| BackgroundBenign prostatic hyperplasia (BPH) is one of the most common diseases of urinary system troubled in elderly men with the major clinical ma-nifestations of frequent urination, urgency, dysuria. The major task of social population aging in this century is unavoidable, especially in China. With the speed-up of social aging process, the incidence of BPH will further increase, which will seriously affect the quality of life of older men, and even result in the emergence of many kinds of serious complica-tions, until the threat to the lives of patients.Methods in the treatment of BPH can roughly be divided into three kinds: watchful waiting, drug treatment, surgical operation treatment. The BPH patients with mild symptoms can choose to wait while heavy need drug treatment. Generally the medicine such as5α-reductase inhibitor, alpha blockers is a choice. Alpha blockers can improve voiding symptoms by relaxing smooth muscle, and5α-reductase inhibitor can lower the dihydrotestosterone concentrations so that it can reduce the volume of the prostate, but these drugs cause postural hypotension, weakness, low sexual desire, erectile dysfunction and other complications. Because of adverse reactions and drug tolerance The appli-cation of these drugs subject to certain restrictions. Although the operation therapy is considered as the preferred method for severe BPH, the older patients often make the operation treatment has certain limition.The pathogenesis of BPH is not very clear and there are lots of theories in which the androgen theory is paid most attention and widely recognized. The theory put forward by Wilson in1970is that the occurrence of the prostate tissue dihydrotestosterone (DHT) content abnormally increased leading to BPH. The5alpha reductase in the prostate tissue converts testosterone into DHT and finasteride which is a kind of5α-reductase inhibitor is just developed on this theory with many years clinical practice and curative effect.Traditional Chinese medicine believes that this disease belongs to "Uroschesis","Jing Long" category. At present, many domestic scho-lars treat this disease from the theory such as spleen and kidney deficiency, dampness heat in lower Jiao, pulmonary congestion and stagnation of liver qi, blood stasis and sputum or corruptive essence stagnating the orifices etc. Professor Cui Xuejiao, an andrology expert in our hospital, pointed out that the location of this disease is sperm chamber, and its etiology and pathogenesis is deficiency of kidney and blood stasis. Because Kidney Qi is deficient and it cannot warm Yan to generate Gas which acting as the commander of blood, Qi is unable to promote blood circulation, that leads to blood stasis, stagnation of essence room, blocking waterways. Yishentong prescription brought about by professor Cui is fine and ingenious with the formula of exquisite, tonification and purgation in combination, treatment in both the incidental and fundamental aspects. It has obtained the good curative effect in clinical application for many years. In recent years there has been a few clinical research reports on the Yishentong Capsule, but seldom syste-matically, especially on the experimental study.ObjectivesTo objectively assess the treatment effect on BPH by Yishentong capsule both clinically and experimentally;to comprehensively evaluate Yishentong capsule in the treatment of Kidney deficiency and Blood stasis type BPH and to explore the mechanism of Yishentong capsule on BPH.Methods1. Clinical Observation60patients randomly divided into Yishentong capsule group and finasteride group were selected from urology and andrology outpatient in the First Affiliated Hospital of Guangzhou University of Chinese Medicine between2012October and2013July. Yishentong group (A group) were treated with Yishentong capsules,4capsules each time,3times a day, for3consecutive months; finasteride group (B group) with Finasteride Tablets,1tablet each time, once a day, for3consecutive months. To observe before and after treatment the International Prostate Symptom Score(IPSS), quality of life score(QOL), prostate volume(VP), maximal urinary flow rate(Qmax), residual urine(Ur) changes, and to comprehensively evaluate the treatment effect of Yishentong capsule on BPH.2. Experimental Study40healthy SPF male KM mice were randomly divided into4groups:(1)the normal control group;(2) the model control group;(3) the finasteride group;(4) the Yishentong group.10mice in each group. Except the normal control group, the other groups of animal was given dai-1y subcutaneous injection of testosterone propionate at5mg/kg with a consecutive injection for21days. After model establishment, the normal control group and the model control group were daily with0.3ml saline by gavage once; the finasteride group with0.7mg/kg Finasteride Tablets (after crushing, dissolved in distilled water of0.3m1) daily by gavage once; the Yishentong group with0.7g/kg Yishentong (powder properties, directly dissolved in distilled water of0.3ml) by gavage once daily.0.3ml is the total quantity in gavage. At the51st day after weighing each mouse was decapitated, abdominaldissected, whose prstate gland was carefully separated and extracted(removal of incidental prostatecon-nective tissue), with filter paper suction to the surface of liquid, after being weighed by1/10000precision balance, fixed in10%formalin48h, alcohol dehydration step by step, xylene transparent, paraffin, paraffin sections4μm, HE staining. The mice prostatic stromal hyperplasia and inflammatory cell infiltration was observed under OLYMPUS optical microscope, followed by Ki67immunohisto-chemical detection of indicators, using Ki67-LI (Ki67-LI, labeling index, that is, Counting positive cells of500cells and the percentage in5random high magnification view of each slice) as the sta-tistical indicator.Result1. Clinical ObservationComparison of IPSS, QOL, Vp, Qmax, Ur of the treatment group three months after treatment, P<0.05; Comparison of IPSS, QOL, Vp, Qmax, Ur of the control group three months after treatment, P<0.05; Comparison of IPSS, QOL, Vp, Qmax, Ur betwwen the treatment group and the control group three months after treatment, P<0.05.2. Experimental Study Comparison of prostate index in mice:P12=0.001(Note:P12is the P value between group1and group2. the same below), P13=0.905, P14=0.000, P23=0.001, P24=0.494, P34=0.000; Comparison of K167-LI in mice:P12=0.000(Note:P12is the P value between group1and group2. the same below), P13=0.000, P14=0.000, P23=0.000, P24=0.241, P34=0.000.Conclusion1. Yishentong capsule in the treatment of BPH with the type of Kidney deficiency and Blood stasis in three months has got an equivalent clinical efficacy with Finasteride, Including both the patient’s subjective feelings, such as IPSS, QOL and objective indicators, such as Vp, Qmax, Ur etc. IPSS, QOL in the treatment group (Yishentong group) after three months of treatment decreased obviously, prostate volume decreased, maximum urine flow rate increased,residual urine reduced, the quality of life of patients has been improved; There is no statistical significance between the control group (Finasteride group)and the treatment group in each index, namely the Yi-shentong capsule in three months in the treatment of BPH with the type of Kidney deficiency and Blood stasis is clinically similar to Finasteride.2. Yishentong has no obvious inhibitory effect on mouse prostatic hyperplasia tissue cells while finasteride inhibits or reverses the mouse prostate hyperplasia tissue, puts up a obvious effect of reducing mouse prostate volume.3. Considering the Clinical and the experimental results, we speculate that Yishentong in the short term (3months) can get the clinical curative effect similar to Finasteride, but the mechanisms of the two are different. The therapeutic mechanism of Yishentong may be more complex, not like that Finasteride does through inhibition of testosterone into dihydrotestosterone and suppression prostate hyperplasia. |
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