OBJECTIVE: To assess the effectiveness and safety of Xianling Gubao(XLGB) Capsule in the treatment of osteoporotic fracture(OF). METHODS: Published articles from eight Chinese and English databases were searched from ...OBJECTIVE: To assess the effectiveness and safety of Xianling Gubao(XLGB) Capsule in the treatment of osteoporotic fracture(OF). METHODS: Published articles from eight Chinese and English databases were searched from inception to August 2017. Clinical trials were selected according to inclusion criteria and exclusion criteria. Risk evaluation tool was used to assess the quality of studies. Data was extracted and meta-analysis was performed by RevMan5.3 software. RESULTS: A total of 229 articles were searched, and 27 were included for study with 2292 samples,including 1152 cases in the experiment group and 1140 cases in the control group. For patients with four limbs OF,XLGB Capsule combined with manipulation reposition with plaster external fixation can shorten healing time of fracture[MD=–0.77, 95% CI(–1.25, –0.30)], increase bone mineral density(BMD) [MD=0.17, 95% CI(0.10, 0.25)], blood calcium content [MD=0.52, 95% CI(0.38, 0.64)], phosphorous content in serum [MD=0.28, 95% CI(0.21, 0.35)], and alkaline phosphatase content [SMD=–5.24, 95% CI(–3.45, –2.42)]. In the treatment of spine OF, XLGB Capsule had no significant effects on reducing re-fracture rate of non-surgical vertebral body, but it could postpone the interval time of refracture of non-surgical vertebral bodies [RR=0.71, 95% CI(0.23, 2.18)]. Combined treatment with XLGB Capsule could improve clinical effective rate [RR=1.17, 95% CI(1.11, 1.23)]. Both alone and combined application of XLGB Capsule could increase BMD and calcitonin content of patients with spine OF. Combined application of calcium or medicine that regulating calcium metabolism was faster in reducing Cobb angle of centrum kyphosis than application alone [MD=–2.68,95% CI(–3.72, –2.12)]. Alone or combined application showed no significant effects on osteoporotic pain. The adverse reactions reported in the study were mainly the digestive system damage. CONCLUSIONS: XLGB Capsule alone or combine with other western medicine had better efficacy in treating OF than western medicine treatment alone. However,there was potential bias in the included studies, so the conclusion still needed further high quality randomized controlled trials to improve the evidence level.展开更多
Objective:To study the effect of Xianling Gubao-assisted surgical treatment on postoperative healing, calcium and phosphorus contents as well as bone metabolism in elderly women with Colles fracture.Methods:A total of...Objective:To study the effect of Xianling Gubao-assisted surgical treatment on postoperative healing, calcium and phosphorus contents as well as bone metabolism in elderly women with Colles fracture.Methods:A total of 96 elderly female patients with Colles fracture treated in our hospital between June 2013 and December 2015 were selected and randomly divided into two groups, the observation group of patients received Xianling Gubao capsule combined with manual reduction and plaster external fixation therapy, and control group of patients only received reduction and external fixation therapy. The fracture healing time was followed up after treatment, and 3 months after treatment, serum was collected to determine the content of calcium-phosphorus metabolism indexes and bone metabolism indexes.Results:The fracture healing time of observation group was significantly shorter than that of control group;1 month and 3 months after treatment, serum Ca, P, ALP, IGF-1, PDGF, BGP and PICP levels of both groups were significantly higher than those before treatment while CTX-1, tPINP and TRACP-5b levels were significantly lower than those before treatment;serum Ca, P, ALP, IGF-1, PDGF, BGP and PICP levels of observation group after treatment were significantly higher than those of control group while CTX-1, tPINP and TRACP-5b levels were significantly lower than those of control group.Conclusion:Adjuvant Xianling Gubao capsule therapy can promote the Colles fracture healing in elderly women, also improve calcium-phosphorus metabolism, promote bone formation and inhibit bone resorption.展开更多
Objective:A typical case of Xianling Gubao(XLGB)Tablets-induced liver injury was systematically studied in the clinic and the laboratory.Methods:A patient with herb-induced liver injury(HILI)and a history of taking XL...Objective:A typical case of Xianling Gubao(XLGB)Tablets-induced liver injury was systematically studied in the clinic and the laboratory.Methods:A patient with herb-induced liver injury(HILI)and a history of taking XLGB Tablets before disease onset was engaged as the study subject,and the case was diagnosed according to the updated Roussel Uclaf Causality Assessment Method(RUCAM)and the integrated evidence chain(iEC)method recommended by the Guidelines for Diagnosis and Treatment of Herb-induced Liver Injury(HILI Guidelines).Results:Clinical history,biochemical indexes and imaging tests were used to exclude the influence of fundamental diseases and confusing liver diseases such as viral,alcoholic and autoimmune liver diseases on the diagnosis.Based on an investigation of the patient’s medication history,she was suspected to have HILI caused by XLGB Tablets,as the patient was only taking an oral preparation of XLGB Tablets,and the influence of other drugs on the diagnosis was excluded.This patient with alanine aminotransferase(ALT)3 upper limit of normal(ULN)and a calculated R of 6 was diagnosed with possible acute drug-induced hepatocellular injury.The relationship was considered“highly probable”(score of 9)using the updated RUCAM of 2016.Moreover,the fingerprint similarity between the preparation taken by the patient and a commercially available preparation was 0.99,suggesting that the patient was consuming XLGB Tablets rather than another drug.LC-MS technology and the Agilent Fake TCM-Drugs database were used to investigate the drug,and no chemical additions were found.Examination of the drug for pesticide residues,heavy metals,aflatoxins and other exogenous substances indicated compliance with the content limits of the Chinese Pharmacopoeia.Conclusion:In summary,the final diagnosis of XLGB-induced liver injury reached the clinical diagnosis of HILI and was acute severe hepatocellular injury type by the updated RUCAM and iEC.Therefore,this study provides scientific evidence regarding the causality evaluation of compound preparations of traditional Chinese medicines-induced liver injury.展开更多
系统评价仙灵骨葆胶囊上市后用药安全性,计算机检索Medline,EMbase,the Web of Science,Clinical Trials.gov,the Cochrane Library,CNKI,VIP,Wan Fang Data,CBM。按纳入、排出标准筛选文献,依据国际公认的质量评价标准进行各类研究质...系统评价仙灵骨葆胶囊上市后用药安全性,计算机检索Medline,EMbase,the Web of Science,Clinical Trials.gov,the Cochrane Library,CNKI,VIP,Wan Fang Data,CBM。按纳入、排出标准筛选文献,依据国际公认的质量评价标准进行各类研究质量的评价,提取资料并进行分析。该研究最终纳入156篇文献,随机对照试验117篇,半随机对照试验11篇,非随机对照试验10篇,病例系列11篇,个案报告7篇,共分析167项研究。7 496例患者使用仙灵骨葆胶囊,累计发生不良反应共377例,严重不良反应4例,其中包含1例死亡病例,1例脑血管意外,1例皮肤过敏反应和1例胃肠道不适;轻度ADR中最常见为胃肠损害。该研究分析发现仙灵骨葆胶囊总体安全性可接受,虽系统分析了关于该药安全性病例报告的直接证据,但缺少针对该药上市后安全性的机制研究或前瞻性长期的临床观察性研究,因此关于其安全性研究还需进一步深入;同时仙灵骨葆胶囊在适应症方面,临床中存在超说明书使用范围,因此需要相关部门尽快制定用药规范,给临床用药提供更好的指导。展开更多
文摘OBJECTIVE: To assess the effectiveness and safety of Xianling Gubao(XLGB) Capsule in the treatment of osteoporotic fracture(OF). METHODS: Published articles from eight Chinese and English databases were searched from inception to August 2017. Clinical trials were selected according to inclusion criteria and exclusion criteria. Risk evaluation tool was used to assess the quality of studies. Data was extracted and meta-analysis was performed by RevMan5.3 software. RESULTS: A total of 229 articles were searched, and 27 were included for study with 2292 samples,including 1152 cases in the experiment group and 1140 cases in the control group. For patients with four limbs OF,XLGB Capsule combined with manipulation reposition with plaster external fixation can shorten healing time of fracture[MD=–0.77, 95% CI(–1.25, –0.30)], increase bone mineral density(BMD) [MD=0.17, 95% CI(0.10, 0.25)], blood calcium content [MD=0.52, 95% CI(0.38, 0.64)], phosphorous content in serum [MD=0.28, 95% CI(0.21, 0.35)], and alkaline phosphatase content [SMD=–5.24, 95% CI(–3.45, –2.42)]. In the treatment of spine OF, XLGB Capsule had no significant effects on reducing re-fracture rate of non-surgical vertebral body, but it could postpone the interval time of refracture of non-surgical vertebral bodies [RR=0.71, 95% CI(0.23, 2.18)]. Combined treatment with XLGB Capsule could improve clinical effective rate [RR=1.17, 95% CI(1.11, 1.23)]. Both alone and combined application of XLGB Capsule could increase BMD and calcitonin content of patients with spine OF. Combined application of calcium or medicine that regulating calcium metabolism was faster in reducing Cobb angle of centrum kyphosis than application alone [MD=–2.68,95% CI(–3.72, –2.12)]. Alone or combined application showed no significant effects on osteoporotic pain. The adverse reactions reported in the study were mainly the digestive system damage. CONCLUSIONS: XLGB Capsule alone or combine with other western medicine had better efficacy in treating OF than western medicine treatment alone. However,there was potential bias in the included studies, so the conclusion still needed further high quality randomized controlled trials to improve the evidence level.
文摘Objective:To study the effect of Xianling Gubao-assisted surgical treatment on postoperative healing, calcium and phosphorus contents as well as bone metabolism in elderly women with Colles fracture.Methods:A total of 96 elderly female patients with Colles fracture treated in our hospital between June 2013 and December 2015 were selected and randomly divided into two groups, the observation group of patients received Xianling Gubao capsule combined with manual reduction and plaster external fixation therapy, and control group of patients only received reduction and external fixation therapy. The fracture healing time was followed up after treatment, and 3 months after treatment, serum was collected to determine the content of calcium-phosphorus metabolism indexes and bone metabolism indexes.Results:The fracture healing time of observation group was significantly shorter than that of control group;1 month and 3 months after treatment, serum Ca, P, ALP, IGF-1, PDGF, BGP and PICP levels of both groups were significantly higher than those before treatment while CTX-1, tPINP and TRACP-5b levels were significantly lower than those before treatment;serum Ca, P, ALP, IGF-1, PDGF, BGP and PICP levels of observation group after treatment were significantly higher than those of control group while CTX-1, tPINP and TRACP-5b levels were significantly lower than those of control group.Conclusion:Adjuvant Xianling Gubao capsule therapy can promote the Colles fracture healing in elderly women, also improve calcium-phosphorus metabolism, promote bone formation and inhibit bone resorption.
基金supported by the National Natural Science Foundation of China(No.82174071).
文摘Objective:A typical case of Xianling Gubao(XLGB)Tablets-induced liver injury was systematically studied in the clinic and the laboratory.Methods:A patient with herb-induced liver injury(HILI)and a history of taking XLGB Tablets before disease onset was engaged as the study subject,and the case was diagnosed according to the updated Roussel Uclaf Causality Assessment Method(RUCAM)and the integrated evidence chain(iEC)method recommended by the Guidelines for Diagnosis and Treatment of Herb-induced Liver Injury(HILI Guidelines).Results:Clinical history,biochemical indexes and imaging tests were used to exclude the influence of fundamental diseases and confusing liver diseases such as viral,alcoholic and autoimmune liver diseases on the diagnosis.Based on an investigation of the patient’s medication history,she was suspected to have HILI caused by XLGB Tablets,as the patient was only taking an oral preparation of XLGB Tablets,and the influence of other drugs on the diagnosis was excluded.This patient with alanine aminotransferase(ALT)3 upper limit of normal(ULN)and a calculated R of 6 was diagnosed with possible acute drug-induced hepatocellular injury.The relationship was considered“highly probable”(score of 9)using the updated RUCAM of 2016.Moreover,the fingerprint similarity between the preparation taken by the patient and a commercially available preparation was 0.99,suggesting that the patient was consuming XLGB Tablets rather than another drug.LC-MS technology and the Agilent Fake TCM-Drugs database were used to investigate the drug,and no chemical additions were found.Examination of the drug for pesticide residues,heavy metals,aflatoxins and other exogenous substances indicated compliance with the content limits of the Chinese Pharmacopoeia.Conclusion:In summary,the final diagnosis of XLGB-induced liver injury reached the clinical diagnosis of HILI and was acute severe hepatocellular injury type by the updated RUCAM and iEC.Therefore,this study provides scientific evidence regarding the causality evaluation of compound preparations of traditional Chinese medicines-induced liver injury.
文摘系统评价仙灵骨葆胶囊上市后用药安全性,计算机检索Medline,EMbase,the Web of Science,Clinical Trials.gov,the Cochrane Library,CNKI,VIP,Wan Fang Data,CBM。按纳入、排出标准筛选文献,依据国际公认的质量评价标准进行各类研究质量的评价,提取资料并进行分析。该研究最终纳入156篇文献,随机对照试验117篇,半随机对照试验11篇,非随机对照试验10篇,病例系列11篇,个案报告7篇,共分析167项研究。7 496例患者使用仙灵骨葆胶囊,累计发生不良反应共377例,严重不良反应4例,其中包含1例死亡病例,1例脑血管意外,1例皮肤过敏反应和1例胃肠道不适;轻度ADR中最常见为胃肠损害。该研究分析发现仙灵骨葆胶囊总体安全性可接受,虽系统分析了关于该药安全性病例报告的直接证据,但缺少针对该药上市后安全性的机制研究或前瞻性长期的临床观察性研究,因此关于其安全性研究还需进一步深入;同时仙灵骨葆胶囊在适应症方面,临床中存在超说明书使用范围,因此需要相关部门尽快制定用药规范,给临床用药提供更好的指导。
