ObjectiveThis paper aims to investigate and evaluate the staged efficacy and safety of the representative empirical prescription of the “Zhu Ke Jiao” theory， Qijia Rougan prescription， combined with entecavir in the treatment of hepatic fibrosis in chronic hepatitis B. MethodsA multicenter randomized controlled clinical study was conducted， and 101 patients diagnosed with chronic hepatitis B-related hepatic fibrosis （CHB-HF） who met the diagnosis and inclusion criteria were randomly assigned to an observation group （Qijia Rougan prescription + entecavir） and a control group （entecavir）. The treatment duration was 24 weeks. Liver stiffness measurement （LSM）， fibrosis-4 index （FIB-4）， portal vein diameter， hepatitis B serology， biochemical indicators， hepatic fibrosis markers in serum ［hyaluronic acid （HA）， laminin （LN）， procollagen Ⅲ peptide （PⅢP）， and type Ⅳ collagen （Ⅳ-C）］， and traditional Chinese medicine syndrome scores were used as efficacy evaluation indicators. Efficacy assessments and explorations of different staged subgroups of Qijia Rougan prescription were conducted according to LSM values based on the Metavir pathological staging standard. ResultsA total of 98 cases were included for statistical analysis， with 49 cases in the observation group and 49 in the control group. The general data of the patients in both groups were comparable. Compared with the same group before treatment， the observation group showed a significant reduction in LSM and FIB-4 （P<0.01）， as well as notable improvements in LN， Ⅳ-C， and various TCM syndrome scores （P<0.05， P<0.01）. When compared to the control group after treatment， the observation group demonstrated significant improvements in LSM， FIB-4， and various TCM syndrome score indicators （P<0.05， P<0.01）， indicating that the observation group performed better than the control group. Subgroup analysis of the regression of hepatic fibrosis stages showed that compared to the same group before treatment， the observation group had better improvement in regression of stages F2 and F3 （P<0.05）. When compared to the control group after treatment， the observation group exhibited superior improvement in regression of stage F3 （P<0.05）. No adverse events occurred in either group during the treatment period. ConclusionCompared with entecavir alone， the combination of Qijia Rougan prescription and entecavir significantly improves the degree of hepatic fibrosis and clinical TCM symptoms in patients. The optimal intervention period is primarily during stage F3， which is a potential “interception” point of the “Zhu Ke Jiao” theory.

Objective To provide suggestions for the clinical efficacy evaluation method of manual therapy for knee osteoarthritis(KOA)by analyzing the current status of the use of outcome indicators in randomized controlled trials(RCTs)of manual therapy for KOA.Methods RCTs about manual treatment of KOA were retrieved from CNKI,Wanfang Data,VIP,SinoMed,PubMed,Cochrane Library,Scopus and Web of Science from March 2014 to March 2024.Two researchers screened literature,extracted literature features,analyzed the RCT indicator domain,measurement tools,and measurement time points for manual treatment of KOA.Results A total of 134 articles were included,with a sample size of 17 659.A total of 138 outcome indicators were used to classify the outcome indicators:64 symptoms and signs(46.4%),54 physical and chemical examinations(39.1%),11 quality of life(8.0%),2 psychological status indicators(1.4%),2 safety indicators(1.4%),2 muscle strength testing indicators(1.4%)and 3 other indicators(2.2%).Among 134 articles,there were a total of 36 measurement time points,with a research time span of 1 hour to 1 year after treatment;91 articles(67.9%)used"clinical efficacy"as the outcome measure;27 articles(20.1%)were evaluated for safety and reported adverse events.Conclusion The RCT outcome indicators of manual therapy for KOA lack representativeness,integrality,objectivity and specificity.The rigorism of the outcome indicators should be improved from the aspects of representativeness,integrality,objectivity and specificity,in order to achieve a complete evaluation effect on disease research.

ObjectiveTo evaluate the therapeutic effect and mechanism of tendon-management and patella-movement therapeutic manipulation in the treatment of patellofemoral arthritis based on imaging evaluation. MethodsTotally 126 patients with patellofemoral arthritis were recruited and divided into a treatment group and a control group according to a randomised numerical table. The control group received routine sodium hyaluronate injection once a week for a total of 5 times； the treatment group received tendon-management and patella-movement therapeutic manipulation three times a week for four weeks. We compared the Western Ontario and McMaster University osteoarthritis index score （WOMAC）， visual analogue scale （VAS）， imaging indicators including patellar external displacement distance， patellofemoral fit angle， lateral patellofemoral angle， and patellofemoral index， and overall effectiveness evaluation between the two groups before and one week after treatment. ResultsThe total effective rate of the treatment group （45/54， 83.33%） was significantly higher than that of the control group （36/54， 66.67%，P＜0.05）. One week after the end of treatment， the VAS scores and WOMAC scores of both groups were lower than those before treatment in the same group （P＜0.01）， and the patellofemoral index and patellofemoral fit angle of the treatment group decreased compared with that of the control group （P＜0.05）. Compared with the pre-treatment， the distance of patellar external displacement， patellofemoral index， and patellofemoral fit angle decreased in the treatment group 1 week after the end of treatment， and the patellofemoral fit angle decreased in the control group （P＜0.05）. ConclusionThe therapeutic manipulation of tendon-management and patella-movement can correct the degree of patellar external displacement， alleviate joint pain symptoms， improve joint function， and achieve the goal of treating patellofemoral arthritis.

Objective:To compare the clinical efficacy of laparoscopic pelvic floor autologous fascia integral repair based on membrane anatomy versus transperineal proctosigmoidectomy (Altemeier procedure) in the treatment of patients with complete rectal prolapse (CRP).Methods:This study employed a retrospective observational cohort design. Clinical data were collected from a total of 55 CRP patients who underwent surgical treatment between January 2018 and July 2023, including 25 patients from Luoyang Central Hospital, affiliated with Zhengzhou University, and 30 patients from the 989th Hospital of the Joint Logistics Support Force & Military Anorectal Surgery Research Institute. All patients undergoing surgery met the following criteria: aged ≥ 18 years, rectal prolapse protruding outside the anus, prolapse length > 5 cm with inability to self-reduce, conforming to the diagnostic criteria for CRP, and being first-time treated patients. Twenty-seven patients who underwent the Altemeier procedure between January 2018 and March 2021 were assigned to the Altemeier group; 28 patients who underwent laparoscopic pelvic floor autologous fascia integral repair based on membrane anatomy between April 2021 and July 2023 were assigned to the integral repair group. The therapeutic efficacy differences between the two groups were analyzed and compared, including the CRP length (DCRP), Wexner Constipation Score, Wexner Fecal Incontinence Score, and Gastrointestinal Quality of Life Index (GIQLI) before surgery and at 6, 12, and 24 months after surgery, as well as postoperative complications and recurrence at 24 months after surgery.Results:There were no statistically significant differences between the two groups in terms of gender distribution, age, preoperative body mass index (BMI), defecation frequency, DCRP, Wexner Constipation Score, Wexner Fecal Incontinence Score, and GIQLI (all P>0.05). All patients completed the surgery. The length of hospital stay and intraoperative blood loss in the integral repair group were significantly less than those in the Altemeier group (both P<0.01). At 6, 12, and 24 months after surgery, the DCRP, Wexner Constipation Score, Wexner Fecal Incontinence Score, and GIQLI in both groups significantly improved compared with the preoperative values (all P<0.001). At 6, 12, and 24 months after surgery, the CRP treatment effect, Wexner Constipation Score, Wexner Fecal Incontinence Score, and GIQLI in the integral repair group were significantly better than those in the Altemeier group (χ2=15.821, P<0.001; χ2=18.238, P<0.001; χ2 = 12.558, P=0.001; and χ2 =22.413, P<0.001, respectively). In the integral repair group, 4 patients (14.3%) developed grade I-III postoperative complications, including 2 cases of urinary retention, 1 case of anastomotic bleeding, and 1 case of anastomotic stenosis. In the Altemeier group, 11 patients (40.7%) developed grade I-III postoperative complications, including 4 cases of urinary retention, 3 cases of anastomotic bleeding, 1 case of anastomotic stenosis, 2 cases of intestinal fistula, and 1 case of fecal incontinence. The difference between the two groups was statistically significant (χ2=4.850, P=0.028). There was no recurrence of CRP in the integral repair group at 24 months after surgery, while 7 cases of CRP recurrence were observed in the Altemeier group at 24 months after surgery. The difference between the two groups was statistically significant (χ2=6.148, P=0.013). Conclusion:The autologous fascia repair technique based on membrane anatomy and the pelvic floor integral theory is superior to the transperineal Altemeier procedure in the treatment of CRP. Furthermore, it is an effective surgical method for CRP.

Objective To provide suggestions for the clinical efficacy evaluation method of manual therapy for knee osteoarthritis(KOA)by analyzing the current status of the use of outcome indicators in randomized controlled trials(RCTs)of manual therapy for KOA.Methods RCTs about manual treatment of KOA were retrieved from CNKI,Wanfang Data,VIP,SinoMed,PubMed,Cochrane Library,Scopus and Web of Science from March 2014 to March 2024.Two researchers screened literature,extracted literature features,analyzed the RCT indicator domain,measurement tools,and measurement time points for manual treatment of KOA.Results A total of 134 articles were included,with a sample size of 17 659.A total of 138 outcome indicators were used to classify the outcome indicators:64 symptoms and signs(46.4%),54 physical and chemical examinations(39.1%),11 quality of life(8.0%),2 psychological status indicators(1.4%),2 safety indicators(1.4%),2 muscle strength testing indicators(1.4%)and 3 other indicators(2.2%).Among 134 articles,there were a total of 36 measurement time points,with a research time span of 1 hour to 1 year after treatment;91 articles(67.9%)used"clinical efficacy"as the outcome measure;27 articles(20.1%)were evaluated for safety and reported adverse events.Conclusion The RCT outcome indicators of manual therapy for KOA lack representativeness,integrality,objectivity and specificity.The rigorism of the outcome indicators should be improved from the aspects of representativeness,integrality,objectivity and specificity,in order to achieve a complete evaluation effect on disease research.

Objective:To compare the clinical efficacy of laparoscopic pelvic floor autologous fascia integral repair based on membrane anatomy versus transperineal proctosigmoidectomy (Altemeier procedure) in the treatment of patients with complete rectal prolapse (CRP).Methods:This study employed a retrospective observational cohort design. Clinical data were collected from a total of 55 CRP patients who underwent surgical treatment between January 2018 and July 2023, including 25 patients from Luoyang Central Hospital, affiliated with Zhengzhou University, and 30 patients from the 989th Hospital of the Joint Logistics Support Force & Military Anorectal Surgery Research Institute. All patients undergoing surgery met the following criteria: aged ≥ 18 years, rectal prolapse protruding outside the anus, prolapse length > 5 cm with inability to self-reduce, conforming to the diagnostic criteria for CRP, and being first-time treated patients. Twenty-seven patients who underwent the Altemeier procedure between January 2018 and March 2021 were assigned to the Altemeier group; 28 patients who underwent laparoscopic pelvic floor autologous fascia integral repair based on membrane anatomy between April 2021 and July 2023 were assigned to the integral repair group. The therapeutic efficacy differences between the two groups were analyzed and compared, including the CRP length (DCRP), Wexner Constipation Score, Wexner Fecal Incontinence Score, and Gastrointestinal Quality of Life Index (GIQLI) before surgery and at 6, 12, and 24 months after surgery, as well as postoperative complications and recurrence at 24 months after surgery.Results:There were no statistically significant differences between the two groups in terms of gender distribution, age, preoperative body mass index (BMI), defecation frequency, DCRP, Wexner Constipation Score, Wexner Fecal Incontinence Score, and GIQLI (all P>0.05). All patients completed the surgery. The length of hospital stay and intraoperative blood loss in the integral repair group were significantly less than those in the Altemeier group (both P<0.01). At 6, 12, and 24 months after surgery, the DCRP, Wexner Constipation Score, Wexner Fecal Incontinence Score, and GIQLI in both groups significantly improved compared with the preoperative values (all P<0.001). At 6, 12, and 24 months after surgery, the CRP treatment effect, Wexner Constipation Score, Wexner Fecal Incontinence Score, and GIQLI in the integral repair group were significantly better than those in the Altemeier group (χ2=15.821, P<0.001; χ2=18.238, P<0.001; χ2 = 12.558, P=0.001; and χ2 =22.413, P<0.001, respectively). In the integral repair group, 4 patients (14.3%) developed grade I-III postoperative complications, including 2 cases of urinary retention, 1 case of anastomotic bleeding, and 1 case of anastomotic stenosis. In the Altemeier group, 11 patients (40.7%) developed grade I-III postoperative complications, including 4 cases of urinary retention, 3 cases of anastomotic bleeding, 1 case of anastomotic stenosis, 2 cases of intestinal fistula, and 1 case of fecal incontinence. The difference between the two groups was statistically significant (χ2=4.850, P=0.028). There was no recurrence of CRP in the integral repair group at 24 months after surgery, while 7 cases of CRP recurrence were observed in the Altemeier group at 24 months after surgery. The difference between the two groups was statistically significant (χ2=6.148, P=0.013). Conclusion:The autologous fascia repair technique based on membrane anatomy and the pelvic floor integral theory is superior to the transperineal Altemeier procedure in the treatment of CRP. Furthermore, it is an effective surgical method for CRP.

Objective:To explore the effects of Zhiyan mixture on the activation of classically activated macrophages(M1)and T helper cells 2(Th2)immune responses in mice with mycoplasma pneumoniae(MP)infection.Methods:C57BL/6J mice were divided into control group,MP group,Zhiyan mixture group and azithromycin group.Except control group,models of MP infection were prepared by nasal drip of MP bacterial solution(1×107 CFUs/ml)in the other groups.Zhiyan mixture group was given intragastric administration of Zhiyan mixture,azithromycin group was given intragastric administration of azithromycin,control group and MP group were given the same volume of normal saline.The pathological damage of lung tissues were observed by HE staining,and patho-logical scoring was conducted.The changes of MP load in lung tissues were detected by solid culture method.M1 level was detected by flow cytometry.The mRNA levels of inducible nitric oxide synthase(iNOS),TNF-α and CXC chemokine 1(CXCL1)in lung tissues were detected by PCR.The levels of IL-4,IL-5,IL-10 and IL-13 in lung tissues were detected by ELISA.The expressions of NF-κB pathway-related proteins in lung tissues were detected by Western blot.Results:The pathological scores of lung tissues,MP load,F4/80+cell level,ratios of CD86+/F4/80+and MHC Ⅱ+/F4/80+,and mRNA levels of iNOS,TNF-α and CXCL1 in MP group,Zhiyan mix-ture group and azithromycin group were higher than those in control group(P<0.05),levels of IL-4,IL-5,IL-10 and IL-13,and ex-pressions of p-p65/p65 and p-IKK/IKK in lung tissues were all higher than those in control group(P<0.05).The pathological scores of lung tissues,MP load,F4/80+level,ratios of CD86+/F4/80+and MHC Ⅱ+/F4/80+,and mRNA levels of iNOS,TNF-α and CXCL1 in Zhiyan mixture group and azithromycin group were lower than those in MP group(P<0.05),levels of IL-4,IL-5,IL-10 and IL-13 were higher than those in MP group(P<0.05),and protein expressions of p-p65/p65 and p-IKK/IKK in lung tissues were lower than those in MP group(P<0.05).Conclusion:Zhiyan mixture can improve lung injury in mice with MP infection,which may be related to reducing M1 activity,increasing Th2 immune response and inhibiting NF-κB pathway.

Objective:To investigate the effect of Qingjin Huazhuo Decoction combined with conventional western medicine on blood hypercoagulability in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) of phlegm-heat stasis lung syndrome.Methods:Randomized controlled trial. According to random number table method, allocation of cases in the observation and control groups. From April 2021 to March 2022, 66 hospitalized patients with AECOPD of phlegm-heat stasis and lung syndrome were randomly divided into control group ( n=32) and study group ( n=34). The control group was treated with conventional western medicine. The study group was treated with Qingjin Huazhuo Decoction on the basis of the control group. Both groups were treated for 7 days. Plasma thrombomodulin (TM), thrombin-antithrombin complex (TAT), tissue plasminogen activator-plasminogen activator inhibitor-1 complex (t-PAIC), plasmin-antiplasmin complex (PIC), prothrombin time (PT), partial thromboplastin time (APTT) and D-dimer levels were measured by automatic immunoassay analyzer; serum TNF-α levels were measured by ELISA and CRP levels were measured by immunoturbidimetry. Adverse reactions and acute thrombotic events during treatment were recorded. Results:During the treatment period, 4 of 66 patients had hemolysis, 2 were mistakenly included in the withdrawal study, 28 in the final control group and 32 in the study group were included for the analyses. After treatment, plasma t-PAIC [(6.19±1.93) μg/L vs. (7.42±2.71) μg/L, t=2.04] level in study group was significantly lower than that of the control group ( P<0.05), and the serum TNF-α [(71.15±25.25) ng/L vs. (122.60±98.76) ng/L, t=2.42] level was significantly lower than that of the control group ( P<0.05), plasma PT [(11.98±0.74) s vs. (11.55±0.77) s, t=-2.19] was significantly longer than that of the control group ( P<0.05). No thrombotic events occurred during hospitalization in the study group, and 1 case of acute myocardial infarction occurred in the control group. Conclusion:Qingjin Huazhuo Decoction combined with conventional western medicine therapy can improve the blood hypercoagulability of AECOPD patients with phlegm-heat stasis lung syndrome.

Objective:To compare the clinical efficacy of laparoscopic pelvic floor three-level internal repair and stapled transanal rectum resection (STARR) in the treatment of male patients with intrarectal prolapse. Mlethds A total of 101 male patients with rectal intrarectal prolapse from Feb 2013 to Oct 2017 were enrolled into this study. Fifty-two patient in group A received laparoscopic pelvie floor three-level internal repair, and 49 patients in group B received STARR. The Wexner incontinence scale (WIS), Wexner constipation scale (WCS) score, gastrointestinal quality of life index (GIQLI) and degree of internal rectal prolapse (DIRP) were systematically evaluated before surgery and 3 months, 1 year and 3 years after surgery. Results:There were no significant differences in age, BMI, number of bowel movements(BM), WIS, WCS, GIQLI and DIRP between the two groups before surgery(all P>0.05). The WIS, WCS, GIQLI and DIRP in 3 months, 1year and 3 years after surgery in both two groups were significantly better than those before surgery ( t=20.169, 25.229, 27.278, 23.818, 23.489, 21.152, -3.550, -23.042, -22.901, 82.852, 40.915, 30.010, 11.323, 13.237, 11.452, 19.473, 18.647, 17.108, -8.791, -5.254, -5.846, 37.439, 30.598, 22.852, all P<0.001). The GIQLI in Group A was significantly better than that of group B at 1 year and 3 years after surgery ( P<0.001) but close to that in Group B at 3 months after surgery ( t=1.428, P=0.156). The WIS, WCS and DIRP in group A were significantly better than those in group B at 3 months, 1 year and 3 years after surgery, with statistical significance ( t=-8.243, -15.688, -20.193, -4.268, -4.768, -4.851, 11.329, 13.543, -5.399, -4.745, -4.598, all P<0.001). There was no signifcant difference in grade Ⅰ-Ⅲ complications between the two groups (χ 2=0.046, P=1.00). Conclusion:Laparoscopic pelvic floor three-level internal repair is more effective than transanal STARR in the treatment of male internal rectal prolapse.

Objective:To compare the clinical efficacy of laparoscopic integral pelvic floor/ligament repair (IPFLR) combined with a procedure for prolapse and hemorrhoids (PPH) and that laparoscopic IPFLR alone in the treatment of internal rectal prolapse (IRP) in women.Methods:Patients were divided into groups A in which 63 patients undergoing laparoscopic IPFLR alone, and group B of 67 patients reciving laparoscopic IPFLR combined with PPH. The degree of internal rectal prolapse (DIRP), Wexner constipation scale (WCS) score, Wexner incontinence scale (WIS) score, and Gastrointestinal Quality of Life Index (GIQLI) score were compared between these two groups and in each group those before surgery and 6 months, 2 years, and 5 years after surgery.Results:The number of bowel movements , DIRP, WCS score, WIS score, and GIQLI score before surgery were not significantly different between the two groups (all P>0.05). The DIRP, WCS score, WIS score, and GIQLI score in each group 6 months, 2 years, and 5 years after surgery in both two groups were significantly better than those before surgery (all P<0.001). The DIRP, WCS score, WIS score, and GIQLI score in group B were significantly better than those in group A at 6 months, 2 years, and 5 years after surgery (all P<0.05) except DIRP at 2 years after surgery (all P<0.05). There was a significant difference in the recurrence rate of IRP between the two groups when evaluated at 5 years after surgery ( P=0.001). Conclusions:Integral theory-guided laparoscopic IPFLR combined with PPH has a higher cure rate and a better clinical efficacy than laparoscopic IPFLR alone.