1.Clinical trial of parecoxib sodium combined with dexmedetomidine for surgery in patients with osteoporotic compression fractures
Kai LUO ; Qing WANG ; Gao-Ju WANG ; Jin YANG ; Guang-Zhou LI ; Shi-Jie SONG ; Shun-Gui CAI
The Chinese Journal of Clinical Pharmacology 2024;40(20):2963-2967
Objective To investigate the effects of parecoxib sodium injection combined with dexmedetomidine hydrochloride injection on postoperative cognitive function and stress response in patients with osteoporotic compression fractures.Methods The patients with osteoporotic compression fractures were divided into treatment group and control group according to the treatment plan.The control group was given intravenous injection of dexmedetomidine hydrochloride injection 0.2 μg·kg-1load dose,then micro pump injection 0.2 μg·kg-1·min-1 maintenance dose,until 30 min before the end of the operation;patients in the treatment group were intravenously injected with parecoxib sodium injection 20 mg before local anesthesia and 30 min before the end of operation on the basis of the control group.The pain,sedation,hemodynamics[mean arterial pressure(MAP),heart rate(HR)],cognitive function and safety evaluation were compared between the two groups before operation(T0),2 h after operation(T1),6 h after operation(T2),12 h after operation(T3)and 24 h after operation(T4).Results There were 39 cases in the treatment group and 41 cases in the control group.Visual analogue scale(VAS)scores in treatment group and control group were(3.09±0.55)and(3.41±0.62)scores at T1;VAS scores were(3.02±0.57)and(3.35±0.48)scores at T2;VAS scores were(2.64±0.44)and(2.90±0.46)scores at T3;VAS scores were(2.02±0.41)and(2.35±0.47)scores at T4;MMSE scores were(25.28±1.57)and(24.33±1.42)scores at T2;MMSE scores were(28.16±1.01)and(27.25±0.89)scores at T4;MoCA scores were(24.63±1.60)and(23.59±1.25)scores at T2;MoCA scores were(27.20±0.97)and(26.48±0.83)scores at T4.There were statistically significant differences in the above indexes between the treatment group and the control group(all P<0.05).Adverse drug reactions in the treatment group included bradycardia,hypotension,nausea vomiting and hypokalemia;adverse drug reactions in the control group included bradycardia,hypotension and nausea vomiting.The total incidence rates of adverse drug reactions were 12.82%and 9.76%,without statistically significant difference(P>0.05).Conclusion Compared with using dexmedetomidine alone,parecoxib sodium combined with dexmedetomidine is beneficial for relieving postoperative pain in patients with osteoporotic compression fractures,improving postoperative cognitive function.
2.Clinical effects of proximal ulnar artery perforator flap combined with iliac bone graft in the reconstruction of subtotal thumb or finger defects.
Yu Jun ZHANG ; Ji Hui JU ; Qiang ZHAO ; Ben Yuan WANG ; He Yun CHENG ; Gui Yang WANG ; Rui Xing HOU
Chinese Journal of Burns 2022;38(10):959-963
Objective: To explore the clinical effects of proximal ulnar artery perforator flap combined with iliac bone graft in the reconstruction of subtotal thumb or finger defects. Methods: A retrospective observational study was conducted. From August 2016 to August 2019, 7 patients with thumb or finger defects caused by mechanical damage who met the inclusion criteria were admitted to Ruihua Affiliated Hospital of Soochow University, including 6 males and 1 female, aged 46 to 58 years. Their length of fingers was repaired with iliac bone, with length of 2.0 to 3.0 cm. After the bone graft, the skin defect area of the affected finger ranged from 2.8 cm×2.2 cm to 6.0 cm×3.2 cm. Then the free proximal ulnar artery perforator flap with area of 3.0 cm×2.4 cm to 6.5 cm×3.5 cm was used to cover the wounds. The wounds in donor sites of iliac crest and flap were directly sutured. The survival of flap in one week post surgery and the donor site wound healing in 2 weeks post surgery were observed, respectively. During the follow-up, the appearance and sensory function of the affected finger, bone healing, and scar hypertrophy of wound in the donor site were observed and evaluated. At the last follow-up, the functional recovery of the affected finger was evaluated with trial standard for the evaluation of functions of the upper limbs of the Hand Surgery Society of Chinese Medical Association. Results: In one week post surgery, all the flaps survived. In 2 weeks post surgery, the iliac bone and the wounds in forearm donor site healed. During the follow-up of 5 to 13 months, the flap was good in appearance, without obvious pigmentation; the sensory recovery reached level S2 in 5 patients and S0 in 2 patients; all the grafted iliac bones were bony union without obvious resorption; the wounds in donor site healed well, with only mild scar formation. At the last follow-up, the shape of the reconstructed finger was close to the healthy finger, and the functional evaluation results were excellent in 3 cases and good in 4 cases. Conclusions: The use of proximal ulnar artery perforator flap combined with iliac bone graft to reconstruct subtotal thumb or finger can partially restore part of the appearance and function, with less damage to the donor site. It is a good choice for patients who have low expectations of appearance and function for the reconstructed finger.
Male
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Humans
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Female
;
Soft Tissue Injuries/surgery*
;
Perforator Flap/transplantation*
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Skin Transplantation/methods*
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Thumb/surgery*
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Plastic Surgery Procedures
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Ulnar Artery/surgery*
;
Cicatrix/surgery*
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Ilium/surgery*
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Treatment Outcome
3.Quality control of red ginseng based on the ratio of ginsenosides Ro/Re
Yuan-gui YANG ; Ying-bo YANG ; Zheng-cai JU ; Yan-hai ZHANG ; Li YANG ; Zheng-tao WANG
Acta Pharmaceutica Sinica 2020;55(8):1897-1902
Ginsenoside Ro decreased measures of inflammation, aging, oxidants and thrombus formation in a previous study. To measure ginsenoside Ro content in red ginseng from different years, an optimized extraction method was developed to determine ginsenoside Rg1, Re, Rb1 and Ro content by HPLC in 43 batches of red ginseng from different origins, growing years and manufacturers. The results indicate that the best extraction method was to ultrasonify a 1 g sample in 70% methanol for 50 min. The total running time of the optimized gradient was 50 min using a C18 core-shell column and was half the time described in the Chinese Pharmacopoeia, 2015 edition. The separation resolution of all of targeted compounds was greater than 1.6. The peak shape of ginsenoside Ro was optimal when the mobile phase consisted of acetonitrile and water with 0.1% phosphoric acid. The content of ginsenoside Ro was in the range of 0.11% to 0.43%, and the average content was 0.26%, which was higher than that of ginsenoside Rg1 and Re. The ratio of ginsenoside Ro and Re as a threshold could be used to discriminate red ginseng from different growing years; in addition, 100%, 94.4% and 46.6% of red ginseng from six, five and four years exceeded the threshold of 1.3. Our optimized analytical method for characterization of red ginseng is convenient and shortens the assay time.
4.Comprehensive evaluation and risk control measures of Xanthii Fructus.
Yan HU ; Jing-Xia WANG ; Li ZHANG ; Ju-Kai HUANG ; Xiao-Hui YANG ; Gui-Bo SUN ; Xue-Min GAO ; Xiao-Bo SUN
China Journal of Chinese Materia Medica 2017;42(21):4079-4085
By retrieving domestic and foreign literatures, the authors provided a systematic review for effects of Xanthii Fructus, toxicity recorded in ancient/current literatures and relevant toxicological experience, and summarized clinical characteristics of clinical cases related to Xanthii Fructus and influencing factors. In addition to liver and kidney injuries as the major side effects of Xanthii Fructus, neurotoxicity and cardio-toxicity of Xanthii Fructus were also common clinical adverse events. However, there have been a few animal experimental studies so far. Oral administration and external application with Xanthii Fructus have often caused skin reactions, even such severe cases as exfoliative dermatitis. The authors suggested standardizing the clinical medication, avoiding to use untreated prescriptions and unprocessed herbs, ensuring the effective and safety use of Xanthii Fructus in strict accordance with the recommended dosage and usage in pharmacopeia, paying attention to the accumulation of safety signals, strengthening studies on toxic substance, toxicity mechanism, and synergy and attenuation effects.
5.Systematic evaluation for safety of traditional Chinese medicine Areca catechu and its preparations.
Lu SUN ; Hai-Bo SONG ; Li ZHANG ; Ju-Kai HUANG ; Jing-Xia WANG ; Xiao-Hui YANG ; Gui-Bo SUN ; Xue-Min GAO ; Xiao-Bo SUN
China Journal of Chinese Materia Medica 2017;42(21):4067-4073
The authors systemically evaluated and analyzed the safety of Areca catechu from domestic and foreign literatures about the herbal origin, toxicity recorded in ancient/current documents, safety case reports of clinical A. catechu, experimental studies on toxicity in recent years, and differences of safety risk between edible and medicinal A. catechu. Subsequently, they proposed a preliminary summary about the clinical characteristics and potential risk factors of safety related cases of A. catechu and its preparations. According to the authors, although clinical adverse events of A. catechu were fewer and controllable, clinicians shall stillstrictly standardize its application, and rationally combine it with other herbs, while strengthening fundamental and clinical studies related to safety, so as to give better guidance to safety application of A. catechu in clinic.
6.Safety evaluation and risk control measures of Psoralea corylifolia.
Wen-Yang TIAN ; Shan LAN ; Li ZHANG ; Lu SUN ; Ju-Kai HUANG ; Xiao-Hui YANG ; Gui-Bo SUN ; Xue-Min GAO ; Xiao-Bo SUN
China Journal of Chinese Materia Medica 2017;42(21):4059-4066
Through a systematic and comprehensive study of domestic and foreign literatures and information, this study aims to trace the herbal origin and the toxicity recorded in ancient and current documents, analyze the safety case reports of Psoralea corylifolia and experimental studies on toxicity in recent years, and make a preliminary summary about the clinical characteristics and potential risk factors of cases related to the safety of P. corylifolia and its preparations. The study involved 84 patients in the safety case reports of P. corylifolia. The adverse events were mainly liver damage (55.95%) and light toxic contact dermatitis (38.10%), sugguesting that P. corylifolia may lead to liver damage and photo toxicity. However, reproductive toxicity and renal damage were only reported in animal studies, but not in clinical reports. Because of its complicated ingredients, the toxic components and mechanisms of P. corylifolia have not been clear at present. Therefore, the authors proposed to strictly apply P. corylifolia in clinic, use it rationally and combine it with other medications. Besides, efforts shall be made to strength the guidance for doctors, the safety monitoring of P. corylifolia and relevant preparations, and actively carry out safety-related basic and clinical studies, so as to give a better guidance to safe medication, full exert the efficacy and avoid the medication risk.
7.Efficacy and safety of traditional Chinese medicine combined with sildenafil in the treatment of ED in Chinese men: A real-world study.
Jun GUO ; De-Gui CHANG ; Lei CHEN ; Bin OU-YANG ; Rui ZHANG ; Qiang GENG ; Chao YU ; Fu WANG ; Qing-He GAO ; Guo-Jin YU ; Xiu-Ju ZHANG
National Journal of Andrology 2017;23(10):917-921
Objective:
To make a real-world study on the efficacy and safety of traditional Chinese medicine (TCM) combined with sildenafil in the treatment of erectile dysfunction (ED) that failed to respond to TCM medication.
METHODS:
This study included 1 038 ED patients with the International Index of Erectile Function-5 (IIEF-5) scores ≤21 and improvement <30% after 4 weeks of TCM medication, differentially diagnosed with kidney-yang or kidney-yin deficiency syndrome. We administered TCM combined with sildenafil (Viagra, Pfizer Pharmaceutical Co., Ltd) at 100 mg 1 hour before sexual intercourse. After 2 and 4 weeks of medication, we recorded the scores in IIEF-5, erection hardness, Sexual Encounter Profile question 2 (SEP-2: whether vaginal penetration is successful), SEP-3 (whether sexual intercourse is successful), and TCM Syndromes Scale as well as the indexes of routine blood, urine, liver function, and renal function of the patients, and compared them with those obtained before treatment.
RESULTS:
No serious adverse reactions were observed in any of the patients. Compared with the baseline, the patients achieved significantly increased IIEF-5 scores after 2 and 4 weeks of medication (15.01 ± 2.25 vs 16.96 ± 2.55 and 19.41 ± 2.82, P <0.05), penileelectionhardness remarkably improved at 4 weeks (3.36% vs 44.58%, P<0.05), and the positive answers to SEP-2 and SEP-3 both markedly increased at 2 (38.11% vs 90.49%, P<0.05; 22.01% vs 63.77% , P<0.05) and 4 weeks (38.11% vs 96.95% , P<0.05; 22.01% vs 89.73%, P<0.05).
CONCLUSIONS
TCM combined with sildenafil is safe and effective in the treatment of ED in Chinese men, which can significantly improve the IIEF-5 score and erection hardness of the patients.
Aged
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Asian Continental Ancestry Group
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Coitus
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Drug Therapy, Combination
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methods
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Drugs, Chinese Herbal
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therapeutic use
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Erectile Dysfunction
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drug therapy
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etiology
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Humans
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Male
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Medicine, Chinese Traditional
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Penile Erection
;
drug effects
;
physiology
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Sildenafil Citrate
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therapeutic use
;
Treatment Outcome
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Yang Deficiency
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complications
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Yin Deficiency
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complications
8.Wheat peptides reduce oxidative stress and inhibit NO production through modulating μ-opioid receptor in a rat NSAID-induced stomach damage model.
Hong YIN ; Hui-Zhen CAI ; Shao-Kang WANG ; Li-Gang YANG ; Gui-Ju SUN
Chinese Journal of Natural Medicines (English Ed.) 2015;13(1):22-29
Non-steroidal anti-inflammatory drugs (NSAIDs) induce tissue damage and oxidative stress in animal models of stomach damage. In the present study, the protective effects of wheat peptides were evaluated in a NSAID-induced stomach damage model in rats. Different doses of wheat peptides or distilled water were administered daily by gavage for 30 days before the rat stomach damage model was established by administration of NSAIDs (aspirin and indomethacin) into the digestive tract twice. The treatment of wheat peptides decreased the NSAID-induced gastric epithelial cell degeneration and oxidative stress and NO levels in the rats. Wheat peptides significantly increased the superoxide dismutase (SOD) and glutathione peroxidase (GPx) activities and decreased iNOS activity in stomach. The mRNA expression level of μ-opioid receptor was significantly decreased in wheat peptides-treated rats than that in in the control rats. The results suggest that NSAID drugs induced stomach damage in rats, wchih can be prevented by wheat peptides. The mechanisms for the protective effects were most likely through reducing NSAID-induced oxidative stress.
Animals
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Anti-Inflammatory Agents, Non-Steroidal
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adverse effects
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Antioxidants
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pharmacology
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Aspirin
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adverse effects
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Gastric Mucosa
;
drug effects
;
Gene Expression
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Glutathione Peroxidase
;
drug effects
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Indomethacin
;
adverse effects
;
Male
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Nitric Oxide
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biosynthesis
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Nitric Oxide Synthase
;
chemical synthesis
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Oxidation-Reduction
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Oxidative Stress
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drug effects
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Plant Proteins
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pharmacology
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RNA, Messenger
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genetics
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Rats
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Rats, Sprague-Dawley
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Receptors, Opioid, mu
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drug effects
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Stomach
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drug effects
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Superoxide Dismutase
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drug effects
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Triticum
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chemistry
9.Chinese experts′consensus on protocol of breakpoints setting of new antibacterial agents for clinical trial
Yun LI ; Bo ZHENG ; Yuan LV ; Min-Ji WEI ; Ai-Lian SHAN ; Zhao-Long CAO ; Ruo-Yu LI ; Qin-Ping LIAO ; Ming-Gui LIN ; Xiao-Ju LV ; Xiao-Jun MA ; Yun-Xing NI ; Ming-Qing TONG ; Rui WANG ; Ying-Chun XU ; Xue-Fu YOU ; Jing ZHANG ; Qiong ZHANG ; Sui-Yang ZHANG ; Ming ZHAO ; Qing-Shan ZHENG ; Chao ZHUO
The Chinese Journal of Clinical Pharmacology 2015;(11):1069-1076
Clinical breakpoints are used in phaseⅡorⅢclinical trials to categorize microorganisms if susceptibility to new tested antibacterial agents that means the patient infected by the pathogen will be enrolled the study or not.The role of this consensus is to define procedure and required data to setting breakpoints and how to revaluate it in clinical trials.
10.Comparison of dietary food and nutrient intakes by supplement use in pregnant and lactating women in Seoul.
Hyesook KIM ; Won JANG ; Ki Nam KIM ; Ji Yun HWANG ; Hae Kyung CHUNG ; Eun Ju YANG ; Hye Young KIM ; Jin Hee LEE ; Gui Im MOON ; Jin Ha LEE ; Tae Seok KANG ; Namsoo CHANG
Nutrition Research and Practice 2013;7(3):199-206
This study was performed to compare the dietary food and nutrient intakes according to supplement use in pregnant and lactating women in Seoul. The subjects were composed of 201 pregnant and 104 lactating women, and their dietary food intake was assessed using the 24-h recall method. General information on demographic and socioeconomic factors, as well as health-related behaviors, including the use of dietary supplements, were collected. About 88% and 60% of the pregnant and lactating women took dietary supplements, respectively. The proportion of dietary supplements used was higher in pregnant women with a higher level of education. After adjusting for potential confounders, among the pregnant women, supplement users were found to consume 45% more vegetables, and those among the lactating women were found to consume 96% more beans and 58% more vegetables. The intakes of dietary fiber and beta-carotene among supplement users were higher than those of non-users, by 23% and 39%, respectively. Among pregnant women, the proportion of women with an intake of vitamin C (from diet alone) below the estimated average requirements (EAR) was lower among supplement users [users (44%) vs. non-users (68%)], and the proportion of lactating women with intakes of iron (from diet alone) below the EAR was lower among supplement users [usesr (17%) vs. non-users (38%)]. These results suggest that among pregnant and lactating women, those who do not use dietary supplements tend to have a lower intake of healthy foods, such as beans and vegetables, as well as a lower intake of dietary fiber and beta-carotene, which are abundant in these foods, and non-users are more likely than users to have inadequate intake of micro-nutrient such as vitamin C and iron.
Ascorbic Acid
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beta Carotene
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Diet
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Dietary Fiber
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Dietary Supplements
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Ear
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Eating
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Fabaceae
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Female
;
Humans
;
Iron
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Pregnant Women
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Socioeconomic Factors
;
Vegetables

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