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.

OBJECTIVES: Managing patients with refractory head and neck cancer pain is one of the more challenging issues in clinical practice, and traditional intrathecal drug delivery also fails to provide adequate analgesia. There are currently no comprehensive and effective treatment methods. This study aims to observe the efficacy and safety of treating intractable head and neck cancer pain with morphine pump via lumbar approach to the prepontine cistern. METHODS: A total of 18 patients with intractable head and neck cancer pain treated with prepontine cistern morphine pumps were selected from the Department of Pain Management, Second Xiangya Hospital, Central South University between September 2019 and July 2023. Statistical analysis was performed on patients' preoperative and postoperative (1 week, 1 month, and 2 months after surgery), Numerical Rating Scale (NRS) scores, Self-Rating Depression Scale (SDS) scores, daily oral morphine consumption, the number of daily breakthrough pain episodes, and postoperative daily intrathecal morphine dosage. RESULTS: The NRS scores, SDS scores, daily oral morphine consumption, and the number of daily breakthrough pain episodes of patients at each time point after surgery were significantly lower than before surgery (all P<0.05). With the gradual increase in the dosage of intrathecal morphine, the daily oral morphine consumption of patients at each postoperative time point was significantly reduced compared to preoperative levels (all P<0.05). The complications related to the operation were mild, including nausea in 5 cases (31.3%), headache in 2 cases (12.5%); hypotension, urine retention, hypersomnia and constipation in 1 case (6.3% each), and no serious adverse events occurred. All improved and were discharged after symptomatic treatment. CONCLUSIONS The implantation of prepontine cistern morphine pump effectively controls intractable head and neck cancer pain, demonstrating characteristics of minimal invasiveness, mild side effects, and low medication dosage under the premise of standardized procedures.
Humans ; Morphine/administration & dosage* ; Male ; Female ; Middle Aged ; Head and Neck Neoplasms/surgery* ; Analgesics, Opioid/administration & dosage* ; Cancer Pain/drug therapy* ; Pain, Intractable/etiology* ; Aged ; Adult ; Infusion Pumps, Implantable ; Pain Management/methods*

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 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 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.

Objective:The distribution characteristics of intrathecal drugs and the limitation of current catheterization techniques make traditional intrathecal analgesic treatment nearly useless for refractory craniofacial pain,such as trigemina neuralgia.This technical guideline aims to promote the widespread and standardize the application of intra-prepontine cisternal drug delivery via spinal puncture and catheterization. Methods:A modified Delphi approach was used to work for this guideline.On the issues related to the intra-prepontine cisternal targeted drug delivery technique,the working group consulted 10 experts from the field with 3 rounds of email feedback and 3 rounds of conference discussion. Results:For the efficacy and safety of the intra-prepontine cisternal targeted drug delivery technique,a consensus was formed on 7 topics(with an agreement rate of more than 80%),including the principles of the technique,indications and contraindications,patient preparation,surgical specifications for intra-prepontine cisternal catheter placement,analgesic dosage coordination,analgesic management,and prevention and treatment of complications. Conclusion:Utilizing the intra-prepontine cisternal drug infusion system to manage refractory craniofacial pain could provide advantages in terms of minimally invasive,secure,and effective treatment.This application can not only alleviate the suffering of individuals experiencing the prolonged pain but also support the maintenance of quality of life and dignity in their final moments,justifiing its widespread dissemination and standardized adoption in domestic and international professional fields.

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:To investigate the clinical efficacy of superior hypogastric nerve block (SHNB) in relieving pelvic pain after uterine artery embolization (UAE).Methods:Totally 50 patients of UAE before the curettage of uterine incision pregnancy were selected in Affiliated Zhenjiang Fourth People′s Hospital,Jiangsu University from February 2019 to December 2020 and were randomly divided into SHNB group( n=22) and control group( n=28) using random number table. The SHNB group underwent fluoroscopy-guided SHNB before UAE, and the control group received dizocine 10 mg intramuscularly before embolization. Both groups were treated with curettage 24 h after UAE. The pain scores were evaluated by using a numerical rating scale (NRS) to compare the pain scores between the two groups atthe time period A1 (from the beginning of UAE to immediate postoperative period) and at the time period A2 (from leaving the interventional operating room to the time before curettage). Data was recorded and compared between the two groups at the time period from the beginning of UAE surgery to the time before curettage for the doses of opioids used.The differences inage and weight between the two groups were compared by independent sample t test, and the NRS score and morphine dose were compared by Mann-whitney U test. Results:All patients completed SHNB and UAE without serious complications.There was no significant difference in age and weight between the two groups ( P>0.05).The maximum pain scores in the SHNB group were lower than those in the control group at both the A1 and A2 time periods[0(0, 0.25) vs. 3.00 (2.00, 4.00), and 2.50 (0.75, 5.50) vs. 4.00 (3.25, 7.00); Z=-4.932, -2.351, P<0.05]. The equivalent dose of morphine required in the SHNB group was lower than that of the control group [0(0, 10.00) vs. 10.00 (5.00, 15.00)mg, Z=-2.247, P=0.025]. Conclusion:Fluoroscopic-guided SHNB is a safe, effective, and minimally invasive way to reduce pain and the opiate dose after UAE.