1.Construction and Verification of An Integrated Traditional Chinese and Western Medicine Model for Predicting Malignant Risk of Pulmonary Nodules
Qian YANG ; Jingmin XIAO ; Yuanbing CHEN ; Lei WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):129-139
ObjectiveThis study explored the risk factors for malignant risks of pulmonary nodules based on clinical data,constructed an integrated traditional Chinese and Western medicine model for predicting malignant risks of pulmonary nodules, and visualized the prediction results by using a nomogram. MethodsBased on a cross-sectional survey study design,patients with pulmonary nodules who were hospitalized in the Department of Respiratory and Cardiothoracic Surgery of Guangdong Provincial Hospital of Traditional Chinese Medicine from April 2023 to January 2024 were included. The dataset was randomly divided into a training set and a validation set according to 7∶3. In the training set,predictive factors were selected through univariate Logistic regression analysis and Least Absolute Shrinkage and Selection Operator (LASSO) regression analysis,and Logistic regression models were built. The discriminative ability,calibration,and clinical decision-making curves of the Western medicine model and the integrated traditional Chinese and Western medicine prediction model were compared to select the optimal model,which was then visualized in a nomogram. ResultsThis study included a total of 366 patients,and they were divided into a training set (258 cases) and a validation set (108 cases). Seven predictive factors were considered including age,preference for fatty and greasy foods,history of environmental or occupational exposure,Qi deficiency,Yang deficiency,nodule density,and nodule diameter. A Logistic regression model was constructed. A Western medicine model,defined as model1,was created using only age,history of environmental or occupational exposure,nodule density,and nodule diameter as predictive factors. In addition,an integrated traditional Chinese and Western medicine model,defined as model2,was created by adding preference for fatty and greasy foods, Qi deficiency,and Yang deficiency as predictive factors. Model2 demonstrated better predictive performance in both the training and validation sets. Its accuracy in training set was 0.740,with precision of 0.825, recall of 0.829, F1 score of 0.827, the area under the curve (AUC)of 0.865 (95% confidence interval (CI):0.815-0.915), and a Brier score of 0.122. The accuracy in validation set was 0.731, with precision of 0.776, recall of 0.831, F1 score of 0.803, AUC of 0.852 (95%CI:0.776-0.927), and a Brier score of 0.149. The calibration curve and decision-making curve analysis showed that this model exhibited good consistency and clinical utility in prediction. The equation for the malignant probability of pulmonary nodules was defined as p=
2.Reliability and Validity of Dampness Syndrome Scale of Chinese Medicine Using for Persistent Asthma Patients: a Cross-Sectional Study
Yihe CHI ; Feiting FAN ; Shushan WEI ; Yuewei LI ; Jingmin XIAO ; Lei WU ; Lin LIN ; Yuanbin CHEN
Journal of Traditional Chinese Medicine 2024;65(11):1132-1138
ObjectiveTo evaluate the reliability and validity of the Dampness Syndrome Scale of Chinese Medicine (DSSCM) among patients with persistent asthma, and to explore the correlation between dampness syndrome and clinical characteristics of persistent asthma. MethodsA cross-sectional survey was conducted. Basic information, examination results, DSSCM, Asthma Control Test (ACT), Generalized Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-9 (PHQ-9) scores were collected from 206 patients with persistent asthma to evaluate the reliability and validity of DSSCM and to explore the correlation between dampness syndrome and clinical characteristics. ResultsThe mean score of DSSCM among 206 patients was 14.59 ± 10.53. The overall Cronbach α coefficient and Spearman-Brown split-half reliability coefficient of the scale were both greater than 0.8, and the success rate of scale convergent and discriminant validity calibration were greater than 80%. The confirmatory factor analysis showed that the χ2/df was 2.309, and the root mean square error of approximation (RMSEA) was 0.08; the root mean square residual (RMR) was 0.049, whereas the comparative fit index (CFI), the goodness of fit index (GFI), the adjusted goodness of fit index (AGFI), the normed fit index (NFI) and the incremental fit index (IFI) were less than 0.9. Correlation analysis showed that DSSCM scores were positively correlated with disease duration, GAD-7 scores, and PHQ-9 scores (P<0.05), and negatively correlated with ACT scores (P<0.01). The DSSCM scores were significantly different between patients with different disease severity (H = 10.92, P = 0.01), and the DSSCM scores of allergic patients were higher than those of non-allergic patients (Z = -4.19, P<0.001). ConclusionDSSCM has acceptable reliability and validity for patients with persistent asthma. The scores of DSSCM correlated with the disease duration, ACT score, GAD-7 score, PHQ-9 score, disease severity and allergic status of persistent asthmatics.
3.Efficacy of tibiofibular-based reconstruction technique with single femoral tunnel for Fanelli type C posterolateral complex injury
Qian ZHAO ; Wenjin HU ; Jiang WU ; Xiao CHEN ; Fuji REN ; Huifeng ZHENG ; Jingmin HUANG
Chinese Journal of Trauma 2024;40(2):154-161
Objective:To investigate the efficacy of tibiofibular-based reconstruction technique with single femoral tunnel for Fanelli type C posterolateral complex (PLC) injury.Methods:A retrospective case series study was conducted to analyze the clinical data of 16 patients with Fanelli type C PLC injury admitted to Tianjin Hospital from July 2016 to July 2019, including 10 males and 6 females, aged 20-61 years [(36.5±13.9)years]. PLC reconstruction was performed by tibiofibular-based technique with single femoral tunnel using gracilis tendon and semi-tendinosus autografts. If the posterior and anterior cruciate ligaments (PCL/ACL) rupture were combined, arthroscopic single bundle reconstruction was performed simultaneously. If the posteromedial corner (PMC) injury was combined, PMC repair or reconstruction surgery was performed simultaneously. Operation time and intraoperative blood loss were recorded. When the bone needle and tunnel for PLC were drilled during the operation, the interference of the femoral tunnel through the cruciate ligament was observed under the arthroscope. Before and at 6 and 12 months after operation, the varus stability of the knee joint was evaluated with the difference of lateral joint space width of both knees and the International Knee Documentation Committee (IKDC) objective classification of varus stability of the knee joint; the external rotation stability was evaluated with the difference of external rotation angle of both knees and the IKDC objective classification of external rotation stability of the knee joint. Before, at 6 and 12 months after operation and at the last follow-up, IKDC 2000 subjective score and Lysholm score were compared. The occurrence of complications was observed.Results:All the patients were followed up for 12-36 months [24(15, 33)months]. The operation time was 100-220 minutes [175.0(111.3, 200.0)minutes], with intraoperative blood loss of 30-150 ml [(84.3±36.5)ml]. Intraoperative arthroscopy showed no interference of perforation between PLC and cruciate ligament femoral tunnel. The differences of lateral joint space width of both knees at 6 and 12 months after operation were 0.5(0.2, 1.4)mm and 0.6(0.2, 1.5)mm respectively, which were both significantly improved compared with 12.1(10.8, 12.6)mm before operation ( P<0.05), while there was no significant difference at 6 and 12 months after operation ( P>0.05). The IKDC objective classification of varus stability of the knee joint was grade A in 13 patients, grade B in two and grade C in one at 6 or 12 months after operation, and showed statistical difference from grade D in all the patients before operation ( P<0.01). At 6 and 12 months after operation, the difference of external rotation angle of both knees was -2.0(-3.2, 1.3)° and -1.4(-3.0, 1.7)° respectively, which were significantly improved compared with 16.8(13.9, 18.4)° before operation ( P<0.05), while there was no significant difference at 6 and 12 months after operation ( P>0.05). IKDC objective classification of external rotation stability of the knee joint was grade A in 14 patients, grade B in one and grade C in one at 6 or 12 months after operation, and showed statistical difference from grade C in 14 patients and grade D in 2 before operation ( P<0.01). At 6 and 12 months after operation and at the last follow-up, the IKDC 2000 subjective scores [(76.3±4.7)points, (80.3±4.4)points, (79.9±3.8)points respectively] and the Lysholm scores [(76.1±3.9)points, (81.1±4.3)points, (82.8±3.2)points respectively] were significantly improved compared with those before operation [(48.6±3.7)points and (52.6±2.4)points] ( P<0.05). The IKDC 2000 subjective scores and Lysholm scores were significantly improved at 12 months after operation and at the last follow-up than those at 6 months after operation ( P<0.05). There were no significant differences in the IKDC 2000 subjective scores and Lysholm scores at 12 months after operation and at the last follow-up ( P>0.05). There were no complications such as wound infection, vascular and nerve injury, joint stiffness or ectopic ossification. Conclusion:For Fanelli type C PLC injury, tibiofibular-based reconstruction technique with single femoral tunnel reduces the interference between the lateral femoral tunnels, significantly improves the varus and external rotation stability and the function of the knee joint, and has few complications and satisfactory short-term clinical efficacy.
4.Xianqi Qinglong Formula (仙芪青龙方) for the Treatment of Cough Variant Asthma with Lung and Kidney Deficiency and Exuberant Wind-induced Spasm and Tension Syndrome: A Randomized, Positive-controlled, Non-inferiority Clinical Trial
Xiaochun CHEN ; Jianya YANG ; Jingmin XIAO ; Feiting FAN ; Mingjuan ZHOU ; Lei WU ; Lin LIN ; Yuanbin CHEN
Journal of Traditional Chinese Medicine 2024;65(20):2109-2115
ObjectiveTo evaluate the clinical efficacy and safety of Xianqi Qinglong Formula (仙芪青龙方, XQF) in the treatment of cough variant asthma (CVS) patients with lung and kidney deficiency and exuberant wind-induced spasm and tension syndrome. MethodsA randomized, positive-controlled, non-inferiority clinical trial was designed. Totally, 102 CVS patients with lung and kidney deficiency and exuberant wind-induced spasm and tension syndrome were randomly divided into a treatment group (52 cases) and a control group (50 cases). The treatment group was given XQF granules orally, 1 dose per day, 2 bags each time (9.25 g/bag), twice a day, after breakfast and dinner; the control group was given XQF granules placebo orally combined with inhaled fluticasone propionate inhalation aerosol (125 μg each time, twice a day). Both groups were treated for 12 weeks and followed up for 12 weeks, with a total of 24 weeks. The primary outcome was the cough symptom score (including daytime, nighttime and total score), evaluated before treatment (at enrollment), during treatment (after the 6th week of enrollment), at the end of treatment (after the 12th week of enrollment), and at the end of follow-up (after the 24th week of enrollment). The non-inferiority was determined by the lower limit (LCL) of the unilateral 95% confidence interval. The secondary outcomes included cough relief and disappearance, total score of TCM syndrome, cough visual analogue (VAS) score, Leicester Cough Questionnaire (LCQ) score, and lung function indicators including forced expiratory volume in 1 second (FEV1), percentage of predicted forced expiratory volume in 1 second (FEV1%pred), forced vital capacity (FVC), and peak expiratory flow (PEF). Blood routine and liver and kidney function were tested before and after treatment, and the adverse events were recorded. ResultsA total of 101 patients were included in the full analysis set (FAS), including 52 cases in the treatment group and 49 cases in the control group. After treatment, the daytime, nighttime and total cough symptom scores during treatment, at the end of treatment and at the end of follow-up all decreased in both two groups (P<0.01). The unilateral 95% LCL of the total cough symptom scores during treatment, at the end of treatment and at the end of follow-up of the two groups were -0.14, -0.47 and -0.27 (95% LCL all>-0.6). There were no significant differences in the cough relief rate, cough disappearance rate, cough relief days and cough disappearance days between the two groups at each time point (P>0.05). Compared to those before treatment, the TCM syndrome scores and cough VAS scores during treatment, at the end of treatment and at the end of follow-up decreased in both groups, while the LCQ scores increased (P<0.01), but there were no significant differences in FEV1, FEV1%, FVC and PEF before and after treatment (P>0.05). There were no significant differences in TCM syndrome scores, cough VAS scores, LCQ scores, FEV1, FEV1%, FVC, and PEF between the two groups at each time point (P>0.05). No clinically significant abnormal liver and kidney function were found in the two groups before and after treatment. ConclusionXQF is not inferior to fluticasone propionate inhalation aerosol in relieving cough symptoms, reducing cough scores, decreasing the number of cough attack days, and improving the quality of life when treating CVS patients with lung and kidney deficiency and exuberant wind-induced spasms and tension syndrome, and relatively safe.
5.Recombinant expression and immunological characterization of Burkholderia pseudomallei type Ⅲ secretion system protein BipD
Dongqi NAN ; Yuan WEN ; Jiangao CHEN ; Chenglong RAO ; Pan WU ; Ziyuan ZHANG ; Shiwei WANG ; Jingmin YAN ; Qian LI ; Xuhu MAO
Journal of Army Medical University 2024;46(15):1713-1720
Objective To express recombinant Burkholderia pseudomallei(B.pseudomallei)type Ⅲ secretion system BipD protein,prepare its polyclonal antibodies and verify their immunological traits.Methods The recombinant pET-28a-BipD plasmid was generated,and the pET-28a-BipD-carried E.coli BL21(DE3)bacteria were induced with isopropyl-β-d-thiogalactoside(IPTG)to express recombinant BipD(rBipD)protein.The rBipD was obtained by affinity chromatography using His Trap column,then mixed with Fredrick's adjuvant to immunize BALB/c mice by intraperitoneal injection in order to obtain anti-rBipD polyclonal antibodies.The immunoreactivity of rBipD was detected by Western blot assay using rabbit anti-melioidosis serum and the serum from melioidosis patients.The immunogenicity of rBipD was evaluated using Western blotting and immunofluorescence staining.Finally,rBipD was used to establish an indirect ELISA to detect serum antibodies of clinical melioidosis patients.Results The recombinant plasmid pET-28a-BipD was successfully constructed and transformed into E.coli BL21(DE3)to induce rBipD expression with IPTG treatment.The obtained rBipD had a relative molecular weight of 36×103 and a purity of 95.4%,and had good immunogenicity and immunoreactivity.It could induce the production of specific antibodies after immunizing mice,and mouse polyclonal antibodies against rBipD were prepared with the titer of 1∶512 000.rBipD of 5.0 μg/mL produced specific immune response with the serum of melioidosis patients,but had no specific reaction with the serum of tuberculosis patients,with statistical difference(P<0.01).Conclusion rBipD with immunological activity is successfully prepared and purified,and its polyclonal antibodies are also developed,which provide a good tool for clinical immunological diagnosis and study of immune mechanism of B.pseudomallei infection.
6.Translocation of Hcp1 protein in type Ⅵ secretion system of Burkholderia pseudomallei mediates formation of multinucleated giant cells
Pan WU ; Chenglong RAO ; Dongqi NAN ; Jiangao CHEN ; Ziyuan ZHANG ; Wenzheng LIU ; Minyang WANG ; Jingmin YAN ; Qian LI ; Xuhu MAO
Journal of Army Medical University 2024;46(15):1721-1728
Objective To analyze the mechanism that Hcp1 protein in type Ⅵ secretion system of Burkholderia pseudomallei(B.pseudomallei)mediates the formation of multinucleated giant cells(MNGCs)when host cells are infected by the bacterium.Methods The mutant strain(BPC006 Δhcp1)and complementation strain(BPC006 Δhcp1::hcp1)were constructed by homologous recombination and plasmid complement technology,respectively.After RAW264.7 cells were infected with B.pseudomallei,the localization of Hcp1 in host cells was analyzed by immunofluorescence staining.The localization was further verified by cytoplasmic-membrane isolation in 293T cells after transfecting pCDNA4.1-Hcp1.The biological significance and effect of Hcp1 were explored by the anti-Hcp1 polyclonal antibody blocking and the formation of MNGC was detected by Giemsa staining.Results Western blotting showed that BPC006 Δhcp1 could not express Hcp1,while BPC006 Δhcp1::hcp1 restored Hcp1 expression.The above results proved that the mutant and complement strains were successfully constructed.Both cellular immunofluorescence co-localization and cytoplasmic-membrane isolation experiments showed that Hcp1 localized to host cell membranes.Last but not least,compared with the control group,anti-Hcp1 polyclonal antibodies inhibited the formation of MNGC(P<0.01).Conclusion Hcp1 protein in type Ⅵ secretion system of B.pseudomallei is able to translocate to the RAW264.7 cell membranes and plays an important role in the formation of MNGCs.
7.Dial test——Unidentified predictive factors for the medial meniscus posterior root tears
Fuji REN ; Jiang WU ; Dong ZHAO ; Rui WANG ; Jingmin HUANG
Chinese Journal of Sports Medicine 2024;43(5):335-340
Objective To evaluate the effect of medial meniscal posterior root tear(MMPRT)on tibi-al external rotation through the dial test and assess the effect of pull-out repair for MMPRT on patho-logical tibial rotation.Methods Totally 40 patients undergoing MMPRT repair using pull-out way be-tween January 2022 and January 2023 were studied retrospectively.The dial test at 30°/90° knee flex-ion was performed on the affected and healthy sides of the patients before and after surgery to assess the tibial external rotation.Results The mean age of the 40 patients was 56.4±7.5 years,with a mean body mass index(BMI)of 24.1±3.0.Among them,6 were male(34%)and 34 were female(85%).The median time from injury to surgery was 3.8±2.9 months.The preoperative tibial external rotation angles measured by the dial test at 30°and 90°knee flexion were 31.34±5.38°and 36.75°±6.62°respectively.Postoperatively,these angles decreased significantly to 24.24°±5.88°and 24.76°±5.47°,respectively(P=0.00).Moreover,significant differences were observed in the changes in tibial external rotation angles of the affected knee before and after surgery,7.10°(95%CI[6.01°,8.19°])at 30°flexion and 11.99°(95%CI[10.68°,13.29°])at 90°flexion.The gap in the tibial external rotation angle between the affected and unaffected sides were significant before surgery at 30°(8.33°,95%CI[7.32°,9.33°])and 90°(13.03°,95%CI[11.82°,14.23°])flexion but not after surgery at 30°(0.48°,95%CI[-0.25°,0.98°])and 90°(0.34°,95%CI[-0.02°,0.70°])flexion.Conclusion The dial test finds increased tibial external rotation in patients with MMPRT,and pull-out repair can correct this pathological tibial external rotation.Moreover,an increased tibial external rotation angle measured by the dial test at 30°and 90°can indicate MMPRT.Therefore,special attention should be given to inter-preting the results of the dial test in cases of MMPRT.
8.Study on the individualized dose verification of patients with CyberKnife treatment based on dose verification system of SRS MapCHECK matrix
Hanshun GONG ; Shanshan GU ; Shaojuan WU ; Jinglin SUN ; Pengfei XU ; Xiaoliang LIU ; Jingmin BAI ; Chuanbin XIE
China Medical Equipment 2024;21(7):17-22
Objective:A dose verification system of two-dimensional semiconductor matrix(SRS MapCHECK)was used to verify the dose of the clinical treatment plan of patients who underwent CyberKnife(CK),which realized rapid verification for individualization of radiotherapy plans of patients through analyzed the γ-passing rates of them.Methods:A total of 253 patients with tumor who received CK clinical treatment in the First Medical Center of Chinese PLA General Hospital from March 2021 to May 2023 were selected.Among of them,121 cases received CK treatment on head,and 30 cases received that on lung,and 102 cases received CK treatment on abdomen and other metastatic tumor.In the MultiPlan treatment plan system,the plan of patient was mapped to the integrated model composed of StereoPHAN model and SRS MapCHECK matrix dose verification system by the means of the plan image center overlap.The dose verification was conducted on the plan of each patient on the basis of ensuring the consistency of the number of beam,direction of beam and the monitor unit.The different γ analysis standards(1%/1 mm,2%/1 mm,3%/1 mm,1%/2 mm,2%/2 mm,3%/2 mm,1%/3 mm,2%/3 mm and 3%/3 mm)were adopted to conduct global analysis of absolute dose for each verification plan,and the threshold(TH)of low dose was set as 10%.Results:The γ passing rates of phantom verification plans of 253 patients were respectively(88.64±5.91)%,(95.43±3.40)%,(97.90±2.06)%,(96.51±2.35)%,(98.15±1.68)%,(99.06±1.12)%,(98.30±1.39)%,(99.09±0.97)%and(99.52±0.63)%under different analysis standards.The γ passing rates of other standards of patients with tumor on different parts were larger than 95%except the analysis result of 1%1 mm standard.The overall analysis result of the deviation of central point dose was(-1.30±2.17)%,among of which the tumor of head,abdominal tumors and other metastatic tumor were about approximately-2%,while that of lung tumors were approximately-3%.The deviation of abdominal and other metastatic tumor was the minimum.The correlation analysis showed that the target volume and the size of the minimum collimator were respectively correlated to the dose deviation of the center.Conclusion:SRS MapCHECK dose verification system can conveniently and quickly realize the individualized verification for the plan of patients who receive CK treatment.
9.Study on clinical characteristics and surgical methods of bucket-handle meniscal tears.
Xingyue NIU ; Qian ZHAO ; Huifeng ZHENG ; Xiao CHEN ; Dong ZHAO ; Jiang WU ; Fuji REN ; Jingmin HUANG
Chinese Journal of Reparative and Reconstructive Surgery 2023;37(11):1335-1341
OBJECTIVE:
To summarize the clinical features, surgical methods, and prognosis of bucket-handle meniscal tears (BHMTs), and provide guidance for clinical treatment.
METHODS:
The clinical data of 91 BHMTs patients (91 knees), who met the selection criteria and were admitted between January 2015 and January 2021, was retrospectively analyzed. There were 68 males and 23 females. Age ranged from 16 to 58 years with an average of 34.4 years. The injury was caused by sports in 68 cases, traffic accident in 15 cases, and falls or sprains in 8 cases. There were 49 cases of left knee injury and 42 cases of right knee injury. The time from the onset of symptoms to the admission ranged from 1 day to 13 months (median, 18 days), including >1 month in 35 cases and ≤1 month in 56 cases. Medial BHMTs occurred in 52 cases and lateral BHMTs in 39 cases. There were 36 cases with ACL rupture and 12 cases with discoid meniscus. The knee extension was limited more than 10° in 55 cases. According to the condition of meniscus injury, the meniscus suture with Inside-out combined with All-inside techniques (54 cases) or meniscoplasty (37 cases) under arthroscopy were selected. ACL reconstruction was performed in all patients with ACL rupture with autogenous hamstring tendon. Postoperative complications were observed. International Knee Documentation Committee (IKDC) score, Lysholm score, and Tegner score were used to evaluate knee function, and clinical failure was recorded.
RESULTS:
Two patients developed intermuscular venous thrombosis, which improved after oral anticoagulant therapy. No vascular injury, postoperative infection, joint stiffness, or other complications occurred in all patients. All patients were followed up 24-95 months, with a median of 64 months. A total of 12 cases (13.19%) failed the operation and were re-operated or given oral anti-inflammatory analgesics and rehabilitation therapy. At last follow-up, IKDC score and Lysholm score of 91 patients significantly increased when compared with those before operation ( P<0.05), while Tegner score significantly decreased ( P<0.05). The above indexes of patients treated with meniscus suture and meniscoplasty were also significantly different from those before operation ( P<0.05).
CONCLUSION
BHMTs occurs mostly in young men and is one of the important reasons for the limitation of knee extension after trauma. Arthroscopic meniscus suture and meniscoplasty can obtain good effectiveness according to individual conditions of patients. But the latter can better preserve the shape and function of meniscus, and theoretically can obtain better long-term outcomes, which needs to be confirmed by further research with larger sample size.
Male
;
Female
;
Humans
;
Adolescent
;
Young Adult
;
Adult
;
Middle Aged
;
Treatment Outcome
;
Retrospective Studies
;
Meniscus
;
Knee Joint/surgery*
;
Menisci, Tibial/surgery*
;
Knee Injuries/diagnosis*
;
Rupture
;
Tibial Meniscus Injuries/surgery*
;
Arthroscopy/methods*
;
Anterior Cruciate Ligament Injuries/surgery*
10.A Non-inferiority Randomized Controlled Trial of Topical Bisaitong (鼻塞通) in Treatment of Moderate to Severe Allergic Rhinitis
Jintao PANG ; Feiting FAN ; Jingmin XIAO ; Bing HE ; Lei WU ; Yisheng XU ; Fuping XU ; Zhongwen WANG ; Yuanbin CHEN
Journal of Traditional Chinese Medicine 2023;64(19):1995-2002
ObjectiveTo evaluate the efficacy and safety of topical Bisaitong (鼻塞通) in treating moderate-to-severe allergic rhinitis (AR). MethodsA randomized, positive-controlled, non-inferiority clinical trial design was adopted. Totally, 108 cases of moderate-to-severe AR were randomly divided into Bisaitong group and mometasone furoate group,with 54 cases in each group. The Bisaitong group was treated with Bisaitong smeared at the nasal cavity twice a day, and the mometasone furoate group received inhalation of mometasone furoate nasal spray 100 μg in each nostril, once a day. Both groups were treated for 4 weeks and followed up after additional 4 weeks. Both groups were compared on the rhinoconjunctivitis quality of life questionnaire (RQLQ), rhinoconjunctivitis total symptom score (RTSS), visual analogue score (VAS) of sneezing, runny nose, nasal itching, nasal congestion degree, days of AR episodes at enrollment, after 2- and 4-week, and at follow-up. The peripheral blood eosinophil (EOS) count and percentage (EOS%), serum eosinophil cationic protein (ECP), serum dust mite, dermatophagoides farinae, and cockroach allergen-specific IgE (sIgE) levels were compared between groups at enrollment and after 4-week treatment. Drug overuse rate was calculated, and the safety was evaluated. The analysis of all efficacy outcomes was based on both full analysis set (FAS) and per-protocol set (PPS). ResultsThe lower limit of the 95% confidence interval for the differences in RQLQ scores were greater than -0.6 measured after 2- and 4-week treatment and at follow-up compared to that measured at the enrollment in both groups, indicating of the Bisaitong group being non-inferior to the mometasone furoate group. There was no statistically significant difference between groups on RTSS score, VAS scores of sneezing, runny nose, nasal itching, nasal congestion degree and days of episodes at all timepoints (P>0.05), but each outcome changed significantly over time in both groups (P<0.01). The differences between groups in EOS count, EOS%, ECP levels, serum dust mite, dermatophagoides farinae, cockroach sIgE levels, and drug overuse rate were not statistically significant at enrollment and after 4-week treatment (P>0.05). Adverse events occurred in eight cases (15.10%) in the Bisaitong group and five cases (9.30%) in the mometasone furoate group, showing no significant difference between groups (P>0.05). ConclusionTopical Bisaitong is non-inferior to mometasone furoate nasal spray in the treatment of moderate to severe AR in terms of clinical symptom relief,reduction in the episodes, improvement of quality of life, and sound safety.

Result Analysis
Print
Save
E-mail