1.The effectiveness and safety of the anti gastroesophageal reflux system in the treatment of gastroesophageal reflux disease: a single center study of 23 cases
Zhiwei HU ; Jimin WU ; Changrong DENG ; Xiulan ZHAN ; Tao JI ; Feng WANG ; Shurui TIAN ; Yu ZHANG ; Dong CHEN ; Qing SONG
Chinese Journal of Surgery 2024;62(8):751-757
Objective:To evaluate the safety and efficacy of domestically produced magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease.Method:This study is a prospective cohort study. Patients with typical heartburn and reflux symptoms (at least partial response to proton pump inhibitors), abnormal esophageal acid exposure and normal esophageal peristalsis were included, prospectively in the Department of Gastroesophageal Surgery, Rocket Force Characteristic Medical Center from June 2019 to September 2022. Patients with hiatal hernia >2 cm and severe esophagitis were excluded. The MSA was wrapped around the distal esophagus after esophageal hiatus repair by laparoscopy. A postoperative questionnaire survey was conducted to assess the relief of symptom, complications, the discontinuation rate of proton pump inhibitor, and surgical satisfaction. Gastroscopy, high-resolution esophageal pressure measurement, and pH value impedance monitoring were also reviewed. The pre- and postoperative rates were compared using the McNeinar χ2 test. Result:Currently, 23 patients with gastroesophageal reflux disease were enrolled and underwent MSA surgery. There were 20 males and 3 females, aged ( M (IQR)) 48 (14) years (range: 25 to 64 years). All cases were successfully implanted with MSA. Subjective indicators were followed for 17 (18) months (range: 14 to 53 months), while objective indicators were followed for 17 (1) months (range: 12 to 23 months). The postoperative gastrointestinal and extraesophageal symptom scores showed a significant decrease compared to preoperative levels as follows: the degree of subjective relief of overall digestive symptoms was 90 (20)% (range:0~100%), the degree of subjective relief of overall respiratory symptoms was 100(10)% (range: 10%~100%), the overall satisfaction rate was 83% (19/23), the proton pump inhibitor discontinuation rate was 70% (16/23). The proportion of esophagitis has decreased from 44% (10/23) to 9% (2/23) ( κ=0.169, P=0.039), The Hill grade of gastroesophageal valve morphology improved from 1 case of grade Ⅰ, 5 cases of grade Ⅱ, 10 cases of grade Ⅲ, and 7 cases of grade Ⅲ preoperative to 22, 1, 0, and 0 cases postoperative. The proportion of lower esophageal sphincter pressure below normal has decreased from 70% (16/23) to 35% (8/23) ( κ=0.170, P=0.012). There were 21 patients who restored normal esophageal acid exposure. Eleven patients had mild long-term dysphagia, but it didn′t affect their daily life. No postoperative device migration, erosion, or secondary surgical removal occurred. Conclusions:Laparoscopic implantation of the MSA device was safe and well tolerated. It can effectively control the symptoms of gastroesophageal reflux disease, reduce medication, restore normal cardia morphology and function, and esophageal acid exposure. The main postoperative complication was dysphagia, but it was relatively mild.
2.The effectiveness and safety of the anti gastroesophageal reflux system in the treatment of gastroesophageal reflux disease: a single center study of 23 cases
Zhiwei HU ; Jimin WU ; Changrong DENG ; Xiulan ZHAN ; Tao JI ; Feng WANG ; Shurui TIAN ; Yu ZHANG ; Dong CHEN ; Qing SONG
Chinese Journal of Surgery 2024;62(8):751-757
Objective:To evaluate the safety and efficacy of domestically produced magnetic sphincter augmentation (MSA) for gastroesophageal reflux disease.Method:This study is a prospective cohort study. Patients with typical heartburn and reflux symptoms (at least partial response to proton pump inhibitors), abnormal esophageal acid exposure and normal esophageal peristalsis were included, prospectively in the Department of Gastroesophageal Surgery, Rocket Force Characteristic Medical Center from June 2019 to September 2022. Patients with hiatal hernia >2 cm and severe esophagitis were excluded. The MSA was wrapped around the distal esophagus after esophageal hiatus repair by laparoscopy. A postoperative questionnaire survey was conducted to assess the relief of symptom, complications, the discontinuation rate of proton pump inhibitor, and surgical satisfaction. Gastroscopy, high-resolution esophageal pressure measurement, and pH value impedance monitoring were also reviewed. The pre- and postoperative rates were compared using the McNeinar χ2 test. Result:Currently, 23 patients with gastroesophageal reflux disease were enrolled and underwent MSA surgery. There were 20 males and 3 females, aged ( M (IQR)) 48 (14) years (range: 25 to 64 years). All cases were successfully implanted with MSA. Subjective indicators were followed for 17 (18) months (range: 14 to 53 months), while objective indicators were followed for 17 (1) months (range: 12 to 23 months). The postoperative gastrointestinal and extraesophageal symptom scores showed a significant decrease compared to preoperative levels as follows: the degree of subjective relief of overall digestive symptoms was 90 (20)% (range:0~100%), the degree of subjective relief of overall respiratory symptoms was 100(10)% (range: 10%~100%), the overall satisfaction rate was 83% (19/23), the proton pump inhibitor discontinuation rate was 70% (16/23). The proportion of esophagitis has decreased from 44% (10/23) to 9% (2/23) ( κ=0.169, P=0.039), The Hill grade of gastroesophageal valve morphology improved from 1 case of grade Ⅰ, 5 cases of grade Ⅱ, 10 cases of grade Ⅲ, and 7 cases of grade Ⅲ preoperative to 22, 1, 0, and 0 cases postoperative. The proportion of lower esophageal sphincter pressure below normal has decreased from 70% (16/23) to 35% (8/23) ( κ=0.170, P=0.012). There were 21 patients who restored normal esophageal acid exposure. Eleven patients had mild long-term dysphagia, but it didn′t affect their daily life. No postoperative device migration, erosion, or secondary surgical removal occurred. Conclusions:Laparoscopic implantation of the MSA device was safe and well tolerated. It can effectively control the symptoms of gastroesophageal reflux disease, reduce medication, restore normal cardia morphology and function, and esophageal acid exposure. The main postoperative complication was dysphagia, but it was relatively mild.
3.Efficacy and safety of micropulse transscleral cyclophotocoagulation in the treatment of refractory glaucoma: a prospective multicenter observational study
Fengbin LIN ; Baiyu HU ; Qiying LING ; Yunhe SONG ; Xinbo GAO ; Yingzhe ZHANG ; Yu CHEN ; Xuanchu DUAN ; Liuzhi ZENG ; Xiulan ZHANG
Chinese Journal of Experimental Ophthalmology 2024;42(6):527-531
Objective:To evaluate the efficacy and safety of micropulse transscleral cyclophotocoagulation (MP-TSCPC) for refractory glaucoma.Methods:A prospective multicenter observational case series study was conducted.A total of 63 refractory glaucoma patients (67 eyes) who underwent MP-TSCPC treatment were enrolled at Zhongshan Ophthalmic Center, Sun Yat-sen University, Chengdu First People's Hospital (Chengdu Integrated TCM& Western Medicine Hospital), and Changsha Aier Eye Hospital from August 2022 to April 2023.Among these cases, there were 40 eyes (59.7%) with unreduced intraocular pressure (IOP) after glaucoma surgery, 4 eyes (6.0%) with secondary glaucoma after vitrectomy, 2 eyes (3.0%) with secondary glaucoma after keratoplasty, 8 eyes (11.9%) with neovascular glaucoma, 3 eyes (4.5%) with secondary glaucoma due to iridocorneal endothelial syndrome, 6 eyes (9.0%) with primary open-angle glaucoma and 4 eyes (6.0%) with primary angle-closure glaucoma.Best corrected visual acuity (BCVA) was measured using the ETDRS chart and the IOP was measured using the Goldmann applanation tonometry before and 6 months after the surgery.The usage of anti-glaucoma medications before and after surgery and postoperative complications were recorded.Surgical success rate was calculated and surgical success was defined as an IOP reduction of more than 20% from baseline or a reduction in the number of ocular hypotensive medications with no change in IOP.This study adhered to the Declaration of Helsinki.The study protocol was approved by the Ethics Committee of Zhongshan Ophthalmic Center, Sun Yat-sen University (No.2022KYPJ225).Written informed consent was obtained from each subject.Results:There was a statistically significant overall difference in IOP at different time points before and after surgery ( F=60.10, P<0.001), and the IOP at different time points after surgery was significantly lower than that before surgery, with statistically significant differences (all at P<0.001).IOP reduction at 6 months after surgery was (43.7±20.7)%.The number of anti-glaucoma medications used postoperatively was 2(0, 3) types, which was significantly less than the 3(2, 3) types used preoperatively ( Z=-2.70, P=0.007).The 6-month postoperative BCVA (LogMAR) was 1.40(0.52, 2.70), which showed no significant change compared to the preoperative 1.40(0.70, 2.70) ( Z=-0.10, P=0.952).The surgical success rate was 83.6%(56/67) at 6 months postoperatively.Postoperative complications included mydriasis (11/67), conjunctival hemorrhage (11/67), mild anterior chamber inflammation (1/67), mild ciliary body detachment (3/67), local choroidal detachment (1/67), and cystoid macular edema (1/67), all of which were reversible after treatment. Conclusions:MP-TSCPC appears to be a safe and effective treatment option for refractory glaucoma.
4.Discussion on acceptance limit of drug metabolites in quality standard
Yunfei LIU ; Lingbo WANG ; Xiulan WU ; Jia YU ; Hao ZHOU ; Lihong YANG
Drug Standards of China 2024;25(5):526-528
This paper discussed how to set the limit of impurities in the quality standard when the impurities in small-molecular innovative drugs were metabolites.Firstly,through the analysis and interpretation of each relevant guideline,in combination with the review cases of FDA and EMA,found out the conditions for qualification of im-purity,and then establ ish the acceptable limit of impurities based on the test results of multiple batches,the incre-ments of production process and storage process.
5.Effect of laparoscopic fundoplication for proton pump inhibitor dependent gastroesophageal reflux disease: a 10-year follow-up report of 160 cases in a single center
Zhiwei HU ; Jimin WU ; Meng LI ; Jiannan LIU ; Changrong DENG ; Xiulan ZHAN ; Tao JI ; Feng WANG ; Shurui TIAN ; Yu ZHANG ; Dong CHEN
Chinese Journal of General Surgery 2024;39(6):423-429
Objective:To explore the long-term efficacy of laparoscopic fundoplication for proton pump inhibitor dependent gastroesophageal reflux disease (GERD).Method:Clinical data of proton pump inhibitor dependent GERD patients who underwent fundoplication at the Rocket Force Characteristic Medical Center from Jan to Jun 2012 were analyzed, including GERD symptom score, subjective symptom relief rate, PPI discontinuation rate and surgical satisfaction, as well as recurrence and complications.Result:A total of 160 GERD patients were included in this study, with 64% of patients having respiratory symptoms. Nissen and Toupet fundoplication were performed in 43 and 117 cases, respectively, with a follow-up time of (127±3) months. The postoperative GERD symptom scores of the patients were significantly lower than before treatment (all P<0.001); The subjective relief of overall symptoms in the digestive tract and airway problem was 90% (80%, 100%) and 100%, respectively. The PPI discontinuation rate was 86%, and the overall satisfaction rate of the treatment was 92%, and the satisfaction rate of patients with respiratory symptoms was 89%. 7% of patients experienced varying degrees of symptomatic recurrence, 4% of patients re-underwent endoscopic treatment and/or laparoscopic fundoplication due to symptom recurrence. The incidence of long-term postoperative dysphagia, bloating, belching, increased exhaust, abdominal pain, diarrhea, and constipation were 11.3%, 16.9%, 0, 1.3%, 0, 2.5%, and 5.6%, respectively. Conclusions:Laparoscopic fundoplication has good long-term efficacy in the treatment of GERD. A small number of patients may experience postoperative recurrence, as well as complications such as dysphagia and gas-bloat syndrome. Most recurrent patients can achieve good therapeutic effect by redoing endoscopic treatment or redoing surgery.
6.Correlation of Tfh cell content in peripheral blood proportion and intracellular IL-21 with retinal damage caused by blue light
Mengyi ZHANG ; Yangyang YU ; Zhengya LI ; Yongzhen YU ; Chunli ZHANG ; Tianhao CHENG ; Yixiao LEI ; Wenjie ZHOU ; Xiulan ZOU ; Yuping ZOU
The Journal of Practical Medicine 2023;39(21):2743-2749
Objective To investigate the correlation between the proportion of peripheral blood follicular T helper cells(Tfh cells)and intracellular interleukin-21(IL-21)content with blue light retinal injury.Methods Brown Norway(BN)rats were randomly divided into 4 groups and were exposed to blue light for 3 hours a day to establish retinal light damage model.According to the duration of illumination,the rats was divided into 0 days(control group),3 days(3 d group),7 days(7 d group)and 14 days(14 d group).The proportion of Tfh cells and content of IL-21 in Tfh cells in peripheral blood of each group was detected by flow cytometry and ELISA sepa-rately after illumination.Electroretinogram(ERG)was used to evaluate retinal function.The changes of fundus in rats were observed by fundus photography.The thickness of outer nuclear layer of retina was analyzed by HE staining.Results After retinal blue light injury,with the extension of illumination time,the proportion of Tfh cells in peripheral blood and intracellular IL-21 content both increased(P<0.05).ERG showed that retinal function decreased after light damage and aggravated with the extension of illumination time,the latency and ampli-tudes of A-wave and B-wave increased and decreased respectively(P<0.05).The retinal fundus of rats showed depigmentation in 3 d,and the retinal vessels became thinner and exudate with the extension of illumination time.HE staining showed that the outer nuclear layer of retina(ONL)became thinner(P<0.05).Correlation analy-sis indicated that the proportion of Tfh cells in peripheral blood and the intracellular IL-21 content could jointly reflect the degree of injury(P<0.000 1),and the proportion of Tfh cells in peripheral blood was negatively corre-lated with ONL thickness and the amplitude of a and b waves,positively correlated with the peak time of a and b waves,(P<0.0001).Conclusion The proportion of Tfh cells in peripheral blood and the intracellular IL-21 content were increased after blue light damage to retina,and were significantly increased with the extension of light time with a certain correlation.
7.Comparison of the application of WOMAC, SF-36 scales and the "Assessment for Therapeutic Efficacy on Kashin-Beck Disease" (WS/T 79-2011) standard in the evaluation of efficacy in patients with Kashin-Beck disease
Xiulan FEI ; Xiaoyan CHEN ; Yanling WANG ; Guohua CHEN ; Ping LI ; Suqin YU ; Shuying BAI
Chinese Journal of Endemiology 2023;42(8):618-622
Objective:To compare the application effect among Western Ontario and McMaster University Osteoarthritis Index (WOMAC) scale, Medical Outcomes Study 36-item Short Form (SF-36) scale and "Assessment for Therapeutic Efficacy on Kashin-Beck Disease" (WS/T 79-2011) standard in the evaluation of therapeutic effect of patients with Kashin-Beck disease, which could provide basis for the treatment evaluation of patients with Kashin-Beck disease.Methods:A total of 213 patients with Kashin-Beck disease in Gansu Province were investigated. WOMAC scale, SF-36 scale and standard of WS/T 79-2011 were used to analyze the quality of life of patients before and after treatment. The reliability, construct validity, content validity, discriminant validity of WOMAC and SF-36 scales were compared. Correlation between WOMAC, SF-36 scales and standard of WS/T 79-2011 were evaluated.Results:Both WOMAC and SF-36 scales had good construct validity and content validity (construct validity showed WOMAC and SF-36 scales contained 1 and 2 common factors, respectively; content validity showed WOMAC and SF-36 scales contained 3 and 8 common factors, respectively). The reliability and discriminant validity of WOMAC scale were better than those of SF-36 seale (reliability showed WOMAC reliability coefficient ≥0.934, the reliability coefficient of SF-36 scale was ranged from 0.386 to 0.999. Discriminant validity showed there were differences in 3 dimensions of the WOMAC scale before and after treatment, while there were differences in 6 out of 8 dimensions of the SF-36 scale). The correlation coefficients between WOMAC scale and standard of WS/T 79-2011 ranged from 0.175 to 0.437, the correlation coefficients between SF-36 scale and standard of WS/T 79-2011 ranged from - 0.434 to - 0.099 ( P < 0.05). Conclusion:The reliability, discriminant validity and correlation with the standard of WS/T 79-2011 of WOMAC scale are better than those of SF-36 scale in efficacy evaluation of patients with Kashin-Beck disease.
8.Clinical Predominance Disease of Traditional Chinese Medicine: Gastroesophageal Reflux Disease
Ping WANG ; Fengyun WANG ; Yu LAN ; Lingyun ZHANG ; Xiaoqing LI ; Kun WANG ; Xiujing SUN ; Zhanfeng YAN ; Xiulan ZHANG ; Demin LI ; Hongmei WU ; Xiaohong LI ; Xiaoke LI ; Jianqin YANG ; Dawei ZOU ; Xiaoxiao ZHANG ; Xudong TANG
Chinese Journal of Experimental Traditional Medical Formulae 2023;29(12):199-208
Gastroesophageal reflux disease (GERD) is a frequently and commonly occurring disease in clinic. In recent decades, with the development in pathophysiology and drug researches, modern medicine has achieved remarkable progress and results in diagnosis and treatment. However, the treatments for non-erosive reflux disease, refractory gastroesophageal reflux disease, proton pump inhibitor resistance, overlap of disease symptoms, and extraesophageal symptoms are limited and ineffective. Traditional Chinese medicine (TCM) was widely used in clinical practice, which has been proved effective in relieving symptoms and improving the quality of life. Sponsored by China Association of Chinese Medicine (CACM) and undertaken by the Spleen and Stomach Disease Branch of CACM, "the 12th Youth Salon of Clinical Predominance Disease Series (GERD)" invited 18 authoritative digestive experts of TCM and western medicine to discuss "the difficulties of clinical diagnosis and treatment of GERD and TCM advantages". The focus issues such as modern medical diagnosis and treatment achievements and contributions, improvement and maintenance of symptoms, response to overlapping disease symptoms, reduction and withdrawal of acid suppressors, and treatment of extra-esophageal symptoms were discussed in depth. TCM and western medicine exchanged and complemented each other's strengths, combing the difficulties of modern medical diagnosis and treatment, which clarified the positioning and advantages of TCM and provided guidance for clinical and scientific research.
9.Epidemic trend of Kaschin-Beck Disease in Gansu Province from 2004 to 2018
Xiulan FEI ; Xiaoyan CHEN ; Yanling WANG ; Guohua CHEN ; Ping LI ; Suqin YU ; Shuying BAI
Chinese Journal of Endemiology 2022;41(2):139-143
Objective:To master the epidemic trend of Kashin-Beck disease (KBD) in Gansu Province and provide a scientific basis for prevention and treatment of KBD.Methods:All children aged 7 - 12 or 16 years old were selected as the survey subjects in 37 KBD districts and counties in Gansu Province, clinical and X-ray monitoring results of KBD in children from 2004 to 2018 were collected to analyze the epidemic trend of the disease.Results:From 2004 to 2018, a total of 97 190 children were examined clinically and 94 180 X-ray films were taken in Gansu Province. Four hundred and twenty-eight clinical positive cases were detected, with a detection rate of 0.44%. There were 649 X-ray positive cases, and the detection rate was 0.69%. There were 435 metaphyseal positive cases, the detection rate was 0.46%. There were 214 positive cases of bone end, and the detection rate was 0.23%. The clinical positive rate was the highest (7.17%, 58/809) in 2004, followed by 2007 (4.60%, 51/1 109) and 2005 (4.48%, 187/4 173), and the positive rate in other years was less than 3%. The positive rate of X-ray was the highest (9.59%, 58/605) in 2004, followed by 2005 (5.10%, 213/4 173), 2008 (3.66%, 45/1 228) and 2006 (3.04%, 125/4 107), the positive rate of other years was less than 3%.Conclusions:The clinical positive rate and X-ray positive rate of KBD in children in Gansu Province are decreased rapidly and then maintain a low fluctuation. The effect of comprehensive prevention and control measures is remarkable.
10.Comparative study on the parameters between reflux asthma and typical gastroesophageal reflux disease
Zhiwei HU ; Hui XU ; Ying ZHAN ; Shurui TIAN ; Yu ZHANG ; Xiulan ZHAN ; Feng WANG ; Changrong DENG ; Tao JI ; Jimin WU
Chinese Journal of Digestion 2021;41(11):760-764
Objective:To analyze the difference and clinical significance of reflux related parameters between patients with reflux asthma (RA) and typical gastroesophageal reflux disease (TGERD).Methods:From June 2017 to June 2020, at PLA Rocket Force Characteristic Medical Center, the clinical data of 120 patients with gastroesophageal reflux disease (GERD) who underwent gastroscopy, high-resolution esophageal manometry (HREM) and 24 h pH-impedance monitoring contemporaneously were retrospectively analyzed. The GERD patients were divided into RA group and TGERD group according to the symptom correlated indexes, 60 cases in each group. The reflux related indexes of two groups were compared, which included reflux esophagitis (RE) score, esophageal hiatal hernia, Hill grade score of gastroesophageal flap valve, upper esophageal sphincter (UES) pressure, DeMeester score, and reflux episodes. Mann-Whitney U test and chi-square test were used for statistical analysis. Results:There were no significant differences in RE score and Hill grade score between TGERD group and RA group (0.0, 0.0 to 1.0 vs. 0.0, 0.0 to 1.8; 3.0, 2.0 to 3.0 vs. 3.0, 2.0 to 3.0) (both P>0.05). The detection rate of UES pressure less than 34 mmHg (1 mmHg=0.133 kPa) of RA group was higher than that of TGERD group (41.7%, 25/60 vs. 23.3%, 14/60), and the difference was statistically significant ( χ2=4.596, P=0.032). The UES pressure of RA group was lower than that of TGERD group (51.7 mmHg, 23.6 mmHg to 70.1 mmHg vs. 62.0 mmHg, 37.4 mmHg to 77.4 mmHg), and the difference was statistically significant ( Z=-2.105, P=0.035). There were no significant differences in other parameters of HREM between TGERD group and RA group (all P>0.05). The detection rates of DeMeester score more than 14.7, acid exposure time more than 4.5% and total reflux episodes more than 73 episodes of RA group were all higher than those of TGERD group (41.7%, 25/60 vs. 23.3%, 14/60; 40.0%, 24/60 vs. 21.7%, 13/60; 38.3%, 23/60 vs. 20.0%, 12/60, respectively), and the differences were all statistically significant ( χ2=5.546, 4.728 and 4.881, all P<0.05). The total reflux episodes and weak acid gas reflux episodes of RA group were both higher than those of TGERD group (60 episodes, 43 episodes to 98 episodes vs. 52 episodes, 34 episodes to 69 episodes; 12 episodes, 6 episodes to 21 episodes vs. 9 episodes, 3 episodes to 14 episodes), and the differences were statistically significant ( Z=-2.323 and -2.053, both P<0.05). There were no significant differences in other parameters of 24 h pH-impedance monitoring between TGERD group and RA group (all P>0.05). Conclusion:Low UES pressure, abnormal esophageal acid exposure and increased reflux episodes, especially weak acid gas reflux episodes, may be more likely to induce RA.

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