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OBJECTIVE：To systematically evaluate the efficacy and safety of Xianling gubao capsule combined with glucosamine in the treatment of knee osteoarthritis （KOA），and to provide evidence-based reference for clinical treatment of KOA. METHODS：Retrieved from Cochrane library ，PubMed，Embase，CNKI，Wanfang database ，CBM and VIP during the inception to Nov. 2020，randomized controlled trials （RCTs）about glucosamine （control group ）combined with Xianling gubao capsule （trial group）in the treatment of KOA were collected. After data extraction ，Cochrane 5.1.0 system evaluator manual was used to evaluate the quality of the included clinical studies met inclusion criteria ，and Rev Man 5.4 software was used for Meta-analysis. RESULTS ： A total of 11 RCTs with 970 patients were included in this study. Results of Meta-analysis showed that cure rate [OR ＝2.41，95％CI （1.48，3.93），P＜0.001]，marked effective rate [OR ＝1.95，95％CI（1.49，2.56），P＜0.001]，total effective rate [OR ＝4.00，95％CI （2.57，6.24），P＜0.001]，visual analogue scale （VAS）score [MD ＝－2.34，95％CI（－2.51，－2.17），P＜0.001]，knee function score [MD ＝31.32，95％CI（27.89，34.75），P＜0.001]，Japanese Orthopaedic Association （JOA）low back pain score [MD ＝ 12.22，95％CI（9.68，14.76），P＜0.001] and pain relief time [MD ＝－1.55，95％CI（－1.84，－1.25），P＜0.001] of trial group were all significantly better than those of control group. The incidence of ADR in trial group was significantly lower than control group [OR ＝0.04，95％CI（0.02，0.12），P＜0.001]. CONCLUSIONS ：Xianing gubao capsule combined with glucosamine in the treatment of KOA is significantly better in cure rate ，marked effective rate ，total effective rate ，VAS，score，knee function score，JOA low back pain score and pain relief time ，and could significantly reduce the incidence of ADR.
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BACKGROUND: Xianling Gubao Capsule can reduce bone loss and promote the formation of osteoblasts. Its efficacy in osteoporosis and fracture has been preliminarily confirmed, but its efficacy in postmenopausal female periodontitis has not been clarified. OBJECTIVE: To assess the effect of Xianling Gubao Capsule on alveolar bone mass in postmenopausal women with periodontitis by cone-beam CT, providing an effective basis for its clinical use. METHODS: One hundred and thirty-five patients with periodontitis diagnosed and treated in the Department of Stomatology, First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine from October 2015 to April 2017 were enrolled. All patents were randomly divided into blank group (basic treatment), control group (basic treatment+vitamin D) and experimental group (basic treatment+Xianling Gubao Capsule), with 45 patients in each group. All patients received oral hygiene and health education, and were guided to brush their teeth correctly and self-control plaques. Basic treatments for periodontal disease were performed to eliminate plaque and calculus by cleaning and curing the gums, and smoothing the root surface, once 3 months for 6 continuous months. The control group received oral Calci-D (600 mg of calcium and 125 U of vitamin D per tablet), one tablet per day, for 6 continuous months. The experimental group was orally given Xianling Gubao Capsule 1.0 g/time, 3 times per day, 3 months as a course of treatment, for two consecutive courses. Cone-beam CT was used to detect the changes of bone mineral density and height of alveolar bone defect in all patients before treatment, 3 and 6 months after treatment. Ethics approval was obtained from the First Affiliated Hospital of Guiyang College of Traditional Chinese Medicine on May 29, 2015 (approval No. K2015-186). RESULTS AND CONCLUSION: (1) Compared with the baseline, the alveolar bone defect height was significantly reduced in the experimental and control groups (P 0.05). The improvement of alveolar bone defect height and bone density was better in the experimental group than the control group (P 0.05). The alveolar bone defect height and bone mineral density of the patients older than 55 years had no changes (P > 0.05). (3) Alveolar bone defect height and bone mineral density were significantly improved in patients with mild and moderate periodontitis (P 0.05). To conclude, the treatment of periodontitis by Xianling Gubao Capsule can significantly improve the alveolar bone defect height and bone mineral density, and cone-beam CT can be used to evaluate its clinical efficacy.
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OBJECTIVE: To establish the fingerprint of Xianling Gubao Capsules (XLGB) by multi-wavelength HPLC-UVD-ELSD and determine the main representative components simultaneously, in order to provide reference for the overall quality control of XLGB.METHODS: The separation was developed on Poroshell 120 EC-C18 column (4.6 mm×100 mm, 2.7 μm) by gradient elution with methanol-water at 240, 270 and 334 nm, the temperature of drift tube was maintained at 105 ℃ and the carrier gas flow rate was 2.0 L•min-1. An HPLC-UVD-ELSD fingerprint of XLGB was set up, and 15 batches of XLGB were evaluated by similarity assay. Furthermore, the contents of the main representative components were determined on the premise of small disparities between batches. RESULTS: The multi-wavelength HPLC-UVD-ELSD fingerprint of XLGB was established with good separation, and six chemical components were determined simultaneously. Thirty-one main characteristic peaks from six herbs of XLGB were chemically identified and 26 main characteristic peaks were assigned to individual herbs. The similarity of 15 batches of XLGB was about 0.943 to 0.997. Moreover, good linear relationships were found (r=0.999 0-0.999 6), and the average recovery rates were 98.5%-104.9%. CONCLUSION: The method can be used for the overall quality control of XLGB with good specificity and high efficiency and is close to the actual production, which is promising to be further improved to be used as an industry internal control standard.
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Objective To explore the characteristics of Xianling Gubao Capsule (XGC) induced adverse reactions, especially drug-induced liver injury, and the occurrence and prognosis of ADR, aiming to provide a reference for clinical rational drug use, and ideas for after-marketing re-evaluation of Chinese materia medica. Methods A total of 788 patients were enrolled in one tertiary hospital to observe the clinical application safety of XGC based on real-word study. Results Compared with the conventional treatment group, the incidence of ADR in the treatment group showed no significant difference (P > 0.05) in XGC group. XGC group had the highest incidence of adverse gastrointestinal reactions (83.0%), and a higher incidence of abdominal distension (P 0.05). Pre-drug liver abnormalities or patients with underlying liver disease were more likely to have drug induced liver injury (30.4%). Conclusion Monitoring adverse reactions of XGC should be enhanced in order to promote the rational use and ensure the safety in clinic.
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OBJECTIVE:To study the effects of new Xianling gubao capsule on fracture healing in rats,and to provide reference for seeking new formula of"to reduce stockpiles and increase efficiency(to reduce stockpiles and constant efficiency)".METHODS:Rats were randomly divided into sham operation group(distilled water),model group(distilled water),Xianling gubao capsule group (350 mg/kg),new Xianling gubao capsule low-dose,medium-dose and high-dose groups (53,105,210 mg/kg),with 14 rats in each group. Except for sham operation group,right middle femur fracture model was established under the anesthetic state. Rats were given relevant medicine 10 mL/kg intragastrically after woken,once a day,for consecutive 4 weeks.After last administration,body weights of rats were determined;the formation of callus and histopathological changes in fracture were observed;biomechanics of fracture side(fracture stress and bone crushing force)was measured. The levels of inflammatory factors (TNF-α ,IL-1 β) in serum were detected by ELISA. RESULTS:Compared with sham operation group,body weight,fracture stress and bone crushing force of fracture side were decreased significantly(P<0.05 or P<0.01),while the serum levels of TNF-α and IL-1 β were increased significantly(P<0.01). In model group,the scab was visible around the fracture,and the trabecular bone was not mature and arranged in confusion. Compared with model group,body weights of rats were increased significantly in new Xianling gubao capsule high-dose group and Xianling gubao capsule group (P<0.05);fracture stress of fracture side were increased significantly in new Xianling gubao capsule medium-dose and high-dose groups and Xianling gubao capsule group(P<0.05 or P<0.01). The serum levels of TNF-α and IL-1β were decreased significantly(P<0.01). There was no statistical significance in above indexes among new Xianling gubao capsule groups and Xianling gubao capsule group(P>0.05).The area of the callus in each group was smaller;the fracture line became blurred;the fracture trace disappeared and the number of bone trabeculae increased. The cortical layer was thickened,and a large number of capillary implants were found in the bone marrow cavity. CONCLUSIONS:New Xianling gubao capsule has a significant role in promoting fracture healing,and can effectively improve the strength of bone biomechanics and inhibit the inflammatory reaction.
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To investigate the effect of Xianling Gubao capsule in preventing postmenopausal osteoporosis, forty-eight female Wistar rats were randomly divided into four groups: sham group (Sham), ovariectomized group (OVX), ethinylestradiol group (EE) and Xianling Gubao capsule group (XLGB). Rats in each group received ovariectomy, except for sham group. The XLGB group received Xianling Gubao capsule at the dose of 378 mg·kg⁻¹·d⁻¹. The dosage of EE group was 200 μg·kg⁻¹·d⁻¹, and OVX and Sham groups were only fed with equal volume of distilled water. All of the rats were put to death two months later. Bone mineral density, bone biomechanics, bone histomorphometry Micro-CT scanning and organ index of vital organs were calculated and pathologically observed. There was no significant difference in the body weight of rats and organ indexes of lung, kidney, heart and spleen in the experimental groups. There was also no significant change in their pathological observation, but the uterine index of OVX group and XLGB group was significantly lower than that of Sham group. According to the results of BMD test, compared with the OVX group, femurs and vertebrae BMD of the other three groups were increased, with statistically significant differences. On the basis of the results of bone biomechanical test, compared with OVX group, the maximum load values of femur and vertebrae of the other three groups were increased, with statistically significant differences, while the change of elastic modulus was not statistically significant. According to the bone histomorphometry results of VG staining, compared with Sham group, the number of trabecular bone was significantly lower than that in OVX group. Compared with OVX group, the number of trabecular bone in EE group and XLGB group was increased, but with no significant difference between EE and XLGB groups. The results of serum biochemical indexes showed that compared with Sham group, osteocalcin (OC) decreased, while tartrate resistant acid phosphatase 5b (TRACP 5b) increased in OVX group, with statistically significant differences. Compared with OVX group, the OC content of XLGB group and EE group increased, while the content of TRACP 5b decreased, with statistically significant differences. On the basis of the results of Micro-CT scanning, the change trends of femur volume BMD, number of trabecular bone (Tb.N), trabecular bone thickness (Tb.Th), trabecular bone separation (Tb.Sp), bone volume/tissue volume (BV/TV) in the groups were consistent with those of bone histomorphometry. There was no significant change in femoral cortical bone between the two groups. Xianling Gubao capsule can prevent osteoporosis in ovariectomized rats. The possible mechanism is the dual activity of inhibiting bone resorption and improving bone formation.
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OBJECTIVE:To investigate the regularity and characteristics of adverse drug reactions (ADR) induced by Xianling gubao capsule,and to provide reference for rational drug use in the clinic.METHODS:ADR induced by Xianling gubao capsule were retrieved from CJFD,CBM,Wanfang database,VIP during Jan.2007-Oct.2016.The related information of 185 ADR cases were statistically analyzed.RESULTS:Among 185 patients,primary disease was mainly osteoporosis (63 cases,34.05％).The incidence of ADR induced by drug combination (70.81％) was higher than single drug (29.19％).ADR mostly occurred within 90 d after medication (67.03％).Main clinical manifestation was digestive system damage (82.68％).Most patients (61.62％) did not need treatment,symptomatic treatment or drug withdrawal to relieve ADR symptoms.CONCLUSIONS:The monitoring for ADR induced by Xianling gubao capsule should be strengthened in clinic,especially for ADR of liver fuction,soas to promote rational drug use.
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OBJECTIVE:To investigate the regularity and characteristics of adverse drug reactions (ADR) induced by Xianling gubao capsule,and to provide reference for rational drug use in the clinic.METHODS:ADR induced by Xianling gubao capsule were retrieved from CJFD,CBM,Wanfang database,VIP during Jan.2007-Oct.2016.The related information of 185 ADR cases were statistically analyzed.RESULTS:Among 185 patients,primary disease was mainly osteoporosis (63 cases,34.05％).The incidence of ADR induced by drug combination (70.81％) was higher than single drug (29.19％).ADR mostly occurred within 90 d after medication (67.03％).Main clinical manifestation was digestive system damage (82.68％).Most patients (61.62％) did not need treatment,symptomatic treatment or drug withdrawal to relieve ADR symptoms.CONCLUSIONS:The monitoring for ADR induced by Xianling gubao capsule should be strengthened in clinic,especially for ADR of liver fuction,soas to promote rational drug use.
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To evaluate the efficacy and safety of Xianling Gubao capsule in the treatment of osteoporosis (OP). Eight Chinese and English databases were retrieved (from establishment to February 2017), and clinical trials were screened according to the preset inclusion criteria and exclusion criteria. Then risk assessment tools were used for quality evaluation of the studies, and data extraction and analysis were conducted by using RevMan 5.3 software for Meta-analysis. A total of 1 895 articles were retrieved, and finally 54 studies were included. The total sample number was 5 030, including 2 543 cases in experimental group and 2 487 cases in control group. As compared with CT (routine therapy) intervention, Xianling Gubao capsules showed higher SOP efficiency and improved bone mineral density in patients with OP [MD=0.08, 95%CI (0.06, 0.10)]. As compared with control group, Xianling Gubao capsule+CT showed higher efficiency in PMOP and SOP, increased bone mineral density in OP patients [MD=0.04, 95%CI (0.03, 0.05)], POP patients [MD=0.08, 95%CI (0.05, 0.10)], and SOP patients [MD=0.06, 95%CI (0.05, 0.07)], relieved osteoporotic pain in OP patients [MD=-0.93,95%CI(-1.16, -0.70), increased alkaline phosphatase level in OP patients [MD=7.53, 95%CI (5.91, 9.14), blood calcium in OP patients [MD=0.03, 95%CI (0.01, 0.06)], and osteocalcin level in OP patients [MD=4.09, 95%CI (3.20, 4.98)], and increased serum phosphorus level in SOP patients [MD=0.03, 95%CI (0.00, 0.05)]. The main adverse reactions reported were liver injury and gastrointestinal symptoms. Xianling Gubao capsule alone or combined use with other medicines had better efficacy than western medicine alone in the treatment of osteoporosis. However, because of potential bias in the included studies, more high-quality randomized controlled trials would be needed to improve the level of evidence.
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To systemically evaluate the safety of Xianling Gubao capsule after launching. Computer retrieval of Medline, EMbase, the Web of Science, Clinical Trials. gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM was conducted to collect information on all the research types of Xianling Gubao capsule. The literature was screened according to inclusion and exclusion criteria, and the quality of the studies was assessed according to the internationally accepted quality evaluation standards for data extraction and analysis. A total of 156 papers were included in this study, including 117 randomized control trials, 11 quasi-randomized control trials, 10 non-randomized control trials, 11 case report series, and 7 individual case reports; a total of 167 studies were analyzed. Xianling Gubao capsules were used in 7 496 patients, with an accumulative 377 cases of adverse reactions (ADR) and 4 cases of severe adverse reactions, including 1 death, 1 cerebrovascular accident, 1 case of skin allergy reaction, and 1 case of gastrointestinal discomfort; gastrointestinal system damage was most common in mild ADRs. In this study, we found that the overall safety of Xianling Gubao capsule was acceptable, but it lacked the mechanism study on the safety of the drug after marketing or the prospective long-term clinical observation study, so the further studies on the safety of drug use should be conducted. Meanwhile, the application scope of Xianling Gubao capsules was beyond the manual, in urgent needs of the relevant departments to formulate norms and provide better guidance for clinical medication.
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Objective To explore the effect of percutaneous kyphoplasty (PKP) combined with Xianling Gubao capsule on treatment of osteoporotic vertebral compression fractures(OVCF).Methods 118 postmenopausal women diagnosed as OVCF and meeting the standard were collected from Mar.2012 to Jul.2016 in our hospital.They were randomly divided into two groups:observation group and the control group.General information of the two groups were comparable.The patients of the control group received PKP combined with traditional anti-osteoporosis therapy.The patients of observation group received Xianling Gubao capsule on the basis of the control group.The lumbar bone density (BMD,greater trochanter BMD,femoral neck BMD,Ward triangle BMD,the Japanese orthopaedic association(JOA)score,the visual analogue score (VAS) score,the serum levels of osteoprotegerin (OPG),receptor activator of nuclear factor-κB ligand (RANKL)and adverse reactions were recorded during the treatment.Results The lumbar BMD,greater trochanter BMD,femoral neck BMD,Ward triangle BMD of observation group at 6-month after operation were higher than those before operation and those of control group (P＜0.05).The VAS score and JOA score of the observation group were superior to those of the control group at 6-month after operation (P＜0.05).The serum levels of OPG of observation group were higher than those of control group,while the serum levels of RANKL of observation group were lower than those of control group at 6-month after operation (P＜0.05).No severe adverse reactions occurred in the two groups during the treatment.Conclusion Xianling Gubao capsule can significantly improve bone metabolism of postmenopausal women with osteoporotic vertebral compression fractures after percutaneous kyphoplasty,increasing BMD,improving lumbar function,relieving pain,without increasing complication rates.
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Objective: To determine asperosaponin VI, psoralen, and angelicin in Xianling Gubao Capsules (XGC) via multi- wavelength HPLC method. Methods: Separation was carried out on Welch Ultimate® XB-C18 column. The mobile phase was acetonitrile-water system and a linear gradient elution was used. The column temperature was 30℃. The detection wavelength for asperosaponin VI was set at 212 nm, those for psoralen and angelicin were set at 246 nm. Results: Three components reached baseline separation, the linearity was good when sample volumes were in the ranges of 144.1-5 764.0 for asperosaponin VI (r = 0.999 6), 5.4-215.2 (r = 0.998 0) for psoralen, and 6.6-265.6 ng (r = 0.998 5) for angelicin. The average recoveries of asperosaponin VI, psoralen, and psoralen were 98.11%, 97.86%, and 98.22%, respectively. The RSDs of recoveries were all less than 2.0%. Conclusion: The method is simple and accurate and has good separation, with high sensitivity and good efficiency for the determination of more-index components in XGC.
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Objective: To investigate the positioning based on the relative retention time of fingerprinting and to establish a new quality evaluation method for traditional Chinese medicine preparations, using one chemical reference substance to calcutate multi- components simultaneously. Methods: Employed icariin as the maker component, icariin relative correction factors (RCF) of epimedin C to icariin, asperosaponin VI to icariin, psoralen to icariin and angelicin to icariin were ealeatated in the chromatographic conditions for determination of the four components in Xianling Gubao Capsule (XGC). The contents of icariin were determined by external standard method, and those of epimedin C, asperosaponin VI, psoralen and angelicin were calculated by icariin and their RCF. The accuracy of the new method was evaluated by comparing the relative retention times and calculating the content which using different brands columns for determination. Results: The analysis methods were established,the linearity was good when sample volume was in the range of at 8.2—328.0 ng for icariine(r = 0.999 5), 0.055 6—2.224 μg for epimedin C (r = 0.999 6), 0.144 1—5.764 μg for asperosaponin VI (r = 0.999 6), 5.4—215.2 ng (r = 0.998 0) for psoralen, 6.6—265.6 ng (r = 0.998 5) for angelicin. The average recoveries of asperosaponin VI, psoralen and psoralen were 97.59%, 98.58%, 98.11%, 97.86%, 98.22%, respectively. The RSDs of recovery were all less than 2.0%; There has been no significant difference between the calculated contents and the determined contents, according to the angle cosine value. Conclusion: The method can control the components without providing epimedin C, asperosaponin VI, psoralen, and angelicin reference. The method is not only save reference substance and medicine resources, but also suitable quality evaluation pattern for TCM preparation. This new method made fingerprinting more meaningful in TCM quality control.
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OBJECTIVE:To investigate the effects of Ossotide tabletcombined with Xianling gubao capsule on the postoperative recovery effect oftrans-traumatic-verterbrae screw-setting combined with bone grafting in the treatment of osteoporotic thoracolum-bar vertebral fractures. METHODS:122 patients with osteoporotic thoracolumbar vertebral fractures who were treated with trans-traumatic-verterbrae screw-setting combined with bone grafting were randomly divided into control group and observation group.The two groups were treated by trans-traumatic-verterbrae screw-setting with bone grafting.Based on this,the control group was treated with 0.3-0.6 g Ossotide tablet,three times a day,taken orally after meals;observation group was additionally treated with 1.5 g Xianling gubao capsule,twice a day,taken orally after meals. Both of the two groups took medicine on the day of oper-ation. A course induded 4 weeks,and it lasted 4 courses. The indexes were observed after 3 and 6 months treatment. The changes of pain score,bone mineral density(BMD)levels,bone gla protein(BGP),bone alkali phsphatase(BALP),procollagen I ntermi-nal peptide (PINP) and other bone metabolism biochemical indexes in 2 groups before and after treatment were observed.Mean-while,the clinical efficacy,rates of thoracolumbar vertebral refractures and incidence of adverse reactions in the 2 groups were re-corded.RESULTS:After treatment,the total effective rate in observation group was significantly higher than control group,pain scores in 2 groups were significantly lower than before,and general decreased by time,observation group was lower than control group;BMD,BGP,BALP and PINP levels in 2 groups were significantly higher than before,and general increased by time,ob-servation group was higher than control group;after 6 months,BMD,BALP and PINP levels in control group were significantly higher than before,the differences were statistically significant(P0.05). CONCLUSIONS:Ossotide tablet com-bined with Xianling gubao capsule can significantly improve the bone metabolism biochemical indexes of patients,promote bone mineral density and fracture healing,with good safety in short-term medication.
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Objective To investigate the clinical effect of hyperbaric oxygen combined with Xianling Gubao capsule in delayed union of elderly proximal femoral fractures.Methods 64 elder patients with proximal femoral fracture form May 2013 to December 2015 in our hospital were selected and divided into two groups.32 cases in the control group were treated with routine clinical treatment, and 32 cases in the experimental group were treated on the basis of the control group with Xianling Gubao capsule combined with hyperbaric oxygen.Fracture healing time and clinical efficacy were compared after the treatment.Results The fracture healing time of experimental group was shorter than that in control group ( P0.05).Conclusion Xianling Gubao capsule combined with hyperbaric oxygen in the treatment of delayed union of proximal femoral fractures in elderly patients has better clinical curative effect and high safety.