1.Laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis versus laparoscopic total colectomy with ileorectal anastomosis for slow transit constipation: a multicenter retrospective cohort study
Yang LUO ; Taotao HOU ; Yifei MU ; Chundi MIAO ; Tingyue GONG ; Jun QIN ; Dongyang WANG ; Dawei SONG ; Hao LI ; Shaolan QIN ; Rong CUI ; Tingfeng WANG ; Ming ZHONG ; Minhao YU
Chinese Journal of Gastrointestinal Surgery 2025;28(12):1426-1433
Objective:To compare postoperative anal function recovery between laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis and laparoscopic total colectomy with ileorectal anastomosis for slow transit constipation.Methods:This multicenter retrospective cohort study enrolled patients meeting the following criteria: (1) severe constipation symptoms (<2 bowel movements/week), absent or insignificant defecation urge, abdominal distension, requiring laxatives to maintain bowel movements or laxatives being ineffective; (2) constipation symptoms for over 5 years, ineffective after >2 years of medical treatment, with strong desire for surgery; (3) significantly prolonged colon transit time (>72 hours) without significant gastric or small intestinal transit dysfunction; (4) no organic colonic lesions confirmed by colonoscopy and abdominal CT. Exclusion criteria: (1) patients undergoing open surgery; (2) exclusion of outlet obstruction constipation (e.g., rectocele, rectal prolapse, puborectalis spasm) by functional defecation MRI; (3) comorbid psychiatric disorders; (4) missing clinical data or loss to follow-up (postoperative follow-up <24 months). Based on these criteria, clinical and follow-up data were collected from 220 patients who underwent either laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis (LSC group, n = 115) or laparoscopic total colectomy with ileorectal anastomosis (LTC group, n = 105) for slow transit constipation between January 2013 and December 2022. Subjective anal function (Constipation Severity Score and Wexner Fecal Incontinence Score) and objective anal function (positive rate of rectoanal inhibitory reflex [RAIR] and anorectal manometry) were observed preoperatively and at 6, 12, and 24 months postoperatively. Results:No significant differences were found in baseline characteristics between the two groups (all P >0.05). All surgeries were completed successfully without major significant complications. Subjective anal function assessment: At 24 months postoperatively, Constipation Severity Scores decreased significantly compared to preoperative scores in both groups [LSC group: (25.2±2.8) vs. (2.9±1.8), P <0.001; LTC group: (25.8±2.9) vs. (2.8±1.9), P<0.001]. No significant differences were found between the groups at 6, 12, and 24 months postoperatively (all P>0.05). Wexner Fecal Incontinence Scores at 24 months were significantly lower than those at 6 months in both groups [LSC group: (12.9±1.8) vs. (3.9±2.5), P<0.001; LTC group: (12.6±1.8) vs. (5.4±2.4), P<0.001]. Although no significant difference was found at 6 months ( P = 0.190), the LSC group had significantly lower Wexner scores than the LTC group at 12 and 24 months postoperatively (both P < 0.001). Objective anal function assessment: (1) Positive RAIR rate: Preoperative positive RAIR rates were 33.0% (38/115) in the LSC group and 25.7% (27/105) in the LTC group ( P > 0.05). At 24 months, positive rates increased significantly in both groups [LSC: 66.1% (76/115); LTC: 63.8% (67/105)] compared to preoperative rates (both P<0.001), but no significant differences were found between groups at 6, 12, and 24 months (all P>0.05). (2) Resting pressure (RP) and squeeze pressure (SP): No significant differences were found in preoperative RP and SP between groups (all P>0.05). The LSC group had significantly higher RP and SP than the LTC group at 6 and 12 months postoperatively (all P<0.05), but no significant differences were found at 24 months ( P>0.05). Conclusion:Both laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis and laparoscopic total colectomy with ileorectal anastomosis are safe for patients with slow transit constipation. However, laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis offers superior postoperative anal function recovery.
2.Effects of quadratus lumborum block at the lateral supra-arcuate ligament versus erector spinae plane block on early postoperative recovery in patients undergoing posterior lumbar surgery
Yuling ZHONG ; Rong WEI ; Liuyu LU ; Xiaoyu KANG ; Yang LU ; Zheng GONG
The Journal of Practical Medicine 2025;41(17):2689-2695
Objective To compare the effects of quadratus lumborum block at the lateral supra-arcuate ligament(QLB-LSAL)and erector spinae plane block(ESPB)on early postoperative recovery in patients undergoing posterior lumbar surgery.Methods Ninety-three patients,aged 25~70 years,BMI 18~30 kg/m2 and ASA physical status Ⅱ or Ⅲ and scheduled for posterior lumbar surgery,were randomly divided into QLB-LSAL combined with general anesthesia(Group Q),ESPB combined with general anesthesia(Group E),and general anesthesia alone(Group N).Postoperatively,all groups received patient-controlled intravenous analgesia(PCIA).The following parameters were recorded:the scores of Richmond Agitation-Sedation Scale(RASS)and Bergman Comfort Scale(BCS)at awakening,6 h,12 h,and 24 h postoperatively;Likert scale score at PCIA cessation;the scores of Pittsburgh Sleep Quality Index(PSQI)and Early Postoperative Quality of Recovery-15(QoR-15)at 1 day preopera-(P<0.05).(2)Compared with Group N,group Q exhibited lower PSQI scores and higher QoR-15 scores at 1 and 3 days postoperatively(P<0.05).No statistically significant difference in PSQI scores was observed between group E and N(P>0.05),while group E had higher QoR-15 score than group N only at 1 day postoperatively(P<0.05).Both at 1 and 3 days postoperatively,group Q had lower PSQI scores and higher QoR-15 scores than group E(P<0.05).(3)Postoperative awakening time,extubation time,PACU stay time,time to first anal exhaust and time to first ambulation were significantly shorter in group Q than those in group N(P<0.05).Group E only showed shorter time to first anal exhaust compared to group N(P<0.05).Furthermore,group Q had a significantly shorter PACU stay time than group E(P<0.01).(4)There was no statistically significant difference in the incidence of adverse reactions among the three groups of patients.(P>0.05).Conclusions Both QLB-LSAL and ESPB effectively improve postoperative analgesia and early recovery quality.However,QLB-LSAL demonstrates advantages in enhancing patient comfort,analgesia satisfaction,sleep quality,and accelerating overall postoperative recovery.
3.Clinical research and characteristic analysis of patients with advanced colorectal cancer treated with Yinyang Gongji Pills and capecitabine.
Lei WANG ; Chao-Yue YAO ; Jie-Ru ZHAN ; Xiao-Xia SUN ; Zhong-Xin YU ; Xiao-Ya LIANG ; Jian WANG ; Xue GONG ; Da-Rong WEI
China Journal of Chinese Materia Medica 2025;50(5):1404-1411
Yinyang Gongji Pills have the effects of strengthening the body resistance to eliminate pathogenic factors, removing stasis, and reducing swelling, which is a commonly used traditional Chinese medicine(TCM) formula for treating intestinal accumulation. A real-world, registered, and single-arm clinical trial was conducted to observe the clinical efficacy and safety of Yinyang Gongji Pills combined with capecitabine in the treatment of advanced colorectal cancer and analyze the clinical characteristics of the patients. A total of 60 patients with advanced colorectal cancer who refused or could not tolerate standard treatment of western medicine were included in the study. They were treated with Yinyang Gongji Pills combined with capecitabine until disease progression or intolerable adverse events occurred. The main observation indicators were progression-free survival(PFS) and safety. The treatment effects of the patients under different baseline characteristics were analyzed. The clinical trial has found that the median PFS of all enrolled patients was 7.3 months, with 30.1% of patients having a PFS exceeding 12.0 months. Layered analysis showed that the median PFS of patients with the onset site being the colon and rectum were respectively 8.4 and 4.7 months. The median PFS of patients with high, medium, and low tumor burden were respectively 7.0, 4.7, and 10.8 months. The median PFS of patients with wild-type and mutant-type RAS/BRAF were respectively 7.9 and 6.9 months. The median PFS of patients with KPS scores ≥80 and ≤70 were respectively 7.9 and 6.5 months. The median PFS of patients treated with Yinyang Gongji Pills for ≥6, 3-6, and ≤3 months were respectively 8.0, 5.2, and 4.2 months. The median PFS of patients with spleen, kidney, liver, and lung syndrome differentiation in TCM were respectively 8.3, 6.7, 7.3, and 5.6 months. The median PFS of patients with TCM pathological factors including phlegm, dampness, and blood stasis were respectively 7.0, 7.3, and 6.5 months. Common adverse reactions include anemia, decreased white blood cells, decreased appetite, fatigue, and hand foot syndrome, with incidence rates being respectively 44.2%, 34.6%, 42.3%, 32.7%, and 17.3%. The results showed that the combination of Yinyang Gongji Pills and capecitabine demonstrated potential clinical efficacy and good safety in this study. The patients have clinical characteristics such as low tumor burden, onset site at the colon, KPS scores ≥ 80, long duration of oral TCM, and TCM syndrome differentiation including spleen or liver.
Humans
;
Capecitabine/adverse effects*
;
Colorectal Neoplasms/mortality*
;
Drugs, Chinese Herbal/adverse effects*
;
Male
;
Middle Aged
;
Female
;
Aged
;
Adult
;
Treatment Outcome
4.Effects of quadratus lumborum block at the lateral supra-arcuate ligament versus erector spinae plane block on early postoperative recovery in patients undergoing posterior lumbar surgery
Yuling ZHONG ; Rong WEI ; Liuyu LU ; Xiaoyu KANG ; Yang LU ; Zheng GONG
The Journal of Practical Medicine 2025;41(17):2689-2695
Objective To compare the effects of quadratus lumborum block at the lateral supra-arcuate ligament(QLB-LSAL)and erector spinae plane block(ESPB)on early postoperative recovery in patients undergoing posterior lumbar surgery.Methods Ninety-three patients,aged 25~70 years,BMI 18~30 kg/m2 and ASA physical status Ⅱ or Ⅲ and scheduled for posterior lumbar surgery,were randomly divided into QLB-LSAL combined with general anesthesia(Group Q),ESPB combined with general anesthesia(Group E),and general anesthesia alone(Group N).Postoperatively,all groups received patient-controlled intravenous analgesia(PCIA).The following parameters were recorded:the scores of Richmond Agitation-Sedation Scale(RASS)and Bergman Comfort Scale(BCS)at awakening,6 h,12 h,and 24 h postoperatively;Likert scale score at PCIA cessation;the scores of Pittsburgh Sleep Quality Index(PSQI)and Early Postoperative Quality of Recovery-15(QoR-15)at 1 day preopera-(P<0.05).(2)Compared with Group N,group Q exhibited lower PSQI scores and higher QoR-15 scores at 1 and 3 days postoperatively(P<0.05).No statistically significant difference in PSQI scores was observed between group E and N(P>0.05),while group E had higher QoR-15 score than group N only at 1 day postoperatively(P<0.05).Both at 1 and 3 days postoperatively,group Q had lower PSQI scores and higher QoR-15 scores than group E(P<0.05).(3)Postoperative awakening time,extubation time,PACU stay time,time to first anal exhaust and time to first ambulation were significantly shorter in group Q than those in group N(P<0.05).Group E only showed shorter time to first anal exhaust compared to group N(P<0.05).Furthermore,group Q had a significantly shorter PACU stay time than group E(P<0.01).(4)There was no statistically significant difference in the incidence of adverse reactions among the three groups of patients.(P>0.05).Conclusions Both QLB-LSAL and ESPB effectively improve postoperative analgesia and early recovery quality.However,QLB-LSAL demonstrates advantages in enhancing patient comfort,analgesia satisfaction,sleep quality,and accelerating overall postoperative recovery.
5.Laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis versus laparoscopic total colectomy with ileorectal anastomosis for slow transit constipation: a multicenter retrospective cohort study
Yang LUO ; Taotao HOU ; Yifei MU ; Chundi MIAO ; Tingyue GONG ; Jun QIN ; Dongyang WANG ; Dawei SONG ; Hao LI ; Shaolan QIN ; Rong CUI ; Tingfeng WANG ; Ming ZHONG ; Minhao YU
Chinese Journal of Gastrointestinal Surgery 2025;28(12):1426-1433
Objective:To compare postoperative anal function recovery between laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis and laparoscopic total colectomy with ileorectal anastomosis for slow transit constipation.Methods:This multicenter retrospective cohort study enrolled patients meeting the following criteria: (1) severe constipation symptoms (<2 bowel movements/week), absent or insignificant defecation urge, abdominal distension, requiring laxatives to maintain bowel movements or laxatives being ineffective; (2) constipation symptoms for over 5 years, ineffective after >2 years of medical treatment, with strong desire for surgery; (3) significantly prolonged colon transit time (>72 hours) without significant gastric or small intestinal transit dysfunction; (4) no organic colonic lesions confirmed by colonoscopy and abdominal CT. Exclusion criteria: (1) patients undergoing open surgery; (2) exclusion of outlet obstruction constipation (e.g., rectocele, rectal prolapse, puborectalis spasm) by functional defecation MRI; (3) comorbid psychiatric disorders; (4) missing clinical data or loss to follow-up (postoperative follow-up <24 months). Based on these criteria, clinical and follow-up data were collected from 220 patients who underwent either laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis (LSC group, n = 115) or laparoscopic total colectomy with ileorectal anastomosis (LTC group, n = 105) for slow transit constipation between January 2013 and December 2022. Subjective anal function (Constipation Severity Score and Wexner Fecal Incontinence Score) and objective anal function (positive rate of rectoanal inhibitory reflex [RAIR] and anorectal manometry) were observed preoperatively and at 6, 12, and 24 months postoperatively. Results:No significant differences were found in baseline characteristics between the two groups (all P >0.05). All surgeries were completed successfully without major significant complications. Subjective anal function assessment: At 24 months postoperatively, Constipation Severity Scores decreased significantly compared to preoperative scores in both groups [LSC group: (25.2±2.8) vs. (2.9±1.8), P <0.001; LTC group: (25.8±2.9) vs. (2.8±1.9), P<0.001]. No significant differences were found between the groups at 6, 12, and 24 months postoperatively (all P>0.05). Wexner Fecal Incontinence Scores at 24 months were significantly lower than those at 6 months in both groups [LSC group: (12.9±1.8) vs. (3.9±2.5), P<0.001; LTC group: (12.6±1.8) vs. (5.4±2.4), P<0.001]. Although no significant difference was found at 6 months ( P = 0.190), the LSC group had significantly lower Wexner scores than the LTC group at 12 and 24 months postoperatively (both P < 0.001). Objective anal function assessment: (1) Positive RAIR rate: Preoperative positive RAIR rates were 33.0% (38/115) in the LSC group and 25.7% (27/105) in the LTC group ( P > 0.05). At 24 months, positive rates increased significantly in both groups [LSC: 66.1% (76/115); LTC: 63.8% (67/105)] compared to preoperative rates (both P<0.001), but no significant differences were found between groups at 6, 12, and 24 months (all P>0.05). (2) Resting pressure (RP) and squeeze pressure (SP): No significant differences were found in preoperative RP and SP between groups (all P>0.05). The LSC group had significantly higher RP and SP than the LTC group at 6 and 12 months postoperatively (all P<0.05), but no significant differences were found at 24 months ( P>0.05). Conclusion:Both laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis and laparoscopic total colectomy with ileorectal anastomosis are safe for patients with slow transit constipation. However, laparoscopic subtotal colectomy with antiperistaltic cecorectal anastomosis offers superior postoperative anal function recovery.
6.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
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East Asian People
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Neoplasms/pathology*
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Antibodies, Monoclonal, Humanized/therapeutic use*
7.A phase I study of subcutaneous envafolimab (KN035) monotherapy in Chinese patients with advanced solid tumors.
Rong Rui LIU ; Shan Zhi GU ; Tie ZHOU ; Li Zhu LIN ; Wei Chang CHEN ; Dian Sheng ZHONG ; Tian Shu LIU ; Nong YANG ; Lin SHEN ; Si Ying XU ; Ni LU ; Yun ZHANG ; Zhao Long GONG ; Jian Ming XU
Chinese Journal of Oncology 2023;45(10):898-903
Objective: To evaluate the safety and antitumor activity of envafolimab monotherapy in Chinese patients with advanced solid tumors. Methods: This open-label, multicenter phase I trial included dose escalation and dose expansion phases. In the dose escalation phase, patients received subcutaneous 0.1, 0.3, 1.0, 2.5, 5.0 or 10.0 mg/kg envafolimab once weekly (QW) following a modified "3+ 3" design. The dose expansion phase was performed in the 2.5 mg/kg and 5.0 mg/kg (QW) dose cohorts. Results: At November 25, 2019, a total of 287 patients received envafolimab treatment. During the dose escalation phase, no dose-limiting toxicities (DLT) was observed. In all dose cohorts, drug-related treatment-emergent adverse events (TEAEs) for all grades occurred in 75.3% of patients, and grade 3 or 4 occurred in 20.6% of patients. The incidence of immune-related adverse reactions (irAE) was 24.0% for all grades, the most common irAEs (≥2%) included hypothyroidism, hyperthyroidism, immune-associated hepatitis and rash. The incidence of injection site reactions was low (3.8%), all of which were grades 1-2. Among the 216 efficacy evaluable patients, the objective response rate (ORR) and disease control rate (DCR) were 11.6% and 43.1%, respectively. Median duration of response was 49.1 weeks (95% CI: 24.0, 49.3). Pharmacokinetic (PK) exposure to envafolimab is proportional to dose and median time to maximum plasma concentration is 72-120 hours based on the PK results from the dose escalation phase of the study. Conclusion: Subcutaneous envafolimab has a favorable safety and promising preliminary anti-tumor activity in Chinese patients with advanced solid tumors.
Humans
;
East Asian People
;
Neoplasms/pathology*
;
Antibodies, Monoclonal, Humanized/therapeutic use*
8.Meta-analysis and trial sequential analysis of Chaihuang Granules in treatment of upper respiratory tract infection in children.
Ni ZHONG ; Wen-Hao GONG ; Tong WAN ; Rong FENG ; Zhi-Fei LI ; Ze-Qi CAI ; Jun-Yuan GAN ; Jun AI
China Journal of Chinese Materia Medica 2023;48(19):5377-5388
This study aimed to evaluate the efficacy and safety of Chaihuang Granules in the treatment of upper respiratory tract infection in children. The databases such as CNKI, Wanfang, VIP, SinoMed, Cochrane Library, PubMed, EMbase, Web of Science, Chinese Clinical Trial Registry, and ClinicalTrials.gov were searched for randomized controlled trial(RCT) of Chaihuang Granules for the treatment of upper respiratory tract infection in children, and supplemented by manual searching of gray literature. Two investigators independently screened the literature, extracted data, and assessed the methodological quality. Meta-analysis was performed using RevMan 5.4 software, trial sequential analysis was conducted using TSA 0.9.5.10 Beta software, and evidence quality evaluation was carried out using GRADE profiler 3.6.1 software. Eighteen RCTs involving 2 459 patients(1 262 in the treatment group and 1 197 in the control group) were included. Meta-analysis showed that compared with conventional therapy alone, Chaihuang Granules significantly improved the total effective rate(RR=1.18, 95%CI[1.15, 1.22], P<0.000 01), reduced the disappearance time of symptoms/signs(MD=-1.39, 95%CI[-1.66,-1.12], P<0.000 01), improved cytokine levels(MD=-2.40, 95%CI[-3.80,-1.00], P=0.000 8), improved humoral immune levels(MD=0.75, 95%CI[0.60, 0.90], P<0.000 01), and reduced the recurrence rate(MD=-2.11, 95%CI[-2.98,-1.25], P<0.000 01). However, the incidence of adverse reactions was not increased(RR=0.94, 95%CI[0.59, 1.49], P=0.78). Subgroup analysis showed that:(1) both Chaihuang Granules used alone(RR=1.19, 95%CI[1.11, 1.27], P<0.000 01) and in combination with other therapies(RR=1.18, 95%CI[1.14, 1.22], P<0.000 01) effectively improved the total effective rate.(2) In terms of symptoms/signs disappearance time, Chaihuang Granules effectively reduced the duration of fever(MD=-1.18, 95%CI[-1.78,-0.58], P=0.000 1), cough with sputum(MD=-1.82, 95%CI[-2.38,-1.25], P<0.000 01), cough(MD=-1.31, 95%CI[-1.89,-0.74], P<0.000 01), sore throat(MD=-1.57, 95%CI[-2.25,-0.89], P<0.000 01), and lung rales(MD=-1.49, 95%CI[-2.06,-0.92], P<0.000 01).(3) Regarding cytokine levels, Chaihuang Gra-nules effectively improved the levels of interleukin(IL)-2(MD=-0.94, 95%CI[-1.16,-0.72], P<0.000 01), IL-6(MD=-4.71, 95%CI[-6.39,-3.03], P<0.000 01), and tumor necrosis factor-α(TNF-α)(MD=-2.07, 95%CI[-2.43,-1.71], P<0.000 01).(4) In terms of cellular immune levels, Chaihuang Granules effectively improved the levels of CD3~+(MD=4.11, 95%CI[1.53, 6.69], P=0.002), CD4~+(MD=4.21, 95%CI[1.69, 6.73], P=0.001), CD8~+(MD=-2.65, 95%CI[-3.93,-1.37], P<0.000 1), and CD4~+/CD8~+(MD=0.25, 95%CI[0.14, 0.37], P<0.000 1).(5) In terms of humoral immune levels, Chaihuang Granules effectively improved the levels of IgA(MD=0.44, 95%CI[0.23, 0.64], P<0.000 1), IgM(MD=0.31, 95%CI[0.15, 0.46], P=0.000 1), and IgG(MD=2.02, 95%CI[1.60, 2.43], P<0.000 01). Trial sequential analysis showed that the cumulative Z-curve of the total effective rate crossed the boundary value, further confirming its clinical efficacy. The GRADE evidence quality evaluation showed that the evidence quality of the above outcome indicators was low or very low, and the recommendation strength was weak. Compared to conventional therapy alone, Chaihuang Granules can effectively improve the total effective rate of treatment, alle-viate symptoms and signs of upper respiratory tract infection in children, improve inflammatory conditions, enhance immune function, and reduce the recurrence rate. Due to the limited quality of the included studies, high-quality RCT is still needed to provide evidence support for the above conclusions.
Child
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Humans
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Drugs, Chinese Herbal/therapeutic use*
;
Treatment Outcome
;
Clinical Trials as Topic
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Respiratory Tract Infections/drug therapy*
9.Meta-analysis and trial sequential analysis of Compound Qinlan Oral Liquid in treatment of acute upper respiratory tract infection.
Ni ZHONG ; Wen-Hao GONG ; Tong WAN ; Rong FENG ; Zhi-Fei LI ; Ze-Qi CAI ; Jun-Yuan GAN ; Jun AI
China Journal of Chinese Materia Medica 2023;48(24):6798-6811
This study aims to evaluate the efficacy and safety of Compound Qinlan Oral Liquid in the treatment of acute upper respiratory tract infection. Computer-based online searching of CNKI, VIP, SinoMed, Wanfang, ChiCTR, ClinicalTrials.gov, Cochrane Library, PubMed, EMbase, and Web of Science was performed to retrieve the randomized controlled trial(RCT) regarding Compound Qinlan Oral Liquid in the treatment of acute upper respiratory tract infection. In addition, manual searching of gray literature was conducted. After two evaluators independently selected articles, extracted data, and evaluated the quality of methodology included in the studies, Meta-analysis was carried out in RevMan 5.4 and trial sequential analysis(TSA) in TSA 0.9.5.10 Beta. GRADE profiler 3.6.1 was employed to evaluate the evidence quality. A total of 21 RCTs were included in this study, involving 2 651 patients(1 330 patients in the observation group and 1 321 patients in the control group). Meta-analysis showed that compared with conventional western medicine alone, Compound Qinlan Oral liquid improved the total response rate(RR=1.15, 95%CI[1.12, 1.19], P<0.000 01) without increasing the incidence of adverse reactions(RR=0.77, 95%CI[0.47, 1.25], P=0.16). The results of subgroup analysis are described as follows:(1) Compared with conventional western medicine alone, Compound Qinlan Oral Liquid improved the total response rate(RR=1.10, 95%CI[1.05, 1.14], P<0.000 01) and shortened the time to symptom relief(SMD=-0.76, 95%CI[-1.02,-0.51], P<0.000 01). There was no significant difference in the incidence of adverse reactions between the two groups(RR=1.16, 95%CI[0.54, 2.47], P=0.71).(2) Compared with conventional western medicine alone, Compound Qinlan Oral Liquid + conventional western medicine improved the total response rate(RR=1.20, 95%CI[1.15, 1.25], P<0.000 01), decreased traditional Chinese medicine(TCM) syndrome scores(MD=-0.58, 95%CI[-0.75,-0.41], P<0.000 01), shortened the time to symptom relief(SMD=-2.44, 95%CI[-3.09,-1.80], P<0.000 01) and physical sign improvement(MD=-2.57, 95%CI[-4.11,-1.04], P=0.001), lowered the serum levels of inflammatory cytokines(SMD=-2.16, 95%CI[-2.61,-1.70], P<0.000 01), improved respiratory function indicators(SMD=1.48, 95%CI[1.00, 1.96], P<0.000 01), and enhanced the humoral immunity(MD=0.94, 95%CI[0.69, 1.18], P<0.000 01). There was no significant difference in the incidence of adverse reactions between the two groups(RR=0.57, 95%CI[0.29, 1.09], P=0.09). TSA showed that the cumulative Z curve of total response rate crossed the traditional threshold and TSA threshold, further confirming the clinical efficacy of Compound Qinlan Oral Liquid. The GRADE graded the evidence of the above outcome indicators as low or extremely low, and yielded weak recommendation. Compared with conventional western medicine alone, Compound Qinlan Oral Liquid can improve the total effective rate and reduce the time to symptom relief. The combination of Compound Qinlan Oral Liquid and conventional western medicine can improve the total response rate, mitigate the symptoms and improve the physical signs, reduce inflammation, and improve respiratory function and immunity of the patients with acute upper respiratory tract infection. In view of the limited number and quality of the included studies, the above conclusions still require high-quality RCT to provide evidence support.
Humans
;
Drugs, Chinese Herbal/therapeutic use*
;
Inflammation/drug therapy*
;
Medicine, Chinese Traditional
;
Respiratory Tract Infections/drug therapy*
;
Treatment Outcome
10.Construction and application of comprehensive system of chronic diseases surveillance in Zhejiang province.
Ru Ying HU ; Wei Wei GONG ; Jie Ming ZHONG ; Jin PAN ; Hao WANG ; Meng WANG ; Fang Rong FEI ; Min YU
Chinese Journal of Epidemiology 2022;43(9):1485-1490
To construct a non-communicable disease system recommended by WHO, develop the key techniques and promote their applications, obtain the main health indicators and understand the prevalence of chronic diseases, and provide support for the prevention, control and research of chronic diseases. Based on factor analysis, K-means clustering and multi-cluster random sampling, 30 typical sampling areas at provincial level were designed and constructed; By referring to WHO's Non-communicable Disease Surveillance Framework and the American behavioral risk factor sampling and questionnaire and combined with China's actual needs, a comprehensive surveillance system for chronic diseases, covering morbidity and mortality, risk factor exposure and community management and control of chronic diseases, was established, a "5+12+1" quality control system for surveillance data collection, management, analysis and feedback was formed and a three-level surveillance information management platform and information technology construction standards in the province were established, resulting the integration of life registration, chronic disease case reporting and community chronic disease management. Using these key techniques, we have obtained high-quality surveillance data of the whole province, produced the main health indicators, carried out research of chronic diseases, and analyze the prevalence and changing trend of the main chronic diseases and related risk factors to boost the government's practical projects for the reform of the people's livelihood and facilitate the construction of "Healthy Zhejiang". The successful experiences and key techniques have been applied in the construction of chronic disease surveillance system in some provinces in China.
China/epidemiology*
;
Chronic Disease
;
Chronic Disease Indicators
;
Humans
;
Noncommunicable Diseases
;
Prevalence

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