1.Efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy for resectable non-small cell lung cancer
Dongbao YANG ; Kaize ZHONG ; Hongmei MA ; Shifa ZHANG ; Hongfeng LIU ; Liji CHEN ; Jishen ZHANG ; Haibo CAI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(06):920-926
Objective To explore the efficacy and safety of neoadjuvant immunotherapy combined with chemotherapy in patients with locally advanced resectable non-small cell lung cancer (NSCLC). Methods The clinical data of patients with stage ⅡA-ⅢB NSCLC who underwent surgical treatment after receiving neoadjuvant immunotherapy combined with chemotherapy or chemotherapy alone at the First People’s Hospital of Jining between April 2021 and January 2024 were retrospectively analyzed. According to the preoperative neoadjuvant regimens, the patients were divided into a combined group and a chemotherapy group, and the clinical data of the two groups were compared. Results A total of 66 patients were included, including 61 males and 5 females. There were 53 patients in the combined group with a mean age of (63.40±6.80) years, and 13 patients in the chemotherapy group with a mean age of (58.62±8.30) years. There was a statistical difference in age between the two groups (P<0.001), while no statistical difference was observed in other baseline data (P>0.05). The major pathological response rates in the combined group and the chemotherapy group were 54.7% and 23.1%, respectively (P=0.041), and the pathological complete response rates were 39.6% and 0.0%, respectively (P=0.006). The operative time in the combined group was shorter (P=0.039). There were no statistical differences between the two groups in intraoperative blood loss, duration of postoperative tube carrying, incidence of postoperative complications, overall survival, or event-free survival (P>0.05). Conclusion Surgical treatment following neoadjuvant immunotherapy combined with chemotherapy is safe and feasible, and its long-term efficacy requires further follow-up for confirmation.
2.Efficacy and safety of neoadjuvant sintilimab plus chemotherapy for locally advanced resectable esophageal squamous cell carcinoma
Liji CHEN ; Junjun HUANG ; Hongmei MA ; Shifa ZHANG ; Dongbao YANG ; Jiuhe SUN ; Hongfeng LIU ; Kaize ZHONG ; Haibo CAI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(07):1071-1078
Objective To observe the efficacy and safety of neoadjuvant sintilimab combined with chemotherapy in the treatment of patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC). Methods Clinical data were collected from patients with locally advanced resectable ESCC who received neoadjuvant immunotherapy combined with chemotherapy followed by surgical treatment at the Department of Thoracic Surgery of Jining No.1 People's Hospital from April 2020 to April 2022. The endpoints included major pathological response (MPR), pathological complete response (pCR), R0 resection rate, safety, and postoperative survival. Results A total of 43 patients with ESCC who received at least one cycle of neoadjuvant immunotherapy before surgery were included. Among them, there were 31 males and 12 females with a median age of 65 years (interquartile range: 58-69). All patients successfully completed the surgery without any surgical delays. The pCR rate was 14.0% (6/43), the MPR rate was 58.1% (25/43), and the R0 resection rate was 97.7% (42/43). Patients exhibited reliable safety during neoadjuvant therapy and postoperatively. The 2-year overall survival and disease-free survival rates were 90.7% and 81.4%, respectively. Kaplan-Meier survival analysis and log-rank test revealed lower recurrence rates and better survival in the MPR patients compared to the non-MPR patients. Conclusion The combination of neoadjuvant sintilimab and chemotherapy in the treatment of patients with locally advanced resectable ESCC has demonstrated significant clinical efficacy, while also being safe and reliable.
3.Association of HER2 expression with clinicopathologic features and prognosis in 519 cases of urothelial carcinoma
Aoling HUANG ; Ting XIE ; Hongfeng ZHANG ; Shuaijun CHEN ; Zhengzhuo CHEN ; Bin LUO ; Feng GUAN ; Hong-lin YAN ; Jingping YUAN
Chinese Journal of Clinical and Experimental Pathology 2025;41(5):602-607,613
Purpose To investigate the immunohistochemical HER2 expression in a large group of patients with urothelial carcinoma and to compare the results with the pathologic features and survival rate.Methods A total of 519 urothelial carcinoma specimens were collected from two centers.HER2 expression was measured by EnVision immuno-histochemistry.HER2 expression was compared with clinicopathological parameters,and further analyzed in relation to patient prognosis.Results The median age of the 519 patients was 66 years with a male to female ratio of 1.93∶1.Among them,160 cases were radical specimens,and 359 were transurethral resection specimens.The overall HER2 positivity rate was 61.7%(320/519),of which 148 cases(28.5%)were HER2 1+,238(45.9%)were HER2 2+,and 82(15.8%)were HER2 3+.In addition,51 cases(9.8%)were HER2-negative.HER2-positive ex-pression was associated with age,tumor location,histological grade,histological type,surgical approach,lymphovas-cular invasion,and neural invasion(all P<0.05),but there was no significant correlation with gender,pT stage,muscular invasion,or lymph node metastasis.Univariate and multivariate logistic regression analysis showed that age≥ 66 years,higher tumor grade,and lymphovascular invasion were risk factors for positive HER2 expression,and high histological grade and lymphovascular invasion were independent risk factors affecting HER2 expression after controlling for confounders.Survival analysis showed no significant difference in recurrence-free survival between patients with HER2-positive and HER2-negative non-muscle-invasive urothelial carcinoma(P=0.274).Conclusion High histologic grade,tumor lymphovascular invasion,and neural invasion were associated with positive HER2 expression in patients with urothelial carcinoma,and higher histologic grade and lymphovascular invasion are important factors affect-ing HER2 expression.However,HER2-positive expression may not affect the prognosis of patients with non-muscle-invasive bladder urothelial carcinoma.
4.Ovarian mature cystic teratoma with mucinous tumors:a clinicopathological anal-ysis of 14 cases
Xiaoxiao ZHAO ; Shuaijun CHEN ; Bo LUO ; Yonghui XIE ; Hongfeng ZHANG
Chinese Journal of Clinical and Experimental Pathology 2025;41(11):1472-1477,1484
Purpose To investigate the clinicopathological features,diagnosis,differential diagnosis,immuno-phenotype,and prognosis of ovarian mature cystic teratoma(MCT)with an associated mucinous tumor(MT).Meth-ods Clinicopathological and follow-up data from 14 cases of MCT with MT were retrospectively analyzed and supple-mented with a literature review.Results 14 patients' ages ranged from 21-70 years,with a median age of 33 years.Tumors were located in the left ovary(4 cases),right ovary(9 cases),or bilaterally(1 case).The tumors,cystic or cyst-solid,measured 6.0-24.0 cm in maximum diameter(mean:11.7±5.7 cm).Histologically,the MT compo-nents were classified as mucinous cystadenoma(MCA)in 9 cases,borderline mucinous cystadenoma(MBT)in 4 ca-ses,and mucinous adenocarcinoma(MAC)in 1 case.Microscopically,MCT elements from multiple germ layers were identified in 13 cases,with one case showing only mature thyroid tissue.The mucinous epithelium in MCA showed no significant atypia.Mucinous epithelial proliferation accounted>10%in MBT.MAC demonstrated moderate-to-severe atypia and invasive growth.Immunohistochemically,the MT epithelium was frequently positive for CK7(6/7),CK20(4/5),CDX2(5/6),Villin(4/4),SATB2(3/3),MUC2(2/3),MUC5AC(2/2),MUC6(1/1),and PAX-8(2/7),while negative for ER(6/6),PR(5/5),and WT-1(5/5).The Ki-67 proliferation index was low(<5%)in 6 cases and high(50%)in one case.During a follow-up of 9-110 months,patients with MCT associated with MCA or MBT were alive without recurrence.The patient with MCT and MAC experienced recurrence 34 months after surgery.Conclusion Ovarian MCT with MT is rare and lacks specific clinical manifestations.Pathological examina-tion combined with immunophenotyping is essential for accurate diagnosis and classification.
5.Consideration and Suggestions on Dosage Labeling Issues in Chinese Patent Medicines Instructions
Juan XU ; Gaiping WANG ; Yu ZHANG ; Lingjun DONG ; Junfei WANG ; Hongfeng LIU ; Weihong CHEN
Herald of Medicine 2025;44(5):720-726
Objective To explore a standardized approach for indicating dosages in Chinese patent medicines(CPM)instructions.Methods A review of 1 378 classic formulas of traditional Chinese medicine in the 2020 edition of the Pharmaco-poeia of the People's Republic of China(Chinese Pharmacopoeia)was conducted,focusing on three aspects:overdose,different dosage forms,and inclusion of toxic herbs.Approximately 50 representative formulas were selected,and their daily dosage of herbal pieces and the corresponding dosage of individual herbs were calculated.These results were then compared and analyzed against the dosages stipulated in the Chinese Pharmacopoeia.Results ①Overdose:Among the 1 378 reviewed formulas,146(10.60%)were found to involve overdose.Specifically,eight formulas were identified as having an overdose of approximately 3 to 5 times the recommended dose,including Duanxueliu tablets and Zhixue Fumai mixture.②Dosage variations across dosage forms:Based on the conversion of the Ming-Qing dynasty dosage of one liang(Chinese traditional weight unit)to 36 g,the estimated dai-ly dose per component of crude herbs in Yinqiao powder was close to the upper limit specified in the Chinese Pharmacopoeia.The total daily dose of crude herbs(75.60 g)was approximately five times that of the Yinqiao powder(15 g)listed in the Chinese Pharmacopoeia and three times that of the Japanese Kampo Yinqiao powder(23.868 g).Significant differences in dosage were ob-served among Yinqiao Jiedu preparations of different dosage forms.In terms of total daily dose of crude herbs,granules(52.50 g)had the highest dose,approximately 3-5 times that of tablets/capsules(11.20 g),soft capsules(13.44 g),and powders(15.00 g),but still 30% lower than the original prescription from ancient texts(75.6 g).Comparing the daily dose per compo-nent,granules fell within the Chinese Pharmacopoeia dose range,while tablets,capsules,soft capsules,and powders were all below the Chinese Pharmacopoeia dose.③Inclusion of toxic herbs:Among the 20 oral formulations containing Strychnos nux-vomica(Maqianzi)listed in the Chinese Pharmacopoeia,seven species exceeded the pharmacopoeial dose of 0.3-0.6 g per day.Notably,Shenjin Huoluo pill and Shufeng Dingtong pill exceeded the Chinese Pharmacopoeia dose by 1.5-2 times.The daily dose of strych-nosine in Shenjin Huoluo pill was 21.3 mg,exceeding the toxic dose range of 5-10 mg.Conclusions The dosage indications in CPM instructions must adhere to a unified format,clearly stating the daily dose per component of crude herbs,the total daily dose of crude herbs,and the total number of administrations under the"Dosage and Administration"section.For instance,"Yinqiao Jiedu granules,with a total daily dose equivalent to 60 g of crude herbs taken in four doses(including:Flos Lonicerae 10.71 g,Fructus Forsythiae 10.71 g,Radix Platycodi 6.43 g,Herba Menthae Haplocalycis 6.43 g,Fructus Arctii 6.43 g,Semen Sojae Preparatum 5.36 g,Radix Glycyrrhizae 5.36 g,Herba Lophatheri 4.29 g,Herba Schizonepetae 4.29 g)."For CPM containing tox-ic herbs,dosage indications are even more crucial,such as specifying the daily dose of Maqianzi powder/processed Maqianzi and strychnosine in formulations containing this herb.
6.STAR Guideline Terminology(Ⅲ):Reporting,Evaluation,Dissemination,Implementation and Updating
Hongfeng HE ; Hui LIU ; Qianling SHI ; Yuanyuan YAO ; Yishan QIN ; Zijun WANG ; Jinhui TIAN ; Long GE ; Xiaohui WANG ; Yaolong CHEN
Medical Journal of Peking Union Medical College Hospital 2025;16(4):1018-1025
Objective To sort,summarize,and introduce key terms related to guideline reporting,evaluation,dissemination,implementation,and updating.Methods We systematically searched guideline de-velopment manuals and methodological literature from database inception to October 25,2024.Terms related to guideline reporting,updating,evaluation,and implementation were extracted,standardized,and finalized through a structured consensus process.Results A total of 13 guideline manuals and 32 methodological articles were included,yielding 14 core terms with standardized definitions.Conclusions This article introduces key terms such as reporting standards,external review,and research gaps across guideline development phases to promote concept application and deepen readers'understanding of guideline development.
7.Prognostic analysis of local excision in 153 cases of locally advanced low rectal cancer following neoadjuvant therapy
Hongfeng PAN ; Jiahong YE ; Heyuan ZHU ; Xiaojie WANG ; Yanwu SUN ; Zhifen CHEN ; Zongbin XU ; Shenghui HUANG ; Weizhong JIANG ; Pan CHI ; Ying HUANG
Chinese Journal of Gastrointestinal Surgery 2025;28(11):1250-1259
Objective:To evaluate the short-term and long-term outcomes of patients with locally advanced low rectal cancer who achieved clinical complete response (cCR) or near-clinical complete response (near-cCR) after neoadjuvant chemoradiotherapy (nCRT) and then underwent local excision.Methods:This was a descriptive case series study. Clinical data of patients with low rectal cancer who received neoadjuvant therapy, achieved cCR or near-cCR, underwent local excision, and had complete postoperative follow-up data were retrospectively analyzed. The study period was from May, 2015 to October, 2024, and the patients were treated at Fujian Medical University Union Hospital. Indications for local excision in this study were as follows: pathologically confirmed rectal adenocarcinoma, with the lower edge of the tumor ≤ 6 cm from the anal verge; maximum diameter of the lesion ≤ 2 cm after nCRT; no regional lymph node metastasis detected by transrectal endoscopic ultrasound (ERUS), pelvic magnetic resonance imaging (MRI), or positron emission tomography-computed tomography (PET-CT) after nCRT; MRI showing fibrosis of the primary lesion with a small amount of high signal on diffusion-weighted imaging (DWI), consistent with ymrT0-1 stage; serum carcinoembryonic antigen level within the normal range (< 5 μg/L) after nCRT; complicated with severe underlying diseases such as cardiovascular and cerebrovascular diseases and assessed as unable to tolerate radical surgery through comprehensive evaluation; and signed informed consent for local excision. The contraindications were: colonoscopic pathology indicating poorly differentiated adenocarcinoma or signet ring cell carcinoma; suspected lateral lymph node metastasis before neoadjuvant therapy; patients with residual lesions exceeding 3 cm in range after treatment. A total of 153 patients were included in this study, including 84 males and 69 females. The median age was 62 years, and the median distance from the tumor to the anal verge after neoadjuvant therapy was 4.0 cm. The short-term efficacy indicators of this study included postoperative complications of local excision and postoperative pathological results, and the long-term efficacy indicators included oncological prognosis (3-year cumulative local recurrence rate, 3-year cumulative distant metastasis rate, 3-year progression-free survival, and 3-year overall survival) and anal function at 1 year after surgery evaluated using the Low Anterior Resection Syndrome (LARS) scale where the total score is 42 points such that 0-20 points indicate no LARS, 21-29 points indicate mild LARS, and 30-42 points indicate severe LARS.Results:Postoperative pathology showed 122 cases (79.7%) of ypT0 stage, 10 cases (6.5%) of ypT1 stage, 18 cases (11.8%) of ypT2 stage, and 3 cases (2.0%) of ypT3 stage. The incidence of surgery-related complications was 42.5% (65/153), and the main complications included perianal pain (39.9%, 61/153), intestinal wall incision dehiscence (21.6%, 33/153), and intestinal wall incision infection (18.3%, 28/153). The proportion of patients who received hypofractionated radiotherapy before surgery and developed intestinal wall incision dehiscence was 65.2% (15/23), which was higher than that in the conventional long-course (13.6%, 16/118) and short-course radiotherapy groups (16.7%,2/12) (χ 2=30.55, P<0.001); of the 20 patients who received additional immunotherapy before surgery, 13 developed intestinal wall incision dehiscence was 65.0%, which was higher than that in the group without additional immunotherapy [15.0%(20/133),χ 2=25.66, P<0.001]. The median follow-up time of the entire group was 35.4 months. During the follow-up period, there were 9 cases of postoperative local recurrence, with a 3-year cumulative local recurrence rate of 7.9% and 5 cases of distant metastasis, with a 3-year cumulative distant metastasis rate of 5.0%. The 3-year progression-free survival rate was 89.0%, and the 3-year overall survival rate was 95.9%. At 1 year after surgery, 10 cases (10.5%, 10/95) had severe anal dysfunction, and the median LARS score of the entire group was 5.0 (range: 0-41.0) points. Conclusions:For patients with locally advanced low rectal cancer who achieve cCR or near-cCR after neoadjuvant therapy, local excision results in favorable oncological prognosis and anal function preservation effects; however, the incidence of complications is relatively high.
8.Ovarian mature cystic teratoma with mucinous tumors:a clinicopathological anal-ysis of 14 cases
Xiaoxiao ZHAO ; Shuaijun CHEN ; Bo LUO ; Yonghui XIE ; Hongfeng ZHANG
Chinese Journal of Clinical and Experimental Pathology 2025;41(11):1472-1477,1484
Purpose To investigate the clinicopathological features,diagnosis,differential diagnosis,immuno-phenotype,and prognosis of ovarian mature cystic teratoma(MCT)with an associated mucinous tumor(MT).Meth-ods Clinicopathological and follow-up data from 14 cases of MCT with MT were retrospectively analyzed and supple-mented with a literature review.Results 14 patients' ages ranged from 21-70 years,with a median age of 33 years.Tumors were located in the left ovary(4 cases),right ovary(9 cases),or bilaterally(1 case).The tumors,cystic or cyst-solid,measured 6.0-24.0 cm in maximum diameter(mean:11.7±5.7 cm).Histologically,the MT compo-nents were classified as mucinous cystadenoma(MCA)in 9 cases,borderline mucinous cystadenoma(MBT)in 4 ca-ses,and mucinous adenocarcinoma(MAC)in 1 case.Microscopically,MCT elements from multiple germ layers were identified in 13 cases,with one case showing only mature thyroid tissue.The mucinous epithelium in MCA showed no significant atypia.Mucinous epithelial proliferation accounted>10%in MBT.MAC demonstrated moderate-to-severe atypia and invasive growth.Immunohistochemically,the MT epithelium was frequently positive for CK7(6/7),CK20(4/5),CDX2(5/6),Villin(4/4),SATB2(3/3),MUC2(2/3),MUC5AC(2/2),MUC6(1/1),and PAX-8(2/7),while negative for ER(6/6),PR(5/5),and WT-1(5/5).The Ki-67 proliferation index was low(<5%)in 6 cases and high(50%)in one case.During a follow-up of 9-110 months,patients with MCT associated with MCA or MBT were alive without recurrence.The patient with MCT and MAC experienced recurrence 34 months after surgery.Conclusion Ovarian MCT with MT is rare and lacks specific clinical manifestations.Pathological examina-tion combined with immunophenotyping is essential for accurate diagnosis and classification.
9.Clinical Study on Chaiqin Xiaoyong Decoction (柴芩消痈饮) Combined with Jinhuang Ointment (金黄膏) for the Nodular Stage of Acne Mastitis of Liver Meridian Heat Accumulation Type:A Randomized,Double-Blind,Placebo-Controlled Trial
Tian MENG ; Feifei MA ; Yuanyuan KANG ; Mengfei SHEN ; Shengfang HU ; Meina YE ; Yiqin CHENG ; Hongfeng CHEN
Journal of Traditional Chinese Medicine 2025;66(9):920-926
ObjectiveTo evaluate the clinical efficacy and safety of the traditional Chinese medicine (TCM) compound Chaiqin Xiaoyong Decoction (柴芩消痈饮, CXD) combined with Jinhuang Ointment (金黄膏, JO) in treating the nodular stage of acne mastitis of liver meridian heat accumulation type. MethodsA randomized, double-blind, placebo-controlled clinical trial was conducted. A total of 108 patients with liver meridian heat accumulation type acne mastitis in the nodular stage were randomly assigned to a treatment group and a control group, with 54 patients in each group. Both groups received topical application of JO once daily at a thickness of 3~5 mm for 8 hours, along with standard nursing care. On this basis, the treatment group received oral CXD granules, while the control group received placebo granules, administered twice daily, 3 sachets per dose, for 14 consecutive days. Clinical efficacy, TCM symptom scores, nodule size, visual analogue scale (VAS) pain scores, white blood cell (WBC) count, C-reactive protein (CRP) level, and systemic immune-inflammation index (SII) were compared. At the end of treatment, efficacy and safety indicators were evaluated. A 6-month follow-up was conducted to compare the proportion of patients undergoing surgical treatment. ResultsThe total clinical efficacy rate in the treatment group was 90.38% (47/52), significantly higher than 32.00% (16/50) in the control group (P<0.01). The treatment group also showed significantly lower TCM symptom scores, VAS scores, nodule size, WBC count, CRP level, and SII (P<0.05 or P<0.01). During follow-up, the surgical intervention rate in the treatment group was 5.77% (3/52), lower than 14.00% (7/50) in the control group, with a statistically significant difference (P<0.01). No significant abnormalities were observed in safety indicators before and after treatment in either group. ConclusionCXD effectively reduces nodule size and alleviates symptoms such as redness and pain in patients with acne mastitis of liver meridian heat accumulation type, improves TCM symptom scores, enhances overall clinical efficacy, and demonstrates good safety.
10.STAR Guideline Terminology(Ⅱ): Clinical Question Formulation, Evidence Retrieval and Appraisal, and Recommendation Development
Di ZHU ; Haodong LI ; Zijun WANG ; Qianling SHI ; Hui LIU ; Yishan QIN ; Yuanyuan YAO ; Zhewei LI ; Hongfeng HE ; Jinhui TIAN ; Long GE ; Yaolong CHEN ;
Medical Journal of Peking Union Medical College Hospital 2025;16(3):756-764
To introduce and analyze guideline terminology related to clinical question formulation, evidence retrieval and appraisal, and recommendation development. A systematic search was conducted in guideline development manuals and relevant methodological literature, covering publications up to October 25, 2024. Terminology related to the three aforementioned stages of related to guideline development was extracted from the included literature, standardized, and refined through consensus meetings to finalize a comprehensive terminology list and definitions. A total of 30 guideline development manuals and 15 methodological articles were included, and 23 core terms were identified. It is recommended to develop a standardized and scientifically sound guideline terminology system with unified naming, clear definitions, and alignment with the linguistic environment and usage habits in China. At the same time, it is essential to strengthen terminology training for both guideline developers and users based on this system, in order to deepen their correct understanding and proper application of guideline terminology.

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