The ethnic medicine for external use is an important dosage form in the external treatment methods of ethnic medicine.China has made significant progress in related research and applications.However,the regulations and guidelines for clinical research on external medicine are limited,and the related technologies and quality standards are not yet well-established in China.This article summarized the specific issues during the implementation of clinical research on ethnic medicine of external use:the research design failing to reflect the value and unique characteristics of these medicine;the big difficulty in the recruitment of participants,leading to delays in progress;inconsistent implementation of interventions;and the quality of research data needing to be improved,etc.Combining the authors'experience in project implementation management,this article proposed solutions to improve research quality and progress,including incorporating experts from various fields including ethnic medicine and research centers;refining participant recruitment strategies;analyzing factors affecting progress and optimizing the implementation process;and strengthening overall management and establishing a competitive enrollment mechanism.The article also shared a case study of the Tibetan medicine Qingpeng Ointment for the treatment of acute gouty arthritis,aiming to provide a reference for the clinical research on ethnic medicine of external use.

Chinese patent medicines for external use represent a distinct category of clinical drugs with unique therapeutic characteristics.At present,the research foundation of some topical Chinese patent medicines for external use is weak,and the accuracy and standardization of clinical application need to be improved.The research on clinical positioning of Chinese patent medicines for external use is of great significance for standardizing clinical medication,exploring the differentiated value of drugs and similar products,enhancing the safety of drug use,improving the efficiency of medical resource use,and promoting the secondary development and cultivation of drugs after listing.On the basis of summarizing the research status of clinical positioning of Chinese patent medicines for external use,this article put forward the significance,necessity and challenges of carrying out this research.Combined with the authors'practical experience,the authors put forward five experiences to carry out the post marketing clinical positioning research of Chinese patent medicines for external use,including distinguishing the theory of external treatment of Chinese materia medica,paying attention to the unmet needs in the modern medical system,not separating from the actual efficacy and dosage form characteristics of Chinese patent medicines for external use,clarifying the mechanism of"same treatment for different diseases",and verifying the clinical positioning hypothesis,which can provide references for relevant research.

The ethnic medicine for external use is an important dosage form in the external treatment methods of ethnic medicine.China has made significant progress in related research and applications.However,the regulations and guidelines for clinical research on external medicine are limited,and the related technologies and quality standards are not yet well-established in China.This article summarized the specific issues during the implementation of clinical research on ethnic medicine of external use:the research design failing to reflect the value and unique characteristics of these medicine;the big difficulty in the recruitment of participants,leading to delays in progress;inconsistent implementation of interventions;and the quality of research data needing to be improved,etc.Combining the authors'experience in project implementation management,this article proposed solutions to improve research quality and progress,including incorporating experts from various fields including ethnic medicine and research centers;refining participant recruitment strategies;analyzing factors affecting progress and optimizing the implementation process;and strengthening overall management and establishing a competitive enrollment mechanism.The article also shared a case study of the Tibetan medicine Qingpeng Ointment for the treatment of acute gouty arthritis,aiming to provide a reference for the clinical research on ethnic medicine of external use.

Chinese patent medicines for external use represent a distinct category of clinical drugs with unique therapeutic characteristics.At present,the research foundation of some topical Chinese patent medicines for external use is weak,and the accuracy and standardization of clinical application need to be improved.The research on clinical positioning of Chinese patent medicines for external use is of great significance for standardizing clinical medication,exploring the differentiated value of drugs and similar products,enhancing the safety of drug use,improving the efficiency of medical resource use,and promoting the secondary development and cultivation of drugs after listing.On the basis of summarizing the research status of clinical positioning of Chinese patent medicines for external use,this article put forward the significance,necessity and challenges of carrying out this research.Combined with the authors'practical experience,the authors put forward five experiences to carry out the post marketing clinical positioning research of Chinese patent medicines for external use,including distinguishing the theory of external treatment of Chinese materia medica,paying attention to the unmet needs in the modern medical system,not separating from the actual efficacy and dosage form characteristics of Chinese patent medicines for external use,clarifying the mechanism of"same treatment for different diseases",and verifying the clinical positioning hypothesis,which can provide references for relevant research.

Objective To study the efficacy and safety of estradiol and drospirenone tablets (Angeliq)in treatment of menopausal symptoms among postmenopausal Chinese healthy women.Methods Total 244 postmenopausal Chinese healthy women who had moderate to severe hot flushes were randomly assigned for 16 weeks in this randomized multi-center double-blind placebo-controlled study.During the trial.the follow-up visits were conducted at week 4,8,12,16 of treatment and 2 weeks after treatment respectively.Height,weight,vital signs,hot flushes,other relevant menopausal symptoms and vaginal bleeding were observed in each follow-up visit,while the clinical global impression scale Was assessed at 16 weeks as well.Results It showed that hot flushes were reduced significantly more in observation group than that in placebo group ( P＜0.01 ), although both treatments were effective. The absolute values of mean severity index of total hot flushes decreased by - 0. 6± 0. 5 in observation group and - 0. 4 ± 0. 4 in placebo group from baseline respectively, which reached significant difference ( P ＜ 0. 05 ). However, the absolute values of mean severity index of moderate to severe hot flushes decreased by - 0. 6± 0. 8 in observation group and -0. 3± 0.6 in placebo group from baseline respectively, which had no significant difference (P ＞ 0. 05 ).After 16 weeks treatment, it also showed that estradiol and drospirenone had significant better efficacy than placebo on moderate to severe sweating, vaginal dryness and clinical global impression scale (P ＜0. 01 ).During the trial, blood pressure in observation group was stable. The rate of vaginal bleeding in observation group was higher than that in the placebo group, especially during the week 4 to week 8 when 48. 9% (87/178) in observation group and 10. 7% (6/56) in placebo group of patients bled. Although the cumulative amenorrhea rate of observation group was lower than that of placebo group in each cycle (28 days), it increased gradually along with duration of the treatment. The commonest adverse event in observation group was breast tenderness which accounted for 12.0% (22/183 ). The level of serum potassium was in the normal range in observation group mostly. Meanwhile, the other adverse events rate was low. Serious adverse events reported in this trial were assessed as not study drug related or as unlikely study drug related. Conclusion Estradiol and drospirenone tablets which could effectively alleviate menopausal symptoms in postmeuopausal Chinese healthy women is a novel hormone replacement therapy regimen with high safety and efficacy.

Objective To study the effect of macrophage, its stimulating factor, granulocyte macrophage colony-stimulating factor (GM-CSF), the combination of GM-CSF and macrophage on the survival of rat deep epigastric perforator flap (DEP). Methods The stable animal model of DEP flap in Sprague-Dawley rat mimicing human deep inferior epigastric perforator flap in breast reconstruction was established. The rats were treated with subcutaneous injection of recombined rat GM-CSF or rat peritoneal macrophages, respectively, or combination of GM-CSF/ Macrophages. Normal saline was used as parallel negative control. The rats were sacrificed and flap specimens were harvested on day 7 after operation, the flaps survival area were measured by the method of rubbings and the survival proportion of flaps were calculated, Von Will brand factor were detected by immunohistochemistry and microvessel density (MVD), and were calculated with microscopic study, and collagen were stained and quantified by Masson staining. Results Survival proportion of flaps in group GM-CSF (53.08% ± 8. 76% ) was not different with that in macrophages group (47. 95% ± 4. 92% ), and both of these two groups were significantly higher than parallel negative control group (43.28% ± 5.27% ) but significantly lower than combination GM-CSF/ macrophages group ( 61.68% ± 6. 60% ). For MVD, flap in GM-CSF group ( 24. 82 ± 4. 18 ) was not significantly different with macrophages group (24.30 ± 3.02 ), and both of these two groups were significantly higher than group parallel negative control (21.37 ± 2.65 ) but significantly lower than combination GM-CSF/macrophages group ( 29. 82 ± 4. 74). Collagen deposition in the flaps in GM-CSF group (17. 25% ± 2. 85% ) were significantly higher than parallel negative control group (14.41% ± 2. 89% ), macrophages group ( 12. 69% ± 3.55% ) were lower than parallel negative control group but there was no significant difference. That in combination GM-CSF/macrophages group (20.31% ± 3.01% )was significantly higher than GM-CSF group ( P < 0. 05 ). Conclusion Treatment with rat GM-CSF or macrophage can significantly promote the survival of the flaps. Combined application of GM-CSF and macrophage could synergetically promote the survival of the flaps, the vasculogenesis and the collagen deposition.