补肾健脾化瘀法治疗男性骨质疏松症疼痛的效果

Effect of the method of tonifying the kidney,strengthening the spleen and removing the stasis on osteoporosis pain in male patients

目的:观察补肾健脾基础上加强化瘀药物制成补肾壮骨中药对男性骨质疏松患者疼痛程度的影响。方法:①选择1998-07/2004-07解放军广州军区广州总医院住院及门诊就诊的男性老年性骨质疏松症患者198例,年龄65～83岁。符合骨质疏松症综合诊断评分标准,且均对治疗方案知情同意。②按随机数字表法将患者分为2组;补肾壮骨中药组101例,降钙素组97例。补肾壮骨中药组:均囗服补肾壮骨中药(由生地、山药、山萸肉、泽泻等药物组成,广东一方制药厂生产,批号:980705,100g/包),1包/次,2次/d。降钙素组:均肌肉注射降钙素(诺华公司产品,生产批号980823,990523,011121,50IU/支),其中第1周100IU,1次/d,第2,3,4周100IU,每周2次。两组均治疗4周。③分别于治疗前,治疗1,2,3,4周后及停药后2周记录疼痛强度(共计0～10,0为无痛,10为剧烈疼痛)、疼痛缓解度(共计0～4度,0度为无缓解,4度为完全缓解),计算镇痛有效率:显效(明显缓解+完全缓解),有效(中度缓解),总有效率(显效+有效)。④计量和计数结果差异比较分别采用t检验和χ2检验。结果:男性老年性骨质疏松症患者198例均进入结果分析。①骨质疏松症疼痛强度:补肾壮骨中药组治疗后2,3,4周和停药后2周和降钙素组治疗后1,2,3,4周和停药后2周疼痛强度明显低于治疗前(t=2.35～2.93,P<0.05),补肾壮骨中药组治疗1和2周后疼痛强度明显高于降钙素组(5.32±1.21,3.26±1.32;3.49±1.39,2.21±1.28,t=2.98,2.36,P<0.05)。②骨质疏松症疼痛缓解情况:治疗2周后,补肾壮骨中药组完全缓解率明显低于降钙素组(5.9%,18.6%,χ2=6.25,P<0.05)。补肾壮骨中药组及降钙素组治疗1,3,4周后和停药后2周疼痛完全缓解率、明显缓解率、中度缓解率差异不明显(P>0.05)。③镇痛有效率:治疗2周后,补肾壮骨组镇痛显效率明显低于降钙素组(44.6%,58.8%,χ2=5.721,P<0.05),有效率和总有效率与降钙素组相近(P>0.05)。补肾壮骨中药组和降钙素组治疗4周后和停药后2周镇痛总有效率、显效率、有效率比较,差异不明显(P>0.05)。结论:补肾壮骨中药可明显缓解男性患者骨质疏松症疼痛,作用效果基本与降钙素相当。

AIM： To investigate the effect of bushen zhuanggu Chinese herb for tonifying the kidney and strengthening the bone composed of bushen, jianpi and huayu medicines on osteoporosis pain in male patients. METHODS： ①Totally 198 male inpatients and Outpatients with osteoporosis pain aged 65-83 years treated in the Guangzhou General Hospital of Guangzhou Military Area Command of Chinese PLA from July 1999 to July 2004 were selected. They were diagnosed according to the Comprehensive Diagnosis and Evaluation Standards for Osteoporosis and all informed and agreed the treatment. ②The patients were randomly divided into bushen zhuanggu Chinese herb group （n=101） and calcitionin （CT） group （n=97）. The Chinese herb group： The patients orally took the bushen zhuanggu granules （composed of shengdi, shanyao, shanyurolt, zexie and so on, produced by Guangdong Yifang Pharmaceutical Co., Ltd, No. 980705, 100 g per package）, one package every time, twice daily. CT group： given the intramuscular injection of CT （product of Nuohua Company, No. 980823, 990523, 011121, 50 IU per ramus）, at the 1^st week, 100 IU, once daily, and the 2^nd, 3^rd and 4^th weeks 100 IU, twice every week. The two groups were treated for 4 weeks.③Before and 1, 2, 3 and 4 weeks after treatment and 2 weeks after withdrawing the drug, the pain intensity （0- 10, 0 meant painless, 10 meant severe pain）, release degree of pain （0-4 grades, o meant no remission, 4 grade meant complete remission） were recorded and the efficiency rate of analgesia was calculated： obvious efficacy： （obvious remission ＋ complete remission）, efficacy： （moderate remission）, total efficiency rate （obvious efficacy ± efficacy）. ④The t-test and X^2- test were used for comparison of measurement data and counting data. RESULTS： All the 198 patients were involved in the result analysis. ① Pain intensity of osteoporosis： The Chinese herb group at 2, 3 and 4 weeks after treatment and 2 weeks after withdrawing drug and CT group at 1, 2, 3 and 4 weeks after treatment and 2 weeks after withdrawing drug were obviously lower than that before treatment （t=2.35-2.93,P 〈 0.05）, the pain intensity of the Chinese herb group at 1 and 2 weeks after treatment was obviously higher than that of the CT group （5.32±1.21, 3.26±1.32; 3.49±1.39, 2.21±1.28, t=2.98, 2.36, P 〈 0.05）. ②Pain remission of osteoporosis： After 2 weeks of treatment, the complete remission rate of the Chinese herb group was significantly lower than that of the CT group （5.9%, 18.6%, X^2=6.25, P 〈 0.05）. There was no significant difference in complete, obvious and moderate remission rates between the Chinese herb group and the CT group at 1, 3 and 4 Weeks after treatment and 2 weeks after withdrawjng the drug （P 〉 0.05）. ③Efficiency rate of analgesia： After 2 weeks of treatment, the obvious efficacy rate of analgesia in the Chinese herb group was significantly lower than that of the CT group （LM.6%, 58.8%, X^2=5.721, P 〈 0.05）, efficacy and total effective rates were similar to the CT group （P 〉 0.05）. There was no significant difference in total, obvious and efficacy rates between the Chinese herb group and the CT group 4 weeks after treatment and 2 weeks after withdrawing the drug （P 〉 0.05）. CONCLUSION： Chinese herb bushen zhuanggu can effectively alleviate the osteoporosis ache of male patients, which is similar to the effect of CT.