1.Association of the total burden of cerebral small vessel disease with the level of tumor necrosis factor-α and prognosis in patients with acute ischemic stroke
Journal of Apoplexy and Nervous Diseases 2026;43(1):20-27
Objective To investigate the association of the total burden of cerebral small vessel disease (CSVD) with the level of tumor necrosis factor-α(TNF-α) and prognosis in patients with ischemic stroke (AIS). Methods A total of 120 patients with AIS who were admitted to our hospital from January 2022 to December 2023 were enrolled as subjects, and all patients underwent cranial MRI scanning. Baseline data and TNF-α level were compared between the patients with different total burden scores of CSVD, and the correlation between TNF-α level and CSVD total burden score was analyzed. TNF-α level and CSVD total burden score were compared between the AIS patients with different prognoses to investigate the influence of TNF-α and CSVD total burden score on the short-term prognosis of AIS, as well as their value in predicting the short-term prognosis of AIS. Results There were significant differences in age, the proportion of patients with hyperlipidemia, the proportion of patients with smoking, and the levels of TNF-α and Hcy between the patients with different CSVD total burden scores (P<0.05). The level of TNF-α was positively correlated with the number of lacunar cerebral infarcts, Fazekas score of white matter lesions, and EPV score (r=0.654, 0.775, 0.820, P<0.05), but it had no linear correlation with the number of cerebral microbleeds (r=-0.035,P>0.05). The logistic regression analysis showed that before correction, age, hyperlipidemia, smoking, TNF-α,and Hcy were significantly correlated with lacunar infarction, white matter lesions, EPV severity, cerebral microbleeds,and CSVD total burden score (P<0.05), and after correction, TNF-α was still significantly correlated with lacunar infarction, white matter lesions,cerebral microbleeds, EPV severity, and CSVD total burden scores (P<0.05). There were significant differences in CSVD total burden score and TNF-α between the patients with a good prognosis and those with a poor prognosis(P<0.05).TNF-α combined with CSVD total burden score had the largest area under the receiver operating characteristic curve(AUC) of 0.912 in predicting the short-term prognosis of AIS,which was significantly higher than the AUC of TNF-α or CSVD total burden score used alone(P<0.05). Conclusion The increase in TNF-α level has a certain relationship with CSVD total burden score and short-term prognosis in AIS patients, and the combination of TNF-α level and CSVD total burden score has a relatively high clinical application value in predicting the short-term prognosis of AIS patients.
Prognosis
2.Clinical efficacy analysis of seven pediatric patients with Acute myeloid leukemia and the t(16;21)(p11;q22) FUS::ERG fusion gene.
Lihuan SHI ; Shan HUANG ; Xing XIE ; Pengkai FAN ; Haili GAO ; Yanna MAO
Chinese Journal of Medical Genetics 2026;43(2):90-95
OBJECTIVE:
To analyze the clinical characteristics, treatment, and prognosis of seven pediatric patients with Acute myeloid leukemia (AML) positive for the t(16;21)(p11;q22) FUS::ERG fusion gene.
METHODS:
A retrospective analysis was carried out on the clinical data, treatment, and prognosis of seven AML patients with t(16;21)(p11;q22) FUS::ERG fusion gene admitted to Henan Children's Hospital between June 2015 and November 2024. Relevant literature was also reviewed. This study was approved by the Medical Ethics Committee of the Hospital (Ethics No.: 2024-102-001).
RESULTS:
Among 297 pediatric patients with AML, 7 cases (2.36%) were positive for the t(16;21)(p11;q22) FUS::ERG fusion gene, including 3 males and 4 females, with a median age of 11 years (range: 3 ~ 12 years). According to the FAB classification, these included 1 case of M2, 3 cases of M5, and 3 cases of AML-not otherwise specified (non-M3). All 7 patients were found to harbor the t(16;21)(p11;q22) translocation, with 3 cases showing additional chromosomal abnormalities. Immunophenotyping revealed universal expression of CD13, CD33, CD34, and CD117, with partial expression of CD56, CD4, CD64, CD123, CD15, CD38, CD11b, HLA-DR, cMPO, and CD16. One patient achieved complete remission (CR) after the first course of DAE (cytarabine + daunorubicin + etoposide) induction chemotherapy but relapsed and discontinued the treatment. Six patients received DAH (cytarabine + daunorubicin + homoharringtonine) induction therapy, of whom 2 achieved CR after two courses and underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT), resulting in an overall CR rate of 42.86%. Five children did not receive allo-HSCT and had a median overall survival of 9 months (range: 6 ~ 18 months). Two children who underwent transplantation achieved bone marrow morphological and molecular biological relapse at 6 and 9 months post-transplantation, respectively. After receiving combined chemotherapy and donor lymphocyte infusion, one child failed to achieve remission and died at 22 months post-transplantation, while the other has been followed up to date with positive fusion gene status. Their overall survival was 25 months and 30 months, respectively.
CONCLUSION
The t(16;21)(p11;q22) FUS::ERG fusion gene is rare in pediatric AML and associated with poor prognosis. Allo-HSCT may mitigate the adverse prognostic impact of the FUS::ERG fusion gene and contribute to prolonged survival.
Humans
;
Male
;
Child
;
Female
;
Leukemia, Myeloid, Acute/drug therapy*
;
Oncogene Proteins, Fusion/genetics*
;
Translocation, Genetic
;
Retrospective Studies
;
RNA-Binding Protein FUS/genetics*
;
Chromosomes, Human, Pair 16/genetics*
;
Adolescent
;
Child, Preschool
;
Chromosomes, Human, Pair 21/genetics*
;
Prognosis
;
Treatment Outcome
3.Analysis of ten cases of Acute lymphoblastic leukemia with non-KMT2A::AFF1 transcriptional variant 11q23 rearrangements.
Yuanyuan WANG ; Shuzhen FU ; Yong SHEN ; Qingxia XU
Chinese Journal of Medical Genetics 2026;43(4):265-272
OBJECTIVE:
To analyze the clinical characteristics of patients with 11q23 rearrangement acute lymphoblastic leukemia (ALL) with non-KMT2A::AFF1 fusion genes.
METHODS:
The clinical data of 10 patients with KMT2A fusion gene positive and partner gene non-AFF1 ALL admitted to Henan Cancer Hospital from December 2016 to December 2024 were retrospectively summarized. The immunophenotype, molecular genetic characteristics, clinical manifestations and disease prognosis of these patients were analyzed. This research has been approved by the Medical Ethics Committee of Henan Cancer Hospital (Ethics No.: 2019342).
RESULTS:
Among the 10 patients, the fusion genes were KMT2A::MLLT1 in 7 cases, KMT2A::MLLT4, KMT2A::MLLT3 and KMT2A::MLLT10 in 1 case each. The European Group for the Immunological Classification of Leukemias (EGIL) classification included 6 cases of T-ALL, 2 cases of pro-B-ALL, 1 case of Common-B-ALL and 1 case of pre-B-ALL. 4 cases of B-ALL all expressed CD19, cCD79a, CD38 and HLA-DR, and some expressed CD34 and CD22, without expression or weak expression of CD10, without expression of CD20. One case was accompanied by myeloid marker CD15 expression. 6 cases of T-ALL all expressed CD34, CD7, most expressed CD38, and some expressed CD3, CD5, CD2, CD4 and CD8, and 1 case expressed CD4 and CD8 together. Chromosomal abnormalities were detected in 3 cases, 5 cases were positive for WT1 fusion gene, and 6 cases had gene alterations. 9 patients achieved the first complete remission (CR1) during chemotherapy, and 1 patient relapsed within 6 months after CR1. At the last follow up, 1 patient (the fusion gene was KMT2A::MLLT4) remained unrelieved. There were 2 cases of KMT2A rearrangement (KMT2A-r) persistent positive (+/+) and 8 cases of KMT2A-r negative (+/-). The overall survival (OS) rate and leukemia-free survival (LFS) rate of patients with KMT2A-r persistent positive were significantly lower than those of patients with negative change, and the differences were statistically significant (P values were all < 0.05). Among the 3 patients who received chemotherapy+allogeneic hematopoietic stem cell transplantation (allo-HSCT), no relapse was observed until the follow up day. The OS rate and LFS rate of patients with KMT2A::MLLT1 and chemotherapy+allo-HSCT were higher than those of non-KMT2A::MLLT1 and single chemotherapy patients, and the differences were not statistically significant (P values were all ≥ 0.05). There was no significant difference in OS rate and LFS rate between T-ALL and B-ALL patients (P values were all ≥ 0.05). The median LFS time of the 10 patients was 32 (0 ~ 100) months, and the median OS time was 36 (1 ~ 101) months.
CONCLUSION
The 11q23 rearrangement ALL with non-KMT2A::AFF1 transcript is mainly KMT2A::MLLT1, T-ALL is more common, and the rate of chromosomal karyotype detection is relatively low. Persistent positive KMT2A-r is unfavorable for patient survival, and allo-HSCT during the CR1 period may improve patient survival.
Humans
;
Precursor Cell Lymphoblastic Leukemia-Lymphoma/genetics*
;
Female
;
Male
;
Myeloid-Lymphoid Leukemia Protein/genetics*
;
Histone-Lysine N-Methyltransferase/genetics*
;
Adult
;
Adolescent
;
Chromosomes, Human, Pair 11/genetics*
;
Child
;
Transcriptional Elongation Factors/genetics*
;
Gene Rearrangement
;
Oncogene Proteins, Fusion/genetics*
;
Retrospective Studies
;
Young Adult
;
Middle Aged
;
Prognosis
;
Child, Preschool
;
DNA-Binding Proteins/genetics*
4.Association between blood pressure variability and early neurological deterioration in patients with acute mild non-disabling ischemic stroke
Journal of Apoplexy and Nervous Diseases 2026;43(3):232-237
Objective To investigate the association of blood pressure variability (BPV) with early neurological deterioration (END) and prognosis in patients with acute mild non-disabling ischemic stroke. Methods The patients with acute mild non-disabling ischemic stroke who were admitted to Stroke Center of Affiliated Hospital of Inner Mongolia University for Nationalities from January 2022 to August 2024 were enrolled, and according to the presence or absence of END, they were divided into non-END group and END group. General information, clinical data, and outcome measures were collected from all patients, and a binary logistic regression analysis was performed to determine independent risk factors for END. According to the modified Rankin Scale (mRS) score, the patients were divided into good prognosis group (mRS score ≤2 points) and poor prognosis group (mRS score >2 points), and a univariate logistic regression analysis was performed to investigate the influence of END on the 90-day neurological function prognosis of patients. Results A total of 61 patients were enrolled, with 14 patients in the END group and 47 patients in the non-END group. There was a significant difference in the coefficient of systolic pressure variation between the END group and the non-END group (P<0.05). The binary logistic regression analysis showed that systolic BPV(BPV>75%) was an independent risk factor for END (OR=14.000, 95%CI 1.471‒133.233,P=0.011).Compared with the non-END group, the END group had a significantly higher proportion of patients with a poor 90-day prognosis.Of all patients, there were 11 patients with poor prognosis and 50 patients with good prognosis on day 90. The univariate logistic regression analysis showed that END (OR=19.556,95%CI 4.038‒94.696,P<0.001) was an independent risk factor for poor prognosis. Conclusion In patients with acute mild non-disabling ischemic stroke, the increase in coefficient of systolic pressure variation is an independent risk factor for END and affects the prognosis of neurological function on day 90.
Prognosis
5.Pattern of lymph node metastasis and p53 abnormal (p53abn) expression in preoperative early-stage endometrial cancer: A 5-year institutional experience.
Angeli Anne C. Ang ; Carolyn R. Zalameda-Castro ; Cecile C. Dungog ; Michele H. Diwa ; Karen Cybelle J. Sotalbo
Acta Medica Philippina 2026;60(8):98-106
BACKGROUND
Early-stage endometrial cancer often presents with favorable survival rates, but high-risk factors, including TP53 mutations and high-grade serous pathology, can lead to recurrence and poor prognosis. The standard primary treatment for endometrial cancer is surgical staging, and lymph node metastases significantly impact adjuvant therapy decisions. The subgroup of p53-abnormal (p53abn) indicates the worst prognosis and potential benefits from adjuvant chemotherapy. Molecular classification, while recommended, faces practical challenges due to resource constraints.
OBJECTIVESThe study aimed to assess the incidence of p53 abnormal expression in clinical stage 1 endometrial cancer cases that underwent surgery at a government tertiary hospital, and assess its relationship with clinicopathologic factors and pelvic and paraaortic lymph node metastasis (LNM).
METHODSA cross-sectional retrospective analysis was conducted on clinical early-stage endometrial cancer cases that underwent surgical primary treatment between January 2018 and December 2022. Patient records were reviewed to gather demographics, surgical information, and pathological evaluations. Preoperative clinical staging was determined through imaging, and surgical staging involved comprehensive lymphadenectomy. Immunohistochemistry studies for p53 were carried out on formalin-fixed paraffin-embedded tissue samples.
RESULTSA total of 233 endometrial cancer cases were included. The mean age at diagnosis was 53.7 years. Common comorbidities included hypertension (47.2%) and dyslipidemia (20.6%). Most cases were endometrioid histology (82.8%) and low-grade tumors (85.8%). Tumor grade (p=0.010), myometrial invasion (p<0.001) and lymphovascular space invasion (p<0.001) significantly correlated with lymph node metastasis. However, tumor size and p53abn were not significantly associated with lymph node metastasis. p53abn overexpression was significantly associated with non-endometrioid histology at 33% and Grade 3 tumors at 23%. Preoperative grading demonstrated moderate reliability (0.51) with postoperative grading, with an agreement of 65.4%.
CONCLUSIONTumor grade, myometrial invasion, and LVSI were all significantly associated with lymph node involvement. While p53 immunohistochemical stains show promise in predicting metastasis and has been associated with tumor aggressiveness, this should still be correlated with clinicopathological parameters to carry out a more accurate risk stratification of early-stage patients.
Therapeutics ; Survival Rate ; Risk Factors ; Recurrence ; Prognosis ; Pathology ; Endometrial Neoplasms ; Immunohistochemistry ; Tumor Suppressor Protein P53 ; Lymph Node Excision ; Risk Assessment
6.Primary aldosteronism in a Malaysian Tertiary Centre: A retrospective audit of clinical characteristics, diagnostic pathways, and treatment outcomes (2018–2025)
Ahmad Hambal Bin Zamari ; Yusniza Yusof
Journal of the ASEAN Federation of Endocrine Societies 2026;41(S1):19-20
Introduction:
Primary aldosteronism (PA) is a common yet underdiagnosed cause of secondary hypertension, associated
with increased cardiovascular and renal morbidity. Early
detection and subtype-directed management significantly
improve outcomes. However, adherence to recommended
diagnostic pathways in real-world practice remains
variable.
Case:
We conducted a retrospective audit of patients diagnosed
with PA in a Malaysian tertiary centre from January 2018
to December 2025. Data collected included demographics,
clinical presentation, biochemical parameters, diagnostic
workup (aldosterone-renin ratio [ARR], confirmatory
testing, adrenal imaging, and adrenal venous sampling
[AVS]), treatment modality, and outcomes. Audit standards
were based on established international guidelines.
A total of 14 patients were included, with equal gender
distribution. The cohort comprised 57% Malay and 43%
Chinese. Most patients presented with hypertension
(mean ~170/100 mmHg), and hypokalemia was present
in approximately 70% of the patients. ARR and adrenal
imaging were performed in all patients (100%), while
confirmatory testing was conducted in 85% of the patients.
However, AVS utilization remained limited (50%).
Contributing factors included failed cannulation, technical
challenges in overweight patients, preference for medical
therapy, refusal of surgery, and limited access to AVS
services. The majority had unilateral adrenal adenoma
(~75%). Treatment was divided between surgical (55%) and
medical (45%) approaches. Post-treatment, hypokalemia
resolved in 90% of patients, with a significant reduction
in antihypertensive burden and complete hypertension
resolution in approximately 35% of the patients. Quality of
life improved in most patients.
Conclusion
This audit demonstrates good adherence to initial screening
and imaging in PA but highlights suboptimal utilization
of AVS. Barriers to AVS utilization are multifactorial,
encompassing technical, patient-related, and system level limitations. Addressing these barriers is essential to
optimize subtype-directed management and improve longterm cardiovascular outcomes in patients with PA. Despite
this, clinical outcomes were favorable. Strengthening
adherence to diagnostic pathways, particularly subtype
confirmation, may further improve patient outcomes.
Hyperaldosteronism
;
Treatment Outcome
;
Retrospective Studies
7.Impact of Glycemic Control on Tuberculosis Treatment Outcomes in Patients With Diabetes Mellitus: A Retrospective Audit
Chitra Devi Balasubramaniyam ; Mohammad Ulilamri Tukiman ; Yusniza Yusoff ; Mohammad Nur Syafiq Mohammad Azman ; Choo Jia Qing
Journal of the ASEAN Federation of Endocrine Societies 2026;41(S1):37-38
Introduction:
Diabetes mellitus (DM) is a significant comorbidity
associated with adverse tuberculosis (TB) treatment
outcomes and remains an ongoing clinical challenge.
Chronic hyperglycemia impairs host immune responses,
particularly macrophage function, leading to delayed
bacillary clearance. This contributes to poorer outcomes,
including delayed sputum conversion, prolonged
treatment duration, relapse, and increased mortality. Poor
glycemic control is a key modifiable factor influencing
these outcomes. This study aimed to evaluate the impact
of glycemic control at diagnosis on TB treatment outcomes
in a Malaysian cohort.
Methodology:
A retrospective cross-sectional audit was conducted using
the TB clinic registry at Hospital Sungai Buloh from 2022
to 2025. Adult patients (≥18 years) with confirmed TB (any
form) and DM (Type 1 or Type 2) with complete records
were included. Of 241 patients screened, 131 were included
after exclusions due to incomplete records (29.9%), transfer
(29.9%), loss to follow-up (19.9%), and drug-resistant TB
(2.9%). Data collected included demographics, hemoglobin
A1c (HbA1c) at diagnosis, sputum conversion duration,
treatment duration, type of DM therapy, and clinical
outcomes.
Results:
The cohort had a mean age of 53 years, with 97% having
Type 2 DM.
Mean HbA1c at diagnosis was 10.5%. Poorer glycemic
control was associated with delayed sputum conversion.
Patients who achieved sputum conversion by 8 weeks had
an average HbA1c of 9.6%, compared to 11.8% in those
with delayed conversion. Longer treatment duration was
associated with higher HbA1c (mean 10.5, 8.6, and 11.8%
for 6-, 12-, and 18-month regimens, respectively). Relapse
analysis demonstrated a trend towards higher HbA1c with
increasing relapse episodes (11.2, 13.75, and 14.5% for one, two, and three relapses, respectively). Overall mortality
was 17% (22/131), with markedly higher mean HbA1c in
deceased patients compared to survivors (16.0% vs 10.5%).
Conclusion
Poor glycemic control at TB diagnosis is associated with
delayed sputum conversion, prolonged treatment duration,
and increased mortality. These findings are consistent with
regional evidence, including a South Asian systematic
review (Gautam et al., 2021), demonstrating higher mortality
and treatment failure in patients with TB and DM. Early
and aggressive optimization of glycemic control, alongside
standard anti-TB therapy, is essential to improve outcomes.
Humans
;
Glycemic Control
;
Retrospective Studies
;
Diabetes Mellitus
;
Treatment Outcome
;
Tuberculosis
8.Clinical Effects of Thread-Dragging Therapy on Gangrene of Non-ischemic Diabetic Foot Ulcers.
Fang-Fang WU ; Jie WANG ; Guo-Bin LIU
Chinese journal of integrative medicine 2025;31(6):552-557
OBJECTIVE:
To investigate the clinical effects of thread-dragging therapy on gangrene of non-ischemic diabetic foot ulcers (NIDFU).
METHODS:
A total of 136 patients with NIDFU were recruited from the Department of Peripheral Vascular Surgery, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine between June 21, 2021 and February 1, 2023, and randomized into an intervention group and a control group, with 68 cases in each group. Both groups received basic treatment. The intervention group was treated with thread-dragging therapy, while the control group was treated with debridement combined with routine dressing changes after surgery. Both groups were treated continuously for 2 months. The amputation rates and changes in the ulcer area were compared between the groups. The inflammatory response index including peripheral white blood cells (WBCs), neutrophil percentage (NEUT%), C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), procalcitonin (PCT), and interleukin 6 (IL-6) were compared between the two groups.
RESULTS:
After treatment, the ulcer areas in the intervention group were significantly smaller than that of the control group (8.50±3.88 cm2 vs. 10.11±4.61 cm2, P<0.05). The amputation rates of the two groups were not statistically significant (4.4% vs. 5.9%, P>0.05). Differences of WBCs count, CRP, and ESR before and after therapy in the intervention group were better than the control group (P<0.05). However, there were no significant differences in changes of NEUT%, PCT, and IL-6 between the two groups (P>0.05).
CONCLUSION
Thread-dragging therapy may be effective in the treatment of NIDFU, with the additional advantages of less tissue damage after healing. (Registration No. ChiCTR2100047496).
Humans
;
Diabetic Foot/blood*
;
Male
;
Female
;
Middle Aged
;
Gangrene/therapy*
;
Medicine, Chinese Traditional/methods*
;
Aged
;
C-Reactive Protein/metabolism*
;
Amputation, Surgical
;
Wound Healing
;
Treatment Outcome
;
Interleukin-6/blood*
9.Efficacy and Safety of Yangxue Qingnao Pills Combined with Amlodipine in Treatment of Hypertensive Patients with Blood Deficiency and Gan-Yang Hyperactivity: A Multicenter, Randomized Controlled Trial.
Fan WANG ; Hai-Qing GAO ; Zhe LYU ; Xiao-Ming WANG ; Hui HAN ; Yong-Xia WANG ; Feng LU ; Bo DONG ; Jun PU ; Feng LIU ; Xiu-Guang ZU ; Hong-Bin LIU ; Li YANG ; Shao-Ying ZHANG ; Yong-Mei YAN ; Xiao-Li WANG ; Jin-Han CHEN ; Min LIU ; Yun-Mei YANG ; Xiao-Ying LI
Chinese journal of integrative medicine 2025;31(3):195-205
OBJECTIVE:
To evaluate the clinical efficacy and safety of Yangxue Qingnao Pills (YXQNP) combined with amlodipine in treating patients with grade 1 hypertension.
METHODS:
This is a multicenter, randomized, double-blind, and placebo-controlled study. Adult patients with grade 1 hypertension of blood deficiency and Gan (Liver)-yang hyperactivity syndrome were randomly divided into the treatment or the control groups at a 1:1 ratio. The treatment group received YXQNP and amlodipine besylate, while the control group received YXQNP's placebo and amlodipine besylate. The treatment duration lasted for 180 days. Outcomes assessed included changes in blood pressure, Chinese medicine (CM) syndrome scores, symptoms and target organ functions before and after treatment in both groups. Additionally, adverse events, such as nausea, vomiting, rash, itching, and diarrhea, were recorded in both groups.
RESULTS:
A total of 662 subjects were enrolled, of whom 608 (91.8%) completed the trial (306 in the treatment and 302 in the control groups). After 180 days of treatment, the standard deviations and coefficients of variation of systolic and diastolic blood pressure levels were lower in the treatment group compared with the control group. The improvement rates of dizziness, headache, insomnia, and waist soreness were significantly higher in the treatment group compared with the control group (P<0.05). After 30 days of treatment, the overall therapeutic effects on CM clinical syndromes were significantly increased in the treatment group as compared with the control group (P<0.05). After 180 days of treatment, brachial-ankle pulse wave velocity, ankle brachial index and albumin-to-creatinine ratio were improved in both groups, with no statistically significant differences (P>0.05). No serious treatment-related adverse events occurred during the study period.
CONCLUSIONS
Combination therapy of YXQNP with amlodipine significantly improved symptoms such as dizziness and headache, reduced blood pressure variability, and showed a trend toward lowering urinary microalbumin in hypertensive patients. These findings suggest that this regimen has good clinical efficacy and safety. (Registration No. ChiCTR1900022470).
Humans
;
Amlodipine/adverse effects*
;
Drugs, Chinese Herbal/adverse effects*
;
Male
;
Female
;
Hypertension/complications*
;
Middle Aged
;
Treatment Outcome
;
Drug Therapy, Combination
;
Adult
;
Blood Pressure/drug effects*
;
Double-Blind Method
;
Aged
;
Antihypertensive Agents/adverse effects*
10.Efficacy and Safety of Zihua Wenfei Zhisou Granule in Treatment of Postinfectious Cough: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Clinical Trial.
Ting LI ; Xue-Mei LIU ; Mei YANG ; Yan-Qing WU ; Wei LIU ; Bing MAO ; Hong-Li JIANG
Chinese journal of integrative medicine 2025;31(1):3-10
OBJECTIVE:
To evaluate the efficacy and safety of Chinese medicine (CM) Zihua Wenfei Zhisou Granule (ZWZG) in postinfectious cough (PIC) patients with CM syndrome of wind-cold invading Fei (Lung, WCIF).
METHODS:
This is a multicenter, randomized, double-blind, parallel-group, placebo-controlled phase II clinical trial. PIC patients with WCIF syndrome were recruited from the Respiratory Departments in 6 hospitals across China between March 2019 and December 2020. Eligible patients were randomly assigned to group A (ZWZG-matched placebo 15 g), group B (active ZWZG 15 g), and group C (active ZWZG 10 g plus ZWZG-matched placebo 5 g) in a 1:1:1 ratio. All medications were taken orally 3 times daily for 14 consecutive days. The primary outcomes were cough relief rate and cough disappearance rate. The secondary outcomes included time to cough relief, time to cough disappearance, and changes in cough symptom score (CSS), cough Visual Analog Scale (VAS) value, Cough-Specific Quality of Life Questionnaire (CQLQ) score, and CM syndrome score from baseline (day 0) to post-treatment (day 14). Adverse events (AEs) in each group were recorded.
RESULTS:
A total of 198 patients were included in the full analysis set (FAS) and safety analysis set (SS), while 183 were enrolled in the per-protocol analysis set (PPS). In the FAS population, the cough relief rate was 47.76%, 90.77% and 84.85% in groups A, B, and C, respectively; while the cough disappearance rate was 31.34%, 72.31% and 68.18%, respectively. The cough relief rates and cough disappearance rates in groups B and C were significantly higher than group A (P<0.0001). Both the median time to cough relief and cough disappearance in groups B and C were shorter than group A (P<0.0001). Compared with group A, groups B and C showed significantly greater improvements from baseline to post-treatment in CSS during daytime and nighttime as well as VAS (P<0.05). There were no significant differences in changes from baseline to post-treatment in CQLQ and CM syndrome scores among 3 groups (P>0.05). Results in the PPS population were consistent with those in the FAS population. Groups B and C showed lower incidence in AEs than group A (P<0.05), while there was no significant difference between groups B and C (P>0.05). No drug-related severe AEs were reported.
CONCLUSIONS
ZWZG can increase cough disappearance rate and cough relief rate; and it is beneficial in shortening cough duration and reducing cough severity and frequency in patients suffering from PIC. It is safe and generally well tolerated. (Registration No. ChiCTR1900022078).
Humans
;
Cough/drug therapy*
;
Double-Blind Method
;
Male
;
Female
;
Drugs, Chinese Herbal/adverse effects*
;
Middle Aged
;
Treatment Outcome
;
Adult
;
Aged
;
Quality of Life


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