CN112972562B

CN112972562B - Traditional Chinese medicine composition for treating erectile dysfunction of middle-aged and elderly men and application thereof

Info

Publication number: CN112972562B
Application number: CN201911290034.8A
Authority: CN
Inventors: 周智恒; 郁超; 陈磊
Original assignee: Longhua Hospital Affiliated to Shanghai University of TCM
Current assignee: Longhua Hospital Affiliated to Shanghai University of TCM
Priority date: 2019-12-16
Filing date: 2019-12-16
Publication date: 2022-02-11
Anticipated expiration: 2039-12-16
Also published as: CN112972562A

Abstract

The invention discloses a traditional Chinese medicine composition for treating male erectile dysfunction of middle-aged and elderly people, which comprises the following raw material medicines in parts by weight: 6-10 parts of ginseng, 120 parts of pubescent holly root, 180 parts of saffron, 1 part of saffron, 30-60 parts of panax notoginseng, 60-90 parts of raw astragalus, 30 parts of common cnidium fruit, 30 parts of medlar, 30 parts of epimedium herb, 24 parts of cynomorium songaricum, 30 parts of prepared rehmannia root, 24 parts of Chinese thorowax root, 18 parts of immature bitter orange and 30 parts of tribulus terrestris. The Chinese medicinal composition prescription with the effects of tonifying qi, dredging collaterals and tonifying liver and kidney has good curative effect on improving the clinical symptoms of erectile dysfunction of middle-aged and elderly people and the refractory erectile dysfunction and other diseases of modern medicaments, and has certain clinical popularization value.

Description

Traditional Chinese medicine composition for treating erectile dysfunction of middle-aged and elderly men and application thereof

Technical Field

The invention relates to a Chinese medicinal compound composition; in particular to a traditional Chinese medicine composition for treating male erectile dysfunction by oral administration, in particular to male erectile dysfunction of middle-aged and elderly people.

Background

Erectile Dysfunction (ED) is one of the most common conditions afflicting men, and generally refers to a condition in which the penis fails to erect, or is weak, rigid and short enough to fail to complete normal intercourse. In 1993, NIH in the united states expressed that the penis was not sustained (for at least 6 months) to achieve and maintain a sufficient erection to achieve satisfactory sexual life. Although ED is a benign disorder, it affects physical and mental health of patients and is closely related to quality of life, sexual partner relationship, family stability of patients. A recent epidemiological survey found that approximately 5% to 20% of men had moderate to severe degrees of ED, and that the differences between epidemiological surveys were related to different ages and socioeconomic status of the population studied and the methods employed^【1】. Epidemiological survey data from the Massachusetts male age-increasing study (MMAS) in Massachusetts, USA show^【2】The incidence of ED increases with age. Generally, the male starts to appear gradually after the age of 30 years, and 52.8 percent of men with different degrees of ED exist in China according to statistics of 30-70 years old^【3】In addition, the epidemiological survey results of the middle-aged and the elderly male by the scholars are shown^【4】ED occurs gradually starting at age 30, with an incidence of ED 73.1% in people over age 40 and rising to 86.3% by over age 70. Studies suggest that the occurrence of ED is often associated with a declining level of testosterone activity and receptor expression in humans with increasing age, while ED is often regarded as delayed gonadal function in the age range of 40-70 yearsLate onset hypogonadism LOH, also known as Men's climacteric syndrome, partial androgen decline syndrome in middle-aged and elderly men, is a high-grade stage of hypoactive syndrome (LOH)^【5】. As in developed countries, the aging of the population of our country is also rapidly advancing. At present, the population of the old people in China exceeds 10 percent of the total population, and the old people step into the old society. Health and quality of life issues in the aging population, particularly in the aging men, have raised social and medical concerns. Erectile Dysfunction (LOHED), which is an important symptom of LOH patients, is a hot topic in health hotspots of middle-aged and elderly men, and seriously affects family happiness and male dignity.

The current relatively acknowledged research^【6】The etiology of ED is thought to be multifaceted, including endocrine, neurological, vascular, systemic, topical penile disease, nutritional, psychological factors, and drug related. Modern fundamental research suggests that ED, and especially LOHED, has a four-sided etiology: vascular endothelial dysfunction^【6】Regulatory transduction pathways for signal pathways such as NO-cGMP^【7】Local tissue expression regulation of hormones^【8】Other factors such as psychological stress^【9】. It is well known to many scholars that vascular endothelial dysfunction is a pathophysiological mechanism that triggers ED, that hormone levels such as testosterone deficiency accelerate its development, and that other conditions such as insulin resistance trigger ED by affecting signal transduction pathways. The NO-cGMP signaling pathway has been proven to be a key pathway for the onset of ED, and the research result is also applied to clinic, and has remarkable clinical effect as a cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 selective inhibitor, such as sildenafil and tadalafil, for treating ED. In terms of treatment, although there are measures such as intracapsular drug injection, vacuum aspiration and prosthetic implantation, the most commonly used ED treatment at present is oral drug Phosphodiesterase type 5 (PDE 5) inhibitor, the European Association of Urology, EAU, guideline 2010 formally lists PDE5 inhibitor as the first line drug for treating all EDs including diabetic ED, vascular ED, LOHEDThese include sildenafil (Vardenafil), vardenafil (Elida) and tadalafil (Cilienfei), it being noted that these drugs do not induce an erection spontaneously but require sexual stimulation to promote an erection, and the efficacy is strictly assessed on the basis of successful vaginal insertion. The choice and preference of different inhibitors of PED5 depends on the frequency of intercourse (temporary or regular treatment, 3-4 times a week) and the patient's experience with the drug. Common side effects of PED5 inhibitors include headache, flushing, dizziness, dyspepsia and nasal congestion. It is reported that^【1】Less than 2% of patients with sildenafil (wanaco) and vardenafil (erfida) may experience temporary abnormal visual changes, while in tadalafil (lilac), 6% of patients experience back pain and muscle soreness. These are more common with cardiovascular side effects. Although the advent of the PED5 inhibitor opened a milestone for ED treatment, its efficacy was well recognized and clinical data suggest that this drug alone is effective in 70-80% of patients^【10】. This ratio is also low in elderly ED patients, especially in patients with delayed hypogonadism syndrome^【11】. How to find a small side effect and effectively improve the LOHED is a hot point of research in the male scientific community at present, the intervention of the traditional Chinese medicine is more and more emphasized, and clinically, aiming at the complexity of the etiology of the LOHED, the mode of treating ED by combining traditional Chinese medicines or replacing a PDE5 inhibitor is accepted by more and more urologists^{【12、13】}。

In recent years, as a common disease of men, the incidence rate of erectile dysfunction in China is increasing. The current relatively acknowledged research^【6】The etiology of ED is thought to be multifaceted, including endocrine, neurological, vascular, systemic, topical penile disease, nutritional, psychological factors, and drug related. Modern fundamental research suggests that ED has four main causes: vascular endothelial dysfunction^【6】Regulatory transduction pathways for signal pathways such as NO-cGMP^【7】Local tissue expression regulation of hormones^【8】Other factors such as psychological stress^【9】. In which vascular endothelial dysfunction is one of the causes of EDA pathophysiological mechanism has become common to many scholars, and hormone levels such as testosterone deficiency can accelerate its development, while others such as insulin resistance can trigger ED by affecting signal transduction pathways. The NO-cGMP signaling pathway has been proven to be a key pathway for the onset of ED, and the research result is also applied to clinic, and has remarkable clinical effect as a cyclic guanosine monophosphate (cGMP) specific phosphodiesterase type 5 selective inhibitor, such as sildenafil and tadalafil, for treating ED. In terms of treatment, although there are measures such as intracapsular drug injection, vacuum aspiration and prosthesis implantation, the currently most commonly used ED treatment is oral drug Phosphodiesterase type 5 (PDE 5) inhibitor, and the European society of Urology (EAU) guidelines in 2010 formally list PDE5 inhibitors as first-line drugs for treating all EDs including diabetic ED, vascular ED, LOHED, including sildenafil (waniger), vardenafil (alexand) and tadalafil (celecoxib), and it is noted that these drugs do not automatically induce an erection, but require sexual stimulation to promote erection, and the therapeutic efficacy is strictly assessed according to successful vaginal insertion. The choice and preference of different inhibitors of PED5 depends on the frequency of intercourse (temporary or regular treatment, 3-4 times a week) and the patient's experience with the drug. Common side effects of PED5 inhibitors include headache, flushing, dizziness, dyspepsia and nasal congestion. It is reported that^【1】Less than 2% of patients with sildenafil (wanaco) and vardenafil (erfida) may experience temporary abnormal visual changes, while in tadalafil (lilac), 6% of patients experience back pain and muscle soreness. These are more common with cardiovascular side effects. Although the advent of the PED5 inhibitor opened a milestone for ED treatment, its efficacy was well recognized and clinical data suggest that this drug alone is effective in 70-80% of patients^【10】. This ratio is also low in elderly ED patients, especially in patients with delayed hypogonadism syndrome^【11】. How to find a small side effect and effectively improve the ED of the middle-aged and the elderly is a hot spot of the current research of the male scientific communityThe intervention of traditional Chinese medicine is more and more paid attention, and clinically, aiming at the complexity of the etiology of ED, the mode of treating ED by combining traditional Chinese medicine or replacing PDE5 inhibitor is accepted by more and more urologists.

Reference documents:

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[21] Clinical observation of Chenyu Chinese medicine for treating erectile dysfunction in Yuan nationwide, compilation of annual meeting treatise on the Male Special Committee of Chinese and Western medicine, 2004: 68-69

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[23] Swertia, kangjian, linfan, etc. panax notoginseng saponins improve erectile dysfunction in diabetic rats by protecting the function of the inner skin of the corpus cavernosum [ J ]. Chongqing medicine, 2014, 21: 2743-2746.

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Disclosure of Invention

In view of the above-mentioned deficiencies of the prior art, it is desirable to find a Chinese medicinal composition which has less side effects and is effective in treating erectile dysfunction in men, particularly middle-aged and elderly men, according to embodiments of the present invention.

According to the embodiment of the invention, the traditional Chinese medicine composition for treating male erectile dysfunction, particularly middle-aged and elderly male erectile dysfunction, provided by the invention, comprises the following raw material medicines in parts by weight: 6-10 parts of ginseng, 120 parts of pubescent holly root, 180 parts of saffron, 1 part of saffron, 30-60 parts of panax notoginseng, 60-90 parts of raw astragalus, 30 parts of common cnidium fruit, 30 parts of medlar, 30 parts of epimedium herb, 24 parts of cynomorium songaricum, 30 parts of prepared rehmannia root, 24 parts of Chinese thorowax root, 18 parts of immature bitter orange and 30 parts of tribulus terrestris.

In the traditional Chinese medicine composition, the functions of the raw materials are as follows:

ginseng, sweet in taste, slightly bitter, warm in nature and mild in nature. It enters spleen, lung and heart meridians. Tonify qi, secure collapse, promote fluid production, induce tranquilization, and promote intelligence.

Mao Dong is bitter and astringent in flavor and cool in nature. It enters heart and lung meridians. Promoting blood circulation, dredging collaterals, clearing away heat and toxic materials. It can be used for treating thoracic obstruction, cardialgia, apoplexy, paralysis, obstruction of vessels, affection of exogenous wind-heat, cough with asthma due to lung-heat, pharyngalgia, tonsillitis, eye diseases, blurred vision, carbuncle, cellulitis, erysipelas, burn, scald, and swelling and pain due to traumatic injury.

Xihong Hua is sweet in flavor and neutral in nature. It enters heart and liver meridians. Promoting blood circulation, removing blood stasis, cooling blood, removing toxic substance, resolving stagnation, and tranquilizing mind. Can be used for treating amenorrhea, puerperal stagnation, toxic heat, speckle, melancholy, stuffiness, palpitation, and mania.

Shen san is sweet, slightly bitter and warm. It enters heart, liver and spleen meridians. Can be used for treating internal and external hemorrhage, traumatic injury, and swelling and pain due to blood stasis.

Astragalus root, sweet, warm; it enters spleen and lung meridians. Benefiting wei-defensive qi, consolidating superficial resistance, invigorating qi, invigorating yang, expelling toxin, promoting granulation, inducing diuresis, and relieving swelling. Can be used for treating deficiency of qi, asthenia, anorexia, loose stool, collapse of middle-warmer energy, chronic diarrhea, rectocele, spontaneous perspiration, night sweat, blood deficiency, sallow complexion, dorsal furuncle, edema, internal heat, and diabetes.

Wolfberry fruit, fructus Lycii, sweet in flavor, mild in nature, nontoxic, enters liver and kidney meridians. Nourishing liver and kidney, replenishing vital essence and improving eyesight. Can be used for treating asthenia, soreness of waist and knees, vertigo, tinnitus, internal heat, diabetes, blood deficiency, sallow complexion, and blurred vision.

Xian Ling Pi, pungent and sweet with warm property. It enters liver and kidney meridians. Tonify kidney, strengthen yang, dispel wind and remove dampness. Can be used for treating kidney deficiency, sexual impotence, asthenia of waist and knees, arthralgia due to wind-cold-dampness, and soreness of tendons and bones.

Fructus cnidii: pungent, bitter and warm. It enters kidney meridian. Warming kidney and strengthening yang, dispelling cold and dispelling wind, drying dampness and killing parasites. Can be used for treating sexual impotence, infertility due to cold womb, leukorrhagia due to cold-dampness, lumbago due to arthralgia, pudendum pruritus, eczema, and scabies.

Cynomorium songaricum, sweet and warm. It enters liver, kidney and large intestine meridians. Tonify kidney yang, replenish essence and blood, moisten intestines to relieve constipation. Can be used for treating sexual impotence, spermatorrhea, soreness of waist and knees, weakness of tendons and bones, and constipation.

Prepared rehmannia root, radix rehmanniae Preparata, sweet and slightly warm. It enters liver and kidney meridians. To nourish yin, enrich blood, replenish essence and replenish marrow. Can be used for treating deficiency of liver-yin and kidney-yin, soreness of waist and knees, hectic fever, night sweat, nocturnal emission, internal heat, diabetes, blood deficiency, sallow complexion, cardiopalmus, severe palpitation, menoxenia, metrorrhagia, metrostaxis, hemorrhage, giddiness, tinnitus, and early white beard and hair.

Bupleurum root: bitter, pungent and slightly cold. The heart-meridian entered envelope, liver, gallbladder and triple energizer meridians. Disperse and abate fever, soothe the liver and relieve depression, lift yang qi. Can be used for treating common cold, fever, distending pain of hypochondrium, menoxenia, proctoptosis, and uterine prolapse.

Zhi Shi is slightly cold in nature, bitter and pungent in flavor. Enter spleen, stomach and large intestine meridians. Break qi and remove food retention, resolve phlegm and remove stuffiness. Can be used for treating food stagnation, abdominal pain, constipation, dysentery, abdominal distention, thoracic obstruction, uterine prolapse, gastroptosis, and proctoptosis.

Tribulus terrestris, bitter, pungent and mild. It enters liver meridian. Calm liver yang, soothe liver and relieve depression, improve vision, dispel wind and relieve itching. Can be used for treating headache, vertigo, chest and costalgia, galactostasis, conjunctival congestion, lacrimation, and rubella with pruritus.

The preparation method of the traditional Chinese medicine composition is not special, and the traditional preparation method of the formula in the field is adopted, wherein the ginseng and the saffron are separately stewed, and the ginseng and the saffron are added into the traditional Chinese medicine composition after other raw materials are decocted conventionally and stewed with medicinal juice.

The research team of the invention is from the andrology department of the sea of the Longhua hospital, the professor of the Zhou Zhiheng of the Chinese medicine of the Shanghai city is one of the creators of the andrology department of the Chinese medicine, the research on the male disease of urinary system begins as early as the eighties of the last century, the traditional Chinese and western medicine combined urinary system of the Longhua hospital which is initiated by the professor is the special clinic for treating the male disease which is set up at the earliest in the Shanghai city, the first prescription of the Weige in the Shanghai city is born in the traditional Chinese and western medicine combined urinary system of the Longhua hospital, the ancient times are the history of the male disease, and the man is good at the aspects of the Zhongzhong Zhong xi, and the impotence is considered from the aspect of the treatment of the kidney and the heart and the liver^【19】. The mechanism of peri-mental homeostasis was inspired from the earliest mechanism of use of wanaike for pulmonary hypertension treatment, and the concept that impotence is a cardiovascular disease was proposed early^【20】Innovatively suggests that impotence is treated from heart and pulse^【21】For heart governing vessels, qi deficiency failing to nourish the vessels and vessels failing to circulate vessels, stagnation will begin to occur, and long-term circulation will be obstructed and the tendons will be flaccid; the Chinese medicinal composition for treating the impotence, which is prepared from the Chinese medicaments for removing blood stasis, promoting blood circulation, tonifying qi and strengthening heart, is summarized according to the clinical medication experience of over ten years, and is currently applied as a Chinese medicinal innovation experience point project in Shanghai city (report number: N2012070302); similarly, the theory of traditional Chinese medicine considers that the liver meridian circulates yin, the liver governs smoothing flow of qi, the smoothing flow of qi is deficient, and qi and blood are not reached, so that the collaterals are not nourished, and the tendons are flaccid and useless. It is also observed in clinic that modern people have great working and life pressure, and the impotence is mainly caused by functional factors and mental factorsThe essence is related to the function of the liver, and the smoothing of qi is not limited to the smooth regulation of qi and is also related to a series of physiological functions such as blood circulation, mental activities, hormone secretion and the like, and the erection and the sustained erection of the liver stem depend on the function of liver storing blood and the rapid and sufficient collection and transportation of the blood stored in the liver. In addition, when sexual intercourse is over, orgasm subsides, the penis recovers fatigue and softness, and the liver is also relied on to dredge, so that the penis can be timely transported. One by one and the other by opposite phases, thereby ensuring the normal erection or recovery of the penis. Therefore, the treatment mainly aims at tonifying qi and dredging collaterals, and the treatment with the functions of tonifying kidney and soothing liver can obtain good curative effect^【19】In the traditional Chinese medicine composition, the ginseng tonifies primordial qi greatly, and the Chinese ilex root promotes blood circulation, removes blood stasis and promotes blood circulation to be the monarch drug; safflower and notoginseng are used for promoting blood circulation and invigorating pulse, and astragalus root is used as ministerial drug for promoting qi circulation, invigorating qi and invigorating yang; the epimedium, the common cnidium fruit, the medlar, the cynomorium songaricum and the prepared rehmannia root are used as assistants for tonifying the kidney and regulating the qi and the yin; radix bupleuri, immature bitter orange and tribulus terrestris are used for soothing the liver, regulating qi and activating yang. The medicines of the whole formula are combined to play the function of strengthening tendons and curing flaccidity together. Modern pharmacological research finds that ginsenoside which is a main component in ginseng has concentration-dependent relaxation effect on cavernous body smooth muscle of penis and can improve acetylcholine-induced cavernous body smooth muscle relaxation^【22】It is shown that ginsenosides induce engorgement of the corpora cavernosa by promoting the release of Nitric Oxide (NO) by endothelial cells. Panax Notoginsenosides (PNS) as the main ingredient of Panax notoginseng has a hyperemic effect on the corpora cavernosa of human, monkey and dog, and is achieved by activating Nitric Oxide Synthase (NOS), stimulating endothelial cells to release NO, and relaxing the smooth muscle of corpora cavernosa^【23】. Similarly, icariin in herba Epimedii, osthole in fructus Cnidii, and Protodioscin in fructus Atriplicis Sibiricae have different degrees of effects in promoting penis cavernous body congestion and erection^【24-26】The traditional Chinese medicine composition has obvious curative effect on ED in clinical use.

Compared with the prior art, the invention has the following obvious advantages:

firstly, the traditional Chinese medicine composition is mainly developed according to the pathogenesis characteristics of male erectile dysfunction of middle-aged and elderly people. The causes of erectile dysfunction of middle-aged and elderly men are various and comprise endocrine, nerve, blood vessel, systemic diseases, local penis diseases, nutrition, psychological factors and medicine relation, and the traditional Chinese medicine considers that after the men enter the middle-aged age, namely the age ranges of five-eight (40) -eight (64), as congenital kidney qi becomes gradually weak and essence and blood become deficient day by day, and then natural fatigue and heart-blood are haggard, yin-yang imbalance of heart, liver and kidney is caused. Aiming at that the Zhou's andrology team puts forward the concept that impotence is cardiovascular disease very early, and innovatively puts forward that impotence is treated from heart and pulse, the traditional Chinese medicine composition for treating impotence, which is summarized according to the clinical medication experience of more than ten years, can remove blood stasis, promote blood circulation, tonify qi and strengthen heart, has extremely strong targeted curative effect on erectile dysfunction of men, particularly middle-aged and old men, has lasting curative effect, and addresses both the symptoms and root causes.

Secondly, the traditional Chinese medicine composition has simple preparation process, advanced dosage form, convenient taking and good tolerance of patients.

Thirdly, after a research team formed by clinicians clinically observes and acts on a patient who uses modern drug sildenafil (viagra) ineffectiveness and intervenes and treats 1 course of treatment (2 months) by using the traditional Chinese medicine composition, the result shows that the treatment group not only obviously improves the traditional Chinese medicine symptoms such as soreness and weakness of waist and knees, listlessness, hectic fever, night sweat, insomnia, amnesia, sexual apathy, erectile dysfunction and the like, but also obviously improves physical and vasomotor symptoms, psychology symptoms, sexual function symptoms and the like (P <0.05), and compared with penis erection hardness grade reflecting main curative effect indexes and international erection function scale score (IIEF), the improvement (P <0.05) is obviously superior to that of a sildenafil and classic kidney tonifying traditional Chinese medicine Yougi control group, and the difference has statistical significance (P < 0.05). Research results show that the traditional Chinese medicine composition prescription with the effects of tonifying qi, invigorating pulse-beat and tonifying liver and kidney has good curative effect on improving the clinical symptoms of erectile dysfunction of middle-aged and elderly people and the refractory erectile dysfunction and other diseases of modern medicines, and has certain clinical popularization value.

Detailed Description

The invention will be further illustrated with reference to the following specific examples. These examples are to be construed as merely illustrative and not limitative of the remainder of the disclosure in any way whatsoever. After reading the description of the invention, one skilled in the art can make various changes and modifications to the invention, and such equivalent changes and modifications also fall into the scope of the invention defined by the claims.

Firstly, implementing clinical observation:

1 data and method

1.1 case selection

1.1.1 diagnostic criteria

The diagnosis of Erectile Dysfunction (ED) conforms to the European urinary surgery Association for diagnosis and treatment guidelines for erectile dysfunction^[2]I.e. the international erectile function index questionnaire IIEF-5 score^[3]<For 22 minutes, the penis is not sustained (at least 6 months) to achieve and maintain a sufficient erection for satisfactory sexual life.

1.1.2 inclusion criteria

Meeting the diagnosis standard of the erectile dysfunction; ② the product is 45-65 years old and has fixed mate; ③ the course of disease is more than 6 months; and the curative effect of sildenafil is unsatisfactory within 2 months.

1.1.3 exclusion criteria

Firstly, other treatment means are used in nearly 7 days to possibly interfere with the judgment of curative effect; ② patients with obvious genital deformity and genital system infection; ③ those who have mental disorders; fourthly, patients with serious primary diseases of cardiovascular, liver, kidney and hematopoietic systems are combined; people with allergic constitution or allergic to the study medicine; sixthly, patients with active infectious disease history; seventhly, if the treatment is not performed according to the regulation, the curative effect cannot be judged, or the data is not enough to influence the curative effect or the safety judgment.

1.2 general data

The 60 cases are patients treated by the outpatient department of urology andrology at the hospital from 8 months to 2015 months in 2013, and are divided into a treatment group and a control group by a random digital table method, wherein each group comprises 30 cases. The age of the treatment group is 46-65 years, and the average (54.38 +/-5.92) years; the course of disease is 6-9 months, and the average (6.95 +/-1.13) months. The age of the control group is 45-63 years, and the average (53.67 +/-6.03) year; the disease course is 6-10 months, and the average (6.78 +/-1.49) months. The difference between the two groups of baseline data is not statistically significant (P >0.05) and is comparable.

1.3 methods of treatment

1.3.1 control group

Sildenafil citrate (Perey pharmaceuticals, Inc., batch No. H20020528), 100mg each time, is orally administered about 1-2H before sexual activity. The treatment course is 2 months, and the treatment course is 4 times. ② Yougui pill (Henan province, Asahi pharmaceutical Co., Ltd., batch number: Z41022170), 9g each time, 3 times a day, orally taken. The treatment course is 2 months.

1.3.2 treatment groups

The administration method and the treatment course of sildenafil citrate are the same as those of a control group. ② the traditional Chinese medicine composition (5 g of ginseng, 60g of pubescent holly root, 0.5g of saffron, 15g of panax notoginseng, 30g of raw astragalus root, 15g of common cnidium fruit, 15g of medlar, 15g of epimedium herb, 12g of cynomorium songaricum, 15g of prepared rehmannia root, 12g of bupleurum, 9g of immature bitter orange and 15g of tribulus terrestris) is decocted with water for 1 dose per day and is taken separately in the morning and evening. The treatment course is 2 months.

1.4 Observation items and methods

1.4.1 penile erection hardness rating

Before and after treatment, the international penis erection hardness grade evaluation standard (EHGS) is adopted^[3]And evaluating the erection hardness condition of the penis. Stage I: the penis is enlarged in volume and poor in hardness; II stage: hard, but not insertable into the vagina; grade III: can be inserted into the vagina, but is not completely rigid; IV stage: completely firm erection and firmness.

1.4.2 erectile function score

Before and after treatment, the international erectile function index questionnaire (IIEF-5) is adopted, and the erectile function condition is evaluated by a scoring method.

1.4.3 Targeted Lesion score for delayed onset testicular hypofunction

Before and after treatment, a delayed testicular hypofunction questionnaire (SILOH) is adopted, and physical symptoms, vasomotor symptoms, psychosomatic symptoms and sexual hypofunction symptoms are evaluated by a scoring method. There were 12 questions in 4 groups of symptoms, each with most of the time, typically the time, few, and no 4 options, respectively, on a 1 point, 2 points, 3 points, and 4 points.

1.4.4 safety

Blood routine, urine routine, liver function, renal function, electrocardiogram and blood pressure are detected before and after treatment, and adverse reaction related to the medicine is observed and recorded during the test.

1.5 statistical methods

The experimental data were statistically analyzed using SPSS 15.0 software. Measure data to

Representing, adopting t test; ridit analysis was used for the grade data. Both tests were bilateral, and P.ltoreq.0.05 was considered statistically significant for the differences.

2 results

2.1 grade Change in penile erection hardness

The difference of the penis erection hardness grades of the two groups before treatment has no statistical significance (P is more than 0.05); after 2 months of treatment, 22 patients in the treatment group reach above grade III, and 17 patients in the control group; compared with the penis erection hardness grade after treatment among groups, the difference has statistical significance (P is less than 0.05), and the treatment group is superior to the control group. See table 1.

TABLE 1 comparison of grade change of penis erection hardness in two groups (example)

Note: p is less than 0.05 compared with the two groups before and after treatment

2.2 IIEF-5, SILOH integral Change

The pre-treatment IIEF-5 and SILOH scores in the two groups were not statistically significant (P > 0.05). The IIEF and SILOH scores of the two groups are obviously increased (P is less than 0.05) compared with the groups before and after treatment. The IIEF score of the treated group was higher than that of the control group compared after treatment among the groups, and the difference was statistically significant (P < 0.05). See table 2.

TABLE 2 comparison of the integral changes of two groups of IIEF and SILOH (

Minute)

Note: p <0.05 compared to the group before treatment; after treatment with control group, # P <0.05

2.4 Security comparison

In the control group, 1 case showed mild transient facial flushing, which did not affect the test and observation, and no treatment was performed; no obvious abnormal changes were observed in all cases in the treatment group. No obvious abnormality is found in blood routine, urine routine, liver function, renal function, electrocardiogram and blood pressure before and after treatment in the two groups.

The clinical observation results show that the Chinese medicinal composition prescription with the effects of tonifying qi, invigorating pulse-beat and tonifying liver and kidney has good curative effect on improving the clinical symptoms of erectile dysfunction of middle-aged and elderly people and treating refractory erectile dysfunction of modern medicaments, and has certain clinical popularization value. And the use is safe, and the clinical popularization value is certain.

Second, typical medical record

1. Patient name: sex of sheet XX: birth date of 46 years old teacher: 9/1972

The date of the visit: onset solar terms of the first diagnosis in 9 months and 4 days in 2018: after white dew

The main complaints are: impotence after 1 year with lassitude

The current medical history: the patient has no obvious reasons before 1 year, and has occupational lassitude, haggard heart, sexual impotence, debilitation and mental fatigue, normal physical examination in internal medicine and elimination of secondary diseases. Yohimbine and Wanyike are used successively, so the effect can be achieved after the medicine is taken and the medicine is stopped and repeated. After the treatment of negative pressure suction, the improvement is still not achieved. Lusterless complexion, lassitude, soreness and weakness of the loins and knees, aversion to cold, cold limbs, mental depression, thin and white tongue coating and thready and weak pulse. And (4) checking: the external genitalia has no abnormal size and shape, the volume of the testicles on both sides is about 15ml respectively, the prepuce is too long, the penis body has no obvious nodes, lumps and scars after trauma. 9.2 my house BUS: no obvious abnormality was seen in bilateral spermatic vein testis. Endocrine hormone levels: meets the standard of the age group, and has no interruption of urination, frequent micturition, odynuria, fever, loose stool, anorexia, and insomnia.

History of the past: deny the history of family genetic disease, no operation history, no history of trauma and drug allergy, and no history of parotitis.

History of allergy: deny the history of medicinal and edible allergy.

Physical examination: the external genitalia has no abnormal size and shape, the volume of the testicles on both sides is about 15ml respectively, the prepuce is too long, the penis body has no obvious nodes, lumps and scars after trauma. A thin and white coating and a thready and weak pulse.

Auxiliary inspection: 9.2 my house BUS: no obvious abnormality was seen in bilateral spermatic vein testis. Endocrine hormone levels: meets the standard of the age group

Traditional Chinese medicine diagnosis: impotence

Syndrome diagnosis: decline of vital gate-fire and kidney yang deficiency

And (3) Western diagnosis: erectile dysfunction (grade I erection)

Therapeutic method: warming and recuperating kidney yang, benefiting qi and dredging collaterals

Prescription: 5g of ginseng, 60g of pubescent holly root, 0.5g of saffron, 15g of panax notoginseng, 30g of raw astragalus membranaceus, 15g of fructus cnidii, 15g of medlar, 15g of herba epimedii, 12g of cynomorium songaricum, 15g of radix rehmanniae preparata, 12g of radix bupleuri, 9g of immature bitter orange and 15g of tribulus terrestris. The X14 dose is decocted with water, 1 dose per day, and 200ml of decoction is taken after 2 times of decoction, and the decoction is taken in the morning and evening. Meanwhile, spicy, uncooked, cold and greasy substances and wine and tobacco are forbidden, the diet is light and rich in nutrition, the daily life is regular, and the increase of aerobic exercise is recommended.

And B, diagnosis: after 14 doses, the sexual dysfunction is gradually improved, and the patient feels intolerant to cold. Then the medicine is taken for 14 doses,

three diagnoses: after 28 doses, the yang has already developed and the feelings of the couples are improved, and the patients are cured by oral administration for half a year with the addition and subtraction of the re-diagnosis according to the syndrome.

Claims

1. A traditional Chinese medicine composition for treating male erectile dysfunction of middle-aged and elderly people is characterized by comprising the following raw material medicines in parts by weight: 6-10 parts of ginseng, 120 parts of pubescent holly root, 180 parts of saffron, 1 part of saffron, 30-60 parts of panax notoginseng, 60-90 parts of raw astragalus, 30 parts of common cnidium fruit, 30 parts of medlar, 30 parts of epimedium herb, 24 parts of cynomorium songaricum, 30 parts of prepared rehmannia root, 24 parts of Chinese thorowax root, 18 parts of immature bitter orange and 30 parts of tribulus terrestris.

2. Use of the Chinese medicinal composition of claim 1 in the preparation of a medicament for treating erectile dysfunction in middle-aged and elderly men.