of Organ Transplantation 2023;44(5):269-274
Objective:To explore the risk factors affecting the incidence of acute kidney injury(AKI)after liver transplantation(LT).Methods:From November 2019 to November 2022, clinical data were retrospectively reviewed for 105 recipients of classic orthotopic LT.There are 89 males and 16 females with an age range of(50.52±10.35)years.They are assigned into two groups of AKI(66 cases)and non-AKI(39 cases)according to the AKI diagnostic and staging criteria of Global Kidney Disease Prognosis Organization in 2012.General profiles and clinical data(e.g.previous medical history, MELD score, total bilirubin, albumin, serum creatinine level, coagulation function, anhepatic phase and time to surgery)of two groups of recipients are compared.The factors with statistically significant differences are included into multivariate Logistic regression analysis for obtaining independent risk factors for early AKI post-LT.Results:Among them, 66 patients developed AKI within 7 days post-operation with an incidence rate of 62.86%(66/105).The clinical stages of AKI are Ⅰ(46 cases, 69.70%), Ⅱ(10 cases, 15.15%)and Ⅲ(10 cases, 15.15%).Statistically significant inter-group differences exists in age, abdominal surgery history, preoperative serum level of creatinine, operative duration, anhepatic phase and intraoperative plasma transfusion(all P<0.05).Multivariate Logistic regression analysis indicated that abdominal surgery history( OR=5.803, 95% CI: 1.008~33.401, P=0.049), anhepatic phase( OR=1.054, 95% CI: 1.008~1.101, P=0.020)and preoperative serum level of creatinine( OR=0.968, 95% CI: 0.943~0.994, P=0.016)are independent risk factors for early AKI after classical orthotopic LT recipients. Conclusions:Abdominal surgery history, anhepatic phase, and preoperative serum level of creatinine are independent risk factors for early AKI in classic orthotopic LT recipients.
8.UR value of thyroid scintigraphy in differential diagnosis of thyrotoxicosis
Hongtao SONG ; Shiyu LUO ; Xiaoya CHEN ; Lei WANG
Chinese Journal of General Practitioners 2023;22(9):960-963
The clinical and imaging data of 99 patients with Graves′ disease, 78 patients with thyroiditis and 28 patients with other diseases (resolving thyroiditis, non thyroid disease and simple goiter) who underwent thyroid scintigraphy in Beijing Shijingshan Hospital from January 2016 to March 2022 were retrospectively reviewed. The UR value of thyroid scintigraphy was calculated and ROC curve was used to assess the UR value in diagnosis of Graves′ disease. The UR value of patients with Graves′ hyperthyroidism was significantly higher than that of patients with thyroiditis and other diseases ( H=163.62, P<0.05). UR>4.84 was taken as optimal cutoff value to diagnose Graves′ hyperthyroidism, with the sensitivity and specificity of 95.0% and 98.1%, respectively.
9.Comparison of two types of flaps based on dorsal cutaneous branch of proper palmar digital artery for repair of wound of fingertip or finger-pulp
Hui WANG ; Yihan ZHANG ; Hongtao WANG ; Xinwei JIA ; Xue ZHANG ; Song JIA ; Xiaoxi YANG
Chinese Journal of Microsurgery 2023;46(3):278-283
Objective:To compare the clinical effectiveness of propeller flap and vascular chain flap based on dorsal cutaneous branch of proper palmar digital artery for repair of wounds of fingertip or finger-pulp.Methods:From April 2018 to May 2021, a total of 55 patients (55 fingers) with wounds of fingertip or finger-pulp in the 2nd-5th fingers were treated in emergency surgery in the Department of Hand Surgery, the Second Hospital of Tangshan. The patients were randomly divided into 2 groups by the method of drawing lots. The wounds of 29 patients (29 fingers) were repaired by propeller flaps based on dorsal cutaneous branch of proper palmar digital artery (propeller group) and that of 26 patients(26 fingers) were treated by vascular chain flaps based on dorsal cutaneous branch of proper palmar digital artery(vascular chain group). Survival of the flaps and the skin grafts at donor sites were observed between the 2 groups. The operation and follow-up time in both groups were recorded. Postoperative follow-up included outpatient clinic visits, telephone reviews and WeChat video-clips. At final follow-up, the static TPD of the flaps, patient satisfaction with the appearance of flaps and donor sites and the Range of motion(ROM) of the injured fingers were recorded. The measurement and count data of both groups were compared by independent sample t-test, χ2 tests or Fisher's exact test, respectively. P<0.05 was considered a statistically significant. Results:All the flaps and skin grafts survived primarily in both groups. The operation time in propeller group was 57.55 minutes±4.35 minutes. It was less than what in the vascular chain group (61.12 minutes±4.58 minutes) and with statistically significant difference( P<0.05). The follow-up period was 14.55 months±2.89 months in propeller group and 15.15 months±3.78 months in the vascular chain group. There was no significant difference between the 2 groups( P>0.05). At final follow-up, the static TPD and patient satisfaction with the appearance of flaps in propeller group were 6.55 mm±1.24 mm and 4.59±0.50, which were better than 7.46 mm±1.27 mm and 4.31±0.47 in the vascular chain group with a statistically significant difference( P<0.05). The patient satisfaction with the appearance of donor sites and ROM of the injured digital joints in propeller group were 4.45±0.57 and 190.86°±8.56°, while what in the vascular chain group were 4.35±0.56 and 185.96°±10.58°. There was no significant difference between the 2 groups( P>0.05). Conclusion:The propeller flap and vascular chain flap are both based on dorsal cutaneous branch of proper palmar digital artery and are both suitable for repair of wounds of fingertip or finger-pulp. Compared with the vascular chain flap, the propeller flap has the advantages in shorter operation time, better flap sensation and appearance.
10.Study on preparation technology of long-acting sustained-release oral ulcer membrane based on analytic hierarchy process and orthogonal design
Xiang XU ; Xu CHEN ; Yuejiao KE ; Zhihong LIU ; Yufang CHEN ; Xin ZHOU ; Hongtao SONG
Journal of Pharmaceutical Practice 2023;41(8):501-508
Objective To prepare a sustained-release membrane with longer adhesion time and dissolution time, and compare it with the commercially available oral ulcer membrane. Method Adhesion strength, adhesion time, swelling coefficient, dissolution time, etc. were used as the inspection indicators, and a combination of single factor inspection and analytic hierarchy process were used to screen the membrane -forming materials. The dispersion method of clotrimazole, ornidazole and borneol were investigated to prevent the drug from seed out. The method of combining orthogonal experiment and analytic hierarchy process were used to optimize the dosage of CMC-Na, PVA-1788 and glycerin; and the commercial products were compared. Results Through single-factor investigation and orthogonal experiment, the optimal ratio of excipients was selected as CMC-Na∶PVA-1788∶glycerol (3∶1∶0.08). The water-insoluble component clotrimazole, ornidazole and borneol were treated by precipitation in liquid with good effect. The best method was used to prepare the membrane. The adhesion strength was 102 g. The adhesion time was 55 min. The swelling coefficient was 1 939.52. The average dissolution time was 110 min. The appearance was white and the surface was free of bubbles, soft and elastic. The membrane forming time at 60 ℃ was 300 min and the demolding effect was better which could be completely peeled off with moderate thickness. Conclusion The oral ulcer membrane developed in this method has good appearance, comfortable use, strong adhesion, long adhesion time and dissolution time, and could stay on the ulcer surface for a long time to form physical isolation, and slowly release the drug during the dissolution process, which could play the role of long-term pain relief, antibacterial, anti-inflammatory and promote healing effects on oral ulcers.

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