AIM:To compare the analgesic properties and efficacy of transnasal butorphanol with intramuscular meperidine after anal surgery.METHODS: Sixty patients who underwent fistulectomy were enrolled in the study from Januar...AIM:To compare the analgesic properties and efficacy of transnasal butorphanol with intramuscular meperidine after anal surgery.METHODS: Sixty patients who underwent fistulectomy were enrolled in the study from January 2006 to December 2007. They were randomly divided into transnasal butorphanol (n=30) or intramuscular meperidine (n=30) treatment groups. Assessment of postoperative pain was made using a visual analogue scale (VAS). The VAS score was recorded 6 h after the completion of surgery, before receiving the first dose of analgesic, 60 min after analgesia and the next morning. Any adverse clinical effects such as somnolence, dizziness, nausea or vomiting were recorded. Satisfaction with narcotic efficacy, desire to use the particular analgesic in the future and any complaints were recorded by patients using questionnaires before being discharged.RESULTS: Forty-two men and eighteen women were included in the study. There were no significant differences in VAS scores between the groups within 24 h. Length of hospital stay and the incidence of adverse effects between the groups were similar. In addition, most patients were satisfied with butorphanol nasal spray and wished to receive this analgesic in the future, if needed.CONCLUSION: Butorphanol nasal spray is effective for the relief of pain after fistulectomy. However, it offered patients more convenient usage and would be suitable for outpatients.展开更多
Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang ...Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang Qi,黄芪),Paeoniae Radix Alba(Bai Shao,白芍)and Moutan Cortex(Mu Dan Pi,牡丹皮),which have well-established histories of use for treatment of rheumatic and arthritic diseases.We intended to establish the optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT to develop it as a novel botanical drug product for treatment of rheumatoid arthritis(RA).Methods The combinative approaches of chemical assessment,toxicological and pharmacological evaluation were explored to define the pharmaceutical preparation of QFJBT.Results The optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT were established in terms of greatest chemical contents of bioactive constituents,potent anti-inflammatory and antinociceptive activities,and favorable safety profile.Quality analysis of the pilot product of QFJBT by high-performance liquid chromatography(HPLC)demonstrated that the chromatographic fingerprint profiles of three batches of QFJBT were basically identical and the contents of four characteristic and bioactive markers were relatively consistent.General toxicological studies showed a favorable safety profile of QFJBT.The maximum tolerated single dose of QFJBT was determined in both sexes of rats to be 33.63 g/kg body weight which is equivalent to 346 times of clinical dose.In the chronic oral toxicity study,the results of laboratory investigation showed that QFJBT at doses of 3.89,6.80 and 9.72 g/kg body weight(equivalent to 40,70 and 100-fold clinical doses,respectively)caused no changes in all hematological parameters and blood biochemical parameters of rats.No mortality or specific toxic responses were observed in animals after three months of repeated dosing with QFJBT.Conclusion The optimized and standardized pharmaceutical and manufacturing processes for the production of QFJBT have been successfully screened and identified through established rigorous in-process controls.展开更多
文摘AIM:To compare the analgesic properties and efficacy of transnasal butorphanol with intramuscular meperidine after anal surgery.METHODS: Sixty patients who underwent fistulectomy were enrolled in the study from January 2006 to December 2007. They were randomly divided into transnasal butorphanol (n=30) or intramuscular meperidine (n=30) treatment groups. Assessment of postoperative pain was made using a visual analogue scale (VAS). The VAS score was recorded 6 h after the completion of surgery, before receiving the first dose of analgesic, 60 min after analgesia and the next morning. Any adverse clinical effects such as somnolence, dizziness, nausea or vomiting were recorded. Satisfaction with narcotic efficacy, desire to use the particular analgesic in the future and any complaints were recorded by patients using questionnaires before being discharged.RESULTS: Forty-two men and eighteen women were included in the study. There were no significant differences in VAS scores between the groups within 24 h. Length of hospital stay and the incidence of adverse effects between the groups were similar. In addition, most patients were satisfied with butorphanol nasal spray and wished to receive this analgesic in the future, if needed.CONCLUSION: Butorphanol nasal spray is effective for the relief of pain after fistulectomy. However, it offered patients more convenient usage and would be suitable for outpatients.
基金support from the National Natural Science Foundation of China(No.81704065)China Postdoctoral Science Foundation(No.2016M600632 and No.2017T100604)+3 种基金Hunan Provincial Natural Science Foundation(No.2017JJ3239 and No.2018JJ2293)Hunan Education Department’s Science&Research Project(No.17K069)Hunan Provincial Science&Research Project of Chinese Medicine(No.201790)National First-class Disciple Construction Project of Chinese Medicine of Hunan University of Chinese Medicine
文摘Objective Qing Fu Juan Bi Tang(QFJBT)is an anti-arthritic Chinese medicine formula consisting of five herbs:Aconiti Lateralis Radix Praeparata(Fu Zi,附子),Sinomenii Caulis(Qing Feng Teng,青风藤),Astragali Radix(Huang Qi,黄芪),Paeoniae Radix Alba(Bai Shao,白芍)and Moutan Cortex(Mu Dan Pi,牡丹皮),which have well-established histories of use for treatment of rheumatic and arthritic diseases.We intended to establish the optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT to develop it as a novel botanical drug product for treatment of rheumatoid arthritis(RA).Methods The combinative approaches of chemical assessment,toxicological and pharmacological evaluation were explored to define the pharmaceutical preparation of QFJBT.Results The optimized and standardized pharmaceutical procedures and manufacturing processes for the pilot production of QFJBT were established in terms of greatest chemical contents of bioactive constituents,potent anti-inflammatory and antinociceptive activities,and favorable safety profile.Quality analysis of the pilot product of QFJBT by high-performance liquid chromatography(HPLC)demonstrated that the chromatographic fingerprint profiles of three batches of QFJBT were basically identical and the contents of four characteristic and bioactive markers were relatively consistent.General toxicological studies showed a favorable safety profile of QFJBT.The maximum tolerated single dose of QFJBT was determined in both sexes of rats to be 33.63 g/kg body weight which is equivalent to 346 times of clinical dose.In the chronic oral toxicity study,the results of laboratory investigation showed that QFJBT at doses of 3.89,6.80 and 9.72 g/kg body weight(equivalent to 40,70 and 100-fold clinical doses,respectively)caused no changes in all hematological parameters and blood biochemical parameters of rats.No mortality or specific toxic responses were observed in animals after three months of repeated dosing with QFJBT.Conclusion The optimized and standardized pharmaceutical and manufacturing processes for the production of QFJBT have been successfully screened and identified through established rigorous in-process controls.