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| 穴位压力刺激贴联合地舒单抗对PMOP的临床疗效研究 |
| Clinical effect of acupoint pressure stimulation patch combined with denosumab on PMOP |
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| DOI：10.3969/j.issn.1006-7108.2024.09.014 |
| 中文关键词: 穴位压力刺激贴 地舒单抗 绝经后骨质疏松症 疗效 |
| 英文关键词:acupressure stimulation patch denosumab postmenopausal osteoporosis curative effect |
| 基金项目:基金项目：国家自然科学基金( 82074183)；浙江省中医药卫生科技计划(2024ZL075)；浙江省中医药重点研究项目(2022ZZ020) |
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| 中文摘要: |
| 目的 观察穴位压力刺激贴联合地舒单抗干预绝经后骨质疏松症（PMOP）患者，评估其临床疗效。方法 将110例绝经后骨质疏松症患者随机分为两组，对照组及试验组各55例。对照组给予地舒单抗、骨化三醇、钙尔奇干预；试验组在对照组基础上联合穴位压力刺激贴干预。观察并比较对照组及试验组在治疗前、治疗6个月腰椎定量CT骨密度（qctBMD），骨代谢水平血清Ⅰ型原胶原N-端前肽（PINP）和Ⅰ型胶原交联C-末端肽(β-CTX)，腰背疼痛评分（VAS评分）及中医症候学评分。结果 对照组脱落了6例，试验组脱落了4例；最终100例患者完成了临床试验。 ①骨密度：对照组及试验组治疗在治疗6个月，骨密度逐渐增加（P<0.05），且试验组显著高于对照组（P<0.05）。②骨代谢水平PINP：对照组及试验组血清PINP水平在治疗6个月后相比治疗前显著降低（P<0.05），但试验组PINP的降低幅度要低于对照组（P<0.05）；骨代谢水平β-CTX：对照组及试验组治疗6个月与治疗前相比，β-CTX都显著降低（P<0.05），但两组之间差异无统计学意义（P>0.05）。③VAS评分：对照组在治疗6个月，腰背痛VAS评分都显著下降（P<0.05）。两组比较差异无统计学意义（P>0.05）。④中医症候学评分：对照组及试验组治疗6个月腰背VAS评分都显著低于治疗前（P<0.05），且试验组显著低于对照组（P<0.05）。结论 穴位压力刺激贴联合地舒单抗治疗绝经后骨质疏松在提升骨密度、改善骨代谢水平、降低腰背痛及缓解中医症状效果显著，在改善BMD、PINP、及中医症状方面优于对照组，但目前尚无证据表明穴位压力刺激贴联合地舒单抗在改善β-CTX、腰背痛方面比单用地舒单抗有优势。 |
| 英文摘要: |
| Objective To observe the intervention of acupoint pressure stimulation patch combined with denosumab in postmenopausal osteoporosis (PMOP) patients and to evaluate its clinical efficacy. Methods A total of 110 postmenopausal patients with osteoporosis were randomly divided into two groups, with 55 cases in each group. Patients in the control group received disuzumab, calcitriol, and calcitral intervention. Patients in the experimental group received additional acupoint pressure stimulation patch on the basis of the control group. Quantitative CT bone mineral density (qctBMD), bone metabolism level of serum type I procollagen N-terminal peptide (PINP) and type I collagen cross-linked C-terminal peptide (β-CTX), low back pain score (VAS), and TCM symptomatology score were observed and compared between control group and experimental group before treatment and 6 months after treatment. Results Six cases fell off in the control group and 4 cases fell off in the experimental group. Eventually, 100 patients completed the clinical trial.①BMD: BMD in the control group and the experimental group gradually increased after 6 months of treatment (P<0.05). BMD in the experimental group was significantly higher than that in the control group (P<0.05).②Bone metabolism level PINP: serum PINP level in the control group and the experimental group decreased significantly after 6 months of the treatment compared to that before treatment (P<0.05). The reduction of PINP in the experimental group was lower than that in the control group (P<0.05). Bone metabolism level β-CTX: after 6 months of the treatment, β-CTX decreased significantly in both control group and experimental group compared to that before treatment (P<0.05). There was no significant difference between the two groups before (P>0.05). ③VAS score: in the control group, the VAS score of low back pain decreased significantly after 6 months of the treatment (P<0.05). There was no significant difference between the two groups (P>0.05).④TCM symptomatology scores: the lumbar and dorsal VAS scores in the control group and experimental group were significantly lower than those before the treatment at 6 months (P<0.05). VAS scores in the experimental group was significantly lower than those in the control group (P<0.05). Conclusion Acupoint pressure stimulation patch combined with denosumab in the treatment of postmenopausal osteoporosis significantly improves BMD and bone metabolism, reduces back pain and symptoms of traditional Chinese medicine. It is superior to the control group in improving BMD, PINP, and symptoms of traditional Chinese medicine. However, at present, there is no evidence that the combination of acupressure stimulation patch has an advantage over denosumab alone in improving β-CTX and low back pain. |
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