1997 results about "Clinical efficacy" patented technology

The present invention provides a method, apparatus, and computer instructions for improved control of clinical trials. In a preferred embodiment, after a clinical trial is initiated, data is regularly cleaned and processed to statistically analyze the data. The outcome includes a predictive measure of the timing and level by which the study will achieve one or more statistically significant levels, allowing mid-course modifications to the study (e.g., in population size, termination, etc.). Modification can be planned as part of the initial protocol, using thresholds or other appropriate criteria relating to the statistical outcome, making possible pre-approved protocol changes based on the statistical findings. This process has significant implications for the management of clinical studies, including ensuring the minimum possible time and number of patients are used in clinical studies to either prove (or disprove) the clinical efficacy of drugs or treatments.

The present invention relates generally to medical devices containing nanoporous surfaces and methods for making same. More specifically, the invention relates to implantable vascular stents or other biomedical devices having at least one nanoporous layer that promotes improved cellular adhesion properties that promote healing and long term biocompatibility. In the case of stents, the nanoporous layer promotes re-endothelialization at sites of stent implantation vasculature, improves overall healing, and reduces inflammation and intimal disease progression. The nanoporous layer may be optionally loaded with one or more therapeutic agent to further improve the function of the implanted stent and further augment clinical efficacy.

Methods of identifying, monitoring and matching patients with appropriate treatments who are at risk for developing a systemic inflammatory condition using a systemic mediator-associated physiologic test profile are provided. The methods of the present invention increase the likelihood of demonstrating clinical efficacy in clinical trial datasets.

This invention provides novel injectable compositions comprising botulinum toxin that may be administered to a subject for various therapeutic, aesthetic and/or cosmetic purposes. The injectable compositions contemplated by the invention exhibit one or more advantages over conventional botulinum toxin formulations, including reduced antigenicity, a reduced tendency to undergo unwanted localized diffusion following injection, increased duration of clinical efficacy or enhanced potency relative, faster onset of clinical efficacy, and/or improved stability.

The invention discloses a new traditional Chinese medicine composition for treating insomnia and a preparation method thereof. The traditional Chinese medicine composition mainly comprises the following raw Chinese medicinal herbal materials: cinnabar, nacre mother of pearl, cortex albiziae, semen boitae, tuber fleeceflower stem, polygala root, amber, fossil fragments, spina date seed, glossy ganoderma, shell of abalone, oyster, gastrodia elata, root of straight ladybell, ophiopogon japonicus, lucid asparagus, fruit of Chinese wolfberry, fushen, motherwort, Chinese angelica, radix paeoniae alba, cortex lycii radicis, agilawood, root of three-nerved spicebush, rhizoma cyperi and the like. The traditional Chinese medicine composition can be prepared into any one common oral preparation according to a conventional traditional Chinese medicine preparation method. The invention can remarkably improve symptoms of insomnia, difficulty falling asleep, easy awakening, difficulty falling asleep after awakening, alternation of falling asleep and awakening, difficulty falling asleep all through the night, doldrums, slow response, fatigue, even vexation and the like, and has the advantages of accurate clinical treatment effect, remarkable treatment effect, low cost, basically no toxic or side effects, and the like.

The invention discloses a new traditional Chinese medicine composition for treating cerebral thrombosis and cerebral infarction and a preparation method thereof. The traditional Chinese medicine composition mainly comprises the following Chinese medicinal herbs such as dutchmanspipe root, fruit of immature citron, dried orange peel, pangolin scales, ground beeltle, ligusticum wallichii, cassia twig, angelica sinensis, radix paeoniae alba, root of red-rooted salvia, agilawood, rhizoma cyperi, rhizoma corydalis, radix curcumae, pseudo-ginseng, common burreed rhizome, curcuma zedoary, red flower, peach kernel, rhizoma gastrodiae, uncaria rhynchophylla, white muscardine silkworm, scorpio, styrax asiatic styrax and rhizoma acori graminei. The traditional Chinese medicine composition can be prepared into any one common oral preparation according to a conventional traditional Chinese medicine preparation method. The invention can remarkably improve the symptoms of aphasia from apoplexy, facial paralysis, numb hands and feet, blindness, dizziness and faint, hypertension, blood viscosity increase, insufficiency of cerebral blood supply and the like, and has accurate clinical treatment effect, remarkable treatment effect and rapid effect. The traditional Chinese medicine composition has the advantages of low cost, basically no toxic or side effects and the like.

The invention relates to a liver targeting anticancer nanometer prodrug system basing on dendritic polymer, provides a method for preparing the prodrug system and the uses thereof and belongs to the technical field of biological medicine as well as the technical field of nano medicine. With the polyethylene glycol modified PAMAM treelike polymer of distal liver targeting group (T) as a carrier (T-PEG-PAMAM) and Doxorubicin (DOX) as treatment drug, the invention obtains the prodrug (T-PEG-PAMAM-DOX) through the covalent bond connection with degradable lysosome between the carrier and the Doxorubicin. The invention further provides the application of the liver targeting anticancer nanometer prodrug system basing on the dendritic polymer in the preparation of drugs for treating solid tumors. With the long-acting cycle in blood, the liver targeting anticancer nanometer prodrug system basing on the dendritic polymer can enhance the phagocytosis of hepatoma cells on polymers nano-micelles, realize the active and passive targeting on liver tumor tissues, improve the clinical efficacy and the bioavailability of present liver cancer therapeutic drugs and lower toxic and side effects.

The present invention relates generally to a drug eluting stent containing metallic surfaces modified in microsphere metallic matrix structure and methods for making same. More specifically, the invention relates to an expandable and implantable vascular stent having at least one matrix layer that promotes improved cellular adhesion properties for healing promotion healing and long term biocompatibility. In the case of coronary stents, the metallic matrix layer promotes re-endothelialization at sites of stent implantation, improves overall healing, and reduces inflammation and intimal disease progression. The microsphere metallic matrix layer may be optionally loaded with one or more therapeutic agent to further improve the function of the implanted stent and further augment clinical efficacy and safety. The active compounds are selected primarily for their anti-proliferative, immunosuppressive, and anti-inflammatory activities, among other properties, which prevent, in part, smooth muscle cell proliferation and promote endothelial cell growth.

The invention discloses a new traditional Chinese medicine composition for treating the disease of chronic nephritis and a preparation method thereof. The composition mainly comprises the following raw medicines: tuckahoe, notopterygium root, atractylodes macrocephala koidz, oriental waterplantain rhizome, plantain seed, rhizoma atractylodis, officinal magnolia bark, areca peel, rheum officinale,chrysanthemum, taraxacum officinale root, amur corktree bark, rhizoma cyperi, eucommia bark, zanthoxylum pipertum, talc, Japanese climbing fern spore, glossy privet fruit, epimedium herb, semen alliituberose, angelica, pyrrosia lingua, akebiaquinata, medicated leaven, malt, gizzard pepsin, cape jasmine, immature bitter orange, pericarpium zanthoxyli, Chinese eaglewood, loosestrife, pollen typhaecarbonisatus, cacumen biotae carbonisatus and semen euryales. The composition can be prepared into any one common oral preparation according to the conventional traditional Chinese medicine preparation method. The composition can obviously improve the symptoms such as abdominal fullness and distention, anasarca, fatigue and heaviness, chest stuffiness and poor appetite, aching and limp waist and knees, extreme chilliness, palpitation and severe palpitation and the like, and features confirmed clinical effects, obvious and quick effects. The composition basically combines the medicinal and editable medicines specified in the State Pharmacopoeia, thus having the advantages of low cost and no toxic side effects basically, etc.

There is disclosed a once daily oral pharmaceutical compositon for controlled release of tramadol or a salt thereof, wherein the composition, when ingested orally, provides a clinical effect over 24 hours which is a least as good as the clinical effect over 24 hours of two doses of a twice daily oral pharmaceutical composition for controlled release of tramadol, taken 12 hours apart

The invention discloses a traditional Chinese medicine composition for treating colon cancer and a preparation method thereof. The traditional Chinese medicine composition mainly comprises the following raw medicinal herbs: indigo naturalis, tuckahoe, coix seed, taraxacum officinale root, herba violae, Mangnolia officinalis, houttuynia cordata, patrinia, angelica sinensis, radix paeoniae alba, Chinese lobelia herb, radix sophorae falvescentis, dried orange peel, medicated leaven, rhizoma cyperi, aspongopus, prepared frankincense, prepared myrrh, corydalis tuber, manis pentadactyla, raw astragalus mongholicus, radix notoginseng, charred sanguisorba officinalis, rhizoma sparganii, curcuma zedoary and the like. The Traditional Chinese medicine composition can be prepared into any one common oral preparation according to a conventional traditional Chinese medicine composition method. The invention can remarkably improve symptoms of frequency increase of defecate, blood and mucus brought in the defecate, bellyache, diarrhea or astriction, intestinal obstruction and malaise, weight reduction, anemia and the like, and has accurate clinical treatment effect, remarkable treatment effect and rapid effect taking. Because of being combined by basically adopting medicinal and edible medicines specified in National Formulary, the traditional Chinese medicine composition has the advantages of low cost, basic no toxic and side effect, and the like.

The invention discloses a Chinese medicinal composition for treating pelvic inflammation and a preparation method thereof. The Chinese medicinal composition of the invention mainly comprises the following raw materials: lightyellow sophora root, figwort root, gardenia, dandelion, violet, weeping forsythia, divaricate saposhnikovia root, root of rehmannia, sinkiang arnebia root, vine root, plaster, rhizoma anemarrhenae, reed rhizome, cogongrass rhizome, mongolian snakegourd root, common lophatherum herb, coptis, ash bark, cotex dictamni, dahurian patrinia herb, tree peony bark, root-bark of Chinese wolfberry, costus root, India madder root, rosewood heart wood, szechuan lovage rhizome, tuber, root of red-rooted salvia, motherwort and the like. The Chinese medicinal composition of the invention can be prepared into any one common oral preparation by the conventional Chinese medicinal preparation method. The Chinese medicinal composition can obviously improve pelvic inflammations, including symptoms such as endometritis, salpingitis, tubo-ovarian abscesses, pelvic peritonitis, salpingitis, salpingo oophoritis and the like, and has definite clinical therapeutic effect, obvious therapeutic effect and quick response. The Chinese medicinal composition of the invention also has the advantages of low cost, basically no toxic or side effect and the like.

The invention discloses a total bufogenin extract with antitumor function and also discloses a preparation method of the extract and application thereof in the preparation of antitumor medicines. The total bufogenin extract of the invention is prepared by organic solvent extraction, column chromatography separation and purification of dried toadskin; the content of total bufogenin is over 80 percent, wherein the content of resibufogenin is over 12 percent, the content of cinobufagin is over 4 percent, and the content of bufotalin is over 10 percent. Compared with the prior art, the invention eliminates bufotenine alkaloid which has irritation, is easy to cause hypersensitivity but has no antitumor activity, efficiently collects the effective part of total bufogenin which has significant antitumor activity, therefore pharmacological action is stronger, the clinical curative effect is higher and the toxic and side effect is lower. The total bufogenin extract can be prepared into various pharmaceutical preparations for clinical application, therefore the invention has the functions of killing tumor cells, inducing differentiation and apoptosis of tumor cells, inhibiting the neovascularization of tumor cells and lowering the neoplasm metastasis rate, etc.

The invention relates to a moldavica dragonhead extract, a moldavica dragonhead dropping pill and a production method thereof, wherein, the moldavica dragonhead extract contains higher total flavonoids and luteolin and the production method of the moldavica dragonhead extract is simply operated. Pharmacodynamics test result indicates that the moldavica dragonhead dropping pill acquired from the invention has excellent curative effect to rat ischemia myocardial injury; each dose group of the moldavica dragonhead dropping pill has varying degrees of protection; Composite salviae dropping pill has similar effect with the middle-dose group of moldavica dragonhead dropping pill; all dose groups of the moldavica dragonhead dropping pill have better curative effect than Yixing Badiranjibuya Keli at ischemia myocardial; dosages of middle-dose group of moldavica dragonhead dropping pill and low-dose group of moldavica dragonhead dropping pill are only 50 percent and 25 percent of the dosage of Yixing Badiranjibuya Keli respectively, thereby greatly improving the compliance of sufferers. The moldavica dragonhead dropping pill acquired from the invention is a novel preparation of convenient use and good compliance, thus bringing into play better clinical curative effect of the moldavica dragonhead, an age-old Uighur medicinal material. The production method of the moldavica dragonhead dropping pill can be carried out easily.

The invention discloses a new traditional Chinese medicine composition for treating advanced malignant liver tumor symptoms and a preparation method thereof. The traditional Chinese medicine composition is mainly prepared from the following medicine components: angelica, tuckahoe, hemlock parsley, cassia twig, dried ginger, Bupleurum, kudzu root, Baikal skullcap root, coptis, flavescent sophora root, honeysuckle, Taraxacum, pangolin, leech, natural indigo, subprostrate sophora, moutan bark, red-rooted salvia root, red paeonia, white peony root, white atractylodes rhizome, gromwell, cornu antelopis powder, rhubarb, magnolia bark, three-nerved spicebush root, notoginseng, madder, draconis sanguis, rhizoma corydalis, raw Astragalus root, codonopsis pilosula, peach seed, safflower, turmeric, Endothelium Corneum Gigeriae Galli, Fructus Aurantii Immaturus, Polyporus umbellatus, rhizoma alismatis, Plantain seed, climbing fern spore, giant knotweed, Evodia rutaecarpa, nut grass, galangal and allium macrostemon. The traditional Chinese medicine composition can be prepared into any commonly-used oral preparation by using the conventional traditional Chinese medicine preparation method. The traditional Chinese medicine composition can be prepared into any commonly-used oral preparation by using the conventional traditional Chinese medicine preparation method. The invention can obviously improve the intense pain, obstructs the canceration of liver tumor cells, interdicts the reproduction of tumor cells, recovers the activity of liver cells, enhances the self-repairing function of the liver, resists the diffusion and prevent the metastasis, obviously shrinks the liver tumors, relieves and eliminates the ascites, improves the life quality, prolongs the life, relieves patient's pain and increases the appetite. The traditional Chinese medicine composition has exact and obvious clinical curative effect of improving the overall disease resistance.

The invention discloses a Chinese medicine composition for treating headache and a preparation method thereof. The Chinese medicine composition is mainly formed by the following raw medicine materials: angelica root, Ligusticum wallichii, storax, snowbell, Rhizoma acori Graminei, holy basil, rheum officinale, Chinese angelica, white paeony root, red paeony root, immature bitter orange, rhizoma cyperi, notopterygium root, agilawood, dalbergia wood, Salvia miltiorrhiza Bunge, peach kernel, safflower, motherwort herb, pangolin scale and the like. The Chinese medicine composition of the invention can be prepared into any kind of common oral preparation according to the conventional Chinese medicine preparation method. The invention has the advantages that symptoms such as headache, parietal headache, medial headache and migraine, facial neuralgia, dysphoria, emotional instability, anxiety, insomnia, amnesia and the like are obviously improved, the clinical curative effect is exact, the curative effect is obvious and the rapid effect is obtained. Moreover, the Chinese medicine composition is basically combined by homologous plant food medicines regulated in National Formulary, thereby having the advantages of low cost, basically no toxic side effect and the like.

The invention discloses a new traditional Chinese medicine composition for treating colonitis and a preparation method. The traditional Chinese medicine composition mainly comprises the following raw medicinal herbs: white atractylodes rhizome, tuckahoe, medicated leaven, red halloysite, Yaoli, myristica fragrans, plantain seed, charred cacumen biotae, dried orange peel, prepared frankincense, prepared myrrh, Mangnolia officinalis, fructus amomi, rhizoma atractylodis, radix sophorae falvescentis, scutellaria baicalensis, angelica sinensis, root of common peony, radix paeoniae alba, taraxacum officinale root, elbow, yam, herba cistanche and the like. The traditional Chinese medicine composition can be prepared into any one common oral preparation according to a conventional traditional Chinese medicine composition method. The invention can remarkably improve symptoms of diarrhea, bellyache, mucous stool and bloody purulent stool, tenesmus, even constipation for several days, irregularity of diarrhea and constipation, usually accompanied emaciation and acratia and the like, and has accurate clinical treatment effect, remarkable treatment effect and rapid effect taking. Because of being combined by basically adopting medicinal and edible medicines specified in National Formulary, the traditional Chinese medicine composition has the advantages of low cost, basic no toxic and side effect, and the like.

The invention relates to a nerve ablation catheter and device for a nerve ablation in a cavity-passing and wall-penetrating mode and a method for the nerve ablation. A catheter body comprises a far-end portion, a middle portion and a near-end portion. A catheter-wall-penetrating ablation electrode is arranged at the far end of the catheter body. A catheter-wall-penetrating structure is arranged at the front end of the catheter-wall-penetrating ablation electrode and capable of penetrating into and/or penetrating through the wall of the catheter cavity so as to act on a target tissue. Measurement on volume impedance is carried out on an ablation portion, the conditions of nervous tissue distribution and strength is detected through a special petal-shaped electrode. The petal-shaped electrode can also offer impedance changes generated before the ablation and after the ablation, the changes after the ablation of nervous tissues are reflected, control and mastering of a nerve ablation degree are guided, treatment accuracy and clinical effects are improved, and complications are prevented from happening.

The invention discloses a method for detecting the quality of a compound capsule prepared from 8 kinds of amino acids and 11 kinds of vitamins, mainly comprising the steps of detecting whether the inclusion of the capsule is yellow or tangerine powder or particles, differentiating, checking the loss on drying and measuring the contents of amino acids, vitamin C, niacinamide, vitamin B1, vitamin B6, vitamin B2, calcium pantothenate, folic acid, vitamin A, vitamin D2, vitamin E and 5-hydroxy o-aminobenzoic acid in the capsule by adopting the high-performance liquid chromatography. The method for detecting the quality of the compound capsule prepared from 8 kinds of amino acids and 11 kinds of vitamins is scientific and reasonable, has high degree of accuracy, good repeatability, can comprehensively and effectively control the quality of the compound capsule prepared from 8 kinds of amino acids and 11 kinds of vitamins, and can ensure the clinical efficacy of the preparation.

The invention discloses a serial Chinese medicinal preparation for treating child common cold, a preparation process and a quality control method thereof. Preparations are characterized by being prepared from traditional Chinese medicines, namely indigowoad leaf, Chinese thorowax root, baical skullcap root, fineleaf schizonepeta herb, platycodon root and liquoric root as well as pharmaceutical excipients. The preparations have the effects of clearing away heat, relieving exterior syndromes, reducing inflammation and relieving cough, and are used for common cold and fever, headache and stuffed-up nose, cough and sneeze, and sore throat. Volatile oil from Chinese thorowax root is a material base of the 'defervescence' of the preparation, has the characteristic of quick defervescence, and is an active ingredient for treating exogenous fever of children; and the traditional preparation process is to adopt a way of spraying the volatile oil into the preparation, and the volatile oil is almost completely lost during the production and storage due to the low content of the volatile oil, so that the clinical therapeutic effect is seriously affected. In the preparation process, a beta-cyclodextrin inclusion technology is adopted for the inclusion of the volatile oil from Chinese thorowax root to ensure that a liquid medicine is solidified; and thus the loss of the volatile oil during the production and storage is reduced, and the stability of the medicine is improved and the clinical therapeutic effect of the medicine is ensured at the same time. In addition, the more perfect quality control method is used for ensuring the quality; meanwhile, the clinical medication formulation is also enriched, so that the clinical medication demand can be better met.

The invention relates to a colloid bismuth pectin compound and a quality control method of pharmaceutical compositions of the colloid bismuth pectin compound, and specifically provides a colloid bismuth pectin compound, new quality control indexes of pharmaceutical compositions of the colloid bismuth pectin compound and a detection method of the colloid bismuth pectin compound and the pharmaceutical compositions of the colloid bismuth. In the prior art, the quality of products having poor efficacy can not be well controlled because the efficacy-related indexes are not controlled strictly in the existing quality control methods of colloid bismuth pectin and pharmaceuticals thereof. Based on the existing quality control methods of colloid bismuth pectin and pharmaceuticals thereof, the following detection items and indexes are added: intrinsic viscosity, gel property, uniformity and galacturonic acid content. The invention can effectively ensure clinical efficacy of products, make the product quality standards more scientific, reasonable and controllable, and has great significance in quality control of the colloid bismuth pectin and the pharmaceutical preparation of colloid bismuth pectin.

The invention provides a system for evaluating hearing-speech rehabilitation training and curative effect of patients with post-stroke dysarthria and a device thereof. The system comprises a patient selecting module (1), an effect evaluating module (2), a training module (3) and a clinical curative effect evaluating module (4). The invention also provides a method for evaluating hearing-speech rehabilitation training and curative effect of patients with post-stroke dysarthria. The method comprises the following steps: selecting patients with post-stroke dysarthria, evaluating before training, training language, evaluating after training and evaluating clinical curative effect. The system and the method are used for training pronunciation and reading in hearing-speech rehabilitation treatment of the patients with post-stroke dysarthria, providing curative effect evaluation, improving pronunciation accuracy degree and continuous pronunciation coordination ability of the patients, subdividing treatment grades according to different conditions of the patients, making individual training schemes and improving pertinence, relieving working strength of hearing-speech rehabilitation therapists and effectively improving the working efficiency and the individual treatment training effect.