| 郭氏中药治疗中度地方性氟骨症X线改变的随机对照试验 |
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Received:February 23, 2010
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| 作者 | Author | 单位 | Unit | E-Mail |
| 桑志成 |
ANG Zhi-cheng |
中国中医科学院望京医院,北京 100102 |
he Wangjing Hospital of China Academy of Chinese Medicine,Beijing 100102,China |
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| 周卫 |
ZHOU Wei |
中国中医科学院望京医院,北京 100102 |
he Wangjing Hospital of China Academy of Chinese Medicine,Beijing 100102,China |
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| 张兆杰 |
ZHANG Zhao-jie |
中国中医科学院望京医院,北京 100102 |
he Wangjing Hospital of China Academy of Chinese Medicine,Beijing 100102,China |
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| 吴冠男 |
WU Guan-nan |
中国中医科学院望京医院,北京 100102 |
he Wangjing Hospital of China Academy of Chinese Medicine,Beijing 100102,China |
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| 郭培华 |
GUO Pei-hua |
忻州氟骨症专科医院 |
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| 王慧明 |
WANG Hui-ming |
中国中医科学院望京医院,北京 100102 |
he Wangjing Hospital of China Academy of Chinese Medicine,Beijing 100102,China |
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| 司书文 |
SI Shu-wen |
忻州氟骨症专科医院 |
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| 赵静 |
ZHAO Jing |
忻州氟骨症专科医院 |
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| 郭士秀 |
GUO Shi-xiu |
忻州氟骨症专科医院 |
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| 期刊信息：《中国骨伤》2010年23卷，第5期，第379-382页 |
| DOI：10.3969/j.issn.1003-0034.2010.05.020 |
| 基金项目:国家“十一五”科技支撑计划课题“郭氏疗法治疗中度氟骨症的疗效与安全性评价”(编号:2006BAI04A09) |
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目的：观察中度地方性氟骨症患者骨骼损害的X 线表现特点以及郭氏中药疗法治疗前后X线的变化情况。
方法：2007年12月至2009年8月，采用区组随机化方法，借助中央随机系统将114例中度氟骨症患者随机分为治疗组和对照组，其中治疗组60例，男26例，女34例，年龄39～60岁，平均(51.68±4.98)岁；对照组54例，男30例，女24例，年龄39～60岁，平均(52.15±4.86)岁。两组均采用基础治疗，包括补充钙剂和汤药准备阶段。补充钙剂采用口服钙尔奇D 600 mg,每日1次，连服3个月。汤药准备阶段服用调节胃肠功能，促进消化吸收中药汤剂，服用3 d.治疗组药物采用郭氏马钱汤，口服，分2次服用，每次200 ml,连续服用8周；8周后改服骨康宁胶囊，规格为每粒0.44 g,每次2粒，每日3次，连续服用4周，疗程为12周。治疗后随访24周，总观察期36周。对照组药物采用汤药和胶囊安慰剂，服药方法和疗程与治疗组相同。治疗结束后，由7位骨科及放射学专家，采用事先根据地方性氟骨症X线征象和分度标准(WS192-2008)设计的专家评价表(包括骨质硬化、骨质疏松软化、骨周关节改变及混合改变的发生和改变情况),评价治疗前后X线的情况并进行统计处理。
结果：地方性氟骨症的各种X线征象在114例中度氟骨症的X线片中均可见发生。骨质硬化：前臂4例，小腿7例，骨盆4例，腰椎4例；骨质疏松软化：前臂23例，小腿23例，骨盆5例，腰椎8例；混合改变：前臂6例，小腿9例，骨盆10例，腰椎1例；骨周关节改变：前臂107例，小腿47例，骨盆28例，腰椎19例。对照组治疗前后各部位X线片上的各种表现对比均无变化。治疗组仅有2例在骨周及关节改变情况发生治疗前后的变化，1例表现为小腿骨间膜骨化情况较治疗前好转，另1例表现为骨盆左髋臼外侧骨周增生消失。治疗组其余病例治疗前后各部位X线表现对比无变化。两组治疗前后X线变化情况的差异无统计学意义(P>0.05).
结论：郭氏中药疗法在氟骨症的放射学方面无明显改善作用。 |
| [关键词]:X线 氟骨症 中草药 临床对照试验 |
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| X-ray analysis on 114 patients with moderate endemic skeletal fluorosis by treatment of Guo's Chinese herbal |
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Abstract:
Objective: To observe the X-ray features of bone damage in patients with moderate endemic skeletal fluorosis and the changes of X-ray after treatment with herbal therapy.
Methods: From 2007.12 to 2009.8,114 patients with moderate endemic skeletal fluorosis were randomly divided into treatment group and control group by central randomization system. There were 60 patients in treatment group including 26 males and 34 females,aged from 39 to 60 years with an average of (51.68±4.98) years; There were 54 patients in control group included 30 males and 24 females,aged from 39 to 60 years with an average of (52.15±4.86) years. Both treatment and control groups were treated with basic treatment including calcium supplementation and preparation stage with herb decoction. Patients were orally given 600 mg Caltrate everyday for calcium supplementation for 3 months. In preparation stage,patients were orally given herb decoction with the function of adjusting gastrointestinal function and promoting the digestion and absorption of herb decoction for 3 days. Patients in treatment group were orally given Guo's Maqian decoction(200 ml,twice daily) for 8 weeks. Eight weeks later,Guo's Maqian decoction was replaced by Guokangning capsule (0.44 g per cansule,2 capsules,three times daily) for 4 weeks. The treatment course lasted 12 weeks. The time for followed-up after treatment was 24 weeks. When the treatment finished,7 experts on orthopaedics and radiology evaluated and statistically analyzed the X-ray features pre and post treatment,using expert evaluation scale (including the appearance and changes of osteosclerosis,osteoporosis softening,joint changes close to the bone and mixed changes) designed referring endemic skeletal fluorosis X-ray findings and sub-degree standard(WS192-2008).
Results: All X-ray features of endemic skeletal fluorosis appeared in the X-ray of the 114 patients with moderate endemic skeletal fluorosis. Osteosclerosis:4 cases in forearm,7 in calf,4 in pelvis,4 in lumbar vertebrae;Osteoporosis and bone softening:23 cases in forearm patients,23 in calf,5 in pelvis,8 in lumbar vertebrae;Mixed changes:6 cases in forearm,9 in calf,10 in pelvis,1 in lumbar vertebrae patients; Joint changes:107 cases in forearm,47 in calf,28 in pelvis,19 in lumbar vertebrae. There were X-ray no changes before and after the treatment in all of parts in control group. In treatment group,there were only 2 patients showed extraperiostealin and joint changes after the treatment,in which one showed better ossification of interosseous membrane of leg and another one showed disappearance of the lateral hyperplasia of the left pelvic acetabulum. There were no changes between before and after treatment in X-ray of all parts in the rest patiens of the treatment group. There was no significant difference between before and after treatment in both groups(P>0.05).
Conclusion: There is no obvious improvement in radiology of patients with skeletal fluorosis treated by Guo's therapy. |
| KEYWORDS:X-rays Osteofluorosis Drugs,Chinese herbal Controlled clinical trials |
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| 引用本文，请按以下格式著录参考文献： |
| 中文格式: | 桑志成,周卫,张兆杰,吴冠男,郭培华,王慧明,司书文,赵静,郭士秀.郭氏中药治疗中度地方性氟骨症X线改变的随机对照试验[J].中国骨伤,2010,23(5):379~382 |
| 英文格式: | ANG Zhi-cheng,ZHOU Wei,ZHANG Zhao-jie,WU Guan-nan,GUO Pei-hua,WANG Hui-ming,SI Shu-wen,ZHAO Jing,GUO Shi-xiu.X-ray analysis on 114 patients with moderate endemic skeletal fluorosis by treatment of Guo's Chinese herbal[J].zhongguo gu shang / China J Orthop Trauma ,2010,23(5):379~382 |
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