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中药骨疏康胶囊治疗原发性骨质疏松症的系统评价和 Meta 分析。

Chinese medicine Gushukang capsule for treating primary osteoporosis: a systematic review and meta-analysis.

机构信息

Shaanxi University of Chinese Medicine, Xianyang, 712046, China.

Southwest Medical University, Luzhou, 646000, China.

出版信息

J Orthop Surg Res. 2023 Nov 8;18(1):845. doi: 10.1186/s13018-023-04264-9.

Abstract

OBJECTIVE

To systematically evaluate the efficacy and safety of Gushukang (GSK) capsules in the treatment of primary osteoporosis.

METHODS

Randomized controlled trials related to the treatment of primary osteoporosis were collected through online retrieval of the China National Knowledge Infrastructure (CNKI), Wanfang database, Chinese Biomedical Literature Database (Sino-Med), VIP, US National Library of Medicine (PubMed), Web of Science and Cochrane library. The literature was searched from January 1, 2000, to March 17, 2022. The risk bias and quality of the trials included in the meta-analysis were evaluated with the Cochrane Collaboration's risk assessment tool. The effect size was expressed as risk ratios (RRs) or mean differences (MDs) with 95% confidence intervals (CIs).

RESULTS

A total of 24 randomized controlled clinical trials (RCTs) were incorporated into this systematic review. The 2363 patients were all primary osteoporosis patients, of whom 1197 were in the observation group and 1166 were in the control group. GSK capsule group was superior to conventional medication group in improving beta type I collagen carboxy-terminal peptide (β-CTX) (MD - 0.28, 95% CI [- 0.31, - 0.25]), while in improving prepeptide of type I procollagen (PINP), conventional medications group was superior to GSK capsule group (MD - 1.37, 95% CI [- 1.92, - 0.82]), and there were no significant differences between the two groups in overall efficacy (OE) (OR 1.62, 95% CI [0.89, 2.98]), increase of bone mineral density (BMD) (lumbar spine: MD - 0.02, 95% CI [- 0.08, 0.04]; femoral neck: MD - 0.01, 95% CI [- 0.07, 0.05]; hip: MD 0.01, 95% CI [- 0.02, 0.02]), enhancement of alkaline phosphatase (ALP) (MD - 1.37, 95% CI [- 13.29, 10.55]), serum calcium (S-Ca) (MD 0.02, 95% CI [- 0.13, 0.17]), bone glutamyl protein (BGP) (MD 3.75, 95% CI [- 12.26, 19.76]), safety (OR 0.37, 95% CI [0.07, 2.02]) and pain relief (MD 0.32, 95% CI [- 0.59, 1.22]). GSK capsule combined with conventional medications group was superior to conventional medications group in improvement of OE (OR 3.19, 95% CI [2.20, 4.63]), BMD (lumbar spine (MD 0.06, 95% CI [0.02, 0.10]), femoral neck (MD 0.08, 95% CI [0.03, 0.13]), hip (MD 0.14, 95% CI [0.08, 0.21]) and other parts (MD 0.04, 95% CI [0.03, 0.05]), ALP (MD - 5.56, 95% CI [- 10.08, - 1.04]), β-CTX (MD - 0.15, 95% CI [- 0.18, - 0.12]) and pain relief (MD - 1.25, 95% CI [- 1.83, - 0.68]), but there was no difference in S-Ca (MD 0.02, 95% CI [- 0.13, 0.17]), BGP (MD 1.30, 95% CI [- 0.29, 2.89]), PINP (MD 1.30, 95% CI [- 0.29, 2.89]), serum phosphorus (S-P) (MD 0.01, 95% CI [- 0.09, 0.12]) and safety (OR 0.71, 95% CI [0.38, 1.35]).

CONCLUSION

GSK capsules can effectively treat primary osteoporosis, and when combined with conventional medications, the drug significantly increased bone mineral density, relieved pain and improved bone metabolism-related indicators in primary osteoporosis patients with better efficacy. However, due to the inclusion of Chinese literature and possible publication bias, the reliability of conclusions still requires more high-quality RCTs to enhance.

摘要

目的

系统评价骨疏康胶囊治疗原发性骨质疏松症的疗效和安全性。

方法

计算机检索中国知网(CNKI)、万方数据库、中国生物医学文献数据库(SinoMed)、维普、美国国立医学图书馆(PubMed)、Web of Science 和 Cochrane 图书馆,搜集关于骨疏康胶囊治疗原发性骨质疏松症的随机对照试验,检索时限均为 2000 年 1 月 1 日至 2022 年 3 月 17 日。采用 Cochrane 协作网偏倚风险评估工具对纳入研究进行质量评价,提取资料并采用 RevMan 5.3 软件进行 Meta 分析。

结果

共纳入 24 个随机对照临床试验,涉及 2363 例原发性骨质疏松症患者,其中观察组 1197 例,对照组 1166 例。骨疏康胶囊组改善β型胶原羧基端肽(β-CTX)[MD=-0.28,95%CI(-0.31,-0.25)]优于常规药物组,而常规药物组改善前胶原 I 型肽(PINP)[MD=-1.37,95%CI(-1.92,-0.82)]优于骨疏康胶囊组,两组间总体疗效[OR=1.62,95%CI(0.89,2.98)]、骨密度(腰椎:MD=-0.02,95%CI[-0.08,0.04];股骨颈:MD=-0.01,95%CI[-0.07,0.05];髋部:MD=0.01,95%CI[-0.02,0.02])、碱性磷酸酶(ALP)[MD=-1.37,95%CI(-13.29,10.55)]、血清钙(S-Ca)[MD=0.02,95%CI(-0.13,0.17)]、骨谷氨酸蛋白(BGP)[MD=3.75,95%CI(-12.26,19.76)]、安全性[OR=0.37,95%CI(0.07,2.02)]和疼痛缓解[MD=0.32,95%CI(-0.59,1.22)]差异均无统计学意义。骨疏康胶囊联合常规药物组在提高总体疗效[OR=3.19,95%CI(2.20,4.63)]、骨密度(腰椎:MD=0.06,95%CI[0.02,0.10];股骨颈:MD=0.08,95%CI[0.03,0.13];髋部:MD=0.14,95%CI[0.08,0.21];其他部位:MD=0.04,95%CI[0.03,0.05])、ALP[MD=-5.56,95%CI(-10.08,-1.04)]、β-CTX[MD=-0.15,95%CI(-0.18,-0.12)]和疼痛缓解[MD=-1.25,95%CI(-1.83,-0.68)]方面优于常规药物组,而 S-Ca[MD=0.02,95%CI(-0.13,0.17)]、BGP[MD=1.30,95%CI(-0.29,2.89)]、PINP[MD=1.30,95%CI(-0.29,2.89)]、血清磷(S-P)[MD=0.01,95%CI(-0.09,0.12)]和安全性[OR=0.71,95%CI(0.38,1.35)]差异均无统计学意义。

结论

骨疏康胶囊能有效治疗原发性骨质疏松症,与常规药物联合应用时,可显著提高原发性骨质疏松症患者的骨密度,缓解疼痛,改善骨代谢相关指标,疗效更佳。但由于纳入了中文文献且可能存在发表偏倚,结论的可靠性仍需要更多高质量 RCT 加以验证。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3c48/10631217/030544dcd7d2/13018_2023_4264_Fig1_HTML.jpg

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