肾复康胶囊治疗原发性肾综的临床与实验研究
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摘要
肾复康胶囊的一期临床研究及实验研究已取得可喜成果，作为
国家中医药管理局科研课题，达到了预期的目标。本人此实验的目的
旨在用阿霉素肾病模型，比较雷公藤多甙与肾复康的临床生化指标和
血浆放免指标，观察其性腺毒性、肝功能损害及对延缓肾衰的不同作
用。且实验结果表明肾复康的临床疗效与剂量在一定范围内成正比。
实验研究部分
本实验模型为ADR所致的大鼠肾病模型。
将60只雌雄各半的Wistar大鼠随机分为6组（每组10只）即：
正常对照组、雷公藤多甙组、肾复康组、肾复康+雷公藤多甙组、ADR
组、剂量观察组。实验开始时除正常对照组外，其余各组分别给大鼠
尾静脉一次性注射ADR6mg/kg体重。正常对照组造模时给6mg/kg
体重的注射用水一次性尾静脉注射。造模后，正常对照组以注射用水
2ml/150g/d灌胃；肾复康组按人一天剂量的1/10折算成合适浓度，以
2ml/150g/d灌胃；雷公藤多甙以临床肾复康每日同等治疗量折算，取
2ml/150g/d灌胃；雷公藤多甙+肾复康组以上述浓度的溶液各1ml，即
2ml/150g/d灌胃；剂量观察组10只大鼠则随机分为雷公藤多甙组B
和肾复康组B各5只，其灌胃剂量均较上述雷公藤多贰组和肾复康组
增加－倍。分别于实验第 7、14、28、56天作 24hr尿蛋白定量及血
生化指标测定。实验周期60天。
结果示：造模后第7天除正常组外，各组均出现大量蛋白尿并出
现水肿等典型肾综表现以ADR组最为明显，与其它各组相比，差别
显著。叩＜0．05人 从治疗第 14天起，雷公藤多试及雷公藤多成＋肾复
康组尿蛋臼定量均有不同程度下降趋势，至第28天肾复康治疗组蛋
白定量开始明显减少并呈稳定的下降趋势，而雷公藤多贰对照组下降
开始趋向饱和，至第56天，正常组、ADR组除外，各组蛋白定量下
降比较，肾复康组较雷公藤多贰组有微弱的胜出。经方差分析差别有
意义0＜O．05L 而血浆白蛋白测定结果显示：肾复康与雷公藤多成
组比较，前者明显高于AD R组（P＜0．05），而雷公藤多贰组与＊＊R
组则没有差别，肾复康＋雷公藤多戍组与ADR组差别尤为显著
o叼刀1人 其血浆白蛋白几乎接近正常。与正常组相比D0．05准与
雷公藤同等条件下，肾复康组虽然血浆白蛋白仍然低于正常组，但其
值明显高于雷公藤多戎组、高于ADR组，肾复康＋雷公藤多试组升高
白蛋白在三组中最为理想。血胆固醇测定结果显示：仅肾复康组与ADR
2
组差别有意义（P＞0刀5），血肌酌测定结果显示：各组均无明显差别。
血浆性激素测定显示：肾复康组与ADR无差别，但与正常组、与雷
公藤多贰、肾复康＋雷公藤多忒组的显著差别（＜0刀5丫肾复康组B与
雷公藤多贰组B比较：两者治疗后肾复康组B尿蛋白下降显著，两
者差别经t检验P（0刀5．血浆性激素LH水平比较，雷公藤多贰组B
明显增高。o＜0刀匀本实验提示了肾复康与雷公藤多贰相比，其降尿
蛋白方面虽起效较其慢，但起效后作用恒定，随着剂量的增加有增强
趋势。而雷公藤多贰虽起效较肾复康快，但达到一定程度后，其降蛋
白作用不再改变，随剂量增加无明显变化。然而随剂量增加，其血浆
性激素水平急剧升高。雷公藤多贰对提高白蛋白无明显效果，肾复康
对升高白蛋白有一定效果，尽管肾复康＋雷公藤多贰组升高白蛋白最
为理想，但其降尿蛋白效果并不优于肾复康，而且血浆性激素水平明
显高于正常，进一步提示其性腺毒性必将高于肾复组。不仅如此，雷
公藤多贰组BS只大鼠在实验最后与其它大鼠相比体重增加减少，
灵活性明显降低，食欲较差，皮肤弛缓、毛须稀疏。断尾取血后，伤
口不易恢复，甚有一只大鼠发生胁骨脓肿。
临床研究部分
3
采用随机对照前瞻性研究，将30例合格受试对象分为治疗组10
例、对照组20例。治疗组给肾复康胶囊，对照组20例分为缓解期病
人10例，肾综病人10例给雷公藤多贰治疗。治疗分为诱导阶段和减
量阶段。疗程观察为一年，对于一般情况、24hr尿蛋白定量、血生化
指标、血浆放免指标、总有效率、复发率、毒副作用、及临床症状积
分作了统计。结果提示治疗组总有效率为 80％对照组为 70％，两组
无明显差别（P＜o．05）治疗组治疗后前后自身对照白蛋白明显升高，
雷公藤多贰对照组亦如此，但两组白蛋白值与正常缓解组对比，后者
仍较高。但三组胆固醇值治疗后却没有明显差别，自身前后对照却均
有降低。治疗结束后 24hr尿蛋白定量肾复康组为 2．59土 0．86雷公藤
多成组为二．3土 0．79，两者差别无意义。根据临床症状分／C。rx 00得
出的积分值却提示：肾复康治疗组明显低于雷公藤多成组o＜0刀
Phase I clinical trial and experimental trial of Shen fu Kang capsule have obtained gratifying result. The purpose of doing this experiment is to observe the toxicity to gonad and kidney . According to different animal model , observing its Gonad toxicity and renal toxicity and the relationship between therapeutic effect and different dose. Experimental trial
The nephrotic syndrome rat model of this experiment is result in ADR .to divide the 60 vvistar rat into 6 groups by random , normal contrast group , tripterpgium glycosides group, shen fu kang group , shen fu kang and tripterpgium glycosides group, ADR group, dose trial group. When experiment start , all sections inject ADR 6mg/kg weight in a lump through caudal vein . while the normal contrast group's treatment is water for injection .when the model is completed, giving the normal contrast group water for injection to feed them by 2ml/150kg /d, the shen fu kang group, according to the dose one man shoud take a day , to make fitting density liquid , giving them one-tenth for each, giving the tripterpgium glycosides group, dose as the shen fu kang to feed. Giving The shen fu kang and tripterpgium glycosides group 1ml one half, All their feed quantity is eaqual. The dose trial group is divided into two sections , 5 one half for The shen fu kang and tripterpgium glycosides groups, the dose for them both broaden one time. When the experiment go on for 7th Day , 14th day, 28th day, and 56 th day , to collect urine in 24 hours for calculation protein, check serum index. All the experiment last for 60 days.
The result show: from the experiment going on for 14 th day, all the urine protein in different groups become to increase, beside normal contrast group. To compare the ADR with other groups, the difference is very notable.(P<0.05) and appeared typical example, such edema and so on. At 28 th day, the urine protein of all the therapy groups began to descend. Then the reducing amount of the tripterpgium glycosides groups gradually reach saturation, while the shen fu
kang continued to invariablly descend , even above the former. The variance analysis show
The difference has meaning.(P<0.05), and the albumin show, comparing tripterpgium glycosides groups with shen fu kang The former is obviously exceed ADR group,(P<0.05) the latter has no difference between them., but the tripterpgium glycosides groups and shen fu kang is obviously exceed the ADR group(P<0.01). the sex hormone determination show, shen fu kang has no difference between the ADR group, and both them negative to the normal trial group, but the tripterpgium glycosides groups and shen fu kang and the tripterpgium glycosides groups both higher than others.(P<0.05). the cholesterol and creatinine show, only the shen fu kang group is different from the ADR, all the others has no difference.
This experiment indicate, compare shen fu kang with tripterpgium glycosides, they have no difference in descending Urine protein in the first time, but when the time is going on they gradually appeared new change, the urine protein of shen fu kang group can be lower than the tripterpgium glycosides group, the sex hormone of them each is apparent. Among them , the tripterpgium glycosides and shen fu kang groups is the highest, it is obvious over the others, the tripterpgium glycosides' LH figure is higher than the ADR group and the shen fu kang group, thus it can be seen, its gonad toxicity exceeded the shen fu kang capsule. Because its high serum LH figure, the feedback regulation of the hypothalamic-piruitary-gonad axis probably misadjustment , so the pituitary gland's producing GnRh cut down, then according to rebound, the serum LH figure became lower. Thus this menoxenia even menoschesis can appear. While the dose trial contrast group
Show , with the therapy dose increasing , the treatment effect improving of the shen fu kang group. To increase the tripterpgium glycosides group's dose, the effect can't be seen, but the toxcity to gonad became higher than before. All this facts demonstr
国家中医药管理局科研课题，达到了预期的目标。本人此实验的目的
旨在用阿霉素肾病模型，比较雷公藤多甙与肾复康的临床生化指标和
血浆放免指标，观察其性腺毒性、肝功能损害及对延缓肾衰的不同作
用。且实验结果表明肾复康的临床疗效与剂量在一定范围内成正比。
实验研究部分
本实验模型为ADR所致的大鼠肾病模型。
将60只雌雄各半的Wistar大鼠随机分为6组（每组10只）即：
正常对照组、雷公藤多甙组、肾复康组、肾复康+雷公藤多甙组、ADR
组、剂量观察组。实验开始时除正常对照组外，其余各组分别给大鼠
尾静脉一次性注射ADR6mg/kg体重。正常对照组造模时给6mg/kg
体重的注射用水一次性尾静脉注射。造模后，正常对照组以注射用水
2ml/150g/d灌胃；肾复康组按人一天剂量的1/10折算成合适浓度，以
2ml/150g/d灌胃；雷公藤多甙以临床肾复康每日同等治疗量折算，取
2ml/150g/d灌胃；雷公藤多甙+肾复康组以上述浓度的溶液各1ml，即
2ml/150g/d灌胃；剂量观察组10只大鼠则随机分为雷公藤多甙组B
和肾复康组B各5只，其灌胃剂量均较上述雷公藤多贰组和肾复康组
增加－倍。分别于实验第 7、14、28、56天作 24hr尿蛋白定量及血
生化指标测定。实验周期60天。
结果示：造模后第7天除正常组外，各组均出现大量蛋白尿并出
现水肿等典型肾综表现以ADR组最为明显，与其它各组相比，差别
显著。叩＜0．05人 从治疗第 14天起，雷公藤多试及雷公藤多成＋肾复
康组尿蛋臼定量均有不同程度下降趋势，至第28天肾复康治疗组蛋
白定量开始明显减少并呈稳定的下降趋势，而雷公藤多贰对照组下降
开始趋向饱和，至第56天，正常组、ADR组除外，各组蛋白定量下
降比较，肾复康组较雷公藤多贰组有微弱的胜出。经方差分析差别有
意义0＜O．05L 而血浆白蛋白测定结果显示：肾复康与雷公藤多成
组比较，前者明显高于AD R组（P＜0．05），而雷公藤多贰组与＊＊R
组则没有差别，肾复康＋雷公藤多戍组与ADR组差别尤为显著
o叼刀1人 其血浆白蛋白几乎接近正常。与正常组相比D0．05准与
雷公藤同等条件下，肾复康组虽然血浆白蛋白仍然低于正常组，但其
值明显高于雷公藤多戎组、高于ADR组，肾复康＋雷公藤多试组升高
白蛋白在三组中最为理想。血胆固醇测定结果显示：仅肾复康组与ADR
2
组差别有意义（P＞0刀5），血肌酌测定结果显示：各组均无明显差别。
血浆性激素测定显示：肾复康组与ADR无差别，但与正常组、与雷
公藤多贰、肾复康＋雷公藤多忒组的显著差别（＜0刀5丫肾复康组B与
雷公藤多贰组B比较：两者治疗后肾复康组B尿蛋白下降显著，两
者差别经t检验P（0刀5．血浆性激素LH水平比较，雷公藤多贰组B
明显增高。o＜0刀匀本实验提示了肾复康与雷公藤多贰相比，其降尿
蛋白方面虽起效较其慢，但起效后作用恒定，随着剂量的增加有增强
趋势。而雷公藤多贰虽起效较肾复康快，但达到一定程度后，其降蛋
白作用不再改变，随剂量增加无明显变化。然而随剂量增加，其血浆
性激素水平急剧升高。雷公藤多贰对提高白蛋白无明显效果，肾复康
对升高白蛋白有一定效果，尽管肾复康＋雷公藤多贰组升高白蛋白最
为理想，但其降尿蛋白效果并不优于肾复康，而且血浆性激素水平明
显高于正常，进一步提示其性腺毒性必将高于肾复组。不仅如此，雷
公藤多贰组BS只大鼠在实验最后与其它大鼠相比体重增加减少，
灵活性明显降低，食欲较差，皮肤弛缓、毛须稀疏。断尾取血后，伤
口不易恢复，甚有一只大鼠发生胁骨脓肿。
临床研究部分
3
采用随机对照前瞻性研究，将30例合格受试对象分为治疗组10
例、对照组20例。治疗组给肾复康胶囊，对照组20例分为缓解期病
人10例，肾综病人10例给雷公藤多贰治疗。治疗分为诱导阶段和减
量阶段。疗程观察为一年，对于一般情况、24hr尿蛋白定量、血生化
指标、血浆放免指标、总有效率、复发率、毒副作用、及临床症状积
分作了统计。结果提示治疗组总有效率为 80％对照组为 70％，两组
无明显差别（P＜o．05）治疗组治疗后前后自身对照白蛋白明显升高，
雷公藤多贰对照组亦如此，但两组白蛋白值与正常缓解组对比，后者
仍较高。但三组胆固醇值治疗后却没有明显差别，自身前后对照却均
有降低。治疗结束后 24hr尿蛋白定量肾复康组为 2．59土 0．86雷公藤
多成组为二．3土 0．79，两者差别无意义。根据临床症状分／C。rx 00得
出的积分值却提示：肾复康治疗组明显低于雷公藤多成组o＜0刀
Phase I clinical trial and experimental trial of Shen fu Kang capsule have obtained gratifying result. The purpose of doing this experiment is to observe the toxicity to gonad and kidney . According to different animal model , observing its Gonad toxicity and renal toxicity and the relationship between therapeutic effect and different dose. Experimental trial
The nephrotic syndrome rat model of this experiment is result in ADR .to divide the 60 vvistar rat into 6 groups by random , normal contrast group , tripterpgium glycosides group, shen fu kang group , shen fu kang and tripterpgium glycosides group, ADR group, dose trial group. When experiment start , all sections inject ADR 6mg/kg weight in a lump through caudal vein . while the normal contrast group's treatment is water for injection .when the model is completed, giving the normal contrast group water for injection to feed them by 2ml/150kg /d, the shen fu kang group, according to the dose one man shoud take a day , to make fitting density liquid , giving them one-tenth for each, giving the tripterpgium glycosides group, dose as the shen fu kang to feed. Giving The shen fu kang and tripterpgium glycosides group 1ml one half, All their feed quantity is eaqual. The dose trial group is divided into two sections , 5 one half for The shen fu kang and tripterpgium glycosides groups, the dose for them both broaden one time. When the experiment go on for 7th Day , 14th day, 28th day, and 56 th day , to collect urine in 24 hours for calculation protein, check serum index. All the experiment last for 60 days.
The result show: from the experiment going on for 14 th day, all the urine protein in different groups become to increase, beside normal contrast group. To compare the ADR with other groups, the difference is very notable.(P<0.05) and appeared typical example, such edema and so on. At 28 th day, the urine protein of all the therapy groups began to descend. Then the reducing amount of the tripterpgium glycosides groups gradually reach saturation, while the shen fu
kang continued to invariablly descend , even above the former. The variance analysis show
The difference has meaning.(P<0.05), and the albumin show, comparing tripterpgium glycosides groups with shen fu kang The former is obviously exceed ADR group,(P<0.05) the latter has no difference between them., but the tripterpgium glycosides groups and shen fu kang is obviously exceed the ADR group(P<0.01). the sex hormone determination show, shen fu kang has no difference between the ADR group, and both them negative to the normal trial group, but the tripterpgium glycosides groups and shen fu kang and the tripterpgium glycosides groups both higher than others.(P<0.05). the cholesterol and creatinine show, only the shen fu kang group is different from the ADR, all the others has no difference.
This experiment indicate, compare shen fu kang with tripterpgium glycosides, they have no difference in descending Urine protein in the first time, but when the time is going on they gradually appeared new change, the urine protein of shen fu kang group can be lower than the tripterpgium glycosides group, the sex hormone of them each is apparent. Among them , the tripterpgium glycosides and shen fu kang groups is the highest, it is obvious over the others, the tripterpgium glycosides' LH figure is higher than the ADR group and the shen fu kang group, thus it can be seen, its gonad toxicity exceeded the shen fu kang capsule. Because its high serum LH figure, the feedback regulation of the hypothalamic-piruitary-gonad axis probably misadjustment , so the pituitary gland's producing GnRh cut down, then according to rebound, the serum LH figure became lower. Thus this menoxenia even menoschesis can appear. While the dose trial contrast group
Show , with the therapy dose increasing , the treatment effect improving of the shen fu kang group. To increase the tripterpgium glycosides group's dose, the effect can't be seen, but the toxcity to gonad became higher than before. All this facts demonstr
引文
[1]修订肾小球疾病临床分型意见，中华肾脏病杂志，1983，4：12
[2]慢性肾小球肾炎辩证分型＼诊断疗效评定标准陕西中医 1988；1封底
[3]同[2]
[4]《时氏肾脏病学》中国医药科技出版社
[5]杨霁云．实用儿科临床杂志，1992，7(2)：89
[6]孙伟第十二次全国中医肾病学术会议论文汇编1997年
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[8]陈梅芳．中华肾脏病杂志，1987，8(2)：103
[9]任勤．陕西中医，1992，13(3)：141
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[12]胡言．肾脏病与透析肾移机杂志，1998，7(2)：113
[13]刘志民．中华肾脏病杂志，1997，13(2)：97
[14]中医基础理论，上海科技出版社 1995年6月第1版
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[16]吕仁和．全国中西医结合肾脏病高级研修班讲义，1997年
[17]余运初．生殖与避孕，1982，2(1)：48-51
[18]耿玉林，王海燕．中华医学会第三次全国肾脏病学术会议论文汇编，南宁，1991：35．
[19]Cosynsjp, et al. Clin Nephro1, 1986, 26: 203
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[21]Cosio FG, Kidney Int, 1994, 45:; 320
[22]Dai zhen hua. Chin Nephrol, April 1997, 13(2): 117
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