The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use （T/CACM 1563.5—2024）， the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use， was led by the Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use，the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting， signal identification，as well as assessment and control， addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations， involving multiple rounds of expert consultations，hybrid interviews， and evidence integration （covering literature，medical insurance，essential medicine，pharmacopoeia data， and regulatory information）. With the scope of application defined to include medical institutions， pharmaceutical manufacturers and distribution enterprises，as well as regulatory authorities， the guideline focuses on key issues such as inherent medicine risks，quality risks，off-label use，risks of combination therapy，and the safety in special populations. During the compilation，core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally （PREPARE—2022CN463）. In the future，the implementation of the guideline will be promoted through hierarchical dissemination，dynamic revision，and post-effectiveness evaluation， contributing to rational clinical use and improved patient safety.

The Pharmacovigilance Guideline for Clinical Application of Chinese Patent Medicine for External Use （T/CACM 1563.5—2024）， the first guideline in China specializing for the clinical safety of Chinese patent medicines for external use， was led by the Institute of Basic Research in Clinical Medicine，China Academy of Chinese Medical Sciences，and jointly developed by more than 30 research institutions of medical sciences across the country. Aiming to standardize the pharmacovigilance activities in the clinical application of Chinese patent medicines for external use，the guideline systematically categorizes potential risks and proposes prevention and control measures that cover 11 core sections of risk monitoring and reporting， signal identification，as well as assessment and control， addressing the gap in domestic and international standardization of this field. The compilation of this guideline strictly adhered to international norms and domestic regulations， involving multiple rounds of expert consultations，hybrid interviews， and evidence integration （covering literature，medical insurance，essential medicine，pharmacopoeia data， and regulatory information）. With the scope of application defined to include medical institutions， pharmaceutical manufacturers and distribution enterprises，as well as regulatory authorities， the guideline focuses on key issues such as inherent medicine risks，quality risks，off-label use，risks of combination therapy，and the safety in special populations. During the compilation，core discrepancies such as the definition of application scope and quality risk control were addressed to ensure alignment with regulations such as the Drug Administration Law of the People's Republic of China and the Good Pharmacovigilance Practice. The guideline is registered internationally （PREPARE—2022CN463）. In the future，the implementation of the guideline will be promoted through hierarchical dissemination，dynamic revision，and post-effectiveness evaluation， contributing to rational clinical use and improved patient safety.

Objective To analyze the incidence of contact allergic reactions to ketoconazole shampoo and selenium sulfide shampoo in patients with androgenetic alopecia(AGA).Methods A retrospective analysis was conducted on 683 AGA patients.Based on medical records,dermoscopy findings,fungal examinations and patch test results,the number of patients with seborrheic dermatitis,Malassezia-positive cases and contact allergy to ketoconazole and selenium sulfide shampoos were recorded.Results The incidence of seborrheic dermatitis in AGA patients was 65.59%,and the Malassezia-positive rate was 42.02%.The allergy rate to ketoconazole shampoo in AGA patients was 34.70%,which was significantly higher than the 25.62%allergy rate to selenium sulfide shampoo(P＜0.01).In AGA patients with concomitant seborrheic dermatitis and Malassezia positivity,the allergy rate to ketoconazole lotion was higher than that to selenium sulfide lotion(P＜0.05).The positivity rate of Malassezia was 45.98%in seborrheic dermatitis patients,which was higher than that of the 34.47%in non-seborrheic dermatitis patients(P＜0.01).Conclusion In patients with AGA,ketoconazole shampoo carries a higher allergy risk compared to selenium sulfide shampoo.Long-term use of antifungal shampoos should be avoided in patients with AGA and conduct patch tests for drug detection when necessary.

Objective:To compare the efficacy and safety of a domestic hair follicle extraction system versus traditional follicular unit excision (FUE) in extracting hair follicles for the treatment of androgenetic alopecia (AGA) .Methods:A multicenter, randomized, self-controlled clinical trial was conducted on AGA patients aged 18 - 59 years who were recruited from the Huashan Hospital, Fudan University, the Affiliated Hangzhou First People's Hospital, and the China-Japan Friendship Hospital between June 2023 and September 2024. Each patient's scalp was randomly divided into two sides (experimental side vs. control side) using an envelope method. The experimental side underwent robotic hair transplantation with a domestic hair follicle extraction system, and the control side underwent traditional FUE. Hair follicles were extracted from the safe donor area in the occipital region, and implanted into the ipsilateral hair loss area. The primary outcome was the hair transection rate which was calculated immediately after follicular extraction. The secondary outcomes included the hair follicle unit loss rate and the change in hair density at the recipient site on postoperative day 14. Safety was evaluated by assessing the incidence of folliculitis at the donor site on postoperative day 14 and the overall incidence of adverse events. Surgical outcomes were evaluated at 9 months after surgery. Comparisons of evaluation indicators among groups were performed by using a paired t test or Wilcoxon signed-rank test. Results:A total of 55 patients with AGA (51 males and 4 females, aged 32.71 ± 5.75 years) completed the hair follicle transplantation and postoperative follow-up. The hair transection rate ( M[ Q1, Q3]) was 6.65% (4.56%, 10.16%) in the experimental group and 5.28% (3.04%, 8.89%) in the control group (difference = 1.24%, 95% CI: -0.24%, 2.65%) . The hair follicle unit loss rate was 2.00% (1.00%, 3.50%) in the experimental group and 0.50% (0, 2.00%) in the control group, with a significant difference between the two groups ( P = 0.008) . On postoperative day 14, there was no significant difference in the hair density between the experimental group and control group (72.20 ± 25.95 per cm 2vs. 76.49 ± 30.84 per cm 2, P = 0.173) . At 9-month follow-up, both groups showed improvement in the investigator's overall score in the recipient areas. Seven adverse events occurred in 7 subjects (12.72%) in each group, and all were mild folliculitis. Conclusion:The domestic hair follicle extraction system demonstrated comparable efficacy and safety to the traditional FUE in hair transplantation.

Objective:To analyze the real-world effectiveness and safety of tofacitinib in the treatment of alopecia ophiasis, and to compare characteristics of patients with different clinical responses.Methods:A retrospective study was conducted on patients with alopecia ophiasis who visited the Department of Dermatology, China-Japan Friendship Hospital from March 1, 2022, to July 31, 2023. All patients received tofacitinib in combination with topical minoxidil or glucocorticoids, intralesional glucocorticoid injections, oral isotretinoin, antidepressants, antihistamines, traditional Chinese medicine, etc., and were followed up for 36 weeks. The primary outcome was the number of patients achieving complete remission and partial remission at week 36; secondary outcomes included the number of patients achieving a severity of alopecia tool (SALT) score of ≤ 20 points and those with a response rate of ≥ 50% in scalp hair regrowth (SALT50) . Clinical characteristics were compared between patients who achieved and did not achieve a SALT score of ≤ 20 points. Comparisons among groups were performed using the two-independent-sample t test, Mann-Whitney U test, and Fisher's exact test. Results:A total of 21 patients with alopecia ophiasis were collected, and all received oral tofacitinib citrate at a dose of 5 mg twice daily for at least 36 weeks. After a 36-week follow-up, 2 patients (9.5%) achieved complete remission, 16 (76.2%) achieved partial remission, and 3 (14.3%) showed no response. SALT50 was achieved in 12 patients (57.1%) , and 13 (61.9%) had a SALT score of ≤ 20 points. Adverse reactions included mild liver transaminase elevation (1 case) , headache (1 case) , and folliculitis (2 cases) . At week 36, the patients achieving a SALT score of ≤ 20 points exhibited significantly decreased proportions of patients with body hair loss (7/13) and of patients with childhood-onset alopecia ophiasis (7/13) compared with those having a SALT score of > 20 points (both 8/8, both P = 0.046) . However, there were no significant differences between the above two groups in gender, age, body mass index, total disease duration, baseline SALT scores, positivity rates of thyroid antibodies or prevalence of total allergen-specific IgE abnormalities (all P > 0.05) . Conclusion:Combination therapy with tofacitinib showed generally good efficacy and safety in the treatment of alopecia ophiasis, and poorer outcomes were likely to be observed in patients with body hair involvement and childhood-onset alopecia ophiasis.

Objective:To compare the efficacy and safety of a domestic hair follicle extraction system versus traditional follicular unit excision (FUE) in extracting hair follicles for the treatment of androgenetic alopecia (AGA) .Methods:A multicenter, randomized, self-controlled clinical trial was conducted on AGA patients aged 18 - 59 years who were recruited from the Huashan Hospital, Fudan University, the Affiliated Hangzhou First People's Hospital, and the China-Japan Friendship Hospital between June 2023 and September 2024. Each patient's scalp was randomly divided into two sides (experimental side vs. control side) using an envelope method. The experimental side underwent robotic hair transplantation with a domestic hair follicle extraction system, and the control side underwent traditional FUE. Hair follicles were extracted from the safe donor area in the occipital region, and implanted into the ipsilateral hair loss area. The primary outcome was the hair transection rate which was calculated immediately after follicular extraction. The secondary outcomes included the hair follicle unit loss rate and the change in hair density at the recipient site on postoperative day 14. Safety was evaluated by assessing the incidence of folliculitis at the donor site on postoperative day 14 and the overall incidence of adverse events. Surgical outcomes were evaluated at 9 months after surgery. Comparisons of evaluation indicators among groups were performed by using a paired t test or Wilcoxon signed-rank test. Results:A total of 55 patients with AGA (51 males and 4 females, aged 32.71 ± 5.75 years) completed the hair follicle transplantation and postoperative follow-up. The hair transection rate ( M[ Q1, Q3]) was 6.65% (4.56%, 10.16%) in the experimental group and 5.28% (3.04%, 8.89%) in the control group (difference = 1.24%, 95% CI: -0.24%, 2.65%) . The hair follicle unit loss rate was 2.00% (1.00%, 3.50%) in the experimental group and 0.50% (0, 2.00%) in the control group, with a significant difference between the two groups ( P = 0.008) . On postoperative day 14, there was no significant difference in the hair density between the experimental group and control group (72.20 ± 25.95 per cm 2vs. 76.49 ± 30.84 per cm 2, P = 0.173) . At 9-month follow-up, both groups showed improvement in the investigator's overall score in the recipient areas. Seven adverse events occurred in 7 subjects (12.72%) in each group, and all were mild folliculitis. Conclusion:The domestic hair follicle extraction system demonstrated comparable efficacy and safety to the traditional FUE in hair transplantation.

Objective:To analyze the real-world effectiveness and safety of tofacitinib in the treatment of alopecia ophiasis, and to compare characteristics of patients with different clinical responses.Methods:A retrospective study was conducted on patients with alopecia ophiasis who visited the Department of Dermatology, China-Japan Friendship Hospital from March 1, 2022, to July 31, 2023. All patients received tofacitinib in combination with topical minoxidil or glucocorticoids, intralesional glucocorticoid injections, oral isotretinoin, antidepressants, antihistamines, traditional Chinese medicine, etc., and were followed up for 36 weeks. The primary outcome was the number of patients achieving complete remission and partial remission at week 36; secondary outcomes included the number of patients achieving a severity of alopecia tool (SALT) score of ≤ 20 points and those with a response rate of ≥ 50% in scalp hair regrowth (SALT50) . Clinical characteristics were compared between patients who achieved and did not achieve a SALT score of ≤ 20 points. Comparisons among groups were performed using the two-independent-sample t test, Mann-Whitney U test, and Fisher's exact test. Results:A total of 21 patients with alopecia ophiasis were collected, and all received oral tofacitinib citrate at a dose of 5 mg twice daily for at least 36 weeks. After a 36-week follow-up, 2 patients (9.5%) achieved complete remission, 16 (76.2%) achieved partial remission, and 3 (14.3%) showed no response. SALT50 was achieved in 12 patients (57.1%) , and 13 (61.9%) had a SALT score of ≤ 20 points. Adverse reactions included mild liver transaminase elevation (1 case) , headache (1 case) , and folliculitis (2 cases) . At week 36, the patients achieving a SALT score of ≤ 20 points exhibited significantly decreased proportions of patients with body hair loss (7/13) and of patients with childhood-onset alopecia ophiasis (7/13) compared with those having a SALT score of > 20 points (both 8/8, both P = 0.046) . However, there were no significant differences between the above two groups in gender, age, body mass index, total disease duration, baseline SALT scores, positivity rates of thyroid antibodies or prevalence of total allergen-specific IgE abnormalities (all P > 0.05) . Conclusion:Combination therapy with tofacitinib showed generally good efficacy and safety in the treatment of alopecia ophiasis, and poorer outcomes were likely to be observed in patients with body hair involvement and childhood-onset alopecia ophiasis.

Objective To analyze the incidence of contact allergic reactions to ketoconazole shampoo and selenium sulfide shampoo in patients with androgenetic alopecia(AGA).Methods A retrospective analysis was conducted on 683 AGA patients.Based on medical records,dermoscopy findings,fungal examinations and patch test results,the number of patients with seborrheic dermatitis,Malassezia-positive cases and contact allergy to ketoconazole and selenium sulfide shampoos were recorded.Results The incidence of seborrheic dermatitis in AGA patients was 65.59%,and the Malassezia-positive rate was 42.02%.The allergy rate to ketoconazole shampoo in AGA patients was 34.70%,which was significantly higher than the 25.62%allergy rate to selenium sulfide shampoo(P＜0.01).In AGA patients with concomitant seborrheic dermatitis and Malassezia positivity,the allergy rate to ketoconazole lotion was higher than that to selenium sulfide lotion(P＜0.05).The positivity rate of Malassezia was 45.98%in seborrheic dermatitis patients,which was higher than that of the 34.47%in non-seborrheic dermatitis patients(P＜0.01).Conclusion In patients with AGA,ketoconazole shampoo carries a higher allergy risk compared to selenium sulfide shampoo.Long-term use of antifungal shampoos should be avoided in patients with AGA and conduct patch tests for drug detection when necessary.

ObjectiveTo study the traditional Chinese medicine （TCM） syndromes of children with alopecia areata， and provide evidence for TCM differentiation and treatment in clinic. MethodsA retrospective analysis was conducted on the clinical data of 800 children with alopecia areata admitted to the Hair Medicine Center of the China-Japan Friendship Hospital from January 1， 2012 to December 31， 2021. The clinical data of the children were collected using a four-examination information questionnaire， including clinical characteristics （age of consultation， age of onset， course of disease， family history， severity grading）， alopecia areata-related factors （triggers）， and four-examination information （including sleep， diet， emotions， bladder and bowel function， etc.）. Descriptive frequency analyses， rank sum tests， factor analyses and cluster analyses were performed， and the distribution of the major TCM syndromes was summarised with the clinical data. ResultsThere were 800 children with alopecia areata， including 449 males and 351 females； 8 cases （1.00%） were in infancy， 36 cases （4.50%） were in early childhood， 180 cases （22.50%） were in preschool， 380 cases （47.50%） were in school age， and 196 cases （24.50%） were in puberty at the time of consultation； the average age of consultation was 8.31±3.86 years， the average age of onset of disease was 5.40±3.82 years， and the average duration of disease was 2.94±2.77 years； 527 children （65.87%） with severe alopecia areata； 85 children （13.56%） had a family history of alopecia areata； 772 children （96.50%） had unknown triggers for their first alopecia areata， and 28 children （3.50%） reported the presence of obvious triggers， including fright （9 cases）， high fever （5 cases）， allergic reactions （4 cases）， micronutrient （zinc， iron， etc.） deficiencies （4 cases）， inappropriate diet （2 cases）， environmental factors （1 case， new house renovation）， atopic dermatitis （1 case）， atopic asthma （1 case）， and pneumonia （1 case）. A total of 40 four-examination information items were collected， among which the frequency of kicking quilts was the highest with 380 cases （47.50%）， followed by picky eating （369 cases， 46.13%）， sleeplessness （334 cases， 41.75%）， irritability （334 cases， 41.75%）， partiality towards certain foods （306 cases， 38.25%）， impulsiveness （297 cases， 37.13%）， dry stools （233 cases， 29.13%）， yellow urine （215 cases， 26.88%）， nail biting （213 cases， 26.63%）， bad breath （211 cases， 26.38%）. According to factor analysis and cluster analysis， five types of TCM syndromes were obtained， in order as qi and blood deficiency syndrome （110 cases， 13.75%）， spleen deficiency syndrome （114 cases， 14.25%）， kidney essence deficiency syndrome （140 cases， 17.50%）， dietary stagnation syndrome （150 cases， 18.75%）， and liver depression and spleen deficiency syndrome （286 cases， 35.75%）. Patients in each age group and SALT grading are mainly liver depression and spleen deficiency syndrome. ConclusionThe TCM symptoms of children with alopecia areata are mainly based on qi and blood deficiency syndrome， spleen deficiency syndrome， kidney essence deficiency syndrome， dietary stagnation syndrome， and liver depression and spleen deficiency syndrome， of which liver depression and spleen deficiency syndrome is the most common type at different ages and stages of the disease.

Objective This study aimed to investigate the therapeutic efficacy of Sanjie Quban recipe in a keloid nude mice model and its impact on transforming growth factor-β 1(TGF-β1).Methods Keloid tissue after surgical resection was subcutaneously transplanted into the backs of healthy SPF BALB/C female nude mice,aged 6～8 weeks,and a keloid nude mice model was thus established.The mice were randomly divided into three groups,the Sanjie Quban recipe group,the Asiaticoside tablet group and the control gnup,with five in each group.They were respectively treated with Sanjie Quban recipe,Asiaticoside tablets,or sterile pure water.After 28 days of continuous gavage,the keloid tissue was exfoliated and weighed,and HE staining,Masson staining,and immunohistochemical staining for TGF-β1 were conducted.Differences in keloid weight between the three groups before and after treatment were compared,as were the differences in collagen fiber,fibroblast numbers,and TGF-β1 expression between the three groups after treatment.Results The difference in keloid weight before and after treatment in the Asiaticoside tablet group was greater than that of the control group,and the weight difference before and after treatment keloid treatment was the largest in the Sanjie Quban recipe group(P＜0.01).Compared with the control group,collagen fibers in the Sanjie Quban recipe group were looser and less numerous,and fibroblasts were decreased in number.The expression of TGF-β1 in the Sanjie Quban recipe group was decreased compared with that of the control group(P＜0.01).Conclusions Sanjie Quban recipe has certain therapeutic effects on keloids.The mechanism may involve reducing the expression of TGF-βl in keloid tissue and thereby reducing the proliferation of fibroblasts and the synthesis of extracellular matrix.This study provides experimental and theoretical bases for the clinical treatment of keloids with Chinese medicine.