龟鹿补肾胶囊治疗绝经后骨质疏松症临床研究
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摘要
目的：运用中药龟鹿补肾胶囊对肾阳虚型绝经后骨质疏松症患者的临床实验进行观察，通过临床疗效、肾阳虚症状积分值、生活质量、雌激素水平、骨密度及血碱性磷酸酶ALP的改善作用，以了解中药龟鹿补肾胶囊对绝经后骨质疏松症骨质量的改善作用。并探究补肾中药对骨质疏松症治疗的药理关系及其有效性，同时也从侧面验证了肾与骨的关系，为研究中医“肾主骨”理论及目前对绝经后骨质疏松症的治法即补肾法、补肾活血法和补肾健脾法提供了客观指标。进一步建立中药合方在治疗绝经后骨质疏松症临床应用指标。
方法：临床研究：本研究的观察对象在越南2006年02月～2007年01月期间门诊治疗的60例绝经后骨质疏松症患者，年龄49～68岁；符合纳入病例标准：①符合肾阳虚型绝经后骨质疏松症患者；②有腰椎楔形变、髋部骨折及桡骨远端骨折病史3年以上且未再发生骨折者，或伴有不同程度的腰、背、膝、肩等处疼痛；③近半年内未使用影响骨代谢药物，如维生素D、雌激素、钙制剂、双磷酸盐、氟制剂以及糖皮质激素。病例排除标准：①用药不足规定疗程或因故中断治疗无法评价者；②加用其它影响骨代谢药物者，如糖皮质激素、抗癫痫药、氟化物、利尿剂和雌激素等用药史；③排除肝肾疾病、糖尿病、甲状旁腺机能亢进、甲状腺机能亢进、骨软化症、多发性骨髓瘤、高催乳素血症、风湿性关节炎、慢性风湿性关节炎、强直性脊柱炎、恶性肿瘤等疾病、卵巢及子宫切除术等影响骨代谢疾病的患者；④根据病史、体检和实验室检查未发现其它明显器质性疾病，排除继发性骨质疏松症的可能；⑤有严重干扰中医辨证、中医辨证两型并见无主次之分或三、四型并见证型复杂者等无法判定疗效或资料不全等影响疗效判断的病例。分组：简单随机法分为试验组和对照组，每组各30例。观察方法：试验组服用龟鹿补肾胶囊每天2次，一次3粒；对照组服用仙灵骨葆胶囊每天2次，一次3粒。连续服药6个月。
疗效判定标准及检查指标：①参照《中药新药临床研究指导原则》。郑筱萸主编。(中国医药科技出版社．2002年5月第一版．356～359；385～387)。②肾阳虚症状积分值依临床症状调查表评定。③理化指标包括骨密度，性激素水平，血碱性磷酸酶。服药前及服药6个月后测骨量及骨代谢的生化指标。
结果：本次临床研究通过对60例肾阳虚型绝经后骨质疏松症患者的分组对照治疗发现，试验组总有效率为86.67％，与对照组总有效率83.33％，两组无显著性意义(P＞0.05)；试验组骨密度值及血清E2值疗前、疗后比较有显着差异(P＜0.05)。通过两组对比，发现龟鹿补肾胶囊与仙灵骨葆胶囊临床疗效、提高骨密度及血清E2水平统计学无显着性差异。因此认为龟鹿补肾胶囊在治疗绝经后骨质疏松症疗效方面具有同仙灵骨葆胶囊类似的作用。研究结果显示龟鹿补肾胶囊与仙灵骨葆胶囊尚可提高雌激素水平，说明其具有类雌激素样作用及促进骨形成的作用，也就是说补肾药对骨骼组织有明显的影响，用于临床可抑制骨质疏松的发展，预防骨骼的退行性变化，证明是有效的治疗药物：也验证了现代医学补肾疗法可以纠正机体免疫系统的低下，促进骨钙沉积，抑制骨吸收，加快骨形成，延缓骨量丢失，升高骨矿含量和骨密度，达到治疗骨质疏松症的目的。
结论：原发性的骨质疏松症是以骨量减少、骨组织显微结构退化为特征，以致骨的脆性增高而骨折危险性增加的一种全身骨病。本临床研究在全面、系统地复习有关现代中医防治骨质疏松症临床研究方面的文献的基础上，结合现代中医对骨质疏松症的认识认为骨质疏松症相当于中国医学的“骨痿”这一病名。病因病机特点可概括为“多虚多瘀”，主要与肾虚、脾虚和血瘀三个因素有关，其中肾虚是最主要的因素；治疗原则是“补肾壮骨、健脾益气、滋益肝肾、活血通络”。
根据骨质疏松症的上述病因病机特点和治疗原则，拟定出龟鹿补肾胶囊治疗绝经后骨质疏松症患者的进行临床实验研究，通过本次实验研究研究结果表明：该药可以有效的改善骨质量，推论该方具有：①能改善患者肾阳虚的临床症状；②能改善与延缓绝经后骨质疏松症的临床症状；③能提高患者的生存质量；④增强成骨活性和抑制骨吸收的双重作用；⑤降低骨转换的作用；⑥具性激素样作用。目前不论是促进骨形成或抑制骨吸收的药物，有的太昂贵，有的副作用明显，有的疗效不明显等缺点。
综上所述，中医关于“肾主骨’的理论是科学的，肾在骨的生长和重建，以及有关骨病的防治上均起着重要的作用。龟鹿补肾胶囊的组方以补肾壮骨为主，配健脾益气、滋益肝肾、活血通络符合中医的理法方药理论避免了传统的单纯补肾或健脾疗法而是从肾、脾、肝、气、血诸因素全面考虑，并分清主次，因而提高了疗效。因此补肾壮骨、健脾益气、滋益肝肾、活血通络治疗骨质疏松症的治疗原则是有一定的实用价值和值得推广运用的。且中药龟鹿补肾胶囊毒副作用小、价格低廉等优点。
Objective
To investigate the clinical result of improving function of theGuiLuBuShen capsule on the quality of the bone in the postpausal osteoporosisthrough the observe of clinical research. Methods to demand the improve effectsof the bone after the result of drug feed. Points of the result by observethe deficiency of kidney-yang, the level of estrogen, bone mineral densityand biochemist sections of blood. Accord to these points we can see the improvefunction of GuiLuBuShen capsule on thee quality of the bone in the PMOP. Wealso observed the association and availability of the pharmacology of ChineseHerbal Medicines. At the same time we proved the relation between kidney andbones. For the theory of "the kidney dominates the bone" of TCM and offerexternal guideline of the methods tocure PMOP that include "tonifying thekidney", "tonifying the kidney and remove blood stasis" and "tonifying thekidney and invigorating the spleen". According to these we can build the indexof clinical application in the PMOP by Chinese compound prescriptions.
Method
The clinical research: 60PMOP patients (ages between 49 to 68 years oldand from 2006-02 to 2007-01) were observed by randomly divided into GuiLuBuShen capsule group and XianLingGuBao capsule group. Samples of the standardtype include:①Clinical appearance match to PMOP;②Bone mineral densityexamination match to the approach points of osteoporosis;③Patients with traitof TCM syndrome differentiation. The exclusion type of patients are:①To breakthe remedy process or who take less medicines for treatment;②Take othermedicines that were not allow in the plain of cure and would effect bonemetabolism;③Patients with diseases that would effect bone metabolism;④According to the lab examinations that could be exclusion by secondary osteoporosis;⑤Patients takes medicine out of rules that would interruptedthe syndrome differentiation methods and effect the exam results or make thedata of observation uncompleted should be exclusion. Method of group dividedwas made by simple random type. We separated 60 patients into 2 groups (treatand control groups); 30 in each group. The methods of observation and thepatients of control group were GuiLuBuShen capsule for treat group took themedicine 2 times per day, each time take 3 capsules. Both groups should takemedicines remedy for 6 months. After 6 months of medicines treatment. Weobserve the points of clinical syndrome of TCM, BMD, E2 and ALP. The standardsof the points of clinical syndrome of TCM were judged by:①TCM new drug newdrug guide book, According to the methods were sume the points of results;②The points of the deficiency of kidney-yang was judged by the questionnairesof the clinical syndrome;③Biochemist indexes include estrogen, ALP and bonemineral density were test before and after 6 months of the 60 patients tomeasured the bone mass and metabolism exam of bone.
Result
After we compared the points of all the 60 patients of PMOP by treatmentand control groups and made the conclusion of results. The total effectualratio of treatment was 86.67％. Compared with control(total effectual ratiowas 83.33％). There were no clearing difference between two groups(P＞0.05).There were obvious difference in treat group of the score of bone mineraldensity, the value of estrogen of treatment between before and after 6 months(P＜0.05). Also the same result was resist in control group (P＜0.05),Nodifference between 2 groups (P＞0.05). Through the compared with GuiLuBuShencapsule and XianLingGuBao capsule groups. So we suggested that the GuiLuBuShencapsule has the improvement reaction in the PMOP of remedy effect that wouldbe similar to XianLingGuBao capsule. During the process of observed the 2groups. The results of the experiment show up the GuiLuBuShen capsule can raisethe level of estrogen that can be explained as the function of estrogen-similarand the function for promoting osteoanagensis. It also can be explained therewere obvious effects on medicines of tonifying the kidney to the bone tissue.It would inhibit the development of OP with clinical application. We have toprevent the devolution variation of bone. It would be proved that they wereeffective of remedy medicines. Also proved that modern medical methods oftonifying the kidney could amend the low-lying of the organ immunity system, promte osteo calcin bulk, the function of restraining dessificaation,promoting oste oanagensis, reduce the rate of born mass lose and exalt bonemineral content and bone mineral density to approach the aim of osteoporosistherapy.
Conclusion
For the following traits, less of bone mass, micro-structure of bone tissuewill low-lying of primary osteoporosis will he a full size disease of bonethat could cause the brittleness and increase the danger of structure. Theclinical trail was systematic and all-around to refresher on the basic ofreference of modern TCM to remedy the OP. Combined with the resonator of modernTCM on OP. People always think that OP is equal to the name of flacciditysyndrome involving the bone. The specialties of etiology and pathogenesisinclude into blood stasis and illness of deficiency type. The main 3 factorswere consisting of deficiency of kidney, deficiency of spleen and blood stasis.During the factors deficiency of kidney is the major factor. The principlesof remedy is "tonifying the kidney and strengthening, invigorating the spleenand replenishing Qi and promotion blood circulation and dredging collateral".
We according to the principle of remedy strategy and the specialties ofthe etiology and pathogenesis in osteoporosis. We draw up the GuiLuBuShencapsule to proceed the experiment of clinical trail in the PMOP through 60patients. The results of this experiment showed the GuiLuBuShen capsule canpromote the bone mass effect. That result could be explained the GuiLuBuShencapsule take on the mechanism to increase bone mass and prove:①It couldimprove the clinical syndrome of patients deficiency of kidney-yang;②It couldimprove and delay the clinical syndrome of patients;③It could improve thequality of the life;④The diplex functions of increase the activity ofosteoblast and restrain deossification;⑤Reduce the function of the boneturnover.⑥Exist the function of estrogen-like. In a word of up words, thetheory about the kidney dominates the bone "of TCM is scientism". Inpresent-day, two kinds of treatment(by promoting osteoanagenesis and byrestrain deossification), some are too expensive, some have serve side effect,some are not so efficient, there are some formulas in Chinese market, mostof these formulas are specially designed to treat "kidney weakness".
Kidney take on the important role in the stage of the bone remedy, bonegrowing and all the remedy of bone diseases. The main methods of application that we should tonifying the kidney, match up the method of invigorating thespleen and warming Qi and blood. All these are fit to the recognition in thePMOP of TCM. And it would be a clinical mean and the ideation ground aboutthe remedy of OP. So the GuiluBuShen capsule has to be proved that it iseffectual medicine of OP.
方法：临床研究：本研究的观察对象在越南2006年02月～2007年01月期间门诊治疗的60例绝经后骨质疏松症患者，年龄49～68岁；符合纳入病例标准：①符合肾阳虚型绝经后骨质疏松症患者；②有腰椎楔形变、髋部骨折及桡骨远端骨折病史3年以上且未再发生骨折者，或伴有不同程度的腰、背、膝、肩等处疼痛；③近半年内未使用影响骨代谢药物，如维生素D、雌激素、钙制剂、双磷酸盐、氟制剂以及糖皮质激素。病例排除标准：①用药不足规定疗程或因故中断治疗无法评价者；②加用其它影响骨代谢药物者，如糖皮质激素、抗癫痫药、氟化物、利尿剂和雌激素等用药史；③排除肝肾疾病、糖尿病、甲状旁腺机能亢进、甲状腺机能亢进、骨软化症、多发性骨髓瘤、高催乳素血症、风湿性关节炎、慢性风湿性关节炎、强直性脊柱炎、恶性肿瘤等疾病、卵巢及子宫切除术等影响骨代谢疾病的患者；④根据病史、体检和实验室检查未发现其它明显器质性疾病，排除继发性骨质疏松症的可能；⑤有严重干扰中医辨证、中医辨证两型并见无主次之分或三、四型并见证型复杂者等无法判定疗效或资料不全等影响疗效判断的病例。分组：简单随机法分为试验组和对照组，每组各30例。观察方法：试验组服用龟鹿补肾胶囊每天2次，一次3粒；对照组服用仙灵骨葆胶囊每天2次，一次3粒。连续服药6个月。
疗效判定标准及检查指标：①参照《中药新药临床研究指导原则》。郑筱萸主编。(中国医药科技出版社．2002年5月第一版．356～359；385～387)。②肾阳虚症状积分值依临床症状调查表评定。③理化指标包括骨密度，性激素水平，血碱性磷酸酶。服药前及服药6个月后测骨量及骨代谢的生化指标。
结果：本次临床研究通过对60例肾阳虚型绝经后骨质疏松症患者的分组对照治疗发现，试验组总有效率为86.67％，与对照组总有效率83.33％，两组无显著性意义(P＞0.05)；试验组骨密度值及血清E2值疗前、疗后比较有显着差异(P＜0.05)。通过两组对比，发现龟鹿补肾胶囊与仙灵骨葆胶囊临床疗效、提高骨密度及血清E2水平统计学无显着性差异。因此认为龟鹿补肾胶囊在治疗绝经后骨质疏松症疗效方面具有同仙灵骨葆胶囊类似的作用。研究结果显示龟鹿补肾胶囊与仙灵骨葆胶囊尚可提高雌激素水平，说明其具有类雌激素样作用及促进骨形成的作用，也就是说补肾药对骨骼组织有明显的影响，用于临床可抑制骨质疏松的发展，预防骨骼的退行性变化，证明是有效的治疗药物：也验证了现代医学补肾疗法可以纠正机体免疫系统的低下，促进骨钙沉积，抑制骨吸收，加快骨形成，延缓骨量丢失，升高骨矿含量和骨密度，达到治疗骨质疏松症的目的。
结论：原发性的骨质疏松症是以骨量减少、骨组织显微结构退化为特征，以致骨的脆性增高而骨折危险性增加的一种全身骨病。本临床研究在全面、系统地复习有关现代中医防治骨质疏松症临床研究方面的文献的基础上，结合现代中医对骨质疏松症的认识认为骨质疏松症相当于中国医学的“骨痿”这一病名。病因病机特点可概括为“多虚多瘀”，主要与肾虚、脾虚和血瘀三个因素有关，其中肾虚是最主要的因素；治疗原则是“补肾壮骨、健脾益气、滋益肝肾、活血通络”。
根据骨质疏松症的上述病因病机特点和治疗原则，拟定出龟鹿补肾胶囊治疗绝经后骨质疏松症患者的进行临床实验研究，通过本次实验研究研究结果表明：该药可以有效的改善骨质量，推论该方具有：①能改善患者肾阳虚的临床症状；②能改善与延缓绝经后骨质疏松症的临床症状；③能提高患者的生存质量；④增强成骨活性和抑制骨吸收的双重作用；⑤降低骨转换的作用；⑥具性激素样作用。目前不论是促进骨形成或抑制骨吸收的药物，有的太昂贵，有的副作用明显，有的疗效不明显等缺点。
综上所述，中医关于“肾主骨’的理论是科学的，肾在骨的生长和重建，以及有关骨病的防治上均起着重要的作用。龟鹿补肾胶囊的组方以补肾壮骨为主，配健脾益气、滋益肝肾、活血通络符合中医的理法方药理论避免了传统的单纯补肾或健脾疗法而是从肾、脾、肝、气、血诸因素全面考虑，并分清主次，因而提高了疗效。因此补肾壮骨、健脾益气、滋益肝肾、活血通络治疗骨质疏松症的治疗原则是有一定的实用价值和值得推广运用的。且中药龟鹿补肾胶囊毒副作用小、价格低廉等优点。
Objective
To investigate the clinical result of improving function of theGuiLuBuShen capsule on the quality of the bone in the postpausal osteoporosisthrough the observe of clinical research. Methods to demand the improve effectsof the bone after the result of drug feed. Points of the result by observethe deficiency of kidney-yang, the level of estrogen, bone mineral densityand biochemist sections of blood. Accord to these points we can see the improvefunction of GuiLuBuShen capsule on thee quality of the bone in the PMOP. Wealso observed the association and availability of the pharmacology of ChineseHerbal Medicines. At the same time we proved the relation between kidney andbones. For the theory of "the kidney dominates the bone" of TCM and offerexternal guideline of the methods tocure PMOP that include "tonifying thekidney", "tonifying the kidney and remove blood stasis" and "tonifying thekidney and invigorating the spleen". According to these we can build the indexof clinical application in the PMOP by Chinese compound prescriptions.
Method
The clinical research: 60PMOP patients (ages between 49 to 68 years oldand from 2006-02 to 2007-01) were observed by randomly divided into GuiLuBuShen capsule group and XianLingGuBao capsule group. Samples of the standardtype include:①Clinical appearance match to PMOP;②Bone mineral densityexamination match to the approach points of osteoporosis;③Patients with traitof TCM syndrome differentiation. The exclusion type of patients are:①To breakthe remedy process or who take less medicines for treatment;②Take othermedicines that were not allow in the plain of cure and would effect bonemetabolism;③Patients with diseases that would effect bone metabolism;④According to the lab examinations that could be exclusion by secondary osteoporosis;⑤Patients takes medicine out of rules that would interruptedthe syndrome differentiation methods and effect the exam results or make thedata of observation uncompleted should be exclusion. Method of group dividedwas made by simple random type. We separated 60 patients into 2 groups (treatand control groups); 30 in each group. The methods of observation and thepatients of control group were GuiLuBuShen capsule for treat group took themedicine 2 times per day, each time take 3 capsules. Both groups should takemedicines remedy for 6 months. After 6 months of medicines treatment. Weobserve the points of clinical syndrome of TCM, BMD, E2 and ALP. The standardsof the points of clinical syndrome of TCM were judged by:①TCM new drug newdrug guide book, According to the methods were sume the points of results;②The points of the deficiency of kidney-yang was judged by the questionnairesof the clinical syndrome;③Biochemist indexes include estrogen, ALP and bonemineral density were test before and after 6 months of the 60 patients tomeasured the bone mass and metabolism exam of bone.
Result
After we compared the points of all the 60 patients of PMOP by treatmentand control groups and made the conclusion of results. The total effectualratio of treatment was 86.67％. Compared with control(total effectual ratiowas 83.33％). There were no clearing difference between two groups(P＞0.05).There were obvious difference in treat group of the score of bone mineraldensity, the value of estrogen of treatment between before and after 6 months(P＜0.05). Also the same result was resist in control group (P＜0.05),Nodifference between 2 groups (P＞0.05). Through the compared with GuiLuBuShencapsule and XianLingGuBao capsule groups. So we suggested that the GuiLuBuShencapsule has the improvement reaction in the PMOP of remedy effect that wouldbe similar to XianLingGuBao capsule. During the process of observed the 2groups. The results of the experiment show up the GuiLuBuShen capsule can raisethe level of estrogen that can be explained as the function of estrogen-similarand the function for promoting osteoanagensis. It also can be explained therewere obvious effects on medicines of tonifying the kidney to the bone tissue.It would inhibit the development of OP with clinical application. We have toprevent the devolution variation of bone. It would be proved that they wereeffective of remedy medicines. Also proved that modern medical methods oftonifying the kidney could amend the low-lying of the organ immunity system, promte osteo calcin bulk, the function of restraining dessificaation,promoting oste oanagensis, reduce the rate of born mass lose and exalt bonemineral content and bone mineral density to approach the aim of osteoporosistherapy.
Conclusion
For the following traits, less of bone mass, micro-structure of bone tissuewill low-lying of primary osteoporosis will he a full size disease of bonethat could cause the brittleness and increase the danger of structure. Theclinical trail was systematic and all-around to refresher on the basic ofreference of modern TCM to remedy the OP. Combined with the resonator of modernTCM on OP. People always think that OP is equal to the name of flacciditysyndrome involving the bone. The specialties of etiology and pathogenesisinclude into blood stasis and illness of deficiency type. The main 3 factorswere consisting of deficiency of kidney, deficiency of spleen and blood stasis.During the factors deficiency of kidney is the major factor. The principlesof remedy is "tonifying the kidney and strengthening, invigorating the spleenand replenishing Qi and promotion blood circulation and dredging collateral".
We according to the principle of remedy strategy and the specialties ofthe etiology and pathogenesis in osteoporosis. We draw up the GuiLuBuShencapsule to proceed the experiment of clinical trail in the PMOP through 60patients. The results of this experiment showed the GuiLuBuShen capsule canpromote the bone mass effect. That result could be explained the GuiLuBuShencapsule take on the mechanism to increase bone mass and prove:①It couldimprove the clinical syndrome of patients deficiency of kidney-yang;②It couldimprove and delay the clinical syndrome of patients;③It could improve thequality of the life;④The diplex functions of increase the activity ofosteoblast and restrain deossification;⑤Reduce the function of the boneturnover.⑥Exist the function of estrogen-like. In a word of up words, thetheory about the kidney dominates the bone "of TCM is scientism". Inpresent-day, two kinds of treatment(by promoting osteoanagenesis and byrestrain deossification), some are too expensive, some have serve side effect,some are not so efficient, there are some formulas in Chinese market, mostof these formulas are specially designed to treat "kidney weakness".
Kidney take on the important role in the stage of the bone remedy, bonegrowing and all the remedy of bone diseases. The main methods of application that we should tonifying the kidney, match up the method of invigorating thespleen and warming Qi and blood. All these are fit to the recognition in thePMOP of TCM. And it would be a clinical mean and the ideation ground aboutthe remedy of OP. So the GuiluBuShen capsule has to be proved that it iseffectual medicine of OP.
引文
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